BRC AUDIT CHECKLIST

Compliance
SECTION ITEM Y/N WHAT IS NEEDED FOR COMPLIANCE?
1 Senior Management Commitment
1.1 Senior Management provides required resources
1.2 Clear communicating and reporting channels
1.3 Senior Management ensures objectives are established, documented, monitored, reviewed
1.4 Senior Management ensures process to deal with safety, legal issues strategically
1.5 Senior Management takes responsibility for review process
1.6 Annual reviews, at a minimum, of the food safety and HACCP plan
1.7 Bullet points are included in review
1.8 Records of management reviews are comprehensively documented and retained
1.9 Results of review will be communicated and actions implemented. Document completed actions
1.10 Current issue of GSFS is available
1.11 Maintain certification by planning ahead for audit scheduling
1.12 Most senior production or operations manager attends opening and closing audit meetings
1.13 Senior management ensures that non-conformities are resolved
2 Food Safety Plan - HACCP
2.1 HACCP Food Safety Team Codex Step 1
2.1.1 HACCP plan developed and managed by trained, multi-disciplinary food safety team
2.1.2 HACCP team has a designated and qualified team leader who can demonstrate competency
2.1.3 Records are maintained demonstrating food safety team knowledge of HACCP
2.1.4 Senior Management demonstrates commitment and support of the HACCP team
2.2 Describe the Product Codex Step 2
2.2.1 HACCP team defines specific products/processes in the HACCP Plan
2.2.2 All relevant info needed to conduct hazard analysis is maintained, documented and updated
2.2.3 Full description of products produced is developed
2.3 Identify Intended Use Codex Step 3
2.3.1 Intended use by customer is described
2.4 Construct Process Flow Diagram Codex Step 4
2.4.1 Flow diagram prepared for each product, product category or process from raw materials to distribution
2.5 Verify Flow Diagram Codex Step 5
2.5.1 HACCP team verifies flow diagrams by audits. Documentation is maintained
2.6 List Hazards, Conduct Hazard Analysis, Consider Control Measures Codex Step 6 Principle 1
2.6.1 HACCP team confirms scope of HACCP Plan
2.6.2 HACCP team conducts hazard analysis
2.6.3 HACCP team defines control measures. Justification is documented
2.7 Determine CCP's Codex Step 7 Principle 2
2.7.1 Critical Control Points are determined using a decision tree
2.8 Establish Critical Limits Codex Step 8 Principle 3
2.8.1 Appropriate critical limits for each CCP are defined and rationale for establishment documented.
2.8.2 Critical limits based on subjective data are supported with written protocols and examples
2.8.3 HACCP team validates each CCP. Documents show the control measure is capable of control.
2.9 Establish Monitoring System Codex Step 9 Principle 4
2.9 HACCP team establishes monitoring system for each CCP
2.9.2 Monitoring system will detect loss of control and possibly provide info for corrective action
2.9.3 Monitoring records are signed and dated by the person responsible and verified
2.10 Establish Corrective Action Plan Codex Step 10 Principle 5
2.10.1 HACCP team specifies and documents corrective action when control limits are not met
2.10.2 Procedures for handling potentially unsafe products are established and documented
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2.11 Establish Verification Procedures Codex Step 11 Principle 6
2.11.1 Verification procedures are established to confirm the HACCP plan is effective
2.11.2 Verification results are recorded and communicated to the HACCP team
2.12 HACCP Documentation and Record Keeping Codex Step 12 Principle 7
2.12.1 Documentation and recordkeeping assists in verifying controls are in place and maintained
2.13 Review the HACCP Plan
2.13.1 Procedures exist to review the HACCP plan before changes are made which may affect product safety
2.13.2 The HACCP plan will be reviewed at least annually and records shall be maintained
3 Food Safety and Quality Management System
3.1 Food Safety and Quality Policy
Policy states intention to produce safe, legal and quality product. Policy includes commitment for review
3.1.1 and continuous improvement
3.2 Food Safety and Quality Manual
3.2.1 Manual contains outline of working methods and practices or references where the outline is
3.2.2 Manual shall be readily available to key staff
3.3 Organizational Structure, Responsibilities
3.3.1 Company has an organization chart demonstrating the structure of the company
Documented and defined responsibility for product safety, legality and regulatory compliance as well as
3.3.2 quality systems exists
3.3.3 Documented arrangements are in place to cover the absence of key staff
Senior Management ensures a description of general duties or work instructions are in place and
3.3.4 communicated to all staff involved with product safety, quality, legality and regulatory compliance
Senior management has system in place to ensure company is kept informed of all legislative, scientific
3.3.5 and technical developments
3.4 Contract Review/Customer Focus
3.4.1 Company clearly identifies individuals responsible for communication with customers
