Title Page
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Site conducted
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Conducted on
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Prepared by
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Location
1. Senior management commitment
1.1 Senior management commitment and continual improvement
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1.1.1 The company’s senior management shall develop and document a quality policy statement which states the company’s intentions for the safe and legal storage and/or distribution of products and its responsibility to its customers. This statement shall be:<br>• authorised<br>• reviewed<br>• signed and dated by an appropriate senior manager<br>• effectively communicated throughout the company.
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1.1.2 The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a product safety and quality culture. This shall include: defined activities involving all sections of the site that have an impact on product safety. As a minimum, these activities shall be designed around:<br>• communication<br>• training<br>• feedback from employees<br>• performance measurement on product safety related activities
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1.1.2 The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a product safety and quality culture. This shall include an action plan indicating how the activities will be undertaken and measured, and the intended timescales.
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1.1.2 The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a product safety and quality culture. This shall include a review of the effectiveness of completed activities.
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1.1.3 The company’s senior management shall provide the human and financial resources required to implement the requirements of this Standard and effect improvements identified through management review processes.
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1.1.4 The company’s senior management shall ensure that objectives are established for the storage and/or distribution of products to maintain product safety, quality and legality in accordance with the company’s quality policy and this Standard. The objectives shall be:<br>• documented and include targets or clear measures of success<br>• clearly communicated to relevant staff and each operating location<br>• monitored, and the results reported at least quarterly to the company’s and site’s senior management.
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1.1.5 Employees shall be aware of the need to report any evidence of product safety, legality, quality or integrity issues to a designated manager to enable the resolution of those issues requiring immediate action. This shall include suggestions for improvement.
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1.1.6 The company shall have a confidential reporting system to enable staff to report concerns relating to product safety, legality, quality and integrity.<br>The mechanism for reporting concerns must be clearly communicated to staff.<br>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.
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1.1.7 The company shall have a current, original hard copy or electronic version of the Standard available and be aware of any changes to the Standard or protocol that are published on the BRCGS website.
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1.1.8 The most senior operations manager on site shall attend the opening and closing meetings of the audit for the Standard. Relevant departmental managers or their deputies shall be available as required during the audit. Where central management systems are operated for multi-site operations, a manager with responsibility for the management system shall be available during audits of hub and satellite operations.
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1.1.9 Where required by legislation, the company and operating locations shall be registered with (or approved by) the appropriate authority, and evidence of this shall be available.
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1.1.10 Where the site is certificated to the Standard, it shall ensure that announced recertification audits occur on or before the audit due date indicated on the certificate.
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1.1.11 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.
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1.1.12 The BRCGS logo and references to certification status shall be used only in accordance with the conditions of use detailed in the audit protocol (Part III, section 6.6).
1.2 Management review
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1.2.1 Management review meetings attended by the company’s or site’s senior management shall be undertaken at appropriate scheduled intervals, as a minimum annually, to review the site’s performance against the Standard and the objectives set out in clause 1.1.4.
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1.2.2 The review process shall include, but is not limited to, the evaluation of:<br>• previous management review documents, action plans and timeframes<br>• the results of internal audits, including any prerequisite programmes<br>• the results of second- and third-party audits<br>• any customer performance indicators and feedback<br>• the underlying reasons for any objectives that have not been met. This information shall be used when setting future objectives and to facilitate continual improvement<br>• feedback from a review of the effectiveness of the HARA or HACCP system, product safety and quality culture plan, product fraud vulnerability or authenticity plan, product defence plan and site security risk assessments, where applicable<br>• any complaints, incidents, product rejection/returns, wastage and resultant corrective and preventive action plans, and non-conforming materials<br>• any resource requirements<br>• the impact of any applicable legislative and certification scheme changes.
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1.2.3 The meeting shall be documented and used to revise the objectives. The decisions and actions agreed within the review process shall be effectively communicated to appropriate staff, and actions implemented within agreed timescales. Records shall be updated to show when actions have been completed.
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1.2.4 The site shall have a demonstrable operational meeting programme that enables product safety, legality, quality and integrity issues to be brought to the attention of senior management. These meetings shall occur at least monthly.
1.3 Organisational structure, responsibility and management authority
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1.3.1 The company shall have an up-to-date organisational chart demonstrating the management structure of the company.<br>This shall, where appropriate, include the responsibilities for any associated hub or satellite depots and any responsibilities carried out by a head office.
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1.3.2 The senior management of the company shall ensure that all employees are aware of their responsibilities and that mechanisms are in place to monitor the effectiveness of their operation.
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1.3.3 The senior management of the company shall ensure that levels of responsibility and accountability are clearly defined for key staff involved with product safety, legality and quality systems. To this end, job descriptions shall be available. There shall be appropriate documented arrangements in place to cover for the absence of key staff.
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1.3.4 The senior management of the company shall have a system in place to ensure that it is kept informed of all relevant legislation, product safety issues, scientific and technical developments, and industry codes of practice. There shall be a system in place to ensure that relevant information is passed to the management at other locations, where appropriate.
2. Hazard and Risk Analysis
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2.1 Prerequisite programmes<br>Prior to conducting a hazard analysis, the company shall ensure that any prerequisites are in place. The control measures and monitoring procedures for the prerequisite programmes must be clearly documented and included within the development and reviews of the HARA or HACCP plan. Where applicable, product safety prerequisites or handling requirements shall include, but not be limited to:<br>• the condition and maintenance of buildings, equipment and transport vehicles as appropriate<br>• documented practices for the safe handling, storage and transport of products<br>• procedures for handling damages, waste product and returns<br>• procedures related to the allergen management plan<br>• pest management procedures<br>• the approval of services or subcontractors<br>• sanitation procedures (cleaning and disinfection)<br>• maintenance of the cold chain (not applicable to ambient stable products) and controlled environment (e.g. humidity, modified air)<br>• personal hygiene standards (limited applicability to pre-packed food products or consumer products)<br>• training<br>• any other activities covered by the additional voluntary modules.
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2.2 Multi-disciplinary team<br>The HARA or HACCP plan shall be developed and managed by a multi-disciplinary team, including operators and managers who are experienced in the particular activities undertaken by the site. The team members shall have knowledge of the HARA or Codex-based HACCP principles and have relevant knowledge of the product, processes and associated hazards.
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2.3 Team leader<br>The person responsible for leading the HARA or HACCP team on site shall be able to demonstrate competence, experience and/or training in the understanding of HARA or Codex-based HACCP principles and their application. Where there is a legal requirement for specific training, this shall be in place. In the event of the company not having appropriate in-house knowledge, external expertise may be sought but the day-to-day management of the system shall remain the responsibility of the company and a nominated site deputy team leader shall be identified.
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2.4 Team members shall ensure that the HARA or HACCP study is based on comprehensive information sources, which are referenced and available on request. As a guide, these may include the following, although this is not an exhaustive list:<br>• historical, known and foreseeable product safety hazards associated with specific processes and products<br>• known likely product defects that affect safety, legality, quality and integrity<br>• relevant codes of practice or recognised guidelines (where applicable)<br>• customer requirements<br>• legislative requirements.
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2.5 Where the HARA or HACCP study has been undertaken centrally, the site shall be able to demonstrate that the study has been verified to meet the specific activities of the local operation to which the study applies, including any additional voluntary modules.
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2.6 The HARA or HACCP plan and resulting procedures shall have senior management commitment, and shall be implemented through the site’s documented management systems.
