const BRCGS_DATA_EXT = [{"section": 1, "title": "Senior management commitment", "clauses": [{"id": "1.1.1", "requirement": "The site shall have a documented policy which states the site’s intention to meet its obligation to produce safe, legal and authentic products to the specified quality, and its responsibility to its customers. • be signed by the person with overall responsibility for the site. • be communicated to all staff. • include commitment to continuously improve the site’s food safety and quality culture.", "interpretation": "The site’s policy must clearly state the overall aims to meet customer requirements, including the provision of safe, authentic products of the quality desired by the customer.\nThe policy will also highlight the site’s intention to improve product safety and quality culture on a continuous basis, which, as discussed (for example, in the interpretation for the statement of intent and importantly in clause 1. 1.2), is fundamental in the consistent application of product safety practices. The policy is designed to show the site’s intention, so that all staff can work towards this common goal.\nAuthenticity of products means ensuring that all products sold or purchased are of the nature, substance and quality expected. This applies not just to product claims, but includes all products and raw materials with the assurance that they meet the specification.\nAuthenticity is defined in the glossary.\nThe policy must be signed by the person with overall responsibility for the audited site, to demonstrate the commitment at senior management at site level. Where the policy is a group- or company-wide statement, the site management should endorse it; for example, by countersigning it.\nThe policy statement is only a summary and can usually be expressed in a single page.\nAlthough it does not need to be dated, it must be current and should therefore be updated when significant policies or senior management change. The policy forms the foundation for the site’s ways of working and the auditor will expect to see how the site management ensure staff understanding and engagement. This may include:\n• communication to staff (e. g. through display on noticeboards, inclusion in the induction process, availability on the company intranet, and the use of appropriate languages where the local language is not the first language of all employees. The use of dual languages may improve and speed up understanding and action)\n• inclusion of all staff, including temporary and contract staff, in the communication and engagement processes.", "requirement_fr": "Le site doit posséder une politique documentée établissant ses intentions de répondre à son obligation de produire des produits sûrs, légaux et authentiques ayant la qualité spécifiée et d’assumer ses responsabilités envers ses clients. Celle-ci doit :\n•\t être signée par la personne de plus grande responsabilité du site\n•\t être communiquée à l'ensemble du personnel\n•\t inclure l'engagement de toujours améliorer la culture de sécurité et de qualité des denrées alimentaires du site."}, {"id": "1.1.2", "requirement": "The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a food safety and quality culture. The plan shall include measures needed to achieve a positive culture change. • defined activities involving all sections of the site that have an impact on product safety. As a minimum, these activities shall be designed around: clear and open communication on product safety, training, feedback from employees, the behaviours required to maintain and improve product safety processes, performance measurement of activities related to the safety, authenticity, legality and quality of products. • an action plan indicating how the activities will be undertaken and measured, and the intended timescales. • a review of the effectiveness of completed activities.", "interpretation": "Analysis of the root causes of many non-conformities shows that a proactive, positive product safety and quality culture (hereafter referred to as culture) within a company can make all the difference in the effectiveness of the food safety and quality plan and its consistent implementation throughout the site. Culture must be led by senior management and ‘felt’ throughout the organisation, so that all aspects of the business are informed and involved. It is important to understand that the culture plan is unlikely to be successful if it is viewed as simply a technical function. It will require the input and commitment of the site’s senior leadership team and may also align with several teams around the business; for example, with human resources (HR) or personnel management activities.\nCulture can be challenging. It relies not just on measurables and specifics but an ethos and values felt by people at all levels of the site. The size and complexity (or simplicity) of the site should not be a barrier to a successful culture.\nThe site is required to develop, implement and maintain a clear plan or programme for developing and improving its culture. Such a plan should be based on the nature of the organisation, and dependent on its size, seasonality and the overall aims it has identified as important for its own culture. The clause does not prescribe the exact mechanisms that must be used; this is to allow the site flexibility to develop systems that are effective within its specific ways of working, and its current prevailing culture. It does, however, highlight the minimum scope of the plan.\nThe plan will need to consider the measures needed to achieve the intended positive culture change.\nThe plan does not need to be annual. A strategic plan could, for example, cover 5 years, with activities designed to measure current culture, implement changes and assess improvements (or where improvement was not evident, a review of why). Some aspects of the plan may occur more frequently than others. However, for the plan to be effective, the development and improvement of culture will need to be treated as an ongoing and continuous process, and the auditor will expect to see evidence that activities are being completed each year during which the plan is designed to operate. It is not acceptable to design a 5-year plan where all of the activities are completed within the final year.\nRegardless of the intended length or lifetime of the plan, it is important that it remains relevant and up to date. The site will therefore need to ensure that it is regularly reviewed and updated. At a minimum there must be an annual review.\nA wide range of activities could be incorporated into a culture development plan, some of which the company may already be conducting. As a minimum the Standard requires:\n• a clear and open communication on product safety\n• training\n• feedback from employees\n• behaviour changes required to maintain and improve product safety processes\n• performance measurement on product safety, authenticity, legality and quality related activities.\nHowever, note that culture is not simply a matter of introducing another policy, but on developing attitudes and a positive approach to product safety and product safety processes.\nFor example:\n• Ease of movement of product safety information between different levels and sections of the site can be an indication of a good culture. However, a formal communication policy is not likely to affect company culture, unless the site has considered what is communicated, in what format. For example, if all communication is finance-related and lacks information on product safety, then staff may mistakenly believe that product safety is not important, due to its lack of communication. Instead, regular, open and clear communication, involving all personnel, is needed, including expectations, benefits, product safety successes as well as deviations from what is expected or acceptable.\n• Training and staff development (e. g. the use of annual staff reviews and one-to-ones) should have a number of aims beyond just training the process or procedure (e. g. awareness of food safety issues, management techniques, and development of positive behaviours and staff development).\n• Feedback from employees (e. g. staff surveys), focusing on values and culture, can provide useful information on current mindset and culture, impact of recent initiatives and preferred direction of travel. Feedback mechanisms also provide an opportunity to identify and address staff concerns.\nchoose relevant behaviours that will have a positive impact on product safety. These relevant behaviours may be identified simply by a manager’s knowledge of the site, or identified through the results of a site survey (such as the BRCGS Culture Excellence Module), or by considering the many indicators (or artefacts) of the behaviours, beliefs or attitudes that exist at a site. These can provide an indication of the prevailing culture and could be used in this part of the plan. An artefact of culture is described as an existing product safety activity that is not culture itself, but is indicative of the site’s prevailing culture (i. e. the site’s attitudes towards the value or importance of a specific product safety activity, and its compliance with that activity, is often indicative of the culture of the site). These behaviours or attitudes are often identifiable by the site and useful in the maintenance and improvement of product safety culture and can therefore be built into the culture improvement plan. Many fundamental product safety processes could be considered artefacts of the culture; for example:\n• food safety policy\n• objective setting and management review\n• food safety in management meetings\n• food safety resources\n• risk awareness (e. g. for HACCP development)\n• effectiveness of corrective and preventive actions\n• internal audits\n• training.\nRemember that these activities are not the culture themselves; they are artefacts – indicators of the prevalent product safety behaviours at the site.\n• Performance measurement – this is different from clause 1. 1.3. There, the objectives are used to directly improve food safety, whereas the aim of this clause is to consider the impact of the results and learnings on product safety culture. For example, if an objective is always met, or always missed, or the objective remains unchanged every year, this may indicate a site attitude towards the objectives and provides site leadership with an attitude to focus on. In other words, is the site attitude to develop and continuously improve food safety using the objectives as one of the tools, or are the objectives set only to meet the requirements of the Standard?\nAlong with the activities, the culture plan must also include information indicating how activities will be undertaken, the intended timescales for completion, plans for measurement (including results from previous activities) and a review of the effectiveness of completed activities.\nThis information should be used to review the plan to ensure it remains up to date and relevant for the site. It also has the bonus of creating a history of improvements and impacts.\nThis information can be used, for example, to train new employees, inspire existing staff and further inform the types of activity/implementation that are most effective at the site and those which are more likely to struggle.\nCulture is often considered to be subjective and therefore difficult to audit. It must be emphasised that auditors are not expected to audit ‘food safety culture’ of the site, but the evidence of compliance with the requirements of the clause. The auditor will therefore examine evidence of conformity with this requirement during both the audit of the facilities and the documentation audit. This will be achieved using a number of auditing techniques;\nfor example:\n• a review of the documented plan and records – is it complete, does it contain all the relevant information, how were the activities and objectives set, are the monitoring and review processes operating correctly and have they been used to review and update the plan to ensure it remains relevant for the site?\n• discussion with senior management on the development and implementation of the plan (refer to clause 1. 1.11).\n• discussions may be conducted across all levels of personnel on an informal basis. The auditor would expect to find an awareness of food safety culture, how individuals can impact it, and the company’s objectives.\n• evidence of the site completing the activities in its action plan.\n• timescales and evidence that they have been met.\n• monitoring and review processes, and results from previous activities.\nBRCGS provides a number of services that can support a site’s development of its culture plan, including:\n• an additional voluntary module in product safety culture excellence which helps sites measure the current culture and identify areas for improvement.\n• a guideline on product safety culture which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.\n• a training course explaining culture and its implementation.\nNon-conformities To ensure expectations are understood relating to compliance with clause 1. 1.2, its consistent application at certificated sites, and assessment during audits, BRCGS has trained auditors and certification bodies to apply the following non-conformities, where sites are non- compliant:\n• Major non-conformity Where the site does not have a documented plan for food safety and quality culture. In this context a plan is more than a short statement of intent, but is documentation incorporating all of the requirements of the clause.\n• Minor non-conformity Where a documented plan exists, but:\n• is of poor quality (e. g. lacks detail such as timescales for completion or clear action plans)\n• does not cover all the relevant areas or staff\n• is not fully implemented (e. g. some activities are not implemented or are not completed to a predefined schedule).\nThe final bullet point in the clause requires sites to undertake a review of the effectiveness of completed activities. However, it is possible that this review of the success of the programme would not always be implemented in year 1 (since a review cannot be completed until there are activities to review). Therefore non-compliance with this bullet point is not considered a non-conformity at the site’s initial audit, but will be assessed from the site’s second audit to the Standard onwards.\nThe site is expected to complete corrective action, root cause analysis and preventive action plans in accordance with section 2. 3 of the audit protocol prior to certification, and any non- conformity will be included in the calculation of the site’s grade.\nExample Food safety and quality culture plan The company decides to implement a culture plan. Based on the requirements of the Standard it identifies six key areas to include:\n• Enhanced training Beyond just managing critical control points (CCPs), to an understanding of the reasons for the current product safety processes and involving staff in corrective actions.\n• Communications Regular staff updates in addition to the traditional internal message boards. Updates are used to communicate production, incidences of non-conforming product, customer complaints and their corrective actions, and improvements in product quality. They also focus on company strategy and product safety objectives.\n• A clear feedback process To initiate communication ‘up’ to management, so that communication is not seen just as management ‘telling staff’.\n• Recognition Management instigates ‘employee of the month’ awards as rewards for successful process improvement ideas.\n• Behaviours to maintain and improve product safety The site identifies two areas it would like to focus on:\n• Previously the site had developed reporting and whistleblowing systems which allow staff to feed back concerns relating to product safety, in accordance with clauses 1. 1.\nand 1. 2.3 of the Standard. However, staff feedback has identified a lack of use of the systems due to:\n• a lack of encouragement to report errors and product safety concerns\n• a lack of trust, and a feeling that it is not safe or comfortable to report problems\n• a belief that problems will not be taken seriously or that nothing will improve.\nSenior management therefore decides to include staff reporting and concerns about the current system in the culture improvement plan, and look for ways to build trust and encourage use.\n• Internal audits are an extremely useful site-based tool for monitoring and improving systems. However, the site notices that many departments undervalue the audit programme, with several reports reflecting a negative attitude towards the programme.\nSenior management also notes that internal audits require effort and resource to complete robustly and effectively, which have not always been available. In fact, at a previous management meeting the senior leadership had considered the potential to further minimise the internal audit programme (e. g. by resorting to tick-box exercises, reducing the number of audits or auditors, and completing the minimum activity possible, rather than reviewing the actual risks).\nThe culture plan therefore includes activities to build belief in, and use of, the internal audit programme, starting with education about the programme and its importance, training for new internal auditors, communication of audit results (positives as well as non-conformity), using the management review programme to consider learnings from the programme which can further benefit the site.\n• KPIs The site’s quality KPIs have remained constant for a prolonged period. The site decides to use its annual customer reviews as an opportunity to review the quality KPIs to establish their continuing appropriateness.\nExample To ensure that the activities proceed according to the plan (and in accordance with the Standard), the site management:\n• assigns timescales for the start of each activity\n• nominates leaders for each activity with responsibility to lead the activities identified\n• makes progress against the product safety culture plan an agenda item at the quarterly senior management team meetings\n• schedules a follow-up staff survey for 12 months’ time which will specifically be used to assess the effectiveness of the planned activities\n• sets a review date for the complete plan.", "requirement_fr": "La direction du site doit définir et suivre un plan clair pour le développement et l'amélioration continue d'une culture de sécurité et de qualité des denrées alimentaires. Le plan doit inclure les mesures nécessaires pour parvenir à un changement de culture positif.\nCette procédure doit inclure :\n•\t des activités définies impliquant toutes les sections du site qui ont une incidence sur la sécurité des produits. Au minimum, ces activités doivent inclure :\n•\t une communication claire et transparente sur la sécurité des produits\n•\t la formation\n•\t les retours des employés\n•\t les comportements à adopter pour maintenir et améliorer les processus de sécurité des produits\n•\t des mesures de performance lors d’activités relatives à la sécurité, l'authenticité, la légalité et la qualité des produits\n•\t un plan d'action indiquant comment les activités seront réalisées et mesurées, ainsi que les délais prévus\n•\t un examen de l’efficacité des activités réalisées.\nLe plan doit être réexaminé et mis à jour au minimum une fois par an."}, {"id": "1.1.3", "requirement": "The site’s senior management shall ensure that clear objectives are defined to maintain and improve the safety, authenticity, legality and quality of products manufactured, in accordance with the food safety and quality policy and this Standard. • documented and include targets or clear measures of success. • clearly communicated to all staff. • monitored and results reported at least quarterly to site senior management and all staff.", "interpretation": "Senior management must set objectives concerning food safety, authenticity, legality and quality that help to achieve the stated policy (see clause 1. 1.1).\nThe objectives must be communicated so that staff understand what is required from them. The setting of these objectives also helps the allocation of suitable budgets and resources. Auditors will look for evidence that the objectives are in place and have been communicated.\nGood objectives are usually:\n• Specific Objectives should be clear and directly related to the site’s aims or goals for product safety and quality.\n• Measurable Objectives should be measurable so that the site can assess progress.\n• Achievable Targets that stretch the company are acceptable but it is important that they are realistic and that sufficient resources will be available.\n• Relevant Objectives should be designed to maintain and improve product safety and quality.\n• Time-bound Objectives can be long-term (e. g. throughout the period of certification) or shorter-term (e. g. within the next 3 months); however, the timescales or deadlines should be clear to enable the site to review progress and, if necessary, amend activities.\nThere are many examples of objectives that could be included. For example:\n• reductions in customer complaints, non-conforming products and/or customer rejections or returns\n• reductions in audit failures or audit non-conformities – include both internal and external audits, but ensure that all audits are still completed to a thorough, rigorous quality\n• improved product safety training\n• improvements to the management of product authenticity\n• increases to product testing.\nIn each of these examples it would be necessary for the site to consider how to make the objective specific and measurable (as discussed above); for example, 10% fewer customer complaints to be achieved by year end.\nObjectives associated with product authenticity are likely to be formed differently; for example, they may be linked to:\n• improvements to the traceability systems or traceability testing (section 3. 9)\n• evolution of product monitoring processes such as product testing (section 5. 6)\n• outcomes from the vulnerability assessment (section 5. 4)\n• updates to the supplier approval mechanisms and the ongoing monitoring of suppliers (section 3. 5).\nA similar situation exists for objectives associated with legality, as these will also need to be formed differently from those commonly used for product safety. For example, where there is proposed legislation in the region where the company operates, then possible targets may relate to ensuring that relevant staff are trained in a timely manner.\nProgress against targets must be reviewed and reported to senior management at least quarterly. It may, for example, be included in management meetings (e. g. those scheduled for clause 1. 1.4), or it may be the subject of a separate review or included in a report to management. Auditors will look for documented evidence of communication and the quarterly progress review.\nThe Standard also requires communication to staff (including all employees and agency- supplied staff). The Standard is not prescriptive on the methods of communication used to meet this clause. For example, any of the following could be used: meetings, briefings, cascades, huddles, electronic media (e. g. email), and company noticeboards.\nIndependent sites or facilities that are part of a large group with company-wide objectives can adopt the company-wide objectives, but are required to ‘own’ the objectives and carry out the implementation, monitoring, review etc. at site level.", "requirement_fr": "La direction du site doit s'assurer que des objectifs clairs sont définis afin d'établir et d'améliorer la sécurité sanitaire, l’authenticité, la légalité et la qualité des produits fabriqués, conformément à la politique de sécurité et de qualité des denrées alimentaires et à cette Norme. Ces objectifs doivent :\n•\t être documentés et inclure des buts ou indicateurs clairs de réussite\n•\t être communiqués clairement à tous les employés\n•\t être contrôlés, et leurs résultats doivent être rapportés au moins une fois par trimestre à la direction du site et à l’ensemble des employés."}, {"id": "1.1.4", "requirement": "Management review meetings attended by the site’s senior management shall be undertaken at appropriate planned intervals, annually at a minimum, to review the site performance against the Standard and objectives set in clause 1.1.3. • previous management review action plans and timeframes. • the results of internal, second-party and/or third-party audits. • any objectives that have not been met, to understand the underlying reasons. This information shall be used when setting future objectives and to facilitate continual improvement. • any customer complaints and the results of any customer feedback. • any incidents (including both recalls and withdrawals), corrective actions, out-of-specification results and non-conforming materials. • the effectiveness of the systems for HACCP, food defence and authenticity, and the food safety and quality culture plan. • resource requirements.", "interpretation": "The purpose of the management review meeting is to take an overview of the food safety systems. It should therefore be a full and detailed examination of what has happened and what should happen in future. It is not the ongoing management of an issue or concern (although the agenda may include a review of any such concerns) and it is not just incident/ non-conforming product management (processes for these activities are covered in the relevant sections of the Standard; for example, in sections 3. 8 and 3. 11).\nThe format of the meeting should reflect company size.\nThe Standard identifies specific agenda items that must be included within the meeting;\nhowever, additional relevant subjects should also be included where appropriate. As a minimum the meeting agenda should therefore consider:\n• minutes of the previous management reviews and actions agreed. For example, the previous meeting may have set actions and timescales for their completion; however, if actions were not completed on schedule or have failed to be effective, further investigation and actions will be required\n• what has been achieved or not been achieved and progress against objectives (see clause 1. 1.3); for example:\n• if an objective has been met the site can consider future targets based on achievements to date\n• if an objective has not been met the site can consider why. This can be very informative and allows future objectives (or other actions such as the product safety culture plan) to focus on areas where relevant, achievable actions can take place. This review need not be exhaustive (such as a full root cause analysis) but the site should be able to understand why objectives were not met. The outcome would not be preventive action but continual improvement, allowing the site to refine its future targets\n• internal, second-party and/or third-party audits, and subsequent actions. As a minimum the Standard requires a summary of the results from the internal audit programme to be reviewed at these meetings (see clause 3. 4.3). This provides two opportunities for the senior management team:\n• a review of non-conformities, corrective actions, root causes and preventive actions, with a focus on any outstanding concerns or additional actions required (individual issues should have been identified and acted upon at the time they were identified and where necessary, escalated to the management team during the year)\n• review of the overall performance and key trends should facilitate continuous improvement (e. g. changes to the frequency of auditing particular areas, training needs or suggestions for improvements or further developments of the internal audit programme) Similarly, second- or third-party activities (including customer audits, regulatory authority visits) could be summarised to facilitate further discussion and identify any actions or improvements that need to be made\n• progress against the product safety and quality culture plan and the effectiveness of completed actions\n• product safety incidents, complaints, out-of-specification results or non-conforming products, to ensure these have been fully actioned, to assess any trends and identify any additional follow-up actions or improvements needed as a result of these incidents and non-conforming situations\n• the management and effectiveness of product safety systems such as HACCP, food defence and product authenticity, along with any existing or emerging issues relating to these topics\n• identification of targets and areas of improvement for the coming year\n• changes to resource requirements.\nIt is important that sufficient information is presented to the meeting to enable a full and meaningful discussion and, where appropriate, actions to be agreed.\nSenior management is considered to consist of managers who have the authority to make decisions on food safety objectives and/or the provision of adequate human and financial resources. The management team would usually include the site manager and those managers responsible for production, technical operations, purchasing, engineering and human resources. For large, multi-site organisations the management review meeting may include head office representatives, but this decision should be driven by the senior management on site. It may also include representatives from any departments responsible for specific product safety activities or for specific agenda items.\nGood practice is to ensure that the meeting is put into all attendees’ diaries sufficiently early to maximise attendance and that agendas and papers are circulated in advance.\nThe auditor will be looking for evidence that, for each agenda item, sufficient information has been provided to allow an informed discussion to take place leading to appropriate action plans. This may be demonstrated through a review of the inputs to the meeting, minutes of the discussion of the items and, where necessary, agreed action plans. To demonstrate that, for example, senior management has reviewed the management of the HACCP system, the minutes should contain a general summary of the HACCP review meeting (see section 2. 12. 3) and a record of its outcomes (these would be inputs into the management review meeting), together with any actions requested during the senior management meeting (i. e. outputs of management review meeting).\nOne of the outputs from the meeting is a review of performance against the objectives (clause 1. 1.3) and the establishment of new or amended targets and objectives for the following year. This should be clearly documented within the minutes of the meeting.\nThe outcomes from the review meeting must be communicated to the relevant staff to ensure implementation. It should be evident to the auditor how this has been achieved (e. g. cascaded through staff briefings or posted on noticeboards). It should also be evident that actions are followed up and completed. For example, evidence of completion could be added to meeting records, or assessment of actions could be added to the internal audit programme.\nThe Standard requires an annual review, such as a regular annual management review meeting. However, it is important that meetings are scheduled correctly and of sufficient frequency to maximise the value of the meeting and allow timely actions. Many companies opt to make a review or partial review more frequently (e. g. every 6 months or each quarter), either addressing all the points in summary (after other review meetings) or addressing one or two points in depth in each meeting. The number of meetings and the individual agendas should be based on company need, providing all relevant topics are covered within the 12-month period. Where meetings are scheduled with a large intervening period (e. g. annually) the site needs a process to ensure that any matters needing consideration can be completed in a timely fashion; for example, by incorporating them into management meeting agendas (see clause 1. 1.5).\nSpecial consideration should be given to seasonal and temporary sites to ensure meetings occur at an appropriate point in the season and that actions, targets or objectives can be completed. Some sites therefore opt for two meetings; for example, one at the start of the season, to allow objective setting, and one at the end of the season, when the season’s information can be assessed. Alternatively, a management meeting shortly after an external audit allows any non-conformities to be included in the discussion and relevant corrective actions to be agreed.\nAll sites should have a predefined schedule so all participants are aware, in advance, of when the meetings will take place.", "requirement_fr": "Des réunions d'examen de la gestion, auxquelles la direction du site assiste, doivent être planifiées à intervalles réguliers et au moins une fois par an. Elles seront l'occasion d'examiner les performances du site dans le cadre de la Norme et des objectifs fixés dans la clause 1.1.3. Le processus d'examen inclura l'évaluation :\n•\t des plans d'action et des délais définis lors de l'examen de la gestion précédente\n•\t des résultats d'audits internes réalisés par une seconde ou tierce partie\n•\t de tout objectif n'ayant pas été atteint, afin de comprendre les raisons de cet échec. Ces informations doivent être utilisées pour définir des objectifs futurs et pour faciliter une amélioration continue\n•\t toute réclamation de clients et les résultats de retours éventuels de clients\n•\t tout incident (rappels et retraits inclus), action corrective, résultats non conformes et matériaux non conformes\n•\t l'efficacité des systèmes relatifs aux plans HACCP, de protection de la chaîne alimentaire et d’authenticité des produits, et de culture de sécurité et de qualité des denrées alimentaires\n•\t des exigences en matière de ressources.\nDes enregistrements de la réunion seront rassemblés et utilisés pour revoir les objectifs, encourageant une amélioration continue. Les décisions et actions prises lors du processus d'examen doivent être communiquées de manière efficace au personnel concerné, et les actions seront mises en place dans les délais prévus."}, {"id": "1.1.5", "requirement": "The site shall have a demonstrable meeting programme which enables food safety, authenticity, legality and quality issues to be brought to the attention of senior management. These meetings shall occur at least monthly.", "interpretation": "The objective of this clause is to ensure that there is a mechanism that enables the site to learn and react to available information from both internal (within the site and/or company) and external sources (e. g. wider industry, media, etc), allowing food safety, authenticity, legality and quality issues to be raised and discussed at a senior management level within the site. The meeting could include, for example:\n• review of successes/failures relating to product safety, authenticity, legality and quality and the lessons that can be learnt from these\n• any ongoing concerns\n• review of corrective actions, root causes, preventive actions and the effectiveness of these\n• review of information relating to publications, known recalls of similar products, information from regulatory authorities, media stories and potential implications/learnings for the site. This could include information obtained as a result of activities to comply with clause 1. 1.\n• overview of KPIs, complaint levels or other relevant metrics.\nMeetings will need to include management of a seniority to make decisions, and where appropriate, take actions.\nMost sites have weekly or monthly management meetings and the inclusion of safety, authenticity, legality and quality as an agenda item within this meeting is one way to meet the requirements of this clause.\nA schedule for the meetings needs to be in place.\nSeasonal sites are not expected to have monthly meetings when the site is closed and not operating, but scheduling should consider the length of the season and processes to ensure that food safety, authenticity, legality and quality issues can be discussed in a timely manner.\nFor example, the first meeting could take place shortly before the season begins, with further meetings monthly or even weekly throughout the season, and a final meeting at the end of the season.\nThe audit will confirm whether:\n• the meetings occur at a defined frequency (e. g. a schedule, diary bookings or agendas)\n• previous meetings contained relevant discussions (e. g. agenda and minutes for the meetings which clearly state conclusions and any additional actions).\nGood practice is to ensure that any decisions and actions agreed are communicated to appropriate staff, and that there is a system to check that actions are implemented within agreed timescales.", "requirement_fr": "Le site doit posséder un programme de réunions vérifiable qui permette de porter les problèmes de sécurité, d’authenticité, de légalité et de qualité des denrées alimentaires à l'attention de la direction. Ces réunions doivent avoir lieu au moins une fois par mois."}, {"id": "1.1.6", "requirement": "The company shall have a confidential reporting system to enable staff to report concerns relating to product safety, authenticity, legality and quality. The mechanism (e.g. the relevant telephone number) for reporting concerns shall be clearly communicated to staff. The company’s senior management shall have a process for assessing any concerns raised. Records of the assessment and, where appropriate, actions taken, shall be documented.", "interpretation": "In 2018 a report from the Association of Certified Fraud Examiners found that reports from employees and outside parties are by far the most common method of detecting wrongdoing. It is therefore vital that all sites facilitate effective communication methods allowing staff to report any concerns. Ideally, this will be achievable using procedures developed to meet clause 1. 2.3. However, from time to time it may be necessary for individuals to report on hazards or infractions anonymously and confidentially (e. g. if a staff member felt that a genuine concern raised through other mechanisms, such as those covered in clause 1. 2.3, had not been adequately addressed), so the site (or company) should have a system in place to manage this. Although the aim of the Standard is to ensure these reporting systems relate to product safety, authenticity, quality and legality, the company may choose to incorporate all staff concerns into the system, and not limit it to concerns related to the scope of the Standard.\nAs a minimum, the system used must ensure that the confidentiality of the employee reporting the concern is maintained (i. e. the employee’s identity is not known or released to the site or company management) to protect any staff using it, and the confidential and anonymous nature of the system should be clear to all staff. An email or telephone call to an on-site manager, for example, is unlikely to be anonymous or confidential as the manager is likely to know the employee’s email address or recognise their voice. Therefore this would not be considered a confidential system.\nMany food processors will also have whistleblowing systems established by the brand owners and retailers for which it produces. Where this is the case, the site is still required to have its own system as affected products may not relate to the specific brand owner.\nAdditionally, in some areas, local relevant regulatory authorities will have facilities for confidential reports about a site but this also does not mitigate the need for a site (or company) to have a system.\nAs well as gathering information, the site is required to collate and act on it. The auditor will expect to see a system in place, and transparency about the content of any reports and actions, although not the source of the original concern.\nWhere possible, sites might consider an independent system that receives and processes any concerns raised with appropriate promptness. For example, where quality, safety or conformity of the product is at risk, action should be immediate. This might be by using an independent consultant or a professional organisation that can act as an intermediary.\nWhere local legal requirements prohibit certain activities around confidentiality or such reports, the site will need to ensure the system employed meets these legal requirements.\nThis will also be acknowledged by the auditor and compliance with this clause noted within the context of the legal framework.\nIt is not uncommon for larger companies to base the management of their confidential reporting systems at head office, rather than at each individual site. This is acceptable and the audit process is explained in Appendix 4 of the Standard.\nBRCGS operates the independent ‘Tell BRCGS’ facility (available online). This has been designed so that BRCGS can receive information from any interested party about the status of certificated sites or the certification process. Therefore, when feedback is received, it will be investigated and this may, for example, identify the need for a compliance audit at the implicated site to ensure that it is operating legally and in compliance with the Standard.\nThis is different from the aim of this whistleblowing clause, which is to provide the site/ company management with an opportunity to receive and address any concerns raised by employees without the site being subject to an external review. Therefore, a site using the Tell BRCGS system without its own confidential reporting system will not achieve the intended aim of the clause, although it could be used for situations where an employee has tried other site-specific options and is still sufficiently concerned to raise the matter with BRCGS.", "requirement_fr": "L'entreprise doit disposer d'un système de signalement confidentiel, qui permette au personnel de signaler tout problème relatif à la sécurité, à l’authenticité, à la légalité et à la qualité des produits.\nLe mécanisme (c-à-d. le numéro de téléphone à appeler) de signalement des problèmes doit être clairement communiqué au personnel.\nLa direction de l’entreprise doit disposer d’un processus d'évaluation des problèmes soulevés.\nLes enregistrements de l’évaluation et, le cas échéant, les mesures prises doivent être documentés."}, {"id": "1.1.7", "requirement": "The company’s senior management shall provide the human and financial resources required to produce safe, authentic, legal products to the specified quality and in compliance with the requirements of this Standard.", "interpretation": "Sites must have sufficient financial and human resources to be able to maintain the food safety, authenticity, legality and quality systems.\nAlthough a review of resources forms part of the management review process (clause 1. 1.4), it should not be restricted to a single annual discussion if there is a need to make changes to resource allocation during the course of the year.\nAs well as looking at the minutes of the management review meeting, auditors will also look at the type, number and root causes of non-conformities identified at the audit, as the ability of the site to meet the requirements of the Standard will partly demonstrate that the appropriate resources and skills are available.\nThe auditor will examine this requirement during both the audit of the facilities and documentation. The auditor will expect the site to demonstrate that it is adequately resourcing its product safety, authenticity, legality and quality activities, which may include capital expenditure (e. g. for repairs or new equipment), staff levels and staff training.", "requirement_fr": "La direction de l'entreprise doit apporter les ressources humaines et financières nécessaires à la production d'aliments sûrs, authentiques, à la qualité spécifiée et conformes aux exigences de cette Norme."}, {"id": "1.1.8", "requirement": "The company’s senior management shall have a system in place to ensure that the site is kept informed of and reviews: • scientific and technical developments. • industry codes of practice. • new risks to authenticity of raw materials. • all relevant legislation in the country where the product will be sold (where known).", "interpretation": "Food safety issues and legislative requirements are constantly changing. The objective of this clause is to ensure that sites remain up to date, are able to meet legislation and can adapt their food safety systems to protect against new threats. The company must be able to demonstrate that it maintains up-to-date knowledge of relevant legislation, scientific and technical developments, potential risks to raw materials (e. g. to the authenticity of the raw material) and industry codes of practice, such as Codex Alimentarius. Activities to achieve this may include:\n• membership of a trade association that provides this service\n• subscription to a service provider supplying legal updates\n• help from government officials or local enforcement offices\n• regular review of identified websites covering legislation and standards.\nIn addition to information relating to food safety, the site must also have a system to obtain and review information relating to the authenticity of raw materials and the potential for substitution or dilution of the ingredients. This information will, for example, be required to demonstrate compliance with clause 5. 4.2.\nThe company needs to demonstrate that it can readily access, either directly or through a third party, legislation relating to the product in the country, state or territory where the product is sold to the ultimate consumer (if known, or where it can reasonably be expected to be sold). Good practice is also to consider the country where the product is manufactured.\nThe auditor will therefore look for evidence of systematic checking and of the process for ensuring the information is transferred into action as necessary.", "requirement_fr": "La direction de l'entreprise doit avoir établi un système garantissant que le site est informé des aspects suivants et les examine :\n•\t avancées scientifiques et techniques\n•\t codes d'usage de l'industrie\n•\t nouveaux risques associés à l'authenticité des matières premières\n•\t toute législation pertinente applicable au pays où le produit sera vendu (lorsqu'il est connu)."}, {"id": "1.1.9", "requirement": "The site shall have a genuine, original hard copy or electronic version of the current Standard available and be aware of any changes to the Standard or protocol that are published on the BRCGS website.", "interpretation": "The aim of this clause is to ensure the site has easy access to all the relevant requirements for compliance and certification to the Standard. The site must therefore have an official copy of the Standard available in either paper or electronic form. Either a free or paid-for PDF copy of the Standard demonstrates compliance with this requirement. A subscription to BRCGS Participate provides an online version of the Standard (and interpretation and other guidelines) and therefore also meets this requirement.\nThe site will also need copies of any additional voluntary modules to which they are certificated.\nIn addition, during the lifetime of the Standard, the BRCGS technical advisory committee (TAC) may be asked to:\n• review the wording of a requirement in the Standard or audit protocol\n• provide an interpretation for a requirement\n• rule on the grading of a non-conformity against a clause.\nPublished TAC opinions are defined as ‘position statements’. Position statements are binding on the way that the audit and certification process is carried out and are considered to be an extension to the Standard. Sites must therefore be aware of any published position statements and, where necessary, ensure the information is transferred into action. Position statements are published on the ‘Food Safety Help and Guidance’ page of the BRCGS website and available on BRCGS Participate. They are communicated via the BRCGS newsletter. This newsletter is sent to all certificated companies. Position statements are also communicated to certification bodies via the bulletin.", "requirement_fr": "Le site doit posséder un exemplaire authentique de la Norme actuelle, soit le document original en format papier, soit une version électronique. Il doit également être au courant des modifications éventuelles apportées à la Norme ou au protocole publiées sur le site Internet du BRCGS."}, {"id": "1.1.10", "requirement": "Where the site is certificated to the Standard, it shall ensure that announced or blended announced recertification audits occur on or before the audit due date indicated on the certificate.", "interpretation": "The audit due date is indicated on both the audit report and the certificate issued to all certificated sites. The responsibility for scheduling the next audit rests with the site.\nAnnounced audits may be taken in the 28 calendar days up to and including the audit due date. Blended audits may commence within the 56 calendar days prior to the audit due date.\nLate audits are likely to result in a gap in certification and a major non-conformity will be awarded unless exceptional circumstances occur as identified in the audit protocol section of the Standard (II, section 2. 7.2). This includes situations where the site is:\n• situated in a specific country, or an area within a specific country, where there is government advice not to visit and there is no suitable local auditor\n• within a statutory exclusion zone that could compromise food safety or animal welfare\n• in an area that has suffered a natural or unnatural disaster, rendering the site unable to produce or the auditor unable to visit\n• affected by conditions that do not allow access to the site or restrict travel (e. g. heavy snow)\n• producing seasonal products where production is delayed by a late start to the seasons (e. g. due to weather or product availability).\nLack of personnel is not an acceptable reason for adjusting the audit date. It is expected that the site will appoint adequate deputies and established systems of working to ensure the smooth operation of the site in the absence of individual managers. Nor is the undertaking of building work an acceptable reason for delay unless the site is not in production while the building work is carried out.\nWhere a site has an unannounced audit, either by opting into the voluntary unannounced scheme or due to the requirement for a mandatory unannounced audit, it becomes the responsibility of the certification body to ensure this requirement is met.", "requirement_fr": "Les sites déjà certifiés dans le cadre de la Norme doivent s'assurer que les audits de recertification annoncés ou annoncés mixtes ont lieu à la date d'échéance d'audit indiquée sur le certificat ou à une date antérieure."}, {"id": "1.1.11", "requirement": "The most senior production or operations manager on site shall participate in the opening and closing meetings of the audit for certification to the Standard. Relevant departmental managers or their deputies shall be available as required during the audit. A member of the senior management team on site shall be available during the audit for a discussion on effective implementation of the food safety and quality culture plan.", "interpretation": "For a site to successfully complete a BRCGS audit, it will be necessary to involve a range of different site colleagues, including senior managers, section heads and staff responsible for completing specific activities. Involving a range of site colleagues in this way has a number of advantages, including:\n• It allows the individuals that are responsible for, or who complete, specific activities to explain them and discuss any questions the auditor may have, ensuring that the auditor receives detailed, up-to-date information, and can observe the activity in action.\n• It allows members of the team who are not currently needed for the audit to complete other duties, either as part of their normal work or preparation for other parts of the audit;\nfor example, compiling the information for the vertical audit.\n• It indicates a positive product safety culture, where management encourages staff of all levels to be involved in the audit process.\nAs a minimum the most senior production or operations managers on site (i. e. those who are responsible for the hands-on, daily running of the site) must participate in the opening and closing meetings of the audit. The objective is to ensure that non-conformities are effectively understood and agreed; therefore this site representative will need to be sufficiently senior to make decisions regarding any non-conformities and the corrective action to be taken.\nThe auditor will also need to discuss food safety and quality culture and the site’s implementation of its plan to improve the culture with this manager or an appropriate member of the senior management team.\nIt may be the case that the most senior operations managers within the company are absent on the day of the audit because of other commitments, especially where an audit is unannounced; however, there must always be a nominated deputy available (clause 1. 2.1).", "requirement_fr": "Le responsable de production ou des opérations le plus haut placé dans l'entreprise doit participer aux réunions d'ouverture et de clôture de l'audit pour la certification à la Norme.\nLes responsables des services concernés ou leurs adjoints doivent être disponibles durant l'audit, selon les besoins.\nUn membre de l'équipe de direction doit être présent sur le site et disponible pendant l'audit, afin de discuter de la mise en place efficace du plan de culture de la sécurité et de la qualité des denrées alimentaires."}, {"id": "1.1.12", "requirement": "The site’s senior management shall ensure that the root causes of any non-conformities against the Standard identified at the previous audit have been effectively addressed to prevent recurrence.", "interpretation": "An important aspect of the Standard is to encourage continual improvement of product safety processes (e. g. see the statement of intent for section 1. 1) and the prevention of non- conforming situations is one aspect of this. Therefore, non-conformities identified in the previous certification audit must have been fully and effectively rectified (i. e. corrective and preventive actions completed) and these will be checked during the current audit. Therefore, for each non-conformity at the last audit, the auditor will expect to see:\n• Corrective action The site will have completed its corrective action within 28 days of the last audit. The auditor will therefore expect to see this action in operation (e. g. that the updated procedure submitted to the certification body as evidence of corrective action is in use, or that repairs have been completed and remain effective).\n• Preventive action At the time when the certificate was awarded, the site will have submitted a preventive action plan, but may not have completed all of the preventive action. The auditor will therefore expect to see evidence that the site implemented preventive action and that recurrence of the non-conformity has therefore been effectively prevented.\n• Root cause analysis Root cause analysis is used to identify the fundamental or root cause of a non-conformity, and is therefore a key activity in establishing appropriate preventive action. Although the site submitted the root cause analysis following the previous audit, the auditor may need to review this; for example, if preventive action has been ineffective at preventing the non-conformity.\nThis process is detailed in II of the Standard, section 2. 3.2.\nMany sites have found it useful to retain copies of records and documents implicated by non-conformities with the audit records. This allows quick and easy reference to the specific document while reviewing, investigating and correcting the non-conformity. (The original copy of the document, should, of course, be returned to the appropriate place in the site’s quality system.) Note that additional information on preventive action and root cause analysis, and non- conforming situations which require their use, is detailed in I, section 3. 7 of the Standard, and especially clause 3. 7.2.\nA site’s attitude towards preventive action may also indicate its product safety culture. For example, minimal follow-up, or preventive action that is just seen as a necessary document to pass an audit, may be a sign of a poor culture.\nBRCGS has published a guideline to understanding preventive action and root cause analysis which explains some of the techniques available for identifying the cause of non-conformities and preventing them from recurring. The guideline is available from the BRCGS Store or viewed online at BRCGS Participate.\nIf effective corrective or preventive action has not been introduced (e. g. it has been ineffective at preventing recurrence), a non-conformity may be raised against this clause, in addition to a non-conformity against the clause that has the recurring issue.", "requirement_fr": "La direction du site doit s'assurer que les causes fondamentales de toute non-conformité identifiée lors de l'audit précédent dans le cadre de la Norme ont été prises en compte de manière efficace afin d'éviter toute récurrence."}, {"id": "1.1.13", "requirement": "The BRCGS logo and references to certification status shall be used only in accordance with the conditions of use detailed in the audit protocol section (Part III, section 6.7) of the Standard.", "interpretation": "Sites that have gained certification against any of the BRCGS Standards are entitled to demonstrate their pride in their achievement and use the BRCGS certification logo for marketing purposes. This means the logo can be used on websites, letter headers, business cards, etc.\nHowever, the logo is not a product certification mark, so it (or words stating that the product was produced in a BRCGS-certificated site) cannot be used on product packaging. The rules around logo use are highlighted in the protocol of the Standard (II, section 6. 7) and further guidance is available in the Brand Guidelines on the BRCGS website.\nWhere an auditor finds consumer-facing packaging with any BRCGS logo or wording during an audit, they will raise a non-conformity.", "requirement_fr": "Le logo des Normes du BRCGS et toute mention du statut de certification doivent être utilisés conformément aux conditions d'utilisation détaillées dans la section du protocole d'audit (Partie III, section 6.7) de la Norme."}, {"id": "1.1.14", "requirement": "Where required by legislation, the site shall maintain appropriate registrations with the relevant authorities.", "interpretation": "In countries, states or territories where there is a legal requirement to register premises as food production sites, there must be documentary proof that the site has been appropriately registered.\nThe clause is not limited to food defence, but to all requirements for food manufacturing, food safety, authenticity, food defence, etc. However, the clause does not cover other legal registrations related to personnel, health and safety (such as fire regulations) or employment law, as these are outside the scope of the Standard. Examples of registration include:\n• EU requirements detailed in EC Regulations No. 852/2004 on the Hygiene of Foodstuffs, Article 6(2) and No. 853/2004 for animal products processing\n• FDA registration requirements in the US\n• registration with the local authority in the UK.\n1. 2 Organisational structure, responsibilities and management authority The company shall have a clear organisational structure and lines of communication to enable effective management of product safety, authenticity, legality and quality.\nThis section has three key objectives, to:\n• facilitate clear communication of the roles and responsibilities for food safety, authenticity, legality and quality, and ensure that staff are aware who has these responsibilities\n• ensure responsible individuals have the knowledge and ability to fulfil the role\n• empower staff to communicate any concerns relating to product safety, authenticity, legality or quality to the relevant individuals, to facilitate a timely response where action is required.", "requirement_fr": "Lorsque la loi l'exige, le site doit être enregistré de manière appropriée auprès des autorités concernées.\n1.2 Structure organisationnelle, responsabilités et pouvoir de gestion L'entreprise doit posséder un organigramme et des axes de communication clairement définis afin d'assurer une gestion efficace de la sécurité sanitaire, de l’authenticité, de la légalité et de la qualité du produit."}, {"id": "1.2.1", "requirement": "The company shall have an organisation chart demonstrating the management structure of the company. The responsibilities for the management of activities which ensure food safety, authenticity, legality and quality shall be clearly allocated and understood by the managers responsible. It shall be clearly documented who deputises in the absence of the responsible person.", "interpretation": "An organisational chart must be available, clearly indicating reporting lines for all managers on the site and, where applicable, relationships to the company head office roles. The chart would normally be expected to show both a position and the named person occupying that position. Where the chart shows job titles only, other documents must indicate the person occupying each position.\nThe chart or associated documentation needs to clearly indicate the responsibilities of each relevant member of staff with responsibility for the management of food safety, authenticity, legality or quality. Examples include technical managers, quality assurance staff, section heads/managers (e. g. those accountable for overseeing production and cleaning activities (i. e. those responsible for ensuring the correct standards are maintained)), any on-site laboratory staff and product development teams.\nResponsibilities must be defined for key aspects of the food safety and quality management system, including, for example, decisions on corrective actions, non-conforming products, process deviations, finished product release, document control and customer complaints.\nIt is usual for specific responsibilities to be defined within the job descriptions of key staff (especially for management and supervisors); however, they may instead be described within site procedures (e. g. responsibility for decisions on corrective action may be incorporated into the site’s corrective action procedure).\nIt must be clearly documented who is expected to deputise in the absence of a manager.\nDeputies would usually be identified on the organisational chart and/or in job descriptions, but documentation could also be in the form of an additional table. The responsibility may be assigned to either a more senior or more junior person, as long as the deputy has the knowledge and ability to adequately cover for the absent manager. Deputies may be appointed for the whole role or particular responsibilities may be deputised to different people; as long as this is clearly defined.\nThe auditor will be looking for both documented responsibilities and evidence that the responsible person is able to fulfil the role (clause 7. 1.7 requires the company to review the competencies of staff and ensure that any necessary training, mentoring or experience is provided).", "requirement_fr": "L'entreprise doit posséder un organigramme mettant en évidence la hiérarchie de l'entreprise.\nLes responsabilités relatives à la gestion des activités garantissant la sécurité, l’authenticité, la légalité et la qualité des denrées alimentaires doivent être clairement distribuées et comprises des responsables. Les suppléants des responsables doivent être clairement désignés."}, {"id": "1.2.2", "requirement": "The site’s senior management shall ensure that all staff are aware of their responsibilities and demonstrate that work is carried out in accordance with documented site policies, procedures, work instructions and existing practices for activities undertaken. All staff shall have access to relevant documentation.", "interpretation": "The objective of this clause is to ensure that all staff, including temporary staff and employment agency staff, are able to work effectively and ensure that food safety, authenticity, legality and quality are maintained.\nConsistent application of these systems relies on the correct and established processes being documented, accessible by relevant staff and used in practice. This will usually be established by the auditor discussing roles with the employees themselves during the audit.\nThere is no requirement for a detailed job description; however, staff should be aware of their particular responsibilities. Where the role or an activity that makes up part of the role covers a food safety, authenticity, legality or quality issue described within a procedure (e. g. a CCP or prerequisite programme), the staff must understand what is expected and be able to access the relevant procedure.", "requirement_fr": "La direction du site doit s’assurer que tout le personnel est conscient de leurs responsabilités et démontrent qu’ils effectuent leur travail conformément aux politiques, procédures, instructions de travail et pratiques existantes documentées du site. Tout le personnel doit avoir plein accès aux documents pertinents."}, {"id": "1.2.3", "requirement": "Staff shall be aware of the need to report any risks or any evidence of unsafe or out-of-specification product, equipment, packaging or raw materials, to a designated manager to enable the resolution of issues requiring immediate action.", "interpretation": "Where a food safety risk is identified by a staff member, the reporting function and subsequent activity should be sufficiently rapid and effective to mitigate any food safety risks.\nIdentified risks may be associated with, for example, raw materials, work in progress, final product, packaging or equipment. Good practice is to encourage staff to report as wide a range of situations as possible, including out-of-specification results, damage, errors or when the staff member is concerned that something does not look right or as it normally does.\nThe transfer of information from staff to senior management regarding unsafe or out-of- specification situations is an example of a good food safety culture. If staff feel supported and empowered to identify and report issues and make positive changes, this will typically be reflected in the effectiveness of the site’s product safety management systems.", "requirement_fr": "Tout le personnel doit être conscient de l'importance d'informer un supérieur désigné de tout risque ou de toute preuve de produits, d’équipements, d’emballages ou de matières premières dangereux ou non conformes, afin de permettre la résolution des problèmes requérant une action immédiate."}, {"id": "1.2.4", "requirement": "If the site does not have the appropriate in-house knowledge of food safety, authenticity, legality or quality, external expertise (e.g. food safety consultants) may be used; however, the day-to-day management of the food safety systems shall remain the responsibility of the company.", "interpretation": "Where external food safety consultants have been used as the main source of technical knowledge for a specific activity (e. g. to lead the development of the food safety plan or HACCP plan) it is essential that day-to-day responsibilities are under the control of the site and that it has personnel in place with working knowledge of the product safety systems, who can operate effectively even when the consultant is not available.\nFor example, the requirements of clause 1. 2.1, regarding deputies and documented procedures, apply even where a food safety consultant is used.\nA food safety consultant is seen as a service provider to the site and is therefore subject to the requirements of section 3. 5.3.", "requirement_fr": "Si le site ne dispose pas des connaissances adéquates en matière de sécurité, d'authenticité, de légalité ou de qualité des aliments en interne, il peut avoir recours à des compétences externes (c-à-d. des conseillers en sécurité des denrées alimentaires). Cependant, la gestion quotidienne du système de sécurité des denrées alimentaires doit être du ressort de l’entreprise.\n2 Plan de sécurité des denrées alimentaires – HACCP Fondamental L'entreprise doit disposer d'un plan de sécurité des denrées alimentaires pleinement opérationnel et efficace incorporant les principes HACCP du Codex Alimentarius.\n2.1 Équipe de sécurité des denrées alimentaires HACCP (correspondant à l’Étape 1 du Codex Alimentarius)"}], "statement_of_intent": "The site’s senior management shall demonstrate that they are fully committed to the implementation of the requirements of the Global Standard Food Safety and to processes which facilitate continual improvement of food safety, quality management, and the site’s food safety and quality culture.", "group_intros_fr": {"1.1": "La direction du site doit démontrer qu'elle est pleinement impliquée dans la mise en place des exigences de La Norme Mondiale de Sécurité des Denrées Alimentaires et des processus permettant de faciliter l'amélioration continue de la gestion de la sécurité et de la qualité des denrées alimentaires, et de la culture de sécurité et de qualité des denrées alimentaires du site.", "1.2": "L'entreprise doit posséder un organigramme et des axes de communication clairement définis afin d'assurer une gestion efficace de la sécurité sanitaire, de l’authenticité, de la légalité et de la qualité du produit."}, "group_intros": {"1.2": "The company shall have a clear organisational structure and lines of communication to enable effective management of product safety, authenticity, legality and quality.", "1.1": "The site’s senior management shall demonstrate that they are fully committed to the implementation of the requirements of the Global Standard Food Safety and to processes which facilitate continual improvement of food safety, quality management, and the site’s food safety and quality culture."}}, {"section": 2, "title": "The food safety plan – HACCP", "clauses": [{"id": "2.1.1", "requirement": "The HACCP or food safety plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for quality assurance, technical management, production operations and other relevant functions (e.g. engineering, hygiene). The team leader shall have an in-depth knowledge of Codex HACCP principles (or equivalent) and be able to demonstrate competence, experience and training.", "interpretation": "For a comprehensive HACCP or food safety plan to be established, maintained and kept up to date it needs to be managed by a nominated team with suitable training, relevant skills and experience.\nThe number of HACCP food safety team members needs to be appropriate to the size and structure of the company, as the team will include representatives of each department with responsibility for the operation of the Standard (e. g. technical, quality assurance, purchasing, engineering, new product development, hygiene/sanitation and senior leadership team).\nThere will always be more than one person, since a single person does not constitute a ‘team’. The team needs knowledge of the types of operations that are carried out at the site and the hazards these operations may present to the product.\nIt is good practice to document the team members within the study, with a summary of their roles, experience and areas of responsibility within the company. Membership of the HACCP food safety team needs to be reviewed and, when necessary, updated (e. g. when job responsibilities change or personnel leave or join the company).\nThe team leader must be able to demonstrate competency and experience in HACCP/food safety processes. This can be shown by:\n• the quality of the plan\n• documented evidence of their qualification (e. g. successful completion of an industry- recognised HACCP training course)\n• demonstrable, extensive experience in implementing or training HACCP.\nThe team will need sufficient knowledge of HACCP processes, products manufactured on site, production processes and relevant hazards, to facilitate a thorough hazard and risk analysis and the creation of an appropriate food safety plan. This may be demonstrated by, for example, training records (see clause 7. 1.6) that show adequate training (e. g. through an industry-recognised training course or good quality internal training) has been given to all HACCP food safety team members. Any format or delivery method of training is permitted;\nhowever, the outcome should be a suitably trained individual capable of executing a HACCP or food safety plan as part of their team.\nWhere there is a legal requirement for specific training the site is expected to ensure this has been completed.\nWhere external expertise has been used in developing the HACCP or food safety plan, the site must demonstrate ownership of the identified requirements by ensuring that the day- to-day management of the food safety system remains the responsibility of the site (see clause 1. 2.4).\nAt the audit, the competency and understanding of the HACCP/food safety plan team will be assessed, as well as the quality of the resultant HACCP or food safety plan. The site should also be able to establish the training and competence of any external consultant in HACCP/food safety principles (see section 3. 5.3).\nSenior management commitment (clauses 1. 1.1 to 1. 1.14) is required to support the HACCP food safety team. This may be demonstrated by the presence of senior management within the team, policy statements referring to HACCP or food safety, or evidence within management review meetings that HACCP/food safety issues are discussed and reviewed.\nThe existence of a food safety plan does not, in itself, guarantee product safety, and it is vital that the results of the HACCP or food safety plan are implemented, applied correctly and integrated into the food safety and quality management system.", "requirement_fr": "Le plan de sécurité alimentaire, ou HACCP, doit être conçu et géré par une équipe de sécurité des denrées alimentaires pluridisciplinaire. Elle comprendra les responsables de l’assurance qualité et de la gestion des aspects techniques, des opérations de production et d'autres fonctions concernées (c-à-d. ingénierie, hygiène).\nLe chef d'équipe doit avoir une connaissance approfondie des principes du Codex HACCP (ou équivalent) et être capable de démontrer ses compétences, son expérience et sa formation.\nLorsqu’une formation comporte une exigence juridique, celle-ci doit être en place.\nLes membres de l'équipe doivent avoir des connaissances spécifiques de l'HACCP et des connaissances pertinentes des produits, des processus et des dangers associés."}, {"id": "2.1.2", "requirement": "The scope of each HACCP or food safety plan, including the products and processes covered, shall be defined.", "interpretation": "The scope of the HACCP or food safety plan must be identified. The scope should describe all the products and processes to be included within the study. In sites with a small range of similar products, it may be possible to incorporate all of the products and processes into a single HACCP or food safety plan; however, where there is a wide range of different products or processes with different hazards, it is likely that the site will need to use more than one plan.\nThe format of these plans is not prescribed by the Standard; various formats are acceptable as long as the scope for each plan is clearly defined and all activities and products are covered within the processes. For example, a HACCP or food safety plan may cover each group of products with similar process characteristics, or the plan may be split into ‘modules’ which cover specific process steps; these modules can then be used in a ‘mix and match’ structure to create a HACCP or food safety plan for any given product.", "requirement_fr": "La portée de chaque plan de sécurité alimentaire, ou HACCP, y compris les produits et les processus concernés, doit être définie.\n2.2 Programmes préalables"}, {"id": "2.2.1", "requirement": "The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). • cleaning and disinfection. • pest management. • maintenance programmes for equipment and buildings. • personal hygiene requirements. • staff training. • supplier approval and purchasing. • transportation arrangements. • processes to prevent cross-contamination. • allergen management", "interpretation": "The prerequisites are the basic environmental and production conditions necessary for the manufacture of safe food and the control of generic hazards. Note that the list of examples in the Standard is not exhaustive, and others will exist in some sites; for example, utilities, air and general aspects of the production environment. Sites must therefore define the full range of prerequisites applicable to their site and operations.\nAlthough the prerequisites are usually covered by day-to-day activities such as good manufacturing or hygiene practices, it is vital that they work effectively and to the correct standards as:\n• The prerequisite programme needs to provide a solid base on which the rest of the HACCP or food safety plan can be developed.\n• The company is relying on the prerequisite activities to mitigate the identified hazards and deliver safe product (e. g. if a site identifies cleaning as a prerequisite, then it relies on the cleaning activities to adequately remove food residues and dirt that might otherwise result in hazards such as allergen cross-contamination or microbiological contamination).\nTherefore there should be a whole work stream behind each identified prerequisite to ensure that the relevant activity, procedures and policies are in place, that they are working correctly and that they continue to deliver the level of control required.\nAlthough the prerequisite programme is expected to be effective in achieving the level of control required to ensure food safety, it is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls, often with results that are not quantifiable. However, where a prerequisite programme is used to manage a specific hazard (e. g. cleaning regimes used to prevent allergen cross-contamination), there needs to be a documented validation that the prerequisite controls the identified hazard (see clause 2. 7.4 for further details regarding the validation). Some companies prefer to differentiate prerequisites that manage specific hazards from other prerequisites by referring to them as operational prerequisites (oPRPs).\nSites that need to meet the requirements of the US Food Safety Modernization Act (FSMA) should note that they must ensure that preventive controls are subject to validation and verification. Some of these controls may cover activities that have traditionally formed part of the prerequisite programme.\nThe clause contains references to later sections of the Standard which provide detail on the requirements for effective management of some specific prerequisites, including cleaning (section 4. 11), pest management (section 4. 14) and training (section 7. 1). These are not intended to be an exhaustive list of all prerequisites or all the relevant sections of the Standard.\nThe prerequisite programmes are often dependent on the production risk zoning (see clause 4. 3.1); for example, cleaning within a high-risk zone. Therefore it may be necessary to place greater attention on some prerequisites that are particularly important for food safety in those specific zones.\nGood practice is to review the prerequisite programmes and their management. The frequency of this review should be based on risk, but it could be included, for example, in the annual review of the HACCP or food safety plan.", "requirement_fr": "Le site doit mettre en place et entretenir des programmes environnementaux et opérationnels nécessaires à la création d'un environnement adapté à la fabrication de produits alimentaires sûrs et légaux (programmes préalables). À titre indicatif, ces derniers peuvent intégrer les points suivants, bien que la liste ne soit pas exhaustive :\n•\t nettoyage et désinfection (voir section 4.11)\n•\t lutte contre les nuisibles (voir clause 4.14)\n•\t programmes de maintenance des équipements et bâtiments (voir sections 4.4 et 4.6)\n•\t exigences relatives à l’hygiène personnelle (voir section 7.2)\n•\t formation du personnel (voir clause 7.1)\n•\t approbation des fournisseurs et achats (voir section 3.5.1)\n•\t services de transport (voir section 4.16)\n•\t processus de prévention de la contamination croisée (voir sections 4.9 et 4.10)\n•\t gestion des allergènes (voir section 5.3).\nLa délimitation des zones de risque pour la production (voir clause 4.3.1) doit être prise en compte lors de l’élaboration des programmes préalables des zones particulières du site.\nLes mesures de maîtrise et les procédures de contrôle des programmes préalables seront clairement documentées et incluses dans le développement et les révisions du plan de sécurité alimentaire ou HACCP.\n2.3 Description du produit (correspondant à l’Étape 2 du Codex Alimentarius)"}, {"id": "2.3.1", "requirement": "A full description for each product or group of products shall be developed, which includes all relevant information on food safety. • composition (e.g. raw materials, ingredients, allergens, recipe). • origin of ingredients. • physical or chemical properties that impact food safety (e.g. pH, aw). • treatment and processing (e.g. cooking, cooling). • packaging system (e.g. modified atmosphere, vacuum). • storage and distribution conditions (e.g. chilled, ambient). • maximum safe shelf life under prescribed storage and usage conditions", "interpretation": "A full description of the product is required to ensure that all aspects that could potentially affect food safety are considered. The Standard gives guidance on the factors that may be considered:\n• composition (e. g. raw materials or ingredients used, allergens, recipes)\n• origin of the ingredients (e. g. climatic conditions, culture or food safety standards may make some countries a greater risk than others)\n• physical or chemical properties that impact food safety (e. g. pH, aw)\n• treatment and processing conditions (e. g. cooking, chilling)\n• product packaging system (e. g. modified atmosphere, vacuum packing or canning)\n• storage and distribution conditions (e. g. chilled, frozen or ambient)\n• maximum safe shelf life under prescribed storage and usage conditions.\nGood practice is not to simply describe the product, but to consider the possible implications of what will be needed later in the HACCP study. For example, when considering the origin of ingredients, rather than just stating the material comes from a specific country or region, it may be useful to consider whether the potential climatic conditions, culture or food safety standards in the country change the hazards.\nProduct groups can be used where the products are similar (e. g. different pack sizes).\nHowever, where significantly different products (e. g. coated and non-coated meat products) are manufactured, these are to be treated as separate products or groups.", "requirement_fr": "Une description complète de chaque produit ou groupe de produits doit être rédigée. Elle doit inclure toutes les informations pertinentes relatives à la sécurité des denrées alimentaires.\nÀ titre indicatif, cette dernière peut intégrer les points suivants, bien que la liste ne soit pas exhaustive :\n•\t composition (c-à-d. matières premières, ingrédients, allergènes, recette)\n•\t origine des ingrédients\n•\t propriétés physiques ou chimiques ayant un impact sur la sécurité des denrées alimentaires (c-à-d. lepH, l'aw)\n•\t traitement et transformation (c-à-d. cuisson, refroidissement)\n•\t système d'emballage (c-à-d. atmosphère modifiée, sous vide)\n•\t conditions de stockage et de distribution (c-à-d. réfrigérés, à température ambiante)\n•\t durée de vie maximum sans risque dans des conditions de stockage et d'utilisation prévues."}, {"id": "2.3.2", "requirement": "All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. • the latest scientific literature. • historical and known hazards associated with specific food products. • relevant codes of practice. • recognised guidelines. • food safety legislation relevant for the production and sale of products. • customer requirements. • a copy of any existing site HACCP plans. • a map of the premises and equipment layout. • a water distribution diagram for the site. • indication of any areas (zones) where high-risk, high-care or ambient high-care production facilities are required", "interpretation": "Up-to-date background information must be taken into account when preparing the HACCP or food safety plan. Therefore, suitable information must be collated and maintained.\nThere are many sources of information, particularly on the internet; for example, Codex Alimentarius, European Food Safety Authority, US Food and Drug Administration, or the Rapid Alert System for Food and Feed (RASFF). Sources of information must be referenced in the HACCP or food safety plan and be recoverable or available on request (using an internet search engine to find the information during an audit is not acceptable, as this implies that the information was not collected and maintained for use during the development of the HACCP or food safety plan). A list of legislation and codes of practice referenced may be helpful.\nMany membership organisations also provide useful information. Where membership information is referenced, this also needs to be available on site (either electronically or as hard copy).\nThe Standard gives some guidance on the types of information that may be considered in developing the HACCP or food safety plan. These include:\n• the latest scientific literature (good practice is to understand the source of the material; for example, peer-reviewed science may have greater validity and usefulness)\n• historical and known hazards associated with specific food products (good practice is to be as specific as possible, giving, for example, the name of the micro-organism(s) that are known hazards to the product, rather than just listing ‘bacteria’)\n• relevant codes of practice\n• recognised guidelines – for example:\n• material provided on BRCGS Participate\n• publication by regulatory authorities\n• publications available from industry experts, trade associations, etc.\n• food safety legislation relevant for the production and sale of products in destination countries, states or territories\n• customer requirements\n• existing HACCP plans; i. e. plans from products that are already in production. There are two uses for the existing plan:\n• learnings from previous plans may provide a useful reference\n• existing products, ingredients or processes within the same manufacturing area may result in additional risks that need to be managed\n• a map of the premises and equipment layout\n• a water distribution diagram\n• indication of any production risk zoning.", "requirement_fr": "Toutes les informations pertinentes requises pour effectuer l'analyse des dangers doivent être rassemblées, conservées, consignées et mises à jour. L'entreprise doit s'assurer que le plan de sécurité alimentaire, ou HACCP, est basé sur des sources d'informations globales, référencées et disponibles sur demande. À titre indicatif, cette dernière peut intégrer les points suivants, bien que la liste ne soit pas exhaustive :\n•\t dernières publications scientifiques\n•\t dangers historiques et connus associés à des produits alimentaires spécifiques\n•\t codes d'usage pertinents\n•\t directives reconnues\n•\t législation en matière de sécurité des denrées alimentaires pertinente relative à la production et à la vente de produits\n•\t exigences des clients\n•\t une copie de tout plan HACCP existant sur le site (c-à-d. pour les produits déjà en cours de production sur le site)\n•\t un plan du site et de l’agencement des équipements (voir clause 4.3.2)\n•\t un diagramme du système de distribution de l’eau du site (voir clause 4.5.2)\n•\t une description de toute zone où des installations de production à haut risque, de grande précaution ou de grande précaution pour les produits à température ambiante sont requises (voir clause 4.3.1).\n2.4 Identification de l'utilisation prévue (correspondant à l’Étape 3 du Codex Alimentarius)"}, {"id": "2.4.1", "requirement": "The intended use of the product by the customer, and expected alternative uses, shall be described, defining the consumer target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, allergy sufferers).", "interpretation": "The HACCP food safety team needs to consider and document the intended use of the products by the customer and the ultimate consumer to ensure all the risks have been assessed. For example, the team should consider:\n• the target population (e. g. does this include high-risk groups such as infants, elderly people or allergy sufferers?)\n• handling and preparation (e. g. will the product be consumed without further cooking?)\n• the customer supply chain\n• storage (e. g. frozen, or the requirement for chilled storage after opening the pack).\nWhere there is an expected alternative food use for a product, including the potential for a customer or consumer to misuse or mistreat the product in a way not intended by the manufacturer, this information should be included in the description in the HACCP assessment so that any implications can be considered as part of the subsequent hazard analysis. This alternative use may occur in the consumer’s home (e. g. consumption of a product that looks ready to eat without completing the correct cooking) or elsewhere in the supply chain (e. g. an unintended use of a raw material). A number of product recalls have occurred, for example, with frozen raw vegetables and coated/battered poultry products due to unintended use of the product. Inclusion of intended and expected alternative uses of a product can also provide a useful due diligence reference demonstrating to a customer or regulatory authority the scope of hazards that have been considered.", "requirement_fr": "L'utilisation prévue du produit par le client, ainsi que toute autre utilisation alternative prévisible, doivent être décrites. Les descriptions doivent définir les groupes de clientèle cible et spécifier si le produit est adapté aux groupes de population vulnérable comme les nourrissons, les personnes âgées, les personnes allergiques.\n2.5 Élaboration d'un diagramme de flux de processus (correspondant à l’Étape 4 du Codex Alimentarius)"}, {"id": "2.5.1", "requirement": "A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope. • plan of premises and equipment layout. • raw materials, including introduction of utilities and other contact materials. • sequence and interaction of all process steps. • outsourced processes and subcontracted work. • potential for process delay. • rework and recycling. • low-risk/high-risk/high-care area segregation. • finished products, intermediate/semi-processed products, by-products and waste", "interpretation": "The process flow diagram provides the site with an important tool, allowing it to evaluate the possible introduction, occurrence or change of hazards at each step of the process. It should therefore be used when identifying hazards (see clause 2. 7.1) and conducting hazard analysis (see clause 2. 7.2).\nTherefore, an accurate flow diagram indicating all the process steps, including all inputs and outputs, needs to be constructed for each HACCP or food safety plan. This may be achieved with a single diagram, or it could be in a modular form with several documents compiled to provide the complete information (in this situation it must clearly identify the interaction between the process steps). The Standard lists guidance on the points to consider and include when developing the flow diagram; for example:\n• a plan of the premises and equipment layout to facilitate consideration of cross- contamination risks (e. g. allergen control)\n• raw materials – it should be clear where raw materials are stored and the routes they take into the production area; this includes the introduction of utilities and other contact materials (e. g. water or packaging)\n• sequence and interaction of all process steps (e. g. method of transportation between each step)\n• outsourced processes and subcontracted work, including, for example, off-site processing, storage, packing or transport\n• potential for process delay (i. e. how products or ingredients will be handled if a delay occurs)\n• rework and recycling\n• low-risk/high-risk/high-care segregation (i. e. clearly indicating where the different production zones are located)\n• finished products, intermediate/semi-processed products, by-products and waste (e. g. where waste products leave the production process, and the storage of intermediates and finished products).\nclause 3. 2.1 of the Standard requires the site to have an effective document control system.\nSigning and dating the approved process flow diagram is one method of demonstrating that this is occurring.\nExamples There is no set pattern or format for the diagram. However, it is important to show all the steps in the process, from raw materials through to final products, as shown in Raw Materials All Process Stages Product All products must be covered in the diagram, so if your site has a wide range of similar products or processes, a modular option may be preferable; Figures 2 and 3 show examples.\nOtherwise a separate linear diagram is needed for each product; i. e. 20 products would need 20 linear process flow diagrams.\nRaw Materials All Process Stages Product B All Process Stages Product C All Process Stages Product A Examples All Process Stages Steamed Ingredients (See HACCP Study B1) Final Products Deep Fat Frying (See HACCP Study A1) Raw Ingredients If you use a modular or generic diagram, take care to ensure that it includes all steps and all products. If your site manufactures multiple products that are considerably different or require different processes, you will need to have several separate diagrams.\nIn addition to the process steps, the diagram needs to contain:\n• all raw materials used in the manufacture of the product(s), including the introduction of utilities and other contact materials (e. g. water or packaging)\n• details of any outsourced or subcontracted process (i. e. any activity that is part of the production process but does not occur on site)\n• rework or recycling\n• low-risk, high-care and high-risk segregation\n• routes taken by waste products\n• all finished products, intermediates, semi-processed products or by-products.\nExamples of completed process flow diagrams are shown in Figures 4 and 5.\nExamples\n8. Sieving (Xμm) 9. Tempering (Ambient ≤X hours)\n5. Bulk Storage (Ambient)\n1. Flour 2. Sugar\n7. Chilled Storage (X-Yo C)\n11. Weighing Up\n12. Mixing\n13. Forming\n17. Baking (≥X C, Y minutes)\n18. Cooling (Ambient, X minutes)\n21. Packing\n23. Date Coding\n24. Metal Detection\n25. Ambient Storage\n16. Waste\n15. Rework\n6. Ambient Storage\n3. Walnuts\n10. Water\n26. Dispatch\n22. Waste\t20. Packaging Store\n19. Pre-Printed Plastic Wrap Examples\n7. Curing Brine Preparation\n6. Water 8. Injection 9. Thaw (X C for Y-Z hours)\n4. Ambient Storage\n1. Salt (NaCl) 2. Nitrite Curing Salt\n5. Frozen Storage (<Xo C)\n3. Trimmed Pork Joints\n10. Tumbling 11. Waste (Brine)\n12. Cooking (≥Xo C for Y minutes)\n13. Cooling Blast Chill (<Xo C within Y hours)\n14. Chilled Storage (X-Yo (if required due to delay )\n20. Packing & Labelling\n21. Date Coding\n22. Metal Detection\n23. Chilled Storage (X-Yo C)\n24. Chilled Dispatch (X-Y C)\n16. Waste\n19. Disinfection\t18. Packaging Store\n17. Plastic Trays, Film Lids & Labels LOW RISK HIGH RISK HIGH RISK ENCLOSED PRODUCT AREA", "requirement_fr": "Un diagramme de flux doit être élaboré pour chaque produit, catégorie de produits ou processus. Il doit couvrir tous les aspects des opérations du processus alimentaire dans le cadre du plan de sécurité alimentaire, ou HACCP, depuis la réception des matières premières jusqu'à la distribution en passant par la transformation et le stockage. À titre indicatif ce diagramme doit intégrer les points suivants, bien que la liste ne soit pas exhaustive :\n•\t plan des locaux et distribution des équipements\n•\t matières premières, y compris l'entrée des fluides techniques et autres matériaux de contact comme l'eau ou l'emballage\n•\t séquence et interaction de toutes les étapes du processus\n•\t processus externalisés et travaux sous-traités\n•\t potentiel de retard des processus\n•\t retraitement et recyclage\n•\t séparation en zones à faible risque/à haut risque/de grande précaution\n•\t produits finis, produits intermédiaires/semi-finis, sous-produits et déchets.\n2.6 Vérification du diagramme de flux de processus (correspondant à l’Étape 5 du Codex Alimentarius)"}, {"id": "2.6.1", "requirement": "The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit at least annually, and whenever there are changes to the process.", "interpretation": "The flow diagram shall be verified as accurate. A member of the HACCP food safety team who is based at the site, part of the team, or the whole team must check that the flow diagram is accurate by on-site audit. This may be achieved using a physical walk-through of the process within the production area. A report of the activity and any findings will help to demonstrate that this has been completed.\nDuring the BRCGS audit, the auditor will confirm the accuracy of the documented process flow diagram by following the process in production.\nIt is vital that the process flow diagram remains up to date; therefore verification should occur whenever there is a review of the HACCP or food safety plan (e. g. whenever there is a change to the plan or operational activity) and at least once per year. For example, the manufacture of a new product (see clause 5. 1.2) should result in a HACCP review to confirm that any hazards to existing products have been managed appropriately, as well as ensuring that any hazards affecting the new product are controlled.\nIt is important that any daily (e. g. different shifts, including any night or weekend shifts) or seasonal variations are considered during the verification process (e. g. the production of a Christmas range that uses ingredients or processes not used during the rest of the year or significant changes in production volume).\nThe site must retain records of the diagrams and verification activities. For example, a verification record could include an annotated diagram showing:\n• the date and time of the verification\n• the product(s) being manufactured at the time the activity was observed\n• any amendments or alterations that were noted.\nAlternatively, a separate report could be produced in the format of an internal audit.\nThe records should also be signed to confirm who completed the verification.", "requirement_fr": "L’équipe de sécurité des denrées alimentaires HACCP doit vérifer l’exactitude des diagrammes de flux grâce à un audit sur site au moins une fois par an, et chaque fois que des changements sont apportés au processus, pour garantir que ces modifications ont été prises en compte dans le cadre du plan de sécurité alimentaire ou HACCP. Des modifications quotidiennes et saisonnières doivent être considérées et évaluées. Les diagrammes de flux vérifiés doivent être enregistrés.\n2.7 Établissement de la liste de tous les dangers potentiels associés à chaque étape du processus, réalisation d'une analyse des dangers et considération des mesures permettant de contrôler les dangers identifiés (correspondant à l’Étape 6 du Codex Alimentarius, Principe 1)"}, {"id": "2.7.1", "requirement": "The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. • microbiological. • physical contamination. • chemical and radiological contamination. • fraud (e.g. substitution or deliberate/intentional adulteration). • malicious contamination of products. • allergen risks", "interpretation": "It is expected that the list will include specific hazards. The Standard provides examples of those that should be considered, including:\n• specific micro-organisms (e. g. E. coli or Salmonella)\n• specific chemicals (e. g. veterinary residues, pesticides or radiological contaminants)\n• cleaning chemicals\n• machinery lubricants\n• specific foreign bodies (e. g. glass, metal or plastic)\n• specific allergens (e. g. peanuts or egg); i. e. those identified by the company, materials that are considered allergens in the country of intended sale and any customer requirements\n• the potential for fraud and/or adulteration\n• malicious tampering with the product or processes.\nIt is important that the company considers all relevant potential hazards from all relevant sources. These could include raw materials, processes and the factory environment. The process flow diagram is a useful tool in considering the potential risks at each stage of production. Some sites find it useful to consider each hazard, at each step, in terms of:\n• whether the hazard is likely to be present in, for example, the raw material or the processing environment\n• whether there is the potential to introduce or create a specific hazard at the step in the process being considered\n• if there is the potential for growth of micro-organisms\n• whether the hazard will survive the processing step; for example, whether a pathogen can survive in the product, or whether the contaminant is stable to the process being completed (e. g. heat stable).\nThere must be a description of each hazard and its sources – one hazard may have several potential sources and occur at more than one point in the process. This is important to ensure that effective controls for each source of hazard are established in the subsequent steps of the process.\nThe Standard has referenced food fraud and malicious contamination (food defence) in the list of hazards in this clause to draw attention to the need to include these within site assessments. However, later sections of the Standard (sections 4. 2 and 5. 4) provide greater detail on the expected activity in these areas. This clause does not require those assessments to be repeated or duplicated (as part of the HACCP plan, and then in compliance with sections 4. 2 and 5. 4) – separate assessment processes are acceptable and the site can reference the additional assessment within the HACCP plan. However, the outputs from those separate assessments must be considered as part of this process, to ensure that the correct controls, monitoring, verification, etc. are in place.\nThe aim of including radiological hazards within the clause is to consider potential contamination by radioactive isotopes (a legal requirement in some countries) which may be present in water or soil (either from a naturally occurring source or resulting from contamination caused by humans). A number of authorities produce reports on known radiological hazards; for example:\nIn the UK:\n• FSA: Radioactivity in Food and the Environment (RIFE)\n• UK Health Security Agency:\nThree Steps to Manage Radon in Buildings – Check, Measure, Act\n• UK government: Radioactivity in Food and the Environment (RIFE) Reports.\nIn the US:\n• FDA: FDA Response to the Fukushima Daiichi Nuclear Power Facility Incident.\nIn Ireland:\n• EPA: National Radiation Monitoring Network", "requirement_fr": "L'équipe de sécurité des denrées alimentaires HACCP doit identifier et consigner tous les dangers potentiels raisonnablement prévisibles pouvant survenir à chaque étape et liés au produit, au processus et aux installations. Sont inclus les dangers présents dans les matières premières, ceux introduits lors de la transformation ou ceux qui survivent durant les étapes du processus, ainsi que les types de dangers suivants :\n•\t microbiologiques\n•\t contamination physique\n•\t contamination radiologique et chimique\n•\t fraude (c-à-d. substitution ou adultération intentionnelle/délibérée) (voir section 5.4)\n•\t contamination malveillante des produits (voir section 4.2)\n•\t risques allergéniques (voir section 5.3).\nLes étapes précédentes et suivantes dans la chaîne de processus devront également être prises en compte."}, {"id": "2.7.2", "requirement": "The HACCP food safety team shall conduct a hazard analysis to identify the significant hazards (i.e. those hazards that are reasonably likely to occur at an unacceptable level), which need to be prevented, eliminated or reduced to acceptable levels. • likely occurrence of hazard. • severity of the effects on consumer safety. • vulnerability of those exposed. • survival and multiplication of micro-organisms of specific concern to the product. • presence or production of toxins, chemicals or foreign bodies. • contamination of raw materials, intermediate/semi-processed product, or finished product", "interpretation": "Any hazards identified in clause 2. 7.1 must be evaluated against the criteria detailed in this clause to identify those which are significant. For the purposes of the Standard a significant hazard is a hazard identified by the hazard analysis, which is reasonably likely to occur in the absence of a control, at an unacceptable level (i. e. a level that would be considered unsafe or illegal), and therefore control is essential for the production of a safe product. The HACCP food safety team must therefore take into account:\n• the likely occurrence of the hazard, taking into consideration existing prerequisite programmes, the nature of the facility and the equipment used\n• the severity of the effects on consumer safety\n• the vulnerability of those exposed\n• the survival and growth of micro-organisms (i. e. those of concern to the product(s) within the scope of the HACCP or food safety plan)\n• the presence or production of toxins, chemicals or foreign bodies\n• contamination of raw materials, intermediates, semi-processed product or finished product.\nEvidence of the decisions, along with the justification for the decision and the decision- making process, must be kept within the HACCP or food safety plan.\nThere are a range of tools that may assist with the evaluation of hazards (e. g. quadrant graphs, scoring systems, logic tables or decision trees). The team may choose to use these tools but should keep a record of any that are deployed. Such tools may also help in establishing CCPs.\nIt is useful to remember that the quality of the output from the assessment depends on the quality of the data or evidence used. The hazard analysis should, wherever possible, be based on demonstrable evidence such as documented validation studies, trend analysis and science-based literature. Where this information is not available at the site, it may be necessary for the site to obtain it from suppliers or reputable external sources to establish the likelihood or severity of the specific hazards.\nWhere elimination of a hazard is not possible, acceptable levels need to be defined.\nReference should be made to legal requirements or scientific evidence to justify the acceptable levels (e. g. microbiological standards or presence of mycotoxins).", "requirement_fr": "L’équipe de sécurité des denrées alimentaires HAACP doit effectuer une analyse des dangers pour identifier les risques importants (c-à-d. les dangers susceptibles de se produire à un niveau non acceptable) à prévoir, à éliminer ou à réduire à des niveaux acceptables. Les points suivants doivent être pris en compte :\n•\t probabilité d'occurrence d'un danger\n•\t gravité des effets sur la sécurité du consommateur\n•\t vulnérabilité des personnes exposées\n•\t survie et multiplication de micro-organismes particulièrement préoccupants pour le produit\n•\t présence ou production de toxines, produits chimiques ou corps étrangers\n•\t contamination des matières premières, du produit intermédiaire/semi-fini ou du produit fini.\nDans les cas où l'élimination du danger n'est pas réalisable, une justification des niveaux acceptables du danger dans le produit fini doit être déterminée et documentée."}, {"id": "2.7.3", "requirement": "The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level.", "interpretation": "Control measures required to reduce or eliminate the specific hazards (i. e. each hazard identified in clause 2. 7.1) must be established. Any hazard that cannot be eliminated must have control measures designed to reduce it to an acceptable level of presence. This acceptable level (e. g. setting a target of <100 cfu/g of Staphylococcus aureus in finished product) needs to be justified; in other words the site should understand the potential consequences of the hazard and be able to demonstrate that the acceptable level will adequately protect the consumer.\nIndustry guidelines, codes of practice, legislation etc. can help to establish and justify these levels.", "requirement_fr": "L'équipe de sécurité des denrées alimentaires HACCP doit déterminer quelles mesures de maîtrise sont nécessaires pour éviter ou éliminer un danger pour la sécurité des denrées alimentaires ou pour le réduire à un niveau acceptable.\nIl est recommandé d'envisager plus d'une mesure de maîtrise."}, {"id": "2.7.4", "requirement": "Where the control of a specific food safety hazard is achieved through prerequisite programmes or control measures other than critical control points (CCPs), this shall be stated and the adequacy of the programme to control the specific hazard validated.", "interpretation": "It is important that all controls are effective and consistently prevent identified hazards from occurring. Therefore where specific hazards are controlled by mechanisms other than CCPs (e. g. by prerequisite programmes or other control measures) these also need to be validated.\nIt is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls, often with results that are not quantifiable. However, where a prerequisite programme is used to manage a specific hazard (e. g. cleaning regimes used to prevent allergen cross- contamination), there needs to be a documented validation that the prerequisite controls the identified hazard. Some companies prefer to differentiate these prerequisites that manage specific hazards from other prerequisites, by referring to them as operational prerequisites (oPRPs).\nExamples of prerequisites that require validation include:\n• control of allergen cross-contamination by cleaning the production equipment. Evidence is required that the cleaning regime can effectively and consistently remove the allergen (examples of how this might be achieved are given in the guidance to clause 5. 3.8).\n• chilled storage conditions for product safety. The defined storage temperature must be validated by reference to technical literature, confirming the control of growth of relevant spoilage or food poisoning organisms. The storage facility must be validated as being capable of consistently delivering the defined temperature.\nPrerequisites used to control specific hazards must also be subject to routine verification and monitoring, and records should detail the control measures and monitoring procedures used (see clause 2. 12. 2 for full details of this requirement).", "requirement_fr": "Lorsque la maîtrise d'un danger spécifique pour la sécurité des denrées alimentaires est effectué grâce à des programmes préalables (voir section 2.2) ou de mesures de maîtrise autres que des CCP (Critical control points ou Points critiques pour la maîtrise) (voir clause 2.8.1), cela doit être mentionné, et la capacité du programme à contrôler le danger spécifique doit être validée.\n2.8 Détermination des CCP ou Points critiques pour la maîtrise (correspondant à l’Étape 7 du Codex Alimentarius, Principe 2)"}, {"id": "2.8.1", "requirement": "For each hazard that requires control, control points shall be reviewed to identify those that are critical. This requires a logical approach and may be facilitated by use of a decision tree. CCPs shall be those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level.", "interpretation": "Each control measure must be examined to identify which are critical (i. e. to identify the points at which control can be applied). This is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.\nRecords must be available showing how this has been conducted and how decisions have been reached.\nThe Standard is not prescriptive on the tools used to facilitate this process; for example, a two- or four-question decision tree may be useful. The site must, however, be able to demonstrate that it has used a logical approach and, therefore, a copy of any decision- making tools used and the results (e. g. the results of the questions from the decision tree) must be recorded.\nIf a hazard has been identified as critical but there is no control measure at that step or any other, the product or process should be modified so that a suitable control measure can be incorporated either at this step or at an earlier point in the process.\nSites working in accordance with the US Food Safety Modernization Act (FSMA) are likely to find that the preventive controls required by that legislation include all of the controls that would normally be identified as CCPs using a HACCP system. For example, CCPs are known as process preventive controls (PPCs) in an FSMA-compliant food safety plan. For certification purposes, it does not matter which terms are referenced as their management (for certification purposes) would be the same. Other preventive controls are historically treated as PRPs (prerequisite programmes) in many sites. In some cases, parts of them are elevated to preventive controls; these include food allergen, sanitation, supply chain, based on known or reasonably foreseeable risk of a serious adverse health consequence or death to humans or animals (SAHCODHA) hazard.\nWhere the management components of those preventive controls do not contain all the same elements of the CCPs/PPCs it is expected that the site would combine the most stringent requirements of FSMA and the Standard together. For example, a sanitation preventive control does not require validation for allergen cleaning under FSMA but it is required by the Standard (see clause 2. 7.4), therefore the Standard expects additional compliance with this requirement.\nAuditors shall be looking to confirm that the site has identified the correct points at which control should be exercised by the appropriate control mechanisms.\n2. 9 Establish validated critical limits for each CCP (equivalent to Codex Alimentarius Step 8, Principle 3) Once the HACCP or food safety team has identified all the relevant CCPs, it must then identify critical limits. The critical limit is the point that separates safe from unsafe or acceptable from unacceptable product.\nSome critical limits are defined by legislation; however, many will require experimental results, the advice of appropriate industry specialists or consideration of customer requirements.", "requirement_fr": "Pour chaque danger exigeant un contrôle, des mesures de maîtrise doivent être examinés pour déterminer lesquels sont critiques. Il faut pour cela adopter une approche logique et, dans ce cas, un arbre de décision peut se révéler utile. Les points de contrôle pour la maîtrise CCP sont les mesures de maîtrise nécessaires pour éviter ou éliminer un danger pour la sécurité des denrées alimentaires ou pour le réduire à un niveau acceptable. Si un danger est identifié à une étape où un contrôle est nécessaire pour la sécurité sanitaire, mais que ce contrôle n'existe pas, le produit ou processus doit être modifié à cette étape ou à une étape précédente, afin de fournir une mesure de maîtrise.\n2.9 Mise en place de limites critiques validées pour chaque CCP (correspondant à l'Étape 8 du Codex Alimentarius, Principe 3)"}, {"id": "2.9.1", "requirement": "For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be: • measurable wherever possible (e.g. time, temperature, pH). • supported by clear guidance or examples where measures are subjective (e.g. photographs)", "interpretation": "All identified CCPs must have defined critical limits – the point that, if properly and consistently implemented, separates safe from unsafe or acceptable from unacceptable product.\nWherever possible the criteria used should be objective (i. e. measurable), such as the temperature, time, moisture level, pH and aw.\nWhere objective criteria are not available, subjective parameters can be used. These may include sensory parameters such as visual appearance and texture, but they must be supported by clear guidance or examples. Photographs of acceptable and unacceptable limits or product samples for comparison could be shown as examples to staff at process control points.\nGood practice is often to identify action limits as well as critical limits with the aim of ensuring the measured parameter remains controlled; i. e. to identify a point at which action can be taken or a review completed, when the product or process is approaching the critical limit, but prior to it actually exceeding the critical limit.\nDetails on how the critical limits have been determined must be documented; these may include industry best practice, legislation or validation studies undertaken by the company.", "requirement_fr": "Pour chaque CCP, les limites critiques adéquates doivent être définies pour déterminer clairement si le processus est sous contrôle ou hors de contrôle. Les limites critiques doivent être :\n•\t mesurables dans la mesure du possible (c-à-d. heure, température, pH)\n•\t complétées par des orientations claires ou des exemples présentant des mesures subjectives (c-à-d. des photos)."}, {"id": "2.9.2", "requirement": "The HACCP food safety team shall validate each CCP, including critical limits. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level.", "interpretation": "Documented evidence must be available showing how the control measures for CCPs and critical limits have been validated to ensure they control, reduce or eliminate the hazard to an acceptable level.\nValidation must be specific and demonstrate that if the control measures are followed as specified and the critical limits are met (at minimum and maximum levels where a range is indicated), a consistently safe product will be produced. Evidence could come from professional bodies, trade associations, historical processing data, scientific and technical literature or legislation. In addition, scientifically valid experimental or pilot plant trial data or exercises, such as challenge testing, may be required to confirm the capability of the process.", "requirement_fr": "L'équipe de sécurité des denrées alimentaires HACCP doit valider chaque CCP, y compris les limites critiques. Des documents justificatifs doivent démontrer que les mesures de maîtrise choisies et les limites critiques identifiées sont en mesure de maîtriser les dangers de manière continue au niveau acceptable défini.\n2.10\t Mise en place d'un système de contrôle pour chaque CCP (correspondant à l’Étape 9 du Codex Alimentarius, Principe 4)"}, {"id": "2.10.1", "requirement": "A monitoring procedure shall be established for each CCP to ensure compliance with critical limits. The monitoring system shall be able to detect loss of control of CCPs and, wherever possible, provide information in time for corrective action to be taken. • online measurement. • offline measurement. • continuous measurement (e.g. thermographs, pH meters)", "interpretation": "Each CCP needs to be monitored to ensure the established limits are not exceeded. This can be achieved by observing or measuring the CCP at scheduled intervals or by the use of automated continuous measurement systems.\nA monitoring procedure must be established for each CCP. At a minimum, this should include:\n• the CCP to which the procedure relates\n• the staff (or staff role) responsible for monitoring the CCP (clause 1. 2.1 requires the staff responsible for product safety activities to be documented)\n• training requirements for responsible staff (see clause 7. 