3.4.2 Customer requirements are agreed to and documented where appropriate
3.4.3 Customer requirements are reviewed on a suitable pre-determined frequency
3.4.4 Performance indicators are established relating to customer satisfaction
3.5 Internal Audits
Audits are established in relation to risks associated with the activity. Audits are scheduled so that all
3.5.1 aspects of food safety and quality management systems are audited at least annually
3.5.2 Audits are carried out by trained auditors, independent of the audited department
3.5.3 Audit reports shall identify and verify conformity as well as non-conformity
Results of audits are reported to personnel responsible for the activity audited. Corrective actions and
3.5.4 timelines for implementation are agreed to
3.5.5 Completion of corrective actions are verified
3.5.6 Records of all audits and associated corrective actions are maintained
3.6 Supplier Approval and Monitoring
3.6.1 Documented supplier approval procedure and continual assessment program is in place
3.6.2 Procedures include clear criteria for ongoing assessment and standards of performance required
3.6.3 Procedures define how exceptions are handled
3.6.4 Company reviews performance of new suppliers against defined criteria within a specified frequency
3.7 General Documentation
3.71 Documentation Control
3.7.1.1 All documents in use are properly authorized and are the correct version
3.7.1.2 Documents are legible, unambiguous and sufficiently detailed to enable correct use by staff
The reason for any changes to documents critical to product safety, legality, regulatory compliance or
3.7.1.3 quality systems is documented
3.7.1.4 Procedure is in place to ensure obsolete documentation is removed and replaced by revised version
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3.7.2 Specifications
3.7.2.1 Specifications are adequate/accurate, ensuring compliance with safety and legislative requirements
3.7.2.2 Manufacturing instructions comply with recipes detailed in customer specifications
Company shall seek formal agreement on specifications. Where specifications are not formally agreed to,
3.7.2.3 company must demonstrate they have taken steps to ensure a formal agreement is in place
3.7.3.4 Documented procedure is in place for the amendment and approval of specifications including reviews
3.7.2.5 Specifications and/or their contents shall be accessible to the applicable staff
3.7.3 Record Completion and Maintenance
3.7.3.1 Records shall be legible, genuine, authorized and retained in good condition for a defined time period
3.7.3.2 Alterations to records shall be authorized and justification for alteration shall be recorded
Senior Management ensures that procedures are operated for the organization, review, maintenance,
3.7.3.3 storage and retrieval of records relating to product safety, legality, regulatory compliance and quality
3.7.3.4 The period of retention for records shall relate to shelf life of the product
3.7.3.5 Any legal and customer specific requirements relevant to record retention are taken into account
3.8 Corrective and Preventative Action
3.8.1 Corrective actions are accurately documented, assigning responsibility and accountability
3.8.2 Corrective actions are undertaken as soon as possible to prevent further non-conformity
Corrective actions plans relating to food safety, legality, regulatory compliance or quality shall only be
3.8.3 agreed to by personnel who have responsibility and accountability for these areas of control
3.8.4 Completion of corrective actions are monitored and recorded to ensure effectiveness and completion
3.9 Traceability
3.9.1 Identification of raw materials, packaging and processing aids are adequate to ensure traceability
3.9.2 Traceability system is tested to ensure traceability is "one step back, one step forward"
3.9.3 Where there is a requirement to ensure identity preservation, appropriate controls/testing are in place
If rework is performed, traceability is maintained. Company must be able to demonstrate that rework does
3.9.4 not affect the safety, regulatory or legal status of the finished product
3.10 Complaint Handling
3.10.1 All complaints are recorded, investigated and results of investigation recorded
3.10.2 Actions appropriate to the severity and frequency of problems are carried out promptly by trained staff
3.10.3 Complaint data is analyzed and used to implement ongoing improvements and to avoid recurrence
3.11 Incidents/Withdrawal/Recall
Procedures are in place to manage incidents and potential emergency situations that impact food safety,
3.11.1 legality and quality and have product withdrawal and product recall procedures in place
3.11.2 Written guidance is provided regarding the type of event that would constitute incident/emergency
3.11.3 Incident management procedure is documented, implemented and maintained
Procedures relating to incident reporting, withdrawal and recall are appropriate, formalized and capable of
3.11.4 being operated at any time
Recall/withdrawal procedures are tested at least annually and results of the test retained. Timings of key
3.11.5 activities are included.