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2.7 Scope<br>The scope of the HARA or HACCP plan shall be clearly defined and documented, and shall cover all products/product categories and processes included within the intended scope of certification. Consideration must also be given to the activities that are bespoke to the additional voluntary modules.<br>The scope shall include:<br>• a description of the types of products stored or distributed, subcontracted activities, and any particular specified storage or handling conditions (e.g. temperature control, fragility, maximum stacking height, propensity to water damage, conditions of light)<br>• the product flow from receipt, storage and dispatch, including transport to the recipient of the product, as applicable. The flow shall detail any intermediate storage steps which may be used in the distribution, and any back-haul or returns activities.
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2.8 Product flow<br>A flow diagram shall be prepared to cover all products or product categories and process steps on site. This shall set out all aspects of the operation within the scope of the HARA or HACCP plan as identified in clause 2.7. As a guide, this shall include the following (although this is not an exhaustive list):<br>• plan of premises and equipment layout (including yard)<br>• products handled, including introduction of utilities (e.g. water)<br>• sequence and interaction of all process steps<br>• services and subcontracted activities<br>• any potential for process delay<br>• returns and waste, including recycled materials<br>• activities covered by the additional voluntary modules.
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2.8 The HARA or HACCP team shall verify the accuracy of the flow diagrams at least annually and following any significant incidences (product withdrawals and recalls, etc.) or process changes. Records of verified flow diagrams shall be maintained.
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2.9 Hazard analysis and risk assessment<br>The HARA or HACCP team shall identify and record all potential hazards associated with each step of the product flow as identified in clause 2.8. The company shall include consideration of the following types of hazard:<br>• microbiological growth resulting from temperature abuse of products that require temperature control<br>• physical contamination (e.g. glass contamination from broken lights, wood splinters from pallets, dust, splashing during transfer, pests)<br>• chemical contamination (e.g. product tainting, spillage, cleaning chemicals)<br>• physical damage (e.g. breakage, puncturing of packaging, water damage)<br>• allergenic risks (e.g. cross-contamination of loose product or outer packaging by allergenic products)<br>• malicious contamination of products<br>• hazards mandated by the customer or relevant regulatory authorities<br>• hazards associated with activities covered by the additional voluntary module.
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2.10 The HARA or HACCP team shall complete a documented analysis of the potential hazards in order to identify those which need to be controlled. The following shall be considered:<br>• the likely occurrence of the hazard, as established by previous company/industry experience<br>• the severity of the hazard (e.g. injurious to health, potential to cause food-poisoning, rejection or a product recall)<br>• existing prerequisite programmes that effectively prevent or reduce the hazard to acceptable limits.
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2.11 Critical control points<br>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 the use of a decision tree. Critical control points are defined as those control points which are critical to prevent, eliminate or reduce a significant hazard to acceptable limits.
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2.12 Critical control points – additional requirements<br>If critical control points (CCPs) have been identified where product safety and legality require control measures to be in place (e.g. storage temperature), then for each CCP it is necessary to establish:<br>• critical limits<br>• a system to monitor control of the CCP<br>• the corrective action to be taken when monitoring indicates that a particular CCP is not under control<br>• procedures of validation and verification to confirm that the system is working effectively, including auditing of the system<br>• documentation concerning all procedures and records appropriate to these principles and their application.
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2.13 Control by prerequisites and documentation<br>Where the control of hazards is by means of prerequisite programmes, these shall be fully implemented and be demonstrably effective in controlling or reducing the hazard.
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2.14 Review<br>The HARA or HACCP plan and prerequisite programmes shall be reviewed whenever new product types that have different characteristics from the products included within the original study are stored or transported, or where new operations/process steps (including additional voluntary modules) are introduced that may affect product safety. This review shall be documented by the HARA or HACCP team at least annually.
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2.15 HARA or HACCP plans of service providers or subcontractors<br>Where controls identified by HARA or HACCP plans are operated by service providers or subcontractors, either their plans and controls shall be reviewed by a competent person to determine their effectiveness, or the plans and controls must be within the scope of an accredited certification of the service provider or subcontractor.<br>Contracts must ensure that any significant changes to the HARA or HACCP plans are communicated to the company before the changes are implemented. Any changes shall be reviewed by a competent person to determine the ongoing effectiveness of the plan before the changes are implemented by the service provider or subcontractor. Records shall be maintained to demonstrate the results of these reviews.
3. Product safety and quality management system
3.1 General documentation requirements
3.1.1 Product Safety and quality systems
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3.1.1.1 The site’s documented policies, procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual which is readily accessible.<br>Where the site is part of a company governed by a head office, the interaction between the site’s system and that of other sites and the head office shall be documented. All policies and procedures necessary for the operation of the site must be readily available to relevant staff at the site.
3.1.2 Documentation control
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3.1.2.1 The company shall have a procedure to manage documents which form part of the product safety and quality management system. This shall include a list of all controlled documents indicating the latest version number, and the method for the identification and authorisation of controlled documents.<br>Where documents are stored in electronic form, these shall be stored securely (e.g. with authorised access, control of amendments, or password-protected) and backed up to prevent loss.
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3.1.2.2 Documents shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by appropriate personnel. They shall be readily accessible to relevant staff at all times.
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3.1.2.3 There shall be a record of the reason for any changes or amendments to documents critical to product safety, legality or quality systems and procedures.
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3.1.2.4 Changes to documents shall be effectively notified to document users. A procedure shall be in place to ensure obsolete documentation is rescinded and, if appropriate, replaced with a revised version.
3.1.3 Record completion and maintenance
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3.1.3.1 The records shall be legible and genuine, and retained in good condition for an appropriate defined time period. The record retention time period shall reflect product shelf life and any specific customer or legal requirements, but shall never be less than 1 year.
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3.1.3.2 The company shall operate procedures for the alteration, collation, maintenance, storage and retrieval of all relevant records. Justification for alterations shall be recorded.<br>Where records are in electronic form, these shall be:<br>• suitably backed up to prevent loss<br>• stored securely (e.g. with authorised access, control of amendments, or password-protected).
3.2 Internal audits
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3.2.1 There shall be a scheduled programme of internal audits.<br>As a minimum, the programme shall include at least two 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. All activities and locations included within the scope of certification shall be covered at least once each year.<br>As a minimum, the scope of the internal audit programme shall include the:<br>• HARA or HACCP plan<br>• prerequisite programmes<br>• procedures implemented to achieve the Standard and any additional voluntary modules.
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3.2.2 Internal audits shall be carried out by appropriately trained, competent auditors, who shall not audit their own work or those areas where they have direct influence on the operation being audited.
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3.2.3 Records of internal audits shall be maintained to ensure that conformity, as well as non-conformity, can be clearly identified, and include objective evidence of the findings.
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3.2.4 Results of the internal audit and positive and negative comments shall be brought to the attention of the personnel responsible for the activity audited. Corrective actions and timescales for their implementation shall be agreed. Root cause analysis shall be used to determine preventive actions where appropriate, and their completion verified.
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3.2.5 In addition to the internal audit programme, there shall be a separate programme of documented inspections to ensure that the site environment and equipment are maintained in a suitable condition. The frequency of these inspections shall be based on risk, but no less than once every 3 months. As a minimum, these inspections shall include:<br>• hygiene inspections to assess cleaning and housekeeping performance<br>• inspections to identify risks to the product from the building or equipment.
3.3 Corrective and preventive action
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3.3.1 An appropriate staff member shall be identified and allocated the responsibility and accountability for each corrective action. This shall be documented.