1.2)\n• the frequency at which the monitoring is completed\n• instructions on how the monitoring is completed\n• the requirements for record-keeping (clause 2. 10. 2)\n• the critical limit(s).\nIt is often useful for the procedure to include the action to be taken if the specified limit is exceeded (e. g. who to inform).\nMonitoring must be able to detect variation, which may result in limits being broken if no remedial action is taken. Wherever possible, monitoring must be sufficiently frequent to ensure that any necessary remedial action can be taken in adequate time so that there is no risk to the product and that no potentially affected product is released for sale or dispatched to the customer.\nMethods used may include online or offline measurements and may be continuous or discontinuous.", "requirement_fr": "Une procédure de surveillance doit être mise en place pour chaque CCP afin de garantir leur conformité aux limites critiques. Le système de contrôle doit être capable de détecter toute perte de contrôle des CCP et, dans la mesure du possible, de transmettre des informations à temps afin qu'une action corrective puisse être adoptée. À titre indicatif, il est conseillé d'envisager les points suivants, bien que la liste ne soit pas exhaustive :\n•\t mesure en ligne\n•\t mesure hors ligne\n•\t mesure continue (c-à-d. enregistreurs de température, pH-mètres).\nLorsque des systèmes de mesure discontinue sont utilisés, le système doit s'assurer que l'échantillon prélevé est représentatif du lot de produit."}, {"id": "2.10.2", "requirement": "Records associated with the monitoring of each CCP shall include the date, time and result of measurement, and shall be signed by the person responsible for the monitoring and verified, when appropriate, by a suitably competent and authorised person.", "interpretation": "The results of monitoring activities must be recorded. At a minimum, these records must include:\n• date and time when the measurement was made\n• the result\n• the signature of the individual conducting the monitoring\n• the signature of the individual (e. g. the line manager) checking and verifying the record.\nRecords of the monitoring should be evaluated by a designated person with knowledge to confirm the acceptability (or otherwise) of the results and authority to carry out corrective actions when necessary. It is often valuable for the verification to be completed by a different individual rather than the staff member who completed the monitoring, however, this is not always possible in very small sites. This verification should be completed at appropriate frequencies which, depending on working practices, may be at identified points during the day (e. g. at the end of the shift) rather than every time a measurement is made.", "requirement_fr": "Les enregistrements associés à la surveillance de chaque CCP doivent mentionner la date, l'heure et le résultat des mesures. Ils doivent être signés par le responsable du maîtrise et vérifiés, au moment opportun, par une personne compétente et autorisée. Lorsque les enregistrements sont présentés en format électronique, il doit pouvoir être démontré qu'ils ont été examinés et vérifiés.\n2.11 Mise en place d'un plan d'action corrective (correspondant à l’Étape 10 du Codex Alimentarius, Principe 5)"}, {"id": "2.11.1", "requirement": "The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control.", "interpretation": "A documented procedure needs to be established, detailing the actions to be taken when monitoring indicates that limits have been exceeded or when trends suggest they may be exceeded if no remedial action is taken.\nThe site will need to ensure that all CCPs are covered by corrective action plans. This may be achieved by having a single corrective action document or by individual documents for each CCP. However, it is important that the identified actions are specific to each CCP and not simply generic statements.\nThe procedure must include:\n• Authorised personnel – identify who can make decisions about product produced where limits have been exceeded and the corrective actions to be taken.\n• Immediate remedial action to be taken – for example, to bring the process back within critical limits.\n• Quarantine procedures – instructions on how implicated products (those that have passed through the process and may therefore have exceeded the limits) are identified, handled, isolated and/or stored until their safety status is established (e. g. products that have been metal-detected since the last satisfactory metal detector check). The handling and storage procedure must ensure that implicated product cannot enter production or be distributed to customers unless it has been confirmed as safe and released by the authorised staff.\n• Disposal procedures for unsafe products.\n• Additional actions that may be required (e. g. alternative processing, increased monitoring, etc.).\nGood practice is to use root cause analysis, where possible, to identify and correct the fundamental cause of the out-of-specification result.\nAll actions should be recorded.\nWhen investigation shows that the implicated product is safe and can be released to customers it may be necessary to review the critical limit, as the ‘safe’ product implies that the critical limit has not been set at the correct value.\n2. 12 Validate the HACCP plan and establish verification procedures (equivalent to Codex Alimentarius Step 11, Principle 6) Validation is defined as obtaining evidence through the provision of objective evidence that a control or measure, if properly implemented, is capable of delivering the specified outcome. In other words, it is objectively confirming that the plan will perform, effectively, as intended.\nSimilarly, verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control or measure is or has been operating as intended. In other words, verification seeks to answer the question, ‘Has it been operating effectively, as intended?’ Codex Alimentarius has published guidelines for the validation of food safety control measures (CXG 69-2008) which can be downloaded from the Codex Alimentarius guidelines page of the FAO’s website.", "requirement_fr": "L'équipe de sécurité des denrées alimentaires HACCP doit préciser et documenter l'action corrective à adopter lorsque les résultats des contrôles indiquent que les limites de contrôle ne sont pas respectées, ou lorsque les résultats des contrôles indiquent une tendance à la perte de contrôle. Ce document détaillera l'action que le personnel désigné devra adopter et qui concernera tous les produits fabriqués durant la période où une perte de contrôle du processus a été détectée.\n2.12\t Validation du plan HACCP et mise en place de procédures de vérification (correspondant à l’Étape 11 du Codex Alimentarius, Principe 6)"}, {"id": "2.12.1", "requirement": "HACCP or food safety plans shall be validated prior to any changes which may affect product safety, to ensure that the plan will effectively control the identified hazards before implementation.", "interpretation": "It is important that the site validates the food safety plan to confirm it will perform, effectively, as intended, and therefore prevent food safety hazards from occurring. In other words, the site should assess whether what it intends to put in place will actually work in practice.\nObviously, to be effective this validation needs to be completed before the plan is implemented and before any changes are made (e. g. in production) that could affect food safety.\nIn some countries (e. g. the US), there is an additional legal requirement for a revalidation after implementation, which must occur within a specified timescale, such as 90 days. This is good practice as it allows sites to consider the effects of upscaling (i. e. moving from trial systems to full production) or any other changes that may have occurred during the first few weeks of production, and therefore ensure that the plan still accurately reflects the actual production. Sites operating in countries where this is not a legal requirement may also find this a useful good-practice addition to their ways of working.\nThere are a number of aspects of the plan that should be validated, including:\n• production process flow\n• identification of the correct hazards at the correct steps of the process\n• identification of the correct CCPs\n• the establishment of monitoring and verification activities, including what to monitor and how frequently\n• critical limits and the corrective actions associated with each CCP.\nValidation in this context could include a range of activities, depending on the relevant hazards, such as:\n• review of literature\n• mathematical modelling\n• validation studies\n• guidance from authoritative sources (e. g. legislation).\nIt is important that the site has a mechanism to ensure that every subsequent change is captured and reviewed. This might include changes to processes or seasonality.\nWhere a HACCP plan already exists and has been operating effectively for a period of time the validation may be achieved using established verification and review processes developed in accordance with clauses 2. 12. 2 and 2. 12. 3.", "requirement_fr": "Les plans HACCP, ou de sécurité alimentaire, doivent être validés avant la mise en place de toute modification susceptible d'affecter la sécurité des produits, afin de garantir une gestion efficace des dangers identifiés.\nPour les plans HACCP ou de sécurité alimentaire existants, cette validation peut être obtenue en suivant les processus détaillés dans les clauses 2.12.2 et 2.12.3."}, {"id": "2.12.2", "requirement": "Procedures of verification shall be established to confirm that the HACCP or food safety plan, including controls managed by prerequisite programmes, continues to be effective. • internal audits. • review of records where acceptable limits have been exceeded. • review of complaints by enforcement authorities or customers. • review of incidents of product withdrawal or recall", "interpretation": "The HACCP or food safety plan, including controls managed by prerequisites, must be verified to ensure that it remains effective.\nVerification requires objective evidence that the specified requirements are being met.\nThis may include verification that monitoring has been completed correctly, that results are understood and that appropriate corrective actions have been completed. Examples of activity that can be included in verification studies are:\n• internal audits (e. g. to ensure the correct procedures and work instructions are in use and that monitoring frequencies are correct)\n• review and trending of records (e. g. CCP monitoring records)\n• review of complaints by enforcement authorities or customers\n• review of incidents (e. g. product withdrawal or recall).\nThe results of this verification must be documented and communicated to the HACCP or food safety team as part of the review process.\nVerification should be completed to a planned schedule.", "requirement_fr": "Des procédures de vérification doivent être mises en place pour confirmer que le plan de sécurité alimentaire, ou HACCP, y compris les contrôles gérés par les programmes préalables, est toujours efficace. Les activités de vérification incluent, par exemple :\n•\t les audits internes\n•\t l'étude des enregistrements contenant des cas où les limites acceptables ont été dépassées\n•\t l'étude des réclamations émises par les autorités répressives ou par les clients\n•\t l'étude des incidents de retraits ou de rappels de produits.\nLes résultats des vérifications doivent être consignés et communiqués à l'équipe de sécurité des denrées alimentaires HACCP."}, {"id": "2.12.3", "requirement": "The HACCP food safety team shall review the HACCP or food safety plan and prerequisite programmes at least annually and prior to any changes which may affect food safety. • change in raw materials or supplier of raw materials. • change in ingredients/recipe. • change in processing conditions, cleaning and disinfection procedures, process flow or equipment. • change in packaging, storage or distribution conditions. • change in consumer use. • emergence of a new risk. • review following a significant product safety incident. • new developments in scientific information", "interpretation": "The HACCP or food safety plan and associated prerequisite programmes must be reviewed regularly, at a minimum of once a year, even if there have been no changes to the product range or processing methods. Some or all of the plan should be reviewed whenever there is a significant change.\nChanges that may affect product safety, such as those listed in this clause, need to be evaluated in the context of the plan before they are introduced, and the plan amended as necessary.\nA procedure could be documented that lists the activities or changes which trigger a HACCP review, but this would have to be backed up by documented evidence that the review has actually been carried out (e. g. by documenting minutes of the meeting or an agreed action plan).\nIn the case of published incidents (e. g. recalls or media stories), it is good practice to consider whether the product involved is similar to those produced at the site, and therefore whether a similar problem could occur with the site’s products. Where a genuine risk is identified, the site should complete a review of the existing HACCP controls to establish whether they remain sufficient or whether amendments are required. However, it is not a requirement of the Standard to complete an in-depth analysis of every recall that occurs where no similarity or risk exists.", "requirement_fr": "L'équipe de sécurité des denrées alimentaires HACCP doit vérifier le plan de sécurité alimentaire, ou HACCP, et les programmes préalables au moins une fois par an et avant toute modification pouvant affecter la sécurité alimentaire. À titre indicatif, ces modifications peuvent avoir trait aux points suivants, bien que la liste ne soit pas exhaustive :\n•\t changement de matières premières ou de fournisseur de matières premières\n•\t changement d'ingrédients ou de recette\n•\t changement des conditions de transformation, des procédures de nettoyage et de désinfection, du flux de processus ou de l'équipement\n•\t modification des conditions d'emballage, de stockage ou de distribution\n•\t modification des usages des consommateurs\n•\t apparition d’un nouveau risque (c-à-d. une altération connue d’un ingrédient ou d’autres informations pertinentes publiées, telles que le rappel d’un produit similaire)\n•\t examen suivant un incident important lié à la sécurité d'un produit (c-à-d. un rappel de produit)\n•\t nouvelles avancées scientifiques relatives aux ingrédients, processus, emballages ou produits.\nLes changements pertinents découlant de la révision doivent être inclus dans le plan de sécurité alimentaire, ou HACCP, et/ou dans les programmes préalables. Les modifications doivent être pleinement documentées, et la validation doit être enregistrée.\nLe cas échéant, les changements doivent également être reflétés dans la politique de sécurité des produits et dans les objectifs de sécurité alimentaire de l'entreprise.\n2.13\t Documentation HACCP et tenue de registres (correspondant à l'Étape 12 du Codex Alimentarius, Principe 7)"}, {"id": "2.13.1", "requirement": "Documentation and record-keeping shall be sufficient to enable the site to verify that the HACCP and food safety controls, including controls managed by prerequisite programmes, are in place and maintained.", "interpretation": "Records must be kept to demonstrate that the HACCP or food safety plan, including the prerequisite programmes, is fully implemented. This must include all the steps in creating and reviewing the plan, records of control and monitoring procedures, and training records of staff.\nFurther details on record-keeping are available in the requirements in section 3. 3 of the Standard and its interpretation.\n3 Food safety and quality management system\n3. 1 Food safety and quality manual The company’s processes and procedures to meet the requirements of this Standard shall be documented to allow effective, consistent application, facilitate training, and support due diligence in the production of a safe product.\nA well-documented, systematic management system forms the basis for the product and process controls necessary to produce safe products, meet the requirements of the Standard, meet customer specifications and enable staff to be trained and informed.\nIn many instances, the Standard specifically states that requirements shall be satisfied by documented procedures;\nin others, this is implied as the company needs to ensure consistent application throughout the site and show that systems are in place to demonstrate food safety to external stakeholders (including regulatory authorities, customers and the BRCGS auditor). The Standard therefore requires policies, procedures, records, risk assessments, etc. , to be documented in sufficient detail to achieve these aims.\nThe Standard does not prescribe a review frequency for the food safety and quality manual, or the documents within it; however, good practice is to update the manual, or relevant parts of it, whenever there is a change to processes or procedures.", "requirement_fr": "La documentation et la tenue de dossiers doivent être suffisant pour permettre au site de vérifier que les contrôles de sécurité alimentaires et HACCP, y compris les contrôles gérés par les programmes préalables, sont mis en place et appliqués.\n3 Système de gestion de la sécurité et de la qualité des denrées alimentaires 3.1 Manuel sur la sécurité et la qualité des denrées alimentaires Les processus et procédures de l'entreprise ayant pour objectif le respect des exigences de cette Norme doivent être documentés pour garantir leur application efficace et cohérente, faciliter la formation et contribuer au contrôle préalable de la fabrication d'un produit sûr."}], "statement_of_intent": "The company shall have a fully implemented and effective food safety plan incorporating the Codex Alimentarius HACCP principles.", "group_intro_interps": {"2.10": "Monitoring is a planned set of checks or measurements for each CCP to ensure it is consistently meeting the identified critical limit. Monitoring must be recorded in terms of both the procedures to be followed and the results obtained"}, "section_intro_interp": "The purpose of these requirements is to create a food safety plan to mitigate food safety hazards. The foundation of this food safety plan is a hazard and risk analysis. In order to be effective this analysis must be systematic, science-based, thorough, fully implemented and kept up to date.\nIn the food industry, the principles for assessing hazard and risk are commonly referred to as HACCP. However, the specific terminology used in the Standard, such as prerequisites and critical control points (CCPs), are drawn from global terminology used to describe expectations. Sites are not required to use the specific terminology used in the Standard; alternative terminology is acceptable, providing it is evident that all the requirements have been fully met. For example, legislative requirements in the US (detailed in the Food Safety Modernization Act) use different terminology but still incorporate all the requirements of the Standard.\nSites are advised to avoid having multiple plans with different terminology as this is administratively complex and unnecessary. (It may, of course, be appropriate to have multiple plans where a site produces different types of products with different product safety hazards, but common terminology should be used throughout.) Regardless of the terminology used the food safety plan must incorporate all of the Codex Alimentarius HACCP principles. The clauses in Issue 9 have been updated to reflect the latest publication of the Codex Alimentarius HACCP principles, therefore where it is evident that all the requirements in section 2 have been fully met, a site will not be expected to undertake additional activities to meet the Codex Alimentarius principles.\nThe plan must be specific to the products manufactured, processed or packed on site and the production processes used.\nCodex Alimentarius has published background information and extensive guidance on the HACCP principles which can be found in the General Principles of Food Hygiene (CXC1-1969) last updated in 2020. It can be downloaded from the Codex Alimentarius page on the FAO’s website.\nBRCGS offers training on HACCP implementation. Details are available from the BRCGS website."}, {"section": 3, "title": "Food safety and quality management system", "clauses": [{"id": "3.1.1", "requirement": "The site’s procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual.", "interpretation": "Policies, procedures and work instructions must be in place, easily retrievable and available where needed, and must cover the requirements of the Standard. These documents must be collated into one or more quality manuals which form the reference point for all documents included in the food safety and quality system.\nThese documents may exist on paper (i. e. as hard copy) or may be controlled on an electronic system. In either case, they should be easy to follow and kept up to date.\nIn a small, simple operation, the manual may contain the majority of the procedures controlling the processes. In a complex operation it may contain the headline policies and indicate where more detailed operating instructions can be found.\nThe manual should include an overview of how the company’s policies and procedures are organised. This organisation should be understood by those using the documents and easily demonstrated. Where the site is part of a company governed by a head office, the interaction between the site’s documented system and that of the other sites and the head office should be clear. All policies and procedures necessary for the operation of the site being assessed must be available at that site.\nThere is no requirement for sites to have a quality manual that is numbered in accordance with the Standard’s numbering system.", "requirement_fr": "Les procédures, méthodes de travail et pratiques du site doivent être rassemblées dans un manuel puis imprimées ou conservées sur un support électronique."}, {"id": "3.1.2", "requirement": "The food safety and quality manual shall be fully implemented and the manual or relevant components shall be readily available to relevant staff.", "interpretation": "The objective of this requirement is to ensure that key staff have access to up-to-date policies and procedures at all times and in the most appropriate format. For example, the incident management procedure should be available to the relevant team members via internet link, hard copy or other off-site format.\nStaff needing such documents as part of their role within the company must always have access to them. During the audit the procedures documented in the manual will be evaluated against the actual practices on the site, with the expectation that they are followed correctly.", "requirement_fr": "Le manuel de sécurité et de qualité des denrées alimentaires devra être pleinement mis en œuvre, et le manuel ou les éléments pertinents doivent être facilement accessibles au personnel concerné."}, {"id": "3.1.3", "requirement": "All procedures and work instructions shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by appropriate staff.", "interpretation": "Procedures and work instructions must be documented in a clear and unambiguous format.\nAnyone using an authorised document must be able to understand its relevance, what it is for and how to use it. Evidence is required to demonstrate that staff clearly understand the procedures as this will be challenged by the auditor.\nConsideration may be given to providing procedures in appropriate languages, either written or oral, to ensure staff understand the documents and their role. Where translations are used, a record should be kept of who translated the information into which language(s). Both the translator and the recipient staff should sign the training record to indicate that the translated version has been understood.\nDocumentation should include the use of photographs, diagrams or other pictorial instructions where written communication alone is not sufficient. For example, diagrams added to cleaning instructions can show clearly which pieces of equipment to remove or focus on. Signs and pictures can be particularly useful for communicating personal hygiene and protective clothing requirements.\n3. 2 Document control The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.\nDocuments must be effectively controlled to ensure that staff are working with the most up-to-date information and to minimise the potential for mistakes. Documents include policies, procedures, work instructions, records, forms, specifications, data lists and any information that is written down and defined. They may be available on paper (i. e. as hard copy) or in electronic format.\nKey documents found to be in use during the audit that have not been properly authorised or are not the correct version may lead to a non-conformity.", "requirement_fr": "Toutes les procédures et instructions de travail doivent être clairement lisibles, sans ambiguïté, formulées dans les langues pertinentes et suffisamment détaillées pour permettre leur application correcte par les employés concernés. Elles devraient inclure des photos, diagrammes et autres indications graphiques lorsque les informations écrites ne sont pas suffisantes (c-à-d. dans le cas de problèmes d'alphabétisation ou de langues étrangères).\n3.2 Contrôle des documents L'entreprise doit disposer d'un système de contrôle de documents efficace pour garantir que seules les versions correctes, y compris les formulaires de consignation, sont disponibles et en service."}, {"id": "3.2.1", "requirement": "The company shall have a procedure to manage documents which form part of the food safety and quality system. • a list of all controlled documents indicating the latest version number. • the method for the identification and authorisation of controlled documents. • a record of the reason for any changes or amendments to documents. • the system for the replacement of existing documents when these are updated. • stored securely (e.g. with authorised access, control of amendments, or password protection). • backed up to prevent loss", "interpretation": "The control of all documents within the food safety and quality system (for both external and internal use) is important for several reasons, including:\n• the documents are kept up to date\n• staff are working with the correct version\n• the potential for mistakes caused by multiple versions of a document is minimised.\nTherefore all documents in use need to be properly authorised and must be the correct version.\nThe Standard requires the site to have a documented procedure that describes the method by which documents are controlled and managed. This procedure needs to include instructions on how the following features of the document management system are controlled:\n• responsibilities for the management of the system\n• list of all controlled documents, indicating the current version number and the allocation of controlled copies of the document (see below)\n• identification of controlled documents (e. g. document ID, issue date, version number)\n• records of the reason for any change(s) (see below)\n• method of rescinding and replacing documents.\nIn order to demonstrate the control of document issue, it is necessary to maintain a register of all controlled documents, their allocation and issue status. Where the controlled documents are all contained on an electronic system, it is usual for printed versions to be marked as uncontrolled. Each copy must be authorised (e. g. with a signature or stamp) to show it is for use, and each must be given a version number so that out-of-date documents can be identified and removed. This must be evidenced by the fact that all documents in use are the most up-to-date versions.\nWhere documents are maintained electronically, the site is required to ensure that they are stored securely and cannot be amended by unauthorised persons; for example, by using individual passwords or security swipe cards. This includes backing them up appropriately to ensure no data is lost. The auditor will ask to see evidence (e. g. a procedure) that the site has an effective backup process, rather than auditing that the backup contains all the relevant files.\nThe methodology or type of electronic storage is not specified. The site may choose to use an internal server to store data; or it may use cloud services, which are generally considered to be secure and backed up, providing there is control of authorised/authenticated users.\nWhen a document is changed, a record needs to be made of the change and the reason for it. This can be achieved by keeping a copy of the previous version with the reason for the change written on it, or by keeping a history of amendments. Consideration should also be given to the most effective method of communicating the changes to staff; for example, by highlighting the change within the new document or training relevant staff.\nFurther guidance How to put a document control procedure in place Firstly, ensure there is a single, clear, documented system that operates across all documents within the food safety and quality management system and that it includes the minimum requirements highlighted in the Standard:\n• identification of the individual(s) responsible for management of the system (i. e. who is authorised to issue or amend documents). This might be someone with the authority to instigate and maintain the system\n• the list of all controlled documents\n• methods of identification of controlled documents\n• records regarding the reasons for any changes\n• the method of collecting and replacing documents.\nList of documents Your site needs a list of all the documents within the food safety and quality system.\nTypically this will include:\n• the document identification or number. The Standard does not set out how you should identify your documents, but an example format would be using sequentially numbered documents or an initial letter (often representing a department or activity) followed by a number (e. g. P0123);\n• the document title. Use a concise title that clearly explains the purpose or content of the document (e. g. ‘metal detector check procedure’)\n• the current issue or version number. Each time the document is updated, amended or replaced, a new version number should be used\n• the issue date. Include the date when the current version of the document first came into force\n• withdrawal date (if applicable)\n• review date (if applicable). Documents may require periodic review to ensure the information remains applicable and up to date\n• the allocation of controlled copies (i. e. who has a copy of the document).\nFurther guidance REFERENCE NUMBER TITLE VERSION NUMBER ISSUE DATE WITHDRAWAL REVIEW DATE ALLOCATED COPIES Check Procedure 1 1 June 1 January N/A J Jones B Brown S Smith Check Procedure 2 1 January N/A J Jones B Brown S Smith Check Weight Procedure 1 1 January N/A S Smith G Green Identification and authorisation of your documents The simplest way to identify your document is to include a footer on each page that contains the relevant information, as shown in\n• document reference\n• issue or version number\n• title of the document\n• date of issue\n• page number and total number of pages.\nREFERENCE:\nVersion Number: 2 Issue Date: 1st January 2020\tPage: 1 of Acceptance of Raw Materials Version 1 Page 3 of 4 Issued: 1/1/20\tG001 You will need to include a method of authorisation too (e. g. a signature or a stamp that identifies genuine copies of the document). Where these are held electronically, it may be more convenient to label printed copies as uncontrolled copies.\nMaking changes to your documents When a document is changed, you will need to make a note of the change and the reason for it. You can do this by:\n• keeping a copy of the previous version with the reason for the change written on it, or\n• keeping a ‘history of amendments’ log within each document;\nFurther guidance New metal detector purchased which needed to be reflected in this procedure DATE CHANGES 1 Jan 28 Sept 21 Frequency of checks updated to reflect requirements of a new customer A new issue or revision always replaces an existing document. You must not have two different issues or revisions of the same document at any time.\nYou will also need to ensure that any policy or procedure changes are communicated to the relevant staff. This can be done by highlighting the change within the new document or by specific training prior to the issue of the new version.\nReplacing your documents You will need to keep a record of all controlled documents and their allocation. This will mean that whenever a document is updated or replaced, the person responsible can ensure each old copy is returned when the new version is issued. The easiest way to do this is by using a sign-off sheet where staff sign to indicate that they have returned the previous version and collected the new one.\n3. 3 Record completion and maintenance The site shall maintain genuine records to demonstrate the effective control of product safety, legality and quality.\nRecords are documented information that provide permanent evidence about past events – particularly events concerning product safety, quality and legality. Records must therefore be maintained in an appropriate way to ensure they demonstrate control of systems and operations.\nWhere records are kept electronically, it is good practice to ensure that the IT management system facilitates good quality, secure, accurate record-keeping. For example, it should:\n• include suitable systems for storing and backup of data (it may be useful to check the effectiveness of the system to restore data, e. g. as part of the incident management procedures detailed in section 3. 11)\n• define access and IT management responsibilities\n• set a frequency of backup based on risk\n• confirm the security of data storage.", "requirement_fr": "L'entreprise doit disposer d'une procédure permettant de gérer les documents faisant partie du système de sécurité et de qualité des denrées alimentaires. Cette procédure doit inclure :\n•\t une liste de tous les documents contrôlés où figure le numéro de la dernière version\n•\t la méthode d'identification et d'autorisation des documents contrôlés\n•\t des enregistrements rassemblant les raisons de changements ou de corrections apportés aux documents\n•\t le système de remplacement des documents existants lors de leur mise à jour.\nLorsque les documents sont stockés sous forme électronique, ceux-ci doivent également être :\n•\t conservés de manière sécurisée (c-à-d., avec un accès autorisé, un contrôle des modifications, ou protégés par un mot de passe)\n•\t sauvegardés pour empêcher la perte de données.\n3.3 Réalisation et conservation des enregistrements Le site doit conserver de véritables enregistrements pour démontrer l'existence d'un contrôle efficace de la sécurité sanitaire, légalité et qualité des produits."}, {"id": "3.3.1", "requirement": "Records shall be legible, maintained in good condition and retrievable. Any alterations to records shall be authorised and justification for the alteration shall be recorded. • stored securely (e.g. with authorised access, control of amendments, or password protection). • suitably backed up to prevent loss", "interpretation": "Records must be legible and genuine; for example, they must be completed at the time of the checks (i. e. not before or after the event) and in an appropriate manner (e. g. using a pen, as pencil could be altered after the event). Records should be appropriately authorised; this may include the initials or signature of the operator or supervisor verifying the records.\nAny alterations to records need to be justified and authorised. A suitable procedure must be in place to manage any mistakes that are made (e. g. neatly crossing through the ‘inaccurate’ information, noting the reason for the error and giving the initials of the person making the change). Note that the use of correction fluid is not acceptable as this makes the initial information illegible.\nRecords must be retrievable when required (e. g. during an audit or the investigation of a customer complaint), and must therefore be maintained and stored to allow this (e. g. by being appropriately filed by date or legible within the specified storage timeframe). They must be created in such a manner that they accurately transmit the intended information (e. g. they can be read by others and are traceable to the creator of the record via initials or signature).\nWhere records are stored electronically, this storage must be secure. The site should ensure that passwords or other mechanisms required to access records are known only by the people who need to use them. When using electronic systems, it may also be useful to assign different access levels; for example, for staff who can view records, and for those who can also add or amend existing data.\nElectronic documents must be suitably backed up to prevent loss. Consideration should be given to testing electronic retrieval systems, and records of these tests should be retained.", "requirement_fr": "Les enregistrements doivent être lisibles, conservés dans de bonnes conditions et faciles à trouver. Toute modification des enregistrements doit être autorisée et la justification de la modification doit être consignée. Lorsque les enregistrements sont sous forme électronique, ceux-ci doivent également être :\n•\t conservés de manière sécurisée (c-à-d., avec un accès autorisé, un contrôle des modifications, ou protégés par un mot de passe)\n•\t dûment sauvegardés pour empêcher la perte de données."}, {"id": "3.3.2", "requirement": "Records shall be retained for a defined period with consideration given to: any legal or customer requirements, the shelf life of the product. At a minimum, records shall be retained for the shelf life of the product plus 12 months.", "interpretation": "The retention time for records must be established by the company, and procedures put in place for appropriate handling, so that records are retained in good condition for this period and are retrievable. Consideration should be given to the potential for degradation during storage (e. g. due to fading ink, degradation of thermal paper or breakdown of electronic media).\nRecords that may be called upon to demonstrate the safety, authenticity or legality of the product must be kept for an appropriate period. Examples of appropriate periods for products or ingredients are as follows:\n• Final products A period not less than the indicated shelf life plus 1 year.\n• Ingredients (i. e. where the site sells an ingredient that will be used in the manufacture of a final product) The shelf life of the final product plus 1 year. Where the final-product shelf life is not reasonably known, records should be kept for 3 years or a period agreed with customers.\n• Products of an undefined shelf life (e. g. some wines and alcoholic drinks) The company should define a reasonable record retention period based on experience of customer usage, time for complaints and any legal precedents. It would be usual for records to be kept for at least 3 years in these situations.\nAdditional retention time may be required by legislation, by customers or because of the nature of the product (e. g. extension beyond the normal shelf life by the inclusion of customer freezing instructions on the product packaging must be observed).\nAs records may be called upon by a customer as part of a legal defence, consideration should be given to the length of time that may pass from production of a product to notification of impending legal action in the country of sale.\nSome regions have specific legal requirements. FSMA legislation, for example, requires a storage period of a minimum of 2 years for all documents and records relating to the food safety plan, and records must be retrievable within 24 hours, even when stored off site.\n3. 4 Internal audits Fundamental The company shall be able to demonstrate that it verifies the effective application of the food safety plan, and the implementation of the requirements of the Global Standard Food Safety and the site’s food safety and quality management system.\nAn internal audit is any audit completed by or on behalf of the company rather than by a second or third party. In second-party audits, the company carrying out the audit may have a commercial interest (e. g. a customer audit), while a third-party audit is generally conducted by an independent organisation (e. g. a certification body).\nInternal audits are one of the most powerful self-assessment tools that a site has available; they are a key factor in ensuring compliance with the requirements of the Standard, and the operation of its food safety and quality management systems. They must therefore be regarded by the management of the company as critical to its operation, and this section of the Standard is listed as fundamental to food safety and compliance with the Standard.\nThe internal audit programme can be used to:\n• confirm that the product safety and quality management systems are correct and effective\n• verify that product safety, authenticity, legality and quality activities and processes are being completed correctly (i. e. the actual work completed)\n• monitor and confirm that products are manufactured correctly\n• provide early identification of potential risks or potential non-conformities (sometimes referred to as near-misses), allowing timely correction such that they do not become actual non-conformities\n• identify areas for improvement\n• undertake verification of systems (a crucial step within the control of the HACCP or food safety plan; e. g. see clause 2. 12. 2).\nThe site’s attitude towards its internal audit programme is also likely to indicate its food safety and quality culture.\nFor example, a site with a poor food safety culture may be tempted to:\n• reduce the number of internal audits and inspections to the minimum, rather than the level indicated by thorough risk assessment\n• under-report non-conformity and near-misses (i. e. find less than exist in reality)\n• not follow up on non-conformities (e. g. corrective, preventive actions and root cause analysis).\nThe scope of the internal audit programme must cover all areas of the food safety and quality management system, including all the requirements of the Standard, implementation of the HACCP or food safety plan, prerequisite programmes and procedures, food defence and prevention of food fraud. It must also cover both the systems in place and the work practices.\nIt is not a requirement of the Standard that all of the internal audits in the programme are completed prior to the site’s BRCGS audit. However, the Standard does require the site to have a planned schedule, with audit dates spread throughout the year, and for the site to complete the individual audits according to this schedule (see details below).\nFor sites that are already certificated the auditor may review the internal audits from the previous year, if the BRCGS audit occurs early in the year, and little of the current year’s schedule has been completed.\nThe Standard is not prescriptive on the type of auditing techniques used during internal audits, and the site may therefore choose the most applicable techniques for the activity being audited. For example, there are some areas that may be auditable remotely, while others are likely to require physical, on-site auditing techniques. Whichever techniques the site uses, it is still expected to have an effective audit programme. That means being able to demonstrate that the systems associated with the food safety plan, the Standard and the food safety and quality management system are operating effectively and as intended.", "requirement_fr": "Les enregistrements doivent être conservés pendant une période définie sans perdre de vue les aspects suivants :\n•\t toute exigence légale ou des clients\n•\t la durée de vie du produit.\nCe dernier aspect doit tenir compte, lorsque l'étiquette le précise, de la possibilité que la durée de vie soit prolongée par le consommateur (c-à-d. grâce à la congélation).\nLes enregistrements doivent être conservés au minimum pour une période équivalant à la durée de vie du produit, plus 12 mois.\n3.4 Les audits internes Fondamental L'entreprise doit pouvoir démontrer qu'elle vérifie l'application réelle du plan de sécurité des denrées alimentaires et la mise en place des exigences de la Norme Mondiale de Sécurité des Denrées Alimentaires, ainsi que le système de gestion de la sécurité et de la qualité des denrées alimentaires du site."}, {"id": "3.4.1", "requirement": "There shall be a scheduled programme of internal audits. At a minimum, the programme shall include at least four different audit dates spread throughout the year. The frequency at which each activity is audited shall be established in relation to the risks associated with the activity and previous audit performance. The scope of the internal audit programme shall include: • HACCP or food safety plan, including the activities to implement it. • prerequisite programmes (e.g. hygiene, pest management). • food defence and food fraud prevention plans. • procedures implemented to achieve the Standard", "interpretation": "The scope of internal audits needs to be established and must ensure that all aspects of the food safety and quality management systems (including the HACCP programme, prerequisite programmes, policies, documentation, hygiene and production), the product safety and quality culture plan, and systems associated with authenticity, product legality and quality management are audited at least annually.\nAll the internal audits should not be conducted on a single day; nor should every internal audit attempt to cover all aspects of the food safety and quality management system or the Standard. A once-a-year check against all the requirements of the Standard may be of value as a gap analysis when preparing for an audit or confirming the contents of the food safety and quality management systems, but is insufficient to cover the full requirements of an internal audit programme as it will not provide the depth of assessment or level of confidence required.\nDevelopment of the internal audit schedule should begin with a risk assessment. The aim of this is to identify:\n• all the areas or activities that need to be audited\n• the frequency with which each part of the product safety and quality management system needs to be audited. This will be dependent on the risk inherent in each activity or section of the food safety and quality management system. For example, the site should be aware of the consequences of not complying with its own systems, which could lead to hazards not being identified in a timely manner. Therefore internal audits of CCPs are likely to be more frequent than those for less critical activities.\nFrequency may also be influenced by known issues within the company or customer requirements. This may result in a site needing to audit an activity multiple times throughout the year, or developing a programme with more than four internal audit dates (see below)\n• the most relevant dates for each internal audit; for example, if activities or processes are seasonal (see below) or if specific activities need to be completed more than once a year.\nSites may also find it useful to consider completing internal audits during different shifts, including, for example, nights or weekends.\nThe majority of sites are likely to benefit from a programme of audit dates spread diversely throughout the year, as this maximises the opportunity to identify any non-conforming processes in a timely manner, allowing correction and minimising the potential for standards to fall between audits. The Standard promotes this concept by requiring a minimum of four audit dates spread throughout the year. However, it does not require all audits to be completed quarterly, as there may be genuine situations where risk assessment shows an alternative frequency. Seasonality is an example; if a site is open only for part of the year, then there is little value in completing internal audits while the site is shut. For seasonal production, the site is not expected to complete a series of internal audits when the site is not operating; however, there must be a system for the management of start-up processes, and internal audits are therefore expected to start before the season commences to ensure the site is ready to start production. For example, the HACCP programme should be audited to ensure that it is up to date and appropriate for the forthcoming production; that hygiene and fabrication are correct; and that staff are appropriately trained. The remaining areas of the internal audit programme should be covered throughout the season. Further information is available in the BRCGS Fresh Produce Guideline available from BRCGS Participate or the BRCGS Store.\nEven where a site is open throughout the year, seasonality can affect the internal audit dates; for example, if certain activities, such as the harvest of grapes or bottling of wine, are only completed at certain times, or if there are seasonal changes in production volumes which apply a greater burden on the product safety systems at certain times of year. Where a site is part of a multi-site company, and the company conducts annual corporate food safety audits, it is acceptable for this annual audit to be incorporated into the internal audit schedule. However, additional internal audits that look at specific parts of the food safety and quality system, and compliance with the Standard, should be scheduled throughout the rest of the year.\nThe most common way of completing an internal audit is by taking documented procedures and work instructions and comparing them with the actual working practices and records.\nNote that a tick-box exercise is not sufficient, as it does not provide the rigour or depth that an effective internal audit programme requires.\nThe use of an external consultant (e. g. by small sites) is acceptable, providing the internal audit programme is scheduled throughout the year and not in a single block of activity.\nSee clause 1. 2.4 and section 3. 5.3 for details relating to the requirements for product safety consultants.\nBRCGS has produced a guideline to internal auditing which is available on BRCGS Participate or from the BRCGS Store.", "requirement_fr": "Une planification d'audits internes doit être établie.\nLe programme doit inclure un minimum de quatre dates d’audit différentes, échelonnées sur l’ensemble de l’année. Pour chaque activité, la fréquence des audits doit être définie en fonction des risques associés à l'activité et des résultats des audits précédents. Toutes les activités qui constituent les systèmes de sécurité et de qualité des denrées alimentaires du site, y compris celles relatives à la sécurité sanitaire, l'authenticité, la légalité et la qualité des aliments, doivent être contrôlées au moins une fois par an.\nLa portée du programme d’audit interne doit inclure, bien que la liste ne soit pas exhaustive :\n•\t le plan de sécurité alimentaire, ou HACCP, y compris les activités nécessaires pour le mettre en place (c-à-d. l’approbation du fournisseur, les mesures correctives et la vérification)\n•\t les programmes prérequis (c-à-d. hygiène, lutte contre les nuisibles)\n•\t les plans de protection de la chaîne alimentaire contre les actes malveillants et de prévention de la fraude alimentaire\n•\t les procédures mises en place pour répondre à la Norme.\nChaque audit interne doit avoir une portée définie et examiner une activité ou une section spécifique du plan de sécurité des denrées alimentaires, ou plan HACCP."}, {"id": "3.4.2", "requirement": "Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be independent (i.e. not audit their own work).", "interpretation": "Good auditing is a thorough, evidence-based assessment of an activity or system, completed by an independent auditor. It should ultimately contribute towards the site’s continuous improvement.\nAuditing is therefore an acquired skill and auditors need to be trained and competent to ensure they are carrying out this function effectively. Training should include:\n• auditing skills, such as how to complete an effective audit\n• relevant technical knowledge of the activity to be audited, such as HACCP or appropriate product technical knowledge. This may be by work experience in the sector or specific training\n• soft skills associated with auditing.\nInternal auditors must be able to show via training records (clause 7. 1.6) that they have received formal training on internal auditing, via either attendance at an external course or training within the company.\nTraining should also cover the planning and scheduling of the internal audits, preparing audit reports in the company’s agreed format, the correct use of audit techniques (e. g. documentation and process auditing, audit trails and discussions with colleagues) and follow-up of audit findings (see clause 3. 4.3).\nTraining must be of sufficient duration and depth to ensure that auditors can complete robust, consistent audits.\nExternal auditors may be used where internal resources are insufficient, providing the requirements of clause 3. 4.1 can be met (for scheduling audits throughout the year). The site should refer to clause 1. 2.4 and section 3. 5.3 for the requirements for the management of food safety consultants.\nInternal auditors must be independent of the process being audited. This is to ensure that there is no conflict of interest (i. e. that the audit is rigorous and thorough) and that any work needed to make corrections or improvements can be identified by an auditor who is not biased or influenced by working in the area. Internal auditors may not audit their own work or any programmes for which they are immediately responsible. It is not acceptable, for example, for workers on one shift to audit the work of another shift completing the same work, as they are not independent of the operation.\nDuring the BRCGS audit, the auditor may discuss the process with internal auditors to establish their level of competence.\nSites may find it useful to calibrate their internal auditor team (e. g. at the beginning of the year, before a new schedule of internal audits begins) to ensure that there is a consistent approach across the company.\nA number of sources of further guidance and training for internal auditors are available including:\n• BRCGS guideline on internal auditing (see BRCGS Participate or BRCGS Store)\n• BRCGS internal auditor training\n• ISO 19011 Guidelines for auditing management systems.", "requirement_fr": "Des audits internes doivent être effectués par des auditeurs compétents, formés à cet effet.\nLes auditeurs doivent être indépendants (c-à-d. ils ne doivent pas auditer leur propre activité)."}, {"id": "3.4.3", "requirement": "The internal audit programme shall be fully implemented. Internal audit reports shall identify conformity as well as non-conformity and include objective evidence of the findings. The results shall be reported to the personnel responsible for the activity audited. Corrective and preventive actions, and timescales for their implementation, shall be agreed and their completion verified.", "interpretation": "The management review processes (see clause 1. 1.4) must ensure that the internal audit programme operates effectively and that necessary corrective or preventive actions are appropriately completed. As a result, the internal audit process will often contain a number of steps. For example:\n• internal audit completed\n• corrective actions agreed\n• corrective actions completed and signed off\n• completion verified\n• root cause analysis used to identify any necessary preventive actions\n• preventive actions completed and reviewed\n• overall management review completed.\nEach internal audit must examine the process or activity in detail and will usually include a number of activities such as:\n• observing how activities are completed\n• asking relevant staff how an activity is completed or why it is completed in a specific way\n• reviewing procedures and records to confirm whether the activity has been completed and recorded correctly.\nIn addition to the actual internal audit, it is important that appropriate reports are completed, clearly indicating what was audited, the actions that are agreed and the review of these actions.\nReports must show evidence of conformity as well as non-conformity, with objective supporting evidence (e. g. what documents or actions were observed). Some sites have also found it useful to include recommendations for improvement, where the audit can highlight any that are noted during the audit.\nTick lists showing that items have been assessed will not normally be accepted as the only form of evidence; information showing how the audited items have fulfilled the requirements, or how they are non-compliant, is required. This is important, as recording conformity is documenting evidence that due diligence is taking place; in other words, that required procedures are taking place, and have been observed by auditors who are independent of the process. This may subsequently be useful, for example, in the event of an incident, or for answering questions from regulatory authorities or customers.\nNotes, references or copies of the documents and records should be kept as evidence of aspects that have been examined, to allow an independent reviewer to reach the same conclusion as the internal auditor. For example, the dates and titles of records that were inspected should be noted in sufficient detail to allow them to be traced; if any records are non-compliant, precise details of the non-compliance should be given. The listing of records reviewed also ensures that a wide range of records are considered (e. g. training records of a variety of staff rather than repeated audits of the same records). Records will also confirm whether anything has changed since the last audit.\nThe Standard is not prescriptive regarding the format of the internal audit reports; for example, they may be hand-written, stand-alone electronic documents or uploaded into a company database. Good practice is to retain any auditor notes that are completed during the audit, as well as the final report.\nreport.\nThe results of audits need to be communicated to the relevant staff; i. e. those who are responsible for the area or activity, and corrective actions, root cause and preventive actions and timescales for their completion agreed. This may be achieved via operational or review meetings, or via an update at the end of the audit combined with documentation such as a memo or a copy of the audit report. Responsibility for corrective actions must be documented – for example, by being recorded on the audit record sheet. Full details for handling non-conformities, including corrective and preventive actions, are provided in section 3. 7.\nNote that finding a non-conformity during an internal audit should not necessarily be viewed as a negative, since it allows the site to implement action before the non-conformity becomes a more serious problem.\nWhere non-conformities have been identified, effective completion of corrective and preventive action must be verified. Good practice is to ensure that a nominated member of staff with the appropriate authority checks that the action has been taken within the agreed timescale, and that this has rectified the problem sufficiently to prevent recurrence.\nThe nominated staff member should not be the person responsible for completion of the actions; ideally this should be the original auditor.\nGood practice is to complete a review of the internal audit programme; for example, looking at the outputs and trends, and any insight these provide. A summary of the programme and results will also be required for the management review meeting (see clause 1. 1.4).\nA non-conformity will be raised against clause 3. 4.3 if there is a non-conformity in the operation of the internal audit programme itself. Examples include if the audit schedule is not properly implemented or if corrective and preventive actions are not completed within the agreed timescales.\nWhere the site consistently obtains negative results (i. e. no non-conformities are identified throughout the scheduled programme) good practice is to review the programme to ensure it is operating robustly; for example, to:\n• consider if all activities are correctly incorporated into the programme\n• review rigour, robustness and consistency of the internal audits.\nFull records of all internal audits and the results, including conformities and non- conformities and verification of corrective and preventive actions, must be kept for a defined period, typically 2 years.\nBRC REQUIREMENT SITE POLICY EVIDENCE COMPLIES The site shall ensure that any out of specification product is effectively managed to prevent unauthorised release.\nProcedure QM11 & form QRec11. All non-conformities trended for inclusion in management review meetings (log reviewed and management report for 1/9/21) Y Waste disposal records checked (Sept – Dec 21) against records of non-conformities – disposal of outer packaging on 1/1/22 unaccounted for.\nN There shall be documented procedures for managing non-conforming products.\nProcedure QM11 – specifies all requirements – non-conforming products are stored in identified area and labelled ‘on hold’, ‘reject’ or ‘QC pass’. Form to be completed and specified management. Sign off approved staff only.\nForm QRec11 for recording information.\nProcedure QM11 version 3 dated 1/2/22 in use. Y Records for Aug 21 – Dec 21 checked and indicated correct sign off. Y Random staff check on staff numbers 94, 157 &\n– queried what they should do with incorrectly baked product. N Records of the decision on use or disposal and records of destruction where product is destroyed for food safety reasons.\nForm QRec11 for recording information. Records comply with disposals instructions. Y One pallet of product (failed customer quality checks) segregated for disposal, correctly labelled and authorised for disposal.\nY Records for 12/1/22 reviewed – correctly completed. Y AREA REQUIREMENT: Control of Non-Conforming Product DATE: 14 February 22 AUDITOR: A Checker NON-CONFORMITIES IDENTIFIED:\nNON-CONFORMITY ACTION RESPONSIBILITY DUE BY VERIFIED AS COMPLETE Staff numbers 157 & 196 were unclear of procedure. Retraining to be completed against QM11.\nProduction Manager 21/2/22 A Checker 22/2/ Waste disposal records checked (Sept – Dec 21) against records of non-conformities – disposal of outer packaging on 1/1/22 unaccounted for.\nInvestigate cause and introduce corrective action.\nEnsure staff aware of procedure.\nProduction Manager 24/2/22 A Checker 25/2/ BRCGS has produced a guideline to preventive action and root cause analysis which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Le programme d'audit interne doit être pleinement mis en place. Les rapports d'audit internes doivent détecter les conformités et les non-conformités, et être étayés de preuves objectives.\nLes résultats doivent être rapportés aux employés responsables de l'activité contrôlée.\nDes actions correctives et préventives, et les échéances de leur mise en œuvre, doivent être convenues. Leur exécution doit également être vérifiée. Toutes les non-conformités doivent être traitées tel que décrit dans la section 3.7. Un bilan des résultats doit être examiné lors des réunions de revue de direction (voir clause 1.1.4)."}, {"id": "3.4.4", "requirement": "In addition to the internal audit programme, there shall be a separate programme of documented inspections to ensure that the factory environment and processing equipment are maintained in a suitable condition for food production. At a minimum, these inspections shall include: hygiene inspections, fabrication inspections.", "interpretation": "In addition to the internal audit programme the Standard requires a programme of documented inspections to ensure that the factory environment and processing equipment are maintained in a suitable condition. These inspections are different from the internal audit programme specified in clauses 3. 4.1 to 3. 4.3, which examines practices against documented procedures. Audits are an in-depth challenge to the systems and procedures that a site has put in place to manage hazards, to confirm that the site is effectively mitigating identified risks. A documented inspection, however, is a simpler approach to assessing the conditions present, so an entirely separate inspection plan should be in place.\nThese hygiene- and fabrication-based inspections assess standards of cleaning, equipment, building fabrication and personal hygiene to ensure that high standards are maintained and that a safe, hygienic production environment is in place. For example, inspections should include:\n• appropriateness, status, state of repair and cleaning of doors, walls, floors and other fabrication and facilities (e. g. those detailed in section 4. 4)\n• hygiene inspection to confirm equipment and facilities have been suitably cleaned\n• equipment inspection to identify and control potential foreign bodies (e. g. from worn or damaged equipment) before they have the opportunity to contaminate a product.\nThe frequency of the inspections should be based on risk. For open product areas, inspections need to be at least monthly, whereas inspections in high-care and high-risk areas are likely to be more frequent (e. g. daily or weekly); seasonal products or activities should be included where appropriate. Line start-up checks, which may occur daily or at shift changes in many operations, can form part of this inspection programme.\nIt is also good practice to complete inspections after any activities that potentially change the risk to products; for example, after maintenance.\nA review of the inspection programme should be completed prior to any changes which may affect food safety; for example:\n• introducing new equipment or facilities\n• changes to products\n• changes to processing conditions or process flow\n• following a non-conformity in an audit (e. g. internal, BRCGS, customer, or regulatory audit) or an independent inspection (e. g. following recommendations for improvement from the pest control in-depth survey).\nThe individuals responsible for completing these inspections should be suitably trained for the systems they are checking. However, staff completing hygiene and fabrication inspections do not need the same level of training as internal auditors.\nThe absolute requirements for independence identified in clause 3. 4.2 do not always apply to these inspections; for example, it would be acceptable for line start-up checks to be carried out by line supervisors or managers. External agencies may be used to carry out inspections.\nIt is important that issues identified at the inspections are corrected as soon as possible so that product risk is minimised. The records of inspections and corrective actions must be retained.\nInspection records can provide useful information to identify trends and drive improvements (e. g. through the use of scored inspection results). To facilitate this, and to promote discussions about improvements to hygiene and fabrication, a summary of the results will be discussed at the management review meetings (see clause 1. 1.4).", "requirement_fr": "Un programme d'inspections documentées distinct doit venir compléter le programme d'audit interne. Il garantira que l'usine et les équipements de transformation sont conservés dans des conditions acceptables pour la production alimentaire. Au minimum, ces inspections doivent inclure :\n•\t des inspections relatives à l'hygiène pour évaluer les performances d'entretien et de rangement\n•\t des inspections relatives à la fabrication (c-à-d. portes, murs, installations et équipements) pour identifier les risques provenant du bâtiment ou des équipements et pouvant affecter le produit.\nLa fréquence de ces inspections doit être déterminée par les risques et toute modification pouvant affecter la sécurité alimentaire, mais sera toujours d'une fois par mois minimum pour les zones de produits nus.\nLes résultats doivent être rapportés aux employés responsables de l'activité ou de la zone auditée.\nDes actions correctives et les échéances de leur mise en œuvre doivent être convenues. Leur exécution doit également être vérifiée.\nUn bilan des résultats doit être examiné lors des réunions de revue de direction (voir clause 1.1.4).\n3.5 Approbation des fournisseurs et des matières premières, et contrôle de la performance 3.5.1 Gestion des fournisseurs de matières premières et d'emballages Fondamental L'entreprise doit avoir un système efficace d'approbation et de contrôle des fournisseurs. Il permet de garantir que tous les risques potentiels provenant des matières premières (y compris les emballages primaires) et affectant la sécurité sanitaire, l'authenticité, la légalité et la qualité du produit fini sont compris et gérés."}, {"id": "3.5.1.1", "requirement": "The company shall undertake a documented risk assessment of each raw material or group of raw materials, including primary packaging, to identify potential risks to product safety, authenticity, legality and quality. This shall take into account the potential for: • allergens (allergen content and potential contamination) • foreign-body risks • microbiological contamination • chemical contamination • variety or species cross-contamination • substitution or fraud (see clause 5.4.2) • any risks associated with raw materials which are subject to legislative control or customer requirements. Consideration shall also be given to the significance of a raw material to the quality of the final product. The risk assessment shall form the basis for the raw material acceptance and testing procedure and for the processes adopted for supplier approval and monitoring. The risk assessment for a raw material shall be updated: • when there is a change in a raw material, the processing of a raw material, or the supplier of a raw material • if a new risk emerges • following a product recall or withdrawal, where a specific raw material has been implicated • at least every 3 years.", "interpretation": "The aim of this clause is to ensure the potential risks to product safety, authenticity, legality and quality that could result from specific raw materials, have been identified, and where necessary mitigation measures put in place, for example, by adding controls into: • supplier approval and purchasing processes • goods receipt controls and product testing • the food safety plan (HACCP) or specific parts of the food safety and quality management systems. All proposed ingredients and packaging must be subjected to a documented assessment of their inherent risk. This raw material risk assessment is not intended to be a duplication of other clauses. For example, the reference to authenticity is not intended to duplicate the requirements within section 5.4; the processes are intended to operate together. In other words, section 5.4 should highlight any authenticity risks within the supply and identify suitable controls, whereas this clause is intended to bring those identified risks into the supplier approval, raw material management and raw material receipt processes. Similarly, this may form part of the HACCP or food safety plan; however, as this is an important starting point for the production of safe food, it needs to be detailed and will be specifically assessed by the auditor. The assessment may be of individual products or, where a number of raw materials share the same characteristics and likely risks, these may be grouped together. When grouping materials, each should still be considered separately to ensure that it does not have different risk factors from the rest of the group. Risk, and therefore the opportunity to group ingredients or not, may vary between factories and processes because of the different overall effect on quality. For example, in a bakery, all dried fruit may be considered to be of similar risk, but where flour is a critical ingredient, it may be necessary to consider each type of flour separately (e.g. white or wholemeal); however, other non-bakery sites may group all the types of flour together. The Standard lists the minimum types of hazards that the company must consider, including: • allergens – both the intended allergen content and the potential for the raw material to be contaminated should be included • foreign-body risks – these maybe intrinsic or extrinsic (i.e. an inedible part of the raw material, such as bones in animal products; or materials from the growing environment or manufacturing processes) • microbiological contamination • chemical contamination – including contaminants that occur naturally in the environment, those that migrate from packaging materials, or artificial additions in the supply chain (such as pesticides or veterinary medicines) • potential for variety or species cross-contamination (i.e. where the supplier handles multiple varieties of a product and inadvertent contamination could occur during processing • the potential for fraudulent activity in the supply chain – for example, undeclared additions, dilution or substitution of the raw material or a component of it. (As discussed above, the identification of hazards and necessary control measures may be completed as part of the activities for section 5.4.) • the risk of non-compliance with legal requirements specific to the product (e.g. banned substances) – it is important to remember that legislative requirements in the country of raw material production may be different from those of the country where the site is located or where the final product is intended to be sold • any customer requirements. Identification of the actual level of risk often requires the company to consider several factors; for example: • access to reference information and an awareness of emerging food issues are essential to ensure all known risks are assessed (clause 1.1.8) • how the ingredient is used (e.g. an ingredient added following the final microbiological kill step may present a different risk from an ingredient added at the beginning of a process) • nature of the supplier • historical evidence of the supplier and raw material • geographic origins (products from particular origins may carry a greater risk due to environmental conditions, because of more relaxed local legal requirements or a less developed food safety culture) • methods of manufacture/processing of the raw material (e.g. if a site is using egg as an ingredient, the microbiological risk will depend on whether fresh or pasteurised egg is used. Similarly, the type or level of processing may change the risks; for example, whole carcass, compared to cuts of meat, compared to cubes or mince or mechanically recovered meat) • significance of the ingredient to the final product (e.g. some ‘safe’ ingredients, such as flour in breadmaking, may be fundamental to the performance of the product and therefore require higher levels of control to ensure consistent quality) and the spread of the ingredient in the company/final products • customer or legislative requirements (e.g. suppliers may be specified by customers, but this does not negate the need for risk assessment) • additional focus on raw materials where claims are being made about the final product (e.g. ‘organic’ or ‘suitable for allergy sufferers’) or where there is a microbiological risk from components added after heat treatment. Sites should also consider the primary packaging materials used as they too are raw materials. There is potential for packaging materials to pose a problem, whether because of contamination, malicious intervention or the use of inappropriate materials. Where different departments are involved in the process (e.g. head office or different sections of the site technical team), there needs to be a linked process to demonstrate the responsibilities of each team and how these work together to operate the system. The outcome of this risk assessment must also be considered when assessing the requirements for supplier approval and for monitoring and acceptance procedures (clause 3.5.1.2 and section 3.5.2). Risk assessments must be up to date and the site must therefore review the assessment whenever there is a significant change (e.g. new suppliers, new raw materials, new countries of origin or an emerging risk) or where an incident (e.g. a product recall or withdrawal) is related to a specific raw material. At a minimum risk assessments must be reviewed every 3 years.", "requirement_fr": "L'entreprise doit effectuer une évaluation documentée des risques pour toutes les matières premières ou groupes de matières premières, y compris les emballages primaires, afin d'identifier les risques potentiels pour la sécurité sanitaire, l’authenticité, la légalité et la qualité du produit. Elle doit tenir compte des possibilités :\n•\t d’allergènes (contenu allergénique et contamination potentielle)\n•\t de risques de corps étrangers\n•\t de contamination microbiologique\n•\t de contamination chimique\n•\t de contamination croisée des variétés ou espèces\n•\t de remplacement ou fraude (voir clause 5.4.2)\n•\t de tout risque associé à des matières premières réglementées ou soumises aux exigences des clients.\nL'importance d'une matière première dans la qualité du produit fini doit également être prise en compte.\nL'évaluation des risques doit être la base de la réception de la matière première et de la procédure de tests, et des processus adoptés pour approuver et contrôler un fournisseur.\nL’évaluation des risques d’une matière première doit être mise à jour :\n•\t lorsqu’une matière première, son traitement ou son fournisseur sont modifiés\n•\t si un nouveau risque émerge\n•\t lorsqu'un rappel ou un retrait de produit implique une matière première spécifique\n•\t au moins tous les 3 ans."}, {"id": "3.5.1.2", "requirement": "The company shall have a documented supplier approval procedure to ensure that all suppliers of raw materials, including primary packaging, effectively manage risks to raw material quality and safety and are operating effective traceability processes. The approval procedure shall be based on risk and include either one or a combination of: • a valid certification to the applicable BRCGS Standard or GFSI-benchmarked standard. The scope of the certification shall include the raw materials purchased or • supplier audits, with a scope to include product safety, traceability, HACCP review, the product security and food defence plan, the product authenticity plan and good manufacturing practices. The audit shall ensure that these plans form part of the supplier’s product safety management system and that any resultant actions are implemented. The supplier audit shall be undertaken by an experienced and demonstrably competent product safety auditor. Where the supplier audit is completed by a second or third party, the company shall be able to: • demonstrate the competency of the auditor • confirm that the scope of the audit includes product safety, product security and food defence plan, product authenticity, traceability, HACCP review and good manufacturing practices • obtain and review a copy of the full audit report or • where a valid risk-based justification is provided and the supplier is assessed as low risk only, a completed supplier questionnaire may be used for initial approval. At a minimum, the questionnaire shall have a scope that includes product safety, product security and food defence, product authenticity, traceability, HACCP review and good manufacturing practices. The questionnaire shall have been reviewed and verified by a demonstrably competent person.", "interpretation": "All suppliers must be evaluated for their ability to meet the specifications of the materials (ingredients and primary packaging) they are supplying and requirements for safety, quality and legality. The company must document its procedure for supplier approval and monitoring. This needs to include the methods of approval, frequency of monitoring, responsibilities and how the process will be managed. The acceptable methods of supplier approval will depend on the raw material and the risks associated with it (e.g. the output of clause 3.5.1.1). They will include one or more of the following activities: • Certification to the relevant BRCGS Standard, such as the Global Standard Food Safety; Packaging Materials; Storage and Distribution; Agents and Brokers; or another of the GFSI-benchmarked schemes. The site must confirm the validity of the certification. This will include: • Confirmation of the certification status (e.g. this can be confirmed on an independent database; for BRCGS Standards it can be confirmed in the BRCGS Directory). Photocopies of certificates are not recommended and on their own are not considered suitable validation of certification status. During the BRCGS audit the site may be asked to demonstrate its validation process. • Confirmation that the certification remains up to date (e.g. by receiving confirmation of successful completion of the recertification processes or by recording certificate expiry dates and completing checks for ongoing certification). • Ensuring that the raw materials are within the scope of the certification. Where the product has been excluded from the scope of certification it cannot be assumed that all of the processes relating to its manufacture have been conducted in accordance with the certification requirements. For example, different facilities or equipment may be used; different raw material suppliers or risk assessment; or different staff training. Therefore the site will need to undertake additional supplier approval processes to ensure the material is satisfactory and any risks are appropriately managed. A successful site audit covers at a minimum product safety, traceability, HACCP, product security and the food defence plan (i.e. systems to protect the product from theft and malicious activity), product authenticity and good manufacturing processes. This audit must be completed by an appropriately experienced and competent auditor (i.e. someone who has completed training in auditing techniques, has experience of auditing, and has knowledge of the product, ingredient or processes being audited). Non-conformities should be addressed (e.g. in an agreed action plan with timescales) unless they are critical to product safety or legality, in which case supply should not be permitted until the non-conformities have been satisfactorily addressed. When deciding the type of supplier audit to complete the company should consider the risks associated with the raw material and supplier, using this information to decide the format and duration of the audit, and whether the risk assessment indicates that some or all of the requirements can be completed remotely, or whether an entirely on-site audit is required. If the raw material supplier is independently audited to another standard that is not GFSI- benchmarked, this may be acceptable as an alternative to the site completing its own audit of the supplier providing that: • the scope of the audit meets the requirements of the Standard (i.e. at a minimum product safety, traceability, HACCP review, product security and food defence, food authenticity and good manufacturing practices) • the site has a copy of the full audit report (not just a certificate) • the supplier can demonstrate the competence of the auditor. Where risk assessment (completed as part of this clause) indicates that a supplier is low risk (e.g. due to history of trading with the site or the nature of the raw materials traded) the completion of a supplier questionnaire with a focus on food safety and quality may be sufficient. If a supplier questionnaire is the only mechanism used to assess a supplier (i.e. there are no additional activities such as supplier audits) then it is important that the questionnaire (and replies from the ingredient supplier) contains all the relevant information to allow the site to confidently make a decision on approval. The auditor will expect to see, and will challenge, risk assessments. Approval and the associated risk assessments must be up to date. The site should therefore consider reviewing the assessment whenever there is a significant change (e.g. new suppliers, new countries of origin or new materials).", "requirement_fr": "L'entreprise doit adopter une procédure documentée d'approbation des fournisseurs. Elle garantira que tous les fournisseurs de matières premières, y compris d’emballages primaires, gèrent efficacement les risques pouvant affecter la qualité et la sécurité sanitaire des matières premières, et qu'ils utilisent des processus efficaces de traçabilité. La procédure d'approbation doit être basée sur les risques et inclure un ou plusieurs des points suivants :\n•\t une certification valide dans le cadre de la norme du BRCGS ou d’une norme reconnue par la GFSI. La portée de la certification doit inclure les matières premières achetées ou\n•\t des audits de fournisseurs dont l’étendue inclut la sécurité sanitaire des produits, la traçabilité, l’examen HACCP, le programme de sécurité et de protection de la chaîne alimentaire des produits, le programme d’authenticité des produits et les bonnes pratiques de fabrication. L'audit doit garantir que ces programmes font partie du système de gestion de la sécurité des produits du fournisseur et que toutes les mesures qui en découlent sont mises en place. L’audit des fournisseurs doit être effectué par un auditeur en sécurité sanitaire de produit expérimenté et manifestement compétent. Lorsque l’audit du fournisseur est réalisé par une seconde ou tierce partie, l’entreprise doit pouvoir :\n•\t démontrer la compétence de l’auditeur\n•\t confirmer que la portée de l'audit inclut la sécurité sanitaire des produits, le programme de sécurité et de protection de la chaîne alimentaire des produits, l'authenticité des produits, la traçabilité, l'examen HACCP et les bonnes pratiques de fabrication\n•\t obtenir et examiner une copie du rapport d'audit complet ou\n•\t lorsqu'une justification valide basée sur les risques est fournie et que le fournisseur est considéré à faible risque uniquement, un questionnaire rempli par le fournisseur peut être utilisé pour l'approbation initiale. Au minimum, la portée du questionnaire doit inclure la sécurité sanitaire des produits, le programme de sécurité et de protection de la chaîne alimentaire des produits, l’authenticité des produits, la traçabilité, l'examen HACCP et les bonnes pratiques de fabrication. Le questionnaire doit avoir été examiné et vérifié par une personne manifestement compétente."}, {"id": "3.5.1.3", "requirement": "There shall be a documented process for ongoing supplier performance review, based on risk and defined performance criteria. The process shall be fully implemented. Where approval is based on questionnaires, these shall be reissued at least every 3 years and suppliers shall be required to notify the site of any significant changes in the interim, including any change in certification status. Records of the review shall be kept.", "interpretation": "Although it is important to know how and why suppliers are approved, it is also vital to ensure that ongoing approval is justified. The site is free to determine how it confers continuing approval on its suppliers, but it is important that the site uses a risk-based approach. The defined performance criteria can be determined by the site and should depend on the supplier’s performance. However, it is important that product safety, authenticity, legality and quality are included within all supplier reviews. Therefore, while a company may wish to include other criteria (e.g. financial considerations or reliability of delivery schedules) these additional criteria must not outweigh the need to fully assess food safety, authenticity, legality and quality considerations. As a guide, typical criteria may include: • known risks associated with the raw material or supplier • supplier approach to emerging concerns • incidences of contamination or non-conforming raw materials • quality of material supplied. The frequency of ongoing approval is also important, and this is left to the site to determine. However, where approval is based on supplier questionnaires, these must be reissued at least every 3 years. Good practice is to ensure that a system of proactive communication is in place, where suppliers inform the company of any changes or challenges. The site must be able to demonstrate to an auditor that the monitoring and ongoing review it uses is appropriate, justified and risk-based.", "requirement_fr": "Un processus documenté d'évaluation continue de la performance du fournisseur basé sur les risques et des critères de performance définis doit être en place. Le processus doit être pleinement mis en œuvre.\nLorsque l'approbation s'appuie sur des questionnaires, ceux-ci doivent être soumis au moins une fois tous les 3 ans, et les fournisseurs seront tenus de signaler entre-temps tout changement significatif au site, y compris tout changement du statut de certification.\nDes enregistrements de l’évaluation doivent être conservés."}, {"id": "3.5.1.4", "requirement": "The site shall have an up-to-date list or database of approved suppliers. This may be on paper (hard copy) or it may be controlled on an electronic system. The list or relevant components of the database shall be readily available to the relevant staff (e.g. at goods receipt).", "interpretation": "The company must also maintain an up-to-date list of approved suppliers based on the outcome of the supplier approval process. This list can either be in hard copy (i.e. paper) or electronic format (such as an approval database). It is expected that all purchased raw materials (including packaging) will be from the suppliers on the list unless it is an emergency purchase covered by clause 3.5.1.7. The auditor may refer to the list to facilitate the effective sampling of supplier approval records. The list (or relevant sections of it) should be available where goods are taken in, and be accessible to anyone who needs it at the points at which it should be used. This is likely to include purchasing where this activity is carried out at the site (i.e. not at a corporate facility).", "requirement_fr": "Le site doit conserver une base de données ou une liste actualisée de tous les fournisseurs approuvés. Cette liste peut être imprimée (copie papier) ou stockée sur un système électronique.\nLa liste ou les éléments pertinents de la base de données doivent être facilement accessibles au personnel concerné (c-à-d. à la réception des marchandises)."}, {"id": "3.5.1.5", "requirement": "Where raw materials (including primary packaging) are purchased from companies that are not the manufacturer, packer or consolidator (e.g. purchased from an agent, broker or wholesaler), the site shall know the identity of the last manufacturer or packer, or for bulk commodity products the consolidation place of the raw material. Information to enable the approval of the manufacturer, packer or consolidator, as in clauses 3.5.1.1 and 3.5.1.2, shall be obtained from the agent/broker or directly from the supplier, unless the agent/broker is themselves certificated to a BRCGS Standard (e.g. Global Standard Agents and Brokers) or a standard benchmarked by GFSI.", "interpretation": "Potential product safety risks need to be understood for all raw materials, including those that have been purchased through an agent or broker (see glossary). The purpose of this clause is therefore to ensure that essential information relating to traceability, product safety, authenticity, food defence, etc. is maintained and relevant details communicated, where a site has purchased a raw material from an agent or broker, or a wholesaler (i.e. not the manufacturer, packer or consolidator). The site will need sufficient information to: • ensure traceability • enable timely action in the event of an incident in the supply chain • enable the approval of the last processor of the raw material, the last point of packing or the consolidation place for bulk commodity products, as described in clause 3.5.1.2. The Standard is not prescriptive on the methods of communication used, and this information may be provided directly by the manufacturer, processor, packer or consolidator or alternatively through the agent or broker, depending on the contractual arrangements for data handling and communication agreed between the site and the agent/broker. For the purposes of the Standard, a place of consolidation of bulk materials is a location where a number of smaller batches are mixed to form a single bulk material (e.g. where a number of farms supply grain, which the grain merchant combines in a silo before sale, or where a cooperative arranges for a group of small growers to combine their crops for onward sale to customers). The important difference between consolidation and other types of storage or trade of materials is the mixing or combining of materials from multiple sources or batches, so that it is no longer possible to identify the individual supplier/batch for any specific portion of the bulk material (of course, for traceability purposes, it must still be possible to identify all of the suppliers/batches contributing to the bulk). Therefore, where a trader receives individually traceable units of product (e.g. sacks of material), each of which can be individually traced from supplier to customer, this does not count as a place of consolidation. The bulk material may be sold to one customer or divided and sold to multiple customers. Where the agent or broker is certificated to the Global Standard Agents and Brokers, the wholesale module of the Global Standard Storage and Distribution, the relevant traded products/goods scope of the Global Standard Food Safety or Global Standard Packaging Materials, or a GFSI-benchmarked equivalent, then the site simply needs to know the identity of the manufacturer, packer or place of consolidation of the material (i.e. the location/company where the material underwent the last process other than storage or distribution). In this situation, the requirement to approve the processor, packer or consolidator is not applicable, as the requirements of these Standards ensure that effective systems for supplier approval and traceability are in place. However, the site will still be expected to know the identity of the processor, packer or consolidator.", "requirement_fr": "Lorsque les matières premières (emballage primaire compris) sont achetées auprès d’entreprises qui ne sont pas le fabricant, le conditionneur ou le groupeur (c-à-d. un agent, un courtier ou un grossiste), le site doit connaître l’identité du dernier fabricant ou entreprise de conditionnement, ou dans le cas des marchandises en vrac, le lieu de regroupement des matières premières.\nDes informations permettant d'approuver le fabricant, l'entreprise de conditionnement ou le groupeur, telles que définies dans les clauses 3.5.1.1 et 3.5.1.2, doivent être obtenues auprès de l'agent ou du courtier, ou directement auprès du fournisseur, sauf si l'agent ou le courtier est déjà certifié par une norme du BRCGS (c-à-d. la Norme Mondiale pour les Agents et les Courtiers) ou une norme reconnue par la GFSI."}, {"id": "3.5.1.6", "requirement": "The company shall ensure that its suppliers of raw materials (including primary packaging) have an effective traceability system. Where a supplier has been approved based on a questionnaire instead of certification or audit, verification of the supplier’s traceability system shall be carried out on first approval and then at least every 3 years. This may be achieved by a traceability test. Where the supplier is not the manufacturer, packer or consolidator of the raw material (e.g. purchased from an agent, broker or wholesaler) and approval is based on a questionnaire instead of certification or audit, the verification of the traceability system shall be carried out on the last manufacturer, packer or consolidator of the raw material. Where a raw material is received directly from a farm or fish farm, further verification of the farm’s traceability system is not mandatory.", "interpretation": "It is important for the integrity of products that appropriate traceability systems operate throughout the supply chain. Therefore sites must ensure that their raw material suppliers (including primary packaging suppliers) have suitable traceability systems in operation. This assurance can be obtained from certification, auditing or by directly testing traceability. Examples of acceptable traceability include: • The raw material supplier is certificated to a GFSI-benchmarked standard. Assessment of traceability systems forms part of these audits and therefore no additional action is required to comply with the requirements of this clause; however, a communication mechanism should be in place, such that if the raw material supplier were no longer certificated, the site would be made aware of this change. • The raw material supplier is audited by the site and the audit includes an assessment of the traceability systems. This would comply with the requirement as traceability has been assessed. The audit should be repeated at least every 3 years. • Verification of a supplier’s traceability system where approval has been based solely on a questionnaire with no additional testing (unless the raw material is a primary agricultural product purchased directly from a farm or fishery, where additional testing of the traceability systems is not mandatory). This verification could include, for example: • A test of the raw material supplier’s traceability. For example, as part of the site’s traceability test (see clause 3.9.3), a relevant ingredient is highlighted. The ingredient and batch details are forwarded to the supplier to enable them to complete the traceability test for the specific batch of raw materials and forward the relevant records back to the site. • A worked example from the raw material supplier, which clearly explains the traceability process. • A detailed description of the traceability system provided by the raw material supplier. Information received during the traceability verification should be incorporated into the supplier approval process (clause 3.5.1.2). Where the supplier is not the manufacturer, packer or consolidator of the raw material (e.g. purchased from an agent, broker or wholesaler) and approval is based on a questionnaire instead of certification or audit, the verification of the traceability system required by this clause shall be carried out on the last manufacturer, packer or consolidator of the raw material. Therefore, where the: • agent/broker is certificated to a BRCGS Standard or a standard benchmarked by GFSI, the assessment of supplier approval forms part of these audits and therefore no additional action is required to comply with the requirements of this clause (see clause 3.5.1.5 for further information) • last manufacturer, packer or consolidator is certificated to a BRCGS Standard or a standard benchmarked by GFSI, the assessment of supplier approval forms part of these audits and therefore no additional action is required to comply with the requirements of this clause • last manufacturer, packer or consolidator is audited as part of the supplier approval process, and the audit includes an assessment of the traceability systems, this would comply with the requirement as traceability has been assessed. Traceability verification is a requirement for each raw material supplier. Therefore any traceability test (because the supplier approval is based solely on a questionnaire) should be designed to test the raw material supplier’s systems and not to trace every single material they produce. Where a site purchases multiple ingredients from the same raw material supplier, it is not a requirement to complete a traceability test for every single ingredient purchased; only to complete the traceability test for each supplier from which ingredients are purchased. The frequency of the traceability verification should link to the supplier approval programme; that is, the traceability is verified on first approval of the supplier, and then at least every 3 years. It is good practice to phase these verifications over the 3-year period rather than trying to complete them for all sites at once. Therefore sites that are new to certification (i.e. at their initial audit) may not have fully completed the traceability assessment for all of their suppliers, but should be able to demonstrate verification of the traceability system for at least a third of the suppliers in the first year, prioritising the higher- risk materials; two-thirds completed within the second year; and all suppliers by the third year. During the BRCGS audit the auditor will not undertake a test of raw material suppliers’ traceability systems but they will review the site’s processes and the information received from its raw material suppliers. Issues arise with raw materials from time to time so it is beneficial to consider the monitoring of any materials that may need further transparency within the supply chain. This ensures that the site is proactive, not reactive, potentially mitigating the risk of future concerns about raw materials.", "requirement_fr": "L'entreprise doit s'assurer que ses fournisseurs de matières premières (emballage primaire inclus) disposent d'un système de traçabilité efficace. Lorsque l'approbation d'un fournisseur est basée sur un questionnaire, et non sur une certification ou un audit, la vérification du système de traçabilité du fournisseur doit être effectuée lors de la première approbation, puis au moins une fois tous les 3 ans. Cela peut se faire grâce à un test de traçabilité.\nLorsque le fournisseur n'est pas le fabricant, l'emballeur ou le groupeur de la matière première (c-à-d. si elle est achetée auprès d’un agent, un courtier ou un grossiste) et que l’approbation est basée sur un questionnaire, et non sur une certification ou un audit, une vérification du système de traçabilité du dernier fabricant, emballeur ou groupeur de la matière première doit être effectuée.\nLorsqu'une matière première provient directement d'une exploitation agricole ou aquacole, une vérification supplémentaire du système de traçabilité de l'exploitation n'est pas obligatoire."}, {"id": "3.5.1.7", "requirement": "The procedures shall define the actions required in either of the following circumstances: • an exception to the supplier approval processes in clause 3.5.1.2 occurs (e.g. where raw material suppliers are prescribed by a customer) • information for effective supplier approval is not available (e.g. bulk agricultural commodity products). In both the above situations, product testing is used to verify product quality and safety. When a site produces customer-branded product, the customer shall be made aware of the relevant exceptions.", "interpretation": "In cases where emergency supplies (e.g. where an established supplier is unable to fulfil an order), bulk commodity purchases or purchases from a supplier prescribed by a customer make it impossible to operate the approval processes in clause 3.5.1.2, the site must have a procedure detailing how these exceptions are to be handled. The process will include an assessment of the risk of the purchase and the completion of appropriate checks or tests to mitigate any risk. For example, this may include: • 100% inspection of the product • certificates of analysis • increased microbiological sampling • review of a third-party audit report • a formally agreed specification • confirmation of compliance with customer codes of practice. Where raw materials are obtained from a customer-designated supplier (e.g. packaging or when contract packing), the site must ensure that information is obtained about the product and supplier so that potential risks to other products are assessed and controlled. Where the materials are used to produce a customer-branded product, the exceptions must be communicated to the customer.", "requirement_fr": "Les procédures doivent définir les actions requises dans les circonstances suivantes :\n•\t une exception relative aux processus d’approbation du fournisseur de la clause 3.5.1.2 se produit (c-à-d. lorsque les fournisseurs de matières premières sont imposés par un client)\n•\t les informations permettant une approbation efficace du fournisseur ne sont pas disponibles (c-à-d. produits agricoles en vrac).\nDans les deux situations ci-dessus, les tests du produit sont utilisés pour vérifier sa qualité et sa sécurité sanitaire.\nLorsqu'un site fabrique des produits portant la marque d'un client, ce dernier doit être informé des exceptions applicables.\n3.5.2 Procédures de réception, de contrôle et de gestion des matières premières et des emballages Les contrôles relatifs à la réception des matières premières (emballage primaire compris), doivent garantir que ces dernières ne compromettent pas la sécurité sanitaire, la légalité ou la qualité des produits et, le cas échéant, toute allégation d'authenticité."}, {"id": "3.5.2.1", "requirement": "The company shall have a procedure for the acceptance of raw materials and primary packaging on receipt based upon the risk assessment (clause 3.5.1.1). Acceptance of raw materials (including primary packaging) and their release for use shall be based on either one or a combination of: • product sampling and testing • visual inspection on receipt • certificates of analysis (specific to the consignment) • certificates of conformance. A list of raw materials (including primary packaging) and the requirements to be met for acceptance shall be available. The parameters for acceptance and frequency of testing shall be clearly defined, implemented and reviewed.", "interpretation": "The acceptance or goods-in system must include a documented procedure which requires checks to be completed and any non-conformities recorded. The procedure should document: • who is authorised to accept conforming materials and reject non-conforming batches • the checks and tests that must be completed, and at what frequency • the acceptance criteria (e.g. the maximum or minimum values for tests that need to be completed) • management of non-conforming product (this should also include ingredients that must be kept ‘on hold’ pending further testing or investigation), and the actions to be taken. In the first instance raw materials are normally checked for the accuracy of the order; for example: • visual inspection (e.g. for cleanliness, damaged packaging and spills, pest infestation, pallet condition) • to ensure that the correct materials and quantity have been delivered • to confirm the grade of material delivered • to confirm that the raw material matches the specification • to assure that the shelf life meets the minimum requirements • the traceability of the raw material can be maintained (e.g. that appropriate traceability information has been received). In addition, specific checks will be based on the risk assessment (clause 3.5.1.1) and the specification (section 3.6), and will include one or more of the following: • specific raw material testing to ensure conformance with the specification before acceptance or use • temperature checks (particularly for chilled or frozen materials) and storage instructions (refrigeration, freezing, or segregation for allergens) • the accuracy of printed packaging and labels • sampling (where required) which should include the timing, method and responsibility for completion, as well as retention of samples • certificates of analysis specific to the consignment (i.e. specific to batch, date or lot codes included in the delivery) showing results relevant to the identified risks • certificates of conformance specific to the consignment • all legal requirements; for example, EU legislation includes labelling requirements for foods and some additional specific requirements for certain food types (e.g. country-of- origin labelling of meat). Goods-in acceptance procedures must be fully implemented and therefore it is expected that the procedures and any testing or sampling requirements will be available in the goods receipt area. This may, for example, take the form of a product acceptance matrix identifying each material’s acceptance criteria and, where applicable, the sampling frequency. Records of the raw material checks for each batch of material must be maintained. They are likely to be assessed as part of the traceability challenge completed during the audit (see Part III, section 2.2 of the Standard). Figure 10 shows an example of a good receipt matrix showing the product requirements, frequency of checks and acceptance criteria. In addition to the tests listed above all deliveries will be checked for: • Integrity of packaging – damaged packs to be rejected • Pest control – no evidence of pest ingress Records of each delivery and the checks that have been carried out must be carefully maintained. Figure 11 shows an example of a goods-in acceptance sheet. Following the goods receipt checks the site will need to take appropriate action to manage the ingredient. Typically this will be one of the following: • Accept the batch of ingredient, enter it into the site’s systems for traceability and stock control and move it into the appropriate storage area until it is required for production. It is important that temperature-sensitive ingredients are moved in a timely fashion and not left sitting in goods receipt for a prolonged period. • Put the batch of raw material ‘on hold’ awaiting further paperwork from the supplier, product testing or quality assurance release. The site will need to have a clear policy on labelling and taking action to ensure materials that are on hold are not accidentally used. • Reject the batch of raw material as it does not meet the required standards. The appropriate site representative will need to contact the raw material supplier and agree the next steps. Again, a clear procedure is needed to ensure the ingredient is either segregated and labelled to ensure that it is not accidentally used, or is not off-loaded from the delivery vehicle.", "requirement_fr": "L'entreprise doit disposer d'une procédure pour la réception des matières premières et des emballages primaires lors de leur réception basée sur l'évaluation des risques (clause 3.5.1.1). La réception des matières premières (emballage primaire compris) et leur utilisation doivent être basées sur un ou plusieurs des points suivants :\n•\t échantillonnage et tests du produit\n•\t inspection visuelle lors de la réception\n•\t certificats d'analyse (spécifiques à l'expédition)\n•\t certificats de conformité.\nUne liste des matières premières (emballage primaire compris) et les exigences à respecter pour permettre la réception doivent être disponibles. Les paramètres de réception et la fréquence des tests doivent être clairement définis, mis en place et révisés."}, {"id": "3.5.2.2", "requirement": "Procedures shall be in place to ensure that approved changes to raw materials (including primary packaging) are communicated to goods receipt personnel and that only the correct version of the raw material is accepted. For example, when labels or printed packaging have been amended, only the correct version should be accepted and released into production.", "interpretation": "It is common for raw materials, including primary packaging, to change throughout the life of a product because of the nature of supply or changes to the product. When this occurs, this requirement is designed to ensure that changes are communicated throughout the organisation so that only the relevant materials are shipped onto the site to eliminate the risk of accidental inclusion of out-of-date raw materials or packaging in the product. The Standard does not prescribe the methods used, and it is common for a site to use a mixture of procedures; for example, using and checking unique raw material codes which are changed when a raw material changes. This is particularly pertinent with packaging materials where print has been changed to reflect changed raw materials and, potentially, allergens. Good practice would ensure that approved packaging samples are supplied to the goods-in team with the relevant part codes that can be visually checked by goods receipt staff. It is worth noting that the procedures developed for this clause will need to work with a number of clauses throughout the Standard, including, for example: • clause 5.2.2 – the design of packaging and labels, which includes the need for checks of the accuracy of the printed information • clause 5.5.3 – mechanisms to ensure that obsolete packaging is disposed of in a timely fashion and not incorrectly or accidentally used • clause 6.2.1 – mechanisms to ensure that only the correct packaging is delivered to the production line.", "requirement_fr": "Des procédures doivent être en place pour garantir que les changements approuvés apportés aux matières premières (y compris aux emballages primaires) sont communiqués au personnel chargé de la réception des marchandises et que seule la version correcte de la matière première est acceptée. Par exemple, lorsqu’une étiquette ou un emballage imprimé ont été modifiés, seule la version correcte doit être acceptée et utilisée pour la production.\n3.5.3 Gestion des prestataires de services L'entreprise doit être en mesure de démontrer que, lorsque des services sont externalisés, le service est adapté et que tout risque touchant à la sécurité, à l’authenticité, à la légalité et à la qualité des denrées alimentaires a été évalué afin de garantir la mise en place de contrôles efficaces."}, {"id": "3.5.3.1", "requirement": "There shall be a procedure for the approval and monitoring of suppliers of services. Such services shall include, as appropriate: • pest control • laundry services • contracted cleaning • contracted servicing and maintenance of equipment • transport and distribution • off-site storage of ingredients or packaging (other than at the supplier’s facilities) prior to delivery to the site • off-site packing of products • laboratory testing • catering services • waste management • providers of product safety training • product safety consultants. This approval and monitoring process shall be risk-based and take into consideration: • risk to the safety and quality of products • compliance with any specific legal requirements • potential risks to the security of the product (i.e. risks identified in the vulnerability and food defence assessments).", "interpretation": "The site must document its procedure for the risk-based approval and monitoring of suppliers of services to ensure that these suppliers are competent and capable of providing the service to the required level. Approval may include a combination of the following: • membership of a recognised trade association which specialises in the service provided (e.g. pest control) • historical experience with the supplier • legal registration (e.g. waste licences) • third-party certification to a recognised standard (e.g. the Global Standard Storage and Distribution) • evidence of training and competence in food safety. For example, where the site wishes to contract an external product safety consultant, the site may decide to: • have a clear policy/procedure for the selection of consultants • document a contract highlighting the consultant’s role and availability (see clause 3.5.3.2) • establish the qualifications, competency and experience of the consultant, and confirm these are acceptable for the intended role • consider the potential product safety, authenticity, legality and quality risks associated with the consultant’s role within the site. It may be appropriate to undertake audits or questionnaires where a service is performed off site and may present a food safety risk (e.g. laundry services for high-risk/high-care clothing).", "requirement_fr": "Une procédure permettant l'approbation et le contrôle des fournisseurs de services doit être établie. Ces services doivent inclure s'il y a lieu :\n•\t la lutte contre les nuisibles\n•\t les services de blanchisserie\n•\t les services de nettoyage sous contrat\n•\t les services de réparation et de maintenance du matériel sous contrat\n•\t le transport et la distribution\n•\t le stockage hors site des ingrédients ou des emballages (en dehors des installations du fournisseur) avant la livraison sur le site\n•\t l’emballage des produits hors site\n•\t les analyses en laboratoire\n•\t les services de restauration\n•\t la gestion des déchets\n•\t les formateurs en sécurité des produits\n•\t les conseillers en sécurité des produits.\nCe processus de contrôle et d'approbation doit être basé sur les risques et prendre en considération les aspects suivants :\n•\t les risques posés à la sécurité sanitaire et à la qualité des produits\n•\t le respect de toute exigence juridique spécifique\n•\t les risques potentiels affectant la sécurité du produit (c-à-d. les risques identifiés lors des évaluations de vulnérabilité et de protection de la chaîne alimentaire contre les actes malveillants)."}, {"id": "3.5.3.2", "requirement": "Contracts or formal agreements shall exist with the suppliers of services that clearly define service expectations and ensure that the potential food safety risks associated with the service have been addressed.", "interpretation": "Contracts or formal agreements must be in place for the service providers detailed in clause 3.5.3.1 to ensure the correct level of service is provided. Service providers who will be on site will need to receive appropriate training to ensure they complete their activities in a way that will not negatively impact on the safety, quality or legality of products being manufactured (clause 7.1.1).", "requirement_fr": "Des contrats ou accords formels doivent exister avec les prestataires de services. Ils doivent clairement définir les attentes concernant ces services et garantir que les risques potentiels relatifs à la sécurité des denrées alimentaires associés à ces services ont été correctement pris en compte."}, {"id": "3.5.3.3", "requirement": "There shall be a documented process for ongoing performance review of suppliers of services, based on risk and defined performance criteria. The process shall be fully implemented. Records of the review shall be kept.", "interpretation": "the service. For example, a cleaning service could be assessed as part of the internal audit process (section 3.4) and records maintained of feedback on performance to the cleaning company. Other services, such as pest control or laundry, may be reviewed with the supplier on a 6-monthly or annual basis and a record kept of the review (e.g. minutes of the meeting).", "requirement_fr": "Un processus documenté d'évaluation continue de la performance des prestataires de services, basé sur les risques, et des critères de performance définis, doivent être en place. Le processus doit être pleinement mis en place.\nDes enregistrements de l’évaluation doivent être conservés.\n3.5.4 Gestion de transformation externalisée Le traitement externalisé (ou « transformation sous-traitée ») désigne la prise en charge de la production, du traitement, du stockage ou de tout processus de production intermédiaire d’un produit par une autre entreprise ou un autre site.\nIl convient de noter que le traitement externalisé est une étape intermédiaire. Ainsi, pendant le traitement externalisé, le produit ou le produit partiellement transformé quitte le site à auditer pour subir son traitement externalisé, avant de retourner sur le site. Le site audité peut ou non effectuer des opérations supplémentaires d'emballage ou de traitement du produit.