TMS BRCGS START! Intermediate Audit Checklist

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Site conducted
Conducted on
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Location

1. Senior management commitment

1.1 Senior management commitment and continual improvement

1.1.1 The site shall have a documented policy which states the site’s intention to meet its obligation to produce safe, legal and authentic products to the specified quality, and its responsibility to its customers. This shall be: • signed by the person with overall responsibility for the site • communicated to all staff.
1.1.7 The company’s senior management shall provide the human and financial resources required to produce food safely and in compliance with the requirements of this Standard.
1.1.8 The company’s senior management shall have a system in place to ensure that the site is kept informed of and reviews: • scientific and technical developments • industry codes of practice • new risks to authenticity of raw materials • all relevant legislation in the country where the product will be sold (where known).
1.1.11 The most senior production or operations manager on site shall participate in the opening and closing meetings of the audit for certification to the Standard. Relevant departmental managers or their deputies shall be available as required during the audit.

1.2 Organisational structure, responsibilities and management authority

1.2.1 The company shall have an organisation chart demonstrating the management structure of the company. The responsibilities for the management of activities which ensure food safety, integrity, legality and quality shall be clearly allocated and understood by the managers responsible. It shall be clearly documented who deputises in the absence of the responsible person.
1.2.2 The site’s senior management shall ensure that all employees are aware of their responsibilities. Where documented work instructions exist for activities undertaken, the relevant employees shall have access to these and be able to demonstrate that work is carried out in accordance with the instructions.

2. The food safety plan – HACCP

2.1 The HACCP Food Safety team (equivalent to codex Alimentarius Step 1)

2.1.1 The HACCP or food safety plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for quality assurance, technical management, production operations, engineering and other relevant functions.
2.1.1 The team leader shall have an in-depth knowledge of Codex HACCP principles (or equivalent) and be able to demonstrate competence, experience and training. Where there is a legal requirement for specific training, this shall be in place.
2.1.1 The team members shall have specific knowledge of HACCP and relevant knowledge of products, processes and associated hazards.
2.1.1 In the event of the site not having the 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.

2.2 Prerequisite programmes

2.2.1 The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). As a guide these may include the following, although this is not an exhaustive list: • cleaning and sanitising • pest management • maintenance programmes for equipment and buildings • personal hygiene requirements • staff training • purchasing • transportation arrangements • processes to prevent cross-contamination • allergen controls.
2.2.1 The control measures and monitoring procedures for the prerequisite programmes must be clearly documented and shall be included within the development and reviews of the HACCP or food safety plan.

2.3 Describe the product (equivalent to Codex Alimentarius Step 2)

2.3.1 A full description for each product or group of products shall be developed, which includes all relevant information on food safety. As a guide, this may include the following, although this is not an exhaustive list: • composition (e.g. raw materials, ingredients, allergens, recipe) • origin of ingredients • physical or chemical properties that impact food safety (e.g. pH, aw) • treatment and processing (e.g. cooking, cooling) • packaging system (e.g. modified atmosphere, vacuum) • storage and distribution conditions (e.g. chilled, ambient) • maximum safe shelf life under prescribed storage and usage conditions.

2.5 Construct a process flow diagram (equivalent to Codex Alimentarius Step 4)

2.5.1 A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope, from raw material receipt through to processing, storage and distribution. As a guide, this should include the following, although this is not an exhaustive list: • plan of premises and equipment layout • raw materials, including introduction of utilities and other contact materials (e.g. water, packaging) • sequence and interaction of all process steps • outsourced processes and subcontracted work • potential for process delay • rework and recycling • low-risk/high-risk/high-care area segregation • finished products, intermediate/semi-processed products, by-products and waste.

2.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards (equivalent to Codex Alimentarius Step 6, Principle 1)

2.7.1 The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and consideration of the following types of hazard: • microbiological • physical contamination • chemical and radiological contamination • fraud (e.g. substitution or deliberate/intentional adulteration) • malicious contamination of products • allergen risks (see clause 5.3). It shall also take account of the preceding and following steps in the process chain.
2.7.2 The HACCP food safety team shall conduct a hazard analysis to identify hazards which need to be prevented, eliminated or reduced to acceptable levels. Consideration shall be given to the following: • likely occurrence of hazard • severity of the effects on consumer safety • vulnerability of those exposed • survival and multiplication of micro-organisms of specific concern to the product • presence or production of toxins, chemicals or foreign bodies • contamination of raw materials, intermediate/semi-processed product, or finished product. Where elimination of the hazard is not practical, justification for acceptable levels of the hazard in the finished product shall be determined and documented.
2.7.3 The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Where the control is achieved through existing prerequisite programmes, this shall be stated and the adequacy of the programme to control the specific hazard validated. Consideration may be given to using more than one control measure.