3.11.6 Senior Management ensures results of these tests are used to implement improvements as necessary
3.11.7 In the event of a recall, the certification body issuing the current certificate for the site is informed
4 Site Standards
4.1 External Standards
4.1.1 Consideration is given to local activities and site environment that may adversely impact finished product
4.1.2 External areas are maintained in good order. Condition of the site is included in internal audits
4.1.3 Where natural drainage is inadequate, external drainage shall be installed
4.1.4 External traffic routes under site control are maintained to avoid product contamination
4.1.5 Building construction is maintained to minimize potential for product contamination
4.2 Security
4.2.1 Access to site is controlled and a visitor reporting system is in place
4.2.2 Staff is trained in site security procedures and encouraged to challenge unknown visitors
Measures are in place to maintain site security and to ensure only authorized staff have access to
production and storage areas. Areas are assessed according to risk. Sensitive or restricted areas are
4.2.3 defined, clearly marked, monitored and controlled.
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Measures are in place to maintain site security and to ensure only authorized staff have access to
production and storage areas. Areas are assessed according to risk. Sensitive or restricted areas are
4.2.3 defined, clearly marked, monitored and controlled.
4.2.4 Based on risk assessment, procedures are in place to ensure secure storage of all materials
4.2.5 Procedures in place ensuring finished product is held in secure storage and transportation conditions
4.2.6 When required by government regulations, the site is registered with appropriate governmental body
4.3 Internal Site Standards
4.3.1 Layout, Product Flow and Segregation
Process flow from receiving of materials to shipping of finished product is arranged to minimize risk of
4.3.1.1 product contamination
Physical barriers and/or effective procedures are in place to minimize the risk of contamination of raw
4.3.1.2 materials, work-in-progress, packaging and finished product
Segregation will take into account the flow of product, nature of materials, personnel, waste, airflow, air
4.3.1.3 quality and utilities
Based on risk assessment cleaning of production utensils is carried out in segregated areas separated
4.3.1.4 from the production process
Premises allows sufficient working and storage space to enable operations to be carried out under safe
4.3.1.5 hygienic conditions
4.3.1.6 Cleaning and inspection of areas and equipment shall be aided by the lack of obstructions
Temporary structures shall be designed and located to avoid pest harborage or potential contamination of
4.3.1.7 products
4.3.1.8 Location of transfer points will not compromise high-risk and low-risk segregation
Where high-risk products are manufactured, there shall be physical segregation between processing and
finished product handling areas. Practices shall be in place to control ingredients, equipment, packaging,
4.3.1.9 environment and personnel to prevent product contamination
In high-risk areas where there is significant risk of contamination of chilled ready to eat and/or heat
products by pathogenic micro-organisms the processing or handling of food in these areas shall be
4.3.1.10 appropriate to minimize product contamination by such micro-organisms
4.3.2 Building Construction
4.3.2.1 Walls
4.3.2.1.1 Walls prevent the accumulation of dirt, minimize condensation and mold and facilitate sanitation
4.3.2.2 Floors
4.3.2.2.1 Floors shall meet the demands of the process and withstand cleaning materials and methods
Drainage shall be placed, designed and maintained to minimize risk of product contamination and not
4.3.2.2.2 compromise product safety. Wherever feasible process waste water goes directly to the drain
Where significant amounts of water are used, floors shall have adequate slope to cope with the flow of any
4.3.2.2.3 water or effluent towards suitable drainage
4.3.2.3 Ceilings/Overheads
Ceilings and overheads are designed, constructed, finished and maintained to prevent the accumulation of
4.3.2.3.1 dirt, minimize condensation and mold growth and facilitate cleaning
4.3.2.3.2 Where suspended ceilings are used, adequate access to vacant spaces shall be provided
4.3.2.4 Windows
4.3.2.4.1 Windows and ceiling openings designed for ventilation shall be adequately screened
4.3.2.4.2 Where they pose a risk to product, glass windows shall be protected against breakage
4.3.2.5 Doors
Where external doors to raw material handling, processing, packaging and storage areas are opened,
precautions are taken to prevent pest ingress. Doors and dock levelers are tight fitting or adequately
4.3.2.5.1 sealed
4.3.2.5.2 Doors are in good condition and easy to clean, where required
4.3.2.6 Lighting
Sufficient lighting is provided for a safe working environment, correct operation of processes, inspection of
4.3.2.6.1 product and effective cleaning
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Where they pose a risk to product, bulbs and fluorescent lights shall be adequately protected. Where full
4.3.2.6.2 protection cannot be provided, alternative management or monitoring procedures shall be in place
4.3.2.7 Air Conditioning/Ventilation
4.3.2.7.1 Adequate ventilation and air flow is provided to prevent condensation or excessive dust
Where the process requires screened or filtered air, the equipment used for this purpose is easily
4.3.2.7.2 accessible and adequately maintained
4.3.2.7.3 Where appropriate, positive air-pressure systems shall be in place
4.4 Utilities
All water used as a raw material or for equipment or plant cleaning is supplied in sufficient quantity, be
4.4.1 potable, or pose no risk of contamination.
Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air, compressed
air or other gases that does not constitute an ingredient but comes in direct contact with food or packaging
4.4.2 shall be regularly monitored. It shall present no risk to product safety or quality.
4.5 Equipment
All equipment is properly specified before purchase, constructed of appropriate material, be designed so it
4.5.1 can be effectively cleaned and shall be tested and commissioned prior to use
Equipment shall be positioned to give access under, inside and around for ease of cleaning, inspection
4.5.2 and servicing. If permanently installed equipment shall be secured and sealed to the floor
Certificates of conformity or other evidence shall be available for equipment in direct contact with food to
4.5.3 confirm its suitability for use, e.g. conveyor belts.
4.6 Maintenance
4.6.1 Equipment shall be maintained to minimize the risk of product contamination
When commissioning new equipment, a maintenance program is established and put into place based on
4.6.2 risk assessment
Company ensures that the safety, regulatory compliance or legality of product is not jeopardized during
4.6.3 maintenance and cleaning operations
In addition to planned maintenance, where there is a risk of product contamination arising from equipment
failure, the equipment shall be inspected at predetermined intervals, inspection results are documented
4.6.4 and appropriate action taken
Temporary repairs are controlled to ensure the safety, legality and regulatory compliance of product.
4.6.5 Temporary repairs are permanently repaired as soon as practicable and within a defined time limit
4.6.6 Contractors involved in maintenance or repair are under the supervision of a designated person
Maintenance work is followed by a documented sanitary clearance procedure, which documents that
4.6.7 product contamination hazards have been removed from machinery and equipment
Materials used for maintenance and that pose a risk by direct or indirect contact with product, such as
4.6.8 lubricating oil and paints shall be suitable for the intended use
4.6.9 Maintenance workshops are controlled to prevent contamination risks to the product
4.7 Staff Facilities
4.7.1 Designated changing facilities are provided for all personnel, visitors or contractors
4.7.2 Storage facilities for personal items are provided for all staff personnel
4.7.3 Outdoor clothing and personal items are stored separately from work wear within the changing facilities
4.7.4 Suitable and sufficient hand-washing facilities are provided
Rest rooms are adequately segregated and do not open directly into production, packaging or storage
4.7.5 areas

4.7.6 Designated smoking areas are isolated from production areas. Containers for smokers' waste are provided
Food brought into the facility is stored in a clean and sanitary state. No food is allowed in production,
4.7.7 processing or storage areas
4.7.8 Lunch facilities are controlled to prevent contamination of product
4.7.9 If eating outside is allowed, containers for waste are provided
4.7.10 Facilities for visitors and contractors will enable them to comply with GMP's
Where an operation involving high-risk products exists, personnel enter by a specially designated
4.7.11 changing facility and shall follow specified procedures for putting on visually distinctive clothing
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4.8 Chemical/Physical Contamination Control
Based on risk assessment, company will identify, control and manage any potential risks from chemical,
4.8.1 physical or biological contamination
4.8.2 Chemical Control
Chemical control procedure is in place which manages the use, storage and handling of non-food
4.8.2.1 chemicals
4.8.3 Metal Control
There is a documented policy for control of knives, blades etc. Included are controls both into and out of
4.8.3.1 the factory, and safe disposal
4.8.3.2 Snap off blade knives are not used
Non-production blades, equipment and tools are not left in a position that allows them to contaminate the
4.8.3.3 product
If staples or other items are used that may cause contamination in packaging, appropriate precautions
4.8.3.4 shall be taken to minimize the risk of product contamination
4.8.4 Glass, Brittle and Hard Plastic, Ceramics and Similar Materials
In areas where risk assessment has identified potential for product contamination from glass, glass will be
4.8.4.1 excluded. If glass cannot be excluded, it will be protected from breakage
4.8.4.2 Documented procedures for handling glass, brittle plastics, etc are implemented and in place
4.8.4.3 Documented procedures detailing action to be taken in case of breakage are implemented and in place
4.8.5 Wood
In areas where a risk assessment has identified the potential for product contamination from wood, the
4.8.5.1 use of wood shall be excluded. If wood must be used, the condition is regularly checked
4.8.6 Other
Filters, sieves and magnets used for foreign body control are regularly inspected and maintained. Records
4.8.6.1 are maintained.