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3.3.2 The company shall ensure that effective actions are taken to correct each non-conformity and shall monitor and record their completion within an appropriate timescale.<br>Where a non-conformity places the safety, legality or quality of products at risk, this shall be investigated and recorded including:<br>• clear documentation of the non-conformity<br>• assessment of the consequences by a suitably competent and authorised person<br>• the action to be taken to address the immediate issue<br>• an appropriate timescale for correction<br>• the person responsible for correction<br>• verification that the correction has been implemented and is effective.
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3.3.3 The site shall have a procedure for the completion of corrective actions and root cause analysis to determine preventive actions (where appropriate). As a minimum, root cause analysis shall be used to implement ongoing improvements and to prevent recurrence of non-conformities in the event of:<br>• an analysis of non-conformities for trends which shows that there has been a significant increase in a type of non-conformity<br>• a non-conformity which places the safety, legality, quality or integrity of a product at risk (including withdrawals and recalls).
3.4 Customer contractual arrangements
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3.4.1 Customer requirements for the storage and/or distribution of their product shall have been agreed with the customer and documented prior to fulfilment. This shall include any specific handling requirements for the products, e.g. temperature, humidity, light conditions, stack height or compatibility requirements. This may be in the form of a company-issued service specification where no customer-issued specification exists.
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3.4.2 The company shall have the ability to meet defined customer requirements without compromising product safety, legality and quality.
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3.4.3 Where specified by the customer, a review of customer needs and requirements shall be undertaken. Any changes to existing agreements or contracts shall be agreed, documented and communicated to appropriate personnel.
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3.4.4 There shall be key performance indicators established relating to customer requirements, performance shall be measured, and results communicated to relevant staff.
3.5 Purchasing
3.5.1 Supplier approval and performance monitoring of service providers and equipment suppliers
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3.5.1.1 There shall be a documented procedure for the approval and monitoring of suppliers of services and equipment. Such services, as appropriate, shall include (but not be limited to):<br>• pest control<br>• laundry services<br>• contracted cleaning (both storage and vehicles)<br>• contracted servicing and maintenance of equipment<br>• equipment providers (e.g., of racking, pallets)<br>• use of consultants.<br>The approval and monitoring process shall be risk-based and take into consideration compliance with any specific legal requirements or potential risks to the security of products (i.e. risks identified in the product fraud vulnerability and defence assessments).
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3.5.1.2 Specifications or contracts shall exist between the company and the supplier to define the service provided and ensure that potential product safety risks associated with the service have been addressed. They shall include key data to meet customer and legal requirements and assist the site in the safe handling of the product. Where specifications are not formally agreed, the company shall be able to demonstrate that it has taken steps to put a formal agreement in place.
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3.5.1.3 Specification or contract review shall be sufficiently frequent to ensure that data is current or as a minimum every 3 years, taking into account product changes, suppliers, regulations and other risks. Reviews and changes shall be documented.
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3.5.1.4 The performance of the supplier shall be monitored, and action taken where services fail to meet requirements.
3.5.2 Management of subcontractors
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3.5.2.1 A contract or written agreement shall exist with all subcontractors, which shall, on the basis of risk and any specified customer contracts, define requirements for the safe handling, storage and transport of products (e.g. temperature range, special handling requirements, product security, segregation of incompatible products, vehicle type).
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3.5.2.2 There shall be a documented process for the review and acceptance of a subcontractor who could potentially impact product safety, legality, quality and integrity.<br>The approval and monitoring procedure shall be based on risk and include either one or a combination of:<br>• a valid certification to the applicable BRCGS or GFSI-benchmarked standard. The scope of the certification shall include the products/product categories or process steps being subcontracted or<br>• an audit, with a scope to include product safety, traceability, HARA or HACCP review and good product-handling practices, undertaken by an experienced and demonstrably competent product safety auditor. Where the subcontractor audit is completed by a second or third party, the company shall be able to:<br>• demonstrate the competency of the auditor<br>• confirm that the scope of the audit includes product safety, traceability, HARA or HACCP review, and good product-handling practices<br>• obtain and review a copy of the full audit report or where a valid risk-based justification is provided and the subcontractor is assessed as low risk only, a completed questionnaire may be used for approval. The questionnaire shall have a scope that includes product safety, traceability, HARA or HACCP review, and good product-handling practices, and it shall have been reviewed at least once every 3 years and verified by a demonstrably competent person.
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3.5.2.3 There shall be a documented risk-based process for the ongoing review of subcontractor performance, with defined performance criteria. The process shall be fully implemented, reviewed annually, and records of the review shall be kept.
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3.5.2.4 A register of suitable approved subcontractors shall be maintained, which shall include subcontractors required irregularly (e.g. to meet peak seasonal demand, breakdown cover). The list or relevant components of the register shall be readily available to the appropriate staff.
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3.5.2.5 There shall be a documented procedure to define how exceptions to the subcontractor approval process in clause 3.5.2.2 are handled (e.g. where subcontractors are prescribed by a customer or where information for effective approval is not available).<br>Where a site handles customer-branded product, the customer shall be made aware of any relevant exceptions.
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3.5.2.6 Where a site subcontracts the distribution of products, the requirements of section 5 shall be included within the subcontracted arrangements for each distribution company. There shall be a documented procedure for the site to verify that the activities critical to product safety have been implemented correctly by the subcontractor, or the subcontracted company shall be certificated to the Standard or similar GFSI-recognised scheme.
3.5.3 Product fraud risk management
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3.5.3.1 The company shall develop a documented fraud vulnerability assessment plan to establish levels of confidence in the customers for whom the company stores and/or distributes products to reduce the risk of handling fraudulent products; the plan shall be fully implemented. The plan may consider:<br>• historical trading relationships<br>• the nature of the products with regard to the risk of fraud<br>• the need for a new customer approval process (e.g. trading history, financial security, customer profile).
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3.5.3.2 Where a high risk of fraudulent product handling is identified, the fraud vulnerability assessment plan shall include appropriate processes to mitigate the identified risks.
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3.5.3.3 The fraud vulnerability assessment plan shall be kept under review to reflect any changing circumstances that may alter the potential risks. It shall be formally reviewed annually.
3.6 Traceability
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3.6.1 The site shall have adequate procedures to ensure products and/or pallets are labelled and/or coded to allow product identification and traceability at all times.<br>As a minimum, these shall include:<br>• a description of how the traceability system works, including a summary of the documents and records that capture product identification and traceability information, and the link between them<br>• the documents that should be referenced during a traceability test<br>• a procedure for ensuring that records are maintained.
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3.6.2 Inventory records for vehicles shall enable products to be tracked from loading to delivery, including the tracking of trailers/vehicles.
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3.6.3 Procedures shall ensure traceability of damaged packs and of products returned to stock or disposal.
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3.6.4 The system shall be tested at a predetermined frequency, at least annually, to ensure that traceability can be determined, including consignor details, through the warehouse/store and/or distribution to the final consignee and vice versa, including any quantity check and mass balance exercises. The test shall include subcontracted storage and/or distribution where appropriate. The results shall be retained for inspection. Full traceability should be achievable in 4 hours.
3.7 Management of product withdrawal and product recall
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3.7.1 The company shall have a documented product withdrawal and recall procedure. This shall include, as a minimum:<br>• identification of key personnel who constitute the withdrawal and recall management team, with clearly identified responsibilities<br>• guidelines for deciding whether a product needs to be withdrawn and/or recalled and which records need to be maintained<br>• an up-to-date list of key contacts (including out-of-hours contact details) or reference to the location of such a list (e.g. withdrawal and recall management team, suppliers, customers, certification body, regulatory authority)<br>• a communication plan, including the provision of information to customers, consumers and regulatory authorities in a timely manner, as appropriate<br>• a plan to handle the logistics of product traceability, recovery or disposal of affected product, and stock reconciliation<br>• a plan to record timings of key activities<br>• a plan to conduct root cause analysis and implement ongoing improvements to avoid recurrence.