2.8 Determine the critical control points (CCPs) (equivalent to Codex Alimentarius Step 7, Principle 2)

2.8.1 For each hazard that requires control, control points shall be reviewed to identify those that are critical. This requires a logical approach and may be facilitated by use of a decision tree. Critical control points (CCPs) shall be those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level. If a hazard is identified at a step where control is necessary for safety but the control does not exist, the product or process shall be modified at that step, or at an earlier step, to provide a control measure.

2.9 Establish critical limits for each CCP (equivalent to Codes Alimentarius Step 8, Principle 3)

2.9.1 For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be: • measurable wherever possible (e.g. time, temperature, pH) • supported by clear guidance or examples where measures are subjective (e.g. photographs).
2.9.2 The HACCP food safety team shall validate each CCP. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level.

2.10 Establish a monitoring system for each CCP (equivalent to Codex Alimentarius Step 9, Principle 4)

2.10.1 A monitoring procedure shall be established for each CCP to ensure compliance with critical limits. The monitoring system shall be able to detect loss of control of CCPs and, wherever possible, provide information in time for corrective action to be taken. As a guide, consideration may be given to the following, although this is not an exhaustive list: • online measurement • offline measurement • continuous measurement (e.g. thermographs, pH meters etc.). Where discontinuous measurement is used, the system shall ensure that the sample taken is representative of the batch of product.
2.10.2 Records associated with the monitoring of each CCP shall include the date, time and result of measurement and shall be signed by the person responsible for the monitoring and verified, when appropriate, by an authorised person. Where records are in electronic form, there shall be evidence that records have been checked and verified.

2.11 Establish a corrective action plan (equivalent to Codex Alimentarius Step 10, Principle 5)

2.11.1 The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control. This shall include the action to be taken by nominated personnel with regard to any products that have been manufactured during the period when the process was out of control.

2.12 Establish verification procedures (equivalent to Codex Alimentarius Step 11, Principle 6)

2.12.1 Procedures of verification shall be established to confirm that the HACCP or food safety plan, including controls managed by prerequisite programmes, continues to be effective. Examples of verification activities include: • internal audits • review of records where acceptable limits have been exceeded • review of complaints by enforcement authorities or customers • review of incidents of product withdrawal or recall. Results of verification shall be recorded and communicated to the HACCP food safety team.

2.13 HACCP documentation and record-keeping (equivalent to Codex Alimentarius Step 12, Principle 7)

2.13.1 Documentation and record-keeping shall be sufficient to enable the site to verify that the HACCP and food safety controls, including controls managed by prerequisite programmes, are in place and maintained.

2.14 Review the HACCP plan

2.14.1 The HACCP food safety team shall review the HACCP or food safety plan and prerequisite programmes at least annually and prior to any changes which may affect food safety. As a guide, these may include the following, although this is not an exhaustive list: • change in raw materials or supplier of raw materials • change in ingredients/recipe • change in processing conditions, process flow or equipment • change in packaging, storage or distribution conditions • change in consumer use • emergence of a new risk (e.g. known adulteration of an ingredient or other relevant, published information, such as the recall of a similar product) • review following a recall • new developments in scientific information associated with ingredients, process or product. Appropriate changes resulting from the review shall be incorporated into the HACCP or food safety plan and/or prerequisite programmes, fully documented and the validation recorded. Where appropriate, the changes shall also be reflected in the company’s product safety policy and food safety objectives.

3. Food safety and quality management system

3.1 Food safety and quality manual

3.1.1 The site’s procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual.
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.
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 Document 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: • a list of all controlled documents indicating the latest version number • the method for the identification and authorisation of controlled documents • a record of the reason for any changes or amendments to documents • the system for the replacement of existing documents when these are updated. Where documents are stored in electronic form these shall also be: • stored securely (e.g. with authorised access, control of amendments, or password protected) • backed up to prevent loss.

3.3 Record completion and maintenance

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: • stored securely (e.g. with authorised access, control of amendments, or password protected) • suitably backed up to prevent loss.
3.3.2 Records shall be retained for a defined period with consideration given to: • any legal or customer requirements • the shelf life of the product. 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). At a minimum, records shall be retained for the shelf life of the product plus 12 months.

