Title Page

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  • Audit Title

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3.1 Food Safety & Quality Manual

  • 3.1.1 - The company's documented procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual.<br>The team leader shall have an in-depth knowledge of HACCP and be able to demonstrate competence and experience.<br><br>The team members shall have specific knowledge of HACCP and relevant knowledge of product, process, and associated hazards.<br><br>In the event of the site not having appropriate in-house knowledge, external expertise may be used, but day-to-day management of the food safety system shall remain the responsibility of the company.<br>

  • 3.1.2 - The food safety and quality manual shall be fully implemented and the manual or relevant components shall be readily available to key staff.

  • 3.1.3 - All procedures and work instructions shall be clearly legible, unambiguous, in appropriate languages, and sufficiently detailed to enable their correct application by appropriate staff. This shall include the use of photographs, diagrams, or other pictorial instructions where written communication alone is not sufficient (e.g., there are issues of literacy or foreign language).

3.2 Documentation Control

  • 3.2.1 - The company shall have a procedure to manage documents which form part of the food safety and quality system. This shall include:<br><br>- A list of all controlled documents indicating the latest version number<br>- The method for the identification and authorization of controlled documents<br>- A record of the reason for any changes or amendments to documents<br>- The system for the replacement of existing documents when these are updated.<br><br>

  • 3.3.1 - Records shall be legible, retained in good condition, and retrievable. Any alterations to records shall be authorized and justification for alteration shall be recorded. Where records are in electronic form these shall be suitably backed up to prevent loss.

  • 3.3.2 - Records shall be retained for a defined period with consideration given to:<br>-any legal or customer requirements<br>- the shelf life of the product. <br>This shall take into account, where it is specified on the label, the possibility that shelf life may be extended by the consumer (e.g., by freezing). As a minimum, records shall be retained for the shelf life of the product plus 12 months.<br>

3.4 INTERNAL AUDIT Fundamental The company shall be able to demonstrate it verifies the effective application of the food safety plan and the implementation of the requirements of the Standard.

  • 3.4.1 - There shall be a scheduled programme of internal audits throughout the year which covers the implementation of the HACCP program, prerequisite programs, and procedures implemented to achieve this Standard. The scope and frequency of the audits shall be established in relation to the risks associated with the activity and previous audit performance; all activities shall be covered at least annually.

  • 3.4.2 - Internal audits shall be carried out by appropriately trained competent auditor. Auditors shall be independent ( i.e. not audit their own work).

  • 3.4.3 - The internal audit program shall be fully implemented. Internal audit reports shall identify conformity as well as nonconformity and the results shall be reported to the personnel responsible for the activity audited. Corrective actions and timescales for their implementation shall be agreed and completion of the actions verified.

  • 3.4.4 - In addition to the internal audit program there shall be a program of documented inspections to ensure that the factory environment and processing equipment is maintained in a suitable condition for food production. These inspections shall include:<br><br>- Hygiene inspections to assess cleaning and housekeeping performance<br>- Fabrication inspections to identify risks to the product from the building or equipment.<br><br>The frequency of these inspections shall be based on risk but will be no less than once per month in open product areas.<br>

3.5 SUPPLIER AND RAW MATERIAL APPROVAL AND PERFORMANCE MONITORING 3.5.1 MANAGEMENT OF SUPPLIERS OF RAW MATERIALS AND PACKAGING The company shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials (including packaging) to the safety, legality, and quality of the final product are understood and managed.

  • -The company shall undertake a documented risk assessment of each raw material or group of raw materials including packaging to identify potential risks to product safety, legality, and quality. This shall take into account the potential for:<br><br>- Allergen contamination<br>- Foreign body risks<br>- Microbiological contamination<br>- Chemical contamination.<br>-Substitution or fraud (see clause 5.4.2)<br><br>Consideration shall also be given to the significance of a raw material to the quality of the final product.<br><br>The risk assessment shall form the basis for the raw material acceptance and testing procedure and for the processes adopted for supplier approval and monitoring. The risk assessment is reviewed at least annually.<br>

  • - The company shall have a documented supplier approval and ongoing monitoring procedure to ensure that suppliers of raw materials including packaging .effectively manage risks to raw materials quality and safety, and are operating effective traceability processes. The approval and monitoring procedure shall be based on risk and include one or a combination of:<br>-Certification (eg.BRC Global Standards or other GFSI-recognised scheme)<br>- Supplier audits, with a scope to include product safety, traceability, HACCP review and good manufacturing practices, undertaken by an experienced and demonstrably competent product safety auditor<br><br>Or for supplier assessed as low risk only, supplier questionnaires.<br><br><br>Where approval is based on questionnaires, these shall be reissued at least every 3 years and suppliers required to notify the site of any significant changes in the interim.<br><br>The site shall have an up-to date list of approval suppliers<br>