4.9 Housekeeping and Hygiene
4.9.1 Documented cleaning procedures are in place or building, utilities and equipment
4.9.2 CIP facilities are monitored and maintained to ensure effective operation
Cleaning and housekeeping are carried out by trained personnel in accordance with documented
4.9.3 procedures. Records are maintained
Cleaning chemicals and equipment are suitable for purpose, identified for intended use and stored in a
4.9.4 sanitary manner to prevent contamination
4.9.5 Effectiveness of cleaning procedures are verified and recorded. Corrective actions are documented
Cleaning procedures are revalidated following building or maintenance work, new product introduction or
4.9.6 changes to equipment
4.10 Waste/Waste Disposal
4.10.1 Systems are in place to avoid accumulation of waste in production areas
Where appropriate, waste shall be categorized according to governmental regulations based on intended
4.10.2 means of disposal, segregated and collected in appropriately designated waste containers
4.10.3 Waste disposal meets governmental regulations.
External waste collection containers and rooms housing waste facilities are managed to minimize risk.
They are clearly identified, designed for ease of use and effective cleaning, maintained to allow for
4.10.4 cleaning, emptied at appropriate frequencies and kept covered or doors closed as appropriate
If substandard trademarked materials are transferred to a third party for disposal, that third party shall be a
4.10.5 specialist in secure product or waste disposal and shall provide records of material disposal
4.11 Pest Control
4.11.1 A preventive pest control program is maintained covering all areas of the site
Company contracts services or has trained staff for the regular inspection and treatment of the site to deter
and eradicate infestation. Frequency of inspections is determined by risk assessment and are documented
4.11.2
4.11.3 Written procedures and inspection documentation is maintained
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4.11.4 Bait stations, etc are robust, tamper resistant, secured in place and appropriately located
4.11.5 Insect light traps/pheromone traps are correctly placed and operational
In the event of infestation, immediate actions are taken to eliminate the hazard. Action is taken to identify,
4.11.6 evaluate and authorize the release of any product potentially affected.