\nLorsque les matières premières sont stockées ou transformées avant leur arrivée initiale sur le site, cela ne constitue pas un traitement externalisé, mais doit être géré par le site à l’aide du système d’approbation des fournisseurs, de l'évaluation des risques relatifs aux matières premières et des spécifications des matières premières.\nLorsqu'un produit quitte le site et n'y revient pas, il ne s'agit pas d'un traitement externalisé, et les activités réalisées hors site n'entrent pas dans la portée de l'audit.\nLorsqu'une étape intermédiaire du processus (y compris la production, la transformation ou le stockage) de fabrication d'un produit est externalisée auprès d’un tiers ou effectuée sur un autre site, avant d’être renvoyée ensuite vers le site, elle doit être considérée de manière à garantir qu'elle ne compromet pas la sécurité sanitaire, l’authenticité, la légalité ou la qualité du produit."}, {"id": "3.5.4.1", "requirement": "The company shall be able to demonstrate that, where part of the production process (i.e. any intermediate process step) is outsourced or undertaken off site, and subsequently returned to the site, this has been declared to the customer and, where required, approval granted.", "interpretation": "Customers (e.g. brand owners) must be notified of any intention to outsource part of the production process. (Some customers require the opportunity to formally approve or reject this type of outsourcing.) For example, if this is clearly detailed on the approved product specification, then it would demonstrate that the customer has agreed the process. This requirement is not limited to retail-branded products or to certain markets but applies to any product manufactured on behalf of a customer.", "requirement_fr": "L'entreprise doit être en mesure de démontrer que, lorsqu'une partie du processus de fabrication d'un produit (c-à-d. toute étape du processus intermédiaire) est externalisée auprès d’un tiers ou effectuée sur un autre site, avant d’être renvoyée ensuite vers le site, cela a été communiqué au client et, le cas échéant, approuvé."}, {"id": "3.5.4.2", "requirement": "The company shall ensure that outsourced processors are approved and monitored, to ensure that they effectively manage risks to product safety and quality and are operating effective traceability processes. The approval and monitoring procedure shall be based on risk and include either one or a combination of: • a valid certification to the applicable BRCGS Standard or GFSI-benchmarked standard. The scope of the certification shall include the activities completed for the site or • supplier audits, with a scope to include product safety, traceability, HACCP review, product security and food defence plan, product authenticity plan and good manufacturing practices. The audit shall ensure that these plans form part of the supplier’s product safety management system and that any resultant actions are implemented. The supplier audit shall be undertaken by an experienced and demonstrably competent product safety auditor. Where this supplier audit is completed by a second or third party, the company shall be able to: • demonstrate the competency of the auditor • confirm that the scope of the audit includes product safety, traceability, HACCP review, product security and food defence plan, product authenticity plan and good manufacturing practices • obtain and review a copy of the full audit report. There shall be a documented process for ongoing supplier performance review, based on risk and defined performance criteria. The process shall be fully implemented. Records of the review shall be kept.", "interpretation": "The company must document its procedure for approval and monitoring of outsourced processors. This needs to include the methods of approval, frequency of monitoring, responsibilities and how the process will be managed. The acceptable methods of approval will depend on the nature of the activity performed and its associated risks, and will include one or more of the following: • Certification to the relevant BRCGS Standard or another of the GFSI-benchmarked schemes. The site must confirm the validity of the certification. This will include: • Confirmation of the certification status (this can be confirmed, for example, on an independent database; for BRCGS it can be confirmed in the BRCGS Directory). Photocopies of certificates are not recommended and on their own are not considered suitable validation of certification status. During the BRCGS audit the site may be asked to demonstrate its validation process. • Confirmation that the certification remains up to date (e.g. by receiving confirmation of successful completion of the recertification processes or by recording certificate expiry dates and completing checks for ongoing certification). • Ensuring that the activities are within the scope of the certification. • A successful site audit covers at a minimum product safety, traceability, HACCP review, product security and food defence plan, product authenticity plan and good manufacturing processes. This audit must be completed by an appropriately experienced and competent auditor (i.e. someone who has completed training in auditing techniques, has experience of auditing, and has knowledge of the product, ingredient or processes being audited). Non-conformities should be addressed (e.g. in an agreed action plan with timescales) unless they are critical to product safety or legality, in which case supply should not be permitted until the non-conformities have been satisfactorily addressed. If the outside processor is independently audited to another standard that is not GFSI- benchmarked, this may be acceptable as an alternative to the site completing its own audit of the processor providing that: • The scope of the audit meets the requirements of the Standard (i.e. at a minimum product safety, traceability, HACCP review, product security and food defence plan, product authenticity plan and good manufacturing practices). • The site has a copy of the full audit report (not just a certificate). • The processor can demonstrate the competence of the auditor. The auditor will expect to see, and will challenge, risk assessments. The site must be able to demonstrate to the auditor that the monitoring and ongoing review it uses is appropriate, justified and risk-based.", "requirement_fr": "L’entreprise doit s’assurer que les transformateurs externalisés sont approuvés et contrôlés, afin de garantir que les risques affectant la sécurité et la qualité des produits sont gérés efficacement, et que des processus de traçabilité efficaces sont en place.\nLa procédure d'approbation et de contrôle doit être basée sur les risques et inclure un ou plusieurs des points suivants :\n•\t une certification valide dans le cadre de la Norme du BRCGS ou d’une norme reconnue par la GFSI. La portée de la certification doit inclure les activités réalisées pour le site ou\n•\t des audits de fournisseurs dont l’étendue inclut la sécurité sanitaire des produits, la traçabilité, l’examen HACCP, le programme de sécurité et de protection de la chaîne alimentaire des produits, le programme d’authenticité des produits et les bonnes pratiques de fabrication. L'audit doit garantir que ces programmes font partie du système de gestion de la sécurité des produits du fournisseur et que toutes les mesures qui en découlent sont mises en place. L’audit des fournisseurs doit être effectué par un auditeur en sécurité sanitaire de produit expérimenté et manifestement compétent. Lorsque l’audit de ce fournisseur est réalisé par une seconde ou tierce partie, l’entreprise doit pouvoir :\n•\t démontrer la compétence de l’auditeur\n•\t confirmer que la portée de l'audit inclut la sécurité sanitaire des produits, la traçabilité, l'examen HACCP, le plan de sécurité et de protection de la chaîne alimentaire des produits, le programme d'authenticité des produits et les bonnes pratiques de fabrication\n•\t obtenir et examiner une copie du rapport d'audit complet.\nUn processus documenté d'évaluation continue de la performance du fournisseur, basé sur les risques, et des critères de performance définis doivent être en place. Le processus doit être pleinement mis en œuvre. Des enregistrements de l’évaluation doivent être conservés."}, {"id": "3.5.4.3", "requirement": "Where any processes are outsourced, including production, manufacture, processing or storage, the risks to the product safety, authenticity and legality shall form part of the site’s food safety plan (HACCP plan).", "interpretation": "is therefore vital that any outsourced processing is incorporated into the HACCP plan to ensure that any risks to product safety, authenticity and legality are identified and appropriate controls applied.", "requirement_fr": "Lorsque des processus sont externalisés, y compris la production, la fabrication, la transformation ou le stockage, les risques pour la sécurité, l'authenticité et la légalité des produits doivent être pris en compte dans le plan de sécurité des denrées alimentaires (plan HACCP) du site."}, {"id": "3.5.4.4", "requirement": "Requirements for outsourced processing shall be agreed and documented in a service specification (similar to a finished product specification). This shall include any specific handling requirements for the products.", "interpretation": "maintained during outsourced processing and the return of products to the site. Therefore a service specification shall be in place for all outsourced processes, which details the activities to be completed and any specific handling requirements needed to maintain the safety, authenticity, legality or quality of the product.", "requirement_fr": "Les exigences relatives à la transformation externalisée doivent être définies et documentées dans une spécification de service (similaire à une spécification de produit fini). Cette spécification doit inclure toute exigence spécifique liée à la manipulation des produits."}, {"id": "3.5.4.5", "requirement": "Any outsourced processing operations shall: • be undertaken in accordance with established contracts which clearly define any processing requirements • maintain product traceability.", "interpretation": "Contracts must be in place for the approved processors detailed in clause 3.5.4.2 to ensure: • the correct level of service is provided • the processing requirements are clearly defined in terms of the work to be undertaken, the product, ingredient specification, and any relevant safety, quality, legality or authenticity requirements. There must be documented mechanisms to ensure traceability is maintained throughout the process. Records relating to the traceability of individual batches of processed ingredient or product must be available.", "requirement_fr": "Toute opération de traitement externalisé doit :\n•\t être effectuée conformément aux contrats établis qui déterminent clairement toute exigence de transformation\n•\t garantir la traçabilité du produit."}, {"id": "3.5.4.6", "requirement": "The company shall establish inspection and test procedures for products where part of the processing has been outsourced, including visual, chemical and/or microbiological testing. The frequency and methods of inspection or testing shall depend on risk assessment.", "interpretation": "A documented acceptance procedure must identify the checks to be made when outsourced processing is complete. When products that have been processed are returned to the site, this procedure could form part of the goods receipt system. Acceptance procedures may, for example, include: • visual inspection • chemical, microbiological or allergen testing • hold/release requirements for the specific material (e.g. to allow additional testing or quality assurance checks). The requirements (both acceptance methods and the frequency of any checks or tests) must be based on risk assessment of the nature of the ingredient or product, the process and the outside processor undertaking the processing; for example, the processor may handle allergens that could potentially contaminate the processed product. The acceptance procedure must document any non-conformities, the person(s) authorised to accept conforming materials and reject non-conforming batches, and the action to be taken in the event of a non-conformity.", "requirement_fr": "L'entreprise doit mettre en place des procédures d'inspection et de test pour les produits dont une partie des opérations de transformation a été externalisée, y compris des tests visuels, chimiques et/ou microbiologiques.\nLa fréquence et les méthodes d’inspection ou d'analyse doivent être basées sur l’évaluation des risques.\n3.6 Spécifications Des spécifications doivent exister pour les matières premières (emballage primaire compris), les produits finis et tout produit ou service qui peut avoir un impact sur l'intégrité du produit fini."}, {"id": "3.6.1", "requirement": "Specifications for raw materials and primary packaging shall be adequate and accurate and ensure compliance with relevant safety and legislative requirements.", "interpretation": "Specifications for all raw materials, including primary packaging materials, must be provided and adequately detailed. They must include the defined limits for all parameters critical to the safety, legality and quality of the product. They must also include details of packaging.\nThe specifications may be in the format provided by the supplier or in the company’s own format, as long as the information controlling the product’s quality and safety are clearly defined.", "requirement_fr": "Les spécifications sur les matières premières et les emballages primaires doivent être adaptées et correctes, et garantir la conformité aux exigences applicables en matière de sécurité sanitaire et de légalité. Les spécifications doivent inclure des limites définies applicables aux attributs des matières qui peuvent affecter la qualité ou la sécurité sanitaire des produits finis (c-à-d. normes chimiques, microbiologiques, physiques ou allergéniques)."}, {"id": "3.6.2", "requirement": "Accurate, up-to-date specifications shall be available for all finished products.", "interpretation": "Specifications must be in place detailing all finished products. These specifications must be up to date (i. e. they must accurately represent the current version of the product) and should be reviewed whenever changes occur to the product, process or formulation. Good practice is therefore to ensure that the company has a system of change control where changes in products are identified before manufacture commences, that relevant amendments are made to the specification in a timely manner and that only the correct version of the specification is available to staff (see clause 3. 6.4 for further details).\nThe format of the specifications should be agreed with the customer to ensure that all relevant customer requirements are incorporated. This may, for example, be printed documents, electronic files or an online database. In the case of the company’s branded products, it is acceptable to have an internal specification setting parameters for the manufacture of a product and a technical data sheet for customer use containing the key information for the safe use of the product, including but not limited to:\n• ingredients, including the presence of allergens\n• nutritional information\n• preparation or cooking instructions\n• storage instructions\n• shelf-life/code information\n• quantity.\nSpecifications must be accurate and the control of amendments and approval of specifications should therefore be laid down in a documented procedure. This procedure should also detail who can approve the amendments.", "requirement_fr": "Des spécifications correctes et actualisées doivent être disponibles pour tous les produits finis. Cela peut être sous la forme d’un document imprimé ou électronique, ou faire partie d'un système de spécifications en ligne.\nElles doivent inclure des données clés permettant de répondre aux exigences légales et des clients, et aider l'utilisateur à utiliser le produit sans danger."}, {"id": "3.6.3", "requirement": "Where the company is manufacturing customer-branded products, it shall seek formal agreement of the finished product specifications.", "interpretation": "Customer-branded, finished product specifications must be formally agreed with the relevant customer and must, wherever possible, be signed by both parties. However, where the customer’s signature or approval is not formally available, proof that specifications have been issued (such as an email request for formal acknowledgement or specifications on customer IT specification systems) is required. In this situation the site must be able to demonstrate it is following a formal process agreed with the customer.", "requirement_fr": "Lorsque l’entreprise fabrique des produits portant la marque de clients, elle doit obtenir un accord formel relatif aux spécifications. Lorsque les spécifications ne sont pas convenues formellement, l'entreprise doit pouvoir démontrer qu'elle a pris des mesures pour s'assurer qu'un accord formel soit établi."}, {"id": "3.6.4", "requirement": "Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years.", "interpretation": "Specifications must be reviewed whenever changes occur to the product, process or formulation. Where no known changes have occurred, the specifications must be reviewed at least every 3 years, or more frequently if required by a specific customer, to ensure they remain completely up to date and accurate. Evidence that a review has been completed needs to be available and this should be achieved through the addition of a signature and date to the specification or through the use of a matrix showing specifications and the latest review date and reviewer.\nThe control of the amendment and approval of specifications should be laid down in a documented procedure. The procedure should also detail who can approve the amendments.\nSome sites, companies or customers use cloud-based services which are able to notify the user when there has been a change to the data. In these cases, the site should have a mechanism to review the specification or change to understand whether there is any impact to product safety, the HACCP or food safety plan, or the production processes. This requirement is also reflected in clause 2. 12. 3, which explains how the HACCP or food safety plan needs to be reviewed whenever raw materials change.\n3. 7 Corrective and preventive actions Fundamental The site shall be able to demonstrate that it uses the information from identified issues in the food safety and quality management system (e. g. non-conforming products, internal audits, complaints, product recalls, product testing, second- and third-party audits and online reviews) to complete necessary corrective actions and prevent recurrence.\nThe objective is to ensure there are clear procedures to deal with problems that have the potential to affect safety, authenticity, legality or quality, ensuring that the finished product and consumer safety are not compromised.\nCorrective and preventive actions are applicable to a wide range of non-conforming situations; they are not limited to BRCGS audit results, non-conforming products and complaints. The statement of intent therefore includes some examples of situations in which corrective and preventive actions are required, but this list is by no means definitive.\nThe aim is for information from all issues associated with the safety and quality management system to be used to make improvements, not just those requiring immediate action.", "requirement_fr": "Les spécifications doivent être revues fréquemment afin de garantir que les données sont à jour, ou au minimum tous les 3 ans, en tenant compte des changements de produits, des fournisseurs, des règlementations et autres risques.\nLes revues et changements doivent être documentés.\n3.7 Actions correctives et préventives Fondamental Le site doit être en mesure de démontrer qu’il utilise les informations issues des problèmes identifiés dans le système de gestion de la sécurité et de la qualité des denrées alimentaires (c-à-d. les produits non conformes, les audits internes, les réclamations, les rappels de produits, les tests de produits, les audits par une seconde ou tierce partie et les examens en ligne) pour prendre les mesures correctives nécessaires et en éviter la récurrence."}, {"id": "3.7.1", "requirement": "The site shall have a procedure for handling and correcting issues identified in the food safety and quality management system. The site procedures shall include the completion of root cause analysis and implementation of preventive action.", "interpretation": "There must be a documented procedure for handling issues in the food safety and quality system which have a potential adverse effect on product safety, authenticity, legality or quality. All issues or non-conformities generated by the site (e. g. non-conforming product, internal audits and site inspections, third-party audits or customer complaints, product recalls, product testing (including inspections, quality assurance tests and laboratory testing)) must be subject to corrective action.\nGood practice is for corrective action to be completed as soon after detecting the non- conformity as possible (this is particularly important where the non-conformity could affect product safety, legality or quality – see clause 3. 7.2).\nAn important part of an effective corrective action process is the identification of the root or underlying cause of the non-conformity and the implementation of suitable action to prevent recurrence. Root cause analysis is a process of conducting an investigation into an identified problem to allow the investigator(s) to understand the fundamental cause and put it right. While there are a number of techniques for undertaking root cause analysis, one of the most common and simplest to use is the ‘five whys’ technique. The technique is based on repeatedly digging deeper into the cause of a problem by asking ‘Why …?’ to get to the root of the issue. Usually, the root cause becomes evident after five steps, but this is not fixed and further investigation should be completed where required. This is described in more detail in the example in clause 3. 7.2.\nSome clauses in the Standard specifically require root cause analysis but it is up to the site to establish a procedure for its completion. Root cause analysis procedures should include:\n• a set of parameters that will initiate the use of an appropriate tool (i. e. the site must define when the analysis will be completed if it is not already prescribed by the Standard)\n• who is trained and/or authorised to complete the analysis\n• the methods that the site will use to conduct the analysis\n• the records which detail the analysis and any subsequent preventive actions\n• the methods for the verification of the completed actions.\nThe auditor will expect to see a documented procedure that includes this information, as well as evidence of any root cause analysis and preventive action that the site has carried out.\nIt is worth noting that in some geographies the analysis of trends may be a legal requirement. For example, in the EU, the Microbiological Criteria for Foodstuffs (EC) No 2073/2005 states that food business operators (FBOs) shall analyse trends in test results.\nWhen they observe a trend towards unsatisfactory results, they shall take appropriate actions without undue delay to remedy the situation in order to prevent the occurrence of microbiological risks.", "requirement_fr": "Le site doit disposer d'une procédure permettant de gérer et corriger les problèmes identifiés dans le système de gestion de la sécurité et de la qualité des denrées alimentaires.\nLes procédures du site doivent inclure la réalisation d'une analyse des causes fondamentales et la mise en place d'actions préventives."}, {"id": "3.7.2", "requirement": "Where a non-conformity places the safety, authenticity or legality of a product at risk, or where there is an adverse trend in quality, this shall be investigated and recorded. • clear documentation of the non-conformity. • assessment of consequences. • the corrective action to address the immediate issue. • completion of root cause analysis to identify the fundamental cause (root cause) of the non-conformity. • appropriate timescales for corrective and preventive actions. • the person(s) responsible for corrective and preventive actions. • verification that the corrective and preventive actions have been implemented and are effective.", "interpretation": "Non-conformities with the potential to affect product safety, authenticity, legality or quality must be recorded, and the responsibility for investigating the cause of problems and ensuring that an adequate response is taken must be assigned to specified personnel.\nAction needs to be undertaken as soon as possible after the detection of the non- conformity, but there may also be a need for long-term action to prevent further occurrence of the non-conformity. All actions undertaken must be documented.\nThe records will include:\n• details of the non-conformity and when it occurred or was identified\n• assessment of the potential consequences of the non-conformity by a suitably competent and authorised person\n• details of the action taken to address the immediate issue and dates or timescales for completion of the actions (i. e. corrective action)\n• root cause analysis to identify the fundamental or root cause of the non-conformity\n• details of the preventive action taken to address the root cause and dates or timescales for completion of the actions\n• identification of who is authorised and responsible for the actions\n• details of the verification checks to ensure the action has been implemented and is effective.\nWhere there is a significant trend in a specific type of non-conformity, root cause analysis must be used to investigate the trend and implement action to prevent recurrence.\nAll corrective actions should be completed in a timely fashion. In practice this will depend on the nature of the activity and the potential consequences of a delay. For example, stopping the production line would happen immediately but receiving and fitting a new or replacement part may be a prolonged process.\nThe actions should be included in a regular review of activities and systems.\nThe site must assess the consequences of any delay in action and ensure that product integrity and safety are not jeopardised. Where set timescales are not met, the reason for the delay should be recorded and reviewed by the appropriate site management to ensure ongoing product safety and, where necessary, provide appropriate resources.\nExample Root cause analysis using the ‘five whys’ technique An operator is instructed to perform a simple action, ‘Weigh out ingredient A’. However, the operator inadvertently uses ingredient B instead. The immediate reaction would probably be that this was operator error. Although this may be accurate, it does not establish the reason why the error occurred or prevent it from happening in the future. Using the five whys technique, the root cause analysis should ask and answer a series of questions:\n• Why did the operator make the error? The operator was unfamiliar with the procedure.\n• Why was an operator who was unfamiliar with the procedure asked to complete it? He had been trained but there was no supervision or sign-off of the training to confirm it was satisfactory.\n• Why was the training not satisfactory? The two ingredients looked identical.\n• Why weren’t the ingredients clearly labelled? The labels had been removed during cleaning and not replaced.\n• Why weren’t the labels replaced? The cleaning staff did not consider the significance of the delay or the potential for an error.\n• Why were the ingredient containers being used if they had not been set up correctly for manufacture? Checking the labels did not form part of anyone’s duties.\nThe conclusion of a root cause analysis should be to identify what should be changed to prevent recurrence of the error. In this example, the conclusion might be to:\n• update the training procedure\n• introduce a training sign-off procedure to ensure training is understood\n• replace labels – if practical, with ones that cannot be removed. Where labels must be removed occasionally, ensure that post-maintenance line checks include a check of signage\n• ensure that an individual (e. g. the production manager) is authorised and responsible for post-cleaning line sign-off\n• ensure that cleaning staff fully understand and are trained in the need to return labelling (and all equipment) to a fully operational state.\nNow that the root cause analysis has been completed, it is easy to see how this incident occurred. The causes were:\n• an incomplete training procedure\n• a faulty cleaning process\n• lack of post-cleaning check procedures.\nThe next step of the process is for the site to identify and implement suitable preventive action to ensure the problem does not occur again (where a non-conformity has multiple causes it is important that the preventive action addresses all of these). For example:\n• update the training procedure to ensure sign-off ( and possibly a supervision step)\n• replace ingredient labels ideally with ones that cannot be removed\n• if labels must occasionally be removed, ensure that post-cleaning line checks include a signage check\n• ensure an individual is authorised and responsible for post-cleaning line sign-off\n• ensure cleaners fully understand and are trained in the need to return labelling (and all equipment) in a fully operational state.\nBRCGS has produced a guideline on root cause analysis which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.\n3. 8 Control of non-conforming product The site shall ensure that any out-of-specification product is effectively managed to prevent unauthorised release.\nThe objective is to ensure there are clear documented procedures to deal efficiently with any non-conformity that has the potential to affect product safety or quality. There is also a need to ensure that any non-conforming product or raw material is physically removed from the production process.", "requirement_fr": "Lorsqu'une non-conformité met en danger la sécurité sanitaire, l’authenticité ou la légalité des produits, ou lorsqu’une dégradation de la qualité est constatée, elle doit faire l'objet d'une enquête et être consignée en incluant :\n•\t une documentation claire de la non-conformité\n•\t l'évaluation des conséquences par une personne compétente en la matière et autorisée\n•\t l'action corrective permettant de résoudre le problème immédiat\n•\t la réalisation d'une analyse des causes fondamentales, afin d'identifier la cause première (cause fondamentale) de la non-conformité\n•\t un calendrier approprié pour la mise en place des actions correctives et préventives\n•\t la ou les personne(s) responsable(s) des actions correctives et préventives\n•\t la vérification de la mise en place et de l'efficacité des actions correctives et préventives.\nL'analyse des causes fondamentales doit également être utilisée pour prévenir une récurrence des non-conformités, et pour mettre en place des améliorations continues lorsque l'analyse des tendances montre une hausse significative d'un certain type de non-conformités.\n3.8 Contrôle d'un produit non conforme Le site doit s'assurer que tout produit non conforme sera pris en compte efficacement afin qu'il ne soit pas libéré sans autorisation."}, {"id": "3.8.1", "requirement": "There shall be procedures for managing non-conforming products. • the requirement for staff to identify and report a potentially non-conforming product. • clear identification of a non-conforming product. • secure storage to prevent accidental release. • management of any product returned to the site. • referral to the brand owner where required. • defined responsibilities for decision-making on the use or disposal of products. • records of the decision on the use or disposal of the product. • records of destruction where a product is destroyed for food safety reasons.", "interpretation": "The control of non-conforming product must be described in a documented procedure (in this context the implicated product could be any material, such as an ingredient, final product, packaging, or a combination of these). Procedures must include:\n• ensuring that all staff are aware of the need to report issues that may affect product safety, authenticity, legality or quality, and to whom. This may be covered as part of the induction process for production staff\n• the system for labelling and identification of non-conforming product. This may include both direct labelling and computer-based records.\n• segregation or isolation of non-conforming product. Ideally, the product must be physically segregated by moving it to an identified area within the production site, or clearly marked so that it cannot be confused with in-process material or finished product.\nThe use of electronic inventory systems to ‘electronically isolate’ the material is also acceptable. It is often good practice to confirm the effective control of remaining product by completing a documented inventory; i. e. verifying the amount of non-conforming product that has been isolated with the quantities recorded in the production and dispatch records.\n• procedures for handling returned product; for example, goods receipt actions, secure storage and notifications of returned product to relevant managers.\n• referral to the brand owner where required. The brand owner may need to be notified of quality issues and would expect to be contacted where issues affect product safety.\nAgreement may need to be reached before the held products are released for sale.\nContacting brand owners is not usually necessary where the decision is to destroy, downgrade or rework product, unless this notification is a contractual requirement of the brand owner\n• details of staff responsibilities, including which staff are authorised and responsible for decisions relating to non-conforming products. The final decision on what to do with held product should be taken by an experienced, technically competent manager. Only a limited number of personnel must have the authority to lift the hold notice or remove product from the isolation area\n• records of all products placed on hold. These must include:\n• details of the product quantity and code\n• the reason for isolation\n• action taken or required to assess the suitability of the product\n• the final decision on what to do with the product; for example, rework, downgrading or destruction of the product\n• the name of the person authorising the decision and date\n• confirmation of the action taken\n• any further actions required to prevent recurrence (this may link to an investigation of corrective actions; see section 3. 7)\n• the ‘on hold’ procedure employed while an investigation is completed\n• procedures for the effective safe disposal of product.\nIt is usual to maintain a log of products which are on hold and to undertake periodic physical checks of held stock to ensure that accidental release has not occurred. The summary of products held and actions taken must be reviewed as part of the management review process.\nNon-conforming product is a key prompt to initiate root cause analysis, particularly when there has been an increase in incidents of the same type (e. g. mis-packing).\n3. 9 Traceability Fundamental The site shall be able to trace all raw material product lots (including primary packaging) from its suppliers through all stages of processing and dispatch to its customers and vice versa.\nAs well as being a legislative requirement, traceability is a risk management tool, allowing food businesses and authorities to withdraw or recall products that have been identified as unsafe. It is therefore a fundamental requirement. A traceability system needs to be established at all stages of production, processing and distribution, identifying from whom raw materials have been obtained and to which customers finished product has been supplied. Note that the Standard requires forward and backward traceability throughout the production process. This means that the site should know where the material has come from (i. e. the direct supplier) and to whom finished product is dispatched.\nThere is no requirement for the site to trace raw materials all the way back to the source (e. g. farm) unless the source is the direct supplier to the site.\nThe system must ensure that products supplied to customers are adequately labelled or identified to facilitate traceability. Traceability details need to be retained in a format that allows access in a timely manner.\nBRCGS has published a traceability guideline which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Des procédures relatives à la gestion des produits non conformes doivent exister. Ces procédures doivent inclure :\n•\t les exigences permettant aux employés d'identifier et de signaler un produit potentiellement non conforme\n•\t une description claire d'un produit non conforme (c-à-d. étiquetage direct ou utilisation de systèmes TI)\n•\t un stockage sécurisé pour éviter toute libération accidentelle (c-à-d. isolement physique ou informatique)\n•\t la gestion de tout produit renvoyé sur le site\n•\t une communication au propriétaire de la marque, le cas échéant\n•\t des responsabilités définies quant à la prise de décision sur l'utilisation ou la mise au rebut de produits affectés par le problème (c-à-d. destruction, retraitement, déclassement vers une catégorie alternative ou reception par dérogation)\n•\t des enregistrements sur la décision d'utiliser le produit ou de le mettre au rebut\n•\t des enregistrements sur la destruction lorsqu'un produit est détruit pour des raisons de sécurité des denrées alimentaires.\n3.9 Traçabilité Fondamental Le site doit être en mesure de tracer tous les lots de matières premières (emballage primaire compris) depuis ses fournisseurs en passant par toutes les étapes de transformation et d'expédition aux clients et inversement."}, {"id": "3.9.1", "requirement": "The site shall have a documented traceability procedure designed to maintain traceability throughout the site’s processes. At a minimum this shall include: how the traceability system works, the labelling and records required.", "interpretation": "Sites are free to utilise their own traceability systems; no specific tool or technique is required by the Standard. Nevertheless, it is imperative that the site documents its traceability procedure so that it can be used and understood by the relevant personnel. This is particularly important at times of stress, when it is likely that the procedure will be relied upon to ensure at-risk product is identified and recalled or withdrawn in a timely manner.\nSome countries have specific legislation relating to traceability. The site will therefore need to ensure that any legislative traceability requirements in the country of sale or intended use are met.", "requirement_fr": "Le site doit disposer d'une procédure de traçabilité documentée, conçue pour  garantir la traçabilité des produits tout au long des processus du site. Au minimum, cette procédure doit inclure :\n•\t le mode de fonctionnement du système de traçabilité\n•\t l’étiquetage et les enregistrements requis.\nLe cas échéant, le système de traçabilité doit répondre aux exigences légales du pays où le produit sera commercialisé ou utilisé."}, {"id": "3.9.2", "requirement": "Identification of raw materials (including primary packaging), intermediate/semi-processed products, part-used materials, finished products and materials pending investigation shall be adequate to ensure traceability.", "interpretation": "Products and materials may be identified by physical labelling, by recording systems identifying the allocation of materials to production or mixing areas, or through the use of computerised bar-coding systems. The level of traceability may need to be agreed between the company and its customers, but the system used must be capable of linking all raw material lot codes to finished product codes. This will enable finished product to be identified if a particular batch of raw material needs to be recalled.\nThe limitations of any system must be recognised, as can be demonstrated by the problems associated with bulk storage. Products such as sugar may be delivered with clear batch identification; however, if they are emptied into a single storage tank that is mixed with earlier deliveries, the reduction in accurate traceability is compounded by the potential for product to be trapped in dead zones during filling and emptying. If a particular delivery is identified as being contaminated, the entire product in the storage tank would need to be disposed of, as well as several lot codes of finished product, as the company would not be able to identify the specific batch of finished product that contained the contaminated material. A similar limitation will exist if recyclable packaging is collected from several sources and combined to form a single batch.\nThe traceability system needs to include primary packaging (a full definition of primary packaging is available in the glossary, Appendix 1). Note that processing aids (i. e. substances that are used within the process but are not required to be declared as an ingredient, such as sodium alginate for the clarification of beer) are included in the definition of raw materials (see glossary, Appendix 1) and therefore need to be included in the traceability system.\nAll test results (clause 3. 9.3) must be traceable to specific batches of product or ingredient.\nConsider how the traceability system operates in practice (with the effective physical identification of ingredients and products). For example, if bulk containers are labelled, consider how the information is presented to ensure it is legible and accurate. Common non-conformities include the ineffective labelling of part-used packs in production, work in progress, and storage areas leading to potential errors.\nStrict controls on material identification, traceability and segregation are also required to preserve the integrity of any claims made, such as organic status. Where logos are used that make specific claims about production systems (e. g. farm assurance), full traceability must be demonstrated (see also section 5. 4).\nApart from batch or lot codes, traceability information will usually include date codes to ensure that only ingredients, intermediates and products within the appropriate shelf-life period are used. Particular care is needed for decanted ingredients, work in progress and products stored in bulk where the packaging has been removed.", "requirement_fr": "L'identification des matières premières (emballage primaire compris), des produits intermédiaires/semi-finis, des matières partiellement utilisées, des produits finis et des matières en attente d'examen doit être adaptée et permettre leur traçabilité."}, {"id": "3.9.3", "requirement": "The site shall test the traceability system across the range of product groups to ensure traceability can be determined from the supplier of raw material to the finished product and vice versa. For food raw materials and finished products, the test of the traceability system shall include a quantity check/mass balance. Traceability should be achievable within 4 hours.", "interpretation": "Good practice is for the site to have a procedure or document that highlights the traceability system that is used at each step in the production process. It could include, for example, how incoming raw material batch numbers are captured, and how the outgoing product is traced and labelled. The process flow diagram developed as part of the HACCP plan (see clause 2. 5.1) may be useful to ensure all steps are captured.\nThe site’s traceability system must be tested at least annually, or more frequently if required by a customer. (Note that the frequency of traceability tests relating to provenance and origin claims is covered separately in clause 5. 4.5.) Where traceability for all products manufactured by the site is the same or similar, then a minimum of one traceability test a year must be completed. However, if there are significant differences or specific traceability challenges relating to one product or group of products, additional tests specifically related to that product or group of products may be needed.\nTraceability testing may be completed as part of a real product recall or withdrawal scenario if one has occurred, since the objective is to test the system and identify areas for improvement, rather than supply records of a ‘test’ for its own sake.\nThe system must provide traceability forwards and backwards; therefore the system should be tested in both directions. For example, a raw material could be selected and traced forwards to show in which finished products it was used. A finished product should also be selected and traced backwards to show all the raw material batch codes (including primary packaging) that were used to produce it. The tests should include identifying which customers received the finished products and which suppliers provided the raw materials. The traceability test must also include the traceability of the primary packaging materials. Although there are many benefits to complete supply chain traceability (i. e. from the farm through all stages of processing, distribution and storage, through to the retailer or food service company), this clause does not require sites to complete full supply chain traceability tests. The scope of the traceability test required here is from the suppliers of the raw material, through the site’s processes, to the site’s customers.\nThe site is also expected to compile a summary of the documents that should be referenced during the test, and clearly show the links between them. This is of benefit to both the site and the auditor, as it ensures all relevant documents are retrieved, and explains the traceability system.\nThe test of traceability should be timed and full traceability would be expected to be achieved within 4 hours. This is to reflect the need for rapid traceability in the event of a recall. Where traceability takes longer than 4 hours, review the areas where the retrieval of information is slow in order to identify improvements.\nFor all food products, and printed packaging and labels which have product safety information, the tests must also include a quantity check or mass balance exercise. It is not expected that the full mass balance exercise would always be achievable within 4 hours. The objective is to be able to account for the usage of a full batch of a raw material. This helps to ensure that the traceability systems are capable of operating effectively should a product recall be required based on the recall of an ingredient.\nThe mass balance exercise is usually undertaken as follows:\n• Select a batch code of a particular specific raw material.\n• Identify the quantity of the raw material supplied under that batch code.\n• Identify the recipes in which the ingredient is used.\n• Use production schedules and batch make-up sheets to calculate the quantities of the selected batch of ingredient used in each product.\n• Calculate the quantity of any unused part of the batch in the warehouse.\n• Reconcile the quantity delivered against the amounts used plus any residual unused stock.\nIn some instances quantity checks may take a great deal of time and resource to complete successfully.\nIt is unlikely that the mass balance exercise will be able to account for all materials to 100% accuracy. However, the company needs to justify any discrepancies and demonstrate understanding of the nature of the variance. This may be inherent in the product characteristics (e. g. dehydration of fresh ingredients), or be ascribed to typical wastage on equipment or portion variances. Where the site adds subsequent deliveries to a bulk silo, the test should clearly show how this has been managed. The principle is to ensure that the traceability system is effective. Mass balance is a key measure of its workability and highlights areas for improvement.\nDuring the BRCGS audit, the auditor will ask the site to complete at least one ‘vertical’ audit.\nAt a minimum this will include the traceability of a specific batch of product or ingredient through the site’s production, processing and distribution processes, and a review of the site records related to the product or ingredient. Records will include, for example, supplier approval, goods receipt, process records (such as temperature monitoring), metal detector checks and dispatch records.\nHowever, the vertical audit is not expected to include records that would only be held at other points in the supply chain (e. g. the raw material supplier’s processing records). This vertical audit is in addition to the review of the site’s own traceability tests. The final audit report will include a summary of the vertical audit results.\nThe vertical audit will also include a mass balance exercise and a review of the systems relating to the accuracy of labelling (clause 5. 2.1). Further information on the content of the audit, including the vertical audit, can be obtained from BRCGS’ auditing techniques document. This may be viewed online at BRCGS Participate.\nBRCGS publishes a separate best-practice guideline on traceability, which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Le site doit tester le système de traçabilité sur les différents groupes de produits pour s'assurer que la traçabilité peut être déterminée auprès du fournisseur des matières premières (emballage primaire compris) jusqu'au produit fini et inversement. Pour les matières premières alimentaires et les produits finis (y compris les emballages imprimés et les étiquettes contenant des informations légales et des informations concernant la sécurité des denrées alimentaires), le test du système de traçabilité doit comprendre une vérification de la quantité/ du bilan massique.\nLe test de traçabilité doit inclure un récapitulatif des documents devant être référencés pendant le test, et clairement indiquer leur corrélation. Le test doit être fait à une fréquence déterminée, au moins une fois par an, et les résultats doivent être conservés pour inspection.\nUne traçabilité devrait pouvoir être effectuée dans un délai de 4 heures."}, {"id": "3.9.4", "requirement": "Where rework or any reworking operation is performed, traceability shall be maintained.", "interpretation": "Many sites undertake rework or recycling activities, where raw materials, work in progress or final product that has left the normal production but is still safe, legal and of the appropriate quality, is reprocessed. There may be several reasons for completing rework, including to:\n• reincorporate the material into a batch of the same product (either the batch currently being manufactured or to enable the materials to be stored for inclusion in a future production)\n• incorporate the material into a batch of another product with similar ingredients\n• process the material to meet the requirements of an alternative customer.\nWhere rework is undertaken, procedures must be in place to ensure that traceability is maintained.\n3. 10 Complaint-handling Customer complaints shall be handled effectively and information used to reduce recurring complaint levels.\nComplaints are key sources of information, informing the site of potential concerns and providing the opportunity for continual improvement; for example:\n• in the event of a complaint relating to product safety, authenticity, legality or quality, they may require escalation into emergency plans such as a product withdrawal or recall\n• the company’s attitude to complaints and complaint-handling processes may indicate the company’s product safety and quality culture; for example, the timeliness and robustness of complaint investigation and the appropriateness of any actions.\nTherefore, an effective complaint-handling system needs to be operated by the company. The objective of the complaint investigation process should be to identify and correct causes of complaints, and one measure of an effective system should be a reduction in the number of complaints as a proportion of production volume.", "requirement_fr": "Lorsqu'un retraitement ou une opération de retraitement sont effectués, la traçabilité doit être conservée.\n3.10\t Gestion des réclamations Les réclamations des clients doivent être gérées efficacement, et les informations doivent être utilisées pour réduire les niveaux de récurrence des réclamations."}, {"id": "3.10.1", "requirement": "All complaints shall be recorded and investigated, and the results of the investigation of the issue recorded where sufficient information is provided.", "interpretation": "The company should ensure there is a clear process for customers (and potentially consumers) to raise legitimate complaints about the products. This is usually via the contact information on product labels. Where products are supplied into food service or through intermediaries, every effort should be made to ensure that complaints raised are relayed to the complaints department of the site.\nAll complaints need to be captured to a specified location to ensure they are adequately assessed and investigated, and the results of this investigation recorded. A documented complaints procedure is therefore required and the inclusion of a standardised complaint form may be useful.\nComplaints must be handled by appropriately trained staff to ensure that a proactive system identifies the severity, and therefore the significance, of any complaints received.\nActions must be appropriate to the seriousness of the complaint. A rapid response would be required for serious issues (such as a glass complaint) or where a number of complaints are received, suggesting a widespread problem.\nInvestigation must be completed within a defined timeframe and feedback provided to the complainant wherever contact details are provided.", "requirement_fr": "Toutes les réclamations doivent être consignées et faire l'objet d'enquêtes, et les résultats de l'enquête sur le problème doivent être consignés lorsque des informations sont fournies en nombre suffisant. Des actions adaptées à la gravité et à la fréquence des problèmes identifiés doivent être menées rapidement et efficacement par des employés formés à cet effet."}, {"id": "3.10.2", "requirement": "Complaint data shall be analysed for significant trends. Where there has been a significant increase in a complaint, or a serious complaint, root cause analysis shall be used to implement ongoing improvements to product safety, legality and quality, and to avoid recurrence.", "interpretation": "Data on customer complaints must be analysed to identify trends. A root cause analysis must be carried out where there is evidence of an emerging trend or a serious complaint.\nThis is to help ensure problems are identified and improvements made to prevent recurrence as far as practicable.\nThis may include, for example, an analysis of foreign-body complaint types as complaint numbers per number of units produced, with data by shift or by production line. This data must be communicated to relevant staff and may include graphical displays on staff noticeboards or discussion at routine operations meetings.\nTrend analysis may demonstrate that certain complaints are associated with customer abuse of the product (e. g. not following cooking instructions). A root cause analysis of these complaints should be undertaken to establish whether the underlying cause can be managed by the company. For example, could on-pack instructions be made clearer to reduce customer abuse and therefore the number of complaints?\nBRCGS publishes a separate best-practice guide to complaint-handling, which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.\n3. 11 Management of incidents, product withdrawal and product recall The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of products should this be required.\nIncidents are events that may result in the production of unsafe, illegal, non-conforming product or products that are not authentic, and risks to consumer safety. An emergency situation may also occur as a result of a sudden, unforeseen crisis that requires immediate action. An effective emergency plan must be in place so that if at any stage an incident occurs that impacts food safety, authenticity, legality or quality, it will be managed effectively.\nThe incident may be directly related to the product, the disruption of key services such as power and water, or environmental influences such as fire or flood.\nThe plan must be understood by relevant staff and must be routinely tested so that it can readily be put into practice, as incidents occur when least expected. The importance of a tried and tested procedure, ensuring that personnel know who does what and when, cannot be underestimated.", "requirement_fr": "Les données relatives aux réclamations doivent être analysées pour déterminer des tendances significatives. Lorsqu'une augmentation significative d'une réclamation ou une réclamation grave est survenue, une analyse de la cause fondamentale doit être utilisée pour mettre en place des améliorations continues de la sécurité sanitaire, légalité et qualité du produit, et pour éviter toute récurrence. Cette analyse doit être mise à la disposition des employés concernés.\n3.11 Gestion des incidents, retrait de produit et rappel de produit L'entreprise doit mettre en place un programme et un système pour gérer efficacement les incidents et permettre le retrait et le rappel des produits, le cas échéant."}, {"id": "3.11.1", "requirement": "The company shall have procedures designed to report and effectively manage incidents and potential emergency situations that impact food safety, authenticity, legality or quality. • disruption to key services. • events such as fire, flood or natural disaster. • malicious contamination or sabotage. • product contamination indicating a product may be unsafe or illegal. • failure of, or attacks against, digital cyber-security", "interpretation": "In the event of an incident or emergency situation, the company must be ready to instigate actions as promptly and efficiently as possible. Therefore the site must have a documented incident management plan. The objective of the plan must be to minimise risk to consumers and potential disruption to business. Systems must be in place and used to ensure that information is collated and quickly assessed by staff who understand its significance and who can develop an appropriate action plan. The site might establish a crisis management plan that could address the points listed here, and any additional risks which are outside the scope of the Standard.\nA documented incident management procedure is required. Although it may not be possible to detail exactly what action will be taken, as this will depend on individual circumstances, the company should consider:\n• standard responses to a range of potential disasters, such as fire, flood or the loss of essential services\n• the provision of alternative resources for energy, water, transport and any potential options for subcontracting production\n• how to handle acts of potential malicious contamination or extortion\n• management of unsafe or illegal products; for example, due to contamination or authenticity concerns\n• details of staff responsibilities, including which staff are authorised and responsible for making decisions relating to non-conforming products. The number of incident management team members should be appropriate for the size of the business\n• a plan to handle the logistics of product traceability and the recovery or disposal of affected product and stock reconciliation (i. e. comparing the amount of implicated product with the amounts known to have been destroyed, returned or retained in storage)\n• methods to communicate with key contacts, both internal and external, such as telephone and email contact details (including office hours and out-of-hours details)\n• the communication process, and the way in which enquiries from customers and the media are handled (this can be critical to the effective management of the situation and ultimate business recovery)\n• corrective action that needs to be taken before production can recommence\n• root cause analysis and preventive actions. Sites should reference their root cause procedure (clause 3. 7.1), so that relevant preventive actions can be completed\n• procedures to withdraw or recall affected products.\nThese details must be kept up to date by periodic verification. Customers and suppliers may need to be involved in the development of documented procedures as they may have their own requirements for crisis planning.\nWith more data being stored digitally and in cloud services, the site needs to be aware that such data is valuable to those who might extort or blackmail companies. Even though cloud services can be relatively secure, digital attacks and failures of systems pose a significant risk and the site needs to ensure that digital data is secure by using, for example, password protection, anti-virus software, firewalls and/or data backup systems.\nSome organisations have published advice on cyber-security; for example, the National Cyber Security Centre’s 10 Steps to Cyber Security.\nGood practice following an actual recall is to assess the effectiveness of the plan to identify and implement any appropriate learning or improvements. This process can form part of the evidence of compliance with clause 3. 11. 3.", "requirement_fr": "L'entreprise doit disposer de procédures conçues pour signaler et gérer efficacement les incidents et les situations potentiellement urgentes ayant un impact sur la sécurité, l’authenticité, la légalité ou la qualité des denrées alimentaires. Elle doit prendre en considération des plans d'urgence pour assurer la sécurité sanitaire, l’authenticité, la légalité et la qualité des produits. Les incidents peuvent inclure :\n•\t une interruption des services clés tels que l'eau, l'énergie, le transport, les processus de réfrigération, la disponibilité du personnel et les moyens de communication\n•\t des évènements tels que les incendies, les inondations ou les catastrophes naturelles\n•\t une contamination malveillante ou un sabotage\n•\t une contamination indiquant qu'un produit pourrait être dangereux ou illégal\n•\t une défaillance ou une attaque des systèmes de cybersécurité Lorsque des produits ayant été libérés du site peuvent être affectés par un incident, la nécessité de les retirer ou de les rappeler doit être envisagée."}, {"id": "3.11.2", "requirement": "The company shall have a documented product withdrawal and recall procedure. This shall include, at a minimum: • identification of key personnel constituting the recall management team. • guidelines for deciding whether a product needs to be recalled or withdrawn. • an up-to-date list of key contacts. • a communication plan. • details of external agencies providing advice and support. • a plan to handle the logistics of product traceability, recovery or disposal. • a plan to record timings of key activities. • a plan to conduct root cause analysis and to implement ongoing improvements", "interpretation": "A product recall is defined as any activity that involves the return of an unfit product from customers and final consumers, whereas a withdrawal is the return of out-of-specification or unfit products from customers, but not from final consumers (see glossary for full definitions).\nThe site must have a documented recall and withdrawal procedure. At a minimum, it must include:\n• details of the recall management team members, including their roles, responsibilities and contact details. In larger businesses the recall team will involve head office personnel and it may be run from the head office. In this case the links between the production-site management and the recall team need to be clear\n• guidelines for deciding whether a product needs to be recalled or withdrawn and the records to be maintained. Although causes for recall are often unpredictable, defined responses to known risks (e. g. identification of pathogens in routine product sampling) could be documented\n• an up-to-date list of key contacts (e. g. recall management team, suppliers, customers, the certification body and regulatory authorities). A recall may occur at any time; therefore office hours and out-of-hours contact details must be provided\n• a communication plan including the provision of information to customers, consumers and regulatory authorities in a timely manner. The communication process and the way in which enquiries from customers and the media are handled can be critical to the effective management of the situation and ultimate business recovery. The use of professional resources to assist in communication management may sometimes be advisable\n• details of external agencies providing advice and support as necessary (e. g. specialist laboratories, regulatory authorities and legal expertise)\n• a plan to handle the logistics of product traceability, recovery or disposal of affected product and stock reconciliation\n• a log of activities created as the event unfolds and real-time observations, which could, for example, be used in discussions with customers or regulatory authorities. This may be valuable during a post-incident review to consider improvements to incident management processes\n• reference to the root cause analysis procedure, so that relevant preventive actions can be introduced.\nIn the event of a product recall, it is obviously important that actions are completed in a timely fashion. Therefore, the aim of noting key times in the plan is to ensure that this will happen during both tests of the system and during any actual incident. There are various times that should be recorded, including:\n• when the incident or test started\n• times of internal communications and key decisions\n• when traceability and mass balance exercises were started and completed\n• communication to customers or regulatory authorities.", "requirement_fr": "L'entreprise doit disposer d'une procédure de retrait et de rappel de produit documentée. Elle doit inclure au minimum :\n•\t l'identification des employés clés faisant partie de l'équipe de gestion des rappels de produits, avec une définition détaillée des responsabilités\n•\t les directives déterminant si un produit doit être retiré ou rappelé, et les enregistrements qui doivent être conservés\n•\t une liste actualisée des contacts clés (incluant les coordonnées des employés en dehors des heures de travail) ou une indication quant à l'emplacement de cette liste (c-à-d. équipe de gestion des rappels, services d'urgence, fournisseurs, clients, organisme de certification, autorité légale)\n•\t un programme de communication incluant la communication d'informations aux clients, aux consommateurs et aux autorités légales en temps voulu\n•\t les coordonnées d'agences externes prestataires de conseils et de soutien, le cas échéant (c-à-d. laboratoires spécialisés, autorité légale et expertise légale)\n•\t un programme pour gérer les aspects logistiques de traçabilité du produit, récupération ou mise au rebut du produit affecté et regroupement de stock\n•\t un programme d’enregistrement du minutage des activités clés\n•\t un programme pour procéder à une analyse des causes fondamentales et mettre en place des améliorations continues, afin d’éviter toute récurrence.\nLa procédure doit pouvoir être mise en œuvre à tout moment."}, {"id": "3.11.3", "requirement": "The incident management procedures (including those for product recall and withdrawal) shall be tested, at least annually, in a way that ensures their effective operation.", "interpretation": "The incident management procedure must be tested at least annually. This test must include a test of the product withdrawal and recall processes which form part of the incident management procedure.\nIt should be emphasised that traceability is only part of this procedure and therefore a repeat test of the traceability will not, on its own, be sufficient to demonstrate that the site is meeting this requirement. The aims of testing the full procedure are to:\n• demonstrate that the system works\n• highlight any gaps and where the system requires improvement\n• demonstrate how quickly the required information can be collated, and thereby corrective action taken, such as materials being isolated and quarantined\n• act as a training exercise for personnel to ensure that clear roles and responsibilities are undertaken in the event of a real withdrawal situation.\nThe test of the recall and withdrawal procedure must include verification of the decision- making process, traceability of raw materials through to finished product, verification of contacts, and timings of key activities.\nRecords must be kept of tests of the recall and withdrawal procedure and must include a review of the result of the test and any action taken for improvement.\nIf the site has had an actual withdrawal or recall which fully tested its recall procedures, then this would be a substitute for a recall test as long as records are maintained, an analysis of the effectiveness of the recall procedure is carried out, and any areas for improvement are identified and acted upon.\nIn larger businesses the recall team may involve head office personnel and the test may be run from the head office. In this case the links between the production site management and the head office recall team need to be clear.", "requirement_fr": "Les procédures de gestion des incidents (y compris celles de rappel et de retrait de produits) doivent être testées au moins une fois par an, de manière à garantir leur bon fonctionnement.\nLes résultats du test doivent être conservés et inclure le minutage des activités clés. Les résultats du test ou de tout rappel réel doivent être utilisés pour examiner la procédure et l'améliorer, le cas échéant."}, {"id": "3.11.4", "requirement": "In the event of a significant food safety, authenticity or legality incident, including a product recall, regulatory food safety non-conformity (e.g. a regulatory enforcement notice) or food safety-related withdrawal, the certification body issuing the current certificate for the site against this Standard shall be notified within 3 working days.", "interpretation": "Where there is a significant incident related to product safety, authenticity or legality the site manufacturing or processing the implicated product is required to notify their certification body of the situation. The types of situation that should be notified include:\n• all product recalls\n• any situation where the regulatory authority insists on action (e. g. an enforcement notice) due to product safety or legality concerns\n• legal proceedings with respect to product safety or legality\n• adverse media attention relating to product safety\n• any food safety incident with the potential to harm a consumer\n• any food safety-related product withdrawal (it is worth noting that only product safety- related withdrawals need to be notified to the certification body; other types of product withdrawal, such as those related to product quality, do not need to be notified).\nThe aim of this notification is to ensure that the integrity of the certificate is maintained by allowing the certification body to assess whether the incident affects the certification status of the site.\nIt is important that action is taken in a timely manner; therefore this initial notification, that a notifiable incident has occurred, must be completed within 3 working days of the recall or other action taking place.\nThe company must also provide sufficient information to enable the certification body to assess any effects of the incident on the ongoing validity of the current certificate.\nTherefore, as a minimum, the company must forward copies of its corrective action, root cause analysis and preventive action plan. Note that this additional information may take some time to collate and evaluate prior to communication to the certification body, especially in the case of a complex incident. Therefore, it is not expected that this will be available at the time of the initial notification, but may be submitted to the certification body at a later date. It must, however, be submitted within 21 days of the incident.\nWhere appropriate, the certification body can request further information or conduct a full or partial re-audit of the site to confirm certification.\n4 Site standards\n4. 1 External standards and site security The production site shall be of suitable size, location and construction, and be maintained to reduce the risk of contamination and facilitate the production of safe and legal finished products.\nThis part of the Standard is one of the most straightforward. It requires that the manufacturing facility is fit for purpose, both externally and internally, and that operations are conducted in an orderly fashion so as not to jeopardise the safety, legality or quality of the product.\nThis section also includes the security systems that must be in place to control access to both external and internal areas of the site, buildings and product, including the records of all visitors to the site.", "requirement_fr": "Dans le cas d’un incident significatif en termes de sécurité, d’authenticité ou de légalité des denrées alimentaires, tel qu’un rappel de produit ou une non-conformité réglementaire (c-à-d. un avis d’application réglementaire) ou un retrait lié à la sécurité alimentaire, l’organisme de certification émetteur du certificat actuel pour le site dans le cadre de cette Norme, doit en être informé dans un délai de 3 jours ouvrables.\nL'entreprise doit ensuite fournir des informations suffisantes pour permettre à l'organisme de certification d'évaluer les répercussions éventuelles de l'incident sur la validité du certificat en cours dans un délai de 21 jours calendaires. Au minimum, ces informations doivent inclure des actions correctives, une analyse des causes fondamentales et un plan d'action préventif.\n4 Normes des sites 4.1 Normes extérieures et sécurité des sites La taille, l'emplacement et la construction du site de production doivent être adaptés. Ce dernier doit être entretenu pour réduire tout risque de contamination et faciliter la fabrication de produits finis sûrs et légaux."}], "statement_of_intent": "The company’s processes and procedures to meet the requirements of this Standard shall be documented to allow effective, consistent application, facilitate training, and support due diligence in the production of a safe product.", "group_intros": {"3.2": "The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.", "3.7": "The site shall be able to demonstrate that it uses the information from identified issues in the food safety and quality management system (e.g. non-conforming products, internal audits, complaints, product recalls, product testing, second- and third-party audits and online reviews) to complete necessary corrective actions and prevent recurrence.", "3.9": "The site shall be able to trace all raw material product lots (including primary packaging) from its suppliers through all stages of processing and dispatch to its customers and vice versa.", "3.5.4": "Outsourced processing (also referred to as ‘subcontracted processing’) is defined as where intermediate production, processing, storage or any intermediate step in the manufacture of a product is completed at another company or another site.\nIt should be noted that outsourced processing refers to an intermediate step – therefore during outsourced processing the product or partly processed product leaves the site being audited for the completion of the outsourced processing, before returning to the site. The audited site may or may not complete additional packing or processing steps on the product.\nWhere there is additional storage or processing of raw materials prior to their initial arrival on site, this is not considered outsourced processing, but should be managed by the site using supplier approval, raw material risk assessments and raw material specifications.\nWhere a product leaves the site and does not return to it, this is not outsourced processing, and the activities completed off site are outside the scope of the audit.\nWhere any intermediate process step (including production, processing or storage) in the manufacture of a product is outsourced to a third party or undertaken at another site, and subsequently returned to the site, this shall be managed to ensure it does not compromise the product safety, authenticity, legality or quality.", "3.5.1": "The company shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials (including primary packaging) to the safety, authenticity, legality and quality of the final product are understood and managed.", "3.3": "The site shall maintain genuine records to demonstrate the effective control of product safety, legality and quality.", "3.8": "The site shall ensure that any out-of-specification product is effectively managed to prevent unauthorised release.", "3.4": "The company shall be able to demonstrate that it verifies the effective application of the food safety plan, and the implementation of the requirements of the Global Standard Food Safety and the site’s food safety and quality management system.", "3.5.3": "The company shall be able to demonstrate that where services are outsourced, the service is appropriate and any risks presented to food safety, authenticity, legality and quality have been evaluated to ensure effective controls are in place.", "3.6": "Specifications shall exist for raw materials (including primary packaging), finished products and any product or service which could affect the integrity of the finished product.", "3.10": "Customer complaints shall be handled effectively and information used to reduce recurring complaint levels.", "3.1": "The company’s processes and procedures to meet the requirements of this Standard shall be documented to allow effective, consistent application, facilitate training, and support due diligence in the production of a safe product.", "3.11": "The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of products should this be required.", "3.5.2": "Controls on the acceptance of raw materials (including primary packaging) shall ensure that these do not compromise the safety, legality or quality of products and, where appropriate, any claims of authenticity."}, "group_intro_interps": {"3.5.1": "All materials brought onto the site to become part of the final product must be sourced through approved suppliers and monitored. This approval process and programme for monitoring raw materials will consider the potential risk the material represents (in terms of safety, authenticity, legality and quality). Primary packaging materials are also included in this requirement. Packaging is vital to product integrity in the packing environment, and during storage and distribution within the supply chain. Primary packaging is defined in the Standard as: ‘The packaging that constitutes the unit of sale to the consumer or customer (e.g. bottle, closure, label and tamper- evident seal of a retail pack or a raw material bulk container).’ (A full explanation is available in the glossary.) The supplier approval system must consist of an initial approval process and an ongoing monitoring process. The risk assessment process should help to focus increased attention on the raw materials or suppliers that present a greater risk.", "3.5.2": "Verification procedures need to be in place to demonstrate that materials (including ingredients and primary packaging) from approved suppliers meet agreed specifications and do not compromise the safety, legality, quality or authenticity of products.", "3.5.3": "Supplier approval must include the suppliers of services that could potentially affect product safety, authenticity, legality or quality; for example, the use of agencies to provide temporary staff, laundries, maintenance of equipment (e.g. refrigeration units), waste removal or transport.", "3.5.4": "This section applies to products that are included within the scope of a site’s certification but which have a process step that is outsourced to another company or site. This includes products or intermediates that are partially processed at another location (even a site within the same organisation or group) before being returned to the site. This typically happens when there is a need for specialist equipment (e.g. agglomeration of powders or freeze drying); alternatively the product may be sent to a region with a lower-cost economy for a very labour-intensive part of the process. The scope of the report and any certificate will only reflect the activities undertaken at the site where the audit was undertaken. Therefore, packing of products by third parties (e.g. contract packing) and products that are entirely manufactured at a separate site (i.e. where co-manufacturing occurs), rather than just part of the manufacturing process being outsourced, are not covered by these requirements, since in both of these situations, the individual sites may be separately certificated and traceability coding should be able to identify at which site the product was manufactured. For example, consider a simple manufacturing process, as shown in Figure 12."}, "group_intros_fr": {"3.6": "Des spécifications doivent exister pour les matières premières (emballage primaire compris), les produits finis et tout produit ou service qui peut avoir un impact sur l'intégrité du produit fini.", "3.8": "Le site doit s'assurer que tout produit non conforme sera pris en compte efficacement afin qu'il ne soit pas libéré sans autorisation.", "3.11": "L'entreprise doit mettre en place un programme et un système pour gérer efficacement les incidents et permettre le retrait et le rappel des produits, le cas échéant.", "3.5.4": "Le traitement externalisé (ou « transformation sous-traitée ») désigne la prise en charge de la production, du traitement, du stockage ou de tout processus de production intermédiaire d’un produit par une autre entreprise ou un autre site.\nIl convient de noter que le traitement externalisé est une étape intermédiaire. Ainsi, pendant le traitement externalisé, le produit ou le produit partiellement transformé quitte le site à auditer pour subir son traitement externalisé, avant de retourner sur le site. Le site audité peut ou non effectuer des opérations supplémentaires d'emballage ou de traitement du produit.\nLorsque les matières premières sont stockées ou transformées avant leur arrivée initiale sur le site, cela ne constitue pas un traitement externalisé, mais doit être géré par le site à l’aide du système d’approbation des fournisseurs, de l'évaluation des risques relatifs aux matières premières et des spécifications des matières premières.\nLorsqu'un produit quitte le site et n'y revient pas, il ne s'agit pas d'un traitement externalisé, et les activités réalisées hors site n'entrent pas dans la portée de l'audit.\nLorsqu'une étape intermédiaire du processus (y compris la production, la transformation ou le stockage) de fabrication d'un produit est externalisée auprès d’un tiers ou effectuée sur un autre site, avant d’être renvoyée ensuite vers le site, elle doit être considérée de manière à garantir qu'elle ne compromet pas la sécurité sanitaire, l’authenticité, la légalité ou la qualité du produit.", "3.3": "Le site doit conserver de véritables enregistrements pour démontrer l'existence d'un contrôle efficace de la sécurité sanitaire, légalité et qualité des produits.", "3.4": "L'entreprise doit pouvoir démontrer qu'elle vérifie l'application réelle du plan de sécurité des denrées alimentaires et la mise en place des exigences de la Norme Mondiale de Sécurité des Denrées Alimentaires, ainsi que le système de gestion de la sécurité et de la qualité des denrées alimentaires du site.", "3.2": "L'entreprise doit disposer d'un système de contrôle de documents efficace pour garantir que seules les versions correctes, y compris les formulaires de consignation, sont disponibles et en service.", "3.5.2": "Les contrôles relatifs à la réception des matières premières (emballage primaire compris), doivent garantir que ces dernières ne compromettent pas la sécurité sanitaire, la légalité ou la qualité des produits et, le cas échéant, toute allégation d'authenticité.", "3.10": "Les réclamations des clients doivent être gérées efficacement, et les informations doivent être utilisées pour réduire les niveaux de récurrence des réclamations.", "3.9": "Le site doit être en mesure de tracer tous les lots de matières premières (emballage primaire compris) depuis ses fournisseurs en passant par toutes les étapes de transformation et d'expédition aux clients et inversement.", "3.5.3": "L'entreprise doit être en mesure de démontrer que, lorsque des services sont externalisés, le service est adapté et que tout risque touchant à la sécurité, à l’authenticité, à la légalité et à la qualité des denrées alimentaires a été évalué afin de garantir la mise en place de contrôles efficaces.", "3.1": "Les processus et procédures de l'entreprise ayant pour objectif le respect des exigences de cette Norme doivent être documentés pour garantir leur application efficace et cohérente, faciliter la formation et contribuer au contrôle préalable de la fabrication d'un produit sûr.", "3.7": "Le site doit être en mesure de démontrer qu’il utilise les informations issues des problèmes identifiés dans le système de gestion de la sécurité et de la qualité des denrées alimentaires (c-à-d. les produits non conformes, les audits internes, les réclamations, les rappels de produits, les tests de produits, les audits par une seconde ou tierce partie et les examens en ligne) pour prendre les mesures correctives nécessaires et en éviter la récurrence.", "3.5.1": "L'entreprise doit avoir un système efficace d'approbation et de contrôle des fournisseurs. Il permet de garantir que tous les risques potentiels provenant des matières premières (y compris les emballages primaires) et affectant la sécurité sanitaire, l'authenticité, la légalité et la qualité du produit fini sont compris et gérés."}}, {"section": 4, "title": "Site standards", "clauses": [{"id": "4.1.1", "requirement": "Consideration shall be given to local activities and the site environment, which may have an adverse impact on finished product integrity, and measures shall be taken to prevent contamination.", "interpretation": "Local activities and the site environment must not have an adverse impact on finished product integrity. (A site plan or map that indicates neighbouring activities may be useful.) Points to consider may include:\n• derelict buildings, rubbish dumps, wasteland, etc. which could harbour pests\n• adjacent watercourses at risk of flooding\n• neighbouring companies and the nature of their business (e. g. presenting air or odour taint potential).\nAppropriate measures, such as additional pest or flood control, must be put in place and reviewed to ensure they are continually effective (e. g. by inclusion in internal audit schedules).", "requirement_fr": "L'attention doit être portée sur les activités locales et l'environnement du site, ceux-ci pouvant avoir un impact négatif sur l'intégrité du produit fini, et des mesures doivent être prises pour éviter la contamination. Lorsque des mesures ont été adoptées pour protéger le site (de polluants potentiels, d’inondations, etc.), elles doivent être révisées en réponse à tout changement."}, {"id": "4.1.2", "requirement": "The external areas shall be maintained in good order. Where grassed or planted areas are located near buildings, they shall be regularly tended and well maintained. External traffic routes under site control shall be suitably surfaced and maintained in good repair.", "interpretation": "External areas must be maintained in good order and the condition of the site included in audit procedures. Overgrown areas can harbour pests; therefore, where areas are planted, they must be tended regularly. For example, good practice is to have a 0. 5 m clear zone between the bottom of vegetation and external walls.\nDrainage in external areas is expected to deal with normal quantities of rainfall without long-term pooling of water. If natural drainage is inadequate, external drainage must be installed.\nTo prevent potential contamination by dust, mud etc. , all traffic routes under the control of the company must be suitably surfaced and maintained in good order. It is recognised that traffic routes may have a variety of surfaces, and contamination risk to products will be influenced by other factors, such as weather conditions. The principle is to ensure that products are not placed at additional risk of contamination through the inappropriate surfacing of routes where products are transferred. Risk may also be reduced by a combination of procedures, such as the suitable protection of products while in transit, or wash-down of transit vessels prior to entering production areas.", "requirement_fr": "Les zones extérieures doivent être maintenues en bon état. Lorsque les bâtiments sont entourés de pelouses ou de plantations, celles-ci doivent être entretenues régulièrement. Les voies de circulation extérieures sous le contrôle du site doivent avoir un revêtement adéquat et être en bon état pour atténuer le risque de contamination du produit."}, {"id": "4.1.3", "requirement": "The building fabric shall be maintained to minimise potential for product contamination (e.g. elimination of bird-roosting sites, sealing gaps around pipes to prevent pest entry, ingress of water and other contaminants).", "interpretation": "The outsides of buildings must be monitored and maintained in a condition such that they do not present a risk of product contamination. For example, pipework must be appropriately sealed to prevent pest entry, bird nesting sites must be eliminated (e. g. by using appropriate netting), and ingress of water and other contaminants must be prevented.", "requirement_fr": "L'enveloppe du bâtiment doit être entretenue pour minimiser les risques de contamination du produit (c-à-d. éliminer les sites de nidification des oiseaux, étanchéifier les trous autour des conduits pour éviter l'entrée de nuisibles, d'eau et d'autres contaminants)."}, {"id": "4.1.4", "requirement": "Policies and systems shall be in place to ensure that access to the site by staff, contractors and visitors is controlled. A visitor recording system shall be in place. • Contractors and visitors, including drivers, shall be made aware of the procedures for access to the site. • Only authorised personnel shall have access to production and storage areas. • Staff shall be trained in site security procedures", "interpretation": "There must be a visitor-reporting or monitoring procedure. When visitors or contractors come on site, they should not be able to enter production areas without first reporting to site representatives, who will:\n• make them aware of site rules; for example, relating to access\n• issue them with any protective clothing necessary for the areas they are visiting.\nGood practice is to include details of the name, company, date, time of entry and exit, as well as the purpose of the visit.\nOnly authorised personnel should have access to production and storage areas. Therefore, these areas should have designated access points, which should be directly monitored or locked with, for example, keys issued to nominated personnel, key-code locks or alarmed.\nContractors or visitors working in these areas must be the responsibility of a nominated member of staff. It is normally good practice for them to be accompanied by the nominated staff while in production and storage areas.\nAll staff must be trained in the company security procedures and form part of the security arrangements. They should be encouraged to make enquiries on or report unknown persons in the facility. They must not compromise their personal safety; suspicious activities should always be referred to security staff (where they are available).\n4. 2 Food defence Systems shall protect products, premises and brands from malicious actions while under the control of the site.\nThe objective is to ensure that the safety of finished products is not jeopardised through malicious actions, tampering or unauthorised persons.\nThe following clauses mirror those concerning food fraud (section 5. 4), so the site can choose to consider food defence and food fraud together, if that is a more effective use of time and resource, or separately if the company prefers, providing both food authenticity and food defence are robustly assessed and managed.\nGood practice, especially in larger companies, is to use a multi-disciplinary team that includes different roles within the company; for example, quality assurance, technical management, production, security and human resources.\nIn smaller companies this may not be possible, but consideration should be given to the inclusion of all relevant colleagues or expertise.\nIn companies with multiple sites, some or all of the food defence threat assessment may be developed in one of two ways:\n• centrally; for example, by a head office; or\n• locally at each individual office.\nWhere it is completed centrally it is important to ensure that the assessment and resultant food defence plan remain relevant to the specific sites and their activities. This may be achieved by, for example:\n• including members from the relevant sites in the food defence team\n• ensuring that the study is reviewed by senior members of staff located at the relevant sites\n• including the assessment and plan in the scope of the internal audit programme.\nThe BRCGS auditor will look for evidence of checks against local site activities and sign-off of the completeness and accuracy of the study.\nBRCGS will publish additional guidance on food defence, which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Des politiques et des systèmes doivent être mis en place pour garantir le contrôle de l'accès au site par le personnel, les sous-traitants et les visiteurś. Un système de consignation des visites doit être en place.\nLes sous-traitants et les visiteurs, chauffeurs compris, doivent être informés de toutes les procédures relatives à l'accès au site.\nSeul le personnel autorisé doit avoir accès aux zones de production et de stockage. Les sous- traitants qui travaillent dans les zones de transformation ou de stockage des produits doivent être placés sous la responsabilité d'une personne désignée.\nLe personnel doit être formé aux procédures de sécurité du site.\n4.2 Protection de la chaîne alimentaire contre les actes malveillants Des systèmes doivent protéger les produits, les locaux et les marques placés sous le contrôle du site contre les actes malveillants."}, {"id": "4.2.1", "requirement": "Where personnel are engaged in threat assessments and food defence plans, the individual or team responsible shall understand potential food defence risks at the site.", "interpretation": "It is important that personnel completing food defence threat assessments are competent to develop the plan; they need to understand the risks they are trying to prevent. Therefore, it is expected that within the team there will be knowledge of the principles of food defence and the site.\nThe Standard is not prescriptive regarding how this knowledge is demonstrated and may include, for example:\n• training (e. g. a training course in food defence)\n• experience (e. g. demonstrable knowledge of the site such as security-related duties, or length of service at the site)\n• other competency (e. g. the completeness and effectiveness of the threat assessment and its implementation).\nWhere there is a legal requirement for specific training, for example, in the US FSMA, the site is expected to be able to demonstrate that this has been appropriately completed.\nIn the event of the site not having the appropriate in-house knowledge, external expertise (e. g. food safety consultants) may be used; however, reference should be made to clause", "requirement_fr": "Lorsque des membres du personnel sont impliqués dans les plans d’évaluation des menaces et protection de la chaîne alimentaire contre les actes malveillants, la personne ou l'équipe responsable doit comprendre les risques potentiels liés à la protection de la chaîne alimentaire contre les actes malveillants sur le site. Cela inclut notamment connaître à la fois le site et les principes de protection de la chaîne alimentaire contre les actes malveillants.\nLorsqu'il existe une obligation légale de formation spécifique, celle-ci doit être mise en place."}, {"id": "4.2.2", "requirement": "The company shall undertake a documented risk assessment (threat assessment) of the potential risks to products from any deliberate attempt to inflict contamination or damage. The output shall be a documented food defence plan. • a new risk emerges. • an incident occurs where product security or food defence is implicated", "interpretation": "The company must undertake a threat assessment of the risks inherent to the operation to prevent malicious intervention. The threat assessment needs to consider both external threats (e. g. individuals or organisations gaining unauthorised access to the site, building or products) and internal threats, such as malicious tampering by staff who are authorised to be on site.\nEach area (e. g. warehouses, processing areas and external storage areas) needs to be assessed in terms of how vulnerable the product is to contamination. Sensitive or restricted areas, such as open product areas, are likely to be the most vulnerable; the vulnerability of the packaged product will depend on the nature of the packaging. Details of IT systems and data protection should also be included in the assessment.\nThe output of the threat assessment must be a food defence plan, which details:\n• the identified risks\n• the mitigation strategy; i. e. the steps or mechanisms used to avoid or mitigate the identified risks (see clauses 4. 2.3 and 4. 2.4).\nThe food defence plan must be reviewed periodically; for example:\n• when there is a change to the site or buildings\n• when new market intelligence or supply chain information indicates a new or changed threat\n• following an incident where product security or food defence systems are implicated.\nThis may include all forms of incident, as well as any customer complaints indicating that current food defence measures are not effective\n• at least annually.\nRecords of the review need to be available for the audit.\nWhere there are legal requirements relating to food defence (e. g. in the US FSMA), the site must be able to demonstrate that its food defence plan meets these requirements.", "requirement_fr": "L'entreprise doit entreprendre une évaluation des risques documentée (évaluation des menaces) des risques potentiels affectant les produits et provenant de tentatives délibérées de causer une contamination ou des dommages. Cette évaluation des menaces doit inclure les menaces à la fois intérieures et extérieures.\nLes conclusions de cette évaluation doivent être documentées dans un plan de protection de la chaîne alimentaire contre les actes malveillants. Ce plan doit être révisé pour refléter les circonstances changeantes et les informations du marché. Il fait l'objet d'un examen formel au moins une fois par an et chaque fois que :\n•\t un nouveau risque survient (c-à-d. une nouvelle menace est médiatisée ou identifiée)\n•\t un incident relatif à la sécurité des produits ou à la protection de la chaîne alimentaire contre les actes malveillants se produit.\nLe cas échéant, le plan de protection de la chaîne alimentaire contre les actes malveillants doit répondre aux exigences légales du pays où le produit sera commercialisé ou utilisé."}, {"id": "4.2.3", "requirement": "Where raw materials or products are identified as being at particular risk, the food defence plan shall include controls to mitigate these risks.", "interpretation": "The site’s food defence plan may result in the need to take additional measures to mitigate risks to raw materials or product. This may include extra verification or testing when raw materials are delivered, or additional wrapping with tamper evidence on pallets. Whatever the measure, it should be appropriate and validated to ensure that it is effective.\nThe auditor will expect to see the documented plan (clause 4. 2.2) and the methodology of determining which products, materials or areas require additional control. The additional measures and procedures should be documented and the auditor will expect to see these measures in action at the time of the audit.\nIdeally the controls used should prevent the threat from occurring; however, where this is not possible, the controls should mitigate risk and use tamper evidence so that malicious activity can be seen and addressed in a timely manner, before it becomes a product safety issue.\nThe systems must be reviewed at least annually, including the controls identified in the plan, to check whether they are still effective and relevant.", "requirement_fr": "Lorsque des matières premières ou des produits sont identifiés comme étant particulièrement à risque, le plan de protection de la chaîne alimentaire contre les actes malveillants doit inclure des contrôles destinés à atténuer ces risques. Lorsqu’il n’est pas suffisant ou qu’il est impossible de prévenir ces risques, des systèmes doivent être en place pour identifier toute adultération.\nCes contrôles doivent être surveillés et leurs résultats documentés, et ils doivent être revus au minimum une fois par an."}, {"id": "4.2.4", "requirement": "Areas where a significant risk is identified shall be defined in the food defence plan, monitored and controlled. These shall include external storage and intake points.", "interpretation": "The basic principle is that only authorised staff should have access to production and storage areas. Levels of access for various areas at the site may differ between employees.\nRestriction of access to areas where sensitive materials are stored (e. g. laboratories, maintenance areas or document storage areas) should also be in place. Where appropriate, areas should be locked when not in use.\nAll staff must be trained in the company food defence procedures. This is not the same as the training described in clause 4. 2.1. There, the staff involved in the threat assessment and development of the site’s food defence plan must have knowledge of the principles of food defence and the site, whereas this clause requires all staff to be trained in the relevant food defence procedures; i. e. in the relevant site procedures that have been developed as a result of the food defence threat assessment.\nWhere a site wishes to combine this training with the security training described in clause 4. 1.4, this is acceptable providing both topics are sufficiently covered.\n4. 3 Layout, product flow and segregation Fundamental The factory layout, flow of processes and movement of personnel shall be sufficient to prevent the risk of product contamination and to comply with relevant legislation.\nThe physical layout and flow of processes, materials and personnel must be identified, designed, managed and maintained to protect product integrity and prevent contamination, whether physical, chemical or microbiological.", "requirement_fr": "Les zones dans lesquelles un risque important est identifié doivent être définies dans le plan de protection de la chaîne alimentaire contre les actes malveillants, surveillées et contrôlées.\nCelles-ci doivent inclure les zones de stockage extérieures et les points d’entrée des produits et matières premières (emballage compris).\nLe personnel doit être formé aux procédures de protection de la chaîne alimentaire contre les actes malveillants.\n4.3 Agencement, flux et séparation des produits Fondamental L'agencement de l'usine, le flux des processus et les déplacements du personnel doivent être adéquats pour éviter un risque de contamination du produit et pour être en conformité avec la législation applicable."}, {"id": "4.3.1", "requirement": "The site shall assess the production risk zones required for the products manufactured, processed or packed at the site, using the definitions in Appendix 2 of the Standard.", "interpretation": "All sites need to ensure that the production facilities are suitable for the types of products they are manufacturing, processing or packing. This includes an assessment of the production risk zones needed for the prevention of microbiological contamination.\nFull details of the definitions of the production risk zones recognised by the Standard are given in Appendix 2 of the Standard. However, in summary, the Standard recognises six zones:\n• high-risk and high-care zones for chilled or frozen and ready-to-eat products where there is a risk of contamination\n• ambient high care for products where there is a risk of contamination with vegetative micro-organisms originating from raw materials and the products are stored in ambient conditions (rather than chilled or frozen)\n• low-risk areas\n• enclosed product areas (e. g. storage areas where products are fully enclosed within packaging and production areas where the product is fully enclosed within the equipment or pipework)\n• non-product areas (i. e. areas such as offices, where products are not taken at any stage in their manufacture or storage).\nIt is important to note that the high-risk, high-care and ambient high-care production zones usually only apply to part of a factory’s production processes. These zones typically start when products exit a microbiological kill step and include all the processes and steps until the products are enclosed in packaging.\nThe auditor will expect to see a documented assessment comparing the products manufactured, processed or packed on site with the definitions within Appendix 2 of the Standard.\nWhere a site identifies the need for a high-risk, high-care or ambient high-care production zone, the relevant clauses from section 8 will apply to those areas.", "requirement_fr": "Le site doit évaluer les zones de production à risque requises pour les produits fabriqués, transformés ou emballés sur le site, en s'appuyant sur les définitions de l'Annexe 2 de la Norme."}, {"id": "4.3.2", "requirement": "There shall be a map of the site. At a minimum, this map shall define: • production risk zones. • access points for personnel. • access points for raw materials, semi-finished products and open products. • routes of movement for personnel. • routes of movement for raw materials. • routes for the removal of waste. • routes for the movement of rework. • location of any staff facilities. • production process flows. • any areas where time segregation is used", "interpretation": "The aim of the site map is to provide an overview of all the locations within the site, areas where the product is at different levels of risk from the general environment and the movements of products, materials and people. It can then be used to support the site’s risk assessments and subsequent prevention of contamination; for example, by identifying the locations where potential hazards (e. g. allergen cross-contamination) can occur.\nThe site map will be expected to illustrate the locations of critical facilities and activities, as detailed in the requirement, including:\n• production risk zones (e. g. high-risk areas, high-care areas, low-risk areas, and enclosed product areas; see clause 4. 3.1). The object of identifying the production risk zones is to ensure that the standards of environmental hygiene, particularly those concerning equipment, buildings, cleaning and personnel hygiene, are appropriate for the work being undertaken. It also allows the product and personnel flows to be reviewed, to ensure they do not compromise product safety\n• access points for personnel clearly showing the routes into, and out of the site and production areas\n• access points for raw materials, semi-finished products and open products\n• routes of movement for personnel. If it is necessary to allow access through production areas, good practice is to identify designated walkways that ensure there is adequate separation from materials. Wherever possible, all facilities should be designed and positioned so that the movement of personnel is by simple, logical routes\n• routes of movement for raw materials\n• routes of movement for the removal of waste\n• routes of movement for rework\n• the location of staff facilities, including changing rooms, toilets, canteens and smoking areas\n• areas where time segregation is used; in other words, where the same production area is used as both a high-care and a low-risk production zone at different times, with time segregation being used to separate the products with different risks (see Appendix 1 for definitions).\nSites which have identified the need for high-risk, high-care or ambient high-care areas (see clause 4. 3.1) will also need to include the location of the pathogen control step(s) on the map (see clause 8. 1.1).\nThe Standard is not prescriptive on the format of the map, providing all of the relevant information is available. For example:\n• It is often useful to put the required information on several overlapping maps rather than a single diagram.\n• In complex sites a schematic diagram may be of greater benefit than a map.", "requirement_fr": "Un plan du site doit être présent. Au minimum, ce plan doit indiquer :\n•\t les zones de production à risque, où les produits sont exposés à différents niveaux de risque de contamination par des agents pathogènes - par exemple, les zones à haut risque, de grande précaution, pour les produits à température ambiante, à faible risque et les zones de produits closes (voir clause 4.3.1 et Annexe 2)\n•\t les points d'accès du personnel\n•\t les points d’accès des matières premières (emballage compris), des produits semi-finis et des produits nus\n•\t les zones de transit du personnel\n•\t les zones de transit des matières premières (emballage compris)\n•\t les trajets pour le retrait des déchets\n•\t les zones de transit des produits recyclés\n•\t l'emplacement des installations réservées au personnel, y compris les vestiaires, les toilettes, les cantines et les zones fumeurs\n•\t le flux du processus de production\n•\t toute zone où la ségrégation temporelle est utilisée pour réaliser différentes activités (par exemple, pour les zones de grande précaution)."}, {"id": "4.3.3", "requirement": "Contractors and visitors, including drivers, shall be made aware of the requirements of the areas they are visiting, with special reference to hazards and potential product contamination.", "interpretation": "Contractors and visitors (including drivers) must be made aware of all access restrictions and procedures related to them. Visitors should be told when they sign in and the information should be specific to the areas they will be visiting.\nContractors who visit regularly should be trained to a similar level as employees, and a record of the training retained.", "requirement_fr": "Les sous-traitants et les visiteurs, chauffeurs compris, doivent être informés des exigences requises dans les zones visitées. L'accent doit être mis sur les dangers et les contaminations potentielles de produit."}, {"id": "4.3.4", "requirement": "The movement of personnel, raw materials, packaging, rework and/or waste shall not compromise the safety of products.", "interpretation": "The HACCP or food safety plan must identify the potential risks associated with all production risk zones and the appropriate controls (including the level of prerequisite programmes) for the safe production of the products.\nA combination of process flow and procedures (e. g. the prerequisite programme and work instructions) will be used to minimise risk to raw materials, packaging and products.\nParticular attention needs to be paid to the movement of personnel, raw materials, packaging, rework and waste, to ensure that the routes taken are defined and product safety is not compromised. For example, the removal of unnecessary packaging, such as debagging or removing outer boxes, should take place in a designated area, usually prior to transfer to production areas, in order to avoid potential foreign-body risks from discarded packaging.\nThe procedures developed to ensure product safety must be documented and validated as effective, and the appropriate staff must be trained. For example, where sites are receiving packaging through ‘hole in the wall’ operations, suitable controls should be in place to ensure that there is no risk to the product and the materials are treated appropriately. For example, an adjacent factory might deliver packaging materials on a conveyor or belt, as is often the case in dairy packing and carbonated beverages.", "requirement_fr": "Les déplacements de personnel, matières premières, emballages, produits recyclés et/ ou déchets ne doivent pas compromettre la sécurité des denrées alimentaires. Le flux de processus, ainsi que l'utilisation de procédures ayant fait leurs preuves, doivent être en place de façon à minimiser le risque de contamination des matières premières, des produits intermédiaires/semi-finis, des emballages et des produits finis."}, {"id": "4.3.5", "requirement": "Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe hygienic conditions.", "interpretation": "Premises must be designed to allow sufficient working space and storage capacity so that all operations are carried out properly under safe, hygienic conditions, thereby reducing the potential for cross-contamination between activities because of close proximity. For example, overfull refrigerated storage may lead to doors being left open for extended lengths of time because of difficulties in accessing required materials. This would lead to a non-conformity.\nConsideration should be given to all activities, including inspection, cleaning, pest control and maintenance, as well as manufacturing operations.", "requirement_fr": "Les locaux doivent contenir suffisamment d'espaces de travail et de capacité de stockage pour permettre à toutes les opérations d'être effectuées correctement dans des conditions d'hygiène sûres."}, {"id": "4.3.6", "requirement": "Temporary structures constructed during building work or refurbishment etc. shall be designed and located to avoid pest harbourage and ensure the safety and quality of products.", "interpretation": "Temporary structures (e. g. those constructed during building work or refurbishment) must be designed and located to avoid pest harbourage, unsanitary conditions and potential contamination of products. For example, where walls have to be knocked through during installation or expansion work, the integrity of the unit must be preserved to avoid pest entry, and scaffolding used in open product areas must be of the appropriate hygienic standard.\nRisk assessment of temporary activities or structures should be completed prior to their introduction.\n4. 4 Building fabric, raw material-handling, preparation, processing, packing and storage areas The fabrication of the site, buildings and facilities shall be suitable for the intended purpose.\nThe design, construction and maintenance of the interior of the facility must support effective cleaning and protect products from contamination.\nThe type of finish to walls, floors and ceilings must, at a minimum, meet the requirements laid down in any applicable legislation for the industry, and be suitable for the intended purpose.\nWhere a site has different production risk zones (see clause 4. 3.1), good practice is to consider whether there are different facility requirements for each zone.", "requirement_fr": "Des structures temporaires construites lors de travaux ou de rénovations, etc. doivent être conçues et situées de manière à éviter l'installation de nuisibles et de garantir la sécurité sanitaire et la qualité des produits.\n4.4 Enveloppe du bâtiment, zones de manipulation des matières premières, préparation, transformation, emballage et stockage La structure du site, des bâtiments et des installations doit être adaptée à l'usage prévu."}, {"id": "4.4.1", "requirement": "Walls shall be finished and maintained to prevent the accumulation of dirt, minimise condensation and mould growth, and facilitate cleaning.", "interpretation": "This clause refers to the condition of the internal surfaces of the walls (other aspects of the wall’s condition are covered separately in clause 4. 1.3).\nThe walls in areas handling raw materials and preparing, processing, packing or storing product must be kept in a sound condition and must be easy to clean and, where necessary, to disinfect. For example, walls must have a smooth, impervious finish with sealed surfaces, be in a good state of repair and be free from flaking paint.\nTiling of walls is best avoided but, if present, must be in good condition, with no cracks or loose tiles. Ledges (e. g. from ducting or piping) should be kept to a minimum or designed to facilitate cleaning (e. g. with a slope to avoid dust collection).\nVulnerable wall surfaces or corners (e. g. where vehicles pass in close proximity) should be protected from damage (e. g. with properly sealed metal plating or barriers). Junctions (including ‘wall to floor’, ‘wall to ceiling’ and ‘wall to wall’) should be maintained in good condition to facilitate cleaning (e. g. by being appropriately sealed).", "requirement_fr": "La finition des murs et leur maintenance doivent prévenir l'accumulation de saletés, minimiser la condensation et le développement de moisissures, et faciliter le nettoyage."}, {"id": "4.4.2", "requirement": "Floors shall be suitably hard-wearing, impervious, maintained in good repair and facilitate cleaning.", "interpretation": "The floors in areas handling raw materials and preparing, processing, packing or storing product must be kept in a sound condition and be easy to clean and, where necessary, to disinfect. Floors must be constructed of materials that are impervious, hard-wearing, repairable and resistant to chemical attack so that they can withstand appropriate cleaning procedures.", "requirement_fr": "Les sols doivent être suffisamment résistants pour répondre aux demandes du processus, et résister aux méthodes et aux matériaux d'entretien. Ils doivent être imperméables, maintenus dans de bonnes conditions et faciliter le nettoyage."}, {"id": "4.4.3", "requirement": "Drainage shall be sited, designed and maintained to minimise risk of product contamination. Machinery and piping shall be arranged so that process waste water goes directly to drain where feasible.", "interpretation": "Drainage must be designed and maintained to ensure that product contamination risks are minimised. For example, drainage design might include methods to prevent flow back and pest ingress, and routeing of waste systems to prevent dripping on products, packaging or ingredients.\nDue consideration must be given to drainage from any internal laboratories or other hazardous operations undertaken on site to ensure that blockages or the presence of micro- organisms could not result in the contamination of processing areas.\nDrainage systems must not constitute a potential risk to product (e. g. from potential leakage) when passing through or over production areas. Where feasible, the design of equipment must ensure that process waste water (e. g. condensate drainage from refrigeration or temperature-controlled areas, or sink waste water) goes directly to a drain to minimise contamination risk.\nWhere significant amounts of water are used (e. g. where wet cleaning is carried out) and direct piping to a drain is not possible, floors must have adequate falls to cope with the flow of effluent (i. e. pooling of water should not occur) as this constitutes a splash hazard and, therefore, a contamination risk.\nNote that the additional requirements for drainage in high-risk and high-care areas are covered in section 8. 