3.4 Internal audits

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. At a minimum, these inspections shall include: • hygiene inspections to assess cleaning and housekeeping performance • fabrication inspections to identify risks to the product from the building or equipment. The frequency of these inspections shall be based on risk but will be no less than once per month in open product areas.

3.5 Supplier and raw material approval and performance monitoring

3.5.1 Management of suppliers of raw materials and packaging

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: • a valid certification to the applicable BRCGS Standard or GFSI-benchmarked standard. The scope of the certification shall include the raw materials purchased • 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 the supplier audit is completed by a second or third party, the company shall be able to: - demonstrate the competency of the auditor - confirm that the scope of the audit includes product safety, traceability, HACCP review and good manufacturing practices - obtain and review a copy of the full audit report or • where a valid risk-based justification is provided and the supplier is assessed as low risk only, a completed supplier questionnaire may be used for initial approval. The questionnaire shall have a scope that includes product safety, traceability, HACCP review and good manufacturing practices, and it shall have been reviewed and verified by a demonstrably competent person.

3.5.2 Raw material and packaging acceptance, monitoring and management procedures

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: • product sampling and testing • visual inspection on receipt • certificates of analysis (specific to the consignment) • certificates of conformance. A list of raw materials (including primary packaging) and the requirements to be met for acceptance shall be available. The parameters for acceptance and frequency of testing shall be clearly defined, implemented and reviewed.

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.

3.5.4 Management of outsourced processing

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.
3.5.4.3 Any outsourced processing operations shall: • be undertaken in accordance with established contracts which clearly define any processing and/or packing requirements and product specification • maintain product traceability.

3.6 Specifications

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).
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. They shall include key data to meet customer and legal requirements and assist the user in the safe usage of the product.
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.

3.7 Corrective and preventative actions

3.7.1 The site shall have a procedure for handling and correcting failures identified in the food safety and quality management 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: • clear documentation of the non-conformity • assessment of consequences by a suitably competent and authorised person • the action to address the immediate issue • an appropriate timescale for correction • the person responsible for correction • verification that the correction has been implemented and is effective.

3.8 Control of non-conforming product

3.8.1 There shall be procedures for managing non-conforming products. These procedures shall include: • the requirement for staff to identify and report a potentially non-conforming product • clear identification of a non-conforming product (e.g. direct labelling or the use of IT systems) • secure storage to prevent accidental release (e.g. physical or computer-based isolation) • referral to the brand owner where required • 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) • records of the decision on the use or disposal of the product • records of destruction where a product is destroyed for food safety reasons.

3.9 Traceability

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.
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. The traceability test shall include a summary of the documents that should be referenced during the test, and clearly show the links between them. The test shall occur at a predetermined frequency, at a minimum annually, and results shall be retained for inspection. Traceability should be achievable within 4 hours.
3.9.4 Where rework or any reworking operation is performed, traceability shall be maintained.

3.10 Complaint-handling

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 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.

3.11 Management of incidents, product withdrawal and product recall

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: • disruption to key services such as water, energy, transport, refrigeration processes, staff availability and communications • events such as fire, flood or natural disaster • malicious contamination or sabotage • failure of, or attacks against, digital cyber-security. 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.
3.11.2 The company shall have a documented product withdrawal and recall procedure. This shall include, at a minimum: • identification of key personnel constituting the recall management team, with clearly identified responsibilities • guidelines for deciding whether a product needs to be recalled or withdrawn and the records to be maintained • 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. recall management team, emergency services, suppliers, customers, certification body, regulatory authority) • a communication plan including the provision of information to customers, consumers and regulatory authorities in a timely manner • details of external agencies providing advice and support as necessary (e.g. specialist laboratories, regulatory authority and legal expertise) • a plan to handle the logistics of product traceability, recovery or disposal of affected product, and stock reconciliation • a plan to record timings of key activities • a plan to conduct root cause analysis and to implement ongoing improvements, to avoid recurrence. The procedure shall be capable of being operated at any time.
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.

4. Site standards

4.1 External Standards

4.1.1 Consideration shall be given to local activities and the site environment, which may have an adverse impact on finished product integrity, and measures shall be taken to prevent contamination. Where measures have been put into place to protect the site (from potential contaminants, flooding etc.), they shall be reviewed in response to any changes.
4.1.2 The external areas shall be maintained in good order. Where grassed or planted areas are located near buildings, they shall be regularly tended and well maintained. External traffic routes under site control shall be suitably surfaced and maintained in good repair to mitigate the risk of contamination of the product.