4.11.7 Detailed records of pest control inspections, recommendations and actions taken are maintained
Results of pest control inspection are assessed and analyzed for trends at least annually or in the event of
4.11.8 an infestation
4.12 Storage and Transport
Procedures to maintain product safety and quality during storage, loading and transportation are
4.12.1 developed on the basis of risk assessment and implemented accordingly
4.12.2 Where temperature control is required, facility is capable of maintaining product temp at specification
Where temperature control is required, documented procedures are in place to ensure product
temperature requirements are met. This includes data loggers or a system to verify and record at
4.12.3 predetermined frequencies the correct operation of refrigeration equipment
4.12.4 Where storage outside is necessary, items are protected from contamination and deterioration
Receipt documents and/or product identification facilitates correct stock rotation of goods in storage and
4.12.5 ensure materials are used in the correct order and within their shelf life
If the company employs third-party contractors, all the requirements in this section are clearly defined in
4.12.6 the contract or the contractors are certified to the Global Standard for Storage and Distribution
Traceability is ensured during storage and transportation. Clear records of shipping and receipt of goods
4.12.7 and material demonstrate that sufficient check have been completed during the transfer of goods
Documented maintenance and sanitation procedures are maintained for all vehicles and equipment used
4.12.8 for loading/unloading
Procedures are in place in the case of vehicle or refrigeration equipment breakdown. Incidents of vehicle
4.12.9 or refrigeration equipment breakdown are recorded and corrective action documented
5 Product Control
5.1 Product Design/Development
5.1.1 A HACCP-based study is part of the product design and development process
Production trials are carried out and testing validates that formulation and processes are capable of
5.1.2 producing a safe, compliant and legal product
Shelf-life trials are undertaken using documented protocols reflecting conditions during storage and
5.1.3 handling throughout shelf-life. Results are recorded and retained
Where new products are introduced, the company insures control of handling requirements for specific
5.1.4 materials
Procedures are in place to confirm that product packaging conforms to relevant food safety legislation and
5.1.5 specification and is suitable for its intended use
Senior Management insures that a system is in place to confirm that labeling of product or other forms of
5.1.6 customer information meets legislation requirements
Where a product is designed to enable a claim to made to satisfy a consumer group, the company
5.1.7 ensures that the product formulation and production process is fully validated against the claim
Product design/development process is documented and communicated through the organization to
5.1.8 ensure changes in formulation are assessed for safety, legality and regulatory compliance
5.2 Material Containing Allergens/Identity Preserved Materials
5.2.1 Materials Containing Allergens
Company carries out risk assessment of raw materials to establish the presence and likelihood of
contamination by allergens. This includes raw material specifications. Company implements system to
5.2.1.1 specify integrity of raw material and compliance with specification throughout the purchasing chain
Company identifies and lists allergen materials handled on site. Raw materials, work-in progress and
5.2.1.2 finished product
Risk assessment is carried out to identify routes of contamination and establish documented policies for
5.2.1.3 handling materials to ensure cross contamination is avoided
Where re-work is used procedures are implemented to minimize cross contamination from allergen
5.2.1.4 containing materials and ensure safety, legality, compliance and quality of the finished product
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Where a claim is made regarding suitability of a food for allergy or food sensitivity sufferers, the company
5.2.1.5 ensures and documents that the production process is fully validated to meet the claim
Based on risk assessment, documented equipment or area cleaning procedures are undertaken to
remove or reduce potential cross contamination to acceptable levels. This includes validation of cleaning
5.2.1.6 methods and appropriate waste handling and spillage controls
All relevant personnel, including temporary staff and contractors, are trained in handling procedures for
5.2.1.7 allergen-containing materials prior to commencing work.
Any non-conformities relating to allergen control are included in the management review process. The
5.2.1.8 review process also considers updates or changes in allergen legislation or scientific information
5.2.2 Identity Preserved Materials
Where an identity preserved claim is made, or where products brought into the facility may contain
materials which require segregation, the company carries out a risk assessment of raw materials to specify
5.2.2.1 the integrity of the raw material and compliance with specs throughout the purchasing chain
Risk assessment is carried out to identify routes of contamination and establish documented policies and
procedures for handling raw materials, work-in-progress and finished products to ensure cross
5.2.2.2 contamination is avoided and that controls are in place to maintain identity preserved status
5.3 Foreign Body Detection
Foreign body detection equipment is in place unless it can be justified as not necessary. This justification
5.3.1 shall be documented. Detection equipment is situated to maximize detection
Sensitivity of detection is specified and best practice applied with regard to the nature of the food, the
5.3.2 location of the detector and any other factors influencing the sensitivity of the detector
Metal or foreign body detector will incorporate an alarm on a belt stop system, or an automatic rejection
device which either diverts contaminated product out of the product flow or to a secure unit accessible only
to authorized personnel, or in-line detectors which identify the location of the contaminant and segregates
5.3.3 the affected product
Company establishes and implements procedures for the operation, routine monitoring, testing and
5.3.4 calibration of the metal or other foreign body detectors
Company establishes and implements corrective action and reporting procedures in the event of any
failure of the detector. Action includes a combination of isolation, quarantining and re-inspection of all
5.3.5 product produced since the last acceptable test of the detector
5.4 Product Packaging
5.4.1 Letters of guarantee or other evidence is available for product packaging confirming its suitability
5.4.2 Where appropriate, packaging is stored away from raw material and finished product
5.4.3 Any part-used packaging materials are effectively protected before being returned to storage
Product contact liners are appropriately colored and of sufficient gauge to prevent accidental
5.4.4 contamination
Where packaging material pose a product safety risk, special handling procedures are in place to prevent
5.4.5 product contamination
5.5 Product Inspection and Laboratory Testing
5.5.1 Product Inspection
Based on risk assessment, testing and inspection methods and schedules are established and
5.5.1.1 documented to ensure specified product requirements are met
Test and inspection results are recorded and reviewed regularly to identify trends. Actions are promptly
5.5.1.2 implemented to address any results outside of specifications
Where validation of finished product quality attributes is required, organoleptic tests are carried out
5.5.1.3 regularly in accordance with specifications and are recorded
Company ensures that a system of ongoing shelf life assessments are in place. This is risk based and
includes microbiological and sensory analysis as well as relevant chemical factors such as pH and Aw.