2.", "requirement_fr": "Les canalisations, le cas échéant, doivent être situées, conçues et entretenues pour minimiser le risque de contamination du produit et ne pas compromettre sa sécurité sanitaire. Les machines et les tuyauteries doivent être aménagées de manière à ce que les eaux usées issues du processus soient, dans la mesure du possible, directement évacuées dans les canalisations. Lorsque de grandes quantités d'eau sont utilisées ou que le drainage direct vers les canalisations n'est pas possible, les sols doivent être munis de dénivellations adéquates permettant l'évacuation du flux d'eau ou d'effluents vers les canalisations adaptées."}, {"id": "4.4.4", "requirement": "Ceilings and overheads shall be constructed, finished and maintained to prevent the risk of product contamination.", "interpretation": "Ceilings and overheads in areas handling raw materials and preparing, processing, packing or storing product must be appropriately designed and kept in a sound condition to avoid the risk of contamination to product. Prevention of the accumulation of dirt, minimising condensation and mould growth, and facilitating cleaning should all be considered.\nIn rooms with high ceilings that are difficult to clean or maintain, line covers over open product could reduce the risk of contamination.", "requirement_fr": "Les plafonds et structures en hauteur doivent être construits, revêtus et entretenus de manière à prévenir le risque de contamination du produit."}, {"id": "4.4.5", "requirement": "Where suspended ceilings or roof voids are present, adequate access to the void shall be provided to facilitate inspection for pest activity, unless the void is fully sealed.", "interpretation": "Where suspended ceilings are used (or roof voids are present), access must be available for pest control purposes, even if this roof void is not normally used, unless it can be demonstrated that the void is entirely sealed.\nRefrigeration equipment is often located in the roof void, and access will be required for maintenance.", "requirement_fr": "En cas de présence de faux plafonds ou combles, un accès adapté aux combles doit être prévu pour permettre l'inspection de toute activité de nuisibles, sauf si les combles sont complètement hermétiques."}, {"id": "4.4.6", "requirement": "Where elevated walkways, access steps or mezzanine floors are adjacent to or pass over production lines which have open products, they shall be designed to prevent contamination, easy to clean and correctly maintained.", "interpretation": "Mezzanine floors, access steps and suspended or elevated walkways (for example, in production areas or over production lines) should be safeguarded to ensure they do not present a contamination risk to products below. This is particularly necessary where open products or open raw materials are handled and any contamination could have an immediate impact on the product (e. g. walkways over a production line where open products are processed).\nTheir design could include features such as solid treads (rather than perforated material), back plates and enclosed sides to prevent items from falling into the production area below, for example, from footwear.\nThe cleaning methods for these floors, steps and walkways should not allow waste materials or cleaning materials (e. g. wash water) to fall onto equipment or the production line below;\nfor example, by using minimal amounts of water to reduce the likelihood of splashing or dripping onto materials below.\nSites should include any elevated walkways, access steps and mezzanine floors in the procedures concerning installation and maintenance activities with the express intention of ensuring that they (and their use) do not pose a hazard to the product both:\n• when initially designed and installed, and\n• during use (e. g. due to erosion or ‘wear and tear’).\nFor example, by including the mezzanine floor, access steps or elevated walkway in the programme of documented inspections of the factory environment (see clause 3. 4.4), the site should be able to facilitate prompt corrective action in the event of any problems.", "requirement_fr": "Lorsque des passerelles surélevées, des marches d'accès ou des mezzanines contournent ou surplombent des lignes de production de produits nus, elles doivent être :\n•\t conçues pour éviter la contamination des produits et des chaînes de production\n•\t faciles à nettoyer\n•\t correctement entretenues."}, {"id": "4.4.7", "requirement": "Where there is a risk to product, windows and roof glazing which are designed to be opened for ventilation purposes shall be adequately screened to prevent the ingress of pests.", "interpretation": "Where there is a risk to product, such as in production or storage areas, windows and roof glazing that are designed to be opened for ventilation purposes must be adequately screened to prevent ingress of hazards such as pests or dust (e. g. by the use of mesh of an appropriate size to cover the windows).", "requirement_fr": "Lorsqu'il existe un risque pour le produit, les fenêtres et les verrières de toit conçues pour être ouvertes dans un but d'aération, doivent être adéquatement grillagées pour empêcher l'entrée de nuisibles."}, {"id": "4.4.8", "requirement": "Doors (both internal and external) shall be maintained in good condition. External doors and dock levellers shall be close fitting or adequately proofed.", "interpretation": "Doors and doorway equipment must be maintained in good condition, be easy to clean and kept clean, and provide an adequate level of pest proofing for the site. They should re- establish continuous contact with the floor when lowered.\nDoors through which vehicles (such as forklift trucks) travel should be inspected and door frames should be fitted with close-fitting metal plates for protection. External doors to open product areas where activities such as raw-material handling, preparation, processing and packing occur must not be opened during production, except in emergencies.\nWhere external doors to enclosed product areas are opened, suitable precautions must be taken to prevent pest ingress (e. g. strip curtains – see clause 4. 4.11 for further details).\nSites should be aware that the doors themselves can be a source of physical contamination, particularly where they are designed to rise from floor contact to above the product as it is carried through (e. g. the potential for drip and therefore contamination of product as it passes through the doorway). It is not necessary to remove such doors, but sites should assess whether it is necessary to carry out mitigating steps, such as covering the product before it goes through the doorway.\nMechanical and electronic doors should be included in any planned or condition-based maintenance programmes (i. e. they should be maintained and repaired in a timely fashion).", "requirement_fr": "Les portes (intérieures et extérieures) doivent être maintenues en bon état. Au minimum :\n•\t les portes extérieures et les niveleurs de quai doivent être bien ajustés ou suffisamment hermétiques\n•\t les portes extérieures donnant sur des zones de produits nus ne doivent pas être ouvertes lors des périodes de production, sauf en cas d'urgence\n•\t lorsque des portes extérieures donnant sur des zones de produits clos sont ouvertes, des précautions adaptées doivent être prises pour empêcher l'entrée de nuisibles."}, {"id": "4.4.9", "requirement": "Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of product and effective cleaning.", "interpretation": "Adequate lighting must be provided to allow:\n• staff to be able to monitor quality and defects\n• the correct operation of processes\n• effective cleaning\n• a safe working environment.\nNote that some countries have specific legislation relating to minimal standards of lighting within the workplace. The site will need to be aware of these legislative requirements if it is located in a relevant country or region.\nIn the absence of specific legislation, industry guidelines state that preparation, processing and packing areas should generally be illuminated to a minimum intensity of 200 lux, with inspection areas requiring higher illumination such as 500 or 750 lux. All areas need to be considered; for example, poor lighting in storage areas may hinder effective cleaning or inspection.", "requirement_fr": "Un éclairage adapté et suffisant doit être fourni pour permettre un fonctionnement correct des processus, une inspection des produits et un nettoyage efficace."}, {"id": "4.4.10", "requirement": "Adequate ventilation and extraction shall be provided in product storage and processing environments to prevent condensation or excessive dust.", "interpretation": "Adequate ventilation and extraction must be provided, particularly in areas where very dusty operations are carried out (e. g. in dry-ingredient handling areas) or where there is potential for condensation build-up (e. g. in cooking areas).\nWhere air socks are used, the need for them to be cleaned and maintained should be considered. The frequency of this cleaning should be based on risk.", "requirement_fr": "Une aération et une extraction adaptées doivent être en place dans les zones de stockage et de transformation des produits pour empêcher la condensation ou la poussière excessive."}, {"id": "4.4.11", "requirement": "Where plastic strip curtains are present, these shall be maintained in good condition, clean, fitted correctly, and shall not pose a food safety risk.", "interpretation": "Strip curtains are a common way of providing protection from hazards, or to facilitate environmental controls; for example, to:\n• prevent ingress of pests or dirt (e. g. where there are external doors into production or storage areas)\n• help regulate temperature, air pressure or air flow\n• provide a hygiene barrier (i. e. preventing activities in one area from posing a risk to products or materials in neighbouring areas).\nWhere strip curtains are used, they must be controlled to ensure they achieve the intended purpose and do not pose a food safety risk. For example, they must be:\n• well fitting (usually defined as ‘as close to the floor as possible’, with no missing strips or gaps)\n• repaired or replaced in a timely manner when damage does occur (while slight scratches are unlikely to pose a food safety risk and therefore may not require immediate action, missing strips or gaps caused by damage may allow pest ingress or contamination and will require timely action)\n• in use whenever relevant site activities are occurring, and not tied back when they should be operational\n• kept clean (to ensure they are not a source of product or raw material contamination; for example, to prevent microbiological, physical, chemical or allergen contamination). Ideally, strip curtains will be designed to be easy to clean.\nGood practice is to include strip curtains in the inspection and maintenance programmes (see clauses 3. 4.4 and 4. 7.1) to facilitate timely identification of any concerns and the timely implementation of corrective action.\n4. 5 Utilities – water, ice, air and other gases Utilities used within the production and storage areas shall be monitored to effectively control the risk of product contamination.\nThe utilities included within this requirement are specifically water, steam, ice, air and other gases that need to be controlled to ensure they do not constitute a contamination risk to product. Other commonly considered utilities, such as electricity, natural gas or fuel, are not included within these requirements.", "requirement_fr": "Lorsque des rideaux à lanières en plastique sont présents, ces derniers doivent être conservés en bon état, être propres et correctement installés (c-à-d. pour empêcher l’entrée de nuisibles ou pour réguler la température), et ne doivent pas présenter de risque pour la sécurité des denrées alimentaires.\n4.5 Fluides techniques – eau, glace, air et autres gaz Les fluides techniques utilisés dans les zones de production et de stockage doivent être surveillés pour contrôler efficacement le risque de contamination du produit."}, {"id": "4.5.1", "requirement": "All water used as a raw material, in preparation, hand-washing or cleaning shall be potable at point of use. The microbiological and chemical quality of water shall be analysed at least annually.", "interpretation": "Water used must be provided in sufficient quantities (e. g. for cleaning operations), pose no contamination risk (e. g. be potable), be fit for the intended purpose and conform to relevant legislation by being suitably treated or drawn from mains supply. Where required by legislation, private water supplies and treatment plants should be approved by local or national authorities.\nThe frequency of water analysis must be based on risk, including:\n• legislative requirements for testing\n• historical information\n• the source of the water (e. g. mains supply or bore-hole)\n• specific site concerns (e. g. duration of water storage or the use of lead pipes)\n• treatments given to the water\n• its usage.\nThe water is expected to comply with national legislation (e. g. EU directive 98/83/EC and its subsequent amendments) or, in the absence of this, with World Health Organization (WHO) standards for drinking water. The scope of testing completed by the site should be based on risk; for example:\n• if the site has lead pipes, then tests should include the presence and concentration of lead\n• if historical or published information indicates that the supply in the region has high levels of nitrate, then tests should incorporate this information.\nWater quality tests must be completed at least annually and be based on a risk assessment.\nIf the water is supplied by a water supply company, a chemical analysis from the water company will suffice for the chemical requirements, unless there are other risks identified in the delivery system (e. g. lead pipes). Alternatively, testing should be carried out at the site to ensure that the water is tested and approved at the point of use. Where water is extracted from bore-holes and/or sites have on-site treatment facilities, additional checks will be required to ensure that the water is not contaminated either at the bore-hole or during treatment and that the treatment remains effective. The water should be sampled at appropriate points of use and this should be documented in a sampling plan (see clause 4. 5.2).\nWhere water is stored and handled on site (e. g. in storage or holding tanks), the site must assess any additional controls or testing needed to maintain food safety; for example, any limitation on the maximum storage time, operational controls to prevent microbiological contamination, or any monitoring of the condition of the tanks themselves (e. g. to ensure corrosion cannot become a source of product contamination).\nWhere ice or steam is used in production or is in contact with food, it must be produced from potable water or pose no risk of contamination according to applicable legislation, and must be included within the sampling plan. Where legislation specifically allows the use of non-potable water (e. g. in the washing of raw fish or livestock), the water must meet all legislative requirements for that process. The site will also need to have established through the HACCP process that the water does not present a risk to the final products (e. g. by introduction of chemical contaminants) or to other products within the processing environment.", "requirement_fr": "Toute eau utilisée (glace et vapeur comprises) comme matière première dans la fabrication d'aliments transformés, la préparation de produits, le nettoyage des mains ou celui des équipements ou de l'usine, doit être fournie en quantité suffisante, être potable au point d'utilisation, être adaptée à l'usage prévu et ne poser aucun risque de contamination, conformément à la législation en vigueur.\nLorsque l'eau est stockée et manipulée sur le site (c-à-d. dans des réservoirs ou citernes de stockage), elle doit être gérée de manière à minimiser les risques relatifs à la sécurité des denrées alimentaires.\nLa qualité microbiologique et chimique de l'eau doit être analysée comme la loi l’exige ou au moins une fois par an. Les points d'échantillonnage, la portée du test et la fréquence des analyses doivent être fondés sur les risques, en tenant compte de l'origine de l'eau, du stockage sur site et des installations de distribution, des résultats des échantillonnages précédents et de l'utilisation."}, {"id": "4.5.2", "requirement": "An up-to-date schematic diagram shall be available of the water distribution system on site.", "interpretation": "The aim of this requirement is to identify the key components of the water distribution system and how the components interconnect, particularly where potable and non- potable water are present. A fully detailed architect’s diagram showing the complete pipework system is not required; a general plan, map or schematic diagram is sufficient.\nThe plan should enable the site management and auditor to assess potential hazards in the distribution system and ensure that adequate management systems are in place to negate the hazards. For example, water-holding tanks may present a microbiological hazard if not covered; water pooling may occur if the water flow is not controlled; and where water is recycled (e. g. for can cooling), the water may need to be treated and sometimes filtered to ensure a satisfactory water quality.\nThe source of the water shall be included in the diagram (e. g. a bore-hole, an on-site reservoir or the mains supply), along with any on-site water-treatment processes. The best water sampling points to assess the quality of water should be deduced from this plan.", "requirement_fr": "Un diagramme schématique actualisé du système de distribution de l'eau sur site doit être disponible. Il doit inclure l’origine de l’eau, les citernes de stockage, le traitement de l'eau et le recyclage de l'eau, le cas échéant. Le diagramme doit servir de base à l'échantillonnage de l'eau et à la gestion de la qualité de l'eau."}, {"id": "4.5.3", "requirement": "Air and other gases used as an ingredient or that are in direct contact with products shall be monitored to ensure this does not represent a contamination risk.", "interpretation": "Compressed air, steam or gases used as an ingredient or directly in contact with food must be monitored to ensure they do not contaminate the product. The main risks to consider are: the carry-over of boiler water-treatment chemicals in steam; dust particles in compressed air; and oil used as a lubricant in compressed-air systems.\nThe level of monitoring needs to be based on an assessment of potential risk. Steam generated from potable water free from additives, for instance, is not likely to present a risk.\nCompressed air in direct contact with products needs to be filtered prior to use, and the filters checked and maintained to ensure they remain effective. The gauge of filtration (e. g. mesh size) and frequency of checks should be documented and based on risk assessment, taking into account the source of the air, the type of compressors used and the condition of the pipework (e. g. evidence of corrosion). The compressor suppliers or experts should be consulted to establish any potential risks and any necessary testing. The objective of using filters is to prevent dust particles and lubricating oil from the compression system contaminating the products. Therefore a single central filter, in close proximity to the compressor, but remote from the food-related use of the compressed air, is unlikely to provide sufficient product protection. The site must be able to justify the effectiveness of the filtration system employed.\nIf gases are used, such as in modified atmosphere packing, they must be demonstrated as being of an appropriate quality. Usually such gases are supplied in a compressed form in metal cylinders and the supplier management process (approved suppliers and specifications, with certificates of conformance if required) would be sufficient. In these circumstances, the site would not be expected to undertake its own checks. Compressed gases are generally considered to be microbiologically safe and the Standard does not require routine testing of such gases unless a specific risk has been identified.\nThere may be additional risks where gases are produced on site and these would need to be evaluated through a risk assessment. Additional information can be obtained from the British Compressed Air Society and the European Industrial Gases Association.\n4. 6 Equipment All production and product-handling equipment shall be suitable for the intended purpose and shall be used to minimise the risk of contamination of product.\n‘Suitability of equipment for its intended purpose’ includes the condition of the equipment, so that it does not pose a product contamination hazard; its ability to be effectively cleaned; and its capability of producing safe food products.\nThe site will need to consider the requirements:\n• when purchasing new equipment or equipment that is new to the site (for example, second-hand or reconditioned equipment)\n• when hiring equipment for a designated period\n• where equipment is stored (storage conditions must ensure the safety and integrity of the equipment so that it cannot become a source of contamination; for example, equipment should be stored clean and in such a way that it does not harbour pests)\n• when designing equipment that will be built by the company, e. g. by on-site engineers.\nMovable equipment needs to be controlled to ensure that it cannot be a source of product contamination; for example, by restricting its use to designated areas, or using documented procedures to prevent contamination when moving it between areas.\nRisk assessments and resultant controls must be proportionate to the likely risk to the product; for example, the equipment’s proximity to product (e. g. use in production areas or open product areas), its significance to the production process, and its complexity (for example, a new production line or part of a production line will need significantly more consideration than a small item such as a plastic scoop).\nThere are a number of clauses within the Standard that may need to be considered in conjunction with this section;\nfor example:\n• Equipment maintenance and condition monitoring is covered in section 4. 7.\n• New equipment that includes measuring devices should be calibrated according to the requirements in section\n6. 4.\n• Risks associated with new products or new production processes are covered in section 5. 1; this will include the equipment associated with these new products and production processes.\nThere are a number of standards and industry guidelines that provide detailed recommendations for equipment; for example:\n• EN 1672-2:2009 – Food Processing Machinery – Basic Concepts – Hygiene and Cleanability Requirements\n• ISO 14159:2002 – Safety of Machinery — Hygiene Requirements for the Design of Machinery\n• GFSI Benchmark JI (for building and equipment manufacturers) and JII (for building and equipment users).\nSites will need to ensure any applicable legislative requirements (for example, in the EU, the Machinery Directive 2006/42/EC) are met.", "requirement_fr": "L’air et les autres gaz, utilisés directement, en contact avec les produits ou en tant qu'ingrédients, doivent être contrôlés pour s'assurer qu'ils ne présentent aucun risque de contamination. L'air comprimé utilisé en contact direct avec un produit doit être filtré au point d’utilisation.\n4.6 Équipements Tout équipement de production et de manipulation alimentaire doit être adapté à l'usage prévu et utilisé de manière à minimiser le risque de contamination du produit."}, {"id": "4.6.1", "requirement": "There shall be a documented purchase specification for any new equipment detailing the site requirements for the equipment. • any relevant legislation. • where applicable, requirements for food contact surfaces. • details of intended use", "interpretation": "The process for the purchase of new equipment must start prior to the actual purchase of the equipment, with an equipment purchase specification (sometimes referred to as user requirements). The aim of the clause is not to introduce onerous documentation for all equipment, but to ensure that new equipment meets the site’s needs; for example, it is suitable for its intended use and is designed to eliminate or manage any identified food safety hazards.\nFor the purposes of the Standard, new equipment can be defined as equipment bought directly from a manufacturer, second-hand equipment bought by the site (therefore new to the site) or equipment that has been refurbished externally. It does not include small parts such as screws or other non-food contact fixings.\nPurchase specifications need to contain sufficient information to ensure product safety and suitability of the equipment. This means that the actual amount of detail in the purchase specification will be dependent on the type of equipment being purchased. For example, a simple plastic scoop is only likely to need a very simple set of user requirements, with minimal food hazards identified, whereas a new production line is likely to require significantly more details regarding, for example, product types, production rates and food contact requirements.\nPurchase specifications usually include:\n• reference to any relevant legislation\n• requirements for food contact surfaces (i. e. where product will be in contact with the equipment)\n• intended use of the equipment\n• types of materials that will be used (this is particularly important for food contact surfaces, since potential migration from equipment may be affected by the composition of the food material, e. g. high fat or acidic materials can increase potential for migration).\nGood practice is to consider who within the company can authorise the purchase of new equipment. For re-purchases of simple equipment, this may be simply a case of identifying who is authorised to order the product; however, for complex machinery (such as a new production line), there may need to be input from multiple departments, such as engineering, technical, hygiene and finance. This is to ensure that all critical food safety requirements have been considered and included within the specification.\nNote that where equipment is purchased from suppliers in other regions or countries, legislative requirements may vary, and additional communication of requirements may facilitate the purchasing process.\nThe site should retain evidence of the specification developed, and evidence provided from the supplier demonstrating that the equipment meets these requirements, as this provides evidence of due diligence in the event of a challenge or incident.\nDuring the BRCGS audit, the auditor will expect to see evidence of the purchase specification for any new equipment, the specification’s suitability for the specific equipment, equipment purchase matching the specification, and, as detailed in clauses\n4. 6.2–4. 6.7, commissioning of equipment, hygiene requirements, routine maintenance, etc.\nNote that the clause relates to the purchase of new equipment. It does not require a site to retrospectively develop specifications for equipment that was purchased prior to the publication of the Standard, or prior to its decision to become certificated for the first time.", "requirement_fr": "Il doit exister une fiche d'achat documentée pour tout nouvel équipement, détaillant les exigences du site pour cet équipement. Cela peut être, par exemple :\n•\t toute législation pertinente\n•\t le cas échéant, les exigences relatives aux surfaces en contact avec les aliments, afin de satisfaire aux exigences légales\n•\t une description détaillée de l'utilisation prévue de l'équipement et le type de matériaux qu'il manipulera.\nSelon l'usage auquel il est destiné, un nouvel équipement arrivant sur le site (y compris un équipement d'occasion) peut nécessiter l'autorisation d'une équipe pluridisciplinaire.\nLe fournisseur doit apporter la preuve que l'équipement répond aux exigences du site avant de le livrer."}, {"id": "4.6.2", "requirement": "The design and construction of equipment shall be based on risk, to prevent product contamination. Equipment in direct contact with food shall be suitable for food contact.", "interpretation": "The aim of this requirement is to ensure that equipment is not a source of product contamination, and that it complies with relevant food contact legislation where such legislation exists (for example, in the EU, the Food Contact Materials – Regulation (EC) 1935/2004 and its subsequent amendments).\nThe clause provides some examples of potential issues, including:\n• Food contact surfaces should be smooth and impervious; for example, to prevent accumulation of material that could lead to microbiological or allergen contamination of the product.\n• Welds and joints should form a flat surface (again to prevent microbiological or allergen contamination).\nOther well-documented issues have included the purchase of equipment (especially plastic items) not designed for food use leading to the migration of chemicals into food products.\nThe company must consider the risks associated with the equipment (including any risks associated with its design, construction and installation) and ensure that significant risks have been controlled. This can, for example, be achieved by use of a hygienic design risk assessment, which uses hygienic design principles to consider the risks of foreign-body, microbiological, allergen or chemical contamination of the product.\nBefore using the equipment, the company will need to have evidence that the risks have been considered, and of the suitability of the equipment, and must confirm its acceptability for food contact surfaces. For new equipment, this will usually form part of the purchase specification process (see clause 4. 6.1). Where such evidence is not available (for example, when purchasing second-hand equipment) and the contact material is not a recognised food-safe material (such as certain grades of stainless steel), an additional assessment should be carried out to ensure safe use and to prevent food safety risks. The risk assessment should consider factors such as:\n• the nature of the food contact surface and its known characteristics\n• the length of contact time with the food\n• the nature of the food and its potential for contamination (e. g. fatty or acidic foods are often at increased risk from migration of contaminants from plastic materials).\nDuring the BRCGS audit, the auditor will not inspect every seal, bolt or food contact surface, but will:\n• need to understand the site processes; for example, they may review the documented process and their suitability, whether they have been used in practice, and the completeness of relevant records\n• inspect a small number of relevant examples of equipment where there is a food safety or quality implication; this may, for example, be completed during the inspection of equipment hygiene (see clause 4. 11. 1).", "requirement_fr": "La conception et la construction de l'équipement doivent être fondées sur l'évaluation des risques, afin d’éviter la contamination des produits. Par exemple, une bonne étanchéité, des surfaces imperméables ou des soudures et des joints lisses en contact avec les produits, qui pourraient entraîner une contamination par un corps étranger, des des microorganismes, ou des allergènes.\nLes équipements en contact direct avec des aliments doivent être conçus pour être en contact avec les aliments et être conformes aux exigences légales, le cas échéant."}, {"id": "4.6.3", "requirement": "A documented, risk-based commissioning procedure shall be in place for new equipment. Installation work shall be followed by a documented hygiene clearance procedure.", "interpretation": "The aim of this clause is to ensure there is a formal process for the introduction of equipment that is new to the site (see the interpretation for the statement of intent for this section), which ensures that product safety and integrity is maintained, when the equipment is introduced into and used within the production and storage areas.\nThe hazards associated with any specific item of equipment will vary considerably dependent on the nature of the equipment and its intended use. Using the previous example, a new plastic scoop is likely to require minimal commissioning, whereas a completely new production line is likely to require an extensive commissioning process.\nTherefore the commissioning procedure should be risk-based, allowing the site the flexibility to complete the appropriate activities for the specific equipment. Examples of commissioning activity might include installation and sign-off of equipment, trials operating the equipment, cleaning validation and maintenance checks.\nIn order to facilitate routine cleaning, operation, inspection and servicing, equipment must be appropriately positioned (e. g. access provided under, inside and around it). Where equipment is permanently sited, it should be properly secured and sealed to the floor to prevent the accumulation of food debris underneath, where it cannot be cleaned. It has been well documented that, where equipment or fixtures allow organic matter and/or pathogens to collect and survive, this can subsequently cause product contamination as pathogens such as Salmonella or Listeria can survive for prolonged periods in these conditions if left undisturbed.\nThe site must ensure that the safety and integrity of product is not jeopardised during installation (e. g. equipment is not contaminated either by products used during installation such as sealants, nuts and bolts; by lubricants; or by packaging that has been removed from the equipment). Good practice is to schedule installation of larger or more complex equipment outside production hours. Where this is not practicable, suitable precautions must be taken to prevent contamination of products; for example, the use of screening to protect adjacent production lines.\nFollowing installation, equipment must be cleaned and inspected prior to use. An authorised member of staff (e. g. the production manager) is required to formally accept equipment into operation following this inspection, to confirm that all relevant installation, commissioning and cleaning activities have been completed satisfactorily. Records need to be maintained (e. g. signing the appropriate engineering record or line start-up check sheet) to demonstrate that the equipment has been inspected and is acceptable for use.\nThe commissioning procedure must include the updating of any other relevant site procedures that are affected by the new equipment; for example, training, operating procedures, cleaning, environmental monitoring, maintenance schedules or internal audits.\nThis is to ensure that all staff have access to the relevant procedures and understand how to complete their activities correctly.\nNote that the auditor will not stop equipment operating or the production flow in order to inspect equipment.", "requirement_fr": "Une procédure de mise en service documentée et basée sur les risques doit être en place pour garantir le maintien de la sécurité sanitaire et de l'intégrité des denrées alimentaires pendant l'installation de nouveaux équipements sur le site.\nLes travaux d’installation doivent être suivis d'une procédure de contrôle hygiénique documentée.\nTout nouvel équipement introduit sur le site doit être inspecté par un membre du personnel autorisé avant sa mise en service.\nLa procédure de mise en service doit inclure la mise à jour des autres procédures du site affectées par le nouvel équipement, par exemple, la formation, les procédures de fonctionnement, le nettoyage, la surveillance environnementale, les programmes de maintenance ou les audits internes.\nLa conception et l'aménagement des équipements doivent garantir leur nettoyage et leur entretien de manière efficace."}, {"id": "4.6.4", "requirement": "A procedure shall be in place to manage the movement of static equipment in production areas.", "interpretation": "Static equipment is defined as pieces of equipment that are not ordinarily moved or are moved only in exceptional circumstances; for example, due to redesign of the production area, relocation to another site or necessary maintenance that cannot be completed in situ.\nThere must be a documented procedure which covers how food safety and equipment integrity will be maintained during movement of the equipment.\nGood practice is to complete a risk assessment to determine the specific risks and controls needed.\nThe procedure may include:\n• the type of equipment to be moved\n• how the movement will occur (e. g. whether specialist equipment or contractors are required)\n• requirements for re-installation\n• authorisation (which staff are authorised to permit movement)\n• responsibility (which staff will be responsible for managing the movement)\n• staff training (e. g. on the procedure to ensure they understand the risks involved)\n• records required to demonstrate all necessary controls were completed\n• post-movement cleaning (see, for example, clause 4. 7.4).", "requirement_fr": "Une procédure doit être en place pour gérer le déplacement des équipements statiques dans les zones de production, afin de garantir que la sécurité sanitaire alimentaire et l'intégrité des équipements sont préservées."}, {"id": "4.6.5", "requirement": "Equipment that is not used or is taken out of service shall be cleaned and stored in a manner that does not pose a risk to the product.", "interpretation": "Appropriate precautions must be put in place to prevent product contamination resulting from storage of equipment; for example, dirt or dust accumulation, harbourage of micro- organisms, and potential pest activity if the equipment has not been fully cleaned before being stored.\nWhere equipment is stored within production or storage areas, it must be kept in a clean and hygienic condition (see clause 4. 11. 1). This might, for example, include:\n• a documented cleaning procedure (see clause 4. 11. 2)\n• periodic inspections, checks or condition monitoring (see clause 3. 4.4)\n• labelling to indicate that the equipment cannot be used without cleaning or sign-off\n• management through the food safety plan or HACCP (e. g. clause 5. 1.2).\nWhere equipment is intended for food contact, the equipment must be cleaned and, where necessary, disinfected prior to next use. It is good practice to inspect the equipment once out of storage to ensure it is fit for purpose.", "requirement_fr": "Les équipements qui ne sont pas utilisés ou qui sont mis hors service doivent être nettoyés et stockés de manière à ne poser aucun risque pour les produits.\nLes équipements entreposés dans les zones de production et de stockage internes doivent être gardés en parfait état de propreté.\nLes équipements en contact avec les denrées alimentaires qui ont été entreposés, mais ne sont pas utilisés quotidiennement, doivent être nettoyés et, si nécessaire, désinfectés avant usage."}, {"id": "4.6.6", "requirement": "Mobile equipment used in open product areas shall not pose a risk to the product.", "interpretation": "The aim of this requirement is to ensure that mobile equipment does not pose a risk to the product, including, for example, microbiological, allergen, chemical or foreign-body risks.\nThe site will therefore need defined procedures to ensure that any mobile equipment used in open product areas is used in such a way as to maintain product safety. This could, for example, include:\n• a log of all mobile equipment\n• approved users and training for users\n• dedicated equipment: only used in designated open product areas\n• condition monitoring, to ensure items remain suitable for use in an open product area\n• cleaning and maintenance schedules.\nWhere the use of equipment in external areas cannot be avoided, and there is a risk of product contamination, additional procedures are required to ensure this risk is minimised.\nThese may include:\n• completing a risk assessment to identify areas/products where there is a risk of product contamination (the Standard does not require cleaning and disinfection of every piece of equipment every time it is used in an external area, but that the site should identify when there will be a risk to product, and ensure that appropriate cleaning is completed to prevent this risk)\n• defining where equipment can be used\n• specific cleaning and disinfection procedures prior to re-entry into production areas where a product contamination risk exists. In addition to explaining how the cleaning will be completed, it may be useful to identify the parts of the equipment that need to be cleaned (for example, tyres, wheels and the underbody may be a greater risk than other areas of the equipment).\nNote that where a site operates multiple production risk zones (see Appendix 2 of the Standard), the additional requirements in section 8 of the Standard relating to the movement of equipment between production risk zones will also need to be considered.", "requirement_fr": "Les équipements mobiles (c-à-d. les chariots élévateurs, les transpalettes, les tables élévatrices et les échelles) utilisés dans les zones de produits nus ne doivent pas présenter de risque pour les produits.\nLorsque l'utilisation des équipements mobiles dans les zones extérieures est inévitable et présente un risque pour le produit, l'équipement doit être nettoyé et désinfecté avant de pénétrer dans les zones de production."}, {"id": "4.6.7", "requirement": "Battery-charging equipment shall not be stored in open product areas (unless fully sealed) or where there is a risk to products.", "interpretation": "Mobile equipment may require battery-charging equipment. Where required, the battery- charging equipment must not be stored or used in an open product area, unless the batteries are fully sealed and maintenance-free, to prevent the risk of chemical contamination of food products due to battery leakages or gases being emitted.\nGood practice is to identify locations where battery-charging is permitted.\n4. 7 Maintenance An effective maintenance programme shall be in operation for plant and equipment, to prevent contamination and reduce the potential for breakdowns.\nTo ensure that all equipment (including fixtures, fittings, cleaning tools and utensils), is suitably maintained and does not pose a product contamination risk (for example, due to foreign bodies created by the equipment), it must be controlled by a documented and effective maintenance system.\nPlanned maintenance may be completed internally or via contracted services. Maintenance undertaken internally must be documented (e. g. in the form of a plan or schedule) and records of the maintenance activity kept. For equipment that is maintained under external contracts, evidence of contractual agreements must be available.", "requirement_fr": "Les chargeurs de batteries ne doivent pas être stockés dans les zones de produits nus (à moins que les batteries ne soient totalement scellées et/ou ne requièrent aucun entretien) ou dans des zones présentant un risque pour les produits.\n4.7 Maitenance Un programme de maintenance efficace doit être en place pour l'usine et les équipements afin de  prévenir la contamination et réduire les risques de panne."}, {"id": "4.7.1", "requirement": "There shall be a planned preventive maintenance schedule or condition monitoring system which includes all plant, processing equipment and mobile equipment.", "interpretation": "All plant, processing equipment and mobile equipment must be included in a planned preventive maintenance schedule or condition monitoring system.\nPlanned preventive maintenance is simply a schedule of proactive maintenance or servicing designed to prevent product contamination and reduce the potential for breakdowns.\nThe identified maintenance tasks are completed at defined frequencies based on a risk assessment. This can be supported by condition monitoring where equipment is inspected at a set frequency for problems. The aim is to identify and correct any problem before product contamination or equipment breakdown occurs.\nThe frequency of preventive maintenance or condition monitoring should be based on risk assessment; for example, considering the likelihood of occurrence of a problem (e. g. previous occurrences of the problem or equipment manufacturer’s recommendations) and the likely risk of product contamination if the equipment fails (e. g. proximity to open product).\nActivities should be documented, and appropriate corrective action taken where issues are highlighted.\nMaintenance and condition monitoring requirements must be:\n• established as part of the commissioning process for new equipment\n• reviewed after repairs to equipment, to ensure that current monitoring and preventive maintenance activities remain appropriate.", "requirement_fr": "Un calendrier de maintenance préventif planifié ou un système de contrôle de l'état doivent exister, et inclure tous les équipements de transformation et équipements mobiles.\nLes exigences de maintenance doivent être définies lors des commandes de nouveaux équipements et réexaminées après toute réparation d'équipements existants."}, {"id": "4.7.2", "requirement": "In addition to any planned maintenance programme, where there is a risk of product contamination by foreign bodies arising from equipment damage, the equipment shall be inspected at predetermined intervals.", "interpretation": "Where there is a risk of foreign bodies contaminating product – for example, due to wear, erosion, loose or missing parts, or damage to equipment or pieces of machinery (e. g. sieves, mills, equipment covers) – there must be a periodic check of the equipment.\nA documented check procedure must be carried out at defined intervals (e. g. at process start-up, at start of shift, during product changeover, and after cleaning or maintenance).\nInspection results must be documented and, where appropriate, action taken.", "requirement_fr": "En plus des programmes de maintenance planifiés, lorsqu'il y a un risque de contamination du produit par des corps étrangers causé par un endommagement des équipements, ces derniers doivent être examinés à intervalles prédéterminés, les résultats doivent être documentés et toute mesure nécessaire doit être prise."}, {"id": "4.7.3", "requirement": "Where temporary repairs are made, these shall be documented and controlled to ensure that the safety or legality of products is not jeopardised.", "interpretation": "Temporary repairs must be suitable, kept to a minimum and used only in an emergency. They must be controlled (i. e. documented and notified to a shift leader) to ensure that the safety or legality of product is not jeopardised, and a system must be in place to demonstrate that a permanent repair (or replacement of the equipment) is planned within a defined timescale (e. g. a works order).\nThe Standard is not prescriptive regarding the timescales for permanent repairs, as what is practicable will vary from site to site and according to the nature of the repair and any associated product safety risks. Typically, a full permanent repair is expected as soon as a replacement piece is available, or as soon as the line can be shut down. In all cases, the expectation is that the safety and legality of the product will be maintained in the interim.\nIn an organisation with a strong food safety culture, production staff should be knowledgeable about food safety, be empowered and feel ownership of compliance with the Standard, so that they feel confident about informing the relevant individual or department when a repair or adjustment needs to be made.", "requirement_fr": "Lorsque des réparations provisoires sont effectuées, elles doivent être documentées et contrôlées pour s'assurer que la sécurité sanitaire ou la légalité des produits n’est pas menacée. Ces mesures provisoires doivent faire l'objet de réparations définitives dès que possible et dans les délais prévus."}, {"id": "4.7.4", "requirement": "The site shall ensure that the safety or legality of products is not jeopardised during maintenance and subsequent cleaning operations. Maintenance work shall be followed by a documented hygiene clearance procedure.", "interpretation": "The site must ensure that the safety and legality of product is not jeopardised during maintenance and cleaning operations. There are a number of ways that products can be contaminated during maintenance activities; for example, by:\n• products or materials used during maintenance, such as sealants, nuts and bolts that are either not used correctly or not removed from the line after maintenance (for example, spare bolts, containers of lubricant, etc. need to be removed from the area when maintenance is complete)\n• machinery parts that have broken or disintegrated and have not been adequately removed\n• maintenance tools that have not been stored in a suitably clean condition.\nGood practice is to schedule maintenance work outside production hours. Where this is not practical, suitable precautions must be taken to prevent the contamination of products;\nfor example, by removing the item to be maintained from the production area, or by using suitable screening to protect both the production line and any adjacent equipment or production lines.\nA procedure must be in place to ensure that, following maintenance work, equipment is cleaned and inspected prior to use. An authorised member of staff (e. g. the production manager) is required to formally accept equipment back into operation following this inspection to confirm that maintenance and associated cleaning have been completed satisfactorily. Records need to be maintained (e. g. by signing the appropriate engineering record or line start-up check sheet) to demonstrate that the equipment has been inspected and is acceptable for use.", "requirement_fr": "Le site doit s'assurer que la sécurité sanitaire ou la légalité des produits n’est pas menacée lors des opérations de maintenance et de nettoyage ultérieur. Les travaux de maintenance doivent être suivis d'une procédure de contrôle hygiénique documentée.\nL'équipement et les machines doivent être inspectés par un membre du personnel autorisé, afin de confirmer l'élimination des risques de contamination avant leur remise en service."}, {"id": "4.7.5", "requirement": "Materials and parts used for equipment and plant maintenance shall be of an appropriate grade or quality. Lubricating oil in direct or indirect contact with products shall be food grade.", "interpretation": "Materials used for equipment and plant maintenance that pose a risk of direct or indirect contact with raw material, intermediates or final product must be of food grade and the presence of any allergens must be known and managed accordingly. Documentary evidence of the food-grade status must be held (for example, in a declaration by the supplier, on product data sheets or by demonstrable compliance to a recognised standard such as ISO 21469 for lubricants, or the US Code of Federal Regulations, e. g. 21 CFR 178. 3570).", "requirement_fr": "Les matières et les pièces utilisées pour la maintenance des équipements et de l'usine doivent être de grade ou de qualité appropriés.\nCes matières (telles que les huiles lubrifiantes), qui présentent un risque par contact direct ou indirect avec des matières premières (emballage primaire compris), des produits intermédiaires et des produits finis, doivent être propres à la consommation et leur statut allergénique doit être connu."}, {"id": "4.7.6", "requirement": "Engineering workshops shall be kept clean and tidy.", "interpretation": "The engineering workshop must be controlled to minimise the potential for contamination of product. Consideration should be given to location and design, as well as procedures for control. For example, where it is not possible to avoid having an entrance directly from the engineering workshop to the production area, procedures must be in place to avoid contamination risks (e. g. by debris being carried inadvertently into the production or storage areas). These procedures may include changes of footwear and protective clothing, or matting specifically designed to collect any small pieces of debris from footwear (e. g. swarf mats).\nWorkshops need to be kept clean and tidy, operated in a controlled manner, and included in the housekeeping and cleaning procedures. The provision and location of hand-washing facilities for engineers entering the factory should be considered.\n4. 8 Staff facilities Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and operated to minimise the risk of product contamination. The facilities shall be maintained in good and clean condition.\nThis section focuses on staff facilities from the perspective of eliminating product contamination.\nAppropriate staff facilities must be provided to enable staff to adhere to company policies (e. g. the correct storage of protective clothing and personal belongings) to ensure the risk of product contamination is kept to a minimum.\nThis must include adequate facilities to accommodate staff fluctuations, such as high production times, seasonal variations or the use of agency staff.\nWashing, changing and toilet facilities provided for visitors and contractors must be of a standard that allows non- staff members to meet suitable levels of hygiene. Best practice is that visitors and contractors follow exactly the same changing routine as staff (e. g. change in changing areas and not in management offices).", "requirement_fr": "Les ateliers de construction doivent être propres et ordonnés, et des contrôles doivent être en place pour éviter que des détritus provenant de ces ateliers ne soient transférés dans des zones de production ou de stockage.\n4.8 Installations pour le personnel Les installations pour le personnel doivent exister en nombre suffisant pour héberger le nombre d'employés requis. Elles doivent être conçues et utilisées de manière à minimiser le risque de contamination du produit. Les installations doivent être propres et maintenues en bon état."}, {"id": "4.8.1", "requirement": "Designated changing facilities shall be provided for all personnel. These shall be sited to allow direct access to the production areas without recourse to any external area where possible.", "interpretation": "Designated changing facilities must be provided for all staff (including visitors and contractors). The location and position of facilities is an important consideration, and this must be the subject of a risk assessment to ensure the protection of protective clothing from contamination before entering the production areas.\nThe size of the facilities needs to be adequate for the number of staff working at the factory and at times of peak staff numbers (e. g. at the start and end of shifts or when there are seasonal fluctuations).\nWhere changing facilities cannot be located with direct access to the production, packing or storage areas without recourse to an external area, a risk assessment must be used to identify where additional procedures need to be implemented (e. g. providing cleaning facilities for footwear where footwear is worn outside, or the donning of additional protective clothing on entry to production areas).", "requirement_fr": "Des vestiaires désignés doivent être mis à la disposition de l'ensemble du personnel (employés, visiteurs ou prestataires de services). Ils doivent être situés de manière à permettre un accès direct aux zones de production, d'emballage ou de stockage sans avoir à passer par une zone extérieure. Si cela n'est pas possible, une évaluation des risques doit être effectuée et des procédures mises en place en conséquence (c-à-d. la mise à disposition d'installations de nettoyage des chaussures)."}, {"id": "4.8.2", "requirement": "Storage facilities of sufficient size to accommodate personal items shall be provided for all personnel.", "interpretation": "To prevent staff from bringing personal items (e. g. keys, mobile phones or coins) into production and storage areas where they could contaminate products (e. g. as foreign bodies), there must be sufficient and suitably secure storage for employees’ belongings. Storage for bulky items such as motorbike leathers and helmets should be provided, as well as for smaller items such as jewellery and food.\nStorage areas should be designed to facilitate good practice and cleaning (e. g. lockers with sloping tops to prevent the accumulation of rubbish and raised off the floor to facilitate cleaning).", "requirement_fr": "Des installations de stockage suffisamment grandes pour contenir des effets personnels doivent être fournies à l'ensemble du personnel travaillant dans les zones de manipulation des matières premières, préparation, transformation, emballage et stockage."}, {"id": "4.8.3", "requirement": "Outdoor clothing and other personal items shall be stored separately from production clothing.", "interpretation": "Separate storage facilities for personal items and work clothing are necessary to prevent cross-contamination of clothing via the locker. This can be achieved by:\n• using a locker with a divider to separate work clothing from personal clothing\n• enclosing protective clothing in a bag, such as a laundry bag, before use\n• providing a separate area for the hanging of work clothing.\nBecause of the potential for cross-contamination, clean protective clothing must be segregated from dirty protective clothing (e. g. through the provision of separate locker areas or a dedicated collection point for dirty laundry).", "requirement_fr": "Les vêtements d'extérieur et autres effets personnels doivent être conservés à l'écart des vêtements de production dans les vestiaires. Des installations doivent être disponibles pour séparer les vêtements de production propres des vêtements de production sales."}, {"id": "4.8.4", "requirement": "Suitable and sufficient hand-washing facilities shall be provided at access to, and at other appropriate points within, production areas. • advisory signs. • sufficient quantity of water at suitable temperature. • hands-free taps. • liquid/foam soap. • single-use towels or air driers", "interpretation": "Dedicated hand-washing facilities must be provided at entrances to production areas and, where appropriate, at additional points within production areas. This is to ensure that hands are physically washed, rather than just sanitised, before starting work and as necessary during the working day. In some low-risk operations, the hand-wash prior to entry to the production area may be in a changing facility or toilet rather than within the entrance to the actual production area. In some dry environments where water is avoided, gel or alcohol sanitisers may be used in the production areas in place of hand-washing facilities, although staff will still be required to wash their hands before entering the production area.\nThe hand-washing facilities must be equipped with the following:\n• hand-washing signage to prompt hand-washing at the relevant points in the process\n• appropriate instructions for use, considering the language needs of staff (e. g. including pictorial instructions). For example, good practice is to instruct staff on how to wash in a thorough and appropriate manner and for the correct length of time (usually at least seconds)\n• water in sufficient quantities and at a suitable temperature. The publication WHO Guidelines on Hand Hygiene in Health Care (recommended by Codex Alimentarius) highlights that warm water is more effective at cleaning than cooler water, with 40°C being demonstrably more effective than 20°C. It also notes that warm water is preferable to hot water because repeated exposure to hot water increases the risk of dermatitis (comfortably warm is generally considered to be about 45°C)\n• taps that have hands-free operation (e. g. knee- or foot-operated taps or those with movement sensors)\n• liquid or foam soap solution\n• suitable hygienic hand-drying facilities (either single-use hand towels or suitably designed and located hand driers; roller towels are not acceptable as they are not single use). Where single-use towels are used, suitably designed and located bins should also be provided.\nGood practice is that hand sanitiser is also provided at all hand-washing facilities. (Hand sanitiser is always required for high-risk and high-care operations – see clause 8. 4.1.) The provision and location of hand-wash basins are expected to follow industry best practice within that sector, including a risk assessment for breakage or damage. For some low-risk operations where hand-washing facilities are only provided within toilets before re-entering production, the requirements for hand-washing facilities will also apply to toilet areas.", "requirement_fr": "Des installations adéquates et suffisantes permettant le nettoyage des mains doivent être accessibles à l'entrée des zones de production et dans d'autres points clés de ces zones. Ces installations de nettoyage des mains doivent posséder au minimum :\n•\t des panneaux pour inciter au nettoyage des mains\n•\t une quantité d'eau suffisante à une température adaptée\n•\t des robinets sans contact manuel\n•\t du savon sous forme de mousse/gel\n•\t des serviettes à usage unique ou des sèche-mains conçus et situés de manière adéquate."}, {"id": "4.8.5", "requirement": "Toilets shall be adequately segregated and shall not open directly into production or packing areas. Hand-washing facilities shall be provided within toilets.", "interpretation": "Toilets must be adequately segregated from production areas and must not open directly into production or packing areas. There should be an intermediate ventilated space between the toilet cubicle and any production area to prevent foul odours from entering production areas.\nThe hand-washing facilities provided in toilets must be equipped with:\n• appropriate instructions for use, considering the language needs of staff\n• sufficient water at a suitable temperature (clause 4. 8.4)\n• soap (in any format)\n• suitable hand-drying facilities (in any format).\nWhere hand-washing facilities within toilet facilities are the only ones provided before re-entering production, the requirements of clause 4. 8.4 apply, including suitable signage to direct staff to wash their hands prior to entering production areas.", "requirement_fr": "Les toilettes doivent être correctement séparées et ne doivent pas donner directement sur les zones de production ou d'emballage. Les toilettes doivent inclure des installations de nettoyage des mains comprenant :\n•\t des lavabos avec du savon et de l'eau à une température adaptée\n•\t des installations adaptées pour le séchage des mains\n•\t des panneaux pour inciter au nettoyage des mains.\nLorsque les installations de nettoyage des mains se trouvant dans les toilettes sont les seules présentes avant d'entrer à nouveau dans la zone de production, les exigences de la clause 4.8.4 doivent être appliquées et des panneaux doivent être installés pour diriger le personnel vers les installations de nettoyage des mains avant d'entrer en zone de production."}, {"id": "4.8.6", "requirement": "Where smoking is allowed, designated controlled smoking areas shall be provided. Electronic cigarettes shall not be permitted in production or storage areas.", "interpretation": "Facilities in line with national legislation must be provided for those staff wishing to smoke.\nThese facilities must not be located within the packing or production areas where there is open food or ingredients, or where smoke could reach product or ingredients. Indoor facilities must have sufficient extraction to the exterior of the building.\nProcedures for protective clothing and hand-washing must be in place whenever staff enter or leave production and packing areas (clause 7. 4.1); therefore suitable facilities for staff to remove their protective clothing before smoking and for washing their hands afterwards must be provided. Signs must direct them to the hand-washing facilities.\nThere must be sufficient and appropriately positioned facilities for the waste generated by those persons smoking.\nWhere electronic cigarettes (e-cigs) are permitted on site, instructions for use must comply with national and local legislation. Electronic cigarettes must not be taken into storage, processing or production areas.", "requirement_fr": "Lorsque fumer est autorisé par la loi nationale, des zones fumeurs prévues à cet effet seront mises à disposition. Elles doivent être suffisamment isolées des zones de production pour garantir que la fumée ne puisse pas atteindre le produit et dotées d'une extraction suffisante vers l'extérieur du bâtiment. Des dispositions adéquates permettant la gestion des déchets des fumeurs doivent être en place dans les zones fumeurs intérieures et extérieures. L'usage ou l'introduction de cigarettes électroniques ne doit pas être autorisé dans les zones de production ou de stockage."}, {"id": "4.8.7", "requirement": "All food brought into manufacturing premises by staff shall be appropriately stored in a clean and hygienic state. No food shall be taken into storage, processing or production areas.", "interpretation": "Suitable storage facilities must be provided for food brought on site by staff, enabling it to be stored in a hygienic manner. Where refrigerators are provided for staff food, they should be kept clean, maintained and operated at an appropriate temperature. Refrigerators used for production materials and shelf-life samples must not be used for storing staff foodstuffs.\nFood (including sweets and chewing gum) must not be taken into storage, processing or production areas, as it may constitute a risk to the product. Food must be adequately controlled when stored in other areas.\nAll food and drink must be consumed in designated areas away from food-handling, production and storage areas. Where appropriate, designated outside areas can be provided for staff to eat food; where provided, these must have an appropriate control of waste.\nDrinking of water from purpose-made dispensers by using disposable conical cups or spill- proof containers may be allowed, provided it is confined to a designated area, minimising the risk to product, and suitable disposal facilities are provided.", "requirement_fr": "Tout aliment introduit dans les locaux de production par le personnel doit être convenablement conservé de manière propre et hygiénique. Aucun aliment ne doit être introduit dans les zones de stockage, de transformation ou de production. Lorsque la consommation d'aliments est permise à l'extérieur durant les pauses, elle doit avoir lieu dans des zones prévues à cet effet avec un contrôle adéquat des déchets."}, {"id": "4.8.8", "requirement": "Where catering facilities are provided, they shall be suitably controlled to prevent contamination of products.", "interpretation": "Where the company provides a canteen or other food service (including food vending services) for members of staff, the kitchens and cold-storage areas need to be suitably controlled to prevent the contamination of products (e. g. by microbiological or allergen contamination).\nIn the absence of specific legislative requirements and assessments for the control of hazards in catering facilities, a study based on HACCP principles should have been carried out on any catering facilities provided for the staff. The risks identified should be effectively controlled – in particular, those associated with staff hygiene, cleaning, cross-contamination between raw and cooked foods, and storage conditions.\nWhere hot food is prepared within a site’s facilities, additional safe food-handling may be required; for example, the WHO’s Five Keys to Safer Food Manual promoting safe food- handling highlights the need to:\n• keep clean – wash hands and keep kitchens and food preparation areas washed and sanitised\n• separate raw and cooked foodstuffs, and keep the utensils or equipment used for handling them separated\n• cook or reheat products thoroughly\n• store food at appropriate temperatures to maintain food safety; for example, using fridges and freezers, and keeping cooked food hot before serving\n• use water of an appropriate quality to ensure that it is not the source of a food safety hazard.\nThe Standard requires sites to consider whether there are risks of product contamination from catering activities and vending machines, and, where appropriate, ensure that suitable company policies are in place to manage these risks. For example, in some operations (e. g. sites manufacturing a product with an allergen-free claim), specific allergens may present a particular risk. These sites should specify any relevant company policies to confectionery vending suppliers and catering facilities.\nAt the BRCGS audit, there will be a basic inspection of the kitchen facilities. Catering facilities should be part of the site’s own internal audit or hygiene inspection programme.\n4. 9 Chemical and physical product contamination control: raw material-handling, preparation, processing, packing and storage areas Appropriate facilities and procedures shall be in place to control the risk of chemical or physical contamination of product.\nThe risk of foreign-body and chemical contamination must be minimised through the consideration of potential sources and the implementation of control procedures within the HACCP or food safety plan. Areas to consider include storage, processing, equipment, maintenance, building structures, cleaning operations and personnel.\nStaff facilities and communal areas such as entrance corridors also need to be considered to ensure that their design and the processes carried out within them do not pose a risk to products (e. g. the presence of staples or drawing pins on open noticeboards). Regular documented inspections (clause 3. 4.4) must be carried out to verify that these controls are in place.\nIt is often useful for sites to consider physical contamination controls in three tiers, as shown in Where possible, eliminate the hazard. For example:\n• remove unnecessary glass and wood\n• ban staples in raw material packaging.\nWhere necessary, use control procedures to prevent the risk. For example:\n• debagging and deboxing procedures that avoid\n• creating fragments of packaging.\nWhere the above are not possible, use materials that are easy to detect. For example:\n• metal detectable closures\n• plastic liners with contrasting colours\n• plasters that are both coloured and metal detectable.\nDetect Prevent Eliminate", "requirement_fr": "Lorsque des services de restauration (y compris des distributeurs automatiques) sont proposés dans les locaux, ils doivent être convenablement contrôlés pour éviter la contamination des produits (c-à-d. en tant que source d'intoxication alimentaire ou d'introduction d’une nouvelle substance allergénique dans le site, ou en cas d’utilisation d’ingrédients allergéniques).\n4.9 Contrôle de la contamination chimique et physique des produits : zones de manipulation des matières premières, préparation, transformation, emballage et stockage Des installations et des procédures adaptées doivent être en place pour contrôler le risque de contamination chimique ou physique des produits.\n4.9.1 Contrôle chimique"}, {"id": "4.9.1.1", "requirement": "Processes shall be in place to manage the use, storage and handling of non-food chemicals to prevent chemical contamination. These shall include, at a minimum: • an approved list of chemicals for purchase • availability of material safety data sheets and specifications • confirmation of suitability for use in a food-processing environment • avoidance of strongly scented products • the labelling and/or identification of containers of chemicals at all times • a designated storage area (separate from chemicals used as raw materials in products) with access restricted to authorised personnel • use by trained personnel only • procedures to manage any spills • procedures for the safe, legal disposal or return of obsolete or out-of-date chemicals and empty chemical containers.", "interpretation": "Non-food chemicals present a potential product contamination or taint risk if they are not stored and handled correctly. The site needs to demonstrate controls for non-food chemicals, including the following: • an approved list of chemicals for purchase – this is to prevent inappropriate chemicals from being purchased. This applies to all cleaning chemicals, pesticides and other chemicals which may be used in the production environment • material safety data sheets and specifications provided by the supplier. These should be up to date and accurate for the chemicals currently used by the site • confirmation that the chemicals are suitable for use in a food-processing area (i.e. they are non-tainting and not highly toxic). For example, cleaning chemicals must be selected to avoid the risk of product tainting (chemicals such as phenolics and those that are strongly scented are not suitable) • avoidance of strong-scented products • identification of chemicals (e.g. labelling of all containers) at all times, to minimise the potential for inadvertent use • designated storage with restricted access limited to authorised personnel. Potentially harmful chemicals (e.g. sodium hypochlorite) must be suitably stored to prevent inadvertent product contamination. Sites should ensure that safe-use/storage instructions from the manufacturer are implemented (e.g. store acid and alkaline materials away from each other and store powders above liquids to prevent subsequent reaction in the event of spillage. Good practice also includes supplying cleaning chemicals to production areas ready diluted (for use with verified auto-dosing systems) and to ensure that stocks of cleaning chemicals not required for the current production or cleaning activity are stored away from the production area • ensuring that chemicals that are food raw materials are stored separately from non-food chemicals, to prevent potential contamination from non-food materials into the food raw materials • use of chemicals by trained personnel only, as evidenced by training records • application of procedures to manage any spills, to ensure they do not pose a risk to product safety; for example, good practice is to provide bunded areas around appropriate chemical and oil tanks and ensure that relevant staff are trained in the spillage procedures. Procedures must be in place for the safe, legal disposal of obsolete or out-of-date chemicals and empty chemical containers, to ensure chemical waste is disposed of in the correct manner (for example, by disposing of chemicals and containers in accordance with legislative requirements, using licensed waste disposal contractors, and by returning them to the manufacturer). Procedures must cover unused chemicals (i.e. those that are no longer required) and empty containers. Chemicals that are likely to come into direct contact with foods when used as intended (e.g. materials such as oils or lubricants used on machinery), as well as terminal sanitisers that are designed to be used without rinsing with water, should be confirmed as suitable for food use. (This would not include general detergents and cleaning materials, as these should not come into direct contact with food.) Consideration may need to be given to the legislative requirements of specific countries, states or territories. For example, legislation may require that materials do not contain toxic or prohibited substances, that lubricants are suitable for food use or that terminal sanitisers meet applicable standards (e.g. the Biocidal Products Regulation (EU) No. 528/2012).", "requirement_fr": "Des processus doivent être en place pour gérer l'utilisation, le stockage et la manipulation de produits chimiques non alimentaires afin de prévenir tout risque de contamination chimique.\nCes programmes doivent inclure, au minimum :\n•\t une liste approuvée des produits chimiques à l'achat\n•\t la disponibilité de fiches techniques et de spécifications concernant la sécurité sanitaire des matières\n•\t la confirmation d'une utilisation adaptée à un espace de transformation alimentaire\n•\t la prévention de l'utilisation des produits fortement parfumés\n•\t l'étiquetage et/ou l'identification des conteneurs de produits chimiques à tout moment\n•\t une zone de stockage spécifique (à l'écart des produits chimiques utilisés en tant que matières premières dans les produits) avec un accès limité au personnel autorisé\n•\t une utilisation uniquement réservée au personnel habilité\n•\t des procédures de gestion des déversements éventuels\n•\t des procédures pour l’élimination ou le recyclage sûr et légal des produits chimiques obsolètes ou périmés, et des conteneurs de produits chimiques vides."}, {"id": "4.9.1.2", "requirement": "Where strongly scented or taint-forming materials have to be used, for instance for building work, procedures shall be in place to prevent the risk of taint contamination of products.", "interpretation": "Wherever possible, strongly scented or taint-forming materials must not be used. However, where these are necessary (e.g. for some building work), procedures must be in place to avoid the risk of taint contamination of products. For example, relevant information must be requested from contractors, detailing the chemicals to be used and the controls (such as the extraction of fumes) that will need to be in place. A risk assessment of the information should be completed prior to commencement of the work.", "requirement_fr": "Lorsque des substances présentant un grand risque d'altération de l'odeur ou du goût doivent être utilisées, lors de travaux de construction par exemple, des procédures doivent être en place pour prévenir le risque de contamination des produits par ces substances.\n4.9.2 Contrôle des métaux"}, {"id": "4.9.2.1", "requirement": "There shall be a documented policy for the controlled use and storage of sharp metal implements including knives, cutting blades on equipment, needles and wires. This shall include a record of inspection for damage and the investigation of any lost items. Snap-off blade knives shall not be used.", "interpretation": "Where sharp metals such as knives, needles or cheese wires are used, there must be a documented policy. This will outline: • the controls in place • inspection and breakage/loss reporting procedures • storage when not in use • other controls, such as the numbering of knives or the use of issue and return logs. The company should aim to ensure that shards of missing metal are located and that the source of any loose metal is identified. Snap-off blades (i.e. where the old segment of blade can be snapped off to reveal a new sharp edge) are a source of potential metal contamination and are not permitted in any area of production or storage. Other metal items, such as non-production blades, engineering tools and equipment, must be stored away from production areas to minimise their potential for contaminating product. For example, spanners used for adjusting machinery should not be left out, but should have a designated place for storage, such as a locked toolbox fixed to a wall.", "requirement_fr": "Une politique documentée doit être en place pour permettre l'utilisation et le stockage contrôlés d'instruments métalliques tranchants comme les couteaux, les lames coupantes sur des équipements, les aiguilles et les câbles. Cette politique doit inclure la consignation des inspections relatives aux dommages et les recherches menées en cas d'élément perdu. Les cutters ne doivent pas être utilisés."}, {"id": "4.9.2.2", "requirement": "The purchase of ingredients and packaging which use staples or other foreign-body hazards as part of the packaging materials shall be avoided. Staples, paper clips and drawing pins shall not be used in open product areas. Where staples or other items are present as packaging materials or closures, appropriate precautions shall be taken to minimise the risk of product contamination.", "interpretation": "Staples are often used in packaging. However, their use needs to be considered, since they are a potential source of contamination and the purchase of ingredients or packaging materials containing them must be avoided. Where ingredients with potential foreign bodies cannot be avoided, there need to be controls to manage these hazards. Staples, paper clips and drawing pins (i.e. thumb tacks or pin tacks) or other metal closures must not be used in open product areas.", "requirement_fr": "L'achat d'ingrédients et d'emballages où des agrafes ou des corps étrangers dangereux font partie des matériaux d'emballage doit être évité.\nLes agrafes, trombones et punaises ne doivent pas être utilisés dans les zones de produits nus.\nLorsque des agrafes ou d'autres éléments sont présents dans les matériaux d’emballage ou dans les systèmes de fermeture d'emballage, des précautions adéquates doivent être prises pour minimiser le risque de contamination du produit.\n4.9.3 Verre, plastiques cassants, céramique et matériaux similaires"}, {"id": "4.9.3.1", "requirement": "Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination.", "interpretation": "The aim of this clause is to protect consumers from potentially serious physical hazards that could occur if glass, brittle plastic, ceramics or other similar materials in open product areas of the site, are broken and form fragments which could subsequently contaminate product. The company must undertake an assessment of glass and other brittle items in open product areas, and any areas where there is a risk of contamination of product or packaging and, wherever possible, remove these items. Where it is not possible to remove all items, they must be protected against breakage (e.g. by the use of adhesive plastic sheeting, reinforcement or shielding) and included on a register for inspection purposes (clause 4.9.3.2). This does not apply to glass or brittle materials used to pack final products, which are covered separately in section 4.9.4.", "requirement_fr": "Le verre ou tout autre matériau cassant doit être exclu ou protégé de la casse dans des zones où les produits nus sont manipulés ou dans celles présentant un risque de contamination du produit."}, {"id": "4.9.3.2", "requirement": "Procedures for handling glass and other brittle materials (other than product packaging) shall be in place where open products are handled or there is a risk of product contamination. These procedures shall include, at a minimum: • a list of items detailing location, number, type and condition • recorded checks of the condition of items, carried out at a specified frequency that is based on the level of risk to the product • details on cleaning or replacing items to minimise the potential for product contamination.", "interpretation": "Procedures for handling glass and similar materials (other than packaging, which is covered in section 4.9.4) need to be documented to ensure that the risks of product contamination are managed. The documentation must include: • a list or register of items, detailing their location, number, type and condition. When creating the list, it is important to be realistic; the objective is to remove brittle items where possible and create a list of items for inspection which present a real risk of breakage and contamination of products (i.e. those that are in open product areas or where risk assessment shows there is a genuine risk to product). (The list could also detail the frequency with which the items must be checked.) • recorded, routine inspections to verify the condition of these items. Inspections must be carried out at a specified frequency based on risk assessment; some areas may be checked more frequently than others because of their potential to form a foreign-body hazard in the product. (For example, a factory identifies part of the production line which has plastic-laminated line covers that may chip or break. The condition of this section of the line is specifically checked daily prior to production, because it is above open food and any breakage or damage is likely to result in a foreign-body issue. The same factory has a brittle plastic dial cover on a control panel on the exterior of a piece of equipment not close to open product. This is checked only monthly, as a break and subsequent foreign- body issue is unlikely to arise.) • maintaining a record of the inspection even when there is no change in the condition of the inspected items. Any non-conformities highlighted in previous inspections, but not permanently repaired, should also be checked to confirm no additional deterioration has occurred • the procedures that allow cleaning or replacement of items in a way that minimises potential risk to products (e.g. replacing bulbs in fly-killing devices). To start with, carry out an assessment of the glass and brittle plastic items in open product areas and, wherever possible, remove them (see clause 4.9.3.1). If the item cannot be removed, it must be protected against breakage (e.g. with adhesive sheets or reinforcements) and included on a register for inspection purposes (an example is shown in Figure 15). When creating a list of items for inspection, it is important to be realistic. The objective is to create a list of items that represent a real risk of breakage and product contamination. For example, the window above the production line is likely to be high-risk, as any breakage is likely to contaminate the product. But the window in the Director’s office, on the other side of the site, does not need to be included unless there is a genuine risk of product contamination if the window breaks.", "requirement_fr": "Des procédures relatives à la manipulation du verre et d'autres matériaux cassants (autres que l'emballage du produit) doivent être en place dans les lieux où des produits nus sont manipulés ou dans ceux présentant un risque de contamination du produit. Ces procédures doivent inclure, au minimum :\n•\t une liste des éléments détaillant leur emplacement, leur nombre, leur type et leur état\n•\t des vérifications de l’état des éléments consignées et effectuées à une fréquence spécifiée en fonction du niveau de risque du produit,\n•\t des détails sur le nettoyage ou le remplacement d'éléments afin de minimiser les possibilités de contamination du produit."}, {"id": "4.9.3.3", "requirement": "Procedures detailing the action to be taken in the event of breakage of glass or other brittle items shall be implemented and include the following: • training of staff in the correct procedure • quarantining the products and production area that were potentially affected • cleaning the production area • inspecting the production area and authorising production to continue • changing of workwear and inspection of footwear • specifying those staff authorised to carry out the above points • recording the breakage incident • safely disposing of contaminated product.", "interpretation": "There must be documented procedures detailing the course of action to be taken when a breakage of a glass, brittle or hard plastic material, ceramic or similar item occurs. This must be based on risk assessment (therefore, the action taken may depend on the area in which the breakage occurred) and should include: • who has been trained to clear up broken items safely while minimising risks to product safety • isolation, inspection and management (e.g. product disposal) of potentially contaminated product (raw materials, packaging, final product etc.) • isolation of potentially contaminated area (e.g. specifying a 10-m exclusion zone) • how to clear up the broken item, including any designated equipment such as a brush, shovel and bin • how to clean the area and which cleaning equipment to use – this is important to ensure that glass particles are not transferred on equipment from one area to another • how to dispose of debris • inspection of the production area after cleaning, and the authorisation to recommence production • changing of production clothing (staff and cleaners) • inspection of footwear (staff and cleaners) • records to keep • identification of authorised staff to complete each of the above actions. The site should consider how to remove broken items, particularly larger items, from the premises. A designated, authorised contractor may be required. In the event of a breakage, the following procedure must be followed: • Notify a responsible person. (The site must identify the supervisors, line managers or production managers who should be notified and they should have sufficient knowledge and authority to take action.) • Where the breakage occurs near open product (e.g. near a production line), production in the area should be stopped. • Isolate the area of the breakage to ensure glass is not inadvertently distributed to other areas. • Discard products in the area that are contaminated or likely to be contaminated. If the break is discovered during a routine inspection, it will be necessary to consider all the products that have been manufactured since the last satisfactory inspection and the possibility that these may be contaminated. • Carefully clear the broken glass. The site should have specific cleaning equipment. • Once the area has been cleaned, it should be inspected and signed off before production resumes. • A record of all breakages should be maintained.", "requirement_fr": "Des procédures détaillées des actions à prendre en cas de bris de verre ou de tout autre élément cassant doivent être mises en place et inclure les éléments suivants :\n•\t la formation du personnel aux procédures adéquates\n•\t la mise en quarantaine des produits et de la zone de production potentiellement affectés\n•\t le nettoyage de la zone de production\n•\t l'inspection de la zone de production et l'autorisation de poursuivre la production\n•\t le changement de vêtements de travail et l'inspection des chaussures\n•\t la détermination des employés autorisés à effectuer les points ci-dessus\n•\t la consignation de l'incident de bris\n•\t l’élimination en toute sécurité des produits contaminés."}, {"id": "4.9.3.4", "requirement": "Where they pose a risk to product, glass windows shall be protected against breakage.", "interpretation": "Where it has been assessed that glass windows (including glazing in walls) pose a risk to product (e.g. where they are in close proximity to production or storage areas), they must be protected against breakage. This could be achieved by the use of adhesive plastic sheeting.", "requirement_fr": "Lorsque les vitres présentent un risque pour le produit, elles doivent être protégées contre le bris de verre."}, {"id": "4.9.3.5", "requirement": "Where they pose a risk to product, bulbs and strip lights (including those on electric fly- killer devices) shall be adequately protected. Where full protection cannot be provided, alternative management such as wire-mesh screens or monitoring procedures shall be in place.", "interpretation": "The site must assess where light bulbs and strip lights pose a risk to product (e.g. where they are in close proximity to production, storage areas or staff facilities). Where a risk is identified, light bulbs and strip lights must be protected against breakage. All types of lighting must be considered in order to minimise the likelihood of breakage and the spread of glass shards. Depending on the type of lighting used, protection can normally be achieved through the appropriate use of shatterproof light tubes, plastic sleeving or diffusion covers. Where full protection cannot be achieved, alternative methods of management, such as wire-mesh screens or monitoring procedures, must be in place.", "requirement_fr": "Lorsqu'ils posent un risque pour les produits, les ampoules et tubes néon (y compris ceux des appareils attrape-mouche électriques) doivent être correctement protégés. Lorsqu'une protection totale ne peut être mise en place, une gestion alternative, telle que des grillages ou des procédures de surveillance, doit exister.\n4.9.4 Produits emballés dans des récipients en verre ou autres matériaux cassants"}, {"id": "4.9.4.1", "requirement": "The storage of the containers shall be segregated from the storage of raw materials, product or other packaging.", "interpretation": "There must be dedicated, segregated storage for glass or other brittle containers. Ideally a separate storage room should be used for storage of empty containers. Where the containers are in a shared warehouse, a distinctly separate area must be used. Warehouse product flow must be considered to reduce the risk of broken glass or fragments being carried into raw material storage areas.", "requirement_fr": "Le stockage des récipients doit être séparé du stockage des matières premières, des produits ou de tout autre emballage."}, {"id": "4.9.4.2", "requirement": "Systems shall be in place to manage container breakages between the container-cleaning/ inspection point and container closure. This shall include, as a minimum, documented instructions which ensure: • the removal and disposal of at-risk products in the vicinity of the breakage; this may be specific for different equipment or areas of the production line • the effective cleaning of the line or equipment which may be contaminated by fragments of the container; cleaning shall not result in the further dispersal of fragments, for instance by the use of high-pressure water or air • the use of dedicated, clearly identifiable cleaning equipment (e.g. colour-coded) for removal of container breakages; such equipment shall be stored separately from other cleaning equipment • the use of dedicated, accessible, lidded waste containers for the collection of damaged containers and fragments • a documented inspection of production equipment is undertaken following the cleaning of a breakage, to ensure cleaning has effectively removed any risk of further contamination • authorisation given for production to restart following cleaning • the area around the line being kept clear of broken glass.", "interpretation": "The documented instructions for dealing with breakages must cover those points listed in the requirement. However, where high-speed filling lines are used with automatic breakage detection and cleaning systems, not all these will be practical. In such cases, the site must be able to demonstrate that the system is capable of consistently and safely removing glass fragments, and that factors such as low water pressure which may affect the performance of the acceptance and/or rejection of implicated products are understood, documented and controlled.", "requirement_fr": "Des systèmes doivent être en place pour gérer les bris de récipient entre le nettoyage/le point d'inspection du récipient et sa fermeture. Ils doivent inclure, au minimum, des instructions documentées garantissant :\n•\t le retrait et la mise au rebut de produits à risque à proximité du bris ; ceci peut être adapté à chaque équipement ou zone de la chaîne de production\n•\t le nettoyage efficace de la chaîne de production ou des équipements qui peuvent être contaminés par des débris du récipient ; le nettoyage ne doit pas entraîner de dispersion de débris supplémentaires à cause, par exemple, de l'utilisation d'eau ou d'air sous haute pression\n•\t l'utilisation d'équipements de nettoyage spécifiques et clairement identifiables (c-à-d. avec un code couleur) pour retirer les débris du récipient ; de tels équipements doivent être rangés séparément des autres équipements de nettoyage\n•\t l'utilisation de poubelles spécifiques, accessibles et couvertes pour le ramassage des récipients endommagés et des débris\n•\t une inspection documentée des équipements de production, effectuée suite au nettoyage d'un bris, pour garantir que le nettoyage a permis d'éradiquer efficacement tout risque de contamination supplémentaire\n•\t l'autorisation donnée pour reprendre la production après le nettoyage\n•\t la zone autour de la chaîne de production exempte de bris de verre."}, {"id": "4.9.4.3", "requirement": "Records shall be maintained of all container breakages on the line. Where no breakages have occurred during a production period, this shall also be recorded. This record shall be reviewed to identify trends and potential line or container improvements.", "interpretation": "All breakages must be recorded. This record should include: • the location where the breakage occurred • a record of the action taken • sign-off by an authorised member of staff, e.g. a shift leader, production manager or quality assurance representative, who is trained and competent. Where no breakages have occurred during a production period, this must also be recorded. The records must be periodically reviewed to identify trends (the use of a glass breakage map may be useful in identifying any trends in the locations where breakages occur). The results must be reviewed, for example, during the management review of incidents (clause 1.1.4), to identify opportunities to reduce the risk of glass breakages.", "requirement_fr": "Des enregistrements doivent être conservés quant à tout bris de récipient sur la chaîne de production. Lorsqu’aucun bris n'a eu lieu pendant une période de production, cela doit également être consigné. Ces enregistrements doivent être révisés pour identifier les tendances et les améliorations potentielles relatives à la chaîne de production ou aux récipients.\n4.9.5 Bois"}, {"id": "4.9.5.1", "requirement": "Wood should not be used in open product areas except where this is a process requirement (e.g. maturation of products in wood). Where the use of wood cannot be avoided, its condition shall be monitored on a risk-based frequency to ensure it is in good condition and free from damage or splinters which could contaminate products. Wood used for food contact purposes shall be fit for purpose (e.g. free from damage or splinters, free from taint; and wood treatments, where used, are used only in accordance with legislation and approved for food use).", "interpretation": "The use of wood is not permitted in production areas except where it is a requirement of the process (e.g. wooden casks used for some alcoholic beverages, or wooden crates for incoming raw materials in fresh produce packhouses). Where wood cannot be avoided, a procedure must be in place to: • ensure the use of wood is covered by the HACCP risk assessment • identify damaged items • minimise the potential for contamination • ensure that the wood is monitored (e.g. by regular checks on a risk-based frequency to ensure it is in good condition and clean). Wooden pallets should not be present in open product areas unless there is an essential and justified need, which cannot reasonably be avoided. The site must be able to demonstrate that the presence of the pallet will not result in a product contamination risk. For example, controls might include: • not using wooden pallets in open product areas • designated areas for pallet use (e.g. only at the end of the packing line) • inspection of the pallets before entry to the production area. Where wood is intended for food contact purposes, it must be fit for purpose. This may, for example, include being: • free from damage or splinters which could result in foreign bodies migrating into the products • free from chemical contamination which could migrate into the products, including taint • cleaned or managed to prevent microbiological contamination • used only in accordance with any relevant legislation; for example, any wood treatments must be approved for food use, and in the EU, the Framework Regulation EC 1935/2004 stipulates that food contact materials shall not release their constituents into food in quantities which could cause deterioration in the food’s organoleptic characteristics (i.e. its taste and smell).", "requirement_fr": "Le bois ne doit pas être utilisé dans les zones de produits nus sauf s'il s'agit d'une exigence du processus (c-à-d. le vieillissement des produits dans du bois). Lorsque l'utilisation du bois ne peut être évitée, son état doit être surveillé à une fréquence appropriée basée sur les risques, pour s'assurer qu'il est en bon état et exempt de dommages ou d'éclats qui pourraient contaminer les produits.\nLe bois utilisé en contact avec les denrées alimentaires doit être adapté à l'usage prévu (c-à-d. exempt de dommages, d'éclats ou d’altérations ; et les agents de traitement du bois doivent, le cas échéant, être conformes à la législation et approuvés pour un usage alimentaire).\n4.9.6 Autres contaminants physiques"}, {"id": "4.9.6.1", "requirement": "Procedures shall be in place to prevent physical contamination of raw materials by raw material packaging (e.g. during debagging and deboxing procedures to remove the packaging).", "interpretation": "Raw materials are delivered to sites in a variety of packaging formats composed of different materials (including cardboard boxes, paper liners, plastic bags, sacks, etc.) and with different types of closure (metal fixtures, glue, tape, thread, etc.). Sites must ensure that the risk of these packaging materials contaminating the raw material is prevented. Where packaging is removed from raw materials prior to use, documented procedures must be in place so that staff completing the activity know how to do so without creating a contamination hazard to the raw material.", "requirement_fr": "Des procédures doivent être en place pour prévenir la contamination physique des matières premières par des emballages de matières premières (c-à-d. pendant les procédures de vidage des sacs et des boîtes, pour ôter l’emballage)."}, {"id": "4.9.6.2", "requirement": "Portable handheld equipment, e.g. stationery items (pens, pencils etc.), mobile phones, tablets and similar portable items used in open product areas, shall be controlled by the site to minimise the risk of physical contamination. The site may consider, for example: • excluding non-approved items • restricting the use to site-issued equipment • ensuring stationery items such as pens are designed without small external parts and are detectable by foreign-body detection equipment, or are used in designated areas where contamination is prevented.", "interpretation": "The aim of the clause is to minimise or prevent potential product contamination from pens and small portable items such as stationery, mobile phones and tablets. The type of control applied will depend on the nature of the process, the site, and the potential for contamination should those items be lost or damaged in the production or storage area. Suitable controls may include: • restricting portable items to those approved and issued by the site • use of metal detectable equipment • restricting approved items to those with no small external parts, so that any breakage will not result in small pieces of undetectable plastic in product. The Standard is not prescriptive in the control mechanisms used. For example, it is common for pens used in production areas to be metal detectable; however, other controls may be more suitable in certain circumstances. Therefore metal detection is provided as an example of a common control. Nor does the Standard require pens to be of a specific design, or state that most pens available on the market are not compliant. The Standard does not require the site to test every batch of pens through its metal detector. It does, however, require sites to consider the design of pens and portable items being used, to ensure that potential food safety hazards have been considered and are managed appropriately.", "requirement_fr": "Les équipements portatifs, tels que les articles de papeterie (stylos, crayons, etc.), les téléphones portables, les tablettes et autres appareils similaires utilisés dans les zones de produits nus doivent être contrôlés par le site, afin de minimiser le risque de contamination physique. Le site peut, par exemple, envisager :\n•\t d’interdire les objets non approuvés\n•\t de limiter l'utilisation des équipements fournis par le site\n•\t de s’assurer que les articles de papeterie, tels que les stylos, ne comportent pas de petits composants et sont détectables par les équipements de détection des corps étrangers, ou qu'ils sont utilisés dans des zones désignées où toute contamination est exclue."}, {"id": "4.9.6.3", "requirement": "Based on risk, procedures shall be implemented to minimise other types of foreign-body contamination (i.e. types of contamination that are not specifically covered in section 4.9).", "interpretation": "The aim of this clause is to ensure that sites have considered all of the different types of foreign-body risks that may reasonably be expected to occur within their site, and have introduced suitable controls. For example, this may include significant foreign bodies identified during the development of the food safety plan (see clause 2.7.1) but not already managed through the other clauses in section 4.9. Where risk assessment shows that a genuine risk exists, the site will need to introduce suitable control procedures.", "requirement_fr": "Des procédures fondées sur l’évaluation des risques doivent être mises en place, afin de minimiser les autres formes de contamination par un corps étranger (c.-à-d. les types de contamination qui ne sont pas spécifiquement mentionnés dans la section 4.9).\n4.10\t Équipement de détection et d'élimination des corps étrangers Le risque de contamination du produit doit être réduit ou éliminé grâce à l'utilisation efficace d'équipements d'élimination ou de détection des corps étrangers.\n4.10.1 Sélection et fonctionnement de l’équipement de détection et d'élimination des corps étrangers"}, {"id": "4.10.1.1", "requirement": "A documented assessment in association with the food safety plan (see section 2 – The food safety plan) shall be carried out on each production process to identify the potential use of equipment to detect or remove foreign-body contamination. Typical equipment to be considered may include: • filters and sieves • metal detection and X-ray detection equipment • magnets • optical sorting equipment • other physical separation equipment (e.g. gravity separation, fluid bed technology).", "interpretation": "The food safety plan should be the starting point for implementing an effective foreign- body control programme. Potential hazards and their sources must be identified so that appropriate control procedures can be put in place to minimise the likelihood of product contamination. The Standard lists some of the most common forms of equipment used.", "requirement_fr": "Une évaluation documentée ainsi qu'un plan de sécurité alimentaire (voir section 2 : le plan de sécurité alimentaire) doivent être effectués pour chaque processus de production pour identifier l'utilisation potentielle d'équipements permettant de détecter ou d'éliminer la contamination par des corps étrangers. Les équipements caractéristiques à prendre en compte peuvent inclure :\n•\t les filtres et tamis\n•\t les équipements de détection de métaux et de détection par rayons X\n•\t les aimants\n•\t les équipements de tri optique\n•\t tout autre équipement de séparation physique (c-à-d. séparation par gravité, technologie de lit fluidisé)."}, {"id": "4.10.1.2", "requirement": "The type, location and sensitivity of the detection and/or removal method shall be specified as part of the site’s documented system. Industry best practice shall be applied with regard to the nature of the ingredient, material, product and/or packed product. The location of the equipment or any other factors influencing the sensitivity of the equipment shall be validated and justified.", "interpretation": "The choice of location for foreign-body detection equipment is vital for its effective use. Equipment should be placed as close to the end of the production process as is practical, so that the whole process (including packing lines) is protected. When selecting equipment and determining the best location for it, the potential environmental effects (e.g. temperature, moisture or speed of line) should be considered and discussed with the equipment supplier. The sensitivity of detectors must be specified and best practice applied, taking into account the nature of the food, contamination characteristics, and the location and aperture size of the detector. For example, it is likely that metal detectors will be sensitive to ferrous, non- ferrous and stainless steel test pieces, using test sizes according to industry best practice for the particular product type or customer requirements. Good practice is for foreign-body detectors to have adequate security settings so that only authorised personnel can alter them. The Standard expects the detector and its location to be validated at set-up; for example, by adjusting the machine’s sensitivity using a range of typical products to establish the most sensitive practical setting which gives rise to consistent rejection without false rejects. The established settings must be recorded and verified through regular checks of the equipment; these checks are generally undertaken using test pieces of a size just above the limit of detection.", "requirement_fr": "Le type, l'emplacement et la sensibilité de la méthode de détection et/ou d'élimination doivent être spécifiés dans le cadre du système documenté du site. Les bonnes pratiques industrielles doivent être appliquées quant à la nature de l'ingrédient, du matériau, du produit et/ou du produit emballé. L'emplacement de l'équipement ou tout autre facteur ayant un impact sur la sensibilité des équipements doit être validé et justifié."}, {"id": "4.10.1.3", "requirement": "The site shall ensure that the frequency of the testing of the foreign-body detection and/or removal equipment is defined and takes into consideration: • specific customer requirements • the site’s ability to identify, hold and prevent the release of any affected materials, should the equipment fail. The site shall establish and implement corrective action and reporting procedures in the event of a failure of the foreign-body detector and/or removal equipment. Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.", "interpretation": "The frequency of testing of the monitoring equipment must be assessed and defined in procedures. The frequency of routine tests should consider: • the need for additional checks at start-up and finish of shifts • product changeovers • the need for regular checks throughout production (hourly testing is expected for many detection systems) • changes in machine settings or following downtime • any specific customer requirements • the site’s ability to recover and retest product in the event of a failure. In the event that equipment is discovered not to be working, all of the product that has passed through the detector since it was last verified to be working must be rechecked. There must be procedures in place specifying the action required in the event of the detector failing a routine test (e.g. failing to detect or reject a test piece). The people responsible for completing the tests must also be trained in this procedure (clause 7.1.1). The procedures must include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test. If the cause of the failure is a system fault, the fault should be repaired before recommencing production on the implicated line.", "requirement_fr": "Le site doit s'assurer que la fréquence des tests effectués sur les équipements de détection et/ ou d'élimination des corps étrangers est définie et prend en compte les aspects suivants :\n•\t les exigences spécifiques des clients\n•\t la capacité du site à identifier, retenir et empêcher la libération de tout matériau affecté, en cas de défaillance de l'équipement.\nLe site doit définir et mettre en place une action corrective et des procédures de notification, dans le cas d’une défaillance des équipements de détection et/ou d'élimination des corps étrangers. L'action doit associer l'isolement, la mise en quarantaine et la réinspection de tous les produits élaborés depuis le dernier test ou la dernière inspection réussis."}, {"id": "4.10.1.4", "requirement": "Where foreign material is detected or removed by the equipment, the source of any unexpected material shall be investigated. Information on rejected materials shall be used to identify trends and, where possible, instigate preventive action to reduce the occurrence of contamination by the foreign material.", "interpretation": "Products rejected or retained by detection systems can provide valuable information about possible problems arising from raw materials or the production process, and provide an early warning of potential issues. Rejected products should therefore be examined to identify the cause of rejection. Identified causes should be investigated and recorded. The data on rejected and retained product must also be used as the basis for analysing trends. This trend analysis may be used to establish preventive actions to reduce future contamination. Information about false rejects should also be recorded, because this may suggest an error with the detector or indicate that the settings are too sensitive for a particular product and require adjustment.", "requirement_fr": "Lorsque des corps étrangers sont détectés ou éliminés par les équipements, la source de toute matière inattendue doit être identifiée. Les informations concernant les matières rejetées doivent être utilisées pour identifier des tendances et, dans la mesure du possible, servir à mettre en place des actions préventives afin de réduire l'occurrence de contamination par le corps étranger."}, {"id": "4.10.2.1", "requirement": "Filters and sieves used for foreign-body control shall be of a specified mesh size or gauge and designed to provide the maximum practical protection for the product.", "interpretation": "To ensure the system provides maximum protection, consideration must be given to mesh and gauge size. The smallest practical size should be used. The size will be documented and details made easily available to staff using the equipment.", "requirement_fr": "La taille du maillage ou le calibre des filtres et des tamis utilisés pour le contrôle des corps étrangers doivent être spécifiques et conçus pour fournir la meilleure protection pratique pour le produit."}, {"id": "4.10.2.2", "requirement": "Filters and sieves shall be regularly inspected or tested for damage at a documented frequency based on risk. Records shall be maintained of the checks. Where defective filters or sieves are identified, this shall be recorded and the potential for contamination of products investigated and appropriate action taken.", "interpretation": "Filters and sieves must be monitored to ensure they themselves do not pose a foreign-body hazard and are working effectively. There must be a documented procedure which includes: • the frequency of checks – this should be based on the nature of the sieve (e.g. a perforated-drum sieve is less likely to fail than a wire-mesh sieve), historical evidence of performance, risk to finished product, and the site’s ability to recover product in the event of a failure. Sieves are typically inspected at least once per week. The results of sieve monitoring must be recorded • staff responsibilities • the action to be taken when issues are identified. The material from which sieves and filters are manufactured should be considered, to minimise the potential for breakages that lead to foreign-body issues (e.g. where sieves or filters are used as part of a justification for not requiring metal detection, they should be made of non-metallic mesh). Where defective filters or sieves are identified, this must be recorded, the potential for contamination of products investigated, and appropriate action taken. Depending on the type of sieve or filter used, the site may choose to use visual inspection or a sieve analysis which compares results of the sample for particle size retention. This is often useful for quality control purposes.", "requirement_fr": "Les filtres et les tamis doivent être examinés régulièrement ou testés afin de détecter des altérations possibles selon une fréquence documentée basée sur les risques. Des enregistrements relatifs aux vérifications doivent être conservés. Les filtres ou tamis défectueux identifiés doivent être consignés. La possibilité de contamination des produits doit être identifiée, et des actions adaptées doivent être prises."}, {"id": "4.10.3.1", "requirement": "Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve food safety. Where metal detectors are not used, justification shall be documented. The absence of metal detection would only normally be based on the use of an alternative, more effective method of protection (e.g. use of X-ray, fine sieves or filtration of products).", "interpretation": "The Standard presumes that metal detection provides improved food safety and protection for customers and should form part of the food protection system of a site. Its absence would normally only be based on the use of an alternative, more effective, method of protection (e.g. the use of X-ray, fine sieves or filtration). There will, however, be situations where metal detection does not, on the basis of risk assessment, provide any significant additional protection to the consumer; for example, where whole pieces of fresh produce (e.g. potatoes) are being washed and packed, and any metal contamination would be obvious to the consumer prior to consumption. Where metal detectors are not used, a risk assessment must be available to justify the reasons why. While complaint levels are a factor in making a decision on the necessity for a metal detector, this evidence alone will not be sufficient justification for not using one. (For example, there may be instances of contamination which have not been reported by consumers.) Any justification for the absence of metal detection should be based on the nature of the product, the risk to the consumer, and alternative controls in place at the site which prevent metal contamination. Cost alone is not sufficient reason. In all circumstances where products are manufactured to a customer’s specification, sites must comply with any customer requirement for metal detection of their products. The decision tree in Figure 18 provides further guidance on the need for metal detection equipment for products not packed into metallic containers. Where the product is packed into metal packaging, an effective alternative test method must be developed (e.g. X-ray or metal-detecting the product at the stage prior to packing, or the use of magnets and product inspection). Failsafes or alarms should be implemented to notify production staff when failure of equipment is likely. It is vital to know when equipment designed to remove contaminated product is not functioning.", "requirement_fr": "Des équipements de détection de métaux doivent être en place, sauf si une évaluation des risques prouve qu'ils n'améliorent pas la sécurité des denrées alimentaires. En cas de non- utilisation de détecteurs de métaux, la justification de cette mesure doit être documentée.\nGénéralement, l'absence d'équipement de détection de métaux devrait être justifiée uniquement par l'utilisation d'une méthode de protection alternative plus efficace (c-à-d. utilisation de rayons X, de tamis fins ou de filtration de produits)."