4.2 Site Security and Food Defence

4.2.1 The company shall undertake a documented risk assessment (threat assessment) of the potential risks to products from any deliberate attempt to inflict contamination or damage. This threat assessment shall include both internal and external threats. The output from this assessment shall be a documented threat assessment plan. This plan shall be kept under review to reflect changing circumstances and market intelligence. It shall be formally reviewed at least annually and whenever: • a new risk emerges (e.g. a new threat is publicised or identified) • an incident occurs, where product security or food defence is implicated.
4.2.3 Areas where a significant risk is identified shall be defined, monitored and controlled. These shall include external storage and intake points for products and raw materials (including packaging). Policies and systems shall be in place to ensure that only authorised personnel have access to production and storage areas, and that access to the site by employees, contractors and visitors is controlled. A visitor recording system shall be in place. Staff shall be trained in site security procedures and food defence.

4.3 Layout, product flow and segregation

4.3.3 The movement of personnel, raw materials, packaging, rework and/or waste shall not compromise the safety of products. The process flow, together with the use of demonstrably effective procedures, shall be in place to minimise the risk of the contamination of raw materials, intermediate/semi-processed products, packaging and finished products.
4.3.4 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe hygienic conditions.

4.4 Building fabric, raw material handling, preparation, processing, packing and storage areas

4.4.1 Walls shall be finished and maintained to prevent the accumulation of dirt, minimise condensation and mould growth, and facilitate cleaning.
4.4.2 Floors shall be suitably hard-wearing to meet the demands of the process, and withstand cleaning materials and methods. They shall be impervious, be maintained in good repair and facilitate cleaning.
4.4.3 Drainage, where provided, shall be sited, designed and maintained to minimise risk of product contamination and not compromise product safety. Machinery and piping shall be arranged so that, wherever feasible, process waste water goes directly to drain. Where significant amounts of water are used, or direct piping to drain is not feasible, floors shall have adequate falls to cope with the flow of any water or effluent towards suitable drainage.
4.4.4 Ceilings and overheads shall be constructed, finished and maintained to prevent the risk of product contamination.
4.4.7 Where there is a risk to product, windows and roof glazing which are designed to be opened for ventilation purposes shall be adequately screened to prevent the ingress of pests.
4.4.8 Doors (both internal and external) shall be maintained in good condition. At a minimum: • external doors and dock levellers shall be close fitting or adequately proofed • external doors to open product areas shall not be opened during production periods except in emergencies • where external doors to enclosed product areas are opened, suitable precautions shall be taken to prevent pest ingress.
4.4.9 Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of product and effective cleaning.

4.5 Utilities – water, ice, air and other gases

4.5.1 All water (including ice and steam) used as a raw material in the manufacture of processed food, the preparation of product, hand-washing or for equipment or plant cleaning shall be supplied in sufficient quantity, be potable at point of use or pose no risk of contamination according to applicable legislation. The microbiological and chemical quality of water shall be analysed at least annually. The sampling points, scope of the test and frequency of analysis shall be based on risk, taking into account the source of the water, on-site storage and distribution facilities, previous sample history and usage.
4.5.3 Air and other gases used as an ingredient or that are in direct contact with products shall be monitored to ensure this does not represent a contamination risk. Compressed air that is in direct contact with the product shall be filtered at point of use.

4.6 Equipment

4.6.2 Equipment that is in direct contact with food shall be suitable for food contact and meet legal requirements where applicable.

4.7 Maintenance

4.7.1 There shall be a documented planned maintenance schedule or condition monitoring system which includes all plant and processing equipment. The maintenance requirements shall be defined when commissioning new equipment.
4.7.2 In addition to any planned maintenance programme, where there is a risk of product contamination by foreign bodies arising from equipment damage, the equipment shall be inspected at predetermined intervals, the inspection results documented and appropriate action taken.
4.7.3 Where temporary repairs are made, these shall be documented and controlled to ensure that the safety or legality of products is not jeopardised. These temporary measures shall be permanently repaired as soon as practicable and within a defined timescale.
4.7.4 The site shall ensure that the safety or legality of products is not jeopardised during maintenance and subsequent cleaning operations. Maintenance work shall be followed by a documented hygiene clearance procedure. Equipment and machinery shall be inspected by an authorised member of staff to confirm the removal of contamination hazards, before being accepted back into operation.