5.5.1.4 Records and results validate the minimum shelf life period indicated on the product
5.5.2 Laboratory Testing
Pathogen testing is subcontracted to an external laboratory or, where conducted internally, the laboratory
5.5.2.1 facility is remote from the manufacturing site
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Where routine testing laboratories are present on a manufacturing site, they are located, designed and
5.5.2.2 operated to eliminate potential risks to product safety
When the company subcontracts analyses which are critical to product safety, regulatory compliance or
legality, the laboratory is a recognized laboratory accredited to operate in accordance with ISO 17025.
5.5.2.3 Documented justification is available where accredited methods are not undertaken
5.5.2.4 Procedures are in place to ensure reliability of lab results, other than those specified in 5.5.2.3
5.6 Control of Non-Conforming Product
Procedures for the control of non-conforming material are in place and understood by all relevant staff.
5.6.1 Decisions are approved by authorized staff
Corrective actions are implemented to avoid recurrence of non-conformance. Details of non-conformance
5.6.2 and action taken are documented
All non-conforming material is clearly identified and quarantined as appropriate and handled or disposed
5.6.3 of according to the nature of the problem and/or requirements of the customer
5.7 Product Release
5.7.1
6 Process Control
6.1 Control of Operations
A process ensures that all CCP's and specified limits identified through HACCP are transferred into day-to-
6.1.1 day production controls and are fully validated
Process monitoring is established and adequately controlled to ensure that product is produced within the
6.1.2 required process specification
6.1.3 Process monitoring is carried out by trained staff and is documented
In circumstances where process parameters are controlled by in-line monitoring devices, these shall be
6.1.4 linked to a suitable failure alert system that is routinely tested
In the case of equipment failure or deviation of the process from specification, procedures are in place to
6.1.5 establish the safety status of the product prior to release
6.1.6 Corrective action is taken and documented in the event of deviation of process from specification
Procedures are in place to ensure that products are packed into the correct packaging and correctly
6.1.7 labeled with due consideration given to product changeover
In the event of changes to product formulation, processing methods, equipment or packaging, monitoring
6.1.8 of the specified process is re-established based on HACCP
6.2 Quantity - Weight, Volume and Number Control
The frequency and methodology of quantity checking meets the requirements of appropriate legislation
6.2.1 governing quantity verification
Where the quantity of the product is not governed by legislative requirements, the product must conform to
6.2.2 customer requirements
6.3 Calibration and Control of Measuring and Monitoring Devices
Company identifies measuring equipment used to monitor CCP's and product safety, legality and
regulatory compliance. This includes a documented list of equipment and equipment identified and marked
6.3.1 in accordance with requirements
All identified measuring devices are checked and adjusted at a predetermined frequency, based on risk
assessment, by trained staff, to a defined method traceable to a recognized national or international
6.3.2 standard where possible and the results are documented

6.3.3
Procedures are in place to record actions taken when the prescribed measuring and monitoring devices
6.3.4 are found not to be operating within specified limits
7 Personnel
7.1 Training
All relevant personnel, including temporary staff and contractors, have been appropriately trained prior to
7.1.1 beginning work and are adequately supervised while working
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Where personnel are engaged in activities relating to CCP's relevant training and documented monitoring
7.1.2 procedures are in place
7.1.3 Company has put in place documented programs covering the training needs of relevant personnel
7.1.4 Records of training are available
Company routinely reviews the competencies of staff and provides relevant training as appropriate. This
7.1.5 may be in the form of training, refresher training, coaching, mentoring or on-the-job experience
7.2 Access and Movement of Personnel
7.2.1 There is a site plan that defines access points for personnel, travel routes and staff facilities
If it is necessary to allow access through production areas, designated walkways are provided to ensure
7.2.2 there is adequate segregation from materials
All facilities are designed and positioned, where possible so that movement of personnel is by simple,
7.2.3 logical routes