}, {"id": "4.10.3.2", "requirement": "The metal detector or X-ray equipment shall incorporate one of the following: • an automatic rejection device, for continuous in-line systems, which shall divert contaminated product either out of the product flow or to a secure unit accessible only to authorised personnel • a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very large packs) • in-line detectors which identify the location of the contaminant to allow effective segregation of the affected product.", "interpretation": "There are a variety of types of metal detector available, and selection will usually be dependent on the product and production process; for example, conveyor-based or gravity feed systems. Regardless of the design of the metal detector, the objective of this clause is to ensure that rejected products are effectively removed and not accidentally re-introduced into the process flow. The Standard requires the use of automatic rejection devices incorporated into metal detection and X-ray equipment. The use of belt stop and alarm systems is considered by some to present a greater risk of ‘rejected’ product being re-introduced into the process flow than automatic rejection systems where the product is positively rejected into a locked container. The Standard permits the use of either rejection mechanism providing there are sufficient controls in place to prevent implicated product being inadvertently placed back into the product flow. For belt-stop-style metal detector rejection systems, this will typically include the use of a container into which rejected product is placed, which is secured so that only authorised staff can remove the product (similar to the locked-box system used for automatic rejection systems). Where automatic rejection is not used, the following additional controls should be considered to ensure that rejected product is effectively segregated and managed: • The removal of affected product should be restricted to trained, authorised staff. This may be supported by restricting access to the product once the belt has stopped (e.g. by using a locked production line cover and authorised key holders). • Rejected product may be marked, be destroyed or have its label removed to reduce the risk of re-introduction to the process flow. • The line restart should be restricted to designated personnel who must verify the location of the ‘rejected’ product prior to restart (i.e. the control panel/button for restart is secure, locked or security-coded). • A record should be made of each occasion when the belt stops in response to the detection of metal in a product. Where the product is packed into metal packaging, an effective alternative test method must be developed – for example, the use of X-ray detectors, metal detection, magnets or product inspection prior to packing.", "requirement_fr": "Le détecteur de métaux ou les équipements à rayons X doivent intégrer l'un des aspects suivants :\n•\t un dispositif de rejet automatique pour les systèmes en ligne continus qui doit dévier le produit contaminé soit hors du flux de produits, soit vers une unité sécurisée uniquement accessible au personnel autorisé\n•\t un système d'arrêt de la courroie muni d'une alarme, lorsque le produit ne peut pas être automatiquement rejeté (c-à-d. pour les produits conditionnés très volumineux)\n•\t des détecteurs en ligne permettant d'identifier l'emplacement du contaminant et de procéder à une séparation efficace du produit affecté."}, {"id": "4.10.3.3", "requirement": "The site shall establish and implement procedures for the operation and testing of the metal detection or X-ray equipment. This shall include, at a minimum: • responsibilities for the testing of equipment • the operating effectiveness and sensitivity of the equipment and any variation to this for particular products • the methods and frequency of checking the detector • recording of the results of checks.", "interpretation": "The site must have documented procedures for the operation (including effectiveness and sensitivity) and routine monitoring of metal detector and X-ray equipment. The procedures will identify the individuals authorised to adjust the system as well as those responsible for completing system tests. Note that clause 6.1.2 applies to metal detectors and X-ray detectors, and good practice is to restrict the adjustment of the systems to a limited number of trained, authorised staff, to ensure that any changes are completed and documented correctly and in a controlled manner. The set-up and design of the operating procedures will need to consider a number of factors, which will affect the sensitivity of the detector and the effectiveness of the rejection mechanisms, including, for example: • size and type of product – product size and composition can affect the sensitivity of the detector and therefore its ability to identify • product packaging – product is normally tested in pack, but certain types of packaging will prevent this • line operating speeds – there must be sufficient time for the detector to identify the presence of a contaminant and the rejection mechanism to accurately and consistently remove the implicated pack from the product flow • location of the detector – should be risk-assessed to ensure that the placement efficiently and effectively minimises the risk of foreign bodies in the finished product • customer-specific requirements – some customers have specific requirements relating to detector sensitivity or frequency of tests • identification of the least sensitive (sometimes referred to as the weakest) part of the detector, to ensure that any contaminated product will still be rejected, even if the contaminant is located at this weakest point. The frequency of testing must be based on the quantity and type(s) of product. However, the following should be considered: • start-up and finish of shifts • product changeovers • change in machine settings following downtime for repairs • customer requirements • regular checks throughout production (these should consider the site’s ability to recover and retest product in the event of a failure; therefore a minimum of hourly testing is typically expected). The testing procedures must be based on the requirements of clause 4.10.3.4 but must also ensure that all relevant parts of the metal detector are operating correctly (e.g. the timing of the rejection system, the memory reset function and any failsafe alarms). The results of the tests conducted must be documented to demonstrate that all requirements of the monitoring procedure were executed and were within the correct working parameters. The Standard does not require routine calibration of metal detectors beyond the verification/checking activities described in this section. However, planned maintenance or servicing may have value depending on the machine, the manufacturer’s specification, the contract and/or the operating environment.", "requirement_fr": "Le site doit établir et mettre en place des procédures relatives au fonctionnement et aux tests des détecteurs de métaux ou des équipements à rayons X. Ces procédures doivent inclure, au minimum :\n•\t les responsabilités relatives aux tests des équipements\n•\t l'efficacité et la sensibilité de fonctionnement des équipements, ainsi que toute variation de ces dernières pour des produits particuliers\n•\t les méthodes et la fréquence d'inspection du détecteur\n•\t la consignation des résultats des inspections."}, {"id": "4.10.3.4", "requirement": "Metal detector testing procedures shall, at a minimum, include: • use of test pieces incorporating a sphere of metal of a known diameter selected on the basis of risk. The test pieces shall be marked with the size and type of test material contained • tests carried out using separate test pieces containing ferrous metal, stainless steel and typically non-ferrous metal, unless the product is within a foil container where a ferrous- only test may be applicable • a test to prove that both the detection and rejection mechanisms are working effectively under normal working conditions • tests of the metal detector by passing successive test packs through the unit at typical line operating speed • checks of failsafe systems fitted to the detection and rejection systems. In addition, where metal detectors are incorporated on conveyors, the test piece shall be passed as close as possible to the least sensitive area of the metal detector (usually the centre of the metal detector aperture). Wherever possible, the test piece shall be inserted within a clearly identified sample pack of the food being produced at the time of the test. Where in-line metal detectors are used, the test piece shall be placed in the product flow wherever this is possible, and the correct timing of the rejection system to remove identified contamination shall be validated. Testing of in-line metal detectors shall be completed during both line start-up and at the end of the production period.", "interpretation": "The company must establish procedures for the operation and routine monitoring of the metal detector. Industry best practice, manufacturers’ guidelines and specific customer requirements (clause 4.10.1.3) should be considered when developing these procedures. It is important that the test procedure reflects the normal operation of the production line, to provide confidence that any contamination will be correctly detected and removed during production. For example, the clause requires: • completing tests at typical line operating speeds – to ensure detection and rejection mechanisms operate correctly at intended line speeds • placing test pieces within product packs – to ensure product matrix or packaging does not adversely affect the metal detector • use of successive test packs – to ensure the system can effectively detect and, if necessary, reject, products immediately after a pack has been rejected. Many modern designs of metal detector (and other foreign-body detection systems such as X-rays) have failsafe systems – that is, they monitor their own functions and raise an alarm (usually audible) if something stops working. For example, if a product rejection system is powered by compressed air and the air supply fails, this will sound the alarm immediately, allowing staff to investigate the fault, rather than waiting until the next metal detector check finds a problem. Where these systems exist, it is important to run occasional checks to ensure that the failsafe system itself is operating (e.g. that the alarm will sound if one of its functions fails). The Standard does not expect sites to purchase new metal detection equipment if there is no failsafe system on their current equipment. Within the procedure, consideration must be given to where the test pieces are located. To ensure that the least sensitive areas of the metal detector are able to detect the piece, this is usually the centre of the metal detector aperture.", "requirement_fr": "Au minimum, les procédures de test des détecteurs de métaux doivent inclure :\n•\t des pièces de test incluant une sphère en métal d'un diamètre connu sélectionnée en fonction du risque doivent être utilisées. Les pièces de test doivent indiquer la taille et le type de matière testée qu'elles contiennent.\n•\t Des tests doivent être effectués au moyen de pièces de test distinctes contenant du métal ferreux, de l'acier inoxydable et du métal typiquement non-ferreux, sauf si le produit se trouve dans un récipient en aluminium où un test de métal ferreux uniquement peut s'appliquer.\n•\t Un test prouvant le fonctionnement efficace, dans des conditions de travail normales, des mécanismes de détection et de rejet doit être effectué.\n•\t Les tests du détecteur de métaux consistant à faire passer des produits conditionnés tests successivement dans l'unité à la vitesse normale de fonctionnement doivent être effectués.\n•\t Des vérifications des systèmes à sécurité intégrée adaptés aux systèmes de détection et de rejet doivent être effectuées.\nDe plus, lorsque les détecteurs de métaux sont intégrés aux convoyeurs, la pièce de test doit passer aussi près que possible de la partie la moins sensible du détecteur de métaux (généralement, le centre de l'ouverture du détecteur de métaux). Elle doit, dans la mesure du possible, être placée dans un échantillon clairement identifié de l'aliment produit au moment du test.\nLorsque des détecteurs de métaux en ligne sont utilisés, la pièce de test doit être placée, dans la mesure du possible, dans le flux de produits et le délai correct nécessaire au système de rejet pour éliminer la contamination identifiée doit être validé. Les tests de détecteurs de métaux en ligne doivent être effectués à la fois au démarrage de la ligne et à la fin de la période de production."}, {"id": "4.10.3.5", "requirement": "X-ray equipment testing procedures shall, at a minimum, include: • use of test pieces incorporating a sphere of suitable material (e.g. a typical contaminant) of a known diameter selected on the basis of risk. The test pieces shall be marked with the size and type of test material contained • tests carried out using separate test pieces • a test to prove that both the detection and rejection mechanisms are working effectively under normal working conditions • tests of the X-ray equipment by passing successive test packs through the unit at typical line operating speed • checks of failsafe systems fitted to the detection and rejection systems. In addition, where X-ray equipment is incorporated on conveyors, the test piece shall be passed as close as possible to the least sensitive area of the X-ray equipment (e.g. this may be close to the X-ray source or close to the X-ray equipment). Wherever possible, the test piece shall be inserted into a clearly identified sample pack of the food being produced at the time of the test. Where in-line X-ray equipment is used, the test piece shall be placed in the product flow wherever this is possible, and the correct timing of the rejection system to remove identified contamination shall be validated. Testing of in-line equipment shall be completed both during line start-up and at the end of the production period.", "interpretation": "X-ray detectors generally require slightly different test procedures from metal detectors, and therefore sites using X-ray equipment must establish procedures for the operation and routine monitoring of the X-ray equipment. Industry best practice, manufacturers’ guidelines and any customer-specific requirements should also be considered when developing these procedures. The procedure must consider: • the test pieces – the type of test material chosen should be based on the materials reasonably expected to form contaminants within the products being tested. A number of different test pieces are likely to be required to ensure all potential hazards are monitored • a test to prove that both the detection and rejection mechanisms are effective, to ensure that foreign bodies are removed if present. These tests should be completed with the line running under normal conditions, e.g. with correct line speeds to ensure consistency and accuracy under normal conditions • checking of the failsafe system, to ensure product is removed or held in a separate area (further information regarding failsafe systems can be found in the interpretation for clause 4.10.3.4). The test piece should be passed through the X-ray equipment, ensuring that the least sensitive area is clearly identified, and this should be included in the procedure. Depending on the design of the X-ray equipment, the least sensitive area of the detector may be located close to the X-ray source or the detector. Good practice is to test the system by using test pieces within a clearly identified sample pack of the food being produced at the time of the test. Where in-line X-ray equipment is used, additional consideration will be needed to develop an effective test mechanism. For example, the test piece must be placed in the product flow wherever possible, and the correct timings of the rejection system confirmed, to ensure removal of the test piece. This must be completed at the start-up and end of production. Additional testing, where required, should be based on risk.", "requirement_fr": "Au minimum, les procédures de test des équipements à rayons X doivent inclure :\n•\t l’utilisation de pièces de test incluant une sphère d'un matériau approprié (c-à-d. un contaminant type) d'un diamètre connu sélectionné en fonction du risque. Les pièces de test doivent indiquer la taille et le type de matière testée qu'elles contiennent\n•\t des tests effectués au moyen de pièces de test distinctes\n•\t un test prouvant le fonctionnement efficace, dans des conditions de travail normales, des mécanismes de détection et de rejet\n•\t des tests des équipements à rayons X consistant à faire passer des produits conditionnés tests successivement dans l'unité à la vitesse normale de fonctionnement\n•\t des vérifications des systèmes à sécurité intégrée adaptés aux systèmes de détection et de rejet.\nDe plus, lorsque les équipements à rayons X sont intégrés aux convoyeurs, la pièce de test doit passer aussi près que possible de la zone la moins sensible de l’équipement à rayons X (c-à-d. près de la source de rayons X ou près de l'équipement à rayons X). Elle doit, dans la mesure du possible, être placée dans un échantillon clairement identifié de l'aliment produit au moment du test.\nLorsque des équipements à rayons X en ligne sont utilisés, la pièce de test doit être placée, dans la mesure du possible, dans le flux de produits, et le délai correct nécessaire au système de rejet pour éliminer la contamination identifiée doit être validé. Les tests d’équipements en ligne doivent être effectués à la fois au démarrage de la ligne et à la fin de la période de production."}, {"id": "4.10.4.1", "requirement": "The type, location and strength of magnets shall be fully documented. Procedures shall be in place for the inspection, cleaning, strength testing and integrity checks of magnets used for food safety purposes, including final product testing, e.g. to remove product contamination. Records of all checks shall be maintained.", "interpretation": "Some sectors of the food industry (e.g. grinding of cereals and production of coffee) employ magnets to reduce or remove metal fragments in the finished product. Where a magnet is used for these food safety purposes, it is important to document its type (e.g. electromagnet or permanent magnet), location and strength. Magnets are not an alternative to metal detectors, but an additional control mechanism, and factories using magnets must still comply with the requirements of section 4.10.3. The magnet’s strength should be designed to ensure that it is sufficient to capture metal foreign bodies. A number of factors should be considered when determining the correct strength; for example, the type of product (e.g. the size of the food particles), the width of the conveyor belt, chute or other equipment in which the magnets are located, and the flow rate of the food or raw material. Documented procedures must be in place to ensure: • routine inspection (e.g. visual inspection for damage and the presence of captured metal fragments) • cleaning – the ability of a magnet to capture a foreign body can be hampered if dirt or other material is allowed to collect on the magnet’s surface • strength testing (e.g. by using a magnetic meter (measuring the magnet’s strength in tesla) or through the use of a third-party calibration service). Records of all checks, recalibrations or servicing must be maintained. Clause 4.10.1.3 requires sites to develop test procedures which consider: • the frequency of testing; for example, to ensure the site can take timely action on implicated product in the event of a test failure • any specific customer requirements. Good practice for monitoring a magnet’s performance includes locating a second ‘policing’ magnet as close to the first as possible. Any metal found on this second magnet indicates that the ‘process’ magnet is not performing satisfactorily and is failing to remove all metal particles.", "requirement_fr": "Le type, l'emplacement et la puissance des aimants doivent être pleinement documentés.\nDes procédures doivent être en place pour l’inspection, le nettoyage, le test de puissance et les vérifiations d’intégrité des aimants utilisés à des fins de sécurité alimentaire, y compris le contrôle final du produit, par exemple, pour éliminer toute contamination du produit. Des enregistrements de toutes les vérifications doivent être conservés."}, {"id": "4.10.5.1", "requirement": "Optical sorting equipment used for final product testing shall be checked in accordance with the manufacturer’s instructions or recommendations. Checks shall be documented.", "interpretation": "Optical sorting devices are commonly used in some industries to remove unsatisfactory products or contaminants from finished products, usually on the basis of colour or variance from a reference material. Where equipment is in use, procedures need to be developed for the maintenance and testing of the equipment. This is usually developed with the manufacturer when the equipment is installed and commissioned. Records of all checks and servicing must be maintained.", "requirement_fr": "Les équipements de tri optique utilisés pour le contrôle final du produit doivent être examinés conformément aux instructions ou aux recommandations du fabricant. Les vérifications doivent être documentées."}, {"id": "4.10.6.1", "requirement": "Based on risk assessment, procedures shall be implemented to minimise foreign-body contamination originating from the packaging container (e.g. jars, cans and other pre-formed rigid containers). This may include the use of covered conveyors, container inversion and foreign-body removal through rinsing with water or air jets.", "interpretation": "Where packaging containers are supplied to the production site in a rigid format (e.g. empty cans, bottles or glass jars), there is an increased risk of contamination of the container during storage and transit before filling. Glass containers carry the additional risk of damage during transit. A rigid container is generally any container that is inflexible and would break into separate pieces (i.e. small fragments) if pressure was applied, which could subsequently be a foreign- body hazard. These containers are normally manufactured from glass, metal or inflexible plastics or ceramics, although other materials may be used. These types of packaging can increase the risk of foreign-body contamination either during the manufacturing process or because of breakages during storage and transit. The site needs to consider the potential risks associated with the containers and introduce appropriate controls to reduce the risk. For example, it is usual for such containers to be inverted and cleaned prior to use and for glass jars and bottles to be subject to automatic or manual (by exception) inspection before use. Where the site uses inversion and cleaning (for example, by air jets), it may be necessary to introduce a dust/debris cover, collector or control measure to restrict the movement of the removed debris and therefore prevent it being moved into a situation where it would become another foreign-body hazard. Documented procedures, based on risk assessment, must be available to address the potential risks.", "requirement_fr": "Des procédures fondées sur l'évaluation des risques doivent être mises en place afin de minimiser la contamination par des corps étrangers provenant du récipient d'emballage (c-à-d. bocaux, boîtes de conserve et autres récipients rigides préformés). Elles peuvent inclure l'utilisation de convoyeurs couverts, le retournement des récipients et le retrait des corps étrangers grâce au rinçage au moyen de jets d'eau ou d'air."}, {"id": "4.10.6.2", "requirement": "The effectiveness of the container-cleaning equipment shall be checked and recorded during each production. Where the system incorporates a rejection system for dirty or damaged containers, the check shall incorporate a test of both the detection and effective rejection of the test container.", "interpretation": "In-line cleaning and automatic rejection systems are not a requirement of the Standard, but the use of such systems is strongly encouraged. Where these systems are present, they must be checked and records maintained of checks. Consideration must also be given to the action required in the event of a breakage after cleaning (clause 4.9.3.3).", "requirement_fr": "L'efficacité des équipements de nettoyage des récipients doit être vérifiée et consignée lors de chaque production. Lorsque le système possède un système de rejet des récipients sales ou endommagés, la vérification doit inclure un test portant sur la détection et l'efficacité du rejet du récipient test."}, {"id": "4.10.7.1", "requirement": "Other foreign-body detection and removal equipment, such as gravity separation, fluid bed technology or aspirators, shall be checked in accordance with the manufacturer’s instructions or recommendations. Checks shall be documented.", "interpretation": "All foreign-body detection and removal systems need to be operated correctly to ensure that they provide the required level of operation. The clause is applicable to all types of equipment not mentioned elsewhere within the Standard; for example: • gravity separation – a method of separating components in either a suspension or as dry granular materials. Gravity separation relies on the components of the material having different specific gravities and therefore different relative motion under gravity and drag forces • fluid bed technology – this technology separates particular matter according to size, shape and/or density • aspirators – another technology for separating contaminants on the basis of size, density or shape. It can also be used in the removal of loose outer casings from a variety of foods; for example, grain hulls. All removal equipment must be checked in accordance with the manufacturer’s guidelines and instructions to ensure it is being used in the correct way, such that effective removal of foreign bodies is consistently achieved. All checks must be documented and records retained. Good practice is to ensure any non- conformities are investigated and corrective actions completed in a timely manner.", "requirement_fr": "Tout autre équipement de détection et d’élimination des corps étrangers (c-à-d. séparation par gravité, technologie de lit fluidisé ou aspirateurs), doit être examiné conformément aux instructions ou aux recommandations du fabricant.\nLes vérifications doivent être documentées.\n4.11 Entretien et hygiène Fondamental Des systèmes d'entretien et d'hygiène doivent être en place pour garantir que des normes d'hygiène appropriées sont appliquées à tout moment et que le risque de contamination du produit est minimisé."}, {"id": "4.11.1", "requirement": "The premises and equipment shall be maintained in a clean and hygienic condition.", "interpretation": "It is important that the site, manufacturing environment and equipment are routinely cleaned to an appropriate standard of cleanliness to prevent potential contamination (e.g. with allergens or micro-organisms) and to prevent quality issues such as taint from previously manufactured products. The Standard requires (clause 4.11.3) that appropriate limits of acceptable cleaning performance shall be defined. During the course of the audit, equipment that is not currently operating will be opened and inspected to assess whether cleaning has been completed appropriately and in accordance with the site’s policies (including the acceptable limits), as well as to assess post-cleaning checks (clause 4.11.5). Production lines that are running will not be stopped for inspection, although records may be checked to ensure equipment was appropriately cleaned and checked prior to use (see clauses 4.11.2, 4.11.3 and 4.11.5).", "requirement_fr": "Les locaux et les équipements doivent être maintenus dans de bonnes conditions de propreté et d'hygiène."}, {"id": "4.11.2", "requirement": "Documented cleaning and disinfection procedures shall be in place and maintained for the building, plant and all equipment. Cleaning procedures for the processing equipment and food contact surfaces shall, at a minimum, include: • responsibility for cleaning • item/area to be cleaned • frequency of cleaning • method of cleaning, including dismantling equipment for cleaning purposes where required • cleaning chemicals and concentrations • cleaning materials to be used • cleaning records (including records for completion and sign-off) and responsibility for verification. The frequency and methods of cleaning shall be based on risk. The procedures shall be implemented to ensure appropriate standards of cleaning are achieved.", "interpretation": "Documented cleaning and disinfection procedures must be in place to ensure consistent and effective cleaning and as a guide for training purposes. When documenting such procedures, an emphasis should be placed on the processing equipment and food contact surfaces. The procedures must be in sufficient detail for the cleaning to be carried out to a consistently acceptable standard. In the majority of sites, good practice would normally include six stages of cleaning: • remove gross debris (e.g. sweep or wipe) • rinse with water • wash with detergent solution using hot water • rinse • dry • sanitise. Where equipment requires different levels of cleaning (e.g. between products, or between daily and weekly cleans), each requirement should be clearly detailed and specific to the item of equipment. These procedures need to be reviewed and updated whenever changes to the equipment and areas to be cleaned occur. In addition, a good cleaning instruction would include: • a unique method of reference that can be quoted on paperwork (e.g. cleaning records) • photographs of equipment, which are useful for identifying equipment and for highlighting areas that are difficult to clean, or that form key check/verification points • the appropriate protective clothing or equipment that should be worn when cleaning or handling cleaning chemicals. In order for cleaning to be effective, it is important that the procedures are designed for the specific item, area or site. A generic, off-the-shelf procedure probably would not guarantee a sufficient standard of cleaning. For example, an identical work surface in an area handling bakery products would need to be treated differently from one in a meat-handling area. This would need to be assessed during the development and risk assessment stage. The complexity of the process and equipment, the types of product manufactured, the ease with which debris can be removed, and the need to manage specific hazards (e.g. specific micro- organisms or allergens) are also factors to consider. Developing a cleaning procedure can be done in a few simple steps: • Step 1 Set the required standard of cleaning (clause 4.11.3) Consider legislation, customer requirements, industry or category best practice, etc. The risk assessment should consider the prevention of contamination from previous products, as well as address potential microbiological, chemical or allergen concerns. • Step 2 Develop draft procedures (clause 4.11.2) Ensure all items, areas and equipment are defined and included within the procedures. Think about the order of cleaning too, so that cleaned equipment is not re-contaminated by subsequent cleaning activity. • Step 3 Validate the draft procedures (clause 4.11.3) Use validation to confirm that the required standard of cleaning (Step 1) is met. The Standard requires that cleaning procedures which form part of a defined prerequisite (i.e. procedures that are used to control a specific hazard such as allergen cross- contamination) must be validated to ensure they are effective and deliver the intended level of cleaning. However, it is also good practice for all cleaning procedures to be validated. • Step 4 Finalise procedures and associated documentation (e.g. cleaning records and sign- off) Keep records that show what type of cleaning was completed, when it was completed, who did it, and who checked the cleaning and signed it off as acceptable (a requirement of clause 4.11.2). • Step 5 Train relevant staff (clause 4.11.4). • Step 6 Complete ongoing monitoring and verification (clauses 4.11.2 and 4.11.5). When developing cleaning procedures, it is often useful to remember: • All equipment and areas must be included. • Cleaning needs should be discussed with equipment and chemical suppliers, who can often provide valuable assistance in identifying suitable cleaning materials. • Validation and verification are needed for cleaning activities – validation before introducing the new procedure, and verification on an ongoing basis. Verification is the application of checks or tests, at regular intervals, to ensure the cleaning procedure is still working and continues to deliver the required level of cleaning. Verification of cleaning may include internal audits, record reviews, swabs or tests of the cleaned equipment, and the assessment of staff to ensure they have a clear understanding of the cleaning procedure.", "requirement_fr": "Des procédures de nettoyage et de désinfection documentées doivent être en place et maintenues pour le bâtiment, l'usine et tous les équipements. Les procédures de nettoyage des équipements de transformation et des surfaces en contact avec les aliments doivent inclure au minimum :\n•\t les personnes responsables du nettoyage\n•\t les éléments/zones à nettoyer\n•\t la fréquence du nettoyage\n•\t la méthode de nettoyage, y compris le démontage des équipements pour permettre leur nettoyage, le cas échéant\n•\t les produits chimiques utilisés pour le nettoyage et leur concentration\n•\t le matériel de nettoyage à utiliser\n•\t les enregistrements de nettoyage (y compris les enregistrements des exécutions et des vérifications) et les responsables de la vérification.\nLa fréquence et les méthodes de nettoyage doivent être basées sur les risques.\nLes procédures doivent être mises en place pour garantir que les normes appropriées relatives au nettoyage sont respectées."}, {"id": "4.11.3", "requirement": "Limits of acceptable and unacceptable cleaning performance shall be defined for food contact surfaces and processing equipment. These limits shall be based on the potential hazards relevant to the product or processing area (e.g. microbiological, allergen, foreign- body or product-to-product contamination). Therefore, acceptable levels of cleaning may be defined by visual appearance, ATP bioluminescence techniques (see glossary), microbiological testing, allergen testing or chemical testing as appropriate. The site shall define the corrective action to be taken when monitored results are outside of the acceptable limits. Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard, the cleaning and disinfection procedures and their frequency shall be validated and records maintained. This shall include the risk from cleaning chemical residues on food contact surfaces.", "interpretation": "At a minimum, limits of acceptable and unacceptable cleaning performance must be defined for: • food contact surfaces • processing equipment. The limits need to be based on risk, and this should be used for assessing whether the cleaning undertaken is of an acceptable standard. Acceptable limits may be based on visual inspection, ATP monitoring or specific analysis such as microbiological, allergen or chemical testing. For example, where the cleaning is principally designed to provide a clean processing environment, an assessment of ‘visually clean’ may be sufficient. However, where the level of cleaning is to ensure a sterile food contact surface to make sure that all traces of an allergen have been removed or to prevent cross-contamination of different meat species, the level of acceptable cleaning performance may need to be based on more rigorous checks such as the results of ATP, microbiological or allergen tests. Where the cleaning procedure forms part of a defined prerequisite (section 2.2) designed to manage a specific hazard (e.g. allergen cross-contamination), then the procedure must be validated to confirm that the specified cleaning method, chemicals and concentrations are capable of consistently achieving the level of performance required. Records of validation must be maintained. When designing and validating cleaning procedures, cleaning chemical residues must be considered so that they cannot become a source of product contamination (e.g. manufacturer’s instructions must be followed regarding rinse methods). Cleaning checks should include hard-to-reach locations as well as surfaces and those locations that are easy to reach, effectively confirming satisfactory cleaning of all surfaces and areas. Where results are outside of the acceptable limits, the site’s procedures should ensure that corrective action is taken (e.g. by repeating the cleaning process and rechecking the standard of cleaning). The exact action will depend on the type of cleaning, the check methodology and the acceptable levels that have been defined.", "requirement_fr": "Des limites doivent être définies quant aux pratiques de nettoyage acceptables et non acceptables pour les surfaces en contact avec les aliments et les équipements de transformation. Ces limites doivent se baser sur les dangers potentiels applicables au produit ou à la zone de transformation (c-à-d. contamination microbiologique, allergénique, par un corps étranger ou entre produits). Par conséquent, des niveaux acceptables de nettoyage peuvent être définis en se basant sur l'aspect visuel, les techniques de bioluminescence ATP (adénosine triphosphate) (voir glossaire), les tests microbiologiques, allergéniques ou chimiques, selon les cas.\nLe site doit définir l'action corrective à adopter lorsque les résultats des contrôles se trouvent hors des limites acceptables.\nLorsque les procédures de nettoyage s'inscrivent dans le cadre d'un programme préalable défini pour contrôler le risque d'un danger particulier, les procédures de nettoyage et de désinfection ainsi que leur fréquence doivent être validées et consignées. Elles doivent inclure les risques inhérents au nettoyage des résidus chimiques sur les surfaces en contact avec les aliments."}, {"id": "4.11.4", "requirement": "The resources for undertaking cleaning shall be available. Where it is necessary to dismantle equipment for cleaning purposes or to enter large equipment for cleaning, this shall be appropriately scheduled and, where necessary, planned for non-production periods. Cleaning staff shall be adequately trained or engineering support provided where access within equipment is required for cleaning.", "interpretation": "Appropriate resources are required to ensure that all cleaning is completed correctly and to the appropriate standard. These resources will include: • cleaning equipment • cleaning chemicals (e.g. detergents) • trained personnel. (As per the requirements of section 7.1, all cleaning must be carried out by trained staff. Training records must demonstrate that the relevant training has been completed and must cover all staff involved in cleaning activities, including employment agency and temporary staff.) Where specialist resources or activities are required (e.g. to dismantle or enter large equipment), this must be appropriately scheduled and, where necessary, planned for non- production periods. Full support must be provided by engineering, either by additional training or by having engineering staff present during these cleaning operations.", "requirement_fr": "Les moyens permettant d'effectuer le nettoyage doivent être disponibles. Lorsqu'il est nécessaire de démonter les équipements pour procéder à leur nettoyage ou d'entrer dans des équipements de grande taille pour les nettoyer, ces tâches doivent être planifiées de manière appropriée et, le cas échéant, prévues en dehors des périodes de production. Le personnel chargé du nettoyage doit être correctement formé ou avoir accès à une assistance technique lorsqu'il est nécessaire de pénétrer dans les équipements pour procéder à leur nettoyage."}, {"id": "4.11.5", "requirement": "The cleanliness of equipment shall be checked before equipment is released back into production. The results of checks on cleaning, including visual, analytical and microbiological checks, shall be recorded and used to identify trends in cleaning performance and to instigate improvements where required.", "interpretation": "An authorised member of staff (e.g. line supervisor, quality assurance supervisor or production manager) must formally accept equipment back into operation following an inspection, to confirm that the cleaning has been completed satisfactorily. The results of checks on cleaning, including visual or analytical checks, must be recorded. These records must be used to identify trends in cleaning performance and to instigate improvements where required. For example, trends and potential changes could be discussed during management meetings (clause 1.1.4). Where changes in cleaning regimes are required (e.g. to prevent the build-up of micro- organisms, biofilm or scale), companies may need access to relevant expertise or advice.", "requirement_fr": "La propreté des équipements doit être vérifiée avant que ceux-ci ne soient utilisés à nouveau pour la production. Les résultats des vérifications de nettoyage, y compris les vérifications visuelles, analytiques et microbiologiques, doivent être consignés et utilisés pour identifier des tendances dans la performance de nettoyage et pour mettre en place des améliorations, le cas échéant."}, {"id": "4.11.6", "requirement": "Cleaning equipment shall be: • hygienically designed and fit for purpose • suitably identified for intended use (e.g. colour-coded or labelled) • cleaned and stored in a hygienic manner to prevent contamination.", "interpretation": "Cleaning equipment, including any equipment or utensils used for cleaning activities, must be suitable for the purpose for which it is intended and capable of achieving the desired level of cleaning. For example, equipment would not be suitable if it: • had the potential to shed fibres • was not hygienically designed (to facilitate easy cleaning after use). Equipment must be clearly identified at all times (by colour-coding and/or labelling). This is necessary to ensure that different types of equipment are clearly distinguishable (e.g. floor- cleaning equipment must be distinguishable from items designated for cleaning production equipment). It must also be stored hygienically and in a manner that prevents contamination (e.g. stored in designated locations and not in contact with the floor). The operation of tray/rack washes to ensure that they operate effectively should also be considered; for example, checks could include the visual inspection of cleaned trays, monitoring water temperature or the chemical concentration of detergent, or microbiological swabbing.", "requirement_fr": "Les équipements de nettoyage doivent être :\n•\t conçus de manière hygiénique et adaptés à l'usage prévu\n•\t identifiés correctement en fonction de leur usage prévu (c-à-d. code couleur ou étiquette)\n•\t propres et stockés de manière hygiénique pour éviter la contamination.\n4.11.7 Nettoyage en place (NEP)"}, {"id": "4.11.7.1", "requirement": "All CIP equipment shall be designed and constructed to ensure effective operation. This shall include: • validation confirming the correct design and operation of the system • an up-to-date schematic diagram of the layout of the CIP system • where rinse solutions are recovered and re-used, an assessment of the risk of cross- contamination (e.g. due to the re-introduction of an allergen or the existence of different production risk zones within the site). Alterations or additions to the CIP system shall be authorised by a suitably competent individual before changes are made. A record of changes shall be maintained. The system shall be revalidated at a frequency based on risk, and following any alteration or addition.", "interpretation": "Effective CIP starts with the design (e.g. designed by an approved equipment supplier – see section 4.6 for information regarding new equipment) and set-up of the system. The site will therefore need validation to confirm that the design, set-up and proposed operation of the system are suitable for the intended use. For example: • knowledge of the layout of the pipework and the position of valves, spray balls and holding tanks is essential to ensure that the system will operate consistently and effectively and that there are no dead spots or areas where cross-contamination between cleaning chemicals and product can occur • correct design of the CIP system to ensure good coverage of cleaning solutions with suitable drainage to avoid pools of solutions; for example, the prevention of shadows caused by baffles or spray balls that have been incorrectly located • assurance that the intended cleaning will be effective (e.g. that the food/products intended to be used on the equipment will be effectively removed during cleaning) • consideration of the risk of potential contaminants (e.g. allergens) from previous products being re-introduced onto the equipment during the collection, recycling or re-use of solutions (e.g. rinse solutions). Where rinse solutions are recovered and re-used, there should be a specific risk assessment to prevent cross-contamination; for example, due to allergens or the existence of different production risk zones in the site. See clause 8.5.4 for the specific requirements for CIP systems operating in multiple production risk zones (e.g. high-risk and high-care areas). Confirmation of the correct design and set-up may be achieved by an inspection report (e.g. from the equipment manufacturer) or by separate documented validation. A schematic plan or diagram should be provided by the supplier when the system is installed and must be updated whenever a change is made, including to software, equipment and operation of the system. Issues are most likely to occur where CIP systems are modified or extended. Therefore, controls must be in place to ensure that all changes (e.g. engineering modifications, changes to the programming or operation of the system, and changes to consumables such as the detergents used) are made only by a suitably trained and competent individual. This could be achieved by, for example: • having a company policy that permits modifications only by the manufacturer of the equipment • training engineering staff • password-protecting the system with different levels of access to prevent unauthorised modifications to programme parameters or software. Records of changes must be maintained. The site should use risk assessment to determine suitable intervals for revalidation of the CIP system to ensure its continuing effectiveness. The CIP system will also require revalidation following any alterations or additions to ensure it continues to operate as expected.", "requirement_fr": "Tous les équipements de NEP doivent être conçus et construits pour garantir un bon fonctionnement. Cela doit inclure :\n•\t la validation confirmant la bonne conception et le bon fonctionnement du système\n•\t un diagramme schématique actualisé de la disposition du système de NEP\n•\t une évaluation des risques de contamination croisée (c-à-d. due à la réintroduction d’un allergène ou à l'existence de différentes zones de production à risque au sein du site), dès lors que des solutions de rinçage sont récupérées et réutilisées.\nTout ajout ou modification au système de NEP doivent être autorisés par une personne compétente avant que ces changements n’aient lieu. Un enregistrement de tous les changements doit être conservé.\nLe système doit être revalidé à une fréquence basée sur les risques, et suite à tout ajout ou modification."}, {"id": "4.11.7.2", "requirement": "Limits of acceptable and unacceptable performance for key process parameters shall be defined to ensure the removal of target hazards (e.g. soil, allergens, micro-organisms, spores). At a minimum these parameters shall include: • times for each stage • detergent concentrations • flow rate and pressure • temperatures. These shall be validated and records of the validation maintained.", "interpretation": "The CIP process parameters and tolerances must be identified and limits of acceptable and unacceptable performance set, e.g. detergent concentrations and limits on permitted carry-over into post-rinse solutions. The actual values of acceptable and unacceptable performance will depend on the target hazards that the CIP cleaning is intended to remove and this in turn will depend on the product types being processed. Specific hazards may include, for example, soil, allergens and/or vegetative micro-organisms. The Standard identifies minimum key parameters that need to be defined, and their limits must be validated to confirm effective removal of the identified hazards.", "requirement_fr": "Des limites doivent être définies quant aux pratiques acceptables et non acceptables pour les paramètres clés du processus, afin de garantir l’élimination des dangers ciblés (c-à-d. souillures, allergènes, micro-organismes, germes). Au minimum, ces paramètres doivent inclure :\n•\t les durées correspondant à chaque étape\n•\t les concentrations en détergent\n•\t le débit d'injection et la pression\n•\t les températures.\nCes paramètres doivent être validés et des enregistrements des validations doivent être conservés."}, {"id": "4.11.7.3", "requirement": "The CIP equipment shall be maintained by suitably trained staff to ensure effective cleaning is carried out. This shall include: • routine checking of detergent concentrations • monitoring of recovered post-rinse solutions for build-up of carry-over from the detergent tanks • cleaning and inspection of filters, where fitted, at a defined frequency • storing flexible hoses (where used) hygienically when not in use, and inspecting them at a defined frequency to ensure that they are in good condition.", "interpretation": "A planned maintenance programme must be in place to ensure all aspects of the CIP system are in good working order. At a minimum, this should include: • monitoring detergent concentrations and post-rinse solutions • inspection, cleaning and storage of filters and flexible hoses where they are part of the CIP system. The frequency of maintaining the different aspects of the programme should be based on risk. For example, good practice normally includes ensuring detergent tanks are drained, cleaned and filled, with a log of these activities to confirm that they have been completed to schedule. Monitoring and inspection may be undertaken by trained site staff (e.g. engineers) or carried out as part of a service agreement with the supplier or with the service company maintaining the system. A report of the inspection (that includes an overview of the scope of the inspection, any recommendations for improvement, and confirmation or otherwise of the effectiveness of the system) should be kept.", "requirement_fr": "Les équipements de NEP doivent être entretenus par du personnel formé à cet effet, afin de garantir un nettoyage efficace. Cela doit inclure :\n•\t la vérification régulière des concentrations en détergent\n•\t la surveillance des solutions de post-rinçage récupérées pour vérifier l’absence d’accumulation de résidus dans les réservoirs de détergents\n•\t le nettoyage et l'inspection des filtres, s'ils sont installés, à une fréquence définie\n•\t l’entreposage des tuyaux souples (le cas échéant) de manière hygiénique lorsqu'ils ne sont pas utilisés, et l’inspection à une fréquence déterminée pour garantir qu’ils sont en bon état."}, {"id": "4.11.7.4", "requirement": "CIP facilities, where used, shall be monitored at a defined frequency based on risk. This may include: • monitoring of process parameters defined in clause 4.11.7.2 • ensuring correct connections, piping and settings are in place • confirming the process is operating correctly (e.g. valves are opening/closing sequentially, spray balls are operating correctly) • ensuring effective completion of the cleaning cycle • monitoring for effective results, including draining where required. Procedures shall define the action to be taken if monitoring indicates that processing is outside the defined limits.", "interpretation": "To ensure the ongoing effectiveness of the CIP system, it is important to routinely monitor the operation of the system at a predefined frequency. This will include checks of connections, piping and settings prior to starting the cleaning process and a post-cleaning confirmation of effective cleaning. The frequency of monitoring should be based on risk and outlined in the procedures. This will include the actions necessary if monitoring indicates a result is outside of the defined limits. (Further details on corrective action procedures are in section 3.7).", "requirement_fr": "Les installations de NEP, le cas échéant, doivent être contrôlées à une fréquence définie basée sur les risques. Cela peut inclure :\n•\t la surveillance des paramètres du processus définis dans la clause 4.11.7.2\n•\t la vérification de la conformité de la mise en place des connexions, des tuyauteries et des réglages\n•\t la confirmation que le processus fonctionne correctement (c-à-d. la fermeture/l’ouverture séquencielle des valves, le fonctionnement adéquat des têtes de lavage)\n•\t la vérification de la bonne exécution du cycle de nettoyage\n•\t la surveillance de l’efficacité des résultats, y compris de l’écoulement, si nécessaire.\nLes procédures doivent définir les actions à entreprendre si la surveillance indique que le traitement se trouve hors des limites définies.\n4.11.8 Surveillance environnementale Des programmes de surveillance environnementale basés sur les risques doivent être en place pour les agents pathogènes ou les organismes de détérioration pertinents. Au minimum, ceux-ci doivent inclure toutes les zones de production contenant des produits nus et/ou prêts à consommer."}, {"id": "4.11.8.1", "requirement": "The design of the environmental monitoring programme shall be based on risk, and at a minimum include: • sampling procedures • identification of sample locations • frequency of tests • target organism(s) (e.g. pathogens, spoilage organisms and/or indicator organisms) • test methods (e.g. settle plates, rapid testing and swabs) • recording and evaluation of results. The programme and its associated procedures shall be documented.", "interpretation": "The programme must be based on risk assessment. At a minimum this will include: • a sampling procedure. It is important to ensure that the sampling method does not inadvertently create false positives (e.g. by allowing post-sampling contamination or growth of organisms) or false negatives (e.g. by killing organisms in the sample before the test is completed). Sampling must be appropriate for the target organisms, test methods and locations sampled; techniques may include swabs, air sampling, water/liquid samples etc. The timing and intended purpose of the sampling are also important; for example, cleaning validation, or monitoring of the spread of an organism from a potential harbourage area • identification of suitable test locations, taking into account: • significance of the area or equipment in terms of the potential to affect food safety; for example, food contact surfaces, non-food contact areas which are in close proximity to open products, and non-food contact areas some distance away from open products (e.g. floors, walls and drains) • areas or parts of equipment that are difficult to clean and could harbour pathogens • areas of the site or equipment which previously tested positive • areas where scientific literature has identified a specific risk (e.g. drains) • frequency of tests, taking into account: • products that support the growth of pathogens. These require a greater frequency of testing than those that do not support growth • locations with previous positive results or an upward trend towards an action level (clause 4.11.8.2). These are likely to require increased testing to confirm the effectiveness of the action taken • target organisms. These may include specific pathogens that present a risk to the product or environment (e.g. Listeria spp in wet environments or Enterobacteriaceae in dry environments), specific spoilage organisms (e.g. yeast or mould) or hygiene indicator organisms (e.g. total plate count, total coliforms) • test methods. Rapid on-site and laboratory tests are available, and sites should consider the requirements of section 5.6 when deciding which methods and/or laboratories to use. Where knowledge is not available on site, the site may need to obtain guidance; for example, from an accredited laboratory • recording and evaluation of results. The significance of the results and any actions required must be considered (clause 4.11.8.2) • reviews of any legal requirements in the country or region (e.g. relating to types of products, organisms of concern, or frequency or minimum number of tests). The auditor will expect to see the risk assessment and the subsequent plan along with testing protocols, procedures and evidence that the site is completing the plan to schedule. A number of organisations have published guidelines for the development of environmental monitoring programmes, including, for example, the Codex Alimentarius ‘Guidelines on the application of general principles of food hygiene to the control of Listeria monocytogenes in foods’ (CXG 61-2007) – Annex 1.", "requirement_fr": "Le programme de surveillance environnementale doit être basé sur les risques et inclure, au minimum :\n•\t les procédures d’échantillonnage\n•\t l’identification des points d'échantillonnage\n•\t la fréquence des tests\n•\t le ou les organisme(s) ciblé(s) (c-à-d. les agents pathogènes, les organismes de détérioration, et/ou les organismes indicateurs)\n•\t les méthodes de test (c-à-d. les mises en culture, tests rapides et prélèvements)\n•\t l’enregistrement et l’évaluation des résultats.\nLe programme et les procédures qui lui sont associés doivent être documentés."}, {"id": "4.11.8.2", "requirement": "Appropriate control or action limits shall be defined for the environmental monitoring programme. The company shall document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate an upward trend of positive results (i.e. a trend towards a control or action limit).", "interpretation": "The site will need to establish appropriate control or action limits and the actions to be taken if these are exceeded or when there is a trend towards increasingly positive results. The control limits and actions may be based on: • the organism measured, its level and the location of the positive result • when the testing was completed (e.g. was the sample taken pre- or post-cleaning?) • any legal or customer limits. In addition, many sites have found it useful to: • identify a warning limit (i.e. a limit at a level which is not an exceedance of an action or critical limit, but which allows investigation prior to any exceedance occurring) • use root cause analysis to establish preventive action (e.g. in the case of recurrence of pathogens at a set location).", "requirement_fr": "Des limites d’action ou de contrôle adéquates doivent être définies pour le programme de surveillance environnementale.\nL'entreprise doit documenter l'action corrective à adopter lorsque les résultats des contrôles indiquent que les limites de contrôle ne sont pas respectées, ou lorsque les résultats des contrôles indiquent une tendance à la hausse de résultats positifs (c-à-d. une tendance vers une limite d’action ou de contrôle)."}, {"id": "4.11.8.3", "requirement": "The company shall review the environmental monitoring programme at least annually and whenever there are: • changes in processing conditions, process flow or equipment which could impact the environmental monitoring programme • new developments in scientific information (e.g. new pathogens of concern) • failures of the programme to identify a significant issue (e.g. regulatory authority tests identifying positive results which the site programme did not) • product failures (products with positive tests) • consistently negative results (e.g. a site with a long history of negative results should review its programme to consider whether the correct parts of the factory are being tested, whether the testing is being conducted correctly, whether the tests are for the appropriate organisms, etc.).", "interpretation": "The review of the programme could be accomplished as part of the HACCP review or as a separate review process. The Standard lists several points which might prompt a review, including: • changes in processing, as these could, for example, affect the ease of cleaning or susceptibility of products to contamination and therefore impact the environmental monitoring programme. For example, any changes to the cleaning procedures, including changes in cleaning frequency, cleaning chemicals or cleaning equipment used, may impact the cleanliness of equipment and facilities, and should therefore be considered as part of a review of the environmental monitoring procedures • publication of new scientific information, such as the identification of a micro-organism not previously associated with a specific product type, information relating to the survival of a pathogen in specific environmental conditions, or any new information on new and emerging pathogens • when independent testing (e.g. by a regulatory authority) identifies positives not previously identified by the site’s own tests • when a positive test on a product implicates the effectiveness of the environmental monitoring programme; note that not all product failures indicate a failure in the effectiveness of the programme, but the site’s root cause analysis and corrective action (see section 3.7) should identify those where the environmental monitoring programme should be reviewed. • In most situations, negative results are seen as good news and lead to an assumption that all systems are operating correctly and within permitted parameters. However, if results are continuously and consistently negative and there is a long history of negative results, this may be indicative that the site should review its programme to consider whether the correct locations are being tested, in the correct way, for the correct organisms. The aim of the programme is, after all, to identify areas of concern.", "requirement_fr": "L’entreprise doit revoir le programme de surveillance environnementale au moins une fois par an et en cas :\n•\t de changement des conditions de transformation, du flux de processus ou de l’équipement qui pourraient affecter le programme de surveillance environnementale\n•\t de nouvelles avancées scientifiques (c-à-d. de nouveaux agents pathogènes préoccupants)\n•\t d’échec du programme dans l’identification d’un problème significatif (c-à-d. des tests d’autorités légales positifs que le programme du site a manqué d’identifier)\n•\t de défaillance des produits (produits dont les tests sont positifs)\n•\t de résultats systématiquement négatifs (c-à-d. un site obtenant des résultats invariablement négatifs devrait examiner son programme pour déterminer si les bonnes zones de l’usine sont testées, si les tests sont effectués correctement, si les tests ciblent les organismes appropriés, etc.).\n4.12\t Déchets et traitement des déchets Les déchets doivent être traités conformément aux exigences légales et pour éviter l'accumulation, le risque de contamination et l'attraction des nuisibles."}, {"id": "4.12.1", "requirement": "Where licensing is required by law for the removal of waste, it shall be removed by licensed contractors and records maintained.", "interpretation": "Waste contractors must be appropriately licensed and/or approved where this is required by local law.\nWhere legislation exists for specific waste streams (e. g. disposal of meat products), this must be complied with; such legislation may include requirements for segregation of waste or specific methods of disposal.\nRecords of removal must be maintained and available for audit.", "requirement_fr": "Lorsqu'une licence est requise par la loi pour le retrait des déchets, ces derniers doivent être retirés par des entrepreneurs autorisés, et des enregistrements des retraits doivent être conservés et disponibles en cas d'audit."}, {"id": "4.12.2", "requirement": "Internal and external waste collection containers and rooms housing waste facilities shall be managed to minimise risk (clearly identified, easy to clean, emptied appropriately).", "interpretation": "Waste collection containers and rooms housing waste facilities must be managed to minimise the risk of contamination of products. Particular consideration must be given to:\n• identification of waste containers and storage areas to ensure waste is collected only in designated containers/areas\n• ease and effectiveness of cleaning (see section 4. 11)\n• keeping facilities well maintained\n• emptying at appropriate frequencies\n• keeping external waste containers covered or room doors closed, thus ensuring that waste cannot fall out of containers or stray out of designated rooms to cause a contamination risk\n• the pest control implications of external waste collection areas.", "requirement_fr": "Les conteneurs à déchets intérieurs et extérieurs, et des pièces réservées aux installations de gestion des déchets doivent être organisés de manière à minimiser les risques. Ceux-ci doivent être :\n•\t clairement identifiés\n•\t conçus pour être simples d'utilisation et facilement nettoyables\n•\t bien entretenus pour permettre le nettoyage et, le cas échéant, la désinfection\n•\t vidés à une fréquence adéquate.\nLes conteneurs à déchets extérieurs doivent être couverts ou avec les portes fermées, le cas échéant."}, {"id": "4.12.3", "requirement": "Waste removal from open product areas shall be managed to ensure that it does not compromise product safety.", "interpretation": "Waste should be removed from open product areas to minimise the risk of product contamination (for example, from allergens, pathogens, taint, non-compliance with claims).\nA number of considerations may be needed when planning waste handling, including:\n• risk assessment – to identify the risks associated with specific products or production areas\n• process flow – for example, the movement of product, waste and staff\n• identification of suitable equipment – for example, are lidded or sealed containers needed; are there different types of waste that need to be segregated or handled differently?\n• scheduling of waste removal – for example, how frequently is waste removed; is removal completed during or after the production run?", "requirement_fr": "Dans les zones de produits nus, le retrait des déchets doit être géré de manière à ne pas compromettre la sécurité sanitaire des produits."}, {"id": "4.12.4", "requirement": "If unsafe products or substandard trademarked materials are transferred to a third party for destruction, that third party shall be a specialist and provide records.", "interpretation": "Requirements for the disposal of trademarked waste must be defined within a contract with the waste disposal contractor. Records of destruction or disposal must be maintained. The objective is to ensure that waste products do not re-enter the food supply chain once sent for disposal. If unsafe products are transferred to a third party for destruction, the third party must be a specialist in secure product or waste disposal and must provide records which include the quantity of waste collected.\n4. 13 Management of surplus food and products for animal feed Effective processes shall be in place to ensure the safety and legality of by-products of the primary processing activity of the site.\nAll products intended for the human food chain must not be injurious to health, and must be fit for human consumption. Therefore the site’s procedures to control the handling and storage of surplus food and by-products must ensure that safety and legality are maintained.\nSimilarly, by-products or other materials intended for animal feed must meet the relevant requirements for safety and legality pertaining to those supply chains.", "requirement_fr": "Si des produits dangereux ou des matériaux de qualité inférieure portant un nom de marque sont transférés à un tiers pour qu'il procède à leur destruction ou mise au rebut, ce tiers doit être spécialisé dans la mise au rebut sûre de produits ou déchets, et il doit fournir des enregistrements incluant la quantité de déchets collectée pour leur destruction ou mise au rebut.\n4.13\t Gestion des excédents alimentaires et des produits pour l'alimentation animale Des processus efficaces doivent être en place pour garantir la sécurité sanitaire et la légalité des produits dérivés de l'activité de transformation principale du site."}, {"id": "4.13.1", "requirement": "Surplus customer-branded products shall be disposed of in accordance with customer-specific requirements. Customer brand names shall be removed unless otherwise authorised.", "interpretation": "This clause covers the situation where surplus product is not required by the intended customer (e. g. because of a fall in predicted orders), but is still suitable for sale to alternative customers. It does not include sales to staff or donations to charity, which are covered separately in clause 4. 13. 2.\nThe release of surplus product to alternative customers must only take place in accordance with the original brand owner’s specific requirements. For example, in many cases the product packaging (or associated documentation) will refer to the brand owner and these brand names will need to be removed before the product leaves the site.", "requirement_fr": "L'excédent de produits de la marque du client doit être mis au rebut conformément aux exigences du client. Les noms de marque du client doivent être retirés des produits emballés excédentaires sous le contrôle de l'usine avant que le produit n'entre dans la chaîne d'approvisionnement, sauf autorisation contraire du client."}, {"id": "4.13.2", "requirement": "Where customer-branded products which do not meet specifications are sold to staff or charities, this shall be with the prior consent of the brand owner.", "interpretation": "Many companies sell products to staff or donate them to charity when they are not required by the intended customer (e. g. because of a fall in predicted orders, minor cosmetic damage to packaging, or failure to meet the brand owner’s specification).\nIn many cases the product packaging (or associated documentation) will refer to the brand owner and therefore release to charity or staff must only take place with the prior consent of the brand owner. It is not necessary for the site to obtain this consent for each individual batch of product or on each occasion that the product is sent to a charity; however, the brand owner’s policy or permission must be defined (e. g. in a policy document or within the company’s contract).\nAll products (customer-branded and own brand) must still be safe, be legal (e. g. meet legal requirements for labelling), maintain traceability and be fit for consumption; therefore the site should have documented procedures which detail the product assessment and release process. Staff responsibilities, including which staff have authorisation to release products for staff sale or charitable donation, should also be made clear.", "requirement_fr": "Lorsque des produits portant la marque du client ne répondent pas aux exigences et sont vendus au personnel ou donnés à des organisations caritatives ou autres, l'autorisation préalable du propriétaire de la marque est requise.\nDes processus doivent être en place pour garantir que tous les produits (de marques propres ou portant la marque du client) qui sont vendus au personnel, ou donnés à des organisations caritatives ou autres, sont propres à la consommation et conformes aux exigences légales, et que leur traçabilité est maintenue."}, {"id": "4.13.3", "requirement": "By-products and downgraded/surplus products intended for animal feed shall be segregated from waste and protected from contamination.", "interpretation": "In many parts of the world, there are specific regulations relating to the suitability of products and by-products for inclusion in animal feed (e. g. EU legislation on animal by- products and the control of transmissible spongiform encephalopathies). It is essential that, where products and by-products are supplied for animal feed, the site is aware of, and complies with, the relevant legislation. There are several recognised feed schemes and, where applicable, certification to such a scheme may be required. The animal feed contractor must also be appropriately licensed.\nMaterials for inclusion in animal feed must be segregated from other waste streams and managed to prevent contamination, and should be labelled accordingly.\n4. 14 Pest management The whole site shall have an effective preventive pest management programme in place to minimise the risk of pest presence, and resources shall be available to respond rapidly to any issues which occur to prevent risk to products.\nPest management programmes shall comply with all applicable legislation.\nManagement of pests must be undertaken at a level commensurate with the needs of the whole site, including temporary or seasonal facilities and all storage units, based on the:\n• nature of identified potential pests, including rodents, insects and birds\n• characteristics of raw materials (regarding their potential for stored insect pests)\n• equipment\n• finished products\n• process\n• site and environment (e. g. prevention of ingress and the removal of potential pest harbourage)\n• potential for future pest risks\n• legal requirements in the country or region where the site is located.\nWhere instances of pest ingress (i. e. single occasion or low numbers) occur, these need to be appropriately investigated and actioned but must not be deemed as loss of control. However, where there is pest presence (i. e. evidence of large numbers of pests breeding within the building or site over a period of time), this must be regarded as loss of control and a lack of maintenance of the pest management programme, and will lead to a major non- conformity being awarded.\nWhere a site uses pest management contractors or suppliers, the relevant clauses from sections 3. 5.3, 4. 1 and 7.\napply.\nBRCGS publishes a separate best-practice guideline on pest management, which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Les produits dérivés et les produits de qualité inférieure ou excédentaires destinés à l'alimentation animale doivent être séparés des déchets et protégés de la contamination durant leur stockage. Les produits pour l'alimentation animale doivent être gérés, conformément aux exigences légales applicables.\n4.14\t Lutte contre les nuisibles L'ensemble du site doit avoir mis en place un programme efficace de gestion préventive des nuisibles afin de minimiser les risques de présence de nuisibles. Des moyens doivent être disponibles pour répondre rapidement à tout problème pouvant entraîner un risque pour les produits.\nLes programmes de gestion des nuisibles doivent être conformes à l’ensemble de la législation en vigueur."}, {"id": "4.14.1", "requirement": "If pest activity is identified, it shall not present a risk of contamination to products, raw materials or packaging.", "interpretation": "Where pest activity is identified (for example, during site inspections (clauses 4. 14. 2 and\n4. 14. 10) or reported by staff (clause 4. 14. 12)), actions must be taken to ensure the risk of contamination of products, raw materials or packaging is avoided. The site will therefore need to record and assess any reported pest activity in a timely manner to ensure appropriate action can be taken. This may include action by the site (e. g. isolation of at-risk product) or by its approved pest management contractor (clause 4. 14. 2).\nWhere an infestation occurs, this must be clearly documented and effectively managed (clause 4. 14. 8).\nAny products, raw materials or packaging implicated by pest activity should be subject to the site’s non-conforming product processes (see section 3. 8).", "requirement_fr": "Si une activité de nuisibles est détectée, elle ne doit pas présenter de risques de contamination des produits, des matières premières ou des emballages.\nLa présence d'une infestation sur le site doit être consignée dans les enregistrements de gestion des nuisibles et être ciblée par un programme de contrôle des nuisibles efficace permettant d'éliminer ou de gérer l'infestation de manière à ce qu'elle ne présente aucun risque pour les produits, les matières premières ou les emballages."}, {"id": "4.14.2", "requirement": "The site shall either contract the services of a competent pest management organisation or have appropriately trained staff for regular inspection and treatment. The frequency of inspections shall be determined by risk assessment.", "interpretation": "There must be regular inspection and, where appropriate, treatment of the site to deter and eradicate infestation. The frequency of inspection and treatment of the premises must be based on the product risk, including the age, design and location of the buildings and equipment.\nPest management is often contracted to external companies, which may need to be licensed or approved by local or national authorities. The contractor must demonstrate competence (evidence could, for example, include membership of a national trade association, training records, licence or CEPA certification to EN 16636 for pest management services). Section", "requirement_fr": "Le site doit soit recourir aux services d'une entreprise compétente de gestion des nuisibles, soit compter sur des employés formés correctement, afin de procéder à des inspections et à des traitements réguliers du site pour prévenir et éliminer toute infestation.\nLa fréquence des inspections doit être déterminée sur la base d'une évaluation des risques et être documentée. L’évaluation des risques doit être revue lorsque :\n•\t des changements pouvant avoir une incidence sur le programme de gestion des nuisibles sont apportés au bâtiment ou aux processus de production\n•\t un problème de nuisibles important a été constaté.\nLorsque les services d'une entreprise de gestion des nuisibles sont utilisés, l'étendue du service doit être clairement définie et refléter les activités du site.\nLa prestation de services, quelle qu’en soit la source, doit répondre à toutes les exigences réglementaires applicables."}, {"id": "4.14.3", "requirement": "Where a site undertakes its own pest management, it shall be able to effectively demonstrate that operations are undertaken by trained and competent staff, resources are sufficient, and legislation is complied with.", "interpretation": "With regard to the need for pest management to be undertaken by trained staff, the auditor will check the appropriate training records for proof of adequate training. Suitable training would be expected to cover all relevant activities that the staff member is responsible for, including, for example, legislation, pest management techniques, correct use of monitoring and control devices, or permitted baits.\nAccess to specialist technical knowledge can be obtained by engaging the services of an external contractor or via trade association membership.\nIn some geographic regions legislation governing the use of pest control products is updated frequently and the appointed staff will need to keep abreast of any changes.", "requirement_fr": "Lorsqu'un site met en place sa propre gestion des nuisibles, il doit être en mesure de démontrer efficacement que :\n•\t les opérations de gestion des nuisibles sont effectuées par des employés formés et compétents, disposant de connaissances suffisantes pour choisir les produits chimiques et les méthodes de protection adaptés à la lutte contre les nuisibles, et pour comprendre les limites de leur utilisation, en fonction de la biologie des nuisibles associés au site\n•\t les employés chargés des activités de gestion des nuisibles répondent aux exigences légales de formation ou d'enregistrement\n•\t les moyens suffisants sont disponibles pour répondre à tout problème d'infestation\n•\t il existe un accès facile aux connaissances techniques spécialisées en cas de besoin\n•\t la législation régissant l'utilisation de produits de lutte contre les nuisibles est comprise et respectée\n•\t des installations spécifiques verrouillées sont utilisées pour stocker les pesticides."}, {"id": "4.14.4", "requirement": "Pest management documentation and records shall be maintained. • up-to-date plan of the site identifying devices. • identification of baits/monitoring devices. • clearly defined responsibilities. • details of pest control products used. • any observed pest activity. • details of treatments undertaken", "interpretation": "Written procedures and inspection documentation must be maintained. These must include:\n• an up-to-date site plan identifying the locations of pest monitoring and control devices.\nThis plan should be reviewed periodically, for instance annually or when there are site changes\n• identification (e. g. a numbered list) of the types of bait and monitoring devices on site\n• clearly defined responsibilities for site management and the contractor. This should include methods of communication, contact details for the nominated site and contractor personnel, and dates for when review meetings will take place\n• details of the pest control products used and instructions for their safe and effective use\n• records of any pest activity observed\n• details of pest control activities undertaken.\nAll pest management inspections must be recorded, even when there are only negative findings to report. This is important for due diligence: in the event of an incident, these records can confirm when the site or area was last inspected and confirmed as satisfactory, and demonstrate this to regulatory authorities and customers. Records can be in any format as long as they are accessible by the site. For example, during an audit the auditor may review paper-based pest management records or, where records are online, ask the site to access the records and demonstrate use of the online system.", "requirement_fr": "Des documents et des enregistrements relatifs à la gestion des nuisibles doivent être conservés. Au minimum, cette procédure doit inclure :\n•\t un plan actualisé de l'ensemble du site où les emplacements des dispositifs de lutte contre les nuisibles sont identifiés\n•\t l'identification des appâts et/ou des dispositifs de contrôle sur site\n•\t les responsabilités clairement définies de la direction du site et du prestataire de services\n•\t les détails des produits de lutte contre les nuisibles utilisés, y compris les instructions pour leur utilisation efficace et les mesures à prendre en cas d'urgence\n•\t toute activité de nuisibles observée\n•\t les détails des traitements utilisés pour la lutte contre les nuisibles.\nLes registres peuvent être imprimés (copie papier) ou stockés sur un système électronique (c-à-d. un système de reporting en ligne)."}, {"id": "4.14.5", "requirement": "Bait stations or other rodent monitoring or control devices shall be appropriately located and maintained. Toxic rodent baits shall not be used within production areas where open product is present except when treating an active infestation.", "interpretation": "Bait stations and other rodent monitoring or control devices must be appropriately designed, located and maintained to limit the potential for contamination of products. This can be achieved by:\n• making them tamper-resistant\n• securing them in place or locating them in positions where accidental movement is unlikely\n• using non-spill formulations\n• inspecting them routinely at a frequency based on risk assessment or local legislation (this is particularly important for areas where live catch, break-back traps or spring-powered traps are permitted because of the potential for secondary pests, if the caught pests are not removed sufficiently quickly).\nThe pest management specialist should advise on the quantity and siting of the monitoring devices; their locations might be risk-based rather than evenly distributed. When an active infestation is being treated, the location of additional monitoring or control devices should be considered.\nRodent bait is generally toxic, so must be controlled to avoid contamination of product.\nToxic rodent bait must not be used within production or storage areas where open product is present, except when treating an active infestation. Where this occurs, the bait must be secured to ensure product cannot be contaminated.\nAny missing bait stations or missing rodent control devices should be recorded and investigated. Additional action may be required depending on the reason for the absent bait station; for example, to ensure that there is no risk to product and that any pest activity has been appropriately managed.", "requirement_fr": "Les stations d'appâts ou tout autre dispositif de surveillance ou de lutte contre les rongeurs doivent être situés de manière adéquate et entretenus pour éviter les risques de contamination du produit. Les appâts toxiques pour rongeurs ne doivent pas être utilisés dans les zones de production ou de stockage contenant des produits nus, sauf pour traiter une infestation active. Lorsque des appâts toxiques sont utilisés, ils doivent être sécurisés.\nToute station d'appâts manquante doit faire l'objet d'une consignation, d'une analyse et d'une enquête."}, {"id": "4.14.6", "requirement": "Insect-killing devices, pheromone traps and/or other insect-monitoring devices shall be appropriately sited and operational.", "interpretation": "Where insect-killing devices, pheromone traps or other insect-monitoring devices are used, they must be correctly sited and operational. If insects could be expelled from an insect- killing device and contaminate the product, alternative systems and equipment must be used (e. g. those based on sticky-board technology) or the devices must be moved to a more appropriate position.\nEquipment must be fully operational. For example, bulbs on insect-killing devices must be changed at regular intervals (in accordance with the manufacturer’s instructions) to maintain optimal luminosity performance (there is no minimum frequency for changing the bulbs, as this will depend on a number of factors, including the brand of bulb used), and pheromone traps must be replenished quarterly or in accordance with the manufacturer’s instructions.\nDocumentation must provide evidence of this maintenance.", "requirement_fr": "Les dispositifs d'extermination des insectes, les pièges à phéromones et/ou autres dispositifs de surveillance des insectes doivent être installés à une distance appropriée et être opérationnels. S'il existe un risque d'expulsion d'insectes du dispositif d'extermination des mouches et de contamination du produit, des systèmes et des équipements alternatifs doivent être utilisés."}, {"id": "4.14.7", "requirement": "The site shall have adequate measures in place to prevent birds from entering buildings or roosting above loading or unloading areas.", "interpretation": "The site (or its pest management contractor) should use a risk assessment approach to establish whether there is any potential for the ingress of birds, or for roosting and nesting at loading or unloading areas, and to assess the measures required to mitigate the risk.\nThe expectation here is not necessarily to rebuild or reconfigure facilities; instead, the intention is to recognise any potential problems and take steps to remove or mitigate these risks from birds roosting and nesting.", "requirement_fr": "Le site doit mettre en place des mesures adéquates pour empêcher les oiseaux d’entrer dans les bâtiments ou de se percher au-dessus des zones de chargement ou de déchargement."}, {"id": "4.14.8", "requirement": "In the event of infestation, immediate action shall be taken to identify at-risk products and to minimise the risk of product contamination.", "interpretation": "In the event of infestation (clause 4. 14. 1), immediate action must be taken to eliminate the hazard. This will include identifying and quarantining any potentially affected product so that it can be evaluated in accordance with the site’s non-conforming product procedures.\nAction may also include steps to protect other products, and inspection by the pest management specialist. Any such infestation and corrective actions taken must be recorded;\nsee section 3. 8 for the non-conforming product procedure.", "requirement_fr": "Dans le cas d'une infestation ou de preuve d'activité de nuisibles, des actions immédiates doivent être prises pour identifier les produits à risque et minimiser les risques de contamination des produits. Tout produit potentiellement affecté doit faire l'objet de la procédure relative aux produits non conformes."}, {"id": "4.14.9", "requirement": "Records of pest management inspections, pest proofing and hygiene recommendations and actions taken shall be maintained.", "interpretation": "Records of pest management will include any recommendations made by the pest management specialist (e. g. changes to inspection frequency or pest proofing).\nIt is the responsibility of the company to ensure that all relevant recommendations made by the pest management specialist are carried out within a suitable timescale and verified for effectiveness. Records of these changes must be maintained.", "requirement_fr": "Des enregistrements relatifs à l'inspection de gestion des nuisibles, aux méthodes de lutte contre les nuisibles ainsi qu'aux recommandations et aux actions prises en matière d'hygiène doivent être conservés. Il est de la responsabilité du site de s'assurer que toutes les recommandations pertinentes émises par son fournisseur de services ou par son expert interne sont mises en place rapidement."}, {"id": "4.14.10", "requirement": "An in-depth, documented pest management assessment shall be undertaken at a frequency based on risk, but at least annually, by a pest management expert.", "interpretation": "In-depth pest management assessments are in addition to the regular inspections (e. g. monthly checks of bait and traps) conducted as part of the pest management programme (clause 4. 14. 2).\nThe aim of these assessments is to:\n• ensure an in-depth inspection of the site, equipment and facilities for evidence of pest activity and to determine the current levels of pest activity throughout the site. This should not be a matter of mere bait checking, but should include an audit of the whole of the site, especially in less accessible areas such as voids and cable runs, stores and silos (see below), where established pests are less easy to detect\n• review existing measures to provide a critical appraisal of the site’s pest management activities to ensure they remain appropriate\n• where appropriate, liaise with the technician who completes the routine pest management activities, to agree changes to the pest management programme\n• review pest management-related records\n• suggest alternative approaches to resolving problems\n• liaise with senior site or group management.\nWhere insects in stored product represent a potential hazard, the visits should be scheduled for a time when access to equipment for inspection purposes is available, so that the greatest value can be gained from the survey. Where pest activity is seasonal in nature, the survey may be timed to coincide with the period of greatest risk.\nThe assessment will be completed by a pest management expert (e. g. the pest management contractor’s field biologist or a senior technician with a qualification in pest management and many years of experience). Many countries have formal qualifications for those working in pest management; for example, by operating a legally backed licensing system. Anyone working as a field biologist should at least have a recognised basic pest management qualification, available in the country concerned, irrespective of whether it is a legal requirement. Few countries have formal higher-level pest management qualifications.\nHowever, a field biologist should be a senior, competent technician with a number of years of practical pest management experience. Other desirable qualifications, knowledge and skills may include:\n• possession of a recognised food safety qualification. Field biologists work closely with food, so should be trained to at least the same level as a food-handling employee\n• membership of a relevant continuing professional development (CPD) scheme, if such a scheme exists in the country of operation. At the very least, they should be able to demonstrate that they keep up to date with technical and regulatory developments in pest management\n• knowledge of the scope and content of the food industry standards the site is working to.\nFor example, do they understand the requirements of the Standard and whether the site has to meet any customer-specific requirements?\n• knowledge and understanding of the food manufacturing processes operating at the site, particularly when commodities vulnerable to infestation by stored-product insects are being handled or processed\n• how to use pest monitoring data to effectively target and measure the success of control measures. For example, using monitoring data to generate trend analyses (as opposed to just counts) is key.\nThis highlights an important difference between the in-depth audit and the practical, routine pest management service completed by the pest management technician. It is not simply a second tier of inspection, adding complexity and costs to the contract. The pest management field biologist is on hand to lead the pest management programme, and should use the in-depth audit to guide the efforts of both site personnel and the pest management technician to eliminate problems and maintain pest-free conditions. In pest management terms, the field biologist is the most important person working on behalf of the pest management contractor in any food site. It is therefore important that the site is satisfied that this expert is fully competent and has sufficient knowledge and experience to conduct the audit and produce meaningful results.\nGood practice is to separate the in-depth audit and routine inspections, rather than complete them at the same time. It is also often useful for the in-depth assessment to be conducted by an alternative consultant rather than the staff responsible for the regular inspections, as this has the benefit of a second expert examining the site and the current pest management programme.\nIt is expected that the audits will be completed at least annually; however, risk assessment may indicate that a different frequency is required (e. g. where pest issues are seasonal in nature then the frequency may need to increase). The BRCGS auditor will expect to see the risk assessment that the site has used to determine the appropriate frequency. The results of the surveys should be incorporated into the company management review (clause 1. 1.4).\nThis clause applies to all sites, not just those carrying out their own pest management.\nBRCGS has produced a separate best-practice guideline to pest management which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.\nFurther guidance In-depth report format and content The Standard does not prescribe the format of the report, and each pest management specialist is likely to have their own preferred format. However, it is the content and not the format that is all-important. As a minimum, the report should include:\nAreas inspected The audit report should include reference to the areas inspected, even where no problems have been found. A list of issues requiring attention without any additional detail is unlikely to provide the depth of information that the site requires to improve. If an area has been inspected and found clear, it is important that this is recorded: it is the contractor’s evidence that the area has been inspected, and the food manufacturer’s evidence that there are no problems there.\nAny problems Problems relating to, for example, sanitation and building fabrication should be highlighted.\nThese observations should have as their objective either the eradication of an existing infestation, or the prevention of a new one. Where it is not immediately obvious, the reasons why the observation points to a problem should also be stated, and practical and appropriate recommendations should be made to address these matters.\nFurther guidance Current system review There should be a review of whether the pest management system is suitable; and, if it is found to be inadequate or inappropriate, recommendations should be made regarding alternative proactive pest management practices and strategies.\nSome pest contractors include useful information in addition to the on-site audit; for example, a summary of the pest inspections and trend analysis, as discussed in clause 4. 14. 11.\nThis is acceptable; however, note that this information cannot form a substitute for an on- site visit, or for the audit described above.", "requirement_fr": "Une évaluation de la gestion des nuisibles documentée et approfondie doit être effectuée par un expert en gestion des nuisibles à une fréquence basée sur les risques, mais au moins une fois par an, afin de vérifier les mesures de gestion des nuisibles en place. L’évaluation doit :\n•\t inclure une inspection approfondie du site, des équipements et des installations afin d’identifier toute activité des nuisibles\n•\t vérifier les mesures existantes en matière de gestion des nuisibles et émettre des recommandations sur des changements éventuels.\nLa date de l'évaluation doit être fixée de manière à permettre l'accès aux équipements pour leur inspection lorsqu'il existe un risque d'infestation par des insectes des produits stockés."}, {"id": "4.14.11", "requirement": "Results of pest management inspections shall be assessed and analysed for trends on a regular basis (annually or in the event of infestation).", "interpretation": "There must be a periodic assessment of pest management inspection results and trends. The review will consider:\n• pest control measures\n• bait takes\n• analysis from trapping and monitoring devices\n• identification of any trends\n• action taken\n• recommendations for changes or improvement.\nAt a minimum, this periodic assessment must be conducted annually (or sooner in the event of an infestation).", "requirement_fr": "Les résultats des inspections relatives à la gestion des nuisibles doivent être étudiés et analysés régulièrement pour dégager des tendances. Au minimum, les résultats de ces inspections doivent être analysés :\n•\t une fois par an ou\n•\t dans le cas d'une infestation.\nL’analyse doit inclure les captures réalisées par les pièges et les dispositifs de contrôle, afin d'identifier les zones à problème. L'analyse doit servir de base à l'amélioration des procédures de gestion des nuisibles."}, {"id": "4.14.12", "requirement": "Staff shall understand the signs of pest activity and be aware of the need to report any evidence of such activity.", "interpretation": "Any member of staff on the site should be trained to recognise pest activity in production or storage areas, and this can form part of the site’s induction and refresher training programme.\nThe content might address typical pests, different types of evidence of pest activity, and the food safety implications. Subsequently, any pest activity witnessed by any member of staff needs to be reported to the designated person.\nThe identification of the designated person and the process by which information should be reported also need to be communicated to the staff. The designated person will need to record the evidence and assess whether additional action is required.\n4. 15 Storage facilities All facilities used for the storage of raw materials, packaging, in-process products and finished products shall be suitable for purpose.\nThe site’s procedures for storage must be controlled to ensure they do not pose a risk to products. This includes all raw materials and packaging, intermediates and finished products. Storage facilities must be suitable for all products stored and take into consideration the requirements for specific products; for example:\n• the temperature at which the product must be stored\n• allergen management\n• segregation, where required; for example, food and non-food storage.", "requirement_fr": "Le personnel doit reconnaître les signes d'une activité de nuisibles et être conscient de l'importance d'informer un supérieur désigné de toute preuve d’une telle activité.\n4.15\t Installations de stockage Toutes les installations utilisées pour le stockage des matières premières, des emballages, des produits en cours de transformation et des produits finis doivent être adaptées à leur utilisation prévue."}, {"id": "4.15.1", "requirement": "Procedures to maintain product safety and quality during storage shall be developed on the basis of risk assessment. • managing chilled and frozen product transfer. • segregation of products. • storing materials off the floor and away from walls. • specific handling or stacking requirements", "interpretation": "The company must consider the potential risks to product safety and quality that may develop during storage. For example, if a product is temperature-controlled, the specified temperature must be maintained throughout the storage of the product.\nIn addition to the points listed in the requirement, the company should also maintain the cleanliness of the storage areas (e. g. with appropriate cleaning procedures and identified frequencies, as evidenced by documented records), in accordance with the requirements in section 4. 11.", "requirement_fr": "Des procédures permettant de garantir la sécurité sanitaire et la qualité des produits durant leur stockage doivent être élaborées sur la base de l'évaluation des risques, comprises par le personnel concerné et mises en place correctement. Ces procédures doivent inclure, s'il y a lieu :\n•\t la gestion du transfert des produits réfrigérés et surgelés entre les zones à température maîtrisée\n•\t la séparation des produits, le cas échéant, pour éviter la contamination croisée (physique, microbiologique ou allergénique) ou l'apparition d'altérations du goût ou de l'odeur\n•\t le stockage des matières hors du sol et loin des murs\n•\t des exigences spécifiques relatives à la manipulation ou à l'empilement pour éviter l'endommagement des produits."}, {"id": "4.15.2", "requirement": "Where appropriate, packaging shall be stored away from other raw materials and finished product.", "interpretation": "In order to avoid product contamination risks from packaging (such as glass) or contamination of unused packaging by-products, packaging should be stored away from raw materials and finished product. This may be achieved by use of a dedicated packaging store or a dedicated area of a raw material store. Only packaging required for immediate use should be stored in the actual packing area (clause 6. 2.1).\nThe storage of packaging outside is acceptable only where the packaging material:\n• is not at risk of deterioration (e. g. rusting of cans)\n• is protected from contamination\n• is cleaned effectively before filling.\nOnce packing has finished, controls must be in place to ensure that any leftover packaging is still suitable for use before its return to storage (e. g. it has not been contaminated or printed with code information preventing reuse). Any open containers must be appropriately resealed or rewrapped and returned to appropriate storage to minimise the potential for contamination (such as splashing during cleaning operations) or mis-packs. The traceability of packaging should be retained (i. e. the coding is retained on the outer packs on return to storage).", "requirement_fr": "Les emballages doivent être stockés à l'écart des autres matières premières et produits finis, le cas échéant. Tout matériau d'emballage partiellement utilisé et pouvant être réutilisé doit être efficacement protégé de la contamination et clairement identifié pour pouvoir effectuer sa traçabilité avant qu'il ne reparte vers une zone de stockage adaptée."}, {"id": "4.15.3", "requirement": "Where temperature control is required, the storage area shall be capable of maintaining product temperature within specification. Temperature recording equipment with alarms shall be fitted or manual checks recorded.", "interpretation": "Where temperature control is required for the appropriate storage of products, the storage area must be capable of maintaining the required temperature. Good practice is for doors to close automatically or be alarmed to ensure they cannot be inadvertently left open.\nTemperature management is usually carried out through the use of automatic temperature recording systems, which raise an alarm when temperatures fall outside a set range for a defined period (to allow for the usual defrost cycles). The alarm must be capable of notifying a responsible person outside of normal working hours, either by notification to on-site security, by a home call or by ringing through to a service centre.\nWhere such automatic systems are not in use, the same level of safeguard to product temperature control needs to be instigated through manual temperature checks. To achieve a similar level of control, manual temperature checks should be carried out on a 4-hourly basis, including during nights and weekends. The frequency of checks could be reduced where the nature of the product and the insulating capability of the unit are such that the product would remain unaffected by a refrigeration failure of longer than 4 hours (e. g. some frozen products). Ongoing temperature records must demonstrate that product temperature requirements are being met.\nProcedures must specify the frequency of manual checks or the use of automatic continual monitoring systems. All temperature monitoring must allow intervention before product temperatures exceed defined limits for the safety, legality or quality of products. Procedures should therefore identify the action to be taken in the event that:\n• temperature monitoring indicates temperatures outside of the permitted levels\n• there is a failure of the temperature control systems (e. g. a breakdown of the chiller or freezer).\nIn regions where ambient temperatures may fluctuate considerably (e. g. large seasonal differences, or considerable variation from day to day), the site should be aware that this may have an adverse effect on ambient storage as well as chilled and frozen facilities. Depending on the product type, the site may need to consider emergency contingency monitoring or control to ensure product safety or quality.", "requirement_fr": "Lorsqu'un contrôle de la température est requis (c-à-d. pour les matières premières, les matières semi-finies ou les produits finis), la zone de stockage doit être en mesure de maintenir la température du produit conformément aux spécifications et elle doit être gérée de manière à garantir des températures spécifiques. Des équipements d'enregistrement des températures munis d'alarmes garantissant des températures adéquates doivent être installés sur toutes les installations de stockage, ou un système de vérification de consignation manuelle des températures doit être en place, généralement au moins toutes les 4 heures ou à une fréquence permettant une intervention avant que les températures des produits ne dépassent les limites définies garantissant la sécurité sanitaire, la légalité ou la qualité des produits."}, {"id": "4.15.4", "requirement": "Where controlled atmosphere storage is required, the storage conditions shall be specified and effectively controlled.", "interpretation": "Where storage conditions include other parameters (e. g. modified atmosphere storage of fruit and vegetables), the mix of gases needs to be defined and monitored to ensure the quality of the product is maintained.\nTests are required to ensure that the correct composition of gases is present. They are different from the tests identified in clause 4. 5.3, which relate to contamination and food safety. Test results must be recorded.", "requirement_fr": "Lorsqu'un stockage en atmosphère maîtrisée est nécessaire, les conditions de stockage doivent être spécifiées et contrôlées efficacement. Des enregistrements relatifs aux conditions de stockage doivent être conservés."}, {"id": "4.15.5", "requirement": "Where storage outside is necessary, items shall be protected from contamination and deterioration.", "interpretation": "Where it is necessary to store product and equipment outside, they must be protected from pests and the elements. Therefore storage of products and equipment outside is normally appropriate only where the site can demonstrate that the material:\n• is not at risk of deterioration\n• is protected from contamination\n• is cleaned effectively before being brought into the factory.\nParticular attention must be paid to cleaning and inspection of the materials before they are brought into the factory and used, to prevent contamination.", "requirement_fr": "Lorsqu'un stockage en extérieur est nécessaire, les produits doivent être protégés de la contamination et de la détérioration. Les produits doivent être examinés pour vérifier qu'ils sont adéquats avant d'être introduits dans l'usine."}, {"id": "4.15.6", "requirement": "The site shall facilitate correct stock rotation of raw materials, intermediate products and finished products.", "interpretation": "Stock, whether raw materials, intermediates (including rework) or finished products, must be controlled to ensure that materials are used in an appropriate order and do not exceed their shelf life. This control is generally operated on a ‘first in, first out’ basis.\nProduct identification, such as labelling, and inventory systems can help to facilitate the correct order in relation to the materials’ manufacturing dates and prescribed shelf life.\n4. 16 Dispatch and transport Procedures shall be in place to ensure that the management of dispatch and of the vehicles and containers used for transporting products from the site do not present a risk to the safety, security or quality of the products.\nThe site’s procedures for dispatch and transport must be controlled to ensure they do not pose a risk to final products.\nWhere transport or distribution is subcontracted, the requirements for suppliers of services also apply (see section 3. 5.3).", "requirement_fr": "Le site doit faciliter une rotation adéquate des stocks de matières premières, de produits intermédiaires et de produits finis et s'assurer que les matières sont utilisées dans le bon ordre en fonction de leur date de fabrication et de leur durée de vie.\n4.16\t Expédition et transport Des procédures doivent être en place pour garantir que la gestion de l'expédition des véhicules et conteneurs utilisés pour le transport des produits depuis le site ne présente aucun risque pour la sécurité sanitaire, la sûreté et la qualité des produits."}, {"id": "4.16.1", "requirement": "Procedures to maintain product safety and quality during loading and transportation shall be developed and implemented. • controlling temperature. • use of covered bays. • securing loads on pallets. • inspection of loads", "interpretation": "The site must consider the potential risks to product safety and quality that may develop during dispatch and transport. In addition to the points listed in the requirement, vehicles should also be inspected prior to loading and unloading (clause 4. 16. 2).", "requirement_fr": "Des procédures permettant de garantir la sécurité sanitaire et la qualité des produits durant leur chargement et leur transport doivent être élaborées et mises en place. Ces procédures doivent inclure, s'il y a lieu :\n•\t un contrôle des températures des zones de quai de chargement et des véhicules\n•\t l'utilisation de plateformes couvertes pour le chargement ou le déchargement des véhicules\n•\t la fixation des chargements sur des palettes afin d'éviter tout mouvement durant le transport\n•\t l'inspection des chargements avant leur expédition."}, {"id": "4.16.2", "requirement": "All vehicles or containers used for the transport of raw materials and the dispatch of products shall be fit for purpose (clean, free from odours, suitable condition, equipped for temperature requirements).", "interpretation": "Inspection of vehicles should be a site’s responsibility even where the vehicles and distribution are subcontracted. At a minimum, the inspection will cover whether vehicles have the correct levels of cleanliness and are free from evidence of pests and strong odours (which could taint a product), and have been maintained to prevent product damage during transit.\nThe site should ensure that the correct operating temperatures are capable of being maintained throughout transportation (i. e. that the refrigeration temperature ranges remain within the permitted parameters). This may include pre-cooling trailers for temperature- sensitive products prior to loading, to maintain correct temperatures.\nVehicle inspection records must be maintained.", "requirement_fr": "Tous les véhicules ou conteneurs utilisés pour le transport des matières premières et l'expédition des produits doivent être adaptés à l'usage prévu. L'inspection doit vérifier qu'ils sont :\n•\t propres\n•\t exempts d'odeurs fortes qui pourraient affecter l'odeur ou le goût des produits\n•\t en bon état pour éviter qu'ils n'endommagent les produits durant le transport\n•\t équipés pour garantir le respect de toute exigence de température pendant la durée du transport.\nDes enregistrements de toutes les inspections doivent être conservés."}, {"id": "4.16.3", "requirement": "Where temperature control is required, the transport shall be capable of maintaining product temperature within specification. Temperature data-logging devices or monitoring systems shall be used.", "interpretation": "Vehicles that are temperature-controlled must demonstrate the control of temperature under both minimum and maximum loads. This can be achieved through the use of temperature recorders, data loggers or manual recorded checks. Where manual checks are used, the frequency of checking must ensure that the safety and quality of the product are maintained. The use of data loggers may be considered as a monitoring method; data received should be analysed to ensure that the temperature of products transported is maintained.", "requirement_fr": "Lorsqu'un contrôle de la température est requis, le moyen de transport doit être en mesure de maintenir la température du produit, conformément aux spécifications, dans des conditions de charge minimale et maximale. Des appareils d'enregistrement des données relatives à la température pouvant être consultés pour vérifier les conditions de temps et de température, ou un système de contrôle et d'enregistrement du fonctionnement correct des équipements de réfrigération à des fréquences prédéterminées, doivent être utilisés, et des enregistrements doivent être conservés."}, {"id": "4.16.4", "requirement": "Maintenance systems and documented cleaning procedures shall be available for all vehicles and equipment used for loading/unloading.", "interpretation": "Documented hygiene and maintenance procedures for all vehicles (e. g. forklift trucks, pallet trucks) and equipment (e. g. loading hoses for silos) must be in place. They must include:\n• the method(s) of cleaning\n• the frequency at which the cleaning must be completed\n• records that the cleaning has been completed.", "requirement_fr": "Des systèmes d'entretien et des procédures de nettoyage documentées doivent être disponibles pour tous les véhicules et équipements utilisés pour le chargement/déchargement.\nLes mesures prises doivent être enregistrées."}, {"id": "4.16.5", "requirement": "The company shall have procedures for the transport of products, including restrictions on mixed loads, security requirements and instructions for vehicle breakdown.", "interpretation": "The site must have procedures for the transport of products. The procedures must include:\n• the identification of any restrictions for mixed loads (e. g. specifying where allergen-free materials are to be stored or transported) to avoid cross-contamination or taint uptake\n• the security of all finished products in transport to ensure that they cannot be contaminated, either accidentally or deliberately. This may include tamper-evident packing, vehicle seals or contractual handling arrangements with transport providers (such as not leaving vehicles unattended in insecure situations)\n• breakdown procedures for temperature-controlled vehicles (in case of, for example, vehicle breakdown or failure of the refrigeration system). These should consider:\n• facilities for vehicle drivers to easily contact the company or haulier for assistance\n• provision of a backup vehicle or rapid-repair facility\n• guidelines to evaluate the acceptability of product affected by the breakdown.\nThe appropriate staff must be trained in these procedures.", "requirement_fr": "L'entreprise doit posséder des procédures pour le transport des produits. Ces dernières doivent inclure :\n•\t toute restriction relative à l'utilisation de chargements mixtes\n•\t les exigences de sécurité des produits durant le transport, en particulier lorsque les véhicules sont garés et sans surveillance\n•\t des instructions claires en cas de panne du véhicule, d'accident ou de défaillance des systèmes de réfrigération, permettant de garantir une évaluation de la sécurité sanitaire des produits et la conservation des enregistrements."}, {"id": "4.16.6", "requirement": "Where the company uses contractors, it shall have a documented supplier approval procedure to ensure risks to food quality and safety are effectively managed.", "interpretation": "Where the company uses third-party contractors for transport of products, it must have a documented supplier approval procedure to ensure food safety and quality of products during these activities. As a minimum, the approval procedure will include either:\n• certification to a BRCGS Standard (e. g. Global Standard Storage and Distribution) or standard benchmarked by GFSI or\n• a contract with terms and conditions, verified and reviewed by a competent person. As a minimum, this contract must include terms and conditions to meet all the requirements of clauses 4. 16. 1 to 4. 16. 5.\nThe use of a contract or terms and conditions for defining the requirements may also be an option where other forms of transport are used (e. g. couriers or larger-scale carriage such as rail transport).\nThe requirements in section 3. 5.3 relating to suppliers of services also apply to dispatch and transport contractors.\n5 Product control\n5. 1 Product design/development Product design and development procedures shall be in place for new products or processes and any changes to product, packaging or manufacturing processes to ensure that safe and legal products are produced.\nProcedures must be in place to ensure that all new product development and amendments to existing products result in safe products.\nNew product development or the introduction of new ingredients must not compromise existing activities or products handled in the same area; for example, the introduction of an allergen or microbiological risk that does not already exist in the area would need to be risk-assessed and managed to prevent contamination of existing products.", "requirement_fr": "Lorsque l’entreprise utilise des sous-traitants, elle doit adopter une procédure documentée d’approbation des fournisseurs, afin d’assurer une gestion efficace des risques liés à la qualité et à la sécurité des denrées alimentaires durant les activités d'expédition et de transport. La procédure d'approbation doit être basée sur les risques et inclure un ou plusieurs des points suivants :\n•\t une certification valide dans le cadre de la Norme du BRCGS (c-à-d. la norme Global Standard Stockage et Distribution) ou d’une norme reconnue par la GFSI ou\n•\t un contrat dûment rempli ou des modalités et conditions. Au minimum, ces derniers doivent inclure toutes les exigences des clauses 4.16.1 à 4.16.5. Ils doivent avoir été examinés et vérifiés par une personne manifestement compétente.\n5 Contrôle des produits 5.1 Conception/développement des produits Les procédures de conception et de développement des produits doivent être en place pour les nouveaux produits ou processus et pour toute modification des produits, emballages ou processus de fabrication, afin de garantir que des produits sans danger et légaux sont fabriqués."