4.8 Staff facilities

4.8.1 Designated changing facilities shall be provided for all personnel, whether staff, visitor or contractor. These shall be sited to allow direct access to the production, packing or storage areas without recourse to any external area. Where this is not possible, a risk assessment shall be carried out and procedures implemented accordingly (e.g. the provision of cleaning facilities for footwear).
4.8.3 Outdoor clothing and other personal items shall be stored separately from production clothing within the changing facilities. Facilities shall be available to separate clean and dirty production clothing.
4.8.4 Suitable and sufficient hand-washing facilities shall be provided at access to, and at other appropriate points within, production areas. Such hand-washing facilities shall provide, at a minimum: • advisory signs to prompt hand-washing • a sufficient quantity of water at a suitable temperature • water taps with hands-free operation • liquid/foam soap • single-use towels or suitably designed and located air driers.
4.8.5 Toilets shall be adequately segregated and shall not open directly into production or packing areas. Toilets shall be provided with hand-washing facilities comprising: • basins with soap and water at a suitable temperature • adequate hand-drying facilities • advisory signs to prompt hand-washing. Where hand-washing facilities within toilet facilities are the only facilities provided before re-entering production, the requirements of clause 4.8.4 shall apply and signs shall be in place to direct people to hand-washing facilities before entering production.
4.8.6 Where smoking is allowed under national law, designated controlled smoking areas shall be provided which are both isolated from production areas to an extent that ensures smoke cannot reach the product and fitted with sufficient extraction to the exterior of the building. Adequate arrangements for dealing with smokers’ waste shall be provided at smoking facilities, both inside and at exterior locations. Electronic cigarettes shall not be permitted to be used or brought into production or storage areas.
4.8.7 All food brought into manufacturing premises by staff shall be appropriately stored in a clean and hygienic state. No food shall be taken into storage, processing or production areas. Where eating of food is allowed outside during breaks, this shall be in suitable designated areas with appropriate control of waste.

4.9 Chemical and physical product contamination control: raw material handling, preparation, processing, packing and storage areas

4.9.1 Chemical control

4.9.1.1 Processes shall be in place to manage the use, storage and handling of non-food chemicals to prevent chemical contamination. These shall include, at a minimum: • an approved list of chemicals for purchase • availability of material safety data sheets and specifications • confirmation of suitability for use in a food-processing environment • avoidance of strongly scented products • the labelling and/or identification of containers of chemicals at all times • a designated storage area with restricted access to authorised personnel • use by trained personnel only.

4.9.2 Metal control

4.9.2.2 The purchase of ingredients and packaging which use staples or other foreign-body hazards as part of the packaging materials shall be avoided. Staples, paper clips and drawing pins shall not be used in open product areas. Where staples or other items are present as packaging materials or closures, appropriate precautions shall be taken to minimise the risk of product contamination.

4.9.3 Glass, brittle plastic, ceramics and similar materials

4.9.3.1 Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination.
4.9.3.3 Procedures detailing the action to be taken in case of breakage of glass or other brittle items shall be implemented and include the following: • training of staff in the correct procedure • quarantining the products and production area that were potentially affected • cleaning the production area • inspecting the production area and authorising production to continue • changing of workwear and inspection of footwear • specifying those staff authorised to carry out the above points • recording the breakage incident • safely disposing of contaminated product.
4.9.3.4 Where they pose a risk to product, glass windows shall be protected against breakage.
4.9.3.5 Where they pose a risk to product, bulbs and strip lights (including those on electric fly-killer devices) shall be adequately protected. Where full protection cannot be provided, alternative management such as wire-mesh screens or monitoring procedures shall be in place.

4.9.4 Products packed into glass or other brittle containers

4.9.4.2 Systems shall be in place to manage container breakages between the container cleaning/inspection point and container closure. This shall include, at a minimum, documented instructions which ensure: • the removal and disposal of at-risk products in the vicinity of the breakage; this may be specific for different equipment or areas of the production line • the effective cleaning of the line or equipment which may be contaminated by fragments of the container; cleaning shall not result in the further dispersal of fragments, for instance by the use of high-pressure water or air • the use of dedicated, clearly identifiable cleaning equipment (e.g. colour-coded) for removal of container breakages; such equipment shall be stored separately from other cleaning equipment • the use of dedicated, accessible, lidded waste containers for the collection of damaged containers and fragments • a documented inspection of production equipment is undertaken following the cleaning of a breakage to ensure cleaning has effectively removed any risk of further contamination • authorisation is given for production to restart following cleaning • the area around the line is kept clear of broken glass.

4.9.5 Wood

4.9.5.1 Wood should not be used in open product areas except where this is a process requirement (e.g. maturation of products in wood). Where the use of wood cannot be avoided, the condition of wood shall be continually monitored to ensure it is in good condition and free from damage or splinters which could contaminate products.