Contractors and visitors, including drivers, are made aware of all procedures for access to premises and
the requirements of the area they are visiting, with special reference to hazards and potential product
7.2.4 contamination
7.3 Personnel Hygiene
Requirements for personal hygiene are documented and communicated to all personnel. Compliance with
7.3.1 requirements is checked regularly
7.3.2 Based on risk assessment, the company has documented its jewelry policy
Watches and jewelry shall not be worn, with the exception of a plain wedding ring, wedding wrist band or
continuous loop ear rings, unless identified as a food safety or occupational safety hazard. Rings and
7.3.3 studs in exposed parts of the body, such as noses, tongues or eyebrows shall not be worn
7.3.4 Hand cleaning is performed at a frequency that is appropriate based on risk assessment
Fingernails are kept short, clean and unpolished. False fingernails are not permitted. Where visitors cannot
7.3.5 comply, suitable control procedures are in place
7.3.6 Excessive perfume or aftershave shall not be worn
Smoking, eating and drinking is only permitted in designated areas segregated from food-handling and
7.3.7 storage areas
Cuts and scraped on exposed skin is covered by an appropriately colored bandage different from the
product color containing a metal detectable strip where metal detection/X-ray equipment is in use.
7.3.8 Bandages are company issued and monitored. Where appropriate, finger coverings are also worn
A sample from each batch of bandages are successfully tested through a metal detector and results
7.3.9 documented
7.3.10 Procedures are in place to control the use of personal medicines to minimize the risk of contamination
7.4 Medical Screening
Company has a procedure for the notification by employees, including temporary employees, of any
7.4.1 relevant infections, disease or condition with which they may have been in contact or are suffering from
7.4.2 At least in the US, this has been annotated as N/A
There are written and communicated procedures for employees, including temporary employees,
contractors and visitors, on actions to be taken in the case of infectious disease from which they may be
suffering or have been in contact with. Particular consideration should be given where product safety may
7.4.3 be compromised. Expert medical advice is sought where required.
7.5 Protective Clothing
Based on risk assessment, company had documented and communicated to all employees, contractors or
visitors the rules regarding the wearing and changing of protective clothing in specified work areas. This
also includes policies for wearing of protective clothing away from the production environment, such as
7.5.1 removal before entering rest rooms, break rooms and smoking areas
Protective clothing is available that is provided in sufficient numbers for each employee and of suitable
7.5.2 design to prevent contamination of the product
7.5.3 Clean and dirty clothing is segregated and controlled to prevent cross contamination

Laundering of protective clothing shall take place in-house using defined and verified criteria to validate
the effectiveness of the laundering process, or by approved contracted and audited laundry. The
effectiveness of cleaning shall be monitored. Washing of work wear by employees is exceptional but shall
be deemed acceptable where, based on a detailed risk assessment, it can be confirmed there is no risk to
7.5.4 product safety. Detailed procedures are in place to ensure the effectiveness of the laundering process
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Laundering of protective clothing shall take place in-house using defined and verified criteria validate CHECKLIST
the effectiveness of the laundering process, or by approved contracted and audited laundry. The
effectiveness of cleaning shall be monitored. Washing of work wear by employees is exceptional but shall
be deemed acceptable where, based on a detailed risk assessment, it can be confirmed there is no risk to
7.5.4 product safety. Detailed procedures are in place to ensure the effectiveness of the laundering process
Where there is the risk of contamination, smoking and eating while wearing protective clothing is not
7.5.5 permitted
7.5.6 All scalp hair is fully contained to prevent product contamination
Based on risk assessment, covers for beards and moustaches will be worn to prevent product
7.5.7 contamination
7.5.8 Suitable footwear is worn within the production environment

If gloves are used, they are replaced regularly. Where appropriate, gloves are suitable for food use, of a
7.5.9 disposable type, of a distinctive color (blue where possible, intact and not shed loose fibers
For operations involving high-risk products all visibly distinctive protective clothing is applied when
7.5.10 entering, and removed when leaving the high-risk area and stored in a designated changing area