}], "statement_of_intent": "The production site shall be of suitable size, location and construction, and be maintained to reduce the risk of contamination and facilitate the production of safe and legal finished products.", "group_intros": {"4.5": "Utilities used within the production and storage areas shall be monitored to effectively control the risk of product contamination.", "4.2": "Systems shall protect products, premises and brands from malicious actions while under the control of the site.", "4.11": "Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene are maintained at all times and the risk of product contamination is minimised.", "4.4": "The fabrication of the site, buildings and facilities shall be suitable for the intended purpose.", "4.14": "The whole site shall have an effective preventive pest management programme in place to minimise the risk of pest presence, and resources shall be available to respond rapidly to any issues which occur to prevent risk to products.\nPest management programmes shall comply with all applicable legislation.", "4.10": "The risk of product contamination shall be reduced or eliminated by the effective use of equipment to remove or detect foreign bodies.", "4.3": "The factory layout, flow of processes and movement of personnel shall be sufficient to prevent the risk of product contamination and to comply with relevant legislation.", "4.12": "Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, risk of contamination and the attraction of pests.", "4.11.8": "Risk-based environmental monitoring programmes shall be in place for relevant pathogens or spoilage organisms.\nAt a minimum, these shall include all production areas with open and/or ready-to-eat products.", "4.8": "Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and operated to minimise the risk of product contamination. The facilities shall be maintained in good and clean condition.", "4.16": "Procedures shall be in place to ensure that the management of dispatch and of the vehicles and containers used for transporting products from the site do not present a risk to the safety, security or quality of the products.", "4.6": "All production and product-handling equipment shall be suitable for the intended purpose and shall be used to minimise the risk of contamination of product.", "4.1": "The production site shall be of suitable size, location and construction, and be maintained to reduce the risk of contamination and facilitate the production of safe and legal finished products.", "4.7": "An effective maintenance programme shall be in operation for plant and equipment, to prevent contamination and reduce the potential for breakdowns.", "4.9": "preparation, processing, packing and storage areas Appropriate facilities and procedures shall be in place to control the risk of chemical or physical contamination of product.", "4.15": "All facilities used for the storage of raw materials, packaging, in-process products and finished products shall be suitable for purpose.", "4.13": "Effective processes shall be in place to ensure the safety and legality of by-products of the primary processing activity of the site."}, "group_intro_interps": {"4.9.4": "Where products are packed into glass or other brittle materials (e.g. ceramic pots), the risk of breakage is increased and the packaging materials themselves present a significant foreign-body risk. These requirements deal specifically with the additional controls required to reduce the risk of contamination. They do not apply where products are not packed into glass or similar brittle containers.", "4.11.7": "CIP is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings without disassembly. There are various designs of CIP system, but they are often categorised as either of the following: • single-use systems – where the CIP rinse solution is used and replaced with fresh solution • re-use systems – the rinse solution is used and collected so that it can be re-used multiple times. Additionally, the system may be fully automated or semi-automated. CIP equipment is specialist, and therefore operator training is important. See section 7.1 for information on training.", "4.11.8": "The aim of the environmental monitoring programme is to develop a proactive, preventive monitoring programme that will identify and eliminate sources of environmental micro-organisms (e.g. pathogens and spoilage organisms) in production and open product areas of the site, and facilitate timely and effective corrective action in the event of a risk being identified (i.e. prevent the environmental micro-organisms from becoming the source of product contamination which could lead to non-conforming product, a customer complaint or other incidents). An effective programme can, for example, be used to: • confirm the effectiveness of cleaning and hygiene activities and identify any areas that require further activity • prevent product contamination by acting as an ‘early warning’ – identifying potential contamination from the site facilities before they affect products. The design and structure of this programme will depend on the nature of the products being handled and the potential hazards associated with them. The requirements are expected to apply to all sites with: • open product areas • ready-to-eat products • products that are both processed in open product areas and ready-to-eat. Sites are not expected to ‘opt out’ of this requirement by determining that they have a low-risk product or environment; completion of a risk assessment (clause 4.11.8.1) should only be used to identify relevant hazards, suitable monitoring techniques and appropriate monitoring frequencies. There are, however, a small number of products which are inherently safe from these contaminants (e.g. because the product’s intrinsic properties do not support the growth or survival of pathogens or spoilage organisms) and there is no opportunity for spoilage/pathogen contamination, and therefore an environmental monitoring programme may not be required. Where a site believes that this is not required, this belief must have a strong foundation in science and not be used to prevent good practices. Therefore it is expected that: • all sites with high-risk, high-care or ambient high-care operations will have an environmental monitoring programme within the relevant open product areas • environmental monitoring will be applicable to other products, as there have been a number of very high-profile food poisoning outbreaks associated with products not conventionally considered as high risk or high care (for example, cantaloupe melons, peanut butter, chocolate and milk powder), where environmental monitoring may have been effective in identifying an issue early. Similarly, shelf-life issues such as mould contamination of bakery products may be reduced by suitable monitoring. Where a site believes environmental monitoring is not required due to the absence of risk from pathogens and spoilage organisms, the site must prove this absence of risk. As a minimum, the site will have a robust risk assessment which considers: • both spoilage organisms and pathogens • the complete product range at the site. Note that this risk assessment must be more than a history of product testing – it must demonstrate an absence of risk. Suitable techniques include pathogen modelling, challenge testing and published literature from a reputable source demonstrating that pathogens cannot survive or grow. Examples of products where risk assessment may establish that environmental monitoring is not required include: • alcoholic beverages and vinegars with a sufficiently high level of alcohol or acid to prevent survival and growth • salt and sugar in their dry ‘pure’ form • edible oils with no added ingredients • fully enclosed production. For example, at a specialist HPP (high-pressure processing) facility, where product is received packed, is processed in its packaging and leaves the site in the same packaging • whole vegetables, sold unwashed. Auditors will challenge the basis of any risk assessment to make sure this has properly considered likely issues and is demonstrably based on robust science. The requirements for environmental monitoring indicate that the site’s environmental monitoring programme must be risk-based, therefore the food safety plan/HACCP may indicate risks that should be monitored. Risks may include pathogens and/or spoilage organisms (such as yeasts or moulds), and the site should consider whether it is more suitable to monitor the risk directly or via indicator organisms. Well-known examples of pathogens and spoilage organisms that may be applicable to a site’s environmental monitoring include: • Listeria monocytogenes in ready-to-eat products, including those which are chilled and frozen. Alternatively, some sites monitor Listeria spp. and only examine the species if adverse positive results are obtained • Salmonella and/or Enterobacteriaceae in dry environments where susceptible products are handled • yeasts and/or moulds: these are widespread spoilage organisms which may be of greater relevance for some product types. For example, products such as jam are heated to a temperature that will kill many bacterial contaminants, are hot-filled, and have a low water activity and low oxygen content. Consequently, the risk of pathogen growth is limited. However, there are yeasts and moulds that can cause spoilage in these conditions, and therefore manufacturers must ensure that packaging, food contact surfaces and the environment are monitored to minimise the risk of contamination."}, "group_intros_fr": {"4.14": "L'ensemble du site doit avoir mis en place un programme efficace de gestion préventive des nuisibles afin de minimiser les risques de présence de nuisibles. Des moyens doivent être disponibles pour répondre rapidement à tout problème pouvant entraîner un risque pour les produits.\nLes programmes de gestion des nuisibles doivent être conformes à l’ensemble de la législation en vigueur.", "4.15": "Toutes les installations utilisées pour le stockage des matières premières, des emballages, des produits en cours de transformation et des produits finis doivent être adaptées à leur utilisation prévue.", "4.10": "Le risque de contamination du produit doit être réduit ou éliminé grâce à l'utilisation efficace d'équipements d'élimination ou de détection des corps étrangers.", "4.3": "L'agencement de l'usine, le flux des processus et les déplacements du personnel doivent être adéquats pour éviter un risque de contamination du produit et pour être en conformité avec la législation applicable.", "4.2": "Des systèmes doivent protéger les produits, les locaux et les marques placés sous le contrôle du site contre les actes malveillants.", "4.12": "Les déchets doivent être traités conformément aux exigences légales et pour éviter l'accumulation, le risque de contamination et l'attraction des nuisibles.", "4.11.8": "Des programmes de surveillance environnementale basés sur les risques doivent être en place pour les agents pathogènes ou les organismes de détérioration pertinents. Au minimum, ceux-ci doivent inclure toutes les zones de production contenant des produits nus et/ou prêts à consommer.", "4.8": "Les installations pour le personnel doivent exister en nombre suffisant pour héberger le nombre d'employés requis. Elles doivent être conçues et utilisées de manière à minimiser le risque de contamination du produit. Les installations doivent être propres et maintenues en bon état.", "4.5": "Les fluides techniques utilisés dans les zones de production et de stockage doivent être surveillés pour contrôler efficacement le risque de contamination du produit.", "4.4": "La structure du site, des bâtiments et des installations doit être adaptée à l'usage prévu.", "4.16": "Des procédures doivent être en place pour garantir que la gestion de l'expédition des véhicules et conteneurs utilisés pour le transport des produits depuis le site ne présente aucun risque pour la sécurité sanitaire, la sûreté et la qualité des produits.", "4.11": "Des systèmes d'entretien et d'hygiène doivent être en place pour garantir que des normes d'hygiène appropriées sont appliquées à tout moment et que le risque de contamination du produit est minimisé.", "4.9": "Des installations et des procédures adaptées doivent être en place pour contrôler le risque de contamination chimique ou physique des produits.", "4.7": "Un programme de maintenance efficace doit être en place pour l'usine et les équipements afin de  prévenir la contamination et réduire les risques de panne.", "4.1": "La taille, l'emplacement et la construction du site de production doivent être adaptés. Ce dernier doit être entretenu pour réduire tout risque de contamination et faciliter la fabrication de produits finis sûrs et légaux.", "4.6": "Tout équipement de production et de manipulation alimentaire doit être adapté à l'usage prévu et utilisé de manière à minimiser le risque de contamination du produit.", "4.13": "Des processus efficaces doivent être en place pour garantir la sécurité sanitaire et la légalité des produits dérivés de l'activité de transformation principale du site."}}, {"section": 5, "title": "Product control", "clauses": [{"id": "5.1.1", "requirement": "The company shall have a procedure for new product development and changes to existing product, packaging and manufacturing processes.", "interpretation": "The aim of this clause is to formalise processes for new product development, and changes to existing products, processes and packaging, to ensure the design, development and introduction into production areas does not adversely affect the safety and legality of either the existing products manufactured on site or the new products themselves.\nTherefore the company must have a new product development procedure which ensures that product development activities are aligned with other site policies on the types of product or hazards handled on site, to prevent the unintended introduction of these hazards\n– for example, where a company has an existing policy to exclude a particular allergen from the site, or where an existing product claim will be adversely affected.\nThis requirement must operate in conjunction with the food safety plan (HACCP processes);\nfor example, see clause 5. 1.2 and section 2. 12.\nAny such restrictions must be documented. Where no restrictions apply, this need not be documented.", "requirement_fr": "L'entreprise doit disposer d’une procédure pour le développement des nouveaux produits et pour toute modification des produits, emballages ou processus de fabrication existants.\nCette procédure doit inclure toute restriction relative au champ d'application des développements de nouveaux produits, afin de contrôler l'apparition de dangers qui seraient inacceptables pour le site ou les clients (c-à-d. l'introduction d'allergènes, d'emballages en verre, de risques microbiologiques ou d’ingrédients pouvant affecter les allégations des produits)."}, {"id": "5.1.2", "requirement": "All new products and changes to product formulation, packaging or methods of processing shall be formally approved by the HACCP team leader or an authorised HACCP team member.", "interpretation": "It is important that the site understands the product safety rationale for all new products (i. e. the criteria that make a product safe for consumption). This may, for example, include processing conditions such as cooking or temperature control; intrinsic properties of the product such as pH or water activity; control of shelf life; or the effect of specific ingredients such as preservatives.\nExperience has shown that sometimes even minor changes to ingredients, packaging or processing conditions can have a significant effect on the safety of products. The sign-off of changes by the HACCP team leader or an authorised HACCP team member is designed to ensure that the consequences of any change are understood. Therefore a full description of each proposed change to a product, raw material or process must be made available to the HACCP team. This can be demonstrated by a record of the sign-off of product changes (e. g. a change authorisation form).\nRecords should be available even where the change does not result in any modification to the existing HACCP or food safety plan.\nThe assessment of any potential impact on product safety and subsequent sign-off must occur before the products are introduced into the factory; i. e. sign-off must be completed before production trials begin to ensure that new risks (e. g. from allergens) are not introduced into the factory without suitable controls approved by the HACCP team.", "requirement_fr": "Tous les nouveaux produits et toutes les modifications relatives à la formulation des produits, à l'emballage ou aux méthodes de transformation doivent être approuvés officiellement par le chef d'équipe HACCP ou un membre de l’équipe HACCP autorisé. Cela doit garantir que les dangers ont été évalués et que des contrôles adaptés, identifiés grâce au système HACCP, sont mis en place. Cette approbation doit être émise avant que les produits ne soient introduits dans l'usine."}, {"id": "5.1.3", "requirement": "Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing processes are capable of producing a safe product of the required quality.", "interpretation": "Documented evidence of production trials (i. e. not kitchen-scale trials) need to be available, together with test results validating that the product formulation and manufacturing processes are capable of producing a safe product of the desired quality.\nProduction trials may not be required where new products are very closely based on existing products. Where production trials are not undertaken, the reason must be documented.", "requirement_fr": "Des essais à l'aide des équipements de production doivent être effectués lorsqu'il est nécessaire de confirmer que la formulation et les processus de fabrication des produits sont en mesure de fournir un produit sans danger et ayant la qualité requise."}, {"id": "5.1.4", "requirement": "Initial shelf-life trials shall be undertaken using documented protocols. Results shall be recorded and retained and shall confirm compliance with the relevant microbiological, chemical and organoleptic criteria.", "interpretation": "Incorrect product shelf life can result in serious food safety or quality consequences, unnecessary waste and production costs. For example:\n• an incorrect shelf life that is too long could result in:\n• the growth of pathogens to unacceptable levels\n• product spoilage\n• an incorrect shelf life that is too short can result in:\n• unnecessary waste, as unused product will be disposed of (either in the supply chain or by the consumer) before it actually needs to be\n• increased manufacturing costs (e. g. more frequent production or smaller batch size).\nIt is therefore important to assign shelf life in a systematic and scientific way. The company must establish a documented procedure detailing how initial shelf-life trials are undertaken for new products and changes to existing products. This procedure must consider the handling conditions throughout the supply chain (e. g. chilled products are often subject to 2 hours at an ambient temperature mid-life to mimic the conditions during retail shopping). The aim of shelf-life trials is to confirm that product safety, legality and quality are acceptable throughout the expected shelf life.\nSamples to determine the shelf life should be taken from the trials detailed in clause 5. 1.3.\nWhere long-shelf-life products (e. g. some canned or frozen products) are developed, it may not be possible to complete full shelf-life trials. The justification for the declared shelf life must be documented and based on experience from similar products and science-based evidence.\nWhere rework is used or work in progress is stored, shelf life of the material should be established to ensure it is used within the correct period.\nOngoing verification of shelf life is covered separately in clause 5. 6.3.\n5. 2 Product labelling Product labelling shall comply with the appropriate legal requirements and contain information to enable the safe handling, display, storage and preparation of the product within the food supply chain or by the customer.\nErrors in product labelling remain a significant cause of product recalls. Site processes must therefore have robust processes, capable of consistently developing accurate and legal labels.\nThe labelling of products must meet all of the legal requirements for the designated country of use. The site must therefore have processes to ensure it remains up to date with labelling requirements in that country (or countries) and that these requirements are accurately transferred onto the packaging and labels.\nFor the purposes of the Standard, the following definitions apply:\n• label – any tag, mark, picture or other descriptive matter, whether it is written, printed or otherwise marked, on or attached to the packaging of the product\n• labelling – any words, picture or symbol relating to the food and placed on any packaging or label accompanying the product.\nNote that activities relating to labelling and packing are located in several sections of the Standard. An effective system of label design and packing of products will therefore require these sections to interact and operate together within the company. For example:\n• Section 5. 1 – product design and development\n• Section 5. 2 – design of labelling\n• Section 5. 5 – design and purchase of packaging\n• Section 6. 2 – labelling and packing processes (i. e. packing products and applying labels to products).", "requirement_fr": "Les essais initiaux sur la durée de conservation doivent être effectués à l'aide de protocoles documentés reflétant les conditions subies lors de la fabrication, du stockage, du transport/ de la distribution, de l’utilisation et de la manipulation, afin de déterminer la durée de vie du produit.\nLes résultats doivent être consignés et conservés, et confirmer la conformité aux critères microbiologiques, chimiques et organoleptiques pertinents ou à l’analyse sensorielle. Lorsqu'il est impossible d'effectuer des essais sur la durée de vie avant la production, par exemple pour certains produits de longue conservation, une justification documentée basée sur des faits scientifiques relative à la durée de vie attribuée, doit être émise.\n5.2 Étiquetage des produits L'étiquetage des produits doit être conforme aux exigences légales applicables et contenir des informations permettant la manipulation, la mise en rayon, le stockage et la préparation du produit sans danger au sein de la chaîne d'approvisionnement alimentaire ou par le consommateur."}, {"id": "5.2.1", "requirement": "All products shall be labelled to meet legal requirements for the designated country of use. There shall be a process to verify that ingredient and allergen labelling is correct.", "interpretation": "The site’s procedures must include the completion of a legality check and sign-off of the proofs (or draft designs) of new labels to ensure their compliance; this will include verification of ingredient and allergen information, based on both the product recipe and ingredient specifications. The appropriate legislative requirements in the country (or countries) in which the products will be used must be considered.\nWhere the company is manufacturing customer-branded products, the customer or brand owner will normally have specific policies for the completion of the final artwork; for example, the site may need to seek formal agreement of the finished product artwork. Where artwork is not formally agreed, the company shall be able to demonstrate that it has taken steps to complete the artwork in accordance with the brand owner’s policies.\nWhere the company is the brand owner, sign-off may be undertaken by an experienced and authorised manager or staff member.\nDuring the vertical audit, the auditor will assess the site’s processes for ensuring the accuracy of labelling and verify that the systems are operating correctly. The auditor will not check every aspect of the labelling to confirm its legality, nor validate the label, but will select samples of on-pack information for the site to substantiate and demonstrate the robustness of procedures and compliance with this clause. For example:\n• for a product which claims ‘10% meat’, the auditor may ask for the evidence that demonstrates this claim. This may include the product recipe, the mass balance exercise for the specific batch, etc.\n• for a product which claims to be a ‘product of the UK’, demonstration of the accuracy of the claim could include evidence of the origin of the materials purchased from suppliers\n• the auditor may compare the on-pack ingredient information with the recipe and specification.", "requirement_fr": "Tous les produits doivent être étiquetés pour répondre aux exigences légales du pays d'utilisation prévu et inclure des informations permettant la manipulation, la mise en rayon, le stockage, la préparation et l'utilisation du produit sans danger au sein de la chaîne d'approvisionnement alimentaire ou par le consommateur.\nUn processus doit exister pour vérifier que l'étiquetage des ingrédients et des allergènes est correct, en fonction de la recette du produit et des spécifications des ingrédients.\nL'entreprise doit disposer d'une procédure de vérification et d'approbation du graphisme."}, {"id": "5.2.2", "requirement": "There shall be effective processes in place to ensure that labelling information is reviewed whenever changes occur to: the product recipe, raw materials, supplier, country of origin, legislation.", "interpretation": "The accuracy of product labelling is of primary importance for the legality, consumer safety and the maintenance of product authenticity. It is therefore important that whenever a change occurs to the product, its formulation or the ingredients, there is a review of the label information to ensure it remains correct and up to date. Where it is not, this must lead to a change in the labelling. Reviews, for example, will be required when there are changes to the:\n• product recipe (e. g. reformulation of an existing product)\n• composition of the raw materials. For example, when the recipe of a bought-in compound raw material changes, good practice is for the supplier to notify the site of the proposed change before it actually occurs. This should be documented in the supplier approval process (section 3. 5)\n• supply chain (e. g. the introduction of new suppliers of raw materials)\n• country of origin of the product or ingredients\n• legislation (in the country/ies in which the product is manufactured and sold).", "requirement_fr": "Des processus efficaces doivent être en place pour garantir que les informations figurant sur l'étiquette sont révisées en cas de changement relatif :\n•\t à la recette du produit\n•\t aux matières premières\n•\t au fournisseur de matières premières\n•\t au pays d'origine des matières premières\n•\t à la législation."}, {"id": "5.2.3", "requirement": "Where the label information is the responsibility of a customer, the company shall provide information to enable the label to be accurately created.", "interpretation": "This clause is applicable wherever the decision on pack copy is not controlled by the company but is the responsibility of the customer or a nominated second or third party.\nIn these circumstances, the site is responsible for supplying accurate and reliable information on which to base the label creation. A system must therefore be in place to transfer all the relevant initial information to the relevant customer or nominated party and for ensuring that any changes are communicated in a timely manner.\nclause 5. 2.1 also applies where the customer or a nominated second or third party completes this activity, and therefore there is an expectation that artwork approval and sign-off will be completed.", "requirement_fr": "Lorsque les informations figurant sur l'étiquette dépendent d'un client, ou d’une seconde ou tierce partie désignée, l'entreprise doit fournir des informations :\n•\t pour permettre la création d'une étiquette précise\n•\t dès qu'un changement pouvant affecter les informations de l'étiquette a lieu."}, {"id": "5.2.4", "requirement": "Where cooking instructions are provided to ensure product safety, they shall be fully validated.", "interpretation": "This clause is concerned with cooking instructions that are required to make a product safe to eat when cooked (e. g. products containing raw chicken), and applies to both own-brand and customer-branded products. The site must validate that the cooking instructions will result in a product that is consistently safe to eat when the instructions are followed. Sites should also consider the potential for instructions to be deviated from.\nWhere the cooking instructions are completed by a third party, the site is still responsible for demonstrating that validation is in place. This may be done by completing the validation itself, by management of the service provider (section 3. 5.3) or by having the information available (e. g. a copy of the validation report from the third party). If the site is using cooking instructions in connection with products assessed as high risk or high care, it should refer to Appendix 2 of the Standard.\nThe Standard is not prescriptive on the cooking methods that must be used, as this will be dependent on the product type. However, the site should consider any limitations or challenges in completing the validation for the chosen cooking method(s). For example, microwave ovens provide some additional challenges for the validation of cooking instructions. To ensure validation of microwave cooking instructions (ready to heat/cook), their power and efficiency must be considered.\n5. 3 Management of allergens Pet food and animal feed manufacturers certificated to the Standard are required to meet the appropriate allergen management legislation in the country of intended sale of the products. Therefore, if there is no legislation relating to allergens in pet food/animal feed, this section of the Standard may be considered ‘not applicable’ for pet food or animal feed destined for those countries.\nIn some parts of the world, allergen claims (e g. gluten- or dairy-free) are made on pet food or animal feed products.\nTherefore, where a site makes an allergen claim on a pet food or animal feed, it is required to meet all of the requirements within section 5. 3.\nFundamental The site shall have a system for the management of allergenic materials which minimises the risk of allergen contamination (cross-contact) of products and meets legal requirements for labelling in the country of sale.\nLegislation in many countries requires that the presence of food allergens, when deliberately present in a product, must be declared on the pack.\nIt is important to note that the substances recognised as allergens differ from country to country, and at a minimum the company will need to consider the allergens identified as appropriate to its own business, applicable legislation (in both the country in which its products are manufactured and the intended country of sale) and customer requirements.\nThere are a number of organisations that provide useful information on allergens and allergen legislation; for example, the Food Allergy Research and Resource Programme (FARRP) provides a table of allergens by country, available on its Food Allergens – International Regulatory Chart web page. Leaving aside the deliberate use of allergenic ingredients in a food, there are occasions when a product can be cross-contaminated (cross-contact) because of the supply chain or manufacturing environments. Where there is a genuine risk of cross-contamination (cross-contact) with an allergen, this must be managed by implementing effective allergen management procedures to prevent or minimise (to an acceptable level) both its likelihood and the levels of allergen that are likely to be present.\nThe specific legislative requirements in the geographic origin of the raw material, in the country of manufacture and in the country of sale must be considered. This is necessary to ensure that all the relevant allergens are managed and none is inadvertently omitted because of differences in the legislation. For example, the list of substances that are considered to be allergenic is different in Europe, the US, Australia and Japan.\nWhere products are both produced and sold in countries where there are no legal requirements for the labelling of allergens, the list of allergens as defined in the Codex General Standard for the Labelling of Prepackaged Foods (Codex Stan 1-1985, paragraph 4. 2.1. 4) should be used as the basis for assessing compliance with the Standard.\nResearch is continuing to be conducted in a number of countries, including the UK and Australia, to identify allergen thresholds (i. e. the minimum amount of an allergen that will cause a reaction in the majority of allergic customers).\nSome of this research has now outlined allergen thresholds for a number of allergens, with the aim of assisting in the more appropriate application of precautionary allergen labelling. However, this information must only be used following a meaningful risk assessment applied to a well-managed operation. The values are very low (e. g. a few milligrams), therefore factories must continue to use the full range of risk assessment, risk management and risk communication tools to ensure they produce products that are safe for allergic consumers.\nBRCGS publishes a separate guideline on allergen management, which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Lorsque des conseils de cuisson sont fournis pour assurer la sécurité du produit, ils doivent être pleinement validés, afin de garantir l'obtention systématique d'un produit sûr et prêt-à- consommer, dès lors que le produit est cuit conformément aux instructions.\n5.3 Gestion des allergènes Les fabricants d’aliments pour animaux et animaux domestiques certifiés dans le cadre de la Norme sont tenus de respecter la législation concernant la gestion des allergènes en vigueur dans les pays où les produits sont destinés à la vente. Par conséquent, si la présence d'allergènes dans les aliments pour animaux/animaux domestiques ne fait l'objet d'aucune législation, cette section de la Norme peut être considérée comme \"non applicable\" pour l’alimentation animale ou d'animaux domestiques à destination de ces pays.\nDans certaines régions du monde, les aliments pour animaux et animaux domestiques affichent des allégations concernant la présence d'allergènes (c-à-d. sans gluten ou sans produits laitiers). Ainsi, lorsqu'un site formule une allégation relative aux allergènes sur des aliments pour animaux ou animaux domestiques, celle-ci doit satisfaire à toutes les exigences de la section 5.3.\nFondamental Le site doit disposer d'un système permettant de gérer les allergènes, afin de minimiser le risque de contamination des produits par des allergènes (contact croisé) et de répondre aux exigences légales d'étiquetage dans le pays de vente."}, {"id": "5.3.1", "requirement": "The site shall carry out an assessment of raw materials to establish the presence and likelihood of contamination (cross-contact) by allergens.", "interpretation": "Raw materials are a potential source of allergens and of cross-contamination. Therefore, the supplier approval and raw material risk assessment procedures (section 3. 5.1) must include an assessment of raw materials for the presence of allergens and the potential for cross- contamination.\nRaw material specifications (including flavourings, additives, carriers and processing aids) must be agreed with each raw material supplier and include the allergen status (both content and risk of cross-contamination) of the materials.\nWhere required, additional allergen information must be obtained (e. g. through the use of supplier questionnaires or audits).\nWhere a compound raw material (i. e. one manufactured from a number of ingredients) is purchased, the risk assessment must consider the risks associated with the raw material, its ingredients and the manufacturing sites of the ingredients. The assessment process and the outcome of the assessment must be documented.\nIt is good practice for allergen risk assessments to be reviewed, as part of the review processes for the food safety plan (e. g. see clause 2. 12. 3); for example, when there is a change in raw materials or the supply chain.", "requirement_fr": "Le site doit effectuer une évaluation des matières premières pour déterminer la présence et la possibilité de contamination (contact croisé) par des allergènes. Cette évaluation doit inclure un examen des spécifications relatives aux matières premières et, si nécessaire, impliquer l'obtention d'informations supplémentaires de la part des fournisseurs (grâce à des questionnaires, par exemple, afin de comprendre le profil allérgénique des matières premières, leurs ingrédients et l'usine où elles sont produites)."}, {"id": "5.3.2", "requirement": "The company shall identify and list allergen-containing materials handled on site.", "interpretation": "The aim of this clause is to ensure that the site maintains up-to-date knowledge of the allergens that are handled on the site. It is therefore important that the allergen statuses of all raw materials, additives, processing aids, intermediates and final products are known, in terms of both the deliberate presence of allergens and the potential for cross- contamination.\nAll materials that contain allergenic substances (ingredients, processing aids, intermediates and finished products) must be listed in a single reference document or database. It is not a requirement for this list to be a separate document just for allergen information. Provided that all the relevant information is available in a timely fashion (for example, if an allergen list can be pulled from the company’s raw material database and clearly identifies which allergens are used on site, in which raw materials or finished product), this list or database would fulfil the requirements of this clause. This might also include non-food materials used in production areas (e. g. pest control baits that are wheat-based).\nThe need to maintain an up-to-date list should be communicated to all areas of the company that can introduce new allergens onto the site or is responsible for allergen risk assessment (e. g. the HACCP team, new product development or engineering).", "requirement_fr": "L'entreprise doit identifier les produits contenant des allergènes manipulés sur site et en dresser la liste. Cette dernière doit inclure les matières premières, les adjuvants de fabrication, les produits intermédiaires et finis, et tout nouveau produit développé ou nouvel ingrédient."}, {"id": "5.3.3", "requirement": "A documented risk assessment shall be carried out to identify routes of contamination (cross-contact) and establish documented policies and procedures. • physical state of the allergenic material. • potential points of cross-contamination. • assessment of risk at each process step. • identification of suitable controls", "interpretation": "A risk assessment process must be completed to identify potential routes of cross- contamination (cross-contact). Consideration must be given to\n• the physical state of the allergen. For example:\n• powdered ingredients represent a greater risk of aerial cross-contamination than those in liquid form\n• sticky or fatty ingredients are likely to adhere to surfaces should cleaning be ineffective\n• particulates (such as pieces of nut) may result in significant heterogeneous contamination\n• the identification of potential points of cross-contamination (cross-contact). An ‘allergen process flow diagram’ or ‘allergen map’ can be useful in understanding where allergenic ingredients and foods exist in the plant and where they are introduced into the process. This usually takes the form of a site plan on which are highlighted all the routes each allergenic material can take. This map can subsequently be used to identify areas where cross-contamination between allergenic and non-allergenic materials (ingredients, intermediates or products) can occur. (The map should consider process flow, environmental factors, production activities, shared equipment and people.)\n• an assessment of the risk at each stage identified in the previous step\n• the identification and implementation of all reasonable controls to reduce or eliminate cross-contamination (e. g. segregation, the use of dedicated lines or equipment, enhanced cleaning schedules).\nThe risk assessment process, the assessments and any resulting procedures and/or factory controls must be documented.", "requirement_fr": "Une évaluation des risques documentée doit être effectuée pour identifier les voies de contamination (contact croisé) et définir des politiques et des procédures documentées relatives à la manipulation des matières premières et des produits intermédiaires et finis, afin d'éviter tout risque de contamination croisée (contact croisé). Cette évaluation doit inclure :\n•\t une prise en considération de l'état physique de l'élément allergène (c-à-d. poudre, liquide, particules)\n•\t l'identification de points potentiels de contamination croisée (contact croisé) dans le flux de processus\n•\t l'évaluation des risques de contamination croisée (contact croisé) par des allergènes à chaque étape du processus\n•\t l'identification de contrôles adaptés pour réduire ou éliminer les risques de contamination croisée (contact croisé)."}, {"id": "5.3.4", "requirement": "Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination. • physical or time segregation. • use of separate protective overclothing. • use of identified, dedicated equipment. • scheduling of production. • systems to restrict airborne dust. • waste handling and spillage controls", "interpretation": "The risk assessment (clause 5. 3.3) must be used to develop the factory controls and procedures for handling raw materials, intermediates and finished products to reduce (and, where possible, remove) the risk of allergen cross-contact. All allergens present on site must be considered so that procedures can be designed to prevent allergen cross-contact with each specific allergen. For example, contaminating an allergen-containing product with another allergen-containing product (such as contaminating a nut-containing product with a milk-containing product) is just as significant as contaminating a product with no allergens with that allergen.\nEffective allergen management procedures must be implemented even where on-pack warning labels (clause 5. 3.6) are used. Particular attention should be given to:\n• physical segregation. Ideally, allergenic ingredients and products will be totally segregated from non-allergenic ingredients and products. This could involve, for example, dedicated storage areas, dedicated (and colour-coded) production equipment, and the use of dedicated production lines\n• time segregation. Where products must be handled in the same factory areas or on the same production lines, consideration should be given to the use of time segregation. For example, all non-allergenic products could be produced first and allergenic materials introduced subsequently, or the use of allergenic materials could be confined to the end of a day/shift and only before a full clean. Production scheduling could also be used to minimise the frequency of changeovers between allergen-containing and non-allergen- containing products. For example, in some factories it is possible to limit the use of nuts to a defined period or shift, rather than producing nut-containing products throughout the week\n• the potential for protective clothing to be a source of allergen contamination. The use of separate clothing or overalls for handling allergenic materials should be considered. It is normally useful to colour-code protective clothing to prevent confusion\n• the use of dedicated equipment or utensils. These should be clearly identifiable (e. g. by colour-coding)\n• allergens that can form fine powders (e. g. flour, milk powder and soya isolates). The movement of airborne dust should be minimised by, for example, using physical barriers (such as shrouds, lids or segregated areas) for dispensing and mixing operations. The location of air-conditioning outlets or the use of fans should also be considered to ensure these do not distribute airborne allergens\n• waste handling and spillage controls. Allergens should be removed efficiently, ensuring that the removal process does not become the source of allergen contamination in other areas of the factory\n• the allergens that may be handled in non-production areas of the site (e. g. in canteens or in new product development). A policy for food brought on site by staff, or used in vending machines or catering facilities, should be developed. The policy may ban certain allergens or restrict them to certain areas of the site.\nWhere colour-coding is used, consideration must be given to the choice of colours to ensure that colour-blind staff are able to identify the correct items.", "requirement_fr": "Des procédures doivent être définies pour garantir la gestion efficace des éléments allergéniques, afin d'éviter la contamination croisée (contact croisé) des produits ne contenant pas cet allergène. Ces procédures doivent inclure, s'il y a lieu :\n•\t une séparation physique ou temporelle pendant que les éléments contenant des allergènes sont stockés, transformés ou emballés\n•\t l'utilisation de vêtements de protection distincts ou supplémentaires lors de la manipulation des allergènes\n•\t l'utilisation de matériel et d'ustensiles identifiés et spécifiques pour la transformation\n•\t l'organisation de la production de manière à réduire les changements entre les produits contenant un allergène et les produits n'en contenant pas\n•\t des systèmes de restriction des déplacements de poussière en suspension contenant des éléments allergéniques\n•\t des contrôles quant à la manipulation des déchets et des déversements de liquide\n•\t des restrictions relatives aux aliments introduits sur le site par le personnel, les visiteurs, les prestataires de service et les restaurateurs."}, {"id": "5.3.5", "requirement": "Where rework is used, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen.", "interpretation": "Specific documented procedures must operate to prevent rework containing allergens from being used in products or processes that do not contain those allergens. Best practice is for rework to be used on a ‘like-for-like’ basis (i. e. it is used only in exactly the same product).\nThe use of rework must be documented.", "requirement_fr": "Lorsque des produits recyclés sont utilisés ou des opérations de retraitement sont effectuées, des procédures doivent être mises en place pour garantir que les produits recyclés contenant des allergènes ne sont pas utilisés dans des produits ne contenant pas ces allergènes."}, {"id": "5.3.6", "requirement": "Where a justified, risk-based assessment demonstrates that cross-contamination cannot be prevented, a warning should be included on the label.", "interpretation": "Where well-implemented and managed allergen management controls cannot prevent cross-contamination (cross-contact) and there is a significant and genuine risk of the presence of an allergen that would not otherwise be present and is therefore not mentioned elsewhere on the product (e. g. in the ingredients list), the use of on-pack advisory warning labels should be considered – i. e. an on-pack, advisory, consumer-facing warning label stating that there is a risk of cross-contact from an allergen, which cannot be prevented.\nWhile different wording may be used in different countries (see below), such warnings are often referred to as ‘may contain’ labels, as they refer to unpreventable cross-contact rather than to the deliberate inclusion of the allergen in the product.\nThe use of a warning label should be justifiable on the basis of the risk assessment and procedure (clauses 5. 3.3 and 5. 3.4) and should not be a substitute for effective implementation of good manufacturing practices. Reference must be made to national legislation, guidelines or codes of practice when making such a statement to ensure that best practice is followed. For example, consideration should be given to:\n• the location of the warning (preferably in close proximity to the ingredients list)\n• the visibility of the statement – colour, highlighting, location and font size can all aid consumers\n• the choice of the warning phrase used, so that the meaning is clear to consumers.\nThe site should consider:\n• the allergens identified as important by the company, i. e. from the risk assessments and controls described above\n• legislation in the country of intended sale (relating to both which allergens need to be labelled and the permitted warnings)\n• customer requirements.", "requirement_fr": "Lorsqu’une évaluation justifiée, basée sur les risques, démontre que la nature du processus de production ne permet pas d'éviter la contamination croisée (contact croisé) à partir d'un allergène, un avertissement doit figurer sur l'étiquette. Des lois, des directives nationales ou des codes d'usage doivent être utilisés lors de l'utilisation de ce type d'avertissements."}, {"id": "5.3.7", "requirement": "Where a claim is made regarding the suitability of a food for individuals with a food allergy or sensitivity, the site shall ensure that the production process is fully validated.", "interpretation": "Allergic, food-intolerant and other food-hypersensitive individuals are likely to actively seek and choose products that claim to be suitable for them to consume (e. g. ‘gluten-free’ products). It is therefore essential that any allergen claim is based on rigorous controls to ensure its validity and continuous implementation to prevent adverse health consequences.\nWhere a claim is made regarding the suitability of a food, full validation and verification activities will be required to ensure that the claim is consistently met. Typically, this will include:\n• reference to legislation or national guidelines on the permitted claims and the manufacturing requirements to make the claim. For example, some countries have been discussing tolerances or acceptable limits for allergen labelling\n• demonstration that production processes are in place to ensure the product does not contain unacceptable traces of the allergen\n• analysis of the final product\n• assessment of the adequacy of cleaning, as detailed in clause 5. 3.8 (where the site also produces products containing the allergen about which the claim is made, additional verification controls will be required)\n• raw material controls. In addition to the normal requirements listed in clause 5. 3.1, additional validation/verification requirements are likely to be needed (e. g. raw material testing, additional supplier questionnaires, site audits).\nThe validation and verification activities must be recorded.", "requirement_fr": "Lorsqu'une allégation indique qu'un aliment convient aux personnes allergiques ou souffrant d'intolérances alimentaires (parfois appelées hypersensibilités alimentaires), le site doit s'assurer que le processus de production est pleinement validé, qu'il est conforme à cette allégation, et que l'efficacité du processus est vérifiée régulièrement. Cela doit être documenté."}, {"id": "5.3.8", "requirement": "Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination by allergens. Cleaning methods shall be validated.", "interpretation": "Some standard cleaning regimes will be insufficient to ensure the removal of all allergenic material. Therefore, specific cleaning procedures must be present on site where allergen- containing materials require control.\nCleaning procedures must be designed to remove or reduce to acceptable levels any allergenic material. They must consider:\n• cleaning schedules (i. e. when cleaning will be completed)\n• scheduling sufficient time to fully complete the clean to the required standard\n• ensuring that cleaning instructions contain all the information required\n• the order in which cleaning must be performed (to ensure that cleaning does not move an allergen into a previously cleaned area)\n• the cleaning equipment used for cleaning allergenic materials, which must not be a source of contamination and must therefore be either dedicated for the removal of that allergen, single use or effectively cleaned after use.\nThere is no internationally recognised definition of acceptable allergen levels; this would be dependent on the intended country of sale. For example, reference doses are being discussed in the EU (further information can be found on the German Federal Institute for Risk Assessment’s website).\nWhere multiple allergens are handled on site, consider whether all allergens could be managed by the same cleaning/validation/verification activities. For example, peanuts, milk and sesame seeds may need different controls because of their different physical characteristics. They may also be used on different equipment and production lines, again requiring separate consideration.\nThe effectiveness of the procedures must be validated. The validation must be documented and evidence will typically include:\n• worst-case production/cleaning trials, where all equipment, processes and allergens need to be considered\n• targeted test locations, such as food contact surfaces, difficult-to-clean areas, deadlegs etc.\n• targeted samples, where worst-case samples are identified for laboratory testing using suitably sensitive test methods. (Validation tests should be accredited methods and, wherever possible, quantifiable. Rapid tests, ATP and lateral flow devices are good for verification activities but are not suitable for validation.) Possible samples include the first product manufactured in the next production run, rinse water from cleaning systems, swabs etc.\n• assessment of new equipment for ease of cleaning prior to purchase\n• positive testing of the test method used, to confirm that it will detect the allergen if it is present in a real sample (i. e. confirmation that product matrix will not interfere with the test).\nIt is likely that validation data will need to be collected from several production runs to ensure it is representative and complete. A number of best- practice guidelines have been published on the validation of cleaning (e. g. Campden BRI Guideline 59 – Validation of Cleaning to Remove Food Allergens).\nThe cleaning procedures must be routinely verified by, for example:\n• visual inspections and documented sign-off\n• inclusion in internal audits\n• the use of swabs or testing (e. g. rapid tests, ATP, lateral flow devices or laboratory tests).\nRecords must be maintained of validation and verification tests and activities. Any corrective actions must also be recorded and completed.\nBRCGS has a training course on validation and verification. Further information is available on the BRCGS website.\n5. 4 Product authenticity, claims and chain of custody Systems shall be in place to minimise the risk of purchasing fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are legal, accurate and verified.\nThe objectives of this section of the Standard are to ensure:\n• the site has assessed its raw materials and supply chain for vulnerability to food fraud activities such as the dilution, substitution or misrepresentation of ingredients prior to delivery to the site, all of which could lead to the sale of unfit, illegal or potentially harmful products\n• the site has appropriate controls in place (based on the assessment) to minimise the risk of purchasing fraudulent or adulterated raw materials\n• all claims relating to raw materials used in products can be substantiated and that the audit provides a suitable evaluation of the site’s management of the chain of custody, where claims are made relating to primary agricultural schemes such as GLOBALG. A.P.\nNote that the security of products, while under the management control of the company, is also an important aspect of fraud prevention. Security of products is covered in section 4. 1 and food defence in section 4. 2; this section focuses on the sourcing of raw materials and their vulnerability within the supply chain.\nSection 1 of the Standard deals with senior management commitment in relation to product authenticity; for example, operating processes and objectives that facilitate product authenticity, and the importance of keeping up to date with emerging issues and relevant legislation. These activities complement this section; for example, knowledge of an emerging risk (clause 1. 1.8) could be added to the information relating to potential fraud (clause 5. 4.2), instigating a review of the vulnerability assessment (clause 5. 4.3).\nThis section applies to food raw materials and ingredients; therefore packaging does not need to be considered under this section.\nProduct claims are also covered in this section in clauses 5. 4.5 (raw material status), 5. 4.6 (certification and methods of production) and 5. 4.7 (validation of claims, formulation, and methods of production).", "requirement_fr": "Des procédures de nettoyage des équipements ou des zones doivent être définies pour éliminer toute contamination croisée (contact croisé) potentielle par des allergènes ou la réduire à des niveaux acceptables. Les méthodes de nettoyage doivent être validées pour garantir leur efficacité et l'efficacité de la procédure doit être vérifiée régulièrement. Les équipements de nettoyage utilisés pour nettoyer les matériaux allergéniques doivent être, soit :\n•\t identifiables et spécifiques aux allergènes\n•\t à usage unique\n•\t nettoyés efficacement après utilisation.\n5.4 Authenticité des produits, allégations et chaîne de contrôle Des systèmes doivent être en place pour minimiser les risques d'achats de matières premières alimentaires frauduleuses ou altérées et pour garantir que toutes les descriptions des produits et les allégations sont légales, véridiques et vérifiées."}, {"id": "5.4.1", "requirement": "Where personnel are engaged in vulnerability assessments, the individual or team responsible shall understand potential food fraud risks.", "interpretation": "It is important that personnel completing vulnerability assessments for food fraud are competent to develop the plan; they need to understand the risk they are trying to prevent.\nTherefore, it is expected that within the team there will be knowledge of:\n• the principles of food fraud (e. g. what food fraud is, why its management is important)\n• risk assessment or vulnerability assessment techniques\n• the risks associated with the raw material, product, supply chain or process being assessed.\nThe Standard is not prescriptive regarding how this knowledge is demonstrated and may, for example, include:\n• formal training (e. g. a training course in food fraud, vulnerability assessment or VACCP)\n• internal training, development and experience (e. g. demonstrable knowledge of the site)\n• other competency (e. g. the completeness and effectiveness of the vulnerability assessment and its implementation).\nRisk assessments may be completed either by responsible individuals or by a team. The advantage of a team is that every company has several departments that are likely to possess useful information; for example:\n• technical or QA staff are often subject matter experts\n• supplier approval will see information relating to specific raw materials, suppliers and supply chains\n• purchasing departments are usually well informed about availability or pricing concerns\n• goods receipt and production teams see the materials actually delivered to the site.\nWhere a team is used to complete assessments, it is important to consider the overall capability of the team.\nIf the site does not have the appropriate in-house knowledge, external expertise (e. g. food safety consultants) may be used; however, reference should be made to clause 1. 2.4 and section 3. 5.3.", "requirement_fr": "Lorsque des membres du personnel sont impliqués dans des évaluations de la vulnérabilité, la personne ou l'équipe responsable doit comprendre les risques potentiels liés à la fraude alimentaire. Notamment connaître les matières premières utilisées par le site et les principes d'évaluation de la vulnérabilité."}, {"id": "5.4.2", "requirement": "The company shall have processes in place to access information on historical and developing threats to the supply chain.", "interpretation": "Information relating to the adulteration or substitution of raw materials constantly changes as new risks are identified and existing ones are managed. The objective of this clause is therefore to ensure that sites remain up to date with emerging issues and are able to adapt their systems to protect their products against new and existing risks to the authenticity of their products.\nThe company must be able to demonstrate that it maintains up-to-date knowledge of relevant scientific and technical developments, emerging issues and known risks relating to the authenticity of the raw materials it purchases and the potential for food fraud in the supply chain. The company’s systems therefore must ensure that information is reliably obtained and reviewed in a timely manner. Ideally the company should be proactive, looking for and reviewing information, rather than reacting to situations that have already occurred.\nMechanisms to achieve this may include:\n• membership of a trade association which provides this service\n• help from government officials or local enforcement offices\n• subscription to a service provider supplying updates on food fraud\n• regular review of reputable, quality information sources such as websites covering food fraud.\nThe auditor will look for evidence of systematic checking and a process for ensuring the information is transferred into action as necessary (clause 5. 4.3).\nInformation may be obtained and collated as part of the provision of technical knowledge (clause 1. 1.8) or as a separate exercise, providing it is clear that relevant information is being obtained. Good practice is to reference data sources, as this allows later reference;\nfor example, if further details are required or an update occurs. There are many different types of information that may indicate fraud and are useful when completing or updating a vulnerability assessment; examples are listed in clause 5. 4.3 and its interpretation.\nA number of organisations provide information and updates on food fraud risks; for example:\n• European Commission Knowledge Centre for Food Fraud and Quality\n• Reports from Operation OPSON.", "requirement_fr": "L'entreprise doit disposer de processus permettant d'accéder aux informations sur les menaces passées et actuelles relatives à la chaîne d'approvisionnement, qui peuvent présenter des risques d'adultération ou de substitution des matières premières. Ces informations peuvent provenir, par exemple :\n•\t d’associations professionnelles\n•\t de sources gouvernementales\n•\t de centres de ressources privés\n•\t d’activités réalisées dans le cadre de la clause 1.1.8."}, {"id": "5.4.3", "requirement": "A documented vulnerability assessment shall be carried out on all food raw materials to assess the potential risk of adulteration or substitution. The output shall be a documented vulnerability assessment plan. • historical evidence of substitution. • economic factors. • ease of access to raw materials. • sophistication of routine testing. • nature of the raw material", "interpretation": "A vulnerability assessment is a search for potential weaknesses in the supply chain in order to prevent food fraud (i. e. to prevent the adulteration or substitution of raw materials before they arrive at the site). It is a specialised form of risk assessment, and needs a systematic and structured approach to ensure data gathering, identification of significant food fraud hazards, assessment of likelihood of occurrence, and identification and implementation of controls to mitigate genuine risks. The aim of the assessment is not to assess the potential for fraud at the site, but to examine the supply chain for potential concerns or weaknesses, thereby identifying those raw materials that are at particular risk of adulteration or substitution, so that appropriate controls can be put in place (clause 5. 4.4).\nThe vulnerability assessment will consider information relating to each ingredient in order to assess whether there is a potential for food fraud. Where a site purchases a number of similar raw materials, it may be possible to consider these as a group rather than each raw material individually, providing the risks are similar. The company will need to ensure that all food materials are subject to a vulnerability assessment.\nTypical information to incorporate into the assessment includes:\n• any emerging issues and information identified in clause 5. 4.\n• historical evidence of substitution or adulteration of the ingredient\n• cost/value of the material\n• availability (e. g. a poor harvest may restrict availability and may increase the potential for adulteration)\n• sophistication of routine testing to identify adulterants. If testing within the supply chain is comprehensive and specifically focused on potential fraud issues, then the likelihood of adulteration is reduced (e. g. fruit juice is often tested for a comprehensive range of parameters, including DNA, isotopic analysis, added sugars and added water to prevent potential fraud)\n• country of origin\n• length and complexity of the supply chain\n• supply chain model\n• controls that are already in the supply chain. For example, if the raw material supplier is certificated to the Standard, then as part of that certification the supplier must have completed its own vulnerability assessment, and there is no requirement in the Standard for the site to duplicate its supplier’s vulnerability assessment.\nThe nature of the raw material may change the potential for food fraud. For example, if a slaughterhouse is purchasing cattle, horses and pigs for slaughter, it will be obvious if there is an issue with the live animals; however, if the slaughterhouse intends to make a claim such as organic, Aberdeen Angus or specified country of origin, then greater controls of raw materials will be required to ensure only those which meet the claim are purchased.\nSimilarly, prepared ingredients such as beef mince or ground spices are likely to have a greater risk than the whole ingredient.\nThe Standard does not define the exact process that the site must follow when completing the vulnerability assessment; however, it is likely to incorporate the following steps:\n• draw up a list of raw materials (or groups of raw materials) and the controls (e. g. product testing, traceability systems or supply chain audits) that are already in operation\n• consider the information obtained from clause 5. 4.2 for each ingredient\n• complete a risk assessment on the vulnerability of each ingredient.\nNote that the Standard does not require full supply chain mapping for all raw materials, although this may be a useful tool where a risk assessment indicates that a genuine risk exists and there is a need to identify the point in the supply chain where an effective control can be applied.\nThe output of the vulnerability assessment must include a documented vulnerability assessment plan which should rank or score the materials to identify those which need additional controls. The ranking and actions required could, for example, be as follows:\n• Very high A high-profile raw material with recent reports of adulteration published by regulatory authorities. Action or monitoring is required to ensure only genuine materials are purchased\n• High A high-profile material that provides an attractive target for potential adulteration.\nSome action and/or monitoring is required to ensure only genuine materials are purchased\n• Low This material is unlikely to be a target for substitution or adulteration; however a re- assessment may be necessary if new information becomes available\n• Negligible No further action required as the material is extremely unlikely to be a target for food fraud.\nAs mentioned earlier in this interpretation, situations relating to food fraud change, and it is therefore important that the company has a dynamic system that can react to and assess new information as it becomes available, thereby ensuring the vulnerability assessment remains up to date. At a minimum, the vulnerability assessment must be reviewed at least annually and when there is a significant change to the ingredient. As a guide, a review may be triggered by the following, although this is not an exhaustive list:\n• a change in the country of origin or the supplier of raw materials\n• a change in the financial situation of raw material suppliers or countries of origin\n• a change in cost of raw materials, either upwards or downwards\n• a change in the supply chain, logistics and delivery of materials\n• a change in material availability (e. g. because of seasonal shortages)\n• emergence of a new risk (e. g. known adulteration of an ingredient)\n• developments in scientific information associated with ingredients, process or product\n• information received as part of a supplier approval or raw material risk assessment (e. g. clause 3. 5.1. 1) which highlights new or evolving risks.\nA number of risk assessment tools have been published. These include some specialist vulnerability assessment tools such as CARVER + Shock and TACCP (threat assessment and critical control points), which may be used to achieve a structured approach to the assessment process.\nBRCGS has published a number of items to assist with vulnerability assessments. These include a specific vulnerability assessment guideline that can be obtained from the BRCGS Store or viewed online at BRCGS Participate, and a training course available through BRCGS Performance Enhancement and its global network of approved training providers.\nA number of organisations have produced tools to assist with food fraud and vulnerability assessments, including, for example, the Food Fraud Resilience Self-Assessment Tool available on the UK FSA website.", "requirement_fr": "Une évaluation de la vulnérabilité documentée doit être effectuée pour toutes les matières premières alimentaires ou groupes de matières premières pour évaluer les risques potentiels d'adultération ou de substitution. Elle doit tenir compte :\n•\t des preuves historiques de substitution ou d'adultération\n•\t des facteurs économiques qui rendent l'adultération ou la substitution plus attirante\n•\t de la facilité d'accéder aux matières premières par la chaîne d'approvisionnement\n•\t de la complexité des tests de routine permettant d'identifier les falsificateurs\n•\t de la nature des matières premières.\nLes conclusions de cette évaluation doivent être documentées dans un plan d’évaluation de la vulnérabilité.\nCe plan doit être révisé pour refléter les conjonctures économiques changeantes et les informations du marché qui peuvent modifier les risques potentiels. Il doit être révisé annuellement et à chaque :\n•\t changement de matières premières ou de fournisseur de matières premières\n•\t apparition d’un nouveau risque (c-à-d. une altération connue d’un ingrédient ou l’évolution des informations scientifiques associées à l'authenticité des produits ou des matières premières du site, par exemple, les informations obtenues dans le cadre de la clause 1.1.8)\n•\t incident important relatif à la sécurité sanitaire d'un produit (c-à-d. un rappel de produit), remettant en cause l'authenticité des produits ou des matières premières du site."}, {"id": "5.4.4", "requirement": "Where raw materials are identified as being at particular risk of adulteration or substitution, the vulnerability assessment plan shall include appropriate assurance and/or testing processes.", "interpretation": "Where raw materials are identified as being of particular risk of adulteration or substitution, appropriate assurance controls need to be in place to ensure that only genuine materials are purchased. Depending on the perceived risk, assurance controls may include:\n• certificates of analysis from raw material suppliers\n• raw material testing\n• supply chain audits\n• use of tamper evidence or seals on incoming raw materials\n• enhanced supplier approval checks\n• mass balance exercises at the raw material supplier\n• changes to the supply chain (e. g. a change of supplier or a move to a shorter supply chain).\nIt is worth noting that the best controls are proactive and continuous as these are the most likely to prevent an incident from occurring. For example, product testing is a useful tool but it is reactive (i. e. it can only tell you if something has happened; it cannot prevent it from occurring or recurring in future).", "requirement_fr": "Lorsque des matières premières sont identifiées comme étant particulièrement touchées par des risques d'adultération ou de substitution, le plan d’évaluation de la vulnérabilité doit inclure des garanties adaptées et/ou des processus de test pour réduire les risques identifiés."}, {"id": "5.4.5", "requirement": "Where products are labelled or claims are made on finished packs which are dependent on the status of a raw material, the status of each batch of the raw material shall be verified. • provenance or origin. • breed/varietal claims. • assured status. • GMO status. • identity preserved. • named specific trademarked ingredients", "interpretation": "The types of claim covered by this clause relate to the provenance of ingredients used in a product that differentiates those ingredients or product from the norm. Such a claim may be made either on the product label for the consumer or in business-to-business communication. The types of claim include:\n• varietal claims (e. g. basmati rice, Aberdeen Angus beef, Bramley apples and cod fish cakes)\n• origin claims (e. g. Madagascan vanilla and Florida grapefruit)\n• assurance claims (e. g. GLOBALG. A.P. , Red Tractor, Marine Stewardship, dolphin-friendly tuna and sustainable palm oil)\n• identity-preserved claims (e. g. GMO-free).\nClaims which relate to the composition of the product (e. g. nutritional claims, fat-free, reduced sugar, free-from) are covered in clauses 5. 3.7 and 5. 4.7.\nIt is the responsibility of the site to make reasonable checks to ensure that the raw materials supplied are genuine and that claims made about ingredients are proven.\nFor many assurance schemes, such as GLOBALG. A.P. , it is possible to check the assurance status and the scope of products of the supplier on a database. Reliance solely on a declaration from a supplier will not be sufficient. Where claims relate to variety or species (e. g. varieties of fruit), examination of visual characteristics may suffice. However, for claims where visual analysis is not possible (e. g. block frozen fish), certificates of analysis and periodic sample analysis will be required.\nFull traceability records must be maintained, as required in section 3. 9. The records must also include details of the quantities purchased and amounts used at each step to enable a mass balance exercise to be undertaken.\nIn the absence of more frequent requirements relating to a particular scheme, the site must undertake a mass balance traceability exercise on typical products for which a claim is made at least every 6 months. This must ensure that the system of records maintained enables all finished product batches to be identified for a particular batch of raw materials and that, for a given finished product, the batch(es) of raw materials used for its production can be identified. The test must be carried out in both directions.\nThe ingredients selected for the mass balance exercise must include the ingredient for which a claim is made. The objective is to test the systems and, where necessary, make improvements to information recording to allow claims to be substantiated should they be challenged by a customer or legal authority.\nIt follows that, where very different traceability systems are used within, for example, a complex or multi-product site, more than one mass balance traceability exercise may be required every 6 months to ensure that all systems are working effectively. However, where a site has multiple claims, it is not intended that every claim be mass balance tested every 6 months but that a representative selection of claims are chosen. In this situation, good practice would be to choose different claims or products each time the test is conducted.\nThe use of a third-party mass balance exercise (e. g. by an organic certifier or by the Fairtrade Foundation) would be acceptable evidence of a test, providing that records of the test, the results and evidence of any necessary improvements made as a result of the test are maintained.\nWhere the third-party scheme measures the mass balance over a period (e. g. 1 month) rather than for a single batch code this is considered acceptable providing the requirements discussed above are met. If, as part of the requirements for a particular scheme or to use a logo, there is a requirement for more frequent mass balance traceability exercises, then that scheme’s requirements must be met.", "requirement_fr": "Lorsque des produits sont étiquetés ou que des allégations sont faites sur des paquets finis et dépendent du statut d'une matière première, le statut de chaque lot de matières premières doit être vérifié. Ces allégations incluent :\n•\t une provenance ou origine spécifique\n•\t des allégations de race/variété\n•\t un statut garanti (c-à-d. GLOBALG.A.P.)\n•\t un statut d'organisme génétiquement modifié (OGM)\n•\t une identité préservée\n•\t des ingrédients de marque déposée spécifique.\nLe site doit conserver des enregistrements d'achats, la traçabilité de l'utilisation des matières premières et des enregistrements d'emballage du produit fini pour étayer les allégations. Le site doit effectuer des tests de bilan matière documentés à une fréquence permettant de répondre aux exigences de tout programme auprès duquel il est certifié ou, en l’absence d’une exigence spécifique à un programme, au moins une fois tous les 6 mois."}, {"id": "5.4.6", "requirement": "Where claims are made about the methods of production (e.g. organic, halal, kosher), the site shall maintain the necessary certification status.", "interpretation": "Where a site wishes to make claims relating to specific production methods, such as organic, Halal or Kosher, the site is responsible for maintaining the appropriate certification to those standards.\nWhile the accuracy of the production methods relating to these third-party certification standards will not be assessed during a BRCGS audit, the auditor will require evidence that the appropriate certification is in place (e. g. by reviewing the certificate or an online database of certificated sites).", "requirement_fr": "Lorsque des allégations relatives à des méthodes de production sont faites (c-à-d. biologique, halal, kasher) le site doit conserver le statut de certification nécessaire lui permettant d'émettre de telles allégations."}, {"id": "5.4.7", "requirement": "Where a product is designed to enable a claim to be made, the company shall ensure that all claims are substantiated and fully validated.", "interpretation": "Where a particular claim about the formulation of a product has been made, procedures must be in place to:\n• validate that the claim is correct (this should include all steps in the process including, for example, label design, raw material sourcing and production)\n• ensure legal requirements relating to the claim in the country of intended sale are met; for example, in the EU, nutritional claims are defined\n• identify and prevent potential sources of contamination, loss of identity or variation which adversely affects the claim; for example, by using the process flow diagram to identify steps in the manufacturing process where product may be located in shared production areas or on shared lines.\nFor example, an on-pack claim that a product is plant-based or vegetarian would need to be validated, and this may include:\n• inclusion of the claim in raw material risk assessment, supplier approval and specifications\n• inclusion of the claim in the food safety plan, e. g. use of the process flow (see below) leading to specific controls such as segregation and dedicated equipment, or validated cleaning regimes\n• review of the production processes, equipment segregation etc.\nGood practice is to ensure that a programme of ongoing verification and monitoring is in place to demonstrate that claims are consistently met.\nClaims such as ‘free from allergen’ and ‘allergen-free’ need particular care to ensure that cross-contamination cannot occur during processing. This is covered separately in clause 5. 3.7.\nThe process flow diagram used within the food safety plan (or HACCP process) may be used as the basis for demonstrating compliance with this clause (the requirement may already be covered within the HACCP or food safety plan). The site must identify (e. g. as a list or on the process flow) potential areas where mixing of products or loss of identity may occur.\nProcedures of working or changes in process flow must be introduced to reduce the risk of mistakes and false claims being made. For example, in a large packhouse packing both farm- assured and non-farm-assured fruit, the farm-assured fruit is always stored separately within dedicated cold stores. Grading and packing operations are organised so that the packing of farm-assured product occurs first or on particular packing lines.\n5. 5 Product packaging Product packaging and processes for the purchase of product packaging shall be appropriate for the intended use.\nPackaging shall be stored under conditions to prevent contamination and minimise deterioration.\nConsideration of packaging and the process for the purchase of product packaging is crucial for ensuring the ongoing integrity of the product (i. e. ensuring it is clean, is of the appropriate quality and minimises product deterioration), and in maintaining product safety and legality (e. g. preventing product contamination).", "requirement_fr": "Lorsque la conception d’un produit autorise l’utilisation d’allégations, l’entreprise doit s’assurer que toutes les allégations sont justifiées, et que la formulation du produit et son processus de production sont pleinement validés pour respecter les allégations mentionnées et toute exigence légale (en vigueur dans le pays où la vente est prévue) relative à ces allégations.\nLe flux de processus (voir clause 2.5.1) pour la fabrication de produits faisant l’objet d'allégations doit être documenté, et des zones potentielles de contamination ou de perte d'identité doivent être identifiées.\nDes contrôles adéquats doivent être mis en place pour garantir l'intégrité des allégations de produit.\n5.5 Emballage de produits Les emballages de produits et les processus d'achat des emballages de produits doivent être adaptés à l'usage prévu.\nLes emballages doivent être stockés dans des conditions permettant d'éviter la contamination et de minimiser la détérioration."}, {"id": "5.5.1", "requirement": "When purchasing or specifying primary packaging, the supplier shall be made aware of particular characteristics. Certificates of conformity shall be available.", "interpretation": "There have been incidences of product recalls which have resulted from a lack of communication between the supplier of the packaging materials and the food manufacturer, typically where a packaging material has been used in extreme product conditions or where packaging not designed for direct food contact has been used (e. g. a plastic liner of a carton is removed or changed to reduce costs).\nThe company must be able to demonstrate that each item of product packaging meets legal requirements for its use (e. g. compliance with food contact regulations in the country of sale). This may be in the form of specifications, migration data or a certificate of conformity.\nWhere a declaration of conformity is used, any limitations on usage must be stated (e. g. the food types or storage conditions: ambient, chilled or frozen).\nThe supplier of the packaging must be made aware of the conditions under which the packaging is going to be used, so that the suitability of the packaging materials can be confirmed. This may take the form of a specification provided to the packaging supplier and would include, as appropriate:\n• contact with food – direct food contact or, where not used for direct food contact, the nature of the barrier layer\n• characteristics of the food – any adverse characteristics of the food which may increase migration of chemicals from the packaging (e. g. high fat content, or low or high product pH)\n• conditions of processing (e. g. high-temperature fill, thermal processing in pack, or freezing)\n• expected customer usage (e. g. microwave in pack, cooking in pack, or freezing)\n• use of recyclable or reusable packaging materials\n• other packaging, especially where the components will be supplied by different companies and there is a need for compatibility between the component parts (e. g. a bottle and cap manufactured and supplied by different suppliers).\nDirect food contact materials are of most concern as these have the greatest potential for harm and many geographical regions have specific legislation around direct contact packaging. However, there may be risk associated with the additional layers of packaging, particularly labelling which often comprises the primary pack (consumer unit) and also secondary packaging such as corrugated cases. Physical or chemical contamination can occur from these packaging components.\nDiscussions with the provider of packaging materials are imperative to ensure that the right materials in the right configurations are used (e. g. it may be necessary to use lower levels of recycled content in a corrugated case for products that are susceptible to chemical migration). Extensive work at the start of the process is incredibly valuable and can prevent costly errors from being made in specifications.\nIt is also vital to consider the product supply chain to establish the most appropriate packaging, given the storage and distribution conditions that the product will be subjected to.\nThe requirement allows some flexibility in the approach used; for example, a site could use risk assessment to identify the appropriate controls, and establish the level of evidence that is satisfactory for the level of risk (although the site would need to ensure that any legal requirements were addressed). For example, in the EU the site may decide that it needs to review an EU Declaration of Compliance (DoC) for Food Contact Materials due to a perceived risk of migration.\nThe site would need to demonstrate that the evidence available is appropriate for the level of risk associated with the packaging – it would not be acceptable to list the clause as ‘not applicable’, as there should also be evidence that the matter has been adequately communicated/discussed with the packaging supplier.\nBRCGS has published a guideline on migration from packaging materials into food, which may be purchased from the BRCGS Store or viewed online at BRCGS Participate.", "requirement_fr": "Lors de l'achat ou de la spécification des emballages primaires, le fournisseur de matériaux d'emballage doit être informé de toute caractéristique spécifique des denrées alimentaires ou de l’emballage existant (c-à-d. forte teneur en matières grasses, pH, conditions d'utilisation impliquant un micro-ondes, autres emballages utilisés sur le produit, utilisation de matériaux d’emballage réutilisables ou recyclables) qui pourraient affecter le caractère approprié de l'emballage.\nDes certificats de conformité ou autres justifications relatifs à l'emballage primaire doivent être disponibles, afin de confirmer qu'il est conforme à la législation sur la sécurité des denrées alimentaires applicable et qu'il est adapté à l'usage prévu."}, {"id": "5.5.2", "requirement": "Product liners and bags purchased by the company for use in direct contact with ingredients shall be appropriately coloured and resistant to tearing.", "interpretation": "Materials used as liners for containers, as covers for work in progress or as bags for prepared ingredients may themselves be a source of contamination. Such packaging materials must be visually distinct from the product (e. g. blue or red) and of a sufficient thickness to reduce the potential for ripping or being damaged. Good practice is to ensure that bag and film gauges are documented and communicated to suppliers to ensure that only suitable materials are purchased.\nThe requirement applies only to materials purchased by the site and used on site; it does not apply to finished product packing. However, suppliers of raw materials should be strongly encouraged to supply ingredients in accordance with this requirement to reduce the risk of packaging contaminating products.\nWhere companies are producing products for further processing, clear liners should not be used as they present a potential hazard for the next manufacturer.\nThis clause does not apply to packaging used for sale to the final consumer.", "requirement_fr": "Les revêtements et sacs pour les produits achetés par l'entreprise et en contact direct avec les ingrédients, ou avec les produits en cours de production, doivent être de couleur adaptée (c-à-d. d’une couleur contrastant avec le produit) et résister aux déchirures pour éviter toute contamination accidentelle."}, {"id": "5.5.3", "requirement": "The company shall have a procedure to manage obsolete packaging (including labels).", "interpretation": "Mis-labelling and mis-packing of product is a common cause of product recall. This is of particular concern when, for example, allergens are introduced which are not accurately reflected on the labelling. Effective management of packaging materials, particularly those that are printed, can minimise the risk of these incidents.\nOne of the key aspects of this management is the effective control of obsolete packaging (i. e. items that are no longer required) such as those that are out of date because of a change in the ingredients used in the product. At a minimum sites should have:\n• mechanisms to prevent the accidental use of obsolete packaging (e. g. physical segregation in storage areas, clear ‘do not use’ labelling, blocks in electronic inventory systems)\n• controls for the disposal of obsolete packaging (e. g. timescales for the disposal of materials; how accidental use will be prevented while waiting for disposal; and how materials will be disposed of)\n• appropriate procedures for the disposal of obsolete printed materials (e. g. rendering trademarked materials such as out-of-date labels unusable).\n5. 6 Product inspection, on-site product testing and laboratory analysis The company shall undertake or subcontract inspection and analyses which are critical to confirm product safety, authenticity, legality and quality, using appropriate procedures, facilities and standards.\nThe company needs to identify and schedule the inspection and analyses which are critical for the products it produces. For example, critical analyses may include:\n• known product safety risks associated with the product type or identified during the HACCP risk assessment\n• legal requirements, particularly those associated with the country of intended sale (where this is known)\n• product authenticity (e. g. where a genuine risk of adulteration, substitution or fraud has been identified during the vulnerability assessment described in section 5. 4)\n• quality attributes (e. g. where these form part of a specification agreed with the customer).\nThe frequency and type of inspection and tests are not prescribed by the Standard as these should be risk-based and specific to the type of products (see clause 5. 6.1).", "requirement_fr": "L'entreprise doit disposer d'une procédure permettant de gérer les emballages obsolètes (y compris les étiquettes). Cette procédure doit inclure :\n•\t des mécanismes destinés à prévenir l’utilisation accidentelle d’emballages obsolètes\n•\t le contrôle et la mise au rebut des emballages obsolètes\n•\t des procédures adaptées pour traiter les matériaux imprimés obsolètes (visant par exemple à rendre des matériaux associés à une marque de commerce inutilisables).\n5.6 Inspection des produits, test de produits sur site et analyses en laboratoire L'entreprise doit effectuer ou sous-traiter des contrôles et des analyses indispensables permettant de confirmer la sécurité sanitaire, l’authenticité, la légalité et la qualité des produits, grâce à des procédures, des installations et des normes adaptées."}, {"id": "5.6.1", "requirement": "There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk.", "interpretation": "The company needs to have a documented schedule of tests which are carried out on the products. The objective of these tests is to ensure that products are manufactured to specification and in compliance with safety and legislative requirements. The HACCP or food safety plan is likely to identify some of the tests required and their frequency. However, other tests which ensure the quality of the product and which may not have been included in assessments of product safety must be considered. For example, tests may be identified to:\n• monitor for a potential contaminant (e. g. pesticides, heavy metals or microbiological contamination)\n• test for conformity to a specification or claim (e. g. nutritional content)\n• monitor trends (e. g. environmental monitoring of the site environment – see section 4. 11. for full details)\n• confirm compliance with a customer’s quality requirements\n• monitor potential food fraud or food defence concerns (e. g. as an output from food defence or food fraud assessments – see sections 4. 2 and 5. 4).\nThe processes for obtaining product samples, including, where necessary, their delivery to a laboratory, must be considered and will be dependent on the production process, the type of product, and whether the test is completed on site or at an external laboratory. For example:\n• how the sample is removed from the production flow – identifying the correct product, preventing contamination of the rest of the production, confirming the correct quantity is taken\n• sample integrity – to ensure that the sample is fit for analysis; for example, protecting it from contamination or adverse treatment (e. g. maintaining appropriate product temperature and respecting any time limitations for chilled or frozen products prior to microbiological testing)\n• clear labelling of samples with relevant information, including traceability\n• where required, procedures for:\n• storage of samples before testing\n• delivery to a laboratory\n• clear communication with the laboratory.\nThe frequency and type of product tests should be based on risk and on any particular customer requirements. The site is expected to be able to explain and justify the basis for the frequency of tests with reference to historical or scientific information as appropriate.\nThe test method and specifications for each test must be documented. Where the results of a test include subjective criteria (e. g. bake colour, texture or organoleptic tests), colour standards or reference samples must be used to provide a reference point for the test results (i. e. to define pass/fail criteria).\nWhere tests are completed on site, the location of the testing should be considered; for example, laboratory facilities will need appropriate siting and controls (clause 5. 6.5) and organoleptic tests should be completed in a designated area and not on the production line.", "requirement_fr": "Une planification des tests sur les produits doit être en place. Elle peut inclure des tests microbiologiques, chimiques, physiques et organoleptiques, en fonction des risques. Les méthodes, les processus d’obtention d’échantillons de produits (y compris, le cas échéant, leur livraison à un laboratoire), la fréquence et les limites spécifiées doivent être documentés."}, {"id": "5.6.2", "requirement": "Test and inspection results shall be recorded and reviewed regularly to identify trends.", "interpretation": "Systems of recording and review must be formalised and must include evidence of actions taken on identified trends, or where unsatisfactory results have been recorded. The use of graphs or charts of test results provides a good method of identifying trends and anomalous results.\nWherever testing is carried out, criteria (e. g. acceptable limits, action limits or legal limits) shall be established and documented, so results can be interpreted.\nIt is important that the receiving site understands the test results and the content of any test report and can interpret their significance.\nWhere test results are found to be outside established limits, there must be clear protocols on the actions to be taken (e. g. product hold, additional testing, customer notification, product withdrawal or recall). Appropriate actions should be implemented promptly to address unsatisfactory results or trends and thus protect consumer safety, product quality, legality and brand reputation.\nRecords of the results, review and any actions taken should be maintained.\nThe site must agree with the laboratory on how the measurement uncertainty shall be applied to results (for some tests, in some countries, this may be defined by legislation).\nMeasurement uncertainty Measurement uncertainty (sometimes simply referred to as ‘uncertainty’) is a parameter associated with the result of a quantitative measurement. It is defined as the range of the values that could reasonably be expected for the attribute (e. g. the micro-organism, allergen or chemical) being measured. It is sometimes known as the ‘margin of doubt’ of the result.\nMeasurement uncertainty is important when making conformity decisions (i. e. assessing whether a test result is within legal, safety or acceptable limits), as the range of probable values may cross one of these limits.\nNo matter what method is used, it will be subject to challenges inherent in taking the measurements accurately, day-to-day variations (e. g. in equipment, reagents, personnel or environmental conditions), and any systematic errors, random errors or corrections associated with the test; therefore the result obtained is the best estimate of the value.\nRandom errors are errors that fluctuate due to the unpredictability or uncertainty inherent in the measuring process, or the variation in the quantity being measured (i. e. variation throughout the sample or product being tested, and this is often demonstrated by the normal variation seen in replicate measurements of the same material). A systematic error is one that originates from a persistent issue and leads to a consistent error in the measurements; for example, recovery.\nMeasurement uncertainty Product testing is often completed to establish compliance with limits; i. e. to demonstrate that a product meets the requirements defined in its specification, by regulations and by customers. Knowing the measurement uncertainty is important when making these conformity decisions. For illustrative purposes only, in represents the target value or limit; values above this fall outside the permitted range, and values below it are within the permitted range.\nA B C D Results A and D are well above or well below the limit, and thus applying the measurement uncertainty value will not change the conformity statement made (e. g. A is still outside the limit and D is still in specification). It is in results B and C where measurement uncertainty would impact on the conformity.\nThe value obtained for C is within the limit. However, if the result and measurement uncertainty are combined, the value represented by C may fall above the limit and thus be out of specification.\nThe value obtained for B is above the limit and therefore would be out of specification, but taking measurement uncertainty into consideration, there is a potential that B could fall below the threshold (i. e. be within specification).\nApplying measurement uncertainty in this manner needs careful consideration and justification depending on the risk, applicable legislation or customer requirements. Where the test is of a critical parameter (e. g. product safety or legality), measurement uncertainty must not be used to prevent taking the correct action to protect consumers and/or maintain legality.", "requirement_fr": "Les résultats des tests et des contrôles doivent être consignés et révisés régulièrement pour identifier des tendances.\nLa signification des résultats sur site et de laboratoires doit être comprise, et envisager des actions adaptées. Des actions adaptées doivent être mises en place rapidement face à un résultat ou à une tendance non satisfaisants.\nLorsque des limites légales s'appliquent, celles-ci doivent être comprises, et des actions adaptées doivent être prises rapidement face à tout dépassement de ces limites.\nLe cas échéant, l'incertitude des mesures associée aux résultats des tests effectués en laboratoire doit être prise en compte."}, {"id": "5.6.3", "requirement": "The site shall ensure that a system of validation and ongoing verification of the shelf life is in place.", "interpretation": "Shelf-life testing may be critical to product safety; for example, where the product is susceptible to the growth of pathogens. Therefore, after the initial shelf life is determined (see clause 5. 1.4), the site is expected to have a programme of ongoing shelf-life validation and verification across its range of products or product types. To achieve this, samples should be retained from some or all production runs.\nRecords must be available supporting the declared shelf life for each product or group of similar products. These may include microbiological and sensory analyses, as well as relevant chemical factors such as pH and aw. Shelf-life trials extending beyond the stated life of the product, to ensure a margin of safety, may be required for some product types.", "requirement_fr": "Le site doit s'assurer qu'un système de validation et d'évaluation continue de la durée de vie est en place. Il doit se baser sur les risques et inclure des analyses sensorielles et, le cas échéant, des tests microbiologiques portant sur des facteurs chimiques pertinents, tels que le pH et l'aw. Les enregistrements et les résultats des tests sur la durée de vie doivent correspondre à la durée de vie indiquée sur le produit."}, {"id": "5.6.4", "requirement": "Pathogen testing shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be fully segregated.", "interpretation": "The requirements apply specifically to the testing of pathogens, and not to general microbiological tests such as those for yeasts and moulds, total viable count (TVC), coliforms or Enterobacteriaceae (while these need to be carefully controlled, they present a lower level of risk).\nIf pathogen-testing facilities are not carefully managed, they could present a risk to products. Pathogen testing also tends to be a specialised activity requiring specific facilities, and consequently it is usually outsourced to a specialist laboratory.\nWhere pathogen testing is carried out on the production site, the laboratory facility must be physically segregated (ideally in a separate building) from production, food-handling and storage areas. The company must have documented procedures to prevent product contamination and must be able to justify the controls in place. Consideration of the design of the laboratory is covered in clause 5. 6.5.\nFacilities for testing pathogens, their location (in relation to production and food-storage/ handling operations) and containment arrangements may be subject to legislation and/or guidelines, which the site will need to comply with.\nAllergens and other contaminant tests, for example, will also require suitable facilities, with procedures for the delivery and removal of samples from the laboratory (i. e. this should not be done via production or food-handling areas).\nFor environmental monitoring testing methods and use of rapid testing kits and ATP swabbing, see section 4. 11. 8.", "requirement_fr": "Les analyses des pathogènes (y compris les pathogènes analysés dans le cadre du programme de surveillance environnementale du site) doivent être sous-traitées à un laboratoire extérieur ou, lorsqu'elles sont menées en interne, les installations du laboratoire doivent être complètement isolées des zones de production et de stockage, et disposer de procédures de fonctionnement pour éviter tout risque de contamination des produits ou zones de production."}, {"id": "5.6.5", "requirement": "Where testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety.", "interpretation": "If a laboratory is present within the site, documented control procedures are required to eliminate potential risks to product safety. These include:\n• appropriate containment of the work, i. e. design and operating procedures that ensure that product and production areas cannot be contaminated by laboratory samples or laboratory activities\n• drainage and ventilation systems; for example, by ensuring the drainage does not flow through the production areas\n• restricted or controlled access for authorised personnel only\n• procedures which ensure that protective clothing arrangements are suitable (e. g. not wearing laboratory clothing in other areas of the site, especially in production and storage areas) and coat change procedures\n• movement of materials to and from the laboratory (e. g. laboratory consumables, chemicals, reference materials, equipment and laboratory waste)\n• hygiene procedures such as hand-washing on entry to the area.\nWhere at-line testing is undertaken, measures shall be in place to protect the integrity of testing and production activities (e. g. by locating them in designated areas away from the production line, and allowing them to be completed only by trained and authorised staff).\nAccreditation to ISO/IEC 17025, or a similar recognised national standard with equivalent requirements, will demonstrate that the laboratory meets these requirements.", "requirement_fr": "Lorsque des laboratoires d’analyses sont présents sur un site de fabrication, ils doivent être situés, conçus et utilisés de manière à éliminer tout risque potentiel pour la sécurité sanitaire des produits. Les contrôles doivent être documentés et mis en place, et tenir compte :\n•\t des procédures opérationnelles visant à réglementer les activités du laboratoire, notamment la conception et le fonctionnement des systèmes d’évacuation et d’aération\n•\t de l'accès et de la sécurité du site\n•\t des déplacements du personnel de laboratoire\n•\t des dispositions quant à l’hygiène et aux vêtements de protection\n•\t des déplacements de matériaux pouvant présenter un risque pour les produits, les matières premières ou la zone de production, à l'entrée et à la sortie du laboratoire, y compris le traitement des déchets de laboratoire\n•\t de la gestion et la surveillance des équipements de laboratoire.\nLorsque des tests sont réalisés dans des zones de production ou de stockage (c-à-d. les tests de chaînes ou les tests rapides), ceux-ci doivent être situés, conçus et gérés de manière à prévenir la contamination des produits."}, {"id": "5.6.6", "requirement": "Where the company undertakes or subcontracts analyses which are critical to product safety, authenticity or legality, the laboratory shall have gained recognised laboratory accreditation (ISO/IEC 17025).", "interpretation": "This clause applies to tests which are critical to product safety or legality. Results from such tests must be credible and may be called upon in a court of law.\nThe company needs to identify which tests are critical to product safety, authenticity or legality, such as compliance with label claims or declarations (e. g. nutritional claims, alcohol content) and tests for contamination (e. g. pesticides, aflatoxins), and verify that they are fit for purpose; for example, by confirming that the laboratory and method is covered by the laboratory’s accreditation to ISO/IEC 17025 for the product/material in question.\nNote that while the laboratory itself may have accreditation, the actual test methods must also be accredited, as laboratory accreditation will relate to specific testing activities, and may not cover all of the services that the laboratory provides. The specific tests should be defined within the laboratory’s schedule of accreditation. Any method of analysis that is not accredited needs justification as to why it was used (e. g. it may be a method for which no accreditation is yet available). Where critical tests are carried out by non- accredited laboratories or with non-accredited methods (either contracted or on-site laboratories), there must be suitable documented evidence that the laboratory is working to the requirements and principles of ISO/IEC 17025. This must include confirmation of the laboratory’s procedures to meet the following general principles:\n• document control\n• defined responsibilities and authority\n• staff competency and documented training\n• documented test methodology based on accepted standards\n• equipment that is fit for purpose and appropriately calibrated\n• a documented quality assurance programme, including proficiency testing (this is interlaboratory analysis, where multiple laboratories test the same material to allow a comparison of the results. A site or laboratory can therefore demonstrate that the test procedures used are working effectively and equivalent to those used in other laboratories)\n• completion of internal audits of the laboratory’s operation.\nOther good practices include:\n• equipment control (e. g. maintenance, calibration, traceability to recognised standards, monitoring and result appraisal)\n• validation of methods and materials to confirm fitness for purpose (e. g. test methods, equipment, test kits, reagents, chemicals)\n• quality-monitoring processes (e. g. proficiency tests, reference materials)\n• appropriate monitoring of environmental conditions\n• communication systems between the site and laboratory\n• completeness of record-keeping\n• management of non-conforming laboratory work\n• review of laboratory performance and operations.", "requirement_fr": "Lorsque l'entreprise effectue ou sous-traite des analyses essentielles pour la sécurité sanitaire, l’authenticité ou la légalité des produits, le laboratoire ou les sous-traitants doivent posséder une accréditation de laboratoire reconnue ou travailler conformément aux exigences et aux principes de la norme ISO/CEI 17025, y compris présenter des tests de compétence, le cas échéant. Une justification documentée doit être disponible lorsque des méthodes accréditées ne sont pas employées."}, {"id": "5.6.7", "requirement": "Procedures shall be in place to ensure reliability of laboratory results other than those critical to safety and legality.", "interpretation": "This requirement applies to non-critical product testing. While such tests need not be carried out by a laboratory accredited to ISO/IEC 17025, it is nonetheless important that the results can be relied upon. The clause sets out the documented procedures which must be in place to provide confidence in reliability.\nIn accordance with good laboratory practice, all laboratory testing should be suitability- controlled irrespective of the nature of the tests. clause 5. 6.6 clarifies the requirements for tests relating to product safety, authenticity and legality.\n5. 7 Product release The site shall ensure that finished product is not released unless all agreed procedures have been followed.\nThe site must have a process to ensure that finished product is not released from its control until all production checks have been completed and reviewed. Completion of end-product testing may not be applicable prior to the release of all products. (An example would be microbiological checks on short-shelf-life products such as sandwiches.) However, there must be appropriate checks on the CCPs to ensure that the process was within specification before product is released from the company’s control. This allows product to be held when a review of the process checks identifies a potential problem.", "requirement_fr": "Des procédures doivent être en place pour garantir la fiabilité des résultats de laboratoire, autres que celles essentielles à la sécurité sanitaire et à la légalité spécifiées dans la clause 5.6.6. Ces procédures doivent inclure :\n•\t l'utilisation de méthodes de test reconnues, lorsqu'elles sont disponibles\n•\t des procédures de test documentées\n•\t la garantie que le personnel est qualifié et/ou formé correctement et possède les compétences pour effectuer les analyses requises\n•\t l'utilisation d'un système permettant de vérifier l'exactitude des résultats des tests (c-à-d. idem, le cas échéant)\n•\t l'utilisation de matériel correctement étalonné et entretenu.\n5.7 Libération des produits Le site doit s'assurer que les produits finis ne sont libérés que si toutes les procédures convenues ont été suivies."}, {"id": "5.7.1", "requirement": "Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorised.", "interpretation": "Where products are held either on or off site awaiting positive release, there need to be documented procedures describing the process for release and who authorises it. The procedures need to be sufficiently robust so that accidental release cannot occur; for example, having password control on a computerised system to prevent unauthorised picking of held product, or using the physical identification of pallets in the warehouse.\n5. 8 Pet food and animal feed Where a site produces pet food or animal feed, all the relevant requirements from sections 1–7 of the Standard must be fulfilled in addition to the requirements in this section.\nFor example, pet food and animal feed need to be considered as part of the food safety plan (HACCP), as detailed within section 2 of the Standard.\nWhere a site produces by-products of the food manufacturing process or sells downgraded/surplus products for animal feed, the requirements for this process are detailed in section 4. 13, especially clause 4. 13. 3.\nWhere a site does not manufacture pet food/animal feed, this section can be marked as not applicable (n/a).\nThe site shall ensure that pet food and animal feed products are safe and fit for intended use.\nPet food and/or animal feed is manufactured in the same type of environment as food for human consumption, but there are some specific additional requirements that reflect the nature of pet food and animal feed manufacture.", "requirement_fr": "Lorsque des produits requièrent un contrôle libératoire positif, des procédures doivent être en place pour garantir que la libération n'a pas lieu avant que tous les critères de libération aient été respectés et que la libération ait été autorisée.\n5.8 Aliments destinés aux animaux domestiques et produits destinés à l’alimentation animale Lorsqu'un site produit des aliments pour animaux et animaux domestiques, toutes les exigences pertinentes des sections 1 à 7 de la Norme doivent être respectées, en plus de celles de la présente section.\nLe site doit s'assurer que les aliments destinés aux animaux domestiques et les produits destinés à l’alimentation animale sont sans danger et adaptés à l'usage auquel ils sont destinés."}, {"id": "5.8.1", "requirement": "The site shall ensure that pet food and animal feed is formulated/designed for the intended use.", "interpretation": "Pet food and animal feed are unique in that a product can be designed for complete diet (i. e. a pet may eat the same product at every meal, often without other additions to the diet) or as a complementary product (e. g. as an addition to certain meals or as an occasional treat).\nThe formulation and design (e. g. nutritional composition, portion size etc.) is therefore likely to be different depending on the intended frequency of consumption (complete or complementary).\nAuditors will expect to see documented evidence that this formulation requirement has been considered (e. g. in new product development processes, recipe design and/or specifications).", "requirement_fr": "Le site doit s’assurer que les aliments pour animaux et animaux domestiques sont conçus/ formulés pour l’utilisation prévue (c-à-d. si les produits sont conçus comme une alimentation complète ou comme un complément)."}, {"id": "5.8.2", "requirement": "Where a site’s product range includes pet food or animal feed products for different animal species, the site shall have specific procedures for the management of ingredients/products.", "interpretation": "Sites that produce pet food and/or animal feed for many different animal species (e. g. cats, dogs, fish) must be aware that some ingredients cannot be safely eaten by all species without deleterious effect. For example, there are foods that can be fed to cats but not dogs because of their different dietary requirements. Therefore, sites should consider:\n• a system to identify materials that could potentially be harmful to unintended recipients (i. e. to other species of pets). This shall include raw materials, processing aids, intermediate and finished products, and any new product development ingredients or products\n• a system to ensure incorrect ingredients cannot be used\n• procedures (e. g. cleaning procedures) to prevent cross-contamination from the production of one type of pet food into the subsequent pet food for a different species\n• specific procedures to ensure correct labelling of intended animal species and any limitations on use.", "requirement_fr": "Lorsque la gamme de produits d’un site inclut des aliments pour animaux ou pour animaux domestiques destinés à des espèces différentes, le site doit disposer de procédures spécifiques pour gérer les ingrédients, matières premières, produits ou produits recyclés qui pourraient être néfastes si donnés à un mauvais destinataire."}, {"id": "5.8.3", "requirement": "Where the site manufactures pet food or animal feed products that contain medicinal substances, the site shall have specific procedures for the management of the medicated raw materials and finished products.", "interpretation": "If a site manufactures pet food and/or animal feed which contains medicinal substances, it is vital that these materials (both the raw materials and the finished products) are controlled to ensure correct doses and prevent cross-contamination. At a minimum, procedures must:\n• ensure clear identification of medicated materials (raw materials, processing aids, intermediate products, rework and finished products) throughout the receipt, storage and manufacturing processes, so that all staff are aware that the material is medicated and of the nature of the medication. This is important where multiple medicated substances are handled on site\n• include supplier approval in accordance with section 3. 5.1 for all medicated raw materials (in addition to the other feed ingredients which are already covered in section 3. 5.1); for example, raw material risk assessments, supplier approval and monitoring procedures\n• ensure relevant product safety training, as required by section 7. 1 of the Standard. If the site handles medicated materials, training must provide specific information on the handling of these materials and any relevant procedures specifically related to the medicated substances\n• include processes to evaluate the correct doses of medicated substances for new product development, recipes and specifications\n• ensure that only the correct amounts of medicated substances are added to the batch during manufacture. Any features of the manufacturing process that could affect these concentrations (e. g. uneven distribution through the batch or a production process that effectively concentrates the medication such as a cooking process that causes water loss) must be considered\n• prevent cross-contamination from the production of medicated pet food into subsequent pet food which should not contain the medication. This applies principally to cleaning procedures.