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3.7.2 The company shall ensure that systems are in place to formally notify the owner/manufacturer of products where evidence of a product quality or safety issue becomes apparent during the storage or distribution of their product, and to agree what action should be taken. Documented evidence of the formal notification and agreed actions must be retained.
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3.7.3 The procedures relating to product withdrawal and product recall shall be appropriate, formalised and capable of being operated at any time, and will take into account all stages of stock requisition including disposal (see section 3.9). The procedures shall be regularly reviewed and, if necessary, revised to ensure that they are current.
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3.7.4 The product recall and withdrawal procedures shall be tested at least annually to ensure their effective operation. All records supporting the recall data and results of the test shall be retained.
3.8 Incident management and business continuity
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3.8.1 The company shall provide written guidance to relevant staff regarding the type of event that would constitute an incident, and a documented incident-reporting procedure shall be in place.
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3.8.2 Procedures shall exist to ensure that product put at risk by an incident is held pending further investigation.
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3.8.3 The owner of the product shall be informed when an incident occurs that may put the safety or quality of their product at risk.
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3.8.4 The company shall develop contingency planning for business continuity in the event of major incidents such as:<br>• disruption to key services (e.g. water, energy, staff availability)<br>• events such as flood, fire and natural disaster<br>• malicious contamination or sabotage<br>• failure of, or attacks against, digital cyber-security.
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3.8.5 The procedures shall include, as a minimum:<br>• identification of key staff constituting the incident management team and their responsibilities<br>• an up-to-date list of key contacts (including out-of-hours contact details) or reference to the location of such a list (e.g. deputies, emergency services, suppliers, customers, certification body, regulatory authority)<br>• alternative arrangements to fulfil customer expectations<br>• a communication plan, including the provision of information in a timely manner to customers, consumers and, where appropriate, regulatory authorities.
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3.8.6 In the event of a significant product safety incident or regulatory product safety non-conformity (e.g. a regulatory enforcement notice), the certification body issuing the current certificate for the site against the Standard shall be informed within 3 working days.
3.9 Control of non-conforming product, damages and returns
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3.9.1 There shall be procedures for managing non-conforming products. These procedures shall include:<br>• the requirement for staff to identify and report a potentially non-conforming product<br>• clear identification of a non-conforming product (e.g. direct labelling or the use of IT systems)<br>• secure storage to prevent accidental release (e.g. physical or computer-based isolation)<br>• defined responsibilities for decision-making on the use or disposal of products appropriate to the issue (e.g. destruction or acceptance by concession, with permission from the owner of the products).
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3.9.2 Where products are held pending further investigation, they shall be held in such a way as to minimise any further deterioration or prevent contamination of other products.
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3.9.3 All non-conforming products shall be handled or disposed of according to the nature of the problem and/or the specific requirements of the owner. Records shall be maintained.
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3.9.4 The site shall have a defined policy for customer returns and rejections.
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3.9.5 Where returns are accepted, procedures shall define, on the basis of risk, the disposition of returned stock (i.e. disposal, return to good stock or collection by the product owner). Records shall be retained.
3.10 Complaints handling
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3.10.1 All complaints shall be recorded, adequately assessed and investigated where required. The results of any investigations shall be documented where sufficient information is available. Actions appropriate to the seriousness and frequency of the problems identified shall be carried out promptly and effectively, and records shall be retained.
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3.10.2 Complaint data shall be analysed to identify significant trends. Where there has been an increase or repetition of a complaint type, root cause analysis shall be used to implement ongoing improvements to activities affecting product safety, legality, quality and integrity to avoid recurrence. The trend analysis shall be made available to relevant staff.
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3.10.3 A system shall be in place to notify the product manufacturer, supplier or owner of the complaint about their products where the cause of the complaint does not relate to the activities of the site.
4. Site and building standards
4.1 Location, perimeter and grounds
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4.1.1 Consideration shall be given to local activities and the environment which may have a potentially adverse impact on products, and measures shall be taken to prevent product contamination. Where measures have been put into place to protect the site from any potential contaminants, these shall be regularly reviewed to ensure they continue to be effective.
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4.1.2 All grounds within the site shall be finished and maintained to an appropriate standard. Where grass and other planted areas are located near buildings, they shall be regularly tended and maintained.
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4.1.3 The building fabric shall be maintained to minimise the potential for pest entry (e.g. sealing gaps around pipes). A clean and unobstructed area shall be in place along external walls of buildings used for the storage of products.
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4.1.4 Sites shall be adequately drained. Where natural drainage is inadequate, additional drainage shall be installed.
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4.1.5 Where undertaken, external storage shall be minimised, and items protected from contamination and deterioration.
4.2 Site security and product defence
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4.2.1 A site-specific documented risk assessment (threat assessment) shall be undertaken to identify any potential risks to the security of products held on the premises in storage or on vehicles, and appropriate controls shall be implemented. The threat assessment shall include both internal and external threats, and shall be reviewed at an appropriate frequency or, as a minimum, annually. It shall also be reviewed whenever:<br>• a new risk emerges (e.g. a new threat is publicised or identified)<br>• an incident occurs, where product security or product defence is implicated.
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4.2.2 Access to the site by employees, contractors and visitors shall be controlled and a visitor reporting system shall be in place.
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4.2.3 The company shall have documented site security procedures. Staff shall be trained in the site security procedures and encouraged to question or report unidentified or unknown visitors.
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4.2.4 Contractors and visitors, including drivers, shall be made aware of all procedures for access to premises and the requirements of the areas they are visiting, with special reference to hazards and potential product contamination. Contractors working in product storage areas shall be the responsibility of a nominated person.
4.3 Layout, product flow and segregation – product intake, handling, storage and dispatch areas
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4.3.1 There shall be a current map or plan of the whole site (including internal and external storage areas, and yard) which defines:<br>• access points for personnel<br>• travel routes for personnel and product<br>• staff facilities<br>• routes for the removal of waste<br>• process flows<br>• storage areas (ambient, chilled and frozen areas)<br>• chemical-handling areas (e.g. battery storage areas).
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4.3.2 Premises shall allow sufficient working space to enable all operations to be carried out properly under safe hygienic conditions and prevent the risk of product damage.
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4.3.3 Adequate segregated storage facilities shall be available to enable incompatible products to be effectively segregated, where required, to minimise the risk of taint or cross-contamination.
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4.3.4 The positioning of machinery, equipment, site facilities and services, where provided, shall not jeopardise the integrity of the product, and shall prevent product contamination and damage.
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4.3.5 Suitable and sufficient extraction methods shall be provided in areas where fumes may build up (e.g. battery-charging areas). These areas shall also be segregated from product storage areas.
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4.3.6 Appropriate storage facilities shall be provided for the control and storage of cleaning and maintenance chemicals, and sited so they shall not compromise the safety, legality, quality and integrity of the product.
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4.3.7 Cleaning facilities (e.g. for tray-washing) shall, where appropriate, be adequately segregated from product handling and storage.
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4.3.8 Where products are susceptible to weather damage, vehicles shall be loaded and unloaded in covered bays so as to protect the product, or other effective measures shall be put in place.
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4.3.9 Temporary structures constructed during building work or refurbishment shall be designed and located to avoid pest harbourage, and ensure the safety and integrity of products.