4.10 Foreign-body detection and removal equipment

4.10.1 Selection and operation of foreign-body detection and removal equipment

4.10.1.1 A documented assessment in association with the HACCP study shall be carried out on each production process to identify the potential use of equipment to detect or remove foreign-body contamination. Typical equipment to be considered may include: • filters • sieves • metal detection • magnets • optical sorting equipment • X-ray detection equipment • other physical separation equipment (e.g. gravity separation, fluid bed technology).
4.10.1.2 The type, location and sensitivity of the detection and/or removal method shall be specified as part of the site’s documented system. Industry best practice shall be applied with regard to the nature of the ingredient, material, product and/or the packed product. The location of the equipment or any other factors influencing the sensitivity of the equipment shall be validated and justified.
4.10.1.3 The site shall ensure that the frequency of the testing of the foreign-body detection and/or removal equipment is defined and takes into consideration: • specific customer requirements • the site’s ability to identify, hold and prevent the release of any affected materials, should the equipment fail. The site shall establish and implement corrective action and reporting procedures in the event of a failure of the foreign-body detector and/or removal equipment. Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.
4.10.1.4 Where foreign material is detected or removed by the equipment, the source of any unexpected material shall be investigated. Information on rejected materials shall be used to identify trends and, where possible, instigate preventive action to reduce the occurrence of contamination by the foreign material.

4.10.2 Filters and sieves

4.10.2.1 Filters and sieves used for foreign-body control shall be of a specified mesh size or gauge and designed to provide the maximum practical protection for the product.
4.10.2.2 Filters and sieves shall be regularly inspected or tested for damage at a documented frequency based on risk. Records shall be maintained of the checks. Where defective filters or sieves are identified this shall be recorded and the potential for contamination of products investigated and appropriate action taken.

4.10.3 Metal detectors and X-ray equipment

4.10.3.1 Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve the protection of final products from metal contamination. Where metal detectors are not used justification shall be documented. The absence of metal detection would only normally be based on the use of an alternative, more effective method of protection (e.g. use of X-ray, fine sieves or filtration of products).
4.10.3.2 The metal detector or X-ray equipment shall incorporate one of the following: • an automatic rejection device, for continuous in-line systems, which shall either divert contaminated product out of the product flow or to a secure unit accessible only to authorised personnel • a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very large packs) • in-line detectors which identify the location of the contaminant to allow effective segregation of the affected product.

4.10.6 Container cleanliness – glass jars, cans and other rigid containers

4.10.6.1 Based on risk assessment, procedures shall be implemented to minimise foreign-body contamination originating from the packaging container (e.g. jars, cans and other pre-formed rigid containers). This may include the use of covered conveyors, container inversion and foreign-body removal through rinsing with water or air jets.

4.11 Housekeeping and hygiene

4.11.1 The premises and equipment shall be maintained in a clean and hygienic condition.
4.11.2 Documented cleaning procedures shall be in place and maintained for the building, plant and all equipment. Cleaning procedures for the processing equipment and food contact surfaces shall, at a minimum, include: • responsibility for cleaning • item/area to be cleaned • frequency of cleaning • method of cleaning, including dismantling equipment for cleaning purposes where required • cleaning chemicals and concentrations • cleaning materials to be used • cleaning records and responsibility for verification. The frequency and methods of cleaning shall be based on risk. The procedures shall be implemented to ensure appropriate standards of cleaning are achieved.
4.11.4 The resources for undertaking cleaning shall be available. Where it is necessary to dismantle equipment for cleaning purposes or to enter large equipment for cleaning, this shall be appropriately scheduled and, where necessary, planned for non-production periods. Cleaning staff shall be adequately trained or engineering support provided where access within equipment is required for cleaning.
4.11.6 Cleaning equipment shall be: • hygienically designed and fit for purpose • suitably identified for intended use (e.g. colour-coded or labelled) • cleaned and stored in a hygienic manner to prevent contamination.

4.11.7 Cleaning in place (CIP)

4.11.7.3 The CIP equipment shall be maintained by suitably trained staff to ensure effective cleaning is carried out. This shall include: • detergent concentrations shall be checked routinely • recovered post-rinse solutions shall be monitored for build-up of carry-over from the detergent tanks • filters, where fitted, shall be cleaned and inspected at a defined frequency • where used, flexible hoses shall be stored hygienically when not in use, and inspected at a defined frequency to ensure that they are in good condition.
4.11.7.4 CIP facilities, where used, shall be monitored at a defined frequency based on risk. This may include: • monitoring of process parameters defined in clause 4.11.7.2 • ensuring correct connections, piping and settings are in place • confirming the process is operating correctly (e.g. valves opening/closing sequentially) • ensuring effective completion of the cleaning cycle • monitoring for effective results, including draining where required. Procedures shall define the action to be taken if monitoring indicates that processing is outside the defined limits.