\nMedicated substances and products containing them are likely to be subject to additional procedures and legal requirements; for example:\n• specific storage requirements\n• segregation between medicated and non-medicated materials and products (both in storage and during production)\n• handling of waste materials in a way that is legal and prevents product contamination (as already highlighted in section 4. 12). Medicated substances, and products containing them, are likely to require specific procedures to ensure safe and legal waste disposal;\nfor example, controlled disposal, licensed contractors, prevention of environmental contamination.", "requirement_fr": "Lorsque le site fabrique, traite ou emballe des aliments pour animaux ou animaux domestiques contenant des substances médicamenteuses, le site doit disposer de procédures spécifiques pour gérer les matières premières et produits finis médicamenteux. Au minimum, ces procédures doivent inclure :\n•\t l’identification des matières médicamenteuses manipulées sur le site. Il peut s'agir de matières premières, d’adjuvants de fabrication, de produits intermédiaires et finis, de produits recyclés ou de tout nouveau produit développé ou nouvel ingrédient\n•\t l'approbation du fournisseur, telle que détaillée dans la section 3.5.1 pour toutes les matières premières médicamenteuses\n•\t une formation spécifique pour apprendre au personnel à manipuler correctement les matières médicamenteuses\n•\t des mécanismes destinés à garantir que les produits finis contiennent la concentration de substance médicinale adéquate\n•\t des procédures (c-à-d. des procédures de nettoyage) pour empêcher la contamination des aliments pour animaux et animaux domestiques non médicamenteux par des matières contenant des substances médicinales\n•\t des procédures spécifiques garantissant que les aliments médicamenteux pour animaux et animaux domestiques sont étiquetés correctement\n•\t des mécanismes de traitement des déchets (voir section 4.12) assurant l'élimination sûre et légale des matières premières et produits médicamenteux."}, {"id": "5.8.4", "requirement": "Site procedures shall be designed and implemented to meet the relevant pet food and animal feed product safety legislation.", "interpretation": "Different parts of the world have different legislative requirements relating to pet food and animal feed. For example, in the UK, the production of pet food using materials of animal origin and animal by-products needs to be registered with the Animal and Plant Health Agency (APHA), and the EU Animal Feed Regulations apply, such as the regulation regarding the placing of animal feed on the market.\nclause 1. 1.8 requires sites to have systems in place to ensure that they remain up to date with product safety legislation (as well as other aspects of good practice). clause 5. 8.4 requires that legislation is converted into practice, such that site procedures are designed and implemented to meet the legislative requirements in both the country of manufacture and the country where the product is sold.\n5. 9 Animal primary conversion Where a site completes animal primary conversion (e. g. for red meat, poultry or fish), the following requirements apply, in addition to those within the rest of the Standard.\nAnimal primary conversion is defined as completing the slaughter and/or evisceration of animals (including red meat, poultry and game) or the slaughter and/or gutting of fish. Applicable sites will therefore fall within BRCGS product categories 1, 2 or 4.\nFor animal primary conversion, the site shall operate controlled processes that ensure products are safe and fit for intended use.\nSpecific controls are required to ensure that food remains safe, authentic and legal during animal primary conversion.\nThe clauses in this section are closely linked to clauses in other sections of the Standard and the interpretation provided with them.", "requirement_fr": "Les procédures du site doivent être conçues et mises en œuvre pour satisfaire à la législation pertinente en matière de sécurité des aliments pour animaux et animaux domestiques (tant dans le pays de production que dans le pays de vente).\n5.9 Conversion primaire des animaux Lorsqu'un site est en charge de la conversion primaire d'animaux (c-à-d. pour la viande rouge, la volaille ou le poisson), les exigences suivantes s'appliquent, outre celles détaillées dans le reste de la Norme.\nPour la conversion primaire des animaux, le site doit mettre en place des processus contrôlés garantissant que les produits sont sûrs et adaptés à leur usage prévu."}, {"id": "5.9.1", "requirement": "The company shall undertake a risk assessment for potential prohibited substances (e.g. pharmaceuticals, veterinary medicines, heavy metals).", "interpretation": "Many countries have legislation relating to substances that are prohibited in food, and specifically meat and products of animal origin. A risk assessment is therefore required to assess the risk of raw materials containing these substances.\nThe Standard does not provide a definitive list of prohibited substances, as this will depend on the location of the site and the countries where the products will be sold; however, examples include pharmaceuticals, veterinary medicines (such as growth hormones), specific heavy metals and pesticides.\nThis activity may form part of the larger risk assessment completed on all raw materials (see clause 3. 5.1. 1), be completed as part of the HACCP process (see clause 2. 7.1) or be completed as a separate activity.\nSection 3. 5.1 requires the company to have supplier approval and monitoring processes, and the output from this risk assessment must be included in those activities.", "requirement_fr": "L'entreprise doit entreprendre une évaluation des risques prenant en compte les substances potentiellement prohibées (c.-à-d. les substances interdites par la législation en vigueur dans le pays de production ou de vente). Des exemples de telles substances incluent les produits pharmaceutiques, les médicaments vétérinaires (c-à-d. les hormones de croissance), les métaux lourds et les pesticides.\nL'évaluation des risques peut être réalisée dans le cadre de la clause 3.5.1.1 ou comme une activité distincte.\nLes résultats de l'évaluation des risques doivent être inclus dans les procédures de réception et de test des matières premières, et dans les processus adoptés pour approuver et contrôler le fournisseur (voir les clauses 3.5.1.2 à 3.5.2.2)."}, {"id": "5.9.2", "requirement": "Where the site is in receipt of live animals, there shall be an inspection by a suitably competent individual at lairage and post-mortem.", "interpretation": "This requirement relates only to sites that are in receipt of live animals, such as slaughterhouses and sites receiving live fish.\nThe purpose of the inspection is to ensure that the animals are not diseased and are fit for slaughter for human consumption.\nThe inspection must be carried out both before and after slaughter. It should also identify any live animals that may present an increased risk of cross-contamination in the plant; for example, excessively dirty or salmonella-positive flocks. Such animals require extra actions, such as cleaning or slaughter at the end of production, to prevent cross-contamination of unaffected animals or products.\nIn most countries, official veterinary inspections occur before and after slaughter. This fulfils the primary requirements of the clause. In the absence of an official veterinary inspection, the checks must be carried out by site staff who understand the signs of disease that present a risk to human consumption and any legislative requirements, and who have the authority to reject animals or organs.\nWhere an animal is found to be unfit for human consumption, the site would be expected to have procedures in place for the segregation of unfit meat or animals to prevent them from entering the human food chain.\nRecords should be kept of the inspections.", "requirement_fr": "Lorsqu’un site réceptionne des animaux vivants, des inspections ante-mortem et post-mortem doivent être effectuées par une personne compétente, afin de garantir que les animaux sont propres à la consommation humaine."}, {"id": "5.9.3", "requirement": "The site shall operate procedures to ensure that the traceability of all edible parts of the carcass is maintained.", "interpretation": "The site must operate appropriate procedures to ensure that the traceability of all edible parts of the carcass (i. e. those intended for the human food chain) is maintained, including blood or other by-products for human consumption.\nSimilarly to clause 3. 9.1, the Standard is not prescriptive on the traceability system used.\nHowever, the site must be aware of any limitations of the traceability systems used. If a carcass is deemed unfit for consumption, all edible parts associated with that carcass need to be removed from the product flow. If traceability is to the day or batch rather than to specific carcasses, in the event of a product withdrawal or recall, the whole day of production or batch may need to be recalled for each edible part.\nThe site must document its traceability procedure, and ensure relevant personnel are trained in it and it is fully implemented.\nNote that for the purposes of this clause, edible parts include any part of the carcass which enters the human food chain (including offal, animal by-products for human food chain, and blood for human consumption; e. g. in the UK, blood is incorporated into the manufacture of black pudding).\nThe site should be aware that in addition to a documented procedure, traceability requires a number of activities including identification of raw materials, intermediate/semi-processed products, part-used materials, and finished products in accordance with clause 3. 9.2.", "requirement_fr": "Le site doit appliquer des procédures garantissant la traçabilité de toutes les parties comestibles de la carcasse (c.-à-d. toutes les parties destinées à la chaîne alimentaire humaine)."}, {"id": "5.9.4", "requirement": "The site shall establish defined time and temperature requirements for all post-slaughter processes.", "interpretation": "clause 6. 1.1 requires the site to have documented process specifications and work instructions for all key processes that may adversely affect product safety, legality and quality. This requirement specifically focuses on the need for post-slaughter times and temperatures to ensure product safety. These must be available for:\n• all edible parts intended for the human food chain\n• all parts of the post-slaughter process including, for example, initial cooling (and time to reach intended carcass temperature), any processing stage, storage and distribution.\n6 Process control\n6. 1 Control of operations Fundamental The site shall operate to process specifications and work instructions/procedures that ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP or food safety plan.\nThe principle of these requirements is to ensure that the documented HACCP or food safety plan is put into operation on a day-to-day basis, together with effective procedures to ensure that the product can be produced:\n• to food safety and legality requirements\n• consistently to the specified quality.\nNote that this section of the Standard covers production facilities. In conjunction with these requirements, sites may find it useful to consider sections 4. 15 (product storage) and 4. 16 (management of transportation/distribution of the product).", "requirement_fr": "Le site doit mettre en place des exigences définies de durée et de température pour tous les processus post-abattage (c-à-d., le réfrigération, la transformation, le stockage et la distribution). Ces exigences doivent être définies pour toutes les parties comestibles réfrigérées ou congelées de la carcasse.\n6 Contrôle du processus 6.1 Contrôle des opérations Fondamental Le site doit fonctionner conformément à des spécifications de processus et des instructions/ procédures de travail qui garantissent la production de produits systématiquement sûrs et légaux et ayant les caractéristiques de qualité souhaitées, en totale conformité avec le plan de sécurité des denrées alimentaires, ou HACCP."}], "statement_of_intent": "Product design and development procedures shall be in place for new products or processes and any changes to product, packaging or manufacturing processes to ensure that safe and legal products are produced.", "group_intros_fr": {"5.8": "Lorsqu'un site produit des aliments pour animaux et animaux domestiques, toutes les exigences pertinentes des sections 1 à 7 de la Norme doivent être respectées, en plus de celles de la présente section.\nLe site doit s'assurer que les aliments destinés aux animaux domestiques et les produits destinés à l’alimentation animale sont sans danger et adaptés à l'usage auquel ils sont destinés.", "5.2": "L'étiquetage des produits doit être conforme aux exigences légales applicables et contenir des informations permettant la manipulation, la mise en rayon, le stockage et la préparation du produit sans danger au sein de la chaîne d'approvisionnement alimentaire ou par le consommateur.", "5.1": "Les procédures de conception et de développement des produits doivent être en place pour les nouveaux produits ou processus et pour toute modification des produits, emballages ou processus de fabrication, afin de garantir que des produits sans danger et légaux sont fabriqués.", "5.4": "Des systèmes doivent être en place pour minimiser les risques d'achats de matières premières alimentaires frauduleuses ou altérées et pour garantir que toutes les descriptions des produits et les allégations sont légales, véridiques et vérifiées.", "5.7": "Le site doit s'assurer que les produits finis ne sont libérés que si toutes les procédures convenues ont été suivies.", "5.9": "Lorsqu'un site est en charge de la conversion primaire d'animaux (c-à-d. pour la viande rouge, la volaille ou le poisson), les exigences suivantes s'appliquent, outre celles détaillées dans le reste de la Norme.\nPour la conversion primaire des animaux, le site doit mettre en place des processus contrôlés garantissant que les produits sont sûrs et adaptés à leur usage prévu.", "5.5": "Les emballages de produits et les processus d'achat des emballages de produits doivent être adaptés à l'usage prévu.\nLes emballages doivent être stockés dans des conditions permettant d'éviter la contamination et de minimiser la détérioration.", "5.6": "L'entreprise doit effectuer ou sous-traiter des contrôles et des analyses indispensables permettant de confirmer la sécurité sanitaire, l’authenticité, la légalité et la qualité des produits, grâce à des procédures, des installations et des normes adaptées.", "5.3": "Les fabricants d’aliments pour animaux et animaux domestiques certifiés dans le cadre de la Norme sont tenus de respecter la législation concernant la gestion des allergènes en vigueur dans les pays où les produits sont destinés à la vente. Par conséquent, si la présence d'allergènes dans les aliments pour animaux/animaux domestiques ne fait l'objet d'aucune législation, cette section de la Norme peut être considérée comme \"non applicable\" pour l’alimentation animale ou d'animaux domestiques à destination de ces pays.\nDans certaines régions du monde, les aliments pour animaux et animaux domestiques affichent des allégations concernant la présence d'allergènes (c-à-d. sans gluten ou sans produits laitiers). Ainsi, lorsqu'un site formule une allégation relative aux allergènes sur des aliments pour animaux ou animaux domestiques, celle-ci doit satisfaire à toutes les exigences de la section 5.3.\nFondamental Le site doit disposer d'un système permettant de gérer les allergènes, afin de minimiser le risque de contamination des produits par des allergènes (contact croisé) et de répondre aux exigences légales d'étiquetage dans le pays de vente."}, "group_intros": {"5.3": "Pet food and animal feed manufacturers certificated to the Standard are required to meet the appropriate allergen management legislation in the country of intended sale of the products. Therefore, if there is no legislation relating to allergens in pet food/animal feed, this section of the Standard may be considered ‘not applicable’ for pet food or animal feed destined for those countries.\nIn some parts of the world, allergen claims (e g. gluten- or dairy-free) are made on pet food or animal feed products.\nTherefore, where a site makes an allergen claim on a pet food or animal feed, it is required to meet all of the requirements within section 5.3.\nFundamental The site shall have a system for the management of allergenic materials which minimises the risk of allergen contamination (cross-contact) of products and meets legal requirements for labelling in the country of sale.", "5.9": "Where a site completes animal primary conversion (e.g. for red meat, poultry or fish), the following requirements apply, in addition to those within the rest of the Standard.\nFor animal primary conversion, the site shall operate controlled processes that ensure products are safe and fit for intended use.", "5.4": "Systems shall be in place to minimise the risk of purchasing fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are legal, accurate and verified.", "5.6": "The company shall undertake or subcontract inspection and analyses which are critical to confirm product safety, authenticity, legality and quality, using appropriate procedures, facilities and standards.", "5.1": "Product design and development procedures shall be in place for new products or processes and any changes to product, packaging or manufacturing processes to ensure that safe and legal products are produced.", "5.5": "Product packaging and processes for the purchase of product packaging shall be appropriate for the intended use.\nPackaging shall be stored under conditions to prevent contamination and minimise deterioration.", "5.7": "The site shall ensure that finished product is not released unless all agreed procedures have been followed.", "5.8": "Where a site produces pet food or animal feed, all the relevant requirements from sections 1–7 of the Standard must be fulfilled in addition to the requirements in this section.\nThe site shall ensure that pet food and animal feed products are safe and fit for intended use.", "5.2": "Product labelling shall comply with the appropriate legal requirements and contain information to enable the safe handling, display, storage and preparation of the product within the food supply chain or by the customer."}}, {"section": 6, "title": "Process control", "clauses": [{"id": "6.1.1", "requirement": "Documented process specifications and work instructions/procedures shall be available for the key processes in the production of products to ensure product safety, legality and quality. • recipes – including identification of any allergens. • mixing instructions, speed, time. • equipment process settings. • cooking times and temperatures. • cooling times and temperatures. • labelling instructions. • coding and shelf-life marking. • storage conditions. • any additional critical control points identified in the HACCP or food safety plan", "interpretation": "Documented process specifications, procedures or work instructions must be available for all key stages of the operation. These documents must be readily available to staff in the area in which the activity is undertaken. The documents must be sufficient to ensure that all key process parameters are specified and controlled, thereby ensuring that manufactured product consistently meets safety, legality and quality specifications.\nNote that while some of these key processes are likely to be CCPs or equivalent, they are unlikely to be limited to just CCPs, and sites may need to consider other control points and prerequisites to ensure all relevant parameters are captured. The Standard lists some examples including (although this is not an exhaustive list):\n• recipes – including identification of any allergens\n• mixing instructions such as speed and time\n• equipment process settings; for example, line speed, which may in turn affect other online food safety and quality activities such as:\n• the performance of metal detectors, check weighers and automated packaging accuracy checks\n• manual inspection for quality\n• cooking, chilling and freezing where this is completed using a continuous production line\n• cooking times and temperatures\n• cooling times and temperatures\n• labelling instructions\n• coding and shelf-life marking – it is worth noting that product recalls have occurred when date codes are incorrectly calculated and incorrect information printed on the pack\n• storage conditions (e. g. storage temperatures) for raw materials, intermediates and final products\n• any additional critical control points identified in the HACCP or food safety plan.\nStaff must be trained in the work instructions relevant to their role (section 7. 1).\nManufacturing instructions and process specifications must correctly reflect customer requirements, such as final product specifications. The equipment settings must be checked to ensure that the equipment is set up correctly for the specific product in production, and labelling instructions (such as particular requirements for label positioning on the pack) must be followed.\nSpecifications for work in progress are not applicable to all products. For example, when a product is manufactured in several stages and combined to form the final product, or when a product is partially processed and retained for future processing, a separate specification for that product may be required. It must detail the important criteria that affect the finished product quality or safety parameters (e. g. brix, weight, colour, shelf life or storage conditions) and must include the acceptable range of each parameter.\nSimple photographic specifications, including minimum, target and maximum grading levels for parameters such as size and colour, may be appropriate for production staff.\nThe site must ensure that process specifications and work instructions remain up to date, and therefore needs a review process that ensures that documents are updated prior to any changes.", "requirement_fr": "Des spécifications de processus et des instructions/procédures de travail documentées doivent être disponibles pour les processus clés de fabrication de produits, afin de garantir la sécurité sanitaire, la légalité et la qualité des produits. Les spécifications de processus et les instructions/procédures de travail doivent inclure, le cas échéant :\n•\t les recettes, y compris l'identification des allergènes potentiels\n•\t les instructions, la vitesse et la durée des mélanges\n•\t les paramètres des équipements\n•\t les durées et les températures de cuisson\n•\t les durées et les températures de refroidissement\n•\t les instructions d'étiquetage\n•\t le codage et l'indication de durée de vie\n•\t les conditions de stockage (c-à-d. températures de stockage)\n•\t tout point critique pour la maîtrise supplémentaire identifié dans le plan de sécurité alimentaire, ou HACCP.\nLes spécifications de processus doivent être conformes aux spécifications de produit fini convenues.\nLe site doit examiner les spécifications de processus et les instructions/procédures de travail avant de procéder à tout changement susceptible d'affecter la sécurité, la légalité et la qualité des denrées alimentaires."}, {"id": "6.1.2", "requirement": "Where equipment settings are critical to the safety or legality of the product, changes to the equipment settings shall only be completed by trained and authorised staff.", "interpretation": "As with any electronically stored data or records, equipment settings for product safety and/ or legality should be adjusted only by trained and competent members of staff, and controls should be in place to ensure that this remains the case.\nWhere equipment has the capacity for password protection or other restrictions such as locked controls, these should be used to ensure that only trained and authorised staff can make the amendments. Where equipment does not include these functions, the site will need to identify alternative mechanisms of control.", "requirement_fr": "Lorsque les paramètres des équipements sont essentiels à la sécurité ou à la légalité du produit, seuls des employés formés et autorisés peuvent y apporter des modifications. Le cas échéant, les contrôles doivent être protégés par un mot de passe ou soumis à d'autres restrictions."}, {"id": "6.1.3", "requirement": "Process monitoring, such as temperature, time, pressure and chemical properties, shall be implemented, adequately controlled and recorded.", "interpretation": "Processes must be adequately controlled and monitored to ensure that product is produced within specification. These processes may include CCPs or prerequisite programmes addressing issues such as temperature, time, pressure and chemical properties.\nMonitoring must be carried out at suitable frequencies based on experience of the reliability of equipment, frequency of process changes, and risk to product safety and quality. The frequency of checks should be included on recording forms and/or in procedure documentation. A record of all monitoring must be maintained.\nWhere processes are shown to have exceeded defined limits, corrective actions must be taken and this action must be recorded (clause 6. 1.6).", "requirement_fr": "Le contrôle du processus, notamment la température, la durée, la pression et les propriétés chimiques, doit être mis en place, correctement surveillé et consigné pour s'assurer que le produit est fabriqué conformément aux spécifications de processus requises."}, {"id": "6.1.4", "requirement": "In circumstances where process parameters or product quality are controlled by in-line monitoring devices, these shall be linked to a suitable failure alert system that is routinely tested.", "interpretation": "Where process parameters or product quality are controlled by in-line monitoring devices (e. g. automatic temperature or pH loggers), they must be linked to a suitable failure alert system (e. g. audible/visual alarm, machine stop function or product divert system) which is activated when defined parameters are exceeded. This alarm must be tested routinely to ensure that it functions properly, and records must be maintained.", "requirement_fr": "Lorsque les paramètres de processus ou la qualité des produits sont contrôlés par des dispositifs de contrôle en ligne, ces derniers doivent être reliés à un système d'alarme adapté en cas de défaillance, qui doit être régulièrement testé."}, {"id": "6.1.5", "requirement": "Where variation in processing conditions may occur within equipment critical to the safety or quality of products, the processing characteristics shall be validated and verified at a frequency based on risk.", "interpretation": "The objective is to ensure that products can be consistently produced and stored within clearly defined parameters (e. g. within defined temperatures). It is recognised that process conditions are often not uniform throughout a chill store or an oven. It is important, therefore, to identify hot or cold spots, both to try to improve uniformity and to identify worst-case scenarios to ensure that all products meet at least the minimum process conditions.\nThe Standard includes some common examples of equipment parameters such as:\n• heat distribution in retorts, ovens and processing vessels – the Standard expects heat- distribution studies to be carried out on cooking equipment wherever small variations in process temperature may affect the safety of the products. Heat-distribution studies of a static oven may identify cold spots. If it is not possible to make adjustments to eliminate these cold spots, the areas should be used as the worst-case scenarios when completing heat-distribution studies\n• temperature distribution in freezers and cold stores – when assessing whether to undertake temperature distribution studies on chill or freezer facilities, the level of risk will depend on the product, the time spent in store and any margin allowed by the temperature settings (e. g. setting the temperature at −20°C to ensure achievement of −18°C). Temperature distribution studies would not normally be necessary for small chill or cold stores where product is stored only for short periods.\nHowever, this is not a prescriptive list, and the site should consider all situations where variations in processing conditions may occur in equipment critical to the safety or quality of products. For example, if pH is identified as critical, it may be necessary to validate the pH distribution in a mixing vessel, and consider the thoroughness of the mixing process to achieve the desired pH throughout the batch.\nWhen testing equipment, any seasonal variations in performance must be considered, especially when trying to assess worst-case scenarios. For example, a chiller evaluated in winter may not give the same results in summer, especially if there are large seasonal differences in the ambient temperatures. Some refrigeration equipment may be at the limit of their performance on especially hot days if temperature parameters have not been properly specified.", "requirement_fr": "Lorsque des variations des conditions de transformation peuvent se produire dans des équipements essentiels à la sécurité sanitaire ou à la qualité des produits, les caractéristiques de transformation doivent être validées et vérifiées à une fréquence basée sur les risques et la performance des équipements (c-à-d. distribution de la chaleur dans les autoclaves, les fours et les cuves de fabrication, distribution de la température dans les congélateurs et les chambres froides)."}, {"id": "6.1.6", "requirement": "In the event of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety status and quality of the product.", "interpretation": "In cases of equipment failure or deviation from process or specification (e. g. outside the critical limit), the company must have defined procedures in place to ensure that the product is safe prior to its release. At a minimum, this should include:\n• identification of all products at risk (i. e. product produced since the last satisfactory check)\n• how the affected product will be assessed for suitability/safety (this may include sensory testing, microbiological sampling, reference to thermal process data or the use of mathematical modelling techniques, depending on the product and issue)\n• who is authorised to undertake action and make a final decision on the affected product.\nWhere product safety, authenticity, legality or quality is implicated, the site may need to apply its non-conforming product procedures (see section 3. 8).\nRecords must be kept of any deviation and the action taken.", "requirement_fr": "En cas de défaillance des équipements ou d'écarts de processus par rapport aux spécifications, des procédures doivent être en place pour déterminer le statut en matière de sécurité sanitaire et la qualité des produits, afin de définir les actions à prendre."}, {"id": "6.1.7", "requirement": "Where a site handles products or materials that are outside the scope of the audit, these shall be controlled to ensure that they do not create a product safety, authenticity or legality risk.", "interpretation": "This aim of this requirement is to ensure that the site has considered and managed any potential product safety, authenticity and legality risks associated with products or materials that are outside of the scope of the BRCGS audit.\nDuring the audit, the auditor may request information or watch the process, to ensure procedures are in place and completed appropriately, and therefore do not represent a risk to the products within scope.\nExamples of products outside of scope include, but are not limited to:\n• by-products of the manufacturing process, which are not permitted to be included in the scope of the Standard (e. g. materials taken for non-food use)\n• exclusions from scope (in accordance with section 1. 6.2 of the audit protocol).\n6. 2 Labelling and pack control Fundamental The management controls of product-labelling activities shall ensure that products will be correctly labelled and coded.\nOne of the common causes of withdrawals and recalls is incorrectly packed products and labelling (e. g. allergen labelling) that does not reflect the actual content of the product. Therefore the aim of this section is to ensure that the site has effective procedures to manage packing operations and to pack products in the correct packaging.\nPackaging controls must be in place which ensure the whole packing process is documented and working effectively.\nThese controls must be managed by nominated staff who have received specific labelling and packing process training (see clause 7. 1.5).\nSites may find it beneficial to consider this section in conjunction with sections 5. 2 (product labelling) and 5.\n(product packaging), which detail requirements on the design and purchase of packaging and labels.", "requirement_fr": "Lorsqu'un site manipule des produits ou des matières (c-à-d. des sous-produits issus de processus de production) qui ne rentrent pas dans la portée de l'audit, ceux-ci doivent être contrôlés, afin de garantir qu'ils ne posent pas de risque pour la sécurité, l'authenticité ou la légalité des produits inclus dans la portée de l'audit.\n6.2 Étiquetage et contrôle des produits conditionnés Fondamental Les contrôles de gestion des activités d'étiquetage des produits doivent garantir que les produits seront correctement étiquetés et codés."}, {"id": "6.2.1", "requirement": "There shall be a formal process for the allocation of packaging materials to packing lines and control in the packing area which ensures that only the packaging for immediate use is available. • setting and amendments to the printer parameters shall only be completed by an authorised member of staff. • controls shall be in place to ensure that only correctly printed material is available", "interpretation": "Packaging for each production run must be brought to the line in a formal and controlled manner following a documented process.\nOnly the packaging required for immediate use should be available to the packing line at any one time. Ideally, this will be achieved by only releasing new packaging from the store when all packaging from the previous run has been removed from the area. Where this is not possible (e. g. because of off-site packaging stores), a mechanism must be in place to ensure that only the relevant packaging can be released to the packing line (e. g. by storing packaging in a designated, secure location with authorised access).\nWhere multiple component packaging is used (e. g. pots with separate lids, multi-packs or packaging with separate labels), then the controls will need to apply to all the individual parts, to ensure they all match the product being produced.\nThe integrity of date codes is vital to ensure product safety is maintained. Where date codes (or other information) are applied to packaging or product on site (e. g. on the trays, sleeves or flow wraps), this must be controlled so that only authorised (and competent) personnel can set or make the changes to printers (e. g. inputting the required date code).\nProcesses must be in place to ensure that, after the product run, any unused labels are removed from the packaging line.\nChecks must be in place to monitor that actual label use matches expected label use (i. e. the actual and expected uses are reconciled). The aim is to confirm correct usage, and therefore provide an opportunity for any inconsistencies or unexpected results to be investigated. The Standard is not prescriptive on how this is completed; however, the site may find it useful to consider:\n• the typical waste tolerance, i. e. how many labels are typically wasted or destroyed during a production run (this allows normal waste figures to be included in the reconciliation)\n• the number of labels received, issued, used or restocked, along with any obsolete, misprinted or destroyed labels that need to be accounted for\n• systems for recording packing information; for example, when new reels or new batches of labels are added to the line\n• the frequency of the checks – for most sites, this is likely to be at the end of each production run, as this allows investigation of any inconsistences while the product is still within the site’s control. However, there may be situations, for example, with very long production runs, where an alternative frequency is justified\n• the system to be used to complete the check; for example, an automated label check and accounting system or a manual check system could be used, either of which might take the form of a formal mass balance at the end of each production run, or of a stock take.\nAny inconsistencies or unexpected results must be investigated to ensure correct label use.\nWhere appropriate, non-conforming product procedures (see section 3. 8), corrective action, root cause analysis and preventive actions may be required (see section 3. 7).", "requirement_fr": "Un processus formel doit être en place quant à la distribution des matériaux d'emballage dans les chaînes d'emballage et au contrôle dans les zones d'emballage pour s'assurer que seuls les emballages destinés à une utilisation immédiate sont disponibles dans les machines d'emballage.\nLorsqu'un codage ou un marquage des matériaux d'emballage a lieu hors ligne de production :\n•\t le réglage et les changements apportés aux paramètres de l’imprimante (c-à-d. la saisie ou la modification de codes de date) ne doivent être effectués que par un membre du personnel autorisé\n•\t des contrôles doivent être en place pour garantir que seuls les matériaux correctement imprimés sont disponibles dans les machines d’emballage.\nDes processus doivent être en place pour vérifier que les étiquettes correspondent à l'usage prévu et que toute incohérence fait l'objet d'une enquête."}, {"id": "6.2.2", "requirement": "Documented checks of the production line shall be carried out before commencing production and following changes of product. These shall ensure that lines have been suitably cleared.", "interpretation": "Sites are required to manage product changeovers and line start-ups to ensure the line is ready and correctly set for the next production run. If changeover is completed incorrectly, this represents a weakness at a key point in the production process, which could result in the production of non-conforming products; for example:\n• incorrect products being packed\n• incorrect labels being used (a major cause of product withdrawals and recalls in several parts of the world)\n• insufficient cleaning between products, resulting in:\n• the potential for microbiological or allergen cross-contamination\n• quality issues related to the product being contaminated or tainted with previous products\n• incorrect process parameters being used, e. g. cooking times and temperatures, or incorrect date coding.\nDocumented checks carried out on the production line before production commences must therefore ensure that systems are correctly set and running. Checks must include confirmation that:\n• lines have been suitably cleaned\n• lines have been cleared of any packaging from previous production runs\n• lines are ready for production, with CCPs and quality parameters correctly set (e. g. metal detector checks completed satisfactorily, cookers set to the correct temperature programme, correct packaging selected).\nIf the line is set up with equipment that has not been used for some time, there may be a need to re-disinfect food contact surfaces immediately prior to use, or undertake additional line checks, to ensure appropriate set-up (for example, that condition monitoring has been completed and the correct operating settings selected).\nChecks are also required following changes of product to ensure that all product, packaging and labels from the previous production have been removed and, where appropriate, to ensure that both cleaning and line set-up have been completed correctly for the new product. Line checks are usually the responsibility of the line manager or supervisor.\nEvidence that checks have been carried out (e. g. line check sheets) and guidelines on the checks to complete should be available.\nDuring the audit, the auditor will normally expect to witness at least one product changeover, and wherever practical at least one line start-up. There may be exceptional circumstances where a site has very long production runs, or situations where there are no scheduled product changeovers during the audit (as when the length of the production run is longer than the number of days that the auditor is on site), and therefore the inclusion of a product changeover or a line start-up is not possible; however, this must be considered exceptional, and any exceptions or omissions will be detailed in the audit report.", "requirement_fr": "Des vérifications documentées de la ligne de production doivent être effectuées avant le début de la production et après tout changement de produit. Ces vérifications doivent garantir que les lignes de production ont été correctement dégagées et sont prêtes pour la production.\nDes vérifications documentées doivent être effectuées lors de tout changement de produit pour s'assurer que tous les produits, emballages et étiquettes imprimés de la production précédente ont été retirés de la ligne de production avant de passer à la production suivante."}, {"id": "6.2.3", "requirement": "Procedures shall be in place to ensure that all products are packed into the correct packaging and correctly labelled. • at the start of packing. • during the packing run. • when changing batches of packaging materials. • date coding. • batch coding. • quantity indication. • pricing information. • bar coding. • country of origin. • allergen information", "interpretation": "A high proportion of product withdrawals/recalls are because of products being packed into incorrect packaging or incorrectly labelled. Therefore, specific documented packaging controls must be in place. Particular care is required where:\n• a number of similar-looking products are manufactured\n• a standard product may be packed into different types of packaging\n• there is a family of very similar labels for a product range, each containing different information (e. g. the presence of different allergens or different use-by/best-before dates).\nProcedures must be in place to verify that adequate checks have been carried out to minimise potential errors. The frequency of checks must be predefined, based on risk assessment, but at a minimum those checks specified in the requirement must be included:\n• at the start of packing – this is especially useful to confirm the correct packaging and labels are being used, and that line changeover procedures (clause 6. 2.2) have effectively removed all labels from the previous run\n• during the packing run (i. e. at predefined intervals); for example, the risk assessment may have identified a maximum frequency based on previous experience, or a maximum amount of product based on the site’s ability to recover and check product in the event of a failure\n• when changing batches of packaging materials; for example, when each new reel of labels or new batch of packaging is added to the line\n• at the end of each production run.\nThe packing run can be defined as a batch or lot (e. g. each time a new reel is used), or another distinct period. The intention is to ensure that the site is maintaining control over pre-printed packaging materials and their packing.\nThe procedures must also include verification of any code information or other printing carried out at the packing stage (i. e. applied by the site). This verification shall include those checks as specified in the requirement.\nPackaging and label checks should be recorded.", "requirement_fr": "Des procédures doivent être en place pour garantir que tous les produits sont emballés dans l'emballage adéquat et correctement étiquetés. Ces procédures doivent inclure des vérifications :\n•\t au début du processus d'emballage\n•\t pendant le processus d'emballage (c-à-d. à des intervalles prédéfinis, et lorsque les emballages ou les étiquettes imprimés sont apportés à la chaîne de production)\n•\t À la fin du processus d'emballage ou lors du chargement d’un nouveau lot de matériaux d'emballage.\nCes vérifications doivent également inclure des vérifications relatives aux marquages effectués lors de l'emballage, y compris, le cas échéant :\n•\t le codage de la date\n•\t le codage du lot\n•\t l'indication de la quantité\n•\t l'information du prix\n•\t le code-barres\n•\t le pays d'origine\n•\t les informations relatives aux allergènes."}, {"id": "6.2.4", "requirement": "Where online verification equipment is used to check product labels and printing, the site shall establish and implement procedures for the operation and testing of the equipment.", "interpretation": "Some sites have found that the use of automated online vision equipment (e. g. bar code scanners or cameras) provides a beneficial check of the accuracy of the packing operation.\nThis equipment is able to check that the correct packaging has been consistently used throughout the packing run and that the correct date code has been applied. Any out- of-specification information (as when the wrong packaging is used) is identified by this equipment, and staff are either alerted or the product is rejected out of the product flow.\nWhere a company chooses to use this type of equipment, it is important that procedures are in place to ensure that it is correctly set up and operates effectively throughout the packing run. At a minimum this will include checks:\n• at the beginning of the packing run, so that the equipment is confirmed to be set up correctly before packing commences\n• at the end of the packing run, to confirm that the equipment is still operating effectively when packing is completed\n• during the packing run, at a frequency based on risk (i. e. based on the site’s ability to take appropriate action in the event of an adverse test result, before the implicated materials are released from the site).\nDepending on the function of the vision system, incorrect packaging might include the wrong packaging, an incorrect date code or an obscured label.\nDue to the variations in the different types of online vision equipment, the testing procedures are not prescribed in the Standard. However, where the verification equipment exists as a separate item of equipment (situated, for example, towards the end of a production line, similar to the common placement of metal detectors), good practice is to test the system using incorrect packs to ensure that the equipment identifies and rejects those packs. It is important that these test packs are clearly marked so that they cannot inadvertently enter the process flow. The method can be used to check each function of the equipment (e. g. detection system, rejection mechanism or line stop, authorised restart and mis-read/non-read alarm).\nHowever, where the verification equipment is integral to another piece of equipment on the packing line (e. g. based on cameras or scanners built into the printer, or printed film roll dispensers), or is situated where packaging is constructed (e. g. where cardboard boxes are glued immediately prior to the camera), it may not be possible, or practical, to insert incorrect packaging as a means of testing. In these situations, the site may devise alternative testing solutions. For example, before the packing run begins, a test programme could check each function of the verification equipment by causing the instrument to reject the existing/ correct packaging.\nThe site must consider the procedures it would follow in the event of an equipment failure (e. g. a backup plan).\n6. 3 Quantity – weight, volume and number control The site shall operate a quantity control system which conforms to legal requirements in the country where the product is sold and any additional industry sector codes or specified customer requirements.\nThe site must ensure that products meet the requirements of customers and the legislation of the country, state or territory where the product is sold.", "requirement_fr": "Lorsque des équipements de vérification en ligne (c-à-d. des lecteurs de code-barres) sont utilisés pour vérifier les étiquettes et le marquage des produits, le site doit établir et mettre en place des procédures relatives au fonctionnement et aux tests des équipements, afin de garantir que le système est correctement programmé et qu’il est en mesure d’alerter ou de rejeter un produit lorsque les informations figurant sur l’emballage ne sont pas conformes aux spécifications.\nAu minimum, les équipements doivent être testés :\n•\t au début du processus d’emballage\n•\t à la fin du processus d’emballage\n•\t à une fréquence basée sur la capacité du site à identifier, suspendre et prévenir la production de tout matériau concerné en cas de défaillance de l'équipement (c-à-d. pendant le processus d'emballage ou lors du chargement d’un nouveau lot de matériaux d'emballage).\nEn cas de défaillance des équipements de vérification en ligne, le site doit établir et mettre en place des procédures (c-à-d. une procédure de vérification manuelle documentée et spécialisée).\n6.3 Quantité – contrôle du poids, du volume et du nombre Le site doit utiliser un système de contrôle de la quantité conforme aux exigences légales du pays où le produit est vendu et conforme aux codes supplémentaires du secteur de l'industrie ou aux exigences spécifiques des clients."}, {"id": "6.3.1", "requirement": "The frequency and methodology of quantity checking shall meet the requirements of the appropriate legislation governing quantity verification, and records of checks shall be retained.", "interpretation": "The type of quantity control used (e. g. average weights, catch weight, minimum weight or count) may be determined by the company in conjunction with the requirements of the customer.\nThe system used must operate to the legal requirements in the country, state or territory in which the product is sold.\nPotential changes during transport and shelf life (e. g. weight loss during transport or water loss (desiccation) during storage) may need to be factored in, so that the weight at the end of shelf life continues to meet statutory and customer requirements.\nAdequate records must be kept or, where automatic check-weighing equipment is used, this must be properly set up and the rejection system tested according to industry-sector guidelines. Checks of automatic reject systems must be carried out using representative packs of the product being produced.\nThe colour-coding of the clause indicates that it should be audited during on-site audits of production areas where the equipment is located, as the auditor will normally expect to see the process in operation, and not just a review of records.", "requirement_fr": "La fréquence et la méthodologie relatives aux contrôles de la quantité doivent être conformes aux exigences légales applicables en matière de vérification de la quantité, et des enregistrements des vérifications doivent être conservés."}, {"id": "6.3.2", "requirement": "Where the quantity of the product is not governed by legislative requirements, the product shall conform to customer requirements.", "interpretation": "Where there are no legislative requirements (e. g. where bulk quantities are supplied to the customer), procedures must be in place to ensure that customer requirements are met (e. g. monitoring by flow meter or calibrated weighbridge for tanker loads).\nGood practice is to ensure that the customer requirements are clearly defined; for example, in a specification or buying contract.\nRecords must be maintained.", "requirement_fr": "Lorsque la quantité du produit n'est pas régie par des exigences légales (c-à-d. quantité en vrac), le produit doit être conforme aux exigences du client, et des enregistrements doivent être conservés."}, {"id": "6.3.3", "requirement": "Where used, the site shall establish procedures for the operation and testing of online check weighers. • consideration of any legal requirements. • responsibilities for testing. • operating effectiveness. • methods and frequency of testing. • processes for handling rejected packs. • records of test results", "interpretation": "A check weigher is defined as automated equipment for checking that the weight of products is correct and within relevant limits (e. g. it meets legislative and customer limits).\nThe equipment must be sufficiently rigorous for the intended purpose. For example, a check weigher that is simply used to provide a rough check during production is likely to be less critical to product legality than one used to verify legal compliance of a final product.\nThe effective operation of a check weigher must be verified within the context of legal requirements (e. g. minimum fill weights against declaration), and its function must be assured through testing and operation.\nThe Standard lists the minimum items that the site procedures will need to include:\n• consideration of any legal requirements – depending on the product and the legislation in the country of sale, this might include minimum weight, average weight, maximum weight (for example, if large portion size affects minimum cooking times for food safety) etc.\n• methods, frequency and responsibilities for testing the equipment – the method of testing the check weigher; the actions to take if it fails the test; how frequently the tests are completed and the staff responsible for completing them. In accordance with section 7. 1, staff will need to be trained in the correct procedures\n• operating effectiveness and any variations for particular products (e. g. any known and permitted variations)\n• processes for handling rejected packs; for example, ensuring underweight packs are removed and do not re-enter the product flow, procedures indicating whether packs can be opened and the content returned to the product flow, any investigation needed as a result of rejected packs\n• records of the test results.\nclause 6. 4.1 details the requirement for calibration of measuring equipment, which includes check weighers.\nThe methodology of testing should be documented, and the operator or person with responsibility for the check weigher should understand the expected output and frequency.\nParticular consideration should be given to the location of the check weigher to ensure that results accurately reflect the batch of product leaving the site. For example, if the site locates metal detectors, or sampling points after the check weigher, it may need to consider the implications of the removal of product by those systems on, for example, average weight calculations.\n6. 4 Calibration and control of measuring and monitoring devices The site shall be able to demonstrate that measuring equipment is sufficiently accurate and reliable to provide confidence in measurement results.\nThe site must ensure that key pieces of equipment that control and monitor processes are themselves confirmed as operating effectively and accurately. This is routinely confirmed by measurement against recognised standards.\nWhere national or international standards do not exist, the company needs to demonstrate how the equipment is adequately monitored.", "requirement_fr": "Lorsque du matériel de pesée en ligne est utilisé, le site doit établir des procédures relatives au fonctionnement et aux tests de ces équipements. Au minimum, ces procédures doivent inclure :\n•\t la prise en considération de toute exigence juridique\n•\t les responsabilités relatives aux tests des équipements\n•\t l'efficacité de fonctionnement et toute variation pour des produits particuliers\n•\t les méthodes et la fréquence des tests effectués sur le matériel de pesée\n•\t des processus pour traiter les produits rejetés\n•\t les enregistrements des résultats des tests.\n6.4 Calibrage et contrôle des dispositifs de mesure et de contrôle Le site doit être en mesure de démontrer que les dispositifs de mesure sont suffisamment précis et sûrs pour garantir la fiabilité des résultats des mesures."}, {"id": "6.4.1", "requirement": "The site shall identify and control measuring equipment used to monitor critical control points and product safety, legality and quality. • documented list of equipment. • identification code and calibration due date. • prevention from adjustment by unauthorised staff. • protection from damage, deterioration or misuse", "interpretation": "The site needs to identify the measuring equipment (e. g. scales, thermometers and pH meters) that is used to monitor CCPs, product safety, legality and quality.\nAt a minimum, this equipment must be:\n• documented in a list which details the location of each item of equipment\n• marked in accordance with its calibration requirements; for example, with an identification code and the calibration due date. This may be achieved by engraving the piece of equipment with a number that cross-references to the documented list, or labelling the equipment with its calibration due date. Where equipment (e. g. a pH meter) is calibrated daily or more frequently, this could be addressed by a procedure that clearly states the frequency of calibration and a record of the daily calibration activities\n• protected against unauthorised adjustment (e. g. through the use of programme ID codes or locking keys)\n• protected from damage or misuse through good design or the training of staff.", "requirement_fr": "Le site doit identifier et contrôler les dispositifs de mesure utilisés pour contrôler les points critiques pour la maîtrise, la sécurité sanitaire, la légalité et la qualité des produits. Cela doit inclure, au minimum :\n•\t une liste documentée des dispositifs et leur emplacement\n•\t un code d'identification et une date prévue de calibrage\n•\t des mesures empêchant toute personne non autorisée d'effectuer des réglages\n•\t des mesures de protection pour éviter tout dommage, détérioration ou mauvaise utilisation."}, {"id": "6.4.2", "requirement": "All identified measuring devices shall be checked and, where necessary, adjusted at a predetermined frequency based on risk.", "interpretation": "The site needs to establish the method by which the precision and accuracy of equipment is verified. This must include:\n• a predefined check frequency, based on a risk assessment (e. g. historical reliability, nature of use, manufacturer’s recommendations)\n• who is authorised to complete the checks (e. g. trained staff)\n• the method to be used (which must, where possible, be traceable to a recognised standard, e. g. use of a master calibration thermometer that has a certified test certificate traceable to a national standard).\nEquipment must be of a suitable accuracy for the measurements it is required to perform.\nFor example, where temperature is critical to the safety of a product (as in pasteurisation or the canning process), the measuring thermometer requires an accuracy of ±0. 5°C, whereas a thermometer used to check vehicle temperatures may only need an accuracy of ±1°C.", "requirement_fr": "Tout dispositif de mesure identifié, y compris les nouveaux équipements, doit être vérifié et, le cas échéant, réglé :\n•\t à une fréquence prédéterminée, basée sur l'évaluation des risques\n•\t grâce à une méthode définie correspondant à une norme nationale ou internationale reconnue dans la mesure du possible.\nLes résultats doivent être documentés. Les dispositifs doivent être lisibles et leur exactitude doit être adaptée aux mesures qu'ils doivent prendre."}, {"id": "6.4.3", "requirement": "Reference measuring equipment shall be calibrated and traceable to a recognised national or international standard.", "interpretation": "All reference equipment (e. g. a master thermometer) must be calibrated and traceable to a national or international standard.\nWhere equipment is used to measure or monitor a critical limit, it is important that the tolerance (or uncertainty) of the calibration is considered. For example, if a thermometer is required to measure a critical limit of 72°C, but the calibration shows an uncertainty of 0. 5°C, then a thermometer reading of exactly 72°C could in fact represent a true temperature of anywhere between 71. 5 and 72. 5°C (i. e. the temperature could be lower or higher than the critical limit). In this situation, to guarantee a minimum temperature of 72°C, it would be necessary for the reading on the thermometer to always be 72. 5°C or higher.\nRecords must be kept.", "requirement_fr": "Les dispositifs de mesure de référence doivent être calibrés et conformes à une norme nationale ou internationale reconnue, et des enregistrements doivent être conservés.\nL'incertitude du calibrage doit être prise en compte lorsque les dispositifs sont utilisés pour évaluer des limites critiques."}, {"id": "6.4.4", "requirement": "Procedures shall be in place to record actions to be taken when the prescribed measuring devices are found not to be operating within specified limits.", "interpretation": "Documented procedures must detail the action to be taken when equipment is found to be outside specified limits. The documentation must specify what will be done and by whom, and must include what will happen to products that have been monitored by this equipment since the last successful check (to prevent at-risk products from being offered for sale).\nRecords must be kept of the actions taken.\n7 Personnel\n7. 1 Training: raw material-handling, preparation, processing, packing and storage areas Fundamental The company shall ensure that all personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.\nTraining is a fundamental requirement of the Standard, as without properly trained and competent staff, it is unlikely that product safety, authenticity, legality or quality procedures can be completed in a rigorous and consistent manner. Staff must therefore have the knowledge and skills to undertake their role, and must understand the impact their actions will make.\nCompanies must ensure that all training is up to date, covering relevant product safety, legality and quality requirements.\nSeasonal/temporary personnel and contractors must be included. Where employment agencies are used for the provision of staff, all the requirements in this section need to be adequately met and evidenced. This may include:\n• specifying company policies within any supply contract\n• obtaining evidence of staff training records from the agency prior to a staff member commencing work\n• using a risk-based system to challenge staff understanding and ensure competence in carrying out roles.\nEmployment agencies are subcontracted service providers whose business is to assist companies in filling vacant positions. Agency staff are often used to fill temporary positions, such as those caused by seasonal variations in production.", "requirement_fr": "Des procédures doivent être en place pour consigner les actions à prendre lorsque les dispositifs de mesure indiqués s'avèrent ne pas fonctionner dans les limites spécifiées. Lorsque la sécurité sanitaire ou la légalité des produits dépend de dispositifs qui se trouvent être inexacts, des actions doivent être prises pour garantir que des produits à risque ne sont pas commercialisés.\n7 Personnel 7.1 Formation : zones de manipulation des matières premières, préparation, transformation, emballage et stockage Fondamental L'entreprise doit s'assurer que l'ensemble du personnel effectuant des tâches affectant la sécurité sanitaire, la légalité et la qualité des produits est manifestement compétent pour effectuer son activité, soit grâce à des formations, soit de par son expérience professionnelle ou ses qualifications."}], "statement_of_intent": "The site shall operate to process specifications and work instructions/procedures that ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP or food safety plan.", "group_intros_fr": {"6.1": "Le site doit fonctionner conformément à des spécifications de processus et des instructions/ procédures de travail qui garantissent la production de produits systématiquement sûrs et légaux et ayant les caractéristiques de qualité souhaitées, en totale conformité avec le plan de sécurité des denrées alimentaires, ou HACCP.", "6.4": "Le site doit être en mesure de démontrer que les dispositifs de mesure sont suffisamment précis et sûrs pour garantir la fiabilité des résultats des mesures.", "6.3": "Le site doit utiliser un système de contrôle de la quantité conforme aux exigences légales du pays où le produit est vendu et conforme aux codes supplémentaires du secteur de l'industrie ou aux exigences spécifiques des clients.", "6.2": "Les contrôles de gestion des activités d'étiquetage des produits doivent garantir que les produits seront correctement étiquetés et codés."}, "group_intros": {"6.1": "The site shall operate to process specifications and work instructions/procedures that ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP or food safety plan.", "6.4": "The site shall be able to demonstrate that measuring equipment is sufficiently accurate and reliable to provide confidence in measurement results.", "6.2": "The management controls of product-labelling activities shall ensure that products will be correctly labelled and coded.", "6.3": "The site shall operate a quantity control system which conforms to legal requirements in the country where the product is sold and any additional industry sector codes or specified customer requirements."}}, {"section": 7, "title": "Personnel", "clauses": [{"id": "7.1.1", "requirement": "All personnel, including agency-supplied staff, temporary staff and contractors, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period.", "interpretation": "The company must ensure that all staff, including temporary staff, agency-supplied staff (see statement of intent) and contractors, receive training.\nAll staff will need some level of training; this should be proportional to their responsibility and the type of work or activity they perform. The company is responsible for defining the training requirements appropriate for each specific role (see clause 7. 1.3).\nFor example, the following training options may be considered:\n• induction training for all staff, covering company policies on hygiene, allergen awareness (see clause 7. 1.4), quality requirements, entry and exit procedures, pest control, a basic introduction to HACCP, etc.\n• obtaining a qualification in ‘basic food hygiene’ for food handlers\n• training in areas that impact food safety, such as cleaning, machine operation, quality inspections and sampling\n• CCP monitoring (see clause 7. 1.2).\nAll personnel must be adequately supervised throughout the working period. Particular attention should be paid to identifying the needs of temporary/seasonal workers and contractors. Good practice is for new starters to have additional supervision for a defined period. This additional supervision can be reduced or removed at the end of the period following a review of the employee’s competency to complete the role (see clause 7. 1.7).", "requirement_fr": "Tout le personnel, y compris le personnel intérimaire, les employés temporaires et les prestataires de services, doit être correctement formé avant de commencer son travail et convenablement supervisé durant la période de travail."}, {"id": "7.1.2", "requirement": "Where personnel are engaged in activities relating to control measures and critical control points, relevant training and competency assessment shall be in place.", "interpretation": "To ensure that activities identified as either control measures or critical control points (CCPs) within the food safety plan or HACCP are managed correctly, personnel involved in these areas must be appropriately trained in the relevant procedure. This includes the operation of the control and monitoring activities and the implementation of corrective action. Clear, documented instructions must be available, detailing:\n• how to carry out the tasks\n• when the tasks are to be completed\n• records to be maintained\n• action to be taken in the event of a non-conforming result.\nA competency assessment must take place on completion of the training and at predefined intervals (see clause 7. 1.7) (e. g. during internal audits of CCPs). The assessment needs to confirm that the procedure is being followed correctly, test knowledge of the corrective actions, and check for the completion of any relevant training.", "requirement_fr": "Lorsque des membres du personnel sont impliqués dans des activités relatives aux mesures de contrôle et aux points critiques pour la maîtrise, des formations et des évaluations de compétence adaptées doivent être en place."}, {"id": "7.1.3", "requirement": "The site shall put in place documented programmes covering the training needs of personnel. • identifying the necessary competencies for specific roles. • providing training or other action to ensure staff have the necessary competencies. • reviewing the effectiveness of training. • delivery of training in the appropriate language of trainees", "interpretation": "The site must have a documented training programme showing what job role competencies are required, including activities related to food safety, authenticity, legality and quality;\nthe actions taken to ensure that staff obtain these competencies; and a review of the effectiveness of these actions. For example, a job training matrix could list all of the site roles, with details of which procedures and work instructions are required for each role.\nTraining must be delivered in an appropriate language for the trainee (e. g. by providing either written or oral translation where it is required). It is not a requirement for all documentation to be translated into every language of the workforce, but all staff must be able to understand the instructions necessary for their job. For example, hygiene rules may be provided in written translations or in pictorial format, while CCP monitoring instructions may be translated into the languages spoken by the staff involved in these areas.\nThe Standard is not prescriptive on the format of the training, and may, for example, include:\n• internal training provided by the site\n• one-to-one training\n• on-the-job training\n• external training courses\n• computer-based training (CBT)\n• training provided by employment agencies, prior to the agency-supplied staff commencing roles at the site. (In this situation, the site will need to ensure that the agency has the necessary knowledge and training in order to subsequently train staff supplied to the site.) Training may be delivered internally or externally, but the company needs to ensure that the training has been effective. This can be achieved through assessment of the staff’s ability to undertake the tasks they need to perform, by testing their knowledge or by on-the-job assessment.\nA review of training and assessment of its effectiveness is an important part of the process, to ensure that it has achieved the level of learning, understanding or competency required.\nWhere tests of knowledge are used, good practice is to follow these with a review of any areas that were not answered correctly, to ensure that the trainee understands these areas.\nThis is particularly important where product safety or legality could be implicated if the activity was completed incorrectly.", "requirement_fr": "Le site doit mettre en place des programmes documentés pour répondre aux besoins de formation du personnel. Ceux-ci doivent inclure, au minimum :\n•\t une définition des compétences nécessaires à des fonctions spécifiques\n•\t une offre de formation ou toute autre action permettant de s'assurer que le personnel possède les compétences nécessaires\n•\t un contrôle de l'efficacité des formations\n•\t des formations effectuées dans la langue des personnes formées."}, {"id": "7.1.4", "requirement": "All personnel, including engineers, agency-supplied staff, temporary staff and contractors, shall have received general allergen awareness training and be trained in the site’s allergen-handling procedures.", "interpretation": "All personnel, including all agency-supplied staff, temporary staff and contractors, involved in handling materials (ingredients, equipment, utensils, packaging and products), must have received training to raise awareness of food allergens and the specific allergen measures used by the company.\nThe level of training should be appropriate to the individual’s role. For example:\n• Personnel who do not actively handle allergens may require only a general understanding of the importance of allergens (for example, simple allergen awareness training, which could be included as part of the induction process).\n• Those involved in tasks critical to the safety of the product need additional training on specific procedures in which they are involved.\n• The management team responsible for incidents require a more in-depth knowledge.\n• Personnel who develop the allergen management system, and therefore are the site’s subject matter experts, require the highest level of training.\nAll training records must be kept.", "requirement_fr": "Tout le personnel, y compris le personnel de maintenance, le personnel intérimaire, les employés temporaires et les prestataires de services, doit avoir effectué une formation générale de sensibilisation aux allergènes et être formé pour connaître les procédures de manipulation des allergènes du site."}, {"id": "7.1.5", "requirement": "All relevant personnel shall have received training on the site’s labelling and packing processes which are designed to ensure the correct labelling and packing of products.", "interpretation": "Mis-packed and mis-labelled goods are the leading cause of product recalls across the world.\nThis clause requires any personnel linked to the packing or labelling of raw materials, intermediates or finished product to be trained in, and kept up to date with, proper procedures. It is also useful for these staff to understand the implications of mis-packed or mis-labelled product.", "requirement_fr": "Tout le personnel concerné (y compris le personnel intérimaire, les employés temporaires et les prestataires de services) doit être formé aux processus d'étiquetage et d'emballage du site, qui sont conçus pour garantir que les produits soient correctement étiquetés et emballés."}, {"id": "7.1.6", "requirement": "Records of all training shall be available. • the name of the trainee and confirmation of attendance. • the date and duration of the training. • the title or course contents. • the training provider. • for internal courses, a reference to the material, work instruction or procedure that is used in the training", "interpretation": "Evidence of all training needs to be kept and must include all the details as listed in the requirement.\nThese details may be included in the certificate of attendance provided at an external or internal course, or the course contents may be included in a personnel induction booklet that is cross-referenced with a record of the training completed (with trainee name, date and name of trainer, together with the name of any translator).\nWhere training is internal, the site should retain reference to the material used (e. g. to the company procedure and its version number). Where the site has used ‘on-the-job’ or informal training methods (e. g. toolbox talks), a summary of the content could be used and made available for reference.\nTraining records for any temporary agency-supplied staff and/or external consultants must also be available.", "requirement_fr": "Des enregistrements de toutes les formations doivent être disponibles. Celles-ci doivent inclure, au minimum :\n•\t le nom de la personne formée et une confirmation de sa présence\n•\t la date et la durée de la formation\n•\t l'intitulé de la formation ou le contenu du cours, le cas échéant\n•\t le formateur\n•\t une référence au matériel didactique, aux procédures ou aux instructions de travail utilisés pendant l’apprentissage dans le cas de formations internes.\nLorsque les formations sont proposées par des agences au nom de l'entreprise, des enregistrements de ces formations doivent être disponibles."}, {"id": "7.1.7", "requirement": "The company shall routinely review the competencies of its staff and provide relevant training (refresher training, coaching, mentoring).", "interpretation": "The company must ensure there is ongoing assessment of staff competencies in their roles (e. g. through one-to-one appraisals, team performance monitoring by line managers, review of the results of internal audits, or review of records).\nWhere the need is identified (e. g. when a job role changes; following performance issues; or when there are changes in operating procedures such as a change in the requirements for a CCP), there must be appropriate refresher training (supplied internally or externally), coaching, mentoring or on-the-job experience to improve skills and understanding.\nThe site should determine the appropriate frequency for reviews of competency and training needs. There are likely to be several different scenarios; for example:\n• a routine review process (e. g. linked to annual performance reviews)\n• change management (e. g. when a procedure is amended or updated)\n• whenever there is evidence that an update would be beneficial.\n7. 2 Personal hygiene: raw material-handling, preparation, processing, packing and storage areas The site’s personal hygiene standards shall be developed to minimise the risk of product contamination from personnel, be appropriate to the products produced and be adopted by all personnel, including agency-supplied staff, contractors and visitors to the production facility.\nThe site must have documented personal hygiene rules designed to prevent product contamination from personnel.\nThese should be based on risk and may take into account different requirements for different production risk zones, and any national or regional legislation.\nAll personnel, including agency-supplied staff, contractors and visitors entering production areas (including raw material storage, preparation, processing, packing and storage areas), must adhere to the company’s documented personal hygiene rules, including those regarding personal belongings, hand-washing, injuries, illness and medication.", "requirement_fr": "L'entreprise doit régulièrement vérifier les compétences de ses employés. Le cas échéant, elle doit proposer des formations adaptées. Cela peut être sous la forme de formations, de stages de perfectionnement, d'encadrement, de conseils ou d'expérience acquise sur le terrain.\n7.2 Hygiène personnelle : zones de manipulation des matières premières, préparation, transformation, emballage et stockage Les normes du site en matière d'hygiène personnelle doivent être établies afin de minimiser les risques de contamination des produits par le personnel, être adaptées aux produits fabriqués et être adoptées par l'ensemble du personnel, y compris le personnel intérimaire, les prestataires de services et les visiteurs pénétrant dans le site de production."}, {"id": "7.2.1", "requirement": "The requirements for personal hygiene shall be documented and communicated to all personnel. • watches and similar wearable devices shall not be worn. • jewellery shall not be worn (exception: plain wedding ring/wristband/medical alert). • rings and studs in exposed parts of the body shall not be worn. • fingernails shall be kept short, clean and unvarnished. • false fingernails and nail art shall not be permitted. • excessive perfume or aftershave shall not be worn", "interpretation": "This clause is designed to ensure that personal items are not a source of product contamination; for example, small parts that may fall off and become foreign-body hazards, or a source of microbiological or allergen contamination (e. g. if the items were previously worn in an area that was contaminated and the contaminant was transferred into the production area).\nThe site must document its personal hygiene requirements. At a minimum, these must include:\n• Watches are not permitted in open product areas (including devices used for fitness monitoring and tracking). It is good practice to include details for all portable personal items within site policies; for example, mobile phones and tablet devices (e. g. the site might exclude all individuals’ personal mobile phones, but have specific rules relating to company-issued equipment, which could, for example, include instructions for cleaning on entry to production areas).\n• Jewellery must not be worn apart from plain, smooth rings or wristbands (i. e. without stones that may fall out), such as wedding rings. Exceptions must be minimal and must not constitute a risk to product (e. g. wristbands identifying a particular medical condition, such as epilepsy or an allergy, may be worn where product is not at risk of contamination).\nWhere religious reasons prevent the removal of an item of jewellery, it must be covered and the site must complete a risk assessment to determine how this will be achieved (e. g. by totally covering the item with the wearer’s clothing, or by wearing overalls that are buttoned up to cover the item).\n• The potential for broken, damaged or lost glasses and contact lenses to become a foreign- body risk should be considered.\n• Rings and studs must not be worn in exposed parts of the body such as ears, noses, eyebrows and tongues.\n• Long fingernails are not permitted, as they are a contamination hazard since they may break off; nor are nail varnish, nail art or false nails. Fingernails must be kept clean, commensurate with the level of hygiene expected within a food manufacturing environment. Where visitors cannot comply with these rules, other controls (such as limiting where visitors may enter and what they may touch, and the obligatory use of gloves) must be implemented to minimise the risk of contamination.\n• Excessive perfume or aftershave must not be worn, as this has the potential to taint foods.\nThese requirements are applicable to raw-material handling, preparation, processing, packing and storage areas. The requirements for staff working solely in enclosed product areas may be relaxed where no risk is presented to the products.\nThe requirements must be communicated to all personnel (e. g. through induction training and sign-in procedures for visitors and contractors). Consideration must be given to the language in which the training is completed; for example, where employees will be working in their second or third language. Appropriate methods of training (e. g. use of translators) must be provided for them.\nCompliance with requirements must be checked regularly; for example, by incorporating checks into daily or weekly good manufacturing practice audits (see clause 3. 4.4), or through the questioning of personnel at regular intervals.", "requirement_fr": "Les exigences en matière d'hygiène personnelle doivent être documentées et communiquées à l'ensemble du personnel. Ces exigences doivent inclure, au minimum, les aspects suivants :\n•\t le port de montres et autres appareils portables n’est pas autorisé\n•\t le port de bijoux n'est pas autorisé, à l'exception d'une seule alliance simple, d’un bracelet de mariage et d’un bijou d’identification médicale\n•\t le port d'anneaux et de bijoux corporels sur des parties du corps exposées, telles que les oreilles, le nez et les sourcils, n'est pas autorisé\n•\t les ongles des mains doivent être courts, propres et sans vernis\n•\t les faux ongles et les décorations d'ongles ne sont pas autorisés\n•\t l'usage excessif de parfum ou d'après-rasage n'est pas autorisé.\nLe respect de ces exigences doit être vérifié régulièrement."}, {"id": "7.2.2", "requirement": "Hand-washing shall be performed on entry to the production areas and at a frequency that is appropriate to minimise the risk of product contamination.", "interpretation": "Hand-washing must be conducted at a frequency appropriate to the level of risk to the product being produced and in line with good industry practice. At a minimum, hands must be washed before staff enter the production area and whenever an activity is undertaken that could potentially be a risk to products (e. g. after going to the toilet, eating, smoking, blowing noses, sneezing or handling shoes).\nAppropriate instructions for hand-washing, considering the language needs of staff (e. g. including pictorial instructions), must be provided (clause 4. 8.4).\nFurther guidance Introduction to hand-washing techniques Hand-washing is recognised as an effective way to reduce the risk of contaminating food with micro-organisms such as E. coli, Salmonella and Staphylococcus aureus. However, a number of studies have shown that people either do not wash their hands or fail to clean them effectively. So it is vital that food companies not only provide staff with appropriate facilities to wash their hands but also ensure staff are aware of the correct procedure to follow.\nWhat makes a good hand-washing procedure?\nFrequency Hand-washing should be carried out as often as is appropriate for the level of risk to the product. At a minimum hands should be washed:\n• before entering production areas\n• after any break which involves leaving the production area\n• after going to the toilet\n• after eating or smoking\n• after blowing your nose.\nSee also clause 8. 4.1 for hand-washing facilities and procedures in high-risk and high-care zones.\nMethod There are a number of steps in an effective hand-washing procedure:\n• wet hands with water\n• apply soap\n• rub the hands so that all the parts of the hands are cleaned, including palms, backs of hands, between fingers, backs of fingers, thumbs and fingertips\n• rinse hands to remove soap\n• dry hands thoroughly, as careful drying is a vital step in preventing the contamination of food products.\nFor a pictorial example of best practice for hand-washing, visit the World Health Organization’s ‘How to Handwash?’ page.\nIn addition to the above routine, good practice is to apply a sanitiser such as an anti- bacterial hand gel after the hands have been washed and dried. An effective hand-washing routine should take approximately 40–60 seconds to complete.\nTraining It is important that a good hygiene culture operates within the site so that an effective hand-washing routine becomes normal, everyday behaviour. This means that all new staff should be trained (e. g. during induction training) in the site’s hand-cleaning procedures and understand the importance of them. Regular updates can help ensure the information remains fresh in people’s minds.\nFacilities For a description of hand-washing facilities, see the guidance for clause 4. 8.4.", "requirement_fr": "Les mains doivent être nettoyées à l'entrée des zones de production et à une fréquence appropriée pour minimiser les risques de contamination des produits."}, {"id": "7.2.3", "requirement": "All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster that is different from the product colour (preferably blue) and contains a metal detectable strip.", "interpretation": "Cuts and grazes on exposed areas of skin must be covered to prevent contamination of product. To minimise the potential for plasters or band-aids to contaminate product, they must be controlled by the site (e. g. through the use of an issue procedure, where numbered plasters or band-aids are documented in a log, stating when and to whom they were issued).\nThe site may consider the need for an audit of plasters at the end of the shift, and for staff to immediately inform supervisors of any loss.\nPlasters or band-aids must be visually distinct (preferably blue) and include a metal detectable strip. This applies even where the site does not use metal detectors, as many products are sold for further processing and the plaster or band-aid could therefore be detected at a later stage in the supply chain. Where appropriate, in addition to the plaster or band-aid, a glove must be worn.", "requirement_fr": "Toutes les coupures et égratignures sur des parties de peau exposée doivent être couvertes à l'aide d'un pansement de couleur adaptée, différente de celle du produit (de préférence bleue), et contenant une lamelle métallique détectable. Ces pansements doivent être fournis par l'entreprise et contrôlés. Le cas échéant, un gant doit être porté, en plus du pansement."}, {"id": "7.2.4", "requirement": "Where metal detection equipment is used, a sample from each batch of plasters shall be successfully tested through the equipment and records shall be kept.", "interpretation": "To ensure that each batch of plasters purchased fulfils the metal detectable requirement, a sample from each batch must be tested to confirm that it is successfully rejected by the metal detector in use.\nIf multiple metal detectors are used on site, it is good practice to use a risk assessment to identify the least sensitive detector, as using this will ensure that a lost plaster can be detected by all of the detectors on site.\nRecords must be kept.\nWhere the site does not use metal detectors, this requirement (for keeping a sample of the batch of plasters) will not apply.", "requirement_fr": "Lorsqu'un équipement de détection des métaux est utilisé, un échantillon de chaque lot de pansements doit être testé par l'équipement, et des enregistrements doivent être conservés."}, {"id": "7.2.5", "requirement": "Processes and written instructions for staff shall be in place to control the use and storage of personal medicines.", "interpretation": "Personal medicines need to be controlled to ensure they do not constitute a risk to product.\nThe site must have a documented procedure on the control and storage of medicines.\nWherever possible, medicines should not be taken into production areas (e. g. they could be stored in lockers along with other personal items). However, where staff have a medical need to keep personal medicines with them (e. g. they have asthma or diabetes), procedures must be in place to control these medicines (such as a requirement to notify the company of the defined medical need). Consideration should be given to the format and packaging of the medicines (e. g. glass bottles) to minimise the potential risk of product contamination.\n7. 3 Medical screening The company shall have procedures in place to ensure that staff, agency staff, contractors or visitors are not a source of transmission of infections, diseases (including food-borne diseases) or conditions to products.\nTo ensure that all persons who will come into contact with food production and storage areas are not the source of a hazard, the company must have procedures in place by which staff and visitors are fully informed of the health conditions and symptoms which prevent them from working in food production and storage areas.", "requirement_fr": "Des processus et des instructions écrites pour le personnel doivent être en place pour contrôler l'utilisation et le stockage des médicaments personnels, afin de minimiser les risques de contamination des produits.\n7.3 Examens médicaux L'entreprise doit disposer de procédures en place pour s'assurer que l'ensemble du personnel, le personnel intérimaire, les prestataires de services et les visiteurs ne représentent pas une source de transmission d’infections, de maladies (y compris de maladies d'origine alimentaire) ou de conditions aux produits."}, {"id": "7.3.1", "requirement": "The site shall make staff aware of the symptoms of infection, disease or condition which would prevent a person working with open food.", "interpretation": "Personnel need to receive, as part of their training, clear instructions on the potential risks of food-borne disease and the site’s procedures for illness notification. Staff who are suffering from symptoms which may place products at risk must be prevented from working with open food.\nThe site must be expected to define the symptoms, infections or conditions of concern, as advised by local legislation (e. g. a list of communicable diseases). These policies must be documented.\nThis requirement covers all personnel on site, including temporary staff and those employed via an employment agency. The site may consider the use of a pre-employment and/ or return-to-work medical questionnaire or medical examination (e. g. stool testing), as appropriate to the risk.\nThe use of suitably trained and competent persons and external medical experts may be required, particularly where privacy laws exist.\nSome countries have legislation relating to fitness to work with food or the handling of personal information. Sites are therefore expected to operate in accordance with these legislative requirements. For example, in the UK, guidance can be found in the FSA guide ‘Food Handlers: Fitness to Work – Regulatory Guidance and Best Practice Advice For Food Business Operators’.", "requirement_fr": "Le site doit faire en sorte que le personnel connaisse les symptômes des infections, maladies ou problèmes qui pourraient empêcher une personne de travailler avec des aliments nus.\nLe site doit disposer d'une procédure permettant au personnel (y compris les employés temporaires), aux sous-traitants et aux visiteurs du site, de signaler tout symptôme, infection, maladie ou pathologie pertinent avec lequel ils auraient pu être en contact ou dont ils pourraient souffrir."}, {"id": "7.3.2", "requirement": "Where permitted by law, visitors shall be required to complete a health questionnaire or otherwise confirm that they are not suffering from any symptoms which may put product safety at risk.", "interpretation": "The site must ensure that visitors and contractors who enter areas where there may be a risk to product safety, or who undertake work that may constitute a risk to product, are informed of the site’s policies and the medical conditions (e. g. the symptoms) that would prevent entry into production, storage or open product areas.\nWhere permitted by legislation, visitors must be screened by use of a health questionnaire.\nThe site must ensure that regular visitors and contractors, such as external company staff or pest control providers, are included. Where questionnaires are used, these must be reviewed by a competent person.\nA site with live animals (see clause 5. 9.2) may need to include the prevention of transmission of animal diseases; for example, by establishing whether the visitor has been to an area within the last 48 hours, where there has been a known outbreak or other risk to the animals that are on site.\nThe procedure must be documented.", "requirement_fr": "Lorsque la sécurité sanitaire des produits est en jeu, les visiteurs et les prestataires de services doivent être informés des types de symptômes, d'infections, de maladies ou de problèmes qui pourraient empêcher une personne de visiter les zones contenant des aliments nus. Lorsque la loi le permet, il doit être demandé aux visiteurs de remplir un questionnaire de santé ou de confirmer qu'ils ne souffrent d'aucun symptôme pouvant mettre la sécurité sanitaire des produits en danger, avant d'entrer dans les zones de matières premières, de préparation, de transformation, d'emballage et de stockage."}, {"id": "7.3.3", "requirement": "There shall be procedures for staff, contractors and visitors relating to action to be taken where they may be suffering from or have been in contact with an infectious disease.", "interpretation": "Where staff, visitors or contractors declare they are suffering from, or have been in contact with, the identified diseases, infections etc. , they must be subject to, and informed of, the procedures to prevent product contamination. This will usually include relocation to a role where they are not in contact with open products.\n7. 4 Protective clothing: staff or visitors to production areas Suitable site-issued protective clothing shall be worn by staff, contractors or visitors working in or entering production areas.\nThe purpose of protective clothing is to protect the products from contamination. Therefore protective clothing includes uniforms, overalls, head coverings (such as hats and hairnets), shoes and boots, aprons and gloves (whether disposable or washable). A suitable design of protective clothing must be provided to all staff, visitors and contractors working in or visiting production areas.", "requirement_fr": "Des procédures doivent exister pour le personnel (y compris le personnel temporaire), les prestataires de services et les visiteurs, relatives aux actions à entreprendre s’ils souffrent d'une maladie contagieuse ou ont été en contact avec une maladie contagieuse. Un expert médical doit être consulté en cas de besoin.\n7.4 Vêtements de protection : personnel ou visiteurs des zones de production Des vêtements de protection adaptés fournis par le site doivent être portés par le personnel, les prestataires de services ou les visiteurs travaillant ou pénétrant dans les zones de production."}, {"id": "7.4.1", "requirement": "The company shall document and communicate to all staff, contractors and visitors the rules regarding the wearing of protective clothing in specified work areas.", "interpretation": "The company is required to determine and document the procedures for application and use of protective clothing based on a risk assessment. The risk assessment must consider foreign-body, microbiological and allergen risks as appropriate, as well as general good- practice principles. It must document:\n• what must be worn (e. g. footwear, overalls and hair covering) and the design of each\n• where clothing must be put on and taken off, including designated area(s) for changing\n• the order in which clothing is applied (e. g. hairnet, footwear, wash hands and then overall or coat)\n• where protective clothing will be stored when not in use\n• special requirements for specific areas\n• instructions for the removal of protective clothing when moving away from the production area. Good practice is to include details on what should happen to protective clothing after removal; for example, the correct disposal of disposable clothing, correct storage of reusable clothing or where to put clothing that requires laundering\n• removal of protective clothing before entering toilets\n• procedures for the removal of protective clothes in canteens and smoking areas\n• areas where the product is fully enclosed and has no or very little risk of contamination from the factory environment during normal production.\nThe wearing of full company-issued protective clothing is not an absolute requirement if all of the following criteria apply:\n• all products are fully enclosed\n• the product would, if it were not fully enclosed, be classed as a low-risk product\n• the area is separate from areas containing open product\n• staff do not need to pass through open product areas to access the area.\nThe wearing of a company uniform is preferred. Where personal clothing is allowed, sites must provide guidance on the standards of clothing which are acceptable.\nWherever product lines are entered (e. g. adjustments at the filler), protective clothing and hair coverings must be worn.", "requirement_fr": "L'entreprise doit documenter et communiquer à tous le personnel (y compris les employés temporaires et les intérimaires), les prestataires de services et les visiteurs, les règles relatives au port de vêtements de protection dans des zones de travail spécifiées (c-à-d. les zones de production, zones de stockage). Cela doit également inclure des politiques relatives au port de vêtements de protection en dehors des zones de production (c-à-d. le retrait des vêtements avant d'aller aux toilettes, à la cantine ou dans une zone fumeur)."}, {"id": "7.4.2", "requirement": "Protective clothing shall be available that is provided in sufficient numbers, of suitable design (no external pockets above waist), contains all scalp hair, and includes snoods for beards where required.", "interpretation": "Clothing must be available for all staff working in production and storage areas (including employment agency staff, temporary staff and contractors). Items must be provided in sufficient numbers so that they may be maintained in an acceptable condition during working (e. g. to allow for washing).\nThe company needs to consider the design of protective clothing and ensure that it is suitable for the production processes. At a minimum:\n• the clothing must not include external pockets above the waist (e. g. no pockets in coats) and must not have sewn-on buttons\n• the company must consider the design of protective footwear for production areas and must provide footwear that can be kept clean\n• staff and visitors must wear headwear (such as mob caps or hairnets) that completely covers head hair to minimise potential contamination\n• snoods must be provided for staff or visitors who have beards or moustaches where protection is needed to prevent product contamination. Clear rules must be in place and understood by staff, based on an assessment by the company.", "requirement_fr": "Des vêtements de protection doivent être disponibles et :\n•\t fournis en nombre suffisant à chaque employé\n•\t conçus de manière à éviter la contamination des produits (au minimum ne pas posséder de poches extérieures au-dessus de la taille, ni de boutons cousus)\n•\t envelopper l'ensemble de la chevelure pour éviter la contamination des produits\n•\t inclure des résilles pour barbe et moustache, le cas échéant, pour éviter la contamination des produits."}, {"id": "7.4.3", "requirement": "Protective clothing shall be laundered by an approved contracted or in-house laundry using defined criteria to validate the effectiveness of the laundering process. • adequate segregation between dirty and cleaned clothes. • effective cleaning of the protective clothing. • cleaned clothes are supplied protected from contamination until use", "interpretation": "Protective clothing may be cleaned by contracting the services of a specialised laundry, by laundering in-house or, in exceptional circumstances, by employees laundering their own clothes.\nExternal contracted services must be incorporated within the company’s purchasing supplier approval programme (clause 3. 5.3. 1) and have systems of approval and continual assessment to ensure that the process is under control. This should be based on risk assessment and may include self-audit questionnaires where low-risk products are manufactured. The monitoring of the effectiveness of cleaning is likely to consist of visual assessment and the monitoring of complaints.\nIn-house laundering carried out on the company premises must be controlled. This is likely to be via HACCP-style principles, controls and validation data, such as monitoring of the temperature and detergent, specifying items not to be washed together, overseeing drying processes and visual inspection. The laundry will also be included in the programme of internal audits (clause 3. 4.1).\nLaundries (both in-house and contracted) must ensure that:\n• dirty and clean clothing is adequately segregated to ensure that recently laundered items are not re-contaminated\n• the protective clothing is effectively cleaned (e. g. by the completion of microbiological validation and verification tests)\n• cleaned clothes are protected from contamination until delivered to the site (e. g. through the use of covers or bags).\nThe Standard allows home laundering of protective clothing by employees, but only in exceptional circumstances, where both of the following conditions are met:\n• protective clothing is not used for product safety purposes, but is instead used to protect the employee from the products handled; for example, in the produce industry, raw vegetables arriving from the fields may be covered in mud or dirt, and employees wear overalls to protect their personal clothing and\n• it is used only in low-risk or enclosed product areas (these are both defined in Appendix of the Standard).\nIt is important that where a site wishes to approve home laundering, both of these requirements are satisfied. For example, home laundering would not be permitted in bakeries because although the protective clothing is being used in a low-risk area, it is an open product area where the clothing is needed to protect the product, not the employee.\nHome laundering still requires appropriate care and attention to ensure that potential pathogens are removed or killed. Therefore, where approved, home laundering needs to be controlled by written instructions, including, for example:\n• how garments are to be washed (temperature, detergent, specifying items not to be washed together, and drying instructions such as the use of a hot iron to further heat- disinfect the clothes)\n• procedures for transporting clean protective clothing to the workplace; for example, provision of sealable plastic bags or similar, which allow washed garments to be transported from home to the workplace without becoming contaminated\n• on-site procedures; for example, defined responsibility within the company for monitoring the effectiveness of the system (typically achieved by visual inspection). There must also be a procedure and system for effectively dealing with any case where employees are unable to perform self-laundry, either through lack of diligence or through lack of facilities. This system must be capable of being brought into immediate effect once a problem has been identified.", "requirement_fr": "Les vêtements de protection doivent être lavés par une blanchisserie agréée contractée ou en interne, en suivant des critères définis permettant de valider l'efficacité du processus de lavage.\nLa blanchisserie doit utiliser des procédures qui garantissent :\n•\t la séparation adéquate des vêtements sales et des vêtements propres\n•\t un nettoyage efficace des vêtements de protection\n•\t que les vêtements lavés sont livrés protégés de la contamination jusqu'à leur utilisation (c-à-d. en utilisant des couvertures ou des sacs).\nLe lavage des vêtements de protection par les employés est exceptionnel mais peut être accepté lorsque :\n•\t les vêtements de protection ne sont pas utilisés pour garantir la sécurité sanitaire des produits, par exemple, s’ils servent à protéger l’employé des produits manipulés et\n•\t que les vêtements de protection sont utilisés dans les zones de produits clos ou à faible risque uniquement."}, {"id": "7.4.4", "requirement": "Protective clothing shall be changed at an appropriate frequency, based on risk.", "interpretation": "Protective clothing needs to be changed at an appropriate frequency to ensure that clothing cannot become a source of product contamination. The frequency of changes must be based on risk (e. g. using visual inspections, swabbing or contact plates). For example, hairnets are changed daily or whenever they are removed.", "requirement_fr": "Les vêtements de protection doivent être changés à une fréquence appropriée, basée sur les risques."}, {"id": "7.4.5", "requirement": "If gloves are used, they shall be replaced regularly. Where appropriate, gloves shall be suitable for food use, of a disposable type, of a distinctive colour and intact.", "interpretation": "Gloves are a potential source of foreign bodies; therefore, sufficient control procedures (such as regular inspection and replacement) need to be put in place to ensure they are intact and do not shed loose fibres. The company needs to consider the design of gloves and whether they need to be disposable, of food grade and of a visually distinct colour from the product (preferably blue).", "requirement_fr": "Si des gants sont utilisés, ils doivent être remplacés régulièrement. Le cas échéant, les gants doivent être adaptés au contact des aliments, jetables, d'une couleur distinctive (bleue dans la mesure du possible), et intacts et ne doivent pas perdre de fibres."}, {"id": "7.4.6", "requirement": "Where items of protective clothing that are not suitable for laundering are provided (such as chain mail, gloves and aprons), these shall be cleaned and disinfected at a frequency based on risk.", "interpretation": "A documented procedure must be developed for protective items that cannot be laundered, such as shoes, chain mail (cut-resistant, metallic PPE), gloves and aprons. The frequency of cleaning and disinfection must be defined based on risk.", "requirement_fr": "Lorsque des vêtements de protection non lavables sont fournis (comme des gants et des tabliers en cotte de mailles), ils doivent être nettoyés et désinfectés à une fréquence basée sur le risque.\n8 Zones de production à risque – haut risque, grande précaution et grande précaution pour les produits à température ambiante Lorsqu’un site fabrique des produits devant être manipulés, même partiellement, dans des zones de production à haut risque, de grande précaution et/ou de grande précaution pour les produits à température ambiante (voir la clause 4.3.1 pour cette évaluation et l’Annexe 2 pour les définitions de ces zones de production), toutes les exigences pertinentes des sections 1 à 7 de la Norme doivent être respectées, en plus des exigences de la présente section.\nLe site doit être en mesure de démontrer que les contrôles et installations de production sont adaptés pour prévenir la contamination des produits par des agents pathogènes.\n8.1 Agencement, flux et séparation des produits dans les zones à haut risque, de grande précaution et de grande précaution pour les produits à température ambiante."}], "statement_of_intent": "The company shall ensure that all personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.", "group_intros_fr": {"7.3": "L'entreprise doit disposer de procédures en place pour s'assurer que l'ensemble du personnel, le personnel intérimaire, les prestataires de services et les visiteurs ne représentent pas une source de transmission d’infections, de maladies (y compris de maladies d'origine alimentaire) ou de conditions aux produits.", "7.1": "L'entreprise doit s'assurer que l'ensemble du personnel effectuant des tâches affectant la sécurité sanitaire, la légalité et la qualité des produits est manifestement compétent pour effectuer son activité, soit grâce à des formations, soit de par son expérience professionnelle ou ses qualifications.", "7.2": "Les normes du site en matière d'hygiène personnelle doivent être établies afin de minimiser les risques de contamination des produits par le personnel, être adaptées aux produits fabriqués et être adoptées par l'ensemble du personnel, y compris le personnel intérimaire, les prestataires de services et les visiteurs pénétrant dans le site de production.", "7.4": "Des vêtements de protection adaptés fournis par le site doivent être portés par le personnel, les prestataires de services ou les visiteurs travaillant ou pénétrant dans les zones de production."}, "group_intros": {"7.2": "The site’s personal hygiene standards shall be developed to minimise the risk of product contamination from personnel, be appropriate to the products produced and be adopted by all personnel, including agency-supplied staff, contractors and visitors to the production facility.", "7.3": "The company shall have procedures in place to ensure that staff, agency staff, contractors or visitors are not a source of transmission of infections, diseases (including food-borne diseases) or conditions to products.", "7.1": "The company shall ensure that all personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.", "7.4": "Suitable site-issued protective clothing shall be worn by staff, contractors or visitors working in or entering production areas."}}, {"section": 8, "title": "Production risk zones – high risk, high care and ambient high care", "clauses": [{"id": "8.1.1", "requirement": "The map of the site (see clause 4.3.2) shall include the location of the pathogen control step(s).", "interpretation": "clause 4. 3.2 of the Standard requires the site to construct a site map, and this will include reference to the production risk zones appropriate to the site.\nIt is important to note that the high-care, high-risk and ambient high-care production zones usually apply to only part of a factory’s production processes; they typically follow a microbiological kill step or pathogen control step, where any pathogens are removed or reduced to an acceptable level. For example, this could be a microbiological kill step such as heat treatment or cooking, or a process to reduce the pathogen levels such as a chlorine wash of fruit or vegetables. The production risk zone needs to be maintained until the products are enclosed in packaging.\nFor high-risk, high-care and ambient high-care areas, the location of the site’s pathogen control step(s) must be included on the site map.\nAs explained in the interpretation for clause 4. 3.2, the site map must also include an indication of any areas where time segregation is used; for example, which areas apply time segregation between high care and low risk. The boundaries of this segregation must be clearly detailed.\nThe Standard is not prescriptive on the format of the site plan; however, good practice is to include all the information in an easy-to-use form. Examples include:\n• use of schematic diagrams\n• overlaying several maps to form a complete picture, which allows both an overview of the site and a focus into the specific features detailed on individual layers.", "requirement_fr": "Le plan du site (voir clause 4.3.2) doit indiquer l'emplacement de la ou des étape(s) de contrôle des agents pathogènes."}, {"id": "8.1.2", "requirement": "Where high-risk areas are part of the manufacturing site, there shall be physical segregation between these areas and other parts of the site.", "interpretation": "High-risk areas require the highest levels of hygiene, working practices, and design and fabrication of facilities and equipment, to prevent product contamination from microbiological hazards.\nHigh-risk areas must be fully separated areas, with physical segregation in place between them and other parts of the facility. The purpose of the physical segregation is to provide a self-contained area where uncovered (i. e. unprotected) high-risk products are handled after the microbiological kill step (e. g. heat treatment or cooking) until they are fully protected, usually by means of final packaging. The segregating barrier must be capable of minimising the risk of cross-contamination from:\n• pathogens which may be present in a low-risk environment or on products or ingredients that have not received a full cook\n• all people moving between the high-risk area and other areas, except through designated changing areas\n• the movement of all equipment, cleaning chemicals, utensils or materials into the high-risk area, except through designated ports with sanitising controls in place\n• water or other liquids (e. g. cleaning chemicals) on the floor, washing into the high-risk area\n• airborne contaminants (e. g. dust particles or water droplets).\nThe ideal barrier is a full wall (e. g. a separate room) separating the high-risk area from other areas. In assessing the suitability of a segregating barrier, a risk assessment should be carried out and documented.\nTime segregation is not an acceptable alternative for high-risk areas, except for the transfer areas noted below. The location and operation of all transfer points must not compromise high-risk and low-risk segregation. For example, where raw materials or staff move into a high-risk area, consideration must be given to whether this introduces a contamination hazard; it may therefore require measures that involve:\n• use of disinfection\n• removal of outer packaging\n• double-door ovens, blast chillers or freezers (i. e. those with a separate entrance and exit)\n• controlled air flow (clause 8. 2.2)\n• changing the design of entrances and exits (e. g. roller lifting doors may represent a risk when raised, due to the fact they have been in contact with the floor and the difficulty in cleaning them effectively).\nHigh-risk areas are expected to be self-contained and fully segregated. Best practice is that, where there is a cook step in the production of high-risk products, the cooker becomes the transfer point into the high-risk area via a double-door system (i. e. the cooker is loaded in the low-risk area and unloaded directly into the high-risk area). While new cooker installations and new-build sites must incorporate double-door cooking systems, many existing plants are equipped with single-door cookers and have established risk-based procedures for the loading and unloading of the cookers to prevent cross-contamination of cooked products. The Standard will, therefore, accept the use of single-door cooking systems where a thorough risk assessment has been completed as an interim measure prior to the eventual upgrading. Operating practices must be consistently achievable and effective, and prevent cross-contamination of cooked products.\nThe risk assessment must consider, and control potential risk, from:\n• crossover between cooked and raw products in the unloading area\n• operators and their clothing (e. g. handling of cooked products by operators who have previously worked with raw products)\n• hand-contamination resulting from touching surfaces such as common equipment, cooker control panels and cooker door handles\n• equipment used for transferring product into and out of cookers\n• airborne contamination from low-risk processes (e. g. the loading and unloading area should be separate from the main low-risk processing area)\n• the floor (e. g. contamination of the wheels of trolleys transferring cooked products to the high-risk area).\nWhen cooked products are unloaded from the cooker, they must be moved immediately to a designated high-risk area to meet the requirements of the Standard. The auditor will assess the procedures in operation where single-door cookers are in use to ensure they are adequate, effective and understood by operators. The audit report will describe the procedures in place to protect the cooked products from contamination.\nHigh-risk areas contain only components and foods which have undergone a cook or similar process to achieve, typically, a 6-log reduction for Listeria. Where a single area includes, by necessity, some components which have received a lesser kill, together with fully cooked components (e. g. in a sandwich preparation area), this will be classed as high care.\nExample Cooked crustacea – a product requiring a high-risk production zone Where crustacea are cooked as part of the production process, or were cooked at an earlier step in the production process (including at another site), the site will need to ensure the correct production risk zones are used.\nAccording to the definitions in Appendix 2 of the Standard, cooked crustacea fit into the definition of a product requiring a high-risk production zone because:\n• finished product is chilled or frozen to preserve food safety\n• all components have received a full cook (equivalent to a 6 log reduction in Listeria monocytogenes)\n• finished product is vulnerable to growth of pathogens or survival of pathogens that could subsequently grow during normal storage and use\n• finished product is ready to eat or ready to heat or, on the basis of known consumer use, is likely to be eaten without adequate cooking.\nAlthough the Standard recognises that some food products can be effectively managed using consumer cooking instructions, these instructions are not considered a valid justification for using a different production zone for cooked crustacea, as known consumer use in many countries is to eat the product cold without any heating, and therefore without a full cook by the consumer. Furthermore, the product appearance could lead consumers to believe the product is already fully cooked, and that no additional cooking is required.