4.4 Fabrication – product intake, handling, storage and dispatch areas
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4.4.1 Walls, floors, ceilings and pipe work shall be maintained in good condition and shall be capable of being kept clean.
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4.4.2 Floors shall be designed to meet the demands of the operation and, where appropriate, withstand cleaning materials and methods. They shall be impervious and maintained in good repair.
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4.4.3 Where there is a need for drainage, it shall be designed and maintained to minimise risk of product damage or contamination, and not compromise product safety, quality, legality or integrity.
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4.4.4 All water supplies used for cleaning or in connection with any operation in the storage of products (including hand-washing) shall be potable at the point of use or pose no risk of contamination according to applicable legislation. The water shall be either drawn from mains supply or suitably treated according to its source.
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4.4.5 Building voids shall be accessible for inspection and, where appropriate, cleaning.
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4.4.6 Adequate lighting shall be provided for all work areas. Suitable and sufficient lighting shall be provided so as to permit effective inspection of product and effective cleaning.
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4.4.7 All bulbs and strip lights that are vulnerable to breakage, including those on electric fly killer units, shall be protected by shatterproof plastic diffusers, sleeve covers or a shatterproof protective coating. Where full protection cannot be provided, the glass-management system shall take this into account.
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4.4.8 Where there is a risk of contamination from glass window breakage, glass windows shall be protected against breakage or the product shall be adequately protected.
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4.4.9 Buildings shall be suitably proofed against the entry of all pests. This shall include, as appropriate:<br>• the screening of windows that are designed to be open for ventilation<br>• the provision of external doors that are close-fitting or adequately proofed<br>• where external doors to storage areas are kept open due to the design of the building or operational requirements, the site shall adopt suitable precautions to prevent pest ingress when these doors are in use (and be closed when not in use)<br>• the fitting of screens and traps to drains to prevent pest entry<br>• the protection of canopies from bird roosting and nesting.
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4.4.10 The condition of the building fabric shall be monitored through documented audits. Repairs and improvements identified shall be scheduled.
4.5 Staff facilities
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4.5.1 All toilets shall be provided with hand-washing facilities comprising:<br>• basins with soap and water at a suitable temperature<br>• adequate hand-drying facilities<br>• hand-wash signs.
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4.5.2 Suitable and sufficient hand-cleaning facilities based on risk shall be provided and easily accessible to staff and, where applicable, vehicle drivers. Hand-washing shall be performed at an appropriate frequency to minimise the risk of product contamination.
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4.5.3 Facilities shall be provided for the safe storage of personal items so that such items are not taken into storage areas.
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4.5.4 The position of catering facilities, including vending machines where provided, shall not jeopardise the safety, legality and quality of the product.
5. Vehicle operating standards
5.1 Vehicle standards
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5.1.1 The load-carrying area shall be free from loose items, damaged panels or projections which could present a risk of damage to products.
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5.1.2 The load-carrying area shall be maintained in a suitable condition to prevent the ingress of rain or dampness during transport where the product is vulnerable to weather damage.
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5.1.3 The load-carrying area shall be maintained in a condition which facilitates ease of cleaning.
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5.1.4 The load-carrying area shall be inspected prior to loading to ensure it is fit for purpose. This shall ensure that (as a minimum):<br>• it is in a clean condition<br>• the walls, ceiling and floor are in a good condition, with no exposed insulation<br>• the door seal is intact<br>• there is no evidence of pests or pest activity<br>• the drain holes (if present) are clean and designed to prevent pest entry<br>• the polar/strip curtains (if present) are clean and intact<br>• the internal lights (if present) are intact<br>• it is free from strong odours which may cause taint to products<br>• it is free from excess humidity which may cause growth of moulds.<br>Records of inspections shall be retained.
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5.1.5 Load supports, lashing points, load lock strips and fastenings shall be maintained in <br>good condition and adequate in number to allow loads to be stabilised effectively <br>during transport. Fastenings for curtain-sided vehicles shall be in good condition and<br>secure.
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5.1.6 Rear door shutters and tail lifts (where fitted) shall be in good working order.
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5.1.7 Where vehicles are equipped with transfer hoses and pumps for the loading or <br>unloading of tankers, these shall be in good condition, with the hoses capped and <br>securely contained during transport. Any associated product filters shall be maintained <br>in good condition.
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5.1.8 Where bulk tankers are used for transporting food or other vulnerable products, the<br>company shall ensure compliance with relevant safety, legislative and scheme-specific<br>requirements. Records of the vehicle load history and cleaning interventions shall be <br>maintained and available to customers as required.
5.2 Vehicle and load security
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5.2.1 A documented risk assessment (threat assessment) shall be undertaken to identify any potential risks (both internal and external) to the security of the load during transportation, when using drop-offs, or accepting returns on the same vehicle. Appropriate controls shall be implemented to reduce the risks.<br>The threat assessment shall be reviewed at an appropriate frequency or, as a minimum, annually. It shall also be reviewed whenever:<br>• a new risk emerges (e.g. a new threat is publicised or identified)<br>• an incident occurs, where product security or product defence is implicated.
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5.2.2 Access to all vehicles shall be restricted to authorised personnel.
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5.2.3 Procedures for maintaining the security of the vehicle shall be documented and understood by drivers and delivery staff.
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5.2.4 The company shall have procedures for the transport of products, which shall include (where appropriate):<br>• the types of products that will be handled, including returns<br>• exceptions, including any restrictions on mixed loads and waste handling<br>• segregation controls to avoid cross-contamination, mixing of sorts, or taint.<br>This information shall be available and understood by the driver.
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5.2.5 Where vehicle load areas are fully enclosed, doors shall be locked when vehicles have been loaded. Where seals are used, these shall be checked for integrity before unloading.
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5.2.6 Where locks or seals are not fitted to vehicles, alternative security arrangements shall be employed, in accordance with risk, together with inspection procedures. The system shall be sufficient to ensure that if access to the load-carrying area of the vehicle has occurred, this would be evident, and action taken to ensure the safety of the products.
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5.2.7 Procedures shall be in place for mitigating any potential risk to product safety if there is evidence of an incident (either before or at the point of loading/unloading). These shall include details of:<br>• appropriate controls to ensure the correct reporting of incidents both internally and externally (to the customer and relevant authorities)<br>• how to manage any contamination risk to products.
5.3 Vehicle management
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5.3.1 Procedures shall be in place to ensure that road vehicles are maintained in a roadworthy condition to reduce the risk of vehicle breakdown and consequent failure to meet customer requirements.
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5.3.2 Where legally required, vehicle operators shall be registered with the appropriate authority.
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5.3.3 Procedures shall be in place in the case of vehicle breakdown, accident or incident. The procedures shall ensure that product safety, legality and quality are maintained and shall include:<br>• clear instructions and emergency contact numbers for the drivers<br>• instructions on how to preserve any specific temperature or other environmental controls appropriate to the load<br>checks required to be made and recorded on the load before continuing the journey.
5.4 Vehicle temperature controls
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5.4.1 The company shall have a system of validation and ongoing verification in place for the vehicle and equipment employed (within the vehicles) to demonstrate that they are capable of consistently maintaining specified product temperature requirements in all weather conditions, including the warmest and coolest months. The company shall take into consideration:<br>• the effect of maximum and minimum loads<br>• the risks during loading and unloading operations, including those at delivery points.
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5.4.2 Automatic temperature and time-recording equipment shall be used to monitor and record the temperature of the load-carrying area to ensure that the product temperature remains within specification throughout the journey. Where a real-time temperature monitoring system is used, temperature records shall be readily accessible.<br>In the absence of such equipment, manual checks shall be carried out and recorded at an appropriate frequency that allows for intervention before product temperatures exceed the defined limits for the safety, legality, quality or integrity of products. Records of inspections shall be maintained.