4.12 Waste/waste disposal

4.12.1 Where licensing is required by law for the removal of waste, it shall be removed by licensed contractors and records of removal shall be maintained and available for audit.
4.12.2 Internal and external waste collection containers and rooms housing waste facilities shall be managed to minimise risk. These shall be: • clearly identified • designed for ease of use and effective cleaning • well maintained to allow cleaning and, where required, disinfection • emptied at appropriate frequencies. External waste containers shall be covered or doors kept closed as appropriate.

4.14 Pest management

4.14.1 If pest activity is identified, it shall not present a risk of contamination to products, raw materials or packaging. The presence of any infestation on site shall be documented in pest management records and be part of an effective pest control programme to eliminate or manage the infestation so that it does not present a risk to products, raw materials or packaging.
4.14.2 The site shall either contract the services of a competent pest management organisation or have appropriately trained staff for the regular inspection and treatment of the site to deter and eradicate infestation. The frequency of inspections shall be determined by risk assessment and shall be documented. The risk assessment shall be reviewed whenever: • there are changes to the building or production processes which could have an impact on the pest management programme • there has been a significant pest issue. Where the services of a pest management contractor are employed, the service scope shall be clearly defined and reflect the activities of the site. Service provision regardless of the source shall meet with all applicable regulatory requirements.
4.14.3 Where a site undertakes its own pest management, it shall be able to effectively demonstrate that: • 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 • staff undertaking pest management activities meet any legal requirements for training or registration • sufficient resources are available to respond to any infestation issues • there is ready access to specialist technical knowledge when required • legislation governing the use of pest control products is understood and complied with • dedicated locked facilities are used for the storage of pesticides.
4.14.4 Pest management documentation and records shall be maintained. At a minimum, this shall include: • an up-to-date plan of the full site, identifying pest control devices and their locations • identification of the baits and/or monitoring devices on site • clearly defined responsibilities for the site management and the contractor • details of pest control products used, including instructions for their effective use and action to be taken in case of emergencies • any observed pest activity • details of pest control treatments undertaken. Records may be on paper (hard copy) or controlled on an electronic system (e.g. an online reporting system).
4.14.5 Bait stations or other rodent monitoring or control devices shall be appropriately located and maintained to prevent contamination risk to product. Toxic rodent baits shall not be used within production or storage areas where open product is present except when treating an active infestation. Where toxic baits are used, these shall be secured. Any missing bait stations shall be recorded, reviewed and investigated.
4.14.6 Insect-killing devices, pheromone traps and/or other insect monitoring devices shall be appropriately sited and operational. If there is a danger of insects being expelled from a fly-killing extermination device and contaminating the product, alternative systems and equipment shall be used.
4.14.8 In the event of infestation, or 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 should be subject to the non-conforming product procedure.
4.14.9 Records of pest management inspections, pest proofing and 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 carried out in a timely manner.
4.14.12 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.

4.15 Storage facilities

4.15.3 Where temperature control is required (e.g. for raw materials, semi-finished materials or final products), the storage area shall be capable of maintaining product temperature within specification and operated to ensure specified temperatures are maintained. Temperature recording equipment with suitable temperature alarms shall be fitted to all storage facilities or there shall be a system of recorded manual temperature checks, typically on at least a 4-hourly basis or at a frequency which allows for intervention before product temperatures exceed defined limits for the safety, legality or quality of products.
4.15.4 Where controlled atmosphere storage is required, the storage conditions shall be specified and effectively controlled. Records shall be maintained of the storage conditions.
4.15.5 Where storage outside is necessary, items shall be protected from contamination and deterioration. Items shall be checked for suitability before being brought into the factory.
4.15.6 The site shall facilitate correct stock rotation of raw materials, intermediate products and finished products in storage and ensure that materials are used in the correct order in relation to their manufacturing date and within the prescribed shelf life.