  • - Where raw materials are purchased from agents or brokers, the site shall know the identity of the last manufacturer of packer, or for bulk commodity products the consolidation place of the raw material.<br><br>The procedures shall define how exceptions to the supplier approval processes in clause are handled (eg. Where raw material suppliers are prescribed by a customer) or where information for effective supplier approval is not available (e.g bulk agricultural commodity products) and instead product testing is used to verify product quality and safety.<br><br>When site produces customer-branded product the relevant exceptions shall be identified to the customer.<br>.<br>

  • - The procedures shall define how exceptions to the supplier approval processes in clause are handled (eg. Where raw material suppliers are prescribed by a customer) or where information for effective supplier approval is not available (e.g bulk agricultural commodity products) and instead product testing is used to verify product quality and safety.<br><br>When site produces customer-branded product the relevant exceptions shall be identified to the customer<br>

3.5.2 RAW MATERIAL AND PACKAGING ACCEPTANCE AND MONITORING PROCEDURES Controls on the acceptance of raw materials shall ensure that raw materials do not compromise the safety, legality, or quality of products.

  • - The company shall have a documented procedure for the acceptance of raw materials and packaging on receipt based upon the risk assessment ( Raw materials including packaging acceptance and its release for use shall be based on one or combination of:<br><br>- Product sampling and testing.<br>-Visual inspection on receipt<br>- Certificates of analysis - specific to the consignment<br>- Certificates of conformance.<br><br>A list of raw materials including packaging and the requirements to be met for acceptance shall be available. The parameters for acceptance and frequency of testing shall be clearly defined, implemented and reviewed<br>

3.5.3 MANAGEMENT OF SUPPLIERS OF SERVICES The company shall be able to demonstrate that, where services are outsourced, the service is appropriate and any risks presented to food safety, legality and quality have been evaluated to ensure effective controls are in place.

  • - There shall be a documented procedure for the approval and monitoring of suppliers of services. Such services shall include as appropriate:<br><br>- Pest control<br>- Laundry services<br>- Contracted cleaning<br>- Contracted servicing and maintenance of equipment<br>- Transport and distribution<br>- Off-site storage of ingredients, packaging, or products<br>- Laboratory testing<br>- Catering services<br>- Waste management.<br>

  • - Contracts or formal agreements shall exist with the suppliers of services that clearly define service expectations and ensure potential food safety risks associated with the service have been addressed.

3.5.4 MANAGEMENT OF OUTSOURCED PROCESSING AND PACKING Where any process steps in the manufacture of a product which is included within the scope of certification is subcontracted to a third party or undertaken at another site, this shall be managed to ensure it does not compromise the safety, legality, quality or authenticity of the product.

  • - The company shall be able to demonstrate that, where part of the production process is outsourced and undertaken off site, this has been declared to the brand owner and, where required, approval granted.<br><br>

  • - The company shall ensure that subcontractors are approved and monitored by successful completion of either:<br>-Certification to the applicable standard or other GFSI-recognised scheme.<br> - A documented site audit with a scope to include product safety, traceability, HACCP review and good manufacturing practices by an experienced and demonstrably competent product safety auditor <br><br>

  • - Any outsourced processing operations shall:<br><br>- Be undertaken in accordance with established contracts which clearly define any processing and/or packing requirements and product specification.<br>- Maintain product traceability

  • - The company shall establish inspection and test procedures for product where part of the processing or packing have been outsourced, including visual, chemical, and/or microbiological testing, dependent on risk assessment.

3.6 SPECIFICATIONS Specifications shall exist for raw materials including packaging, finished products, and any product or service which could affect the integrity of the finished product.

  • 3.6.1 - Specifications for raw materials and packaging shall be adequate and accurate and ensure compliance with relevant safety and legislative requirements. The specifications shall include defined limits for relevant attributes of the material which may affect the quality or safety of the final products (e.g., chemical, microbiological, or physical standards).

  • 3.6.2 - Accurate, up –to date specification shall be available for all finished products. These shall include key data to meet customer and legal requirements and assist the use in the safe usage of the product.

  • 3.6.3 - The company shall seek formal agreement of specifications with relevant parties. Where specifications are not formally agreed then the company shall be able to demonstrate that it has taken steps to ensure formal agreement is in place.

  • 3.6.4 - Specifications shall be reviewed whenever products change (e.g., ingredients, processing method) or at least every three years. The date of review and the approval of any changes shall be recorded<br><br><br><br><br>

3.7 CORRECTIVE ACTION Fundamental requirement: The site shall be able to demonstrate that it uses the information from identified failures in the food safety and quality management system to make necessary corrections and prevent recurrence.

  • 3.7.1 - The site shall have a documented procedure for handling and correcting failures identified in the food safety and quality system.

  • 3.7.2 - Where a non conformity places the safety, legality or quality of products at risk this shall be investigated and recorded including:<br><br>- Clear documentation of the nonconformity<br>- Assessment of consequences by a suitably competent and authorized person<br>- Action to address the immediate issue<br>-An appropriate timescale for correction<br>- The person responsible for correction<br>- Verification that the corrective has been implemented and is effective.<br>- Identification of the root cause of the nonconformity and implementation of any necessary actions to prevent recurrence.<br>

3.8 CONTROL OF NONCONFORMING PRODUCT The site shall ensure that any out of specification product is effectively managed to prevent unauthorized release.

  • 3.8.1 - There shall be documented procedures for managing nonconforming products. These procedures shall include:<br>- The requirement for staff to identify and report potentially nonconforming product.<br>- Clear identification of nonconforming 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>- Referral to the brand owner where required<br>- Defined responsibilities for decision making on the use or disposal of products appropriate to the issue, e.g., destruction, reworking, downgrading to an alternative label, or acceptance by concession<br>- Records of the decision on the use or disposal of the product<br>- Records of destruction where product is destroyed for food safety reasons.<br>

3.9 TRACEABILITY Fundamental requirement The site shall be able to trace all raw material product lots (including packaging) from their supplier through all stages of processing and despatch to their customer and vice versa.

  • 3.9.1 - Identification of raw materials, including primary and any other relevant packaging and processing aids, intermediate/semi processed products, part-used materials, finished products, and materials pending investigation, shall be adequate to ensure traceability.

  • 3.9.2 - The site shall test the traceability system across the range of product groups to ensure traceability can be determined from raw material including primary packaging to finished product and vice versa, including quantity check/mass balance. This shall occur at a predetermined frequency, as a minimum annually and results shall be retained for inspection.. Full traceability should be achievable within four hours.

  • 3.9.3 - The company shall ensure that its suppliers of raw materials have an effective traceability system. Where a supplier has been approved based on a questionnaire, instead of certification or audit, verification of the supplier’s traceability system shall be carried out on first approval and then at least every 3 years. This may be achieved by a traceability test. Where a raw material is received directly from a farm or fish farm, further verification of the farms traceability system is not mandatory.

  • 3.9.4 - Where rework or any reworking operations is performed, traceability shall be maintained, (Rework is correction of defective, failed or non-conforming items.)

3.10 COMPLAINT HANDLING Customer complaints shall be handled effectively and information used to reduce recurring complaint levels.

  • 3.10.1 - All complaints shall be recorded, investigated, and the results of the investigation of the issue recorded where sufficient information is provided. Actions appropriate to the seriousness and frequency of the problems identified shall be carried out promptly and effectively by appropriately trained staff.

  • 3.10.2 - Complaint data shall be analyzed for significant trends Where there has been a significant increase in a complaint or a serious complaint, root cause analysis shall be used to implement ongoing improvements to product safety, legality and quality and to avoid recurrence, This analysis shall be made available to relevant staff

3.11 MANAGEMENT OF INCIDENTS, PRODUCT WITHDRAWAL, AND PRODUCT RECALL The company shall have a plan and system in place to effectively manage incidents and enable the effective withdrawal and recall of products should this be required.

  • 3.11.1 - The company shall have documented procedures designed to report and effectively manage incidents and potential emergency situations that impact food safety, legality, or quality. This shall include consideration of contingency plans to maintain product safety, quality and legality. Incidents may include:<br>- Disruption to key services such as water, energy, transport, refrigeration processes, staff availability, and communications<br>- Events such as fire, flood, or natural disaster<br>- Malicious contamination or sabotage.<br><br>Where products which have been released from the site may be affected by an incident, consideration shall be given to the need to withdraw or recall products.<br>

  • 3.11.2 - The company shall have a documented product withdrawal and recall procedure. This shall include as a minimum:<br><br>- Identification of key personnel constituting the recall management team, with clearly identified responsibilities<br>- Guidelines for deciding whether a product needs to be recalled or withdrawn and the records to me maintained<br>- An up-to-date list of key contacts or reference to the location of such a list, e.g., recall management team, emergency services, 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<br>- Details of external agencies providing advice and support as necessary, e.g., specialist laboratories, regulatory authority, and legal expertise<br>- A plan to handle the logistics of product traceability, recovery or disposal of affected product, and stock reconciliation.<br>The procedure shall be capable of being operated at any time.<br>

  • 3.11.3 - The product recall and withdrawal procedures shall be tested, at least annually, in a way that ensures their effective operation. Results of the test shall be retained and shall include timings of key activities. The results of the test and of any actual recall shall be used to review the procedure and implement improvements as necessary.

  • 3.11.4 - In the event of a product recall, the certification body issuing the current certificate for the site against this Standard shall be informed within three working days of the decision to issue a recall.<br>

3.12 CUSTOMER FOCUS AND COMMUNCIATION The company shall ensure that any customer-specific policies or requirements are understood, implemented and clearly communicated to relevant staff and where appropriate, supplier of raw materials, packaging and services.

  • 3.12.1 - Where a company is requested to follow specific customer requirements, codes of practice, methods of working etc., these shall be made known to relevant staff within the site and implemented.<br>

  • 3.12.2 - Effective processes shall be in place for communicating customer-specific requirements to the suppliers of raw materials and services as applicable

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