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5.4.3 Where settings can be adjusted, measures shall be in place to verify the temperature settings of vehicles prior to loading and dispatch. Vehicles transporting chilled and frozen products shall be at a suitable temperature before loading, or the required air temperature shall be achieved within a defined time of loading that is commensurate with maintaining the specified product temperature. These adjustments shall be completed and verified by trained staff.
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5.4.4 Loading and unloading operations shall be undertaken in such a way as to maintain product temperature within the specified limits.
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5.4.5 A system shall be in place to enable the driver to be made aware if the temperature of the load-holding area varies from the specified limits.
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5.4.6 In the case of equipment failure, procedures shall be in place to establish the safety and quality status of the product and to determine the actions to be taken prior to release to the customer.
6. Facility management
6.1 Equipment
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6.1.1 Roll cages, pallet lifts and forklift trucks shall be maintained in a good working condition to prevent damage to product.
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6.1.2 If racking is present, it shall be adequately maintained, constructed and periodically inspected for damage. The frequency of inspections shall be determined by a nominated person based on risk assessment. Records shall be maintained.
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6.1.3 All diesel-powered handling equipment, where used, shall incorporate an appropriate exhaust filter system for the removal of particulates that can pose a contamination risk to product.
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6.1.4 Where physical automation systems (including vertical lifts, retrieval systems, conveyor systems, robotics, etc.) are used for product-handling activities, a documented risk assessment shall be completed to identify potential risks to product safety, legality, quality and integrity (including from spillage and damage), while maintaining traceability at all times. The risk assessment shall form the basis for defining a procedure for the acceptance, operation, maintenance, calibration, testing and validation of the system, as appropriate.
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6.1.5 Where appropriate, procedures shall be in place to monitor the condition of wooden pallets and plastic trays to prevent the risk of contamination or damage to products.
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6.1.6 Knives or other tools provided shall be used in such a way as to prevent damage to products. Snap-off blade knives shall not be used.
6.2 Maintenance
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6.2.1 A documented planned maintenance schedule or condition monitoring system shall be in place which includes all plant and equipment. The maintenance requirements shall be defined when commissioning new equipment.
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6.2.2 The site shall ensure that the safety, legality or quality of a product is not jeopardised during maintenance operations.
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6.2.3 All third-party contractors and engineers shall be aware of and adhere to the site’s operating standards. Where appropriate, this shall include the site’s hygiene standards and contamination control policies.
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6.2.4 Cleaning or replacing light fittings and glass shall be done in a manner so as to minimise the potential for product contamination.
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6.2.5 Records shall be kept of vehicle and equipment maintenance.
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6.2.6 Temporary repairs/modifications shall only be permitted in emergencies and where product contamination is not at risk. Such modifications shall be subject to a time limit and shall be recorded and scheduled for permanent repair.
6.3 Calibration and control of measuring and monitoring devices
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6.3.1 The site shall identify and control measuring equipment used to monitor CCPs and product safety, legality and quality. This shall include, as a minimum:<br>• a documented list of equipment and its location<br>• an identification code and calibration due date<br>• prevention from adjustment by unauthorised staff<br>• protection from damage, deterioration or misuse.
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6.3.2 The company shall check measuring and monitoring devices at a predetermined frequency based on risk assessment and, where necessary, adjust the devices to ensure accuracy within agreed parameters. Where adjustment is not possible, inaccurate equipment shall be replaced.
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6.3.3 Equipment shall be readable and of a suitable accuracy for the measurements it is required to perform. Equipment specified to measure CCPs or product safety, legality and quality shall be traceable to a recognised national standard.
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6.3.4 Reference measuring equipment shall be calibrated and traceable to a recognised national or international standard and records maintained. When equipment is used to assess critical limits, any uncertainty in calibration must be considered.
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6.3.5 Procedures shall be in place to record the actions to be taken when the prescribed measuring devices are found not to be operating within specified limits. Where the safety or legality of products is based on equipment that is found to be inaccurate, action shall be taken to ensure that at-risk product is not offered for sale, and the owner/manufacturer of the product shall be notified to agree actions (where appropriate).
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6.3.6 Procedures shall be in place to calibrate, verify or, where necessary, adjust self-calibrating devices (including robotics sensors) to ensure accuracy within agreed parameters at a predetermined frequency (as identified in clause 6.1.4). Where adjustment is not possible, inaccurate equipment shall be replaced.
6.4 Housekeeping and hygiene
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6.4.1 The premises and equipment shall be maintained in a clean and hygienic condition.
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6.4.2 Documented cleaning schedules shall be in place and implemented for the building, vehicles, plant and all equipment. The frequency and depth of cleaning shall be based on risk. Cleaning procedures shall include, where applicable:<br>• responsibility for cleaning<br>• the item/area to be cleaned<br>• frequency of cleaning<br>• method of cleaning<br>• cleaning chemicals and concentrations<br>• cleaning materials to be used<br>• cleaning records and responsibility for verification.
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6.4.3 Cleaning practices shall be completed so as to maintain a suitable environment for the storage and distribution of products. Practices shall minimise risk of contamination to the product. 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.
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6.4.4 Where clean in place (CIP) systems are in use for cleaning tankers, these shall be designed and operated to ensure effective cleaning, commensurate with the products transported. To ensure effective operation, the following shall be in place:<br>• validation, confirming the correct design and operation of the system<br>• an up-to-date schematic diagram of the system layout<br>• where rinse solutions are recovered and re-used, an assessment of the risk of cross-contamination (e.g. due to the re-introduction of allergen).<br>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.<br>The system shall be revalidated at a frequency based on risk and following any alteration or addition.
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6.4.5 Adequate staff, facilities and equipment shall be provided to allow cleaning to be undertaken at a level commensurate with the activities being undertaken by the site.
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6.4.6 Records shall be maintained of the cleaning undertaken. These shall include any cleaning of vehicles carried out by subcontractors (e.g. tanker cleaning) and, where required by customers, cleaning certificates.
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6.4.7 Where appropriate, the effectiveness of the cleaning and sanitation procedures shall be verified and recorded.
6.5 Waste and waste disposal
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6.5.1 Systems shall be in place to minimise the accumulation of waste in handling and storage areas. Bins shall be emptied at appropriate frequencies and maintained in an adequately clean condition.
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6.5.2 External waste collection containers and compactors shall be managed in such a manner as to contain products and not attract pests. Containers holding food products or packaging shall be covered or closed.
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6.5.3 Products that require specific conditions for disposal shall be separated and disposed of using licensed contractors and in compliance with any legal requirements. Records of removal shall be maintained and available.
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6.5.4 In the event that substandard trademarked materials are transferred to a third party for destruction or disposal, that third party shall be in the business of secure product or waste disposal and shall provide records of material destruction or disposal.
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6.5.5 Surplus customer-branded products shall be disposed of in accordance with customer-specific requirements and records maintained. Customer brand names shall be removed from packed surplus products before the product enters the supply chain, unless otherwise authorised by the customer.
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6.5.6 Where customer-branded products which do not meet specification are sold to staff or passed on to charities or other organisations, this shall be with the prior consent of the brand owner. Processes shall be in place to ensure that all products are fit for consumption and meet legal requirements. Records shall be maintained.
6.6 Pest management
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6.6.1 Employees shall understand the signs of pest activity and be aware of the need to report any evidence of pest activity to a designated manager.