4.16 Dispatch and transport

4.16.1 Procedures to maintain product safety and quality during loading and transportation shall be developed and implemented. These may include, as appropriate: • controlling temperature of loading dock areas and vehicles • the use of covered bays for vehicle loading or unloading • securing loads on pallets to prevent movement during transit • inspection of loads prior to dispatch.
4.16.2 All vehicles or containers used for the transport of raw materials and the dispatch of products shall be fit for purpose. This shall ensure that they are: • in a clean condition • free from strong odours which may cause taint to products • in a suitable condition to prevent damage to products during transit • equipped to ensure any temperature requirements can be maintained throughout transportation. Records of inspections shall be maintained.
4.16.3 Where temperature control is required, the transport shall be capable of maintaining product temperature within specification, under minimum and maximum load. Temperature data-logging devices which can be interrogated to confirm time/temperature conditions or a system to monitor and record at predetermined frequencies the correct operation of refrigeration equipment shall be used and records maintained.
4.16.4 Maintenance systems and documented cleaning procedures shall be available for all vehicles and equipment used for loading/unloading. There shall be records of the measures taken.

5. Product control

5.1 Product design/development

5.1.2 All new products and changes to product formulation, packaging or methods of processing shall be formally approved by the HACCP team leader or authorised HACCP committee member. This shall ensure that hazards have been assessed and suitable controls, identified through the HACCP system, are implemented. This approval shall be granted before products are introduced into the factory environment.

5.2 Product labelling

5.2.1 All products shall be labelled to meet legal requirements for the designated country of use and shall include information to allow the safe handling, display, storage, preparation and use of the product within the food supply chain or by the customer. There shall be a process to verify that ingredient and allergen labelling is correct based on the product recipe and ingredient specifications.
5.2.3 Where a product is designed to enable a claim to be made to satisfy a consumer group (e.g. a nutritional claim, reduced sugar), the company shall ensure that the product formulation and production process are fully validated to meet the stated claim.

5.3 Management of allergens

5.3.2 The company shall identify and list allergen-containing materials handled on site. This shall include raw materials, processing aids, intermediate and finished products, and any new product development ingredients or products.
5.3.4 Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination (cross-contact) of products not containing the allergen. These shall include, as appropriate: • physical or time segregation while allergen-containing materials are being stored, processed or packed • the use of separate or additional protective overclothing when handling allergenic materials • use of identified, dedicated equipment and utensils for processing • scheduling of production to reduce changes between products containing an allergen and products not containing the allergen • systems to restrict the movement of airborne dust containing allergenic material • waste handling and spillage controls • restrictions on food brought onto site by staff, visitors and contractors and for catering purposes.
5.3.5 Where rework is used, or reworking operations are carried out, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen.
5.3.6 Where a justified, risk-based assessment demonstrates that the nature of the production process is such that cross-contamination (cross-contact) from an allergen cannot be prevented, a warning should be included on the label. National guidelines or codes of practice shall be used when making such a warning statement.
5.3.8 Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination (cross-contact) by allergens. The cleaning methods shall be validated to ensure that they are effective and the effectiveness of the procedure routinely verified. Cleaning equipment used to clean allergenic materials shall either be identifiable and specific for allergen use, single use, or effectively cleaned after use.

5.4 Product authenticity, claims and chain of custody

5.4.4 Where products are labelled or claims are made on finished packs which are dependent on the status of a raw material, the status of each batch of the raw material shall be verified. These claims include: • specific provenance or origin • breed/varietal claims • assured status (e.g. GlobalG.A.P.) • genetically modified organism (GMO) status • identity preserved • named specific trademarked ingredients. The facility shall maintain purchasing records, traceability of raw material usage and final product packing records to substantiate claims. The site shall undertake documented mass balance tests at a frequency to meet the particular scheme requirements or at least every 6 months in the absence of a scheme-specific requirement.
5.4.5 Where claims are made about the methods of production (e.g. organic, halal, kosher) the site shall maintain the necessary certification status in order to make such a claim.
5.4.6 The process flow for the production of products where claims are made shall be documented and potential areas for contamination or loss of identity identified. Appropriate controls shall be established to ensure the integrity of the product claims.

5.5 Product Packaging

5.5.2 Product liners and bags purchased by the company for use in direct contact with ingredients, or work in process, shall be appropriately coloured (e.g. contrasting colour to the product) and resistant to tearing to prevent accidental contamination.

5.6 Product inspection and laboratory testing

5.6.1 Product inspection and testing

5.6.1.1 There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk. The methods, frequency and specified limits shall be documented.

5.6.2 Laboratory testing

5.6.2.2 Where routine testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented, implemented and include consideration of: • design and operation of drainage and ventilation systems • access and security of the facility • movement of laboratory personnel • protective clothing arrangements • processes for obtaining product samples • disposal of