3. Food Safety and Quality Management System
3.1. Corrective and Preventative Actions
FUNDAMENTAL
1
Clause 3.1.1
The site's procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual.
Outcome Docs Actions Notes
Yes No N/A
Are the site's procedures, working methods and practices collated in a printed or electronic quality manual?
Where is the quality manual held/saved?
Clause 3.1.2
The food safety and quality manual shall be fully implemented and the manual or relevant components shall be readily available to relevant staff.
Outcome Docs Actions Notes
Yes No N/A
Is the food safety and quality manual fully implemented?
Is the manual or relevant components readily available to relevant staff?
Clause 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).
Outcome Docs Actions Notes
Yes No N/A
Are all procedures and work instructions:
Are photographs, diagrams or other pictorial instructions used where written communication alone is not sufficient?
Clause 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.
Outcome Docs Actions Notes
Yes No N/A
Clause 3.10.2
Complaint data shall be analysed for significant trends. Where there has been a significant increase in a complaint or a serious complaint, root cause analysis shall be used to implement ongoing improvements to product safety, legality and quality, and to avoid recurrence. This analysis shall be made available to relevant staff.
Outcome Docs Actions Notes
Yes No N/A
Clause 3.11.1
The company shall have 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:
Outcome Docs Actions Notes
Yes No N/A
Clause 3.11.2
The company shall have a documented product withdrawal and recall procedure. This shall include, at a minimum:
Outcome Docs Actions Notes
Yes No N/A
Clause 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.
Outcome Docs Actions Notes
Yes No N/A
Clause 3.11.4
In the event of a significant food safety incident, including a product recall or regulatory food safety non-conformity (e.g. a regulatory enforcement notice), the certification body issuing the current certificate for the site against this Standard shall be informed within 3 working days.
Outcome Docs Actions Notes
Yes No N/A
3.2. Describe the Product (equivalent to Codex Alimentarius Step 2)
FUNDAMENTAL
1
Clause 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:
Outcome Docs Actions Notes
Yes No N/A
Is there a procedure to manage documents which form part of the food safety and quality system?
What is this procedure called?
Does the procedure include:
For electronic documents related to the food safety and quality system, are they: - stored securely?
3.3. Determine the Critical Control Points (CCPs) (equivalent to Codex Alimentarius Step 7, Principle 2)
FUNDAMENTAL
1
Clause 3.3.1
Records shall be legible, maintained in good condition and retrievable. Any alterations to records shall be authorised and justification for the alteration shall be recorded. Where records are in electronic form these shall also be:
Outcome Docs Actions Notes
Yes No N/A
Are records related to the control of product safety, legality and quality:
Are any alterations to these records justified?
Is the justification for such alterations recorded?
For electronic documents related to the effective control of product safety, legality and quality, are they: - stored securely?
Clause 3.3.2
Records shall be retained for a defined period with consideration given to:
Outcome Docs Actions Notes
Yes No N/A
How long are records that demonstrate the effective control of product safety, legality and quality retained for?
Is this retention period longer than shelf life of the product plus 12 months?
Does this defined period take into consideration:
3.4. Dispatch and Transport
FUNDAMENTAL
1
Clause 3.4.1
There shall be a scheduled programme of internal audits.
Outcome Docs Actions Notes
Yes No N/A
Is there a scheduled programme of internal audits?
Is there a minimum of four different audit dates spread throughout the year?
Have the risks associated with the activity been considered when establishing audit frequency?
Has previous audit performance been considered when establishing audit frequency?
Are all activities covered at least once a year?
Does the scope of the internal audit programme include:
What other points does the scope of the internal audit programme include?
Does each internal audit within the programme:
Clause 3.4.2
Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be independent (e.g. not audit their own work).
Outcome Docs Actions Notes
Yes No N/A
Are internal audits carried out by appropriately trained and competent auditors?
Is there evidence for training of auditors?
Is there evidence for competency of auditors?
Are internal audits carried out by people who are independent?
Clause 3.4.3
The internal audit programme shall be fully implemented. Internal audit reports shall identify conformity as well as non-conformity and include objective evidence of the findings.
Outcome Docs Actions Notes
Yes No N/A
Is the internal audit programme fully implemented?
Do internal audit reports:
Are the results reported to the personnel responsible for the activity audited?
Are corrective actions, including timescales for their implementation, agreed?
Is the completion of corrective actions verified?
Are preventive actions, including timescales for their implementation, agreed?
Is the completion of preventive actions verified?
Clause 3.4.4
In addition to the internal audit programme, there shall be a separate programme of documented inspections to ensure that the factory environment and processing equipment are maintained in a suitable condition for food production.