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6.6.2 All products shall be stored so as to minimise the risk of infestation. Where stored-product pests are considered a risk, appropriate measures shall be included in the control programme.
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6.6.3 In the event of evidence of pest activity, immediate action shall be taken to identify at-risk products and to minimise the risk of product contamination. Any potentially affected products shall be subject to the non-conforming product procedure.<br>The presence of any infestation on site shall be documented in pest control records and be part of an effective pest management programme to eliminate or manage the infestation so that it does not present a risk to products.
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6.6.4 The company shall either contract the services of a competent pest control organisation or shall have trained personnel for the regular inspection and treatment of premises, in order to deter and eradicate infestation.<br>The frequency of inspections shall be determined by risk assessment and documented. The risk assessment shall be reviewed whenever:<br>• there are changes to the buildings or processes which could have an impact on the pest management programme<br>• there has been a significant pest issue.<br>Service provision (regardless of the source) shall meet with all applicable regulatory requirements.
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6.6.5 Where the services of a pest control contractor are employed, the service contract shall be clearly defined and reflect the activities of the site.
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6.6.6 Pest management documentation and records shall be maintained. As a minimum, these shall include:<br>• an up-to-date plan of the whole site, identifying pest control devices and their locations<br>• identification of the baits and/or monitoring devices on site<br>• clearly defined responsibilities for the site management and the contractor<br>• details of pest control products used, including instructions for their effective deployment and action to be taken in the case of emergencies<br>• any observed pest activity<br>• details of pest control treatments undertaken.<br>Records may be on paper (hard copy) or controlled in an electronic system (e.g. an online reporting system).
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6.6.7 Where a site undertakes its own pest management, it shall be able to effectively demonstrate that:<br>• pest management operations are undertaken by trained and competent staff with sufficient knowledge to select appropriate pest control chemicals and proofing methods and understand the limitations of use, relevant to the biology of the pests associated with the site<br>• staff undertaking pest management activities meet any legal requirements for training or registration<br>• sufficient resources are available to respond to any infestation issues<br>• there is ready access to specialist technical knowledge when required<br>• legislation governing the use of pest control products is understood and complied with<br>• dedicated locked facilities are used for the storage of pesticides.
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6.6.8 Results of pest management inspections shall be assessed and analysed for trends on a regular basis. As a minimum, results of inspections shall be analysed annually or in the event of an infestation.<br>The analysis shall include results from trapping and monitoring devices to identify problem areas. The analysis shall be used as a basis for improving the pest management procedures.
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6.6.9 Records of pest management inspections, pest proofing, hygiene recommendations and actions taken shall be maintained. It shall be the responsibility of the site to ensure that all of the relevant recommendations made by its contractor or in-house expert are documented and carried out in a timely manner.
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6.6.10 An in-depth, documented pest management survey shall be undertaken at a frequency based on risk, but at least annually, by a pest control expert to review the pest management measures in place. The survey shall:<br>• provide an in-depth inspection of the facility for pest activity, including advice on stock held for a prolonged period<br>• review the existing pest management measures in place and make any recommendations for change.<br>The survey shall be timed to allow access to equipment for inspection where a risk of stored product insect infestation exists.
7. Good operating practices
7.1 Receipt of goods
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7.1.1 Where specific measurable conditions, such as temperature, are critical to the safety, legality, quality or integrity of products, processes shall be in place to ensure requirements are fulfilled before acceptance.
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7.1.2 There shall be a procedure for inspection of loads on arrival to ensure that products are free from pest infestation, contamination or damage and are in a satisfactory condition.
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7.1.3 Procedures shall also be in place to ensure that the loads or products have been held under secure conditions before acceptance.
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7.1.4 Where products are marked with a durability code, the residual shelf life shall be checked to ensure that this meets any specified customer requirement as a minimum , and assist in stock rotation.
7.2 Product handling
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7.2.1 Personnel shall be aware of any products requiring specific handling conditions and be trained in appropriate procedures. The procedures shall include, as appropriate:<br>• instructions for handling different product types<br>• segregation of products where necessary to avoid cross-contamination (physical, chemical, microbiological or allergenic), mixing of sorts, or taint specific handling requirements to prevent product damage.
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7.2.2 The loading of vehicles or shipping containers shall be carried out in a manner which prevents damage, and loads shall be secured to prevent movement during transit.
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7.2.3 Where products are repacked onto pallets for storage or further distribution, the packing configuration shall prevent the risk of damage (e.g. overhanging cases). Where required, repacked pallets shall be band-wrapped to prevent damage in storage or distribution.
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7.2.4 Products shall be stored off the floor either on pallets or racking.
7.3 Environment control
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7.3.1 Monitoring shall be carried out in accordance with product specification requirements and/or specified procedures.
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7.3.2 Where the storage area is temperature-controlled, temperature-recording equipment with suitable alarms shall be fitted to all storage facilities, or there shall be a system of recorded manual temperature checks, typically every 4 hours or at a frequency which allows for intervention before product temperatures exceed the defined limits for the safety, legality, quality or integrity of products.
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7.3.3 Facilities shall be adequate to maintain products within the temperature range detailed in the product specification.
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7.3.4 Where temperature control is required, process parameters critical to product safety (including product handling and scheduling of transfer operations) shall be monitored to maintain temperature control.<br>Procedures shall be established which clearly define acceptable and unacceptable criteria so that appropriate actions can be taken. The procedures shall take into account:<br>• maximum limits for the period of time that particular types of product may remain outside a temperature-controlled environment, including at loading, unloading and staging areas<br>• the effect of local seasonal temperature variations (e.g. temperature, condensation, humidity).
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7.3.5 In the case of equipment failure, procedures shall be in place to establish, in conjunction with the product owner, the safety status and effect on the quality of the product prior to release to distribution. Records shall be maintained.
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7.3.6 In circumstances where a controlled atmosphere is critical to product safety, quality, legality or integrity, manual or automatic gas proportioning and/or time-recording equipment shall be used to monitor (at an appropriate frequency) the gas proportions in the controlled atmosphere. Changes to the equipment settings shall only be completed by trained and authorised staff and, where applicable, controls shall be password-protected or otherwise restricted.
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7.3.7 Where temperature, humidity or controlled-atmosphere stores are used, the level of uniformity of the environmental condition under control (e.g. temperature distribution) shall be established, validated and verified at a frequency based on risk or where necessary restrictions on product placement have been identified.
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7.3.8 In the event of changes to equipment, the company shall, where appropriate, re-establish the performance capability within the storage area.
7.4 Physical and chemical product contamination risk
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7.4.1 Glass or other brittle materials in product-handling areas shall be excluded or protected against breakage or the product shall be adequately protected. Procedures for handling glass and other brittle materials (other than product packaging) which pose a contamination risk in identified areas shall include:<br>• a list of those items, detailing their location, number, type and condition<br>• recorded checks of the condition of these items, carried out at a specified frequency that is based on the level of risk to the product<br>• details on cleaning or replacing these items to minimise the potential for product contamination.
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7.4.2 All spillages or breakages that pose a risk of product contamination shall be recorded in an incident report.
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7.4.3 Processes shall be in place to manage the use, storage and handling of chemicals to prevent chemical contamination. These shall include, as a minimum:<br>• an approved list of chemicals for purchase<br>• availability of material safety data sheets and specifications<br>• confirmation of suitability for use<br>• avoidance of strongly scented products<br>• the labelling and/or identification of containers of chemicals at all times<br>• a designated storage area with restricted access by authorised personnel<br>• use of chemicals by trained personnel only.