\nWhere a site is partially heating a crustacean (i. e. less than a 6-log reduction in Listeria monocytogenes), a high-care area will be appropriate.", "requirement_fr": "Lorsque le site de fabrication inclut des zones à haut risque, une séparation physique doit être mise en place entre ces zones et les autres parties du site. La séparation doit tenir compte du flux de produits, de la nature des matériaux (emballage compris), de l'équipement, du personnel, des produits chimiques, de l’élimination des déchets, des écoulements d'air, de la qualité de l'air et de l'entrée des fluides techniques (canalisations incluses). L'emplacement des points de transfert ne doit pas compromettre la séparation entre les zones à haut risque et les autres zones de l'usine. Des pratiques doivent être en place pour minimiser le risque de contamination du produit (c-à-d. la désinfection du matériel entrant)."}, {"id": "8.1.3", "requirement": "Where high-care areas are part of the manufacturing site, there should be physical segregation between these areas and other parts of the site. Where physical barriers are not in place, the site shall have undertaken a documented risk assessment.", "interpretation": "This clause is applicable to high-care areas (i. e. areas designed to a high standard, where practices are in place to minimise product contamination by pathogenic micro-organisms; see Appendix 2 of the Standard).\nVulnerable products and ingredients have, before entry to the high-care area, undergone a process to reduce any contamination by pathogenic bacteria (e. g. a chlorine wash of salad materials, or an early cook step as in the pasteurisation of cream). It is important that the high-care area is effectively protected from contamination by low-risk zones. This is most effectively achieved through full physical segregation by means of walls which separate the high-care area from other factory areas.\nWhere a separate, fully walled-off area is not available, alternative procedures must be in place to segregate the high-care area. The segregating barrier must be capable of preventing the risk of cross-contamination from:\n• unauthorised access and movement between high-care and other areas of the factory, except through designated changing areas\n• transfer of materials, cleaning chemicals, utensils or equipment, except through designated ports with sanitising controls in place\n• microbiological contamination which may be present in a low-risk environment\n• airborne contaminants (e. g. dust particles or water droplets).\nThe segregating barrier may include time or space separation, control of movement or other restrictions. In assessing its suitability, a risk assessment must be carried out and documented. The method employed must be validated to demonstrate that the controls are effective in preventing cross-contamination. The auditor will critically examine the arrangements to ensure that potential risks for contamination have been addressed, and that the alternative controls are consistently workable before the solution is considered acceptable. (This will be recorded in the audit report.) Where the solution is time segregation (i. e. a time separation between low-risk and high- care products being produced in the same area, to allow the area to be converted from a low-risk zone to a high-care zone (e. g. by cleaning, changes of protective clothing, or environmental monitoring)):\n• The changeover between low-risk and high-care operations should be as infrequent as possible, as it is unlikely that a sufficient standard of cleaning could be reached if changes occur frequently during the day.\n• Fully validated procedures to change the area from low risk to high care are required.\nThese activities need to be taken into account when scheduling production, to ensure effective transformation of the area, including personnel. If the same personnel are responsible for the area during low-risk and high-care operations, they must undergo a complete change of protective clothing.\n• The shared area must be designed to meet the requirements of the high-care zone.\nTherefore all the facilities must be appropriate for a high-care production zone; for example, drainage is appropriate and meets the requirements of clause 8. 2.1.\nWhere product characteristics meet the description of high care but the systems are fully enclosed (e. g. dairies filling cartons with milk), the production area is considered an enclosed product area. However, additional precautions are required when breaking into the lines or entering filler equipment (e. g. for maintenance, to free product blockage or for cleaning).\nWherever equipment is entered, the necessary hygiene requirements must be completed before operations can recommence.\nIt is expected that newly built factories will employ full wall segregation where high-care facilities are required.", "requirement_fr": "Lorsque le site de fabrication inclut des zones de grande précaution, une séparation physique doit être mise en place entre ces zones et les autres parties du site. La séparation doit tenir compte du flux de produits, de la nature des matériaux (emballage compris), de l'équipement, du personnel, des substances chimiques, de l’élimination des déchets, des écoulements d'air, de la qualité de l'air et de l'entrée des fluides techniques (canalisations incluses).\nLorsque des barrières physiques ne sont pas mises en place, le site doit avoir entrepris une évaluation des risques documentée relative à la contamination croisée potentielle, et des processus efficaces et validés doivent être en place pour protéger les produits de la contamination, notamment des procédures pour le passage des zones à faible risque aux zones de grande précaution."}, {"id": "8.1.4", "requirement": "Where ambient high-care areas are required, a documented risk assessment shall be completed to determine the risk of cross-contamination with pathogens.", "interpretation": "This clause is applicable to ambient high-care areas (i. e. areas designed to a high standard, where practices are in place to minimise product contamination by pathogenic micro- organisms).\nAmbient products that are handled in these areas are vulnerable, as vegetative pathogens are known to survive adverse conditions and may subsequently represent a potential food poisoning risk.\nProducts which require handling in ambient high-care areas are those which meet all of the following criteria:\n• they contain a raw material that is prone to contamination with vegetative pathogens (e. g. Salmonella species)\n• the production process includes a process step which removes or reduces the pathogen (e. g. a microbiological kill step). (Where there is no effective step in the on-site processes, it is assumed that any risk associated with the raw material is controlled as part of the raw material risk assessment and goods receipt processes.)\n• the finished products are stored at ambient temperatures (i. e. above 5°C)\n• the finished products are ready to eat or ready to heat or, on the basis of known consumer use, are likely to be eaten without adequate cooking\n• the finished products are such that vegetative pathogens could survive and grow in normal use, subsequently causing food poisoning, or are of a nature (e. g. fatty foods) that enables food poisoning to result from a very low level of contamination with a pathogen.\nWhere products fall into the ambient high care category, the site should conduct a risk assessment to identify the potential risks of cross-contamination (e. g. locations where cross-contamination could occur) and introduce procedures and processes to manage these potential risks.\nThe procedures required will be dependent on the level of risk, but could, for example, include:\n• segregation – normally this would be physical separation; however, time segregation would be permitted where the site can demonstrate that processes effectively minimise the risk of contamination\n• cleaning and disinfection processes which ensure that areas where at-risk materials are located are maintained at a suitably high level of cleanliness\n• management of the process flow – ensuring a logical (and usually linear process) so that implicated raw materials are not in the same area/zone as final product (or intermediates that have been through the process to remove or reduce micro-organisms)\n• enhanced environmental monitoring.\nAdditional information on ambient high-care areas can be found in Appendix 2 of the Standard.", "requirement_fr": "Lorsque des zones de grande précaution pour les produits à température ambiante sont requises, une évaluation des risques documentée doit être complétée pour déterminer le risque de contamination croisée par des agents pathogènes. L'évaluation des risques doit tenir compte des sources potentielles de contamination microbiologique et inclure :\n•\t les matières premières et les produits\n•\t le flux de matières premières, emballages, produits, équipement, personnel et déchets\n•\t l'écoulement et la qualité de l'air\n•\t l'entrée et l'emplacement des fluides techniques (canalisations incluses).\nDes processus efficaces doivent être en place pour protéger le produit fini de toute contamination microbiologique. Ces processus peuvent inclure la séparation, la gestion du flux de processus et d'autres contrôles.\n8.2 Enveloppe du bâtiment dans les zones à haut risque et de grande précaution"}, {"id": "8.2.1", "requirement": "Where sites include high-risk or high-care facilities, there shall be a map of the drains for these areas which shows the direction of flow and the location of any equipment fitted to prevent the backup of waste water.", "interpretation": "The flow of drains must not present a risk of contamination of the high-risk or high-care areas. There must be a plan of the drains for these areas which shows the direction of flow and location of any equipment fitted to prevent the backing-up of waste water. For example, drains should flow from high-risk to low-risk areas and include suitable barriers, such as separate drains that are not connected to other areas of the site. They should also feature non-return or anti-syphon valves, and one-way traps or a sufficient drop to ensure flow in the correct direction.\nThe map of the drains does not need to be a separate document – it can be incorporated into the site map (see clauses 8. 1.1 and 4. 3.2) if this is more convenient. The direction of flow of the drains must be included on the map.\nGood practice is for the site to have procedures in place for the action to be taken in the event of a failure of the drain traps or if water backs up into the high-risk or high-care areas.\nThis should be more than just mopping up and then continuing production, as the clause requires that drains must not become a risk of contamination. A full clean, microbiological swabbing etc. may be required to reinstate and confirm the status of the high-risk area.", "requirement_fr": "Quand le site comprend des zones à haut risque et de grande précaution, il doit y avoir une carte des zones d’écoulement. Il doit signaler la direction des flux et l'emplacement de tout équipement permettant d'éviter le reflux des eaux usées. Le flux des canalisations ne doit pas présenter de risque de contamination de la zone à haut risque/de grande précaution."}, {"id": "8.2.2", "requirement": "High-risk areas shall be supplied with sufficient changes of filtered air.", "interpretation": "High-risk areas must be supplied with sufficient changes of filtered air. Therefore a risk assessment must be completed, with the aim of ensuring that the air introduced will not contain micro-organisms of concern and will not be a source of additional contamination (e. g. through the formation of airborne water droplets). The following criteria should be considered:\n• the source of air. The air inlet needs to be located to minimise intake of contaminated air (at a minimum, it should be upwind of potential contaminants such as dust and chemical vapours)\n• the frequency of air changes\n• the specification of filter used. There is no absolute global standard for the filters used in specific food industry applications; the grade required will depend on the source of the air and the length of time of exposure of high-risk products/ingredients\n• the frequency of replacement of filters\n• the need to maintain positive pressure compared with adjacent areas, particularly where there is an interface with low-risk areas.\nThe effectiveness of the system employed should be checked using periodic sampling of air microbiological quality.\nWhile there is no specific requirement for an over-pressure of air in high-risk areas, good practice is for the ventilation system to be in balance, so that there is no large movement of air from low-risk into high-risk areas.\nWhere air socks are used for high-risk areas, they should be identifiable and kept separate from those for other areas.", "requirement_fr": "Les zones à haut risque doivent bénéficier de renouvellements d'air filtré suffisants. Les spécifications de filtre utilisées et la fréquence des renouvellements d'air doivent être documentées en se basant sur une évaluation des risques, en tenant compte de l'origine de l'air et de l'exigence de conserver une pression d'air positive par rapport aux zones environnantes."}, {"id": "8.2.3", "requirement": "Where sites include removable walls as part of the design of the high-risk or high-care area, procedures shall be in place to ensure they are tight fitting and their use is managed.", "interpretation": "Production risk zones may have removable walls or removable wall panels, to allow the movement of large items or specialist equipment between areas.\nSites must have documented procedures for the use of removable walls. As a minimum, the Standard expects:\n• these walls are tight fitting (e. g. to ensure pathogen contamination cannot occur through any gaps; for example, if air or water movement occurs between the two areas)\n• use of the removable wall is managed correctly and in a controlled manner (e. g. its removal must be authorised and is only completed by trained and authorised personnel, at approved times when there is no production, and in accordance with documented procedures)\n• cleaning and reconditioning are completed prior to the next production (i. e. to ensure that any contamination that has occurred has been removed, and that the area is reliably returned to its high-risk or high-care status).\nGood practice is to update the site map to show the walls which can be moved.", "requirement_fr": "Lorsque les sites utilisent des parois amovibles dans les zones à haut risque ou de grande précaution (c-à-d. pour permettre le déplacement occasionnel d'objects volumineux ou d'équipements d'entretien spécialisés), des procédures doivent être en place pour garantir :\n•\t un ajustement serré et étanche des parois amovibles\n•\t une bonne gestion de leur utilisation\n•\t le déplacement autorisé des parois par du personnel formé et autorisé uniquement\n•\t le nettoyage et la remise en état des parois avant la production.\n8.3 Équipements et maintenance dans les zones à haut risque et de grande précaution Clause 8.3.1"}, {"id": "8.3.1", "requirement": "Maintenance activities undertaken in high-risk and high-care areas shall respect the segregation requirements of the area. Tools and equipment shall be dedicated for use in that area where possible.", "interpretation": "It is important that maintenance activities do not result in microbiological contamination of high-risk or high-care areas. Tools that are frequently needed in the area (e. g. spanners) should be dedicated to the area and not removed from there. Where specialist tools or equipment need to be brought into an area for a specific task, then mechanisms should be in place to ensure that this does not result in contamination (e. g. cleaning equipment before entry and post-maintenance cleaning of the high-risk or high-care area).", "requirement_fr": "Les activités de maintenance effectuées dans les zones à haut risque et de grande précaution doivent être conformes aux exigences de séparation de la zone. Dans la mesure du possible, les outils et équipements utilisés doivent être réservés à cette zone et conservés dans cette même zone.\nClause 8.3.1"}, {"id": "8.3.2", "requirement": "Where equipment is removed from the high-risk or high-care area, the site shall have a procedure to ensure the cleanliness and removal of contamination hazards before acceptance back into the area.", "interpretation": "Some equipment is moved from place to place in order to be used in different areas. Where this occurs, the site must take steps to ensure that re-introduction to those areas does not compromise the conditions (i. e. the equipment is suitably clean and will not be a source of contamination).\nThe auditor will expect to see a procedure that addresses the re-introduction of equipment to a high-risk or high-care area, as well as evidence of adherence to this procedure where equipment has been moved.", "requirement_fr": "Lorsque des équipements sont retirés de la zone à haut risque ou de grande précaution, le site doit disposer d'une procédure garantissant leur propreté et l'élimination des risques de contamination avant la remise en service de l’équipement.\nLe retour de ces équipements dans la zone doit être enregistré et consigné."}, {"id": "8.3.3", "requirement": "Where portable equipment and battery-charging equipment is used in high-risk or high-care areas, these items shall either be visually distinctive and dedicated, or have specific cleaning procedures.", "interpretation": "Systems must ensure that the use or transportation of small portable equipment, such as handheld devices (e. g. pH meter, temperature probe) and battery-charging, cannot become the source of pathogen contamination.\nGood practice is for these items to be dedicated to the designated area. Where this is not practical, then specific procedures must be in place to prevent contamination (e. g. movement only through designated routes with associated cleaning or sanitising controls).", "requirement_fr": "Lorsque du matériel portatif (c-à-d. des dispositifs portables) ou des chargeurs de batterie sont utilisés dans les zones à haut risque ou de grande précaution, ces équipements doivent :\n•\t être différenciés visuellement et leur usage réservé à cette zone, ou\n•\t répondre à des procédures spécifiques (c-à-d. un nettoyage complet) pour garantir que leur utilisation n’entraîne pas de contamination.\n8.4 Installations réservées au personnel dans les zones à haut risque et de grande précaution"}, {"id": "8.4.1", "requirement": "Where an operation includes a high-risk or high-care area, personnel shall enter via a specially designated changing facility at the entrance to the area. • clear instructions for the order of changing. • protective clothing that is visually distinct. • hand-washing routine during the changing procedure. • dedicated site footwear. • effective control of footwear (barrier/bench or boot-wash)", "interpretation": "The objective of this clause is to ensure that protective clothing, once applied, is not contaminated before entry into the high-risk or high-care area.\nIn facilities with high-risk or high-care areas, personnel must enter these areas via a specific, designated changing facility (i. e. separate from other, lower-risk changing areas) and must follow documented instructions to:\n• apply specific dedicated protective clothing which is visually distinct (e. g. a different colour or style), including clean overalls, headwear and footwear\n• apply clothing in a given order; for example:\n• put on hair covering\n• remove shoes\n• step over barrier (see below)\n• put on dedicated footwear\n• wash hands\n• put on coat or overalls\n• wash and sanitise hands\n• wash hands during the changing procedure.\nWhen personnel leave the high-risk or high-care area, there must be clear instructions for changing out of protective clothing to ensure that they remove their overalls before handling shoes or a hair covering. (This is particularly important where the clothing is to be reused; for example, if someone is temporarily leaving the area for lunch or a break.) The footwear worn in these areas must be dedicated to the factory (i. e. factory-issued and not worn outside the factory) and captive to the area (i. e. worn only in the high-risk area).\nThe changing area must be laid out with an effective system to differentiate areas for wearing high-risk footwear (e. g. by the use of a barrier or bench system).\nBy exception, boot-wash facilities may be used instead of changing into captive footwear dedicated to the area; these must be located at the entrance to an area. Boot-wash facilities must be effectively controlled, managed and validated to prevent the introduction of pathogens. The site must have undertaken a risk assessment to identify the suitability of the boot-wash facilities, and have established controls to manage the effective sanitation of footwear. The controls must have been validated by microbiological swabbing of footwear, floors and drains in the high-risk or high-care area to demonstrate the absence of pathogens (e. g. Listeria species).\nFor controls to be effective, they should include the following criteria:\n• The footwear must be company-issued and of a design which is easily cleaned (i. e. smooth upper surfaces, and cleats on soles sufficiently spaced so as not to trap dirt which may not be easily removed by boot-wash equipment).\n• The potential for cross-contamination of boots prior to boot-washing must be considered.\n• Permitted areas where footwear may be worn prior to entry to an area must be clearly defined. For example, the same footwear must not be worn outside the facility or in low- risk processing areas prior to entering the area.\n• The boot-wash equipment must be suitably designed, well maintained and demonstrably effective in cleaning and sanitising the footwear.\n• The minimum cleaning time and concentrations of detergent and sanitiser must be determined, monitored, documented and controlled to ensure effective cleaning of footwear.\n• A schedule for the cleaning of the boot-wash facility and equipment should be in place to ensure that the boot-wash does not become a source or vector of microbiological contamination.\n• Records of the detergent/sanitiser checks and of the effectiveness of the boot-wash facilities are to be kept.\nEnvironmental monitoring programmes must include specific reference to high-risk and high-care areas (e. g. footwear, floors and drains) to demonstrate the effectiveness of the footwear control.\nAll visitors and contractors entering the area will need dedicated footwear; shoe covers are not satisfactory for high-risk or high-care areas, as they rarely cover the whole shoe and often tear or fragment during use, resulting in a lack of protection and the potential to become foreign-body risks.\nThe objective of the use of dedicated clothing is to prevent the potential contamination of products. If members of the cleaning team (or indeed anyone else, such as engineers or visitors) enter an area while production is in progress or open products are present, they must follow the same clothing rules as production staff. If cleaning occurs outside production time, the absolute rules on protective clothing may be adapted but must ensure that the production area is left in a condition, after cleaning, such that no microbiological risks have been introduced by the cleaners or the equipment used. The same principles apply to engineers undertaking maintenance work (which should be followed by cleaning to restore the microbiological security of the area). Wherever practical, auditors will be expected to observe the cleaning in high-risk areas to ensure that the practices used are effective and that controls are in place to prevent this activity introducing new risks.\nFurther details are available in the BRCGS guideline on Understanding High Risk, High Care and Ambient High Care, available on BRCGS Participate.", "requirement_fr": "Lorsqu'une opération inclut une zone à haut risque ou de grande précaution, le personnel doit y pénétrer via un vestiaire spécialement conçu situé à l'entrée de la zone. Les vestiaires doivent comporter les éléments suivants :\n•\t des instructions claires doivent être fournies concernant l'ordre pour mettre ou enlever les vêtements de protection dédiés afin de prévenir la contamination des vêtements propres\n•\t des vêtements de protection identifiés visuellement pour les différencier de ceux portés dans les autres zones et qui ne doivent pas être portés en dehors de la zone\n•\t une procédure de changement de vêtements incluant le nettoyage des mains, pour éviter la contamination des vêtements propres (c-à-d. nettoyer ses mains après avoir couvert ses cheveux ou mis ses chaussures, mais avant de manipuler des vêtements de protection propres)\n•\t des installations de nettoyage et désinfection des mains qui, au minimum, doivent être placées :\n•\t avant d’entrer dans les zones à haut risque\n•\t à l'entrée des zones de grande précaution\n•\t des chaussures dédiées réservées au site et fournies par celui-ci qui ne doivent pas être portées en dehors de l’usine\n•\t un contrôle efficace des chaussures, afin de prévenir l'introduction de pathogènes dans la zone. Ce contrôle peut se faire au moyen d’un changement de chaussures contrôlé avant l’entrée dans la zone (c-à-d. séparé par un système de barrière ou de banc) ou par l’utilisation d’installations de nettoyage de bottes contrôlées et gérées, lorsque celles-ci permettent un contrôle efficace démontrable des chaussures, afin de prévenir l’introduction de pathogènes dans la zone.\nUn programme de contrôle environnemental doit être utilisé pour évaluer l’efficacité des contrôles de chaussures.\n8.5 Entretien et hygiène dans les zones à haut risque et de grande précaution"}, {"id": "8.5.1", "requirement": "Environmental cleaning procedures in high-care/high-risk areas shall consider the different microbiological risks associated with each production risk zone.", "interpretation": "In addition to clause 4. 11. 2, the site must consider the different microbiological risks associated with each high-risk and high-care area.\nDocumented cleaning procedures must be in place to ensure consistent and effective cleaning. These procedures should be specific to the area being cleaned, i. e. for the high-risk or high-care area, as the risks may be different.\nCleaning procedures for these areas need to include information on the:\n• staff responsible\n• equipment, building and plant to be cleaned\n• frequency of cleaning\n• methods to be used\n• materials to be used (e. g. required chemicals and concentrations – good practice is to follow the cleaning chemical manufacturer’s instructions relating to concentration, temperature and contact time)\n• equipment to be used, such as hoses or brushes\n• instructions on the correct and safe dismantling of equipment where this is required for cleaning purposes\n• records to be kept\n• responsibility for verification of cleaning\n• methods of verification (e. g. visual inspection, ATP monitoring, microbiological swabs or allergen swabs)\n• procedures to prevent contamination; for example, if the cleaning team moves from one production risk zone to another during the cleaning operations, good practice is to move from the higher-risk area to the lower-risk area.\nWhere equipment requires different levels of cleaning (e. g. between products, or between daily and weekly cleans), each requirement should be clearly detailed.\nIt may be useful to include photographs in the instructions. The procedures need to be reviewed and updated when changes occur to the areas to be cleaned.", "requirement_fr": "Les procédures de nettoyage de l’environnement des zones à haut risque/de grande précaution doivent tenir compte des différents risques microbiologiques associés à chaque zone de production à risque.\nLes procédures de nettoyage des zones à haut risque et de grande précaution doivent, au minimum, inclure toutes les exigences décrites dans la clause 4.11.2. La fréquence et les méthodes de nettoyage doivent être basées sur les risques, et les procédures doivent être mises en place pour garantir le respect des normes appropriées relatives au nettoyage."}, {"id": "8.5.2", "requirement": "Microbiological limits for acceptable and unacceptable cleaning performance shall be defined for high-risk/high-care production risk zones.", "interpretation": "At a minimum, limits of acceptable and unacceptable cleaning performance must be defined for environmental cleaning (i. e. the factory environment) in high-risk and high-care areas.\nThe limits need to be based on the risk, and this should be used for assessing whether the cleaning undertaken is of an acceptable standard. Acceptable limits may be based on visual inspection, ATP monitoring or specific analysis such as microbiological testing.\nWhere the cleaning procedure forms part of a defined prerequisite (clause 2. 2.1), designed to manage a specific hazard, the procedure must be validated to confirm that the specified cleaning method, chemicals and concentrations are capable of consistently achieving the level of performance required. Records of validation must be maintained.", "requirement_fr": "Des limites microbiologiques acceptables et non acceptables doivent être définies pour le nettoyage des zones de grande précaution ou à haut risque.\nCes limites doivent se baser sur les dangers potentiels applicables au produit ou à la zone de transformation. Par conséquent, des niveaux acceptables de nettoyage doivent être définis, par exemple, en se basant sur l'aspect visuel, les techniques de bioluminescence ATP (voir glossaire), les tests microbiologiques ou chimiques, selon les cas. Le site doit définir l'action corrective à adopter lorsque les résultats des contrôles se situent hors des limites acceptables.\nLorsque les procédures de nettoyage et de désinfection s'inscrivent dans le cadre d'un programme préalable défini pour contrôler le risque d'un danger particulier, les procédures ainsi que leur fréquence doivent être validées et consignées. Elles doivent inclure les risques inhérents au nettoyage des résidus chimiques sur les surfaces en contact avec les aliments."}, {"id": "8.5.3", "requirement": "Equipment used for cleaning in high-care and high-risk areas shall be visually distinctive, dedicated, hygienically designed and stored hygienically.", "interpretation": "Equipment used for cleaning high-risk or high-care areas must be dedicated for use in that area, and therefore retained in the area (i. e. it should not be removed from the area for cleaning or any other purpose). It should also be visually distinct (e. g. colour-coded) from cleaning equipment used in other areas.\nWhere it is not possible to effectively clean equipment in the high-risk or high-care area, a suitable transfer control should be in operation (e. g. heating or disinfection prior to transfer back into the high-risk or high-care area).\nThe cleaning equipment used in high-risk and high-care areas should also be:\n• hygienically designed and fit for purpose; for example, high-pressure hoses are not normally used in high-risk areas because of the potential to create aerosols and move debris\n• cleaned and stored to prevent contamination; for example, many items of equipment should be stored off of the floors (the obvious exception being equipment designed for cleaning the floors), and in designated storage areas.", "requirement_fr": "Les équipements utilisés pour le nettoyage des zones de grande précaution/à haut risque doivent être :\n•\t différenciés visuellement et leur usage réservé à cette zone\n•\t conçus de manière hygiénique et adaptés à l'usage prévu\n•\t propres et stockés de manière hygiénique pour éviter la contamination (par exemple, en rangeant les équipements dans des endroits désignés, hors sol, lorsqu’ils ne sont pas utilisés)."}, {"id": "8.5.4", "requirement": "Where the site uses CIP equipment, either this shall be for a specific area only or the system shall be designed and controlled to prevent contamination (e.g. no recycling of rinse solutions from low-risk to high-risk).", "interpretation": "It is important that cleaning equipment cannot be a source of product contamination.\nThis includes the use of CIP systems. Therefore, in addition to the requirements for CIP identified in section 4. 11. 7, the site must ensure that specific risks to the high-risk and high- care areas are managed appropriately. As a minimum, the CIP system for high-risk or high- care areas must be either:\n• a dedicated system, with separate CIP from the systems used in other parts of the facility, or\n• controlled so that contamination cannot occur, including controlled direction of flow from higher-risk to lower-risk areas, and not reusing or recycling cleaning chemicals, cleaning solutions or rinse solutions from one area to another.", "requirement_fr": "Lorsque le site utilise des équipements de NEP, ceux-ci doivent être réservés à une zone spécifique (c-à-d. équipements distincts pour les zones à haut risque, les zones de grande précaution et autres zones de production) ou le système de NEP doit être conçu et contrôlé de manière à ne pas poser de risque de contamination pour les zones à haut risque/de grande précaution (c.-à-d. en contrôlant la direction du flux de production, des zones à haut risque/de grande précaution vers les zones à faible risque, en empêchant le recyclage ou la réutilisation des solutions de rinçage d'une zone à l'autre).\n8.6 Déchets et traitement des déchets dans les zones à haut risque et de grande précaution"}, {"id": "8.6.1", "requirement": "Waste disposal systems shall ensure that the risk of contamination of products is minimised through the control of potential cross-contamination. Risk assessment shall consider the movement and flow of waste and waste containers.", "interpretation": "It is important that waste disposal systems are not a source of contamination in high-risk or high-care areas. Therefore risk assessment must consider the movement and flow of waste and waste containers. For example, bins must be dedicated to either high-risk or low-risk areas and must not move between the two. Waste from high-risk and high-care areas should be transferred to other containers at the transfer point.\nThe risk assessment for waste in high-risk and high-care areas may be included in the previous documented risk assessment on waste disposal (see clause 4. 12. 3) or as a separate document.", "requirement_fr": "Les systèmes de traitement des déchets doivent garantir que les risques de contamination des produits sont minimisés, grâce au contrôle des contaminations croisées potentielles.\nL’évaluation des risques doit tenir compte du mouvement et du flux des déchets et conteneurs à déchets. Par exemple, les poubelles doivent être réservées soit aux zones à haut risque, soit aux zones de grande précaution, et ne pas être déplacées entre les différentes zones présentant un risque pour la production.\n8.7 Vêtements de protection dans les zones à haut risque et de grande précaution"}, {"id": "8.7.1", "requirement": "Laundering of protective clothing for high-risk and high-care areas shall be done by an approved contracted or in-house laundry using defined criteria. This includes commercial sterilisation of protective clothing following washing and drying.", "interpretation": "Protective clothing may be cleaned by contracting the services of a specialised laundry, or by laundering in-house.\nExternal contracted services must be incorporated within the company’s purchasing supplier approval programme (clause 3. 5.3. 1) and have systems of approval and continual assessment to ensure that the process is under control.\nIn-house laundering carried out on the company premises must be controlled. This is likely to be done via HACCP-style principles, controls and validation data, such as monitoring of the temperature and detergent, specifying items not to be washed together, overseeing drying processes, and visual inspection. The laundry will also be included in the programme of internal audits (clause 3. 4.1).\nThe aim of the clause is to ensure management of the laundry process for high-risk and high-care protective clothing, including segregation of clean and dirty protective clothing and of clean clothing used in different risk production zones. Therefore laundries (both in- house and contracted) must ensure that:\n• dirty and clean clothing is adequately segregated to ensure that recently laundered items are not re-contaminated\n• high-risk, high-care and low-risk clothing is adequately segregated throughout the laundry process\n• the protective clothing is effectively cleaned (e. g. by the completion of microbiological validation and verification tests)\n• clothing is commercially sterile following the washing and drying process. This means that any vegetative forms of micro-organisms associated with food poisoning and/or spoilage must have been removed. To achieve this, a garment should be laundered at a temperature no lower than 65°C for a minimum of 10 minutes, or laundered at a temperature no lower than 71°C for a minimum of 3 minutes, or in accordance with local regulatory requirements\n• cleaned clothes are protected from contamination until delivered to the appropriate area of the site (e. g. specific storage for clean protective clothing in the high-risk changing facility).\nHome laundering is not considered suitable for protective clothing used in high-risk or high- care areas.", "requirement_fr": "Le lavage des vêtements de protection pour les zones à haut risque et de grande précaution doit être effectué par une blanchisserie agréée contractée ou en interne, en suivant des critères définis permettant de valider l'efficacité du processus de lavage. La blanchisserie doit utiliser des procédures qui garantissent :\n•\t la séparation adéquate des vêtements sales et des vêtements propres\n•\t la séparation adéquate des vêtements pour les zones à haut risque, de grande précaution, à faible risque, etc.\n•\t un nettoyage efficace des vêtements de protection\n•\t la stérilisation commerciale des vêtements de protection, suivant le processus de lavage et de séchage\n•\t la protection des vêtements propres de la contamination jusqu’à leur utilisation."}, {"id": "8.7.2", "requirement": "Where protective clothing for high-care or high-risk areas is cleaned by a contracted or in-house laundry, the laundry shall be audited either directly or by a third party.", "interpretation": "The company will need to assess and monitor the laundry (e. g. through visual inspection, regular audits and a complaints procedure) to ensure that the processes in place for the cleaning of high-risk and high-care clothing are maintained and kept consistently under control.\nThe audits of the laundry can be completed either directly (i. e. by the site) or by a suitable third party. The frequency of the audits should be based on risk.", "requirement_fr": "Lorsque des vêtements de protection pour des zones de grande précaution ou à haut risque sont nettoyés par une blanchisserie externe ou interne, cette dernière doit être auditée soit directement, soit par un tiers. La fréquence de ces audits doit être basée sur les risques."}, {"id": "8.7.3", "requirement": "Protective clothing for use in high-risk and high-care areas shall be changed at an appropriate frequency based on risk, and at a minimum daily.", "interpretation": "Protective clothing needs to be changed at an appropriate frequency to ensure that clothing cannot become a source of product contamination.\nProtective clothing worn in high-risk or high-care areas must be changed at least daily and hairnets changed daily or whenever removed (e. g. when leaving the area).\nWhere risk assessment determines that more frequent changing is appropriate, the site must ensure this occurs. The auditor will expect to see the risk assessment, documented protective clothing procedures, and application of the procedures in practice.\nSpare protective clothing should be available on demand should currently used items become soiled.\n9 Requirements for traded products Traded products are defined as food products that would normally fall within the scope of the Standard and are stored at the facilities of the site being audited, but that are not manufactured, processed, reworked, packed or labelled at that site.\nThe site’s management of these products is covered by the requirements in this section.\nAll the relevant requirements from sections 1 to 8 must also be fulfilled in addition to the requirements outlined in this section.\nWhere a site wishes to be audited against section 9 of the Standard, all of the food products and food raw materials traded must be included in the audit scope. It is not permitted to include some traded food products or food raw materials and exclude others.\nNon-conformities against clauses within section 9 of the Standard will be recorded on the audit report and included in the calculation of the site’s grade.\nWhere a site has traded food products or food raw materials on site but wishes them to be excluded from the scope of the audit, this will be recorded as an exclusion from scope on the audit report.\nTraded products include food final products, food raw materials and food ingredients that are:\n• purchased and sold (but not manufactured, processed, reworked, packed or labelled on site)\n• stored for another site, e. g. another site in the same company (but are not manufactured, processed, reworked, packed or labelled on site).\nTraded products do not include:\n• non-food products, non-food ingredients or non-food raw materials\n• any material that is manufactured, processed, reworked, packed or labelled on site (for example, where a product is subject to an outsourced process, but subsequently returns to the site for further processing, packing or labelling, it is not considered a traded product).\nThe auditor will require some additional time to complete the audit of traded products. Full information on audit duration, including the additional time required for auditing traded products, can be found in the audit duration calculator.\n9. 1 The food safety plan – HACCP The site shall operate a HACCP or food safety plan for the processes for which it is responsible.\nIt is important that traded products are managed correctly to ensure that:\n• product safety, legality and traceability are maintained\n• the traded products do not represent a food safety risk to the products manufactured, processed, reworked, packed or labelled on site.\nThe first step in the management of the traded products is therefore to complete a HACCP or food safety plan which specifically includes these products.", "requirement_fr": "Les vêtements de protection portés dans les zones à haut risque et de grande précaution doivent être changés à une fréquence appropriée basée sur les risques, au minimum quotidiennement.\n9 Exigences relatives aux produits commercialisés Les produits commercialisés sont des produits alimentaires généralement inclus dans la portée de la Norme et qui sont stockés dans les installations du site audité, mais qui ne sont pas fabriqués, traités, recyclés, emballés ou étiquetés sur ce site.\nLa gestion de ces produits entre dans le cadre des exigences décrites dans la présente section.\nOutre les exigences mentionnées dans la présente section, l'ensemble des exigences applicables contenues dans les sections 1 à 8 doivent être respectées.\nLorsqu'un site souhaite être audité dans le cadre de la section 9 de la Norme, tous les produits alimentaires et matières premières alimentaires commercialisés doivent être inclus dans la portée de l'audit. Il n'est pas permis d'inclure certains produits alimentaires ou matières premières alimentaires commercialisés et d'en exclure d'autres.\nLes non-conformités détectées dans le cadre des clauses de la section 9 de la Norme seront enregistrées sur le rapport d'audit et prises en compte lors du calcul du grade du site.\nLorsqu'un site détient des produits alimentaires ou des matières premières alimentaires commercialisés sur site, mais souhaite les exclure de la portée de l'audit, cela sera enregistré comme une exclusion de la portée sur le rapport d'audit.\n9.1 Plan de sécurité des denrées alimentaires – HACCP Le site doit disposer d’un plan HACCP, ou plan de sécurité des denrées alimentaires, pour les processus dont il a la charge."}], "statement_of_intent": "The site shall be able to demonstrate that production facilities and controls are suitable to prevent pathogen contamination of products.", "group_intro_interps": {"8.2": "The requirements in this section are in addition to those in section 4.4. Sites are therefore recommended to review the two sections together, rather than separately", "8.3": "The requirements in this section are in addition to those in sections 4.6 and 4.7. Sites are therefore recommended to review these sections together, rather than separately", "8.4": "The requirements in this section are in addition to those in section 4.8. Sites are therefore recommended to review both of these sections together, rather than separately", "8.5": "The requirements in this section are in addition to those in section 4.11. Sites are therefore recommended to review both of these sections together, rather than separately", "8.6": "The requirements in this section are in addition to those in section 4.12. Sites are therefore recommended to review both of these sections together, rather than separately", "8.7": "The requirements in this section are in addition to those in section 7.4. Sites are therefore recommended to review both of these sections together, rather than separately", "8.1": "The requirements in this section are in addition to those in section 4.3. Sites are therefore recommended to review the two sections together, rather than separately."}, "section_intro_interp": "Where a site produces products where the production process, or part of it, requires high-risk, high-care and/or ambient high-care production zones (see clause 4.3.1 for this assessment and Appendix 2 of the Standard for the definition of these production zones), all the relevant requirements from sections 1–7 of the Standard must be fulfilled in addition to the requirements in this section.\nPrevention of potential contamination with pathogens is of paramount importance in the production of safe food.\nOne of the key ways of achieving this is to ensure the correct design (e.g. segregation) and control (e.g. restricted access) of areas of the site where open products, susceptible to contamination, are handled. The Standard defines these areas as production risk zones.\nThe main principle of the production risk zones in the Standard is to ensure that the environmental conditions and controls in open product areas are appropriate for the products being handled. Therefore the expectations for factory hygiene, finish of buildings, equipment, protective clothing and staff hygiene should reflect the potential risks to the product.\nWhere a site produces products that require handling in high-risk, high-care and/or ambient high-care production facilities (see Appendix 2 of the Standard for the definition of products that require these facilities), equivalent controls are expected for any subsequent handling or re-packing operation where the product is open to the factory environment (i.e. the re-packing site is expected to have equivalent facilities).\nBRCGS has produced a specific guideline on high risk, high care and ambient high care, which explains the requirements and provides details of good practice. It may be purchased from the BRCGS Store or viewed online at BRCGS Participate."}, {"section": 9, "title": "Requirements for traded products", "clauses": [{"id": "9.1.1", "requirement": "The company shall either have a HACCP or food safety plan specifically for the traded products handled on site, or incorporate the traded products into its existing HACCP or food safety plans.", "interpretation": "hazards associated with the traded products. The site may either:\n• complete a separate HACCP or food safety plan solely relating to the traded products.\nA separate plan is most useful in situations where the traded products are considerably different from the products manufactured, processed or packed on site, or have considerably different hazards associated with them; or\n• include the traded products within the existing HACCP or food safety plan completed in accordance with section 2 of the Standard. A combined food safety plan may be useful where the traded products are similar to those manufactured, processed or packed on site, and therefore have similar hazards.\nThe scope must include all the products and processes for which the site is responsible. As a minimum, this will include:\n• receipt of goods\n• storage\n• dispatch.\n9. 2 Approval and performance monitoring of manufacturers/packers of traded food products The company shall operate procedures for approval of the last manufacturer or packer of food products which are traded to ensure that traded food products are safe, legal and manufactured in accordance with any defined product specifications.\nAll traded food products brought onto the site must be sourced from approved suppliers who are regularly monitored for their performance. The risk assessment process should focus more on those products and suppliers that present a greater risk (in terms of safety, authenticity, legality and quality).", "requirement_fr": "L’entreprise doit, soit :\n•\t avoir un plan HACCP ou plan de sécurité des denrées alimentaires spécifique pour les produits commercialisés manipulés sur le site, ou\n•\t inclure les produits commercialisés dans ses plans HACCP ou de sécurité des denrées alimentaires existants (voir section 2).\nLa portée du plan HACCP ou de sécurité des denrées alimentaires relatif aux produits commercialisés doit inclure les produits et processus dont le site a la responsabilité. Au minimum, il doit inclure la réception, le stockage et l'expédition des marchandises.\n9.2 Approbation et contrôle de la performance des fabricants/conditionneurs de produits alimentaires commercialisés L’entreprise doit appliquer des procédures d'approbation du dernier fabricant ou conditionneur des produits alimentaires commercialisés, afin de garantir que ces derniers sont sûrs, légaux et fabriqués conformément à toute spécification de produit définie."}, {"id": "9.2.1", "requirement": "The company shall have a documented supplier approval procedure which identifies the process for initial and ongoing approval of suppliers and the manufacturer/processor of each product traded. • nature of the product and associated risks. • customer-specific requirements. • legislative requirements. • source or country of origin. • potential for adulteration or fraud. • potential risks in the supply chain. • brand identity", "interpretation": "For easier management, sites could choose to integrate the approval process for their traded products suppliers with that for their raw materials suppliers, or organise the traded products suppliers as a separate work stream.\nAll suppliers of traded products must be evaluated on the basis of a documented risk assessment for their ability to meet the specifications of the products they are supplying to the certificated site; in particular the requirements for safety, quality and legality. For example, the assessment should consider:\n• known hazards associated with the product provided (e. g. microbiological, chemical or foreign-body risks). Access to reference information and an awareness of emerging food issues are essential to ensure all known risks are assessed (see clause 1. 1.8)\n• customer or legislative requirements (e. g. suppliers may be specified by customers, but this does not negate the need for risk assessment). Legislation in the country of expected sale should be considered\n• geographic origins (products from particular countries may carry a greater risk because of environmental conditions, more relaxed local legal requirements or a less developed food safety culture)\n• the potential for fraudulent activity or food defence issues in the supply chain (e. g. undeclared additions, dilution or substitution of the raw material or a component of it).\nAdditional focus must be placed on products where claims are being made (e. g. organic, or suitable for individuals with food allergies). Suppliers and their control systems must be assessed robustly to ensure compliance with the requirements.\nThe outcome of this activity must also be considered when assessing the requirements for supplier approval and monitoring procedures (clauses 9. 2.2 and 9. 2.4).", "requirement_fr": "L'entreprise doit adopter une procédure documentée d'approbation des fournisseurs, qui identifie le processus d'approbation initiale et continue des fournisseurs, ainsi que le fabricant/ transformateur de chaque produit commercialisé. Les exigences doivent être basées sur les résultats d’une évaluation des risques devant prendre en compte :\n•\t la nature du produit et les risques qui lui sont associés\n•\t les exigences spécifiques aux clients\n•\t les exigences légales du pays dans lequel le produit est vendu ou importé\n•\t la source ou le pays d’origine\n•\t les risques d'adultération ou de fraude\n•\t les risques potentiels dans la chaîne d'approvisionnement jusqu’au point d’entrée des marchandises dans l’entreprise\n•\t l’identité de la marque des produits (c-à-d. produits de marques propres ou personnalisés à la marque du client)."}, {"id": "9.2.2", "requirement": "The company shall have a procedure for the initial and ongoing approval of manufacturers of products. This approval procedure shall be based on risk and include either a valid certification to a BRCGS/GFSI standard, supplier audits, or a completed supplier questionnaire (for low risk only).", "interpretation": "The company must document its procedure for supplier approval and monitoring. This needs to include the methods of approval, frequency of monitoring, staff responsibilities and how the process will be managed.\nApproval will be dependent on the product and the risks associated with it (the output of clauses 9. 2.1 and 9. 1.1) and will include one or more of the following activities:\n• certification to the relevant BRCGS Standard (such as food safety, packaging, storage and distribution, or agents and brokers) or a GFSI-benchmarked scheme. The site must confirm the validity of the certification. This will include:\n• confirmation of the certification status (this could be confirmed on an independent database; for BRCGS Standards, it can be confirmed in the BRCGS Directory).\nPhotocopies of certificates are not recommended and on their own are not considered suitable validation of certification status. During the BRCGS audit, the site may be asked to demonstrate its validation process\n• confirmation that the certification remains up to date (e. g. by receiving confirmation of successful completion of the recertification process or by recording certificate expiry dates and completing checks for ongoing certification)\n• confirmation that the products are within the scope of the certification.\n• a successful site audit which at a minimum covers product safety, traceability, HACCP and good manufacturing processes. This audit must be completed by an appropriately experienced and competent auditor (i. e. someone who has completed training in auditing techniques, has experience of auditing, and has knowledge of the product, ingredient or processes being audited). Non-conformities should be addressed (e. g. in an agreed action with timescales) unless they are critical to product safety or legality, in which case supply should not be permitted until non-conformities have been satisfactorily addressed. If the supplier is audited to a standard that is not GFSI-benchmarked, this may be acceptable providing that:\n• the scope of the audit meets the requirements of the Standard\n• the site has a copy of the full audit report (not just a certificate)\n• the site can demonstrate the competence of the auditor.\nWhere the risk assessment (completed as part of this clause) indicates that a supplier is low risk (because of the history of trading with the site, the nature of the products traded etc.), the completion of a supplier questionnaire with a focus on food safety and quality may be sufficient. If a supplier questionnaire is the only mechanism used to assess a supplier (i. e. there are no additional activities such as supplier audits), then it is important that the questionnaire (and the replies from the supplier) contains all the relevant information to allow the site to confidently decide on approval.\nThe auditor will expect to see, and will challenge, any risk assessments that determine that suppliers have been deemed to be low risk.", "requirement_fr": "L’entreprise doit disposer d'une procédure permettant l’approbation initiale et continue des fabricants des produits. Cette procédure d'approbation doit être basée sur les risques et inclure un ou plusieurs des points suivants :\n•\t une certification valide dans le cadre de la norme du BRCGS ou d’une norme reconnue par la GFSI. La portée de la certification doit inclure les produits achetés\n•\t des audits de fournisseurs (dont l'étendue inclut la sécurité sanitaire des produits, la traçabilité, l'examen HACCP et les bonnes pratiques de fabrication) effectués par un auditeur en sécurité sanitaire de produit expérimenté et manifestement compétent. Lorsque l’audit de ce fournisseur est réalisé par une seconde ou tierce partie, l’entreprise doit pouvoir :\n•\t démontrer la compétence de l’auditeur\n•\t confirmer que la portée de l'audit inclut la sécurité sanitaire des produits, la traçabilité, l'examen HACCP et les bonnes pratiques de fabrication\n•\t obtenir et examiner une copie du rapport d'audit complet ou\n•\t lorsqu'une justification valide basée sur les risques est fournie et que le fournisseur est considéré à faible risque uniquement, un questionnaire rempli par le fournisseur peut être utilisé pour l'approbation initiale. Le questionnaire doit inclure la sécurité sanitaire des produits, la traçabilité, l'examen HACCP et les bonnes pratiques de fabrication, et doit avoir été examiné et vérifié par une personne manifestement compétente."}, {"id": "9.2.3", "requirement": "Records shall be maintained of the manufacturer’s/packer’s approval process, including audit reports or verified certificates.", "interpretation": "The site is required to maintain records of the approval methods along with the evidence used to approve that supplier.\nApproval and associated risk assessments must be up to date and the site should therefore review the supplier assessment whenever there is an issue at the site manufacturing the traded food product.", "requirement_fr": "Des enregistrements relatifs au processus d'approbation des fabricants/conditionneurs doivent être conservés, y compris les rapports d'audit ou les certificats vérifiés confirmant le statut en matière de sécurité sanitaire des produits des sites de fabrication/ conditionnement fournissant les produits commercialisés. Il doit exister un processus d’examen et d’enregistrement du suivi de tout problème identifié sur les sites de fabrication/ conditionnement, susceptible d'affecter les produits alimentaires commercialisés par l’entreprise."}, {"id": "9.2.4", "requirement": "There shall be a process for the ongoing review of manufacturers/packers, based on risk and using defined performance criteria.", "interpretation": "As much as it is important to know how and why suppliers are approved, it is also vital to ensure that ongoing approval is justified. The site is free to determine how it confers continuing approval on its suppliers, but it must ensure that the supplier’s performance is matching its own food safety objectives.\nThe defined performance criteria can be determined by the site. These may include:\n• punctuality of deliveries against planned delivery times\n• incidences of contamination\n• quality of material supplied.\nFrequency of ongoing approval is also left for the site to determine; however, it must reissue the questionnaires (where used) at least once every 3 years. The site should be able to demonstrate to the auditor that the monitoring it uses is appropriate, justified and risk-based.\nExamples of different types of monitoring will be required.\nAll records of the review must be maintained.\n9. 3 Specifications Specifications or information to meet legal requirements and assist customers in the safe usage of the product shall be maintained and available to customers.\nA finished product specification must exist for all traded food products to ensure that legislation requirements and customer expectations are met.\nConsideration must be given to the legislative requirements in the country where the product will be sold or used.", "requirement_fr": "Un processus d’évaluation continue des fabricants/conditionneurs doit être en place, basé sur les risques et utilisant des critères de performance définis, pouvant inclure des plaintes, des résultats de tests de produits, des avertissements/alertes réglementaires, des rejets ou des commentaires de clients. Ce processus doit être pleinement mis en place.\nLorsque l'approbation s'appuie sur des questionnaires, ceux-ci doivent être soumis au moins une fois tous les 3 ans, et les fournisseurs seront tenus de signaler entre-temps tout changement significatif au site, y compris tout changement du statut de certification.\nDes enregistrements de l’évaluation doivent être conservés.\n9.3 Spécifications Des spécifications ou des informations destinées à répondre aux exigences légales et à aider le client à utiliser le produit sans danger doivent être conservées et mises à la disposition des clients."}, {"id": "9.3.1", "requirement": "Specifications shall be available for all products.", "interpretation": "Specifications for all products must be provided and adequately detailed. They must include the defined data for all parameters critical to the safety, legality and quality of the product.\nThe specifications may be in the format provided by the supplier or in the company’s own format, as long as the information controlling the product’s safety, quality and legality are clearly defined.", "requirement_fr": "Des spécifications doivent être disponibles pour tous les produits. Celles-ci doivent être soit au format convenu fourni par le client ou, s’il n’a pas été spécifié, inclure des données clés permettant de répondre aux exigences légales et d’aider le client à utiliser le produit sans danger.\nElles peuvent être sous la forme d’un document imprimé ou électronique, ou faire partie d'un système de spécifications en ligne."}, {"id": "9.3.2", "requirement": "The company shall seek formal agreement of the specifications with relevant parties.", "interpretation": "The site must have a formal specification approval process for its customers and suppliers.\nFor example, customer-branded finished product specifications must be formally agreed and, wherever possible, signed by both parties. However, where signature or approval is not formally available, proof that specifications have been issued (such as an email request for formal acknowledgement, or specifications uploaded onto a customer IT specification system) is required. In this situation the site must be able to demonstrate it is following a formal process agreed with its customer.", "requirement_fr": "L'entreprise doit obtenir un accord formel relatif aux spécifications avec les parties concernées. Lorsque les spécifications ne sont pas convenues formellement, l'entreprise doit pouvoir démontrer qu'elle a pris des mesures pour s'assurer qu'un accord formel soit établi."}, {"id": "9.3.3", "requirement": "Companies shall operate demonstrable processes to ensure that any customer-specified requirements are met.", "interpretation": "Many customers have specific requirements relating to product safety, authenticity, quality and legality and the site needs to ensure that it is aware of these requirements and understands them (e. g. by retaining copies of relevant customer’s policy documents or service-level agreements).\nThe site must also have a mechanism for ensuring these requirements are met. For example, by communicating with the relevant suppliers of products, by incorporating the information in specifications, or by recording minutes of review meetings in which the requirements are agreed with the supplier.\nOccasionally the site may arrange for additional work to be completed on the product before it is sent to the customer. Good practice is to ensure that any changes to the requirements are communicated and agreed in a timely manner.", "requirement_fr": "Les entreprises doivent mettre en place des processus vérifiables garantissant que toutes les exigences spécifiées par le client sont respectées. Cela peut être réalisé en incluant les exigences du client dans les spécifications d’achat ou en retravaillant le produit acheté pour qu’il réponde aux spécifications du client (c-à-d. tri ou calibrage des produits)."}, {"id": "9.3.4", "requirement": "Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years.", "interpretation": "Specifications must be reviewed whenever changes occur to the product, process or formulation.\nWhere no known changes have occurred, the specifications should be reviewed at least every 3 years, or more frequently if required, to ensure they remain completely up to date and accurate. Evidence that a review has been completed needs to be available. This could, for example, be achieved by the addition of a signature and date to the specification, or by using a matrix showing specifications and the latest review date and reviewer.\nThe control of the amendment and approval of specifications should be documented in a procedure. The procedure should also detail who can approve the amendments.\nSome sites, companies or customers use cloud-based services which are able to notify the user when there has been a change to the data. In this case the site should have a mechanism to review the specification/change to understand whether there is any impact on the product.\n9. 4 Product inspection and laboratory testing The site shall operate processes to ensure that the products received comply with buying specifications and that the supplied product is in accordance with any customer specification.\nThe company needs to identify and schedule critical inspections and analyses for its traded food products. These may include:\n• identification of known product safety risks associated with the product type\n• assessment of legal requirements, particularly those associated with the country of intended sale (where known)\n• assurance of product authenticity (e. g. where a genuine risk of adulteration, substitution or fraud has been identified during a vulnerability assessment; see clause 5. 4.3)\n• inspection of quality attributes (e. g. where these form part of a specification agreed with the customer).\nThe frequency and types of inspections and analyses are not prescribed by the Standard, but should be risk-based, specific to the type of products.", "requirement_fr": "Les spécifications doivent être revues fréquemment afin de garantir que les données sont à jour, ou au minimum tous les 3 ans, en tenant compte des changements de produits, des fournisseurs, des règlementations et autres risques.\nLes révisions et changements doivent être documentés.\n9.4 Inspection des produits et analyses en laboratoire Le site doit mettre en place des processus permettant de garantir que les produits reçus sont bien conformes aux spécifications d'achat et que le produit fourni correspond bien aux spécifications du client."}, {"id": "9.4.1", "requirement": "The site shall have a product sampling or assurance programme to verify that the products are in accordance with buying specifications and meet legal and safety requirements.", "interpretation": "The company needs to have a documented schedule of product sampling or assurance tests which are carried out on the products.\nThe objective of product tests is to ensure that products are manufactured to specification and in compliance with safety and legislative requirements. The frequency and type of product tests should be based on risk and on any particular customer requirements. They may, for example, include:\n• quality tests (e. g. appearance, colour or organoleptic qualities)\n• safety tests (e. g. chemical or microbiological) or tests to confirm legality (e. g. country of origin or species)\n• customer-specific requirements based on the specification or the customer’s contract with the company.\nThe site should be able to explain and justify the basis for the frequency of tests with reference to historical or scientific information as appropriate.\nGood practice is for the test method and specifications to be documented. Where the results of a test are not quantitative, colour standards or reference samples must be used to provide a reference point for the test results (i. e. to define pass/fail criteria).\nWhere tests are completed on site, the location of the testing should be considered. For example, laboratory facilities will need appropriate siting and controls, and organoleptic tests should be completed in a designated area rather than on the production line (see clause 5. 6.5).", "requirement_fr": "Le site doit disposer d'un programme d'assurance ou d’échantillonnage des produits, permettant de vérifier que les produits sont conformes aux spécifications d'achat et qu’ils répondent aux exigences légales et normes de sécurité.\nLorsque la vérification s'appuie sur l’échantillonnage, le processus d’évaluation et la fréquence d’échantillonnage doivent être basés sur les risques.\nLes résultats des évaluations ou analyses doivent être enregistrés et conservés."}, {"id": "9.4.2", "requirement": "Where verification of conformity is provided by the supplier, the level of confidence in the information provided shall be supported by commissioning periodic independent product analysis.", "interpretation": "The company must be able to demonstrate that each product meets legal requirements for its use.\nProducts are often traded with supporting evidence provided by the supplier (e. g. in the form of a certificate of analysis or certificate of conformity relating to the specific batch or lot of product supplied). Where these are used, they must be supported by procedures to substantiate the reliability of the information using independent product analysis.\nThe frequency of this periodic assessment should be based on risk assessment that considers the likelihood of an error occurring and the potential consequences if an error occurred.", "requirement_fr": "Lorsque la vérification de la conformité est pourvue par le fournisseur (c-à-d. certificats de conformité ou d’analyse), ces informations doivent être étayées par des analyses périodiques indépendantes des produits."}, {"id": "9.4.3", "requirement": "Where claims are made about the products being handled, supporting information shall be available from the supplier or independently to verify the claim.", "interpretation": "The types of claim covered by this clause relate to the provenance of products that differentiates it from the norm. Such a claim may be made either on the product label for the consumer or in business-to-business communication. The types of claim include:\n• varietal claims (e. g. basmati rice, Aberdeen Angus beef, Bramley apples and cod fish cakes)\n• origin claims (e. g. Madagascan vanilla and Florida grapefruit)\n• assurance claims (e. g. GLOBALG. A.P. , Red Tractor, Marine Stewardship, dolphin-friendly tuna and sustainable palm oil)\n• identity-preserved claims (e. g. GMO (genetically modified organism) free).\nIt is the responsibility of the site to obtain sufficient supporting information to ensure that the product claims are genuine and proven.\nFor many assurance schemes, such as GLOBALG. A.P. , it is possible to check the assurance status and the scope of products of the supplier on a database. Reliance solely on a declaration from a supplier will not be sufficient. Where claims relate to variety or species (e. g. varieties of fruit), examination of visual characteristics may suffice. However, for claims where visual analysis is not possible (e. g. block frozen fish), certificates of analysis and periodic sample analysis will be required.", "requirement_fr": "Lorsque des allégations sont faites concernant les produits manipulés, y compris la provenance, la chaîne de contrôle et le statut assuré ou « d’identité préservée » d'un produit ou d'une matière première utilisée, des informations complémentaires doivent être obtenues auprès du fournisseur ou indépendamment afin de vérifier l'allégation."}, {"id": "9.4.4", "requirement": "Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation (ISO/IEC 17025).", "interpretation": "This clause applies to tests which are critical to product safety or legality. Results from such tests must be credible and may be called upon in a court of law.\nThe company needs to identify which tests are critical to product safety or legality, such as compliance with label claims/declarations (e. g. nutritional claims, alcohol content) and tests for contamination (e. g. by pesticides, aflatoxins).\nNote that while the laboratory itself may have accreditation, the actual test methods must also be accredited. Any method of analysis that is not accredited needs justification as to why it was used (e. g. it may be a method for which no accreditation is yet available). Where critical tests are carried out by non-accredited laboratories (either contracted or on-site laboratories), there must be suitable documentary assurances that the laboratory is working to the requirements and principles of ISO/IEC 17025. This must include confirmation of the laboratory’s procedures to meet the following general principles:\n• staff competency and documented training\n• documented test methodology based on accepted standards\n• equipment that is fit for purpose and appropriately calibrated\n• a documented quality assurance programme, including paired testing, ring testing etc.\n• completion of internal audits of the laboratory’s operation.", "requirement_fr": "Lorsque l'entreprise effectue ou sous-traite des analyses essentielles pour la sécurité sanitaire ou la légalité des produits, le laboratoire ou les sous-traitants doivent posséder une accréditation de laboratoire reconnue ou travailler conformément aux exigences et aux principes de la norme ISO/CEI 17025. Une justification documentée doit être disponible lorsque des méthodes non accréditées sont employées."}, {"id": "9.4.5", "requirement": "Test and inspection results shall be retained and reviewed to identify trends.", "interpretation": "Systems of recording and review must be formalised and must include evidence of actions taken on identified trends, or where unsatisfactory results have been recorded. The use of graphs or charts of test results provides a good method of identifying trends and anomalous results.\nIt is important that the employees completing the review understand the results and their significance such that appropriate actions can be taken; for example, if a result is outside specification, or exceeds a legal or safety limit.\n9. 5 Product legality The company shall have processes in place to ensure that the food products traded comply with the legal requirements in the country of sale where known.\nThe company needs to maintain awareness of, and ensure compliance with, relevant legal requirements for its products in the countries where the products are sold. These may be associated with composition, labelling or how the products are sold.", "requirement_fr": "Les résultats des tests et des contrôles doivent être consignés et révisés pour identifier des tendances. Des actions adaptées doivent être mises en place rapidement face à un résultat ou à une tendance non satisfaisants.\n9.5 Légalité des produits L'entreprise doit disposer de processus permettant de garantir que les produits alimentaires commercialisés respectent les exigences légales du pays de vente (lorsqu’il est connu)."}, {"id": "9.5.1", "requirement": "The company shall have documented processes to verify the legality of products which are traded. • labelling information. • compliance with relevant legal compositional requirements. • compliance with quantity or volume requirements", "interpretation": "Products traded must meet all the legal requirements for the intended country of use. The site must therefore have processes to ensure it remains up to date with requirements such as labelling in that country and that these requirements are met and fulfilled.\nAt a minimum the Standard requires labelling, composition, and quantity or volume requirements as applicable, depending on the product to be considered.\nWhere labelling is not controlled by the company but is the responsibility of the customer, this shall be clearly stated in contracts. Good practice is to ensure that all the relevant information is transferred to the customer and that any changes are communicated in a timely manner.\n9. 6 Traceability The company shall be able to trace all product lots back to the last manufacturer and forward to the customer of the company.\nIn keeping with the traceability requirements for manufactured and processed products, sites that trade food products are required to maintain traceability, allowing food businesses and authorities to withdraw or recall products that have been identified as unsafe. The system must ensure that products supplied to customers are adequately labelled or identified to facilitate traceability. Traceability details need to be retained in a format that allows access in a timely manner.", "requirement_fr": "L'entreprise doit posséder des processus documentés pour vérifier la légalité des produits qui sont commercialisés. Ces processus doivent inclure :\n•\t les informations figurant sur l’étiquette\n•\t la conformité aux exigences légales applicables en matière de composition\n•\t la conformité aux exigences en matière de quantité et de volume.\nLorsque ces responsabilités sont assumées par le client, cela doit être clairement stipulé dans les contrats.\n9.6 Traçabilité L’entreprise doit être en mesure de tracer tous les lots de produits, du dernier fabricant jusqu’au client de l’entreprise."}, {"id": "9.6.1", "requirement": "The site’s traceability procedure shall include details of the system used for the traceability of traded products.", "interpretation": "The site’s traceability procedure must include details of the system used for the traceability of traded products, to ensure legal requirements are maintained and that the site can identify implicated batches of traded product in the event of a product recall or withdrawal.\nProducts may be identified by physical labelling or through the use of computerised bar- coding systems. The level of traceability must be able to identify the supplier of the product and to whom it is supplied (i. e. one step forwards and one step back). This will enable the product to be identified if a particular batch needs to be recalled.\nConsider how the traceability system operates in practice (with the effective physical identification of products). For example, if batches or lots of product are broken down into smaller consignments for individual customers, is all of the necessary information available to the customer (i. e. was there any additional information on the original outer packaging that the customer would need to ensure traceability?), and can the site confidently identify all of these individual customers?\nStrict controls on identification, traceability and segregation are also required to preserve the integrity of any claims made, such as organic status. Where logos are used that make specific claims about production systems (e. g. farm assurance), full traceability and validations must be demonstrated (see also section 5. 4).", "requirement_fr": "La procédure de traçabilité du site (voir clause 3.9.1) doit inclure des informations détaillées concernant le système utilisé pour tracer les produits commercialisés.\nLe système de traçabilité doit assurer que, pour tous les lots de produits, le site peut identifier le dernier fabricant ou, dans le cas de produits agricoles primaires, le conditionneur ou lieu de la dernière modification importante du produit.\nDes enregistrements doivent également être conservés, afin d’identifier le destinataire de chaque lot de produits envoyés par l’entreprise."}, {"id": "9.6.2", "requirement": "The company shall test the traceability system at least annually to ensure that traceability can be determined back to the last manufacturer and forward to the recipient of the product.", "interpretation": "The site’s traceability system for traded products must be tested at least annually.\nTraceability testing may be completed as part of a real product recall or withdrawal scenario if one has occurred, since the objective is to test the system and identify areas for improvement, rather than supply records of a ‘test’ for its own sake.\nThe system must provide traceability ‘forwards’ and ‘backwards’; therefore it should be tested in both directions. For example, a product could be selected and traced forwards to show to whom it was dispatched.\nFurther information on the content of the BRCGS audit, including the vertical audit, can be obtained in the BRCGS guide to auditing techniques, available from BRCGS Participate.", "requirement_fr": "Le site doit tester le système de traçabilité au moins une fois par an, afin de garantir que la traçabilité puisse être déterminée, du dernier fabricant jusqu’au destinataire du produit envoyé par l’entreprise. Ce système doit identifier la circulation des produits à travers la chaîne d’approvisionnement, du fabricant à la réception des produits par l’entreprise (c-à-d. chaque mouvement et lieu de stockage intermédiaire)."}, {"id": "9.6.3", "requirement": "The traceability test shall include the reconciliation of quantities of product received by the company for the chosen batch or product lot. Traceability should be achievable within 4 hours.", "interpretation": "The test of traceability should be timed, and full traceability would be expected to be achieved within 4 hours, unless information is required from external parties, such as suppliers. This is to reflect the need for rapid traceability in the event of a recall. Where traceability takes longer than 4 hours, the site should review the areas where the retrieval of information is slow, in order to identify improvements.\nThe tests must also include a reconciliation of quantities (sometimes referred to as a quantity check or mass balance exercise). The objective is to be able to account for the usage of a full batch of product. This helps to ensure that the traceability systems are capable of operating effectively should a product recall be required.\nThe reconciliation exercise is usually undertaken as follows:\n• Select a batch code of a particular specific product.\n• Identify the quantity of product received under that batch code.\n• Identify the customers purchasing that product and the amounts each received of the specific batch.\n• Calculate the quantity of any unused part of the batch in the warehouse.\n• Reconcile the quantity received against the amounts sold plus any residual unused stock.\n1 Glossary 2 Sources of further information Appendix Glossary Accreditation The procedure by which an authoritative body gives formal recognition of the competence of a certification body to provide certification services against a specified standard.\nAdulterant An undeclared material added into a food item or raw material for economic gain.\nAdulteration The addition of an undeclared material into a food item or raw material for economic gain.\nAgent A company that facilitates trade between a site or company and their raw material or packaging suppliers or their customers through the provision of services, but does not at any point own or take title to the goods.\nAllergen A known component of food which causes physiological reactions due to an immunological response (e. g. nuts and others identified in legislation relevant to the country of production or sale).\nAllergen cross-contact Allergen cross-contact occurs when an allergenic food, or ingredient, is unintentionally incorporated into another food that is not intended to contain that allergenic substance.\nAmbient high care An ambient area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise potential product contamination by pathogenic micro-organisms.\nAnimal primary conversion Sites that complete the slaughter and/or evisceration of animals (including red meat, poultry and game) or the slaughter and/or gutting of fish. (Applicable sites will therefore fall within BRCGS product categories 1, 2 and 4.) Announced audit An audit where the company agrees the scheduled audit day in advance with the certification body.\nAnnual/annually Within 12 months since the action was last conducted.\nAssured status Products produced in accordance with a recognised product certification scheme, the status of which needs to be preserved through the certified production facility (e. g. GLOBALG. A.P.).\nATP bioluminescence techniques A rapid test for cleanliness of surfaces based on ATP (adenosine triphosphate) – a substance used in energy transfer in cells and therefore present in biological material.\nAudit A systematic examination to measure compliance of practices with a predetermined system, and whether the system is implemented effectively and is suitable to achieve objectives, carried out by certified bodies.\nAuditor A person possessing the appropriate competence and skills to carry out an audit.\nAuthenticity/authentic product Food authenticity is ensuring that food or raw materials purchased and offered for sale, are of the nature, substance and quality expected.\nBatch The quantity of material prepared or required for one production operation.\nBlended audit An audit that is completed in two parts:\n• a remote audit of documents and records using ICT\n• an on-site audit concentrating on production, storage, good manufacturing practices and other on-site activities.\nBrand owner The owner of a brand logo or name who places the said logo or name onto retail products.\nBranded product Products bearing the logo, copyright or address of a company that is not a retailer.\nBroker A company which purchases or ‘takes title to’ products for resale to businesses (e. g. manufacturers, retailers or food service companies) but not to the ultimate consumer.\nBusiness continuity A framework that enables an organisation to plan and respond to incidents of business interruption in order to continue business operations at an acceptable predetermined level.\nCalendar days Calendar days are consecutive days, inclusive of Saturdays and Sundays.\nCalibration A set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or reference material, and the corresponding values realised by standards.\nCertificate suspension Revocation of certification for a given period, pending remedial action on the part of the company.\nCertificate withdrawal Where certification is revoked. Certification may only be regained following successful completion of the full audit process.\nCertification The procedure by which an accredited certification body, based on an audit and assessment of a company’s competence, provides written assurance that a company conforms to a standard’s requirements.\nCertification body Provider of certification services, accredited to do so by an authoritative body and registered with BRCGS.\nCertification extension Where a site is operational, but an on-site audit has been prevented by Covid- restrictions, a site may apply to its certification body for the validity of the current certificate to be extended by a maximum of 6 months.\nA certificate extension can only be granted due to Covid-19 restrictions.\nFull details can be found in BRCGS072, Certification Extension for Audits Impacted by Covid-19, available on the BRCGS website.\nCheckweigher A checkweigher is a piece of automated equipment for checking that the weight of products is correct and within the relevant limits (e. g. meets legislative and customer limits).\nClause A specific requirement or statement of intent that a site must comply with in order to achieve certification.\nCleaning Cleaning is the process of achieving and maintaining an area to a standard deemed visually free from debris that can include dirt, food, faeces, blood, saliva and other bodily secretions. In other words, it is the removal of soil, food residues, dirt, grease and other objectionable matter.\nCleaning in place (CIP) The process of cleaning and sanitising food-processing equipment in its assembled position without the need for dismantling and cleaning the individual parts.\nCodex Alimentarius Commission A body responsible for establishing internationally recognised standards, codes of practice and guidelines, of which HACCP (hazard analysis and critical control points) is one standard.\nCompany The entity with legal ownership of the site which is being audited against a Global Standard.\nCompetence Demonstrable ability to apply skill, knowledge and understanding of a task or subject to achieve intended results.\nCompliance Meeting the regulatory or customer requirements concerning product safety, legality and quality.\nConsultant A company, organisation or individual that is subcontracted by the site to provide technical services relating to the product safety and quality management systems (for example, the development, implementation or maintenance of the product safety management system; the development or implementation of the HACCP plan; and the production of manuals or procedures).\nConsumer The end-user of the finished product, commodity or service.\nContamination Introduction or occurrence of an unwanted organism, taint or substance to packaging, food, raw material or the food environment. Contamination includes physical, chemical, radiological, biological and allergen contamination.\nContract packer A company that packages the final product into consumer packaging.\nContractor or supplier A person or organisation providing services or materials.\nControl To manage the conditions of an operation to maintain compliance with established criteria, and/or the state wherein correct procedures are being followed and criteria are being met.\nControl measure Any action or activity that can be used to prevent or eliminate a product safety hazard or reduce it to an acceptable level.\nControlled document A document which is identifiable and for which revisions and removal from use can be tracked. The document is issued to specified individuals and their receipt of the document is recorded.\nCook ‘Cook’ is a thermal process which is designed to achieve typically a 6 log reduction in Listeria monocytogenes, equivalent to 70ºC for 2 minutes. Alternative cooking processes may be accepted or required where these meet recognised national guidelines and are validated by scientific data.\nNote that other processes achieving a 6 log reduction (e. g. irradiation, high-pressure processes) should be considered in the same way as conventional ‘cook’ processes when assessing product safety requirements.\nCorrective action (correction) Action to eliminate a detected non-conformity or non-conforming product.\nCritical control point (CCP) A step at which control can be applied and is essential to prevent or eliminate a food or product safety hazard or reduce it to an acceptable level.\nCross-contamination (cross-contact) The transfer of any material from one surface or food to another.\nThe terms ‘cross-contact’ and ‘cross-contamination’ are used interchangeably in guidance about allergen management. See allergen cross-contact.\nCross-docking Material is unloaded at distribution premises, and handled, but not formally put away into storage. This may be a staging area where inbound materials are sorted, consolidated and temporarily stored until the outbound shipment is complete and ready to ship.\nCustomer A business or person to whom a service or product has been provided, either as a finished product or as a component part of the finished product.\nCustomer focus A structured approach to determining and addressing the needs of an organisation to which the company supplies products and which may be measured by the use of performance indicators.\nDespatch/dispatch The point at which the product leaves the factory site or is no longer the responsibility of the company.\nDisinfection Disinfection is the process or act of destroying pathogenic micro-organisms; it removes most organisms present on surfaces.\nDistribution The transportation of goods within any container (goods on the move) by road, rail, air or ship.\nEnclosed product area An area of the factory where all products are fully enclosed and therefore not vulnerable to environmental contamination.\nEnd-consumer The ultimate consumer of a foodstuff, who will not use the food as part of any food business operation or activity.\nFlow diagram A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.\nFood defence Procedures adopted to ensure the safety of raw materials and products from malicious contamination or theft.\nFood fraud Fraudulent and intentional substitution, dilution or addition to a product or raw material, or misrepresentation of the product or material, for the purpose of financial gain, by increasing the apparent value of the product or reducing the cost of its production.\nFood handler Anyone who handles or prepares food, whether open (unwrapped) or packaged.\nFood integrity Products that are of the nature, substance and quality expected (e. g. not substituted, diluted, adulterated or misrepresented).\nFood raw materials Food ingredients, additives and processing aids used in the manufacture of a product.\nFood safety Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.\nFood safety and quality culture The attitudes, values and/or beliefs which are prevalent at the site, relating to the importance of product safety and the confidence in the product safety systems, processes and procedures used by the site.\nFood safety plan Often referred to as a HACCP plan. The food safety plan is a set of documents prepared in accordance with the Codex Alimentarius HACCP principles to ensure the control of food-borne hazards.\nThe specific terminology used in the Standard, such as ‘prerequisites’ and ‘critical control points’ (CCPs), is intended to reflect the global terminology used to describe expectations. Sites are not required to use the specific terminology in the Standard;\nalternatives are acceptable providing it is evident that all the requirements have been fully met.\nFood security Procedures adopted to ensure the availability of raw materials and products.\nFundamental requirement A requirement of the Standard that relates to a system which must be well established, continuously maintained and monitored by the company as absence or poor adherence to the system will have serious repercussions on the integrity or safety of the product supplied.\nGenetically modified organism (GMO) An organism whose genetic material has been altered by the techniques of genetic modification so that its DNA contains genes not normally found there.\nGlobal Food Safety Initiative (GFSI) Managed by the Consumer Goods Forum, a project to harmonise and benchmark international food safety standards (www. mygfsi. com).\nGood hygiene practice The combination of process, personnel and/or service control procedures intended to ensure that products and/or services consistently achieve appropriate levels of hygiene.\nGood manufacturing practice (GMP) Implemented procedures and practices undertaken using best-practice principles.\nHazard An agent of any type with the potential to cause harm (usually biological, chemical, physical or radiological).\nHazard Analysis and Critical Control Point (HACCP) A system that identifies, evaluates and controls hazards which are significant for food safety.\nHigh-care area A zone (or area) designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise product contamination by pathogenic micro-organisms.\nHigh-care product A product that requires chilling or freezing during storage, is vulnerable to the growth of pathogens, has received a process to reduce the microbiological contamination to safe levels (typically 1–2 log reduction) and is ready to eat or heat.\nHigh-risk area A physically segregated zone (or area), designed to a high standard of hygiene, where practices relating to personnel, ingredients, equipment, packaging and environment aim to prevent product contamination by pathogenic micro-organisms.\nHigh-risk product A chilled or frozen ready-to-eat/ready-to-heat product or food where there is a high risk of growth of pathogenic micro-organisms.\nIdentity preserved A product which has a defined origin or purity characteristic which needs to be retained throughout the food chain (e. g. through traceability and protection from contamination).\nImporter A company facilitating the movement of products across an international border.\nUsually the first recipient of the products in that country.\nIncident An event that has occurred that may result in the production or supply of unsafe, fraudulent, illegal or non-conforming products.\nInitial audit The audit for certification to a BRCGS standard at a company or site that is not in possession of a valid certificate. This may be the first audit at a site or a subsequent audit of a site whose certification has lapsed.\nInspection Targeted verification (often a visual check against a ‘tick list’ for fabrication, environment and equipment) to ensure operation to safe expected levels.\nIntegrity See food integrity.\nInternal audit General process of audit, for all the activity of the company. Conducted by or on behalf of the company for internal purposes.\nJob description A list of the responsibilities for a given position at a company.\nKey staff Those staff whose activities affect the safety, legality, authenticity and quality of the finished product.\nLabel Any tag, mark, picture or other descriptive matter, whether it is written, printed or otherwise marked, on or attached to the packaging of the product.\nWhere a product is unlabelled, specifications or information to meet legal requirements and to assist customers in the safe usage of the product shall be maintained, and are included in the definition of a label.\nLabelling Any words, picture or symbol relating to the food and placed on any packaging or label accompanying the product.\nLegality In compliance with the law in the place of production and in the countries where the product(s) is/are intended to be sold.\nLot See batch.\nLow-risk area An area where the processing or handling of foods presents minimum risk of product contamination or growth of micro-organisms, or where the subsequent processing or preparation of the product by the consumer will ensure product safety.\nMalicious contamination Deliberate contamination of a product or raw material with the intention to cause harm to the consumer or damage to the company or brand owner.\nManufacturer A company that produces product from raw materials and/or components and packs the product or supplies product in bulk. A packer that packs product into retail units from bulk-supplied material can also be classed as a manufacturer.\nMay Indicates a requirement or text which provides guidance but is not mandatory for compliance with the Standard.\nMeasurement uncertainty (sometimes referred to as uncertainty of measurement) A parameter that is associated with the result of a quantitative measurement. It characterises the range of values that could reasonably be expected for the attribute being measured (e. g. the micro-organism, allergen or chemical). It is sometimes referred to as the margin of doubt for the result.\nMeasurement uncertainty is important when making conformity decisions (i. e. assessing whether a test result is within legal, safe or acceptable limits) as the uncertainty or range of probable values may cross the limit.\nA full explanation of measurement uncertainty is given in the Global Standard Food Safety for clause 5. 6.2.\nMitigation strategies Controls to remove, or reduce to an acceptable level, an identified risk, vulnerability or threat. It is often used in food defence where controls are needed to prevent potential threats from occurring.\nMonitoring A planned sequence of observations or measurements of defined control parameters to assess whether predefined limits are being met.\nNon-conformity The non-fulfilment of a specified product safety, legal or quality requirement or a specified system requirement.\nOnline verification equipment Automated equipment (e. g. bar code scanners) that are used to check the accuracy or quality of product labels and printing.\nOpen product area An area in which product is open to the environment (i. e. not fully enclosed in packaging or within equipment/pipes).\nOuter packaging Packaging which is visible when the product is released from the site. For example, a cardboard box could be considered outer packaging even if wrapped in clear film.\nOutsourced processing (subcontracted processing) Outsourced processing (also referred to as subcontracted processing) is when intermediate production, processing, storage or a step in the manufacture of a product is completed at another company or site.\nOutsourced processing is an intermediate step; therefore during outsourced processing, the product or partly processed product leaves the site being audited for the completion of the outsourced processing before returning to the site. The audited site may or may not complete the additional packing or processing steps of the product.\nWhere raw materials receive additional storage or processing prior to their arrival on site, this is not considered to be outsourced processing, but should be managed by the site using supplier approval mechanisms, raw material risk assessments and raw material specifications.\nWhen a product leaves the site and does not return, this is not outsourced processing;\nthe activities completed off site are outside the scope of the audit.\nOwnership (change of company ownership) A change of ownership occurs when the title is transferred from one individual or entity to another and results in a change of control of the organisation.\nPerformance indicators Summaries of quantified data that provide information on the level of compliance against agreed targets (e. g. customer complaints, product incidents, laboratory data).\nPlant-based product A product that does not intentionally contain materials of animal origin, and has not intentionally used ingredients (including additives, carriers, flavourings and enzymes), processing aids or any other substances that are of animal origin, at any stage during production and processing.\nPosition statement Where clarification of the interpretation of a requirement of a BRCGS Standard or its protocol is necessary, this will be published on the BRCGS website as a position statement. Such statements are binding on the way that the audit and certification process are carried out and are considered to be an extension of the Standard. They are applicable from the date specified for implementation (or the date of publication on the BRCGS website, where no date is specified).\nPositive release Ensuring a product or material is of an acceptable standard prior to release for use.\nPotable water Water that is safe to drink, free from pollutants and harmful organisms, and conforms to local legal requirements.\nPremises A physical building or place owned by the company and audited as part of a site.\nPre-packaged products Products in their final packaging that is designed for sale to the consumer.\nPrepared primary product A food product which has undergone a washing, trimming, size-grading or quality- grading process and is pre-packed.\nPrerequisite The basic environmental and operational conditions in a food business that are necessary for the production of safe food. These control generic hazards covering good manufacturing and hygiene practices, and form a foundation for the food safety or HACCP plan. Prerequisites shall be considered as part of that plan.\nPreventive action Action to eliminate the fundamental underlying cause (root cause) of a detected non- conformity and prevent recurrence.\nPrimary packaging The packaging that constitutes the unit of sale to the consumer or customer (e. g. bottle, closure, label and tamper-evident seal of a retail pack or a raw material bulk container).\nWhen identifying primary packaging, due consideration must be given to the processes that minimise or eliminate any risk which may result in contamination of a food product;\nfor example:\n• using suitable food contact materials\n• consideration of anything that is applied onto the surface of a permeable food contact material (e. g. potential for migration of ink components through cardboard is a well- documented risk that has affected a range of packaging).\nAs a general rule, the Standard would not expect transit materials to be classified as primary packaging (e. g. pallets, pallet wrap, shrink wrap, pallet sheets, labels or cable ties applied on the outside of the pallet wrap, recyclable and re-usable travel containers, and plastic crates used to hold glass bottles).\nProcedure Agreed method of carrying out an activity or process which is implemented and documented in the form of detailed instructions or process description (e. g. a flowchart).\nProcessed food A food product which has undergone any of the following processes: aseptic filling, baking, battering, blending, bottling, breading, brewing, canning, coating, cooking, curing, cutting, dicing, distillation, drying, extrusion, fermentation, freeze drying, freezing, frying, hot filling, irradiation, microfiltration, microwaving, milling, mixing, being packed in modified atmosphere, being packed in vacuum packing, packing, pasteurisation, pickling, roasting, slicing, smoking, steaming or sterilisation.\nProcessing aid Any substance not consumed as a food by itself, intentionally used in the processing of raw materials, foods or their ingredients to fulfil a certain technological purpose during treatment or processing, and which may result in the unintentional but technically unavoidable presence of the residues of the substance or its derivatives in the final product – provided that these residues do not present any health risk and do not have any technological effect on the finished product.\nProduct recall Any measures aimed at achieving the removal of an unfit (e. g. unsafe) product from customers and final consumers.\nProduct security For the purposes of the Global Standard Food Safety, product security refers to measures to prevent theft or malicious damage to products.\nProduct withdrawal Any measures aimed at achieving the removal of out-of-specification or unfit (e. g. unsafe) products from customers, but not from final consumers.\nA withdrawal is normally used to remove product where there is no risk to consumers;\nfor example, where the product has not reached the point of sale to consumers.\nProduction risk zones Zones or areas within the processing and storage facilities that require specified levels of hygiene and segregation to reduce the potential for product contamination with pathogenic micro-organisms. The Standard recognises five production risk zones:\n• high risk\n• high care\n• ambient high care\n• low risk\n• enclosed product areas.\nSites will also have a range of non-product areas which are separate from the processing and storage areas. Full details of the risk zones appropriate to the Standard are located in Appendix 2 of the Standard.\nProtective clothing Clothing and protective equipment (for example, overalls, hairnets, hats and beard snoods) designed to protect the product from potential contamination by the wearer.\nProvenance The origin or the source of food or raw materials.\nQuality Meeting the customer’s specification and expectation.\nQuantity check/mass balance A reconciliation of the amount of incoming raw material against the amount used in the resulting finished products, which also takes into account process waste and rework.\nQuantity control A check on the amount of product in the pack. May be related to weight, volume, number of pieces, size etc.\nQuarantine The status given to any material or product set aside while awaiting confirmation of its suitability for its intended use or sale.\nRaw material Any base material or semi-finished material used by the organisation for the manufacture of a product. Raw materials include food ingredients, packaging materials, additives, processing aids etc.\nReady-to-cook food Food designed by the manufacturer to require cooking or other processing to effectively eliminate, or reduce to an acceptable level, micro-organisms of concern.\nReady-to-eat food Food intended by the manufacturer for direct human consumption without the need for a full cook.\nReady-to-heat food Food designed by the manufacturer to be suitable for direct human consumption without the need for cooking. The heating of the product is intended to make the product more palatable.\nRecognised laboratory accreditation Laboratory accreditation schemes that have gained national and international acceptance, have been awarded by a competent body, and are recognised by government bodies or users of the Standard (e. g. ISO/IEC 17025 or equivalents).\nReference sample Agreed product or components for referral by the manufacturer for production.\nRequirement Those statements comprising a clause with which compliance will allow sites to be certificated.\nRetail brand A trademark, logo, copyright or address of a retailer.\nRetailer A business selling products to the public by retail.\nRetailer-branded products Products bearing a retailer’s logo, copyright, address or ingredients used to manufacture within a retailer’s premises. These are products that are legally regarded as the responsibility of the retailer.\nRetained production sample Representative product or components taken from a production run and securely held for future reference.\nRisk The likelihood of occurrence of harm from a hazard.\nRisk analysis A process consisting of three components: risk assessment, risk management and risk communication.\nRisk assessment The identification, evaluation and estimation of the levels of risk involved in a process to determine an appropriate control process.\nRoot cause(s) The underlying cause(s) of a problem, which, if adequately addressed, will prevent a recurrence of that problem.\nSampling plan A documented plan defining the number of samples to be selected, the acceptance or rejection criteria and the statistical confidence of the result.\nSanitisation Sanitisation means to adequately treat cleaned surfaces by a process that is effective in destroying the vegetative cells of pathogens, and in substantially reducing the numbers of other undesirable micro-organisms, but without adversely affecting the product or its safety for the consumer.\nSatellite depot A warehouse/distribution site receiving products only from another site within the same company.\nSchedule A tabulated statement giving details of actions and/or timings.\nSeasonal production site A site that is opened for a short duration (typically 12 weeks or less) during a 12-month cycle; for example, to specifically harvest and process a product.\nDetails of the additional considerations for the management of the audit and certification process for seasonal production sites are given in II, section 2. 7.8.\nSecondary packaging Packaging that is used to collate and transport sales units to the retail environment or customer (e. g. corrugated case).\nSenior management Person or group of people who direct and control an organisation at the highest level.\nNote that top (senior) management has the power to delegate authority and provide resources within the organisation.\nShall Signifies a requirement to comply with the contents of the clause.\nShould Signifies that compliance with the contents of the clause or requirement is expected or desired.\nSite A unit of a company; the entity which is audited and which is the subject of the audit report and certificate.\nSpecification An explicit or detailed description of a material, product or service.\nSpecifier A company or person requesting the product or service.\nStandard, the The Global Standard Food Safety (Issue 9).\nSupplier The person, firm, company or other entity to which a site’s purchase order to supply is addressed.\nSuspension Where certification is revoked for a given period, pending remedial action on the part of the company.\nThreat assessment A risk assessment designed to examine site processes for potential product security and food defence issues.\nTraceability Ability to trace and follow raw materials, components and products, through all stages of receipt, production, processing and distribution both forwards and backwards.\nTraded goods/products Traded products are defined as food products that would normally fall within the scope of the Standard and are stored at the site’s facilities, but are not manufactured, processed, reworked, packed or labelled at the site being audited.\nTrend An identified pattern of results.\nUnannounced audit An audit undertaken on a date unknown to the company in advance.\nUncertainty See measurement uncertainty.\nUser The person or organisation who requests information from the company regarding certification.\nUtilities Commodities or services, such as electricity or water, that are provided by a public body.\nValidation Obtaining evidence through the provision of objective evidence that a control or measure, if properly implemented, is capable of delivering the specified outcome.\nVehicle Any device used for the conveyance of product that is capable of being moved upon highways, waterways or airways. Vehicles can be motorised (e. g. a lorry) or non-motorised (e. g. container or rail truck).\nVerification The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control or measure is or has been operating as intended.\nVulnerability assessment A risk assessment designed to examine processes and supply chains for potential food fraud.\nWhere appropriate In relation to a requirement of the Standard, the company will assess the need for the requirement and, where applicable, put in place systems, processes, procedures or equipment to meet the requirement. The company shall be mindful of legal requirements, best-practice standards, good manufacturing practice and industry guidance, and any other information relating to the manufacture of safe and legal product.\nWork in progress/work in process Partially manufactured products, intermediates or materials waiting for completion of the manufacturing process.\nWorking day A day on which work is usually or routinely done at the site.\nWorkwear See protective clothing.\nAppendix Sources of further information BRCGS Standards A series of globally recognised certification standards for manufacturers, storage and distribution, agents and brokers, and retail companies. Available from the BRCGS website.\nBRCGS guidelines BRCGS publishes a series of best-practice guidelines on topics including complaint-handling, pest control, internal auditing, product recall, traceability and foreign-body detection. These may be purchased from the BRCGS Store or viewed online at BRCGS Participate.\nBRCGS Performance Enhancement BRCGS Performance Enhancement provides businesses and individuals with BRCGS training and personal development programmes.\nCodex Alimentarius The Codex Alimentarius Commission was created in 1963 by the FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme.\nThe downloadable materials include:\n• General Principles of Food Hygiene (CXC 1-1969 as revised), which contains detailed information on HACCP steps and principles\n• Guidelines for the Validation of Food Safety Control Measures (CXG 69-2008).\nCodex standards, guidelines and codes of practice can be downloaded from the ‘Codex Texts’ page on the FAO website.\nFood and Drug Administration (FDA) The Bad Bug Book provides examples of microbiological sources.\nRASFF The Rapid Alert System for Food and Feed (RASFF), established in 1979, enables the rapid exchange of information whenever a risk to food or feed safety is identified. Members comprise 27 member states, the European Commission, the European Food Safety Authority, Iceland, Liechtenstein, Norway and Switzerland. The 2020 Annual Report is available for download from the Europa website.\nNote: Links and references are made to websites which are intended to help the user with further information.\nBRCGS cannot, however, be responsible for the content or existence of any external website. Also note that legislation and standards change frequently, and a user should confirm for themselves that any references are current and still applicable.\nBRCGS Floor 7 Harp Lane London EC3R 6DP T: +44 (0)20 3931 E: enquiries@ To learn more about the BRCGS certification programme please visit To learn more about the BRCGS online publication service for certificated sites, please visit brcgsparticipate. com To purchase printed copies or PDFs from the full range of BRCGS publications please visit /store Food Safety", "requirement_fr": "Le test de traçabilité doit comparer les quantités de produits reçues par l’entreprise pour le lot de produits choisi. Une traçabilité devrait pouvoir être effectuée dans un délai de 4 heures (1 journée lorsque des informations doivent être obtenues auprès de sources extérieures)."}], "statement_of_intent": "The site shall operate a HACCP or food safety plan for the processes for which it is responsible.", "group_intros_fr": {"9.5": "L'entreprise doit disposer de processus permettant de garantir que les produits alimentaires commercialisés respectent les exigences légales du pays de vente (lorsqu’il est connu).", "9.1": "Le site doit disposer d’un plan HACCP, ou plan de sécurité des denrées alimentaires, pour les processus dont il a la charge.", "9.3": "Des spécifications ou des informations destinées à répondre aux exigences légales et à aider le client à utiliser le produit sans danger doivent être conservées et mises à la disposition des clients.", "9.2": "L’entreprise doit appliquer des procédures d'approbation du dernier fabricant ou conditionneur des produits alimentaires commercialisés, afin de garantir que ces derniers sont sûrs, légaux et fabriqués conformément à toute spécification de produit définie.", "9.6": "L’entreprise doit être en mesure de tracer tous les lots de produits, du dernier fabricant jusqu’au client de l’entreprise.", "9.4": "Le site doit mettre en place des processus permettant de garantir que les produits reçus sont bien conformes aux spécifications d'achat et que le produit fourni correspond bien aux spécifications du client."}, "group_intros": {"9.3": "Specifications or information to meet legal requirements and assist customers in the safe usage of the product shall be maintained and available to customers.", "9.2": "The company shall operate procedures for approval of the last manufacturer or packer of food products which are traded to ensure that traded food products are safe, legal and manufactured in accordance with any defined product specifications.", "9.6": "The company shall be able to trace all product lots back to the last manufacturer and forward to the customer of the company.", "9.1": "The site shall operate a HACCP or food safety plan for the processes for which it is responsible.", "9.4": "The site shall operate processes to ensure that the products received comply with buying specifications and that the supplied product is in accordance with any customer specification.", "9.5": "The company shall have processes in place to ensure that the food products traded comply with the legal requirements in the country of sale where known."}}];