Outcome Docs Actions Notes
Yes No N/A
Is the programme of document inspections separate from the internal audit programme?
Does this programme of documented inspections ensure that the:
Do these inspections include hygiene inspections to assess cleaning and housekeeping performance?
Do these inspections include fabrication inspections to identify risks to the product from the building or equipment?
What other issues should these inspections include?
Are these additional issues covered in the inspections?
Is the frequency of these inspections based on risk?
Are inspections in open product areas carried out at least once a month?
3.5. Document Control
FUNDAMENTAL
1
Clause 3.5.1.1
The company shall undertake a documented risk assessment of each raw material or group of raw materials including primary packaging to identify potential risks to product safety, legality and quality. This shall take into account the potential for:
Outcome Docs Actions Notes
Yes No N/A
Are there documented risk assessments for each raw material, or group, including primary packaging?
Do these risk assessments identify potential risks to product safety, legality and quality?
Which raw materials, or group of raw materials, require these documented risk assessments?
Have the documented risk assessments outlined above been carried out?
Do these documented risk assessments take into account the potential for:
- substitution or fraud (as per clause 5.4.2)?
Which other potential risks need to be accounted for?
Are these additional potential risks accounted for?
Is consideration given to the significance of a raw material to the quality of the final product?
Does the risk assessment form the basis for the:
Is the risk assessment for a raw material updated:
- at least every 3 years?
Clause 3.5.1.2
The company shall have a documented supplier approval procedure to ensure that all suppliers of raw materials, including primary packaging, effectively manage risks to raw material quality and safety and are operating effective traceability processes. The approval procedure shall be based on risk and include either one or a combination of:
Outcome Docs Actions Notes
Yes No N/A
Does the supplier approval procedure ensure that all suppliers of raw materials, including primary packaging:
Is the approval procedure based on risk?
Does the approval procedure include:
Does the scope of this certification include the raw materials purchased?
Does the approval procedure cover supplier audits?
Does the scope of the approval procedure include product safety, traceability, HACCP review and good manufacturing practices?
Where the approval is based on supplier audits, are these audits undertaken by an experienced and demonstrably competent product safety auditor?
Does the approval procedure require: - the competency of the auditor to be demonstrated where audits are completed by a second or third party?
Where the approval is based on supplier audits, are these audits undertaken by an experienced and demonstrably competent product safety auditor?
Does the approval procedure require:
Does the approval procedure require: - the competency of the auditor to be demonstrated where audits are completed by a second or third party?
Does the approval procedure permit that, solely where a valid risk-based justification is provided and the supplier is assessed as low risk, a completed supplier questionnaire is used for initial approval?
Does the scope of this questionnaire include product safety, traceability, HACCP review and good manufacturing practices?
Is this questionnaire reviewed and verified by a demonstrably competent person?
Clause 3.5.1.3
There shall be a documented process for ongoing supplier performance review, based on risk and defined performance criteria. The process shall be fully implemented.
Outcome Docs Actions Notes
Yes No N/A
Is there a documented process for ongoing supplier performance review?
Is the documented process based on risk and defined performance criteria?
Is the process fully implemented?
Where approval is based on questionnaire: - are they reissued at least every 3 years?
Are records of the review kept?
Clause 3.5.1.4
The site shall have an up-to-date list or database of approved suppliers. This may be on paper (hard copy) or it may be controlled on an electronic system.
Outcome Docs Actions Notes
Yes No N/A
Does the site have an up-to-date list or database of approved suppliers?
Where is this list/database held/saved?
Are the list or relevant components of the database readily accessible to the relevant staff?
Clause 3.5.1.5
Where raw materials (including primary packaging) are purchased from companies that are not the manufacturer, packer or consolidator (e.g. purchased from an agent, broker or wholesaler), the site shall know the identity of the last manufacturer or packer, or for bulk commodity products the consolidation place of the raw material.
Outcome Docs Actions Notes
Yes No N/A
Does the site know the identity of the last manufacturer or packer, or the consolidation place of the raw material (as relevant) for raw materials that are purchased?
Is information enabling the approval of the manufacturer, packer or consolidator (as in clauses 3.5.1.1 and 3.5.1.2) obtained when the agent/broker is not BRC standard certified?
Clause 3.5.1.6
The company shall ensure that its suppliers of raw materials (including primary packaging) have an effective traceability system. Where a supplier has been approved based on a questionnaire instead of certification or audit, verification of the supplier's traceability system shall be carried out on first approval and then at least every 3 years. This may be achieved by a traceability test.
Outcome Docs Actions Notes
Yes No N/A
Is there evidence that suppliers of raw materials (including primary packaging) have an effective traceability system?
For suppliers approved via a questionnaire, is verification of their traceability system carried out: - on first approval?
- every 3 years after first approval?
Clause 3.5.1.7
The procedures shall define how exceptions to the supplier approval processes in clause 3.5.1.2 are handled (e.g. 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.
Outcome Docs Actions Notes
Yes No N/A
Do procedures define how exceptions to the supplier approval processes in clause 3.5.1.2 are handled?
Do procedures define how product testing is used to verify product quality and safety when information for effective supplier approval is not available?
For customer-branded products, is the customer made aware of the relevant exceptions?
Clause 3.5.2.1
The company shall have a procedure for the acceptance of raw materials and primary packaging on receipt based upon the risk assessment (clause 3.5.1.1). Acceptance of raw materials (including primary packaging) and their release for use shall be based on either one or a combination of:
Outcome Docs Actions Notes
Yes No N/A
Is there a procedure for the acceptance of raw materials and primary packaging on receipt, based upon the risk assessment (clause 3.5.1.1)?
Is the acceptance of raw materials and their release for use based on either one or a combination of: product sampling and testing; visual inspection on receipt; certificates of analysis; certificates of conformance?
is there a list available of the raw materials and the requirements to be met for acceptance?
Where is this list held/saved?
Are the parameters of acceptance and frequency of testing: - clearly defined?
Clause 3.5.2.2
Procedures shall be in place to ensure that approved changes to raw materials (including primary packaging) are communicated to goods receipt personnel and that only the correct version of the raw material is accepted. For example, when labels or printed packaging have been amended, only the correct version should be accepted and released into production.
Outcome Docs Actions Notes
Yes No N/A
Are there procedures in place to ensure that:
What are the names of these procedures?
Clause 3.5.2.3
Where the site is in receipt of live animals, there shall be an inspection by a suitably competent individual at lairage and post mortem to ensure that the animals are fit for human consumption.
Outcome Docs Actions Notes
Yes No N/A
Are live animals received to site inspected by a competent individual at lairage to ensure that the animals are fit for human consumption?
Are live animals received to site inspected by a competent individual post mortem to ensure that the animals are fit for human consumption?
Clause 3.5.3.1
There shall be a procedure for the approval and monitoring of suppliers of services. Such services shall include, as appropriate:
Outcome Docs Actions Notes
Yes No N/A
Is there a procedure for the approval and monitoring of suppliers of services?
What is the name of this procedure?
Does the procedure for the approval and monitoring of suppliers of services cover:
Is the approval and monitoring process risk based?
Does the approval and monitoring process consider:
Do these contracts or formal agreements:
Clause 3.5.3.2
Contracts or formal agreements shall exist with the suppliers of services that clearly define service expectations and ensure that the potential food safety risks associated with the service have been addressed.
Outcome Docs Actions Notes
Yes No N/A
Are there contracts or formal agreements with the suppliers of services?
Clause 3.5.4.1
The company shall be able to demonstrate that, where part of the production process or any part of the final packing is outsourced and undertaken off-site, this has been declared to the brand owner and, where required, approval granted.
Outcome Docs Actions Notes
Yes No N/A
Where part of the production process or any part of the final packing is outsourced and undertaken off-site, is there evidence that:
Clause 3.5.4.2
The company shall ensure that outsourced processors are approved and monitored, to ensure that they effectively manage risks to product safety and quality and are 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. Where this supplier audit is completed by a second or third party, the company shall be able to: operating effective traceability processes.
Outcome Docs Actions Notes
Yes No N/A
Is there a documented procedure to approve and monitor outsourced processors?
What is this procedure called?
Does the procedure for outsourced processors ensure that they:
Is the approval and monitoring procedure based on risk?
Does the approval and monitoring procedure:
Does the scope of the certification include raw materials purchased?
Does the approval and monitoring procedure:
For supplier audits that are completed by a second or third party:
Is there a documented process for ongoing supplier performance review?
Is the ongoing supplier performance review:
Are records of the ongoing supplier performance review kept?
Clause 3.5.4.3
Any outsourced processing operations shall:
Outcome Docs Actions Notes
Yes No N/A
Are outsourced processing operations undertaken in accordance with established contracts?
Do established contracts: - clearly define any processing and/or packing requirements?
Clause 3.5.4.4
The company shall establish inspection and test procedures for products where part of the processing has been outsourced, including visual, chemical and/or microbiological testing.
Outcome Docs Actions Notes
Yes No N/A
Where part of the processing has been outsourced, including visual, chemical and/or microbiological testing:
Is the frequency of inspection or testing aligned with risk assessment?
Are the methods of inspection or testing aligned with risk assessment?
Clause 3.5.1
Management of Suppliers of Raw Materials and Packaging
Outcome Docs Actions Notes
Yes No N/A
3.6. Effective processes shall be in place to ensure the safety and legality of by-products of the primary processing activity of the site.
FUNDAMENTAL
1
Clause 3.6.1
Specifications for raw materials and primary 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).
Outcome Docs Actions Notes
Yes No N/A
Are specifications for raw materials:
Do specifications for raw materials:
Are specifications for primary packing:
Do specifications for primary packing:
Clause 3.6.2
Accurate, up-to-date specifications shall be available for all finished products. These may be in the form of a printed or electronic document, or part of an online specification system.
Outcome Docs Actions Notes
Yes No N/A
Are specifications for all finished products:
Where are these specifications saved?
Do the specifications for all finished products:
Clause 3.6.3
Where the company is manufacturing customer-branded products, it shall seek formal agreement of the finished product specifications. 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.
Outcome Docs Actions Notes
Yes No N/A
For customer-branded products, is there formal agreement of the finished product specifications?
For customer-branded products where specifications are not formally agreed, can the company demonstrate that steps to ensure formal agreement are in place?
Clause 3.6.4
Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years, taking into account product changes, suppliers, regulations and other risks.
Outcome Docs Actions Notes
Yes No N/A
Are specification reviews sufficiently frequent to ensure that data is current?
Are specification reviews conducted every 3 years at a minimum?
Are the reviews documented?
Are the changes documented?
3.7. Environmental Monitoring
FUNDAMENTAL
1
Clause 3.7.1
The site shall have a procedure for handling and correcting failures identified in the food safety and quality management system.
Outcome Docs Actions Notes
Yes No N/A
Is there a procedure for handling failures identified in the food safety and quality management system?
Is there a procedure for correcting failures identified in the food safety and quality management system?
Clause 3.7.2
Where a non-conformity places the safety, legality or quality of products at risk, this shall be investigated and recorded including:
Outcome Docs Actions Notes
Yes No N/A
Is an investigation conducted and recorded where a non-conformity places the safety, legality or quality of products at risk?
Do the records of these non-conformities include:
Clause 3.7.3
The site shall have a procedure for the completion of root cause analysis. At a minimum root cause analysis shall be used to implement ongoing improvements and to prevent recurrence of non-conformities when:
Outcome Docs Actions Notes
Yes No N/A
Is there a procedure for the completion of root cause analysis?
Is root cause analysis used to:
Is root cause analysis used to prevent recurrence of non-conformities when a non-conformity places the:
3.8. Equipment
FUNDAMENTAL
1
Clause 3.8.1
There shall be procedures for managing non-conforming products. These procedures shall include:
Outcome Docs Actions Notes
Yes No N/A
Are there procedures for managing non-conforming products?
Do the procedures for managing non-conforming products include:
3.9. Establish a Corrective Action Plan (equivalent to Codex Alimentarius Step 10, Principle 5)
FUNDAMENTAL
1
Clause 3.9.1
The site shall have a documented traceability procedure designed to maintain traceability throughout the site's processes. At a minimum this shall include:
Outcome Docs Actions Notes
Yes No N/A
Is there a documented traceability procedure designed to maintain traceability through the site's processes?
Does the documented traceability procedure include:
Which other information should be included in the documented traceability procedure?
Is this additional information included in the documented traceability procedure?
Clause 3.9.2
Identification of raw materials (including primary packaging), intermediate/semi-processed products, part-used materials, finished products and materials pending investigation shall be adequate to ensure traceability.
Outcome Docs Actions Notes
Yes No N/A
Is identification of:
Clause 3.9.3
The site shall test the traceability system across the range of product groups to ensure traceability can be determined from the supplier of raw material (including primary packaging) to the finished product and vice versa, including quantity check/mass balance.
Outcome Docs Actions Notes
Yes No N/A
Is the traceability system across the range of product groups tested to ensure traceability can be determined from the:
Does the traceability test include a summary of the documents that should be referenced during the test?
Does the traceability test clearly show the links between the documents that should be referenced during the test?
Is the test carried out at:
Are the results of the test retained for inspection?
Is traceability achieved within 4 hours?
Clause 3.9.4
Where rework or any reworking operation is performed, traceability shall be maintained.
Outcome Docs Actions Notes
Yes No N/A
Where rework is performed, is traceability maintained?
Where any reworking operation is performed, is traceability maintained?
Clause 3.9
Traceability
Outcome Docs Actions Notes
Yes No N/A
3.10. Product Packaging
FUNDAMENTAL
1
3.11. Customer complaints shall be handled effectively and information used to reduce recurring complaint levels.
FUNDAMENTAL
1