7.5 Stock rotation
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7.5.1 Receipt documents and/or product labelling shall facilitate correct stock rotation.
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7.5.2 An effective system shall be in place for identifying the location of stock within the storage area to facilitate stock rotation.
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7.5.3 Product shall be handled with due regard to the stated shelf life for onward sale, and shall be in compliance with the minimum specified shelf life on delivery where this is specified by customers.
7.6 Product release
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7.6.1 Where products require positive release, procedures shall be in place to ensure that the release does not occur until all release criteria have been met and the release has been authorised. Records shall be retained.
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7.6.2 In circumstances where release of product is authorised by the owner of the products or legal clearance (e.g. customs), the management shall have systems in place to ensure that the authority for release has been provided prior to dispatch. Evidence of authorisation shall be retained.
7.7 Management of allergens
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7.7.1 The company shall have a procedure in place to ensure that the potential risk of allergenic contamination of products is minimised. This shall take into account the particular packaging formats of products that are at an increased risk of damage, along with the physical state of any allergen-containing products (i.e. powder, liquid, particulate).
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7.7.2 A documented allergen management plan shall be established to mitigate the cross-contamination risk to products. Control measures shall consider:<br>• spillage controls<br>• specific handling procedures to reduce product damage<br>• any additional controls requested by the customer/product owner (e.g. segregation control based on manufacturing guidance/specifications).
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7.7.3 Spillage procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination by allergens. The cleaning methods shall be validated and routinely verified for their effectiveness.
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8. Personnel
8.1 Training and competency
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8.1.1 All personnel, including employment agency or temporary personnel and contractors, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period.
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8.1.2 The company shall have documented training procedures and training records to demonstrate that the training is appropriate and effective.
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8.1.3 Records of all training shall be available. These shall include, as a minimum:<br>• the name of the trainee and confirmation of attendance<br>• the date and duration of the training<br>• the title or course contents, as appropriate<br>• the training provider<br>• for internal courses, a reference to the material, work instruction or procedure that is used in the training.<br>Where training is undertaken by employment agencies on behalf of the company, records of the training shall be available.
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8.1.4 Where personnel are engaged in activities relating to critical control points (CCPs), they shall receive specific training relevant to the CCPs. Where personnel carry out activities which could affect product safety, legality and quality, the company shall ensure that personnel have been trained in the best-practice operating principles for the particular task.
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8.1.5 The company shall routinely review the competencies of staff and provide relevant training as appropriate. This may be in the form of training, refresher training, coaching, mentoring or on-the-job experience.
8.2 Personal hygiene
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8.2.1 The site’s personal hygiene standards shall include policy for the following:<br>• the wearing of protective clothing/workwear<br>• the wearing of jewellery<br>• smoking, eating and drinking<br>• hand-cleaning/personal hygiene<br>• reporting of sickness.
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8.2.2 The requirements for personal hygiene shall be communicated to all personnel, agency staff, contractors and visitors. Compliance with the requirements shall be checked regularly.
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8.2.3 Smoking (including the use of electronic cigarettes), where permitted under law, and eating and drinking shall only be permitted in designated areas and shall not be permitted in storage and product-handling areas. Adequate arrangements for dealing with smokers’ waste shall be provided at smoking facilities.
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8.2.4 Where workwear is provided, this shall be maintained in a good and clean condition.
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8.2.5 All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster that is site-issued and monitored.
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8.2.6 Processes and written instructions for staff shall be in place to control the use and storage of personal medicines so as to minimise the risk of product contamination.
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8.2.7 Where permitted by law, visitors and contractors shall be required to fill in a health questionnaire or otherwise confirm that they are not suffering from any symptoms which may put product safety at risk, prior to being allowed into storage areas.
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8.2.8 There shall be a procedure for the notification by employees, including temporary employees, of the details of any relevant infectious disease or condition with which they may have come into contact or from which they may be suffering. Expert medical advice shall be sought where required.
9. Handling of open food products
9.1 Hazard and risk analysis
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9.1.1 The map of the premises (clause 2.8) shall include those areas where the product is at different levels of risk from contamination. The map shall show:<br>• open food product handling areas<br>• pre-packed food product handling areas.<br>These areas shall be considered when determining the prerequisite programmes for reducing the risk of cross-contamination.
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9.1.2 Where open food products that are prone to microbial growth (clause 2.9) are handled, a documented risk assessment shall be completed to determine the risk of pathogenic cross-contamination during storage and transportation, and appropriate controls shall be implemented. The risk assessment shall take into account the potential sources of microbiological contamination and include:<br>• the nature of the products<br>• the flow of products, packaging (where applicable), equipment, personnel and waste<br>• air quality<br>• a programme of environmental control and monitoring (where appropriate)<br>• the provision and location of utilities.
9.2 Staff facilities
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9.2.1 Suitable and sufficient hand-washing facilities shall be provided at access points to open food product handling areas. Such hand-washing facilities shall provide, as a minimum:<br>• advisory signs to prompt hand-washing<br>• a sufficient quantity of water at a suitable temperature<br>• liquid/foam soap<br>• single-use towels or suitably designed and located air driers.
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9.2.2 Where open food products are stored and handled, toilets shall not open directly into the storage areas, and hand-washing facilities cannot be located within the toilets.
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9.2.3 Where separate changing facilities are required, the site shall provide documented instructions on the following:<br>• protective clothing required to be worn<br>• clear instructions for the order of changing into and out of dedicated protective clothes to prevent the contamination of clean clothing<br>• a hand-washing routine during the changing procedure to prevent contamination of the clean clothing.
9.3 Fabrication – product intake, handling, storage and dispatch areas
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9.3.1 Where products come into direct contact with water, steam, ice, air, compressed air or other gases, the microbiological and chemical quality of the product shall be regularly monitored based on risk assessment. The gases, water or ice shall present no risk to product safety or quality and shall comply with relevant legal regulations.
9.4 Maintenance
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9.4.1 Food grade lubricants shall be used and be of a known allergen status.
9.5 Housekeeping and hygiene
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9.5.1 Risk-based limits for acceptable and unacceptable cleaning performance shall be defined for food contact surfaces. These limits shall be based on the potential hazards relevant to the product or handling operations. Therefore, acceptable levels of cleaning may be defined by visual appearance, microbiological testing, allergen testing or chemical testing as appropriate.<br>The site shall define the corrective action to be taken when monitored results fall outside the acceptable limits.
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9.5.2 Where cleaning and disinfection procedures are part of a defined prerequisite plan to control the risk of a specific hazard, the procedures and their frequencies shall be validated. Manufacturers’ instructions must be followed and records maintained.
9.6 Protective clothing
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9.6.1 A documented risk assessment shall be completed to determine what protective clothing is required to be worn by employees to control contamination risk to open food product. Where risk assessment has determined that protective clothing is not required, it shall be fully justified, documented and not pose a contamination risk to the product.
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9.6.2 The company shall document and communicate to all employees (including agency and temporary personnel), contractors and visitors the rules regarding the wearing of protective clothing in specified areas. This shall also include policies relating to the wearing of protective clothing away from the product-handling area (e.g. removal before entering toilets and the use of canteen and smoking areas).
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9.6.3 Protective clothing shall be laundered on a regular basis. A system shall be in place to ensure the effectiveness of the laundering process.
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9.6.4 Disposable protective clothing, if used, shall be subject to adequate control to avoid product contamination.
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9.6.5 All hair shall be fully covered to prevent product contamination.
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9.6.6 All cuts and grazes on exposed skin shall be covered by a contrasting-coloured plaster that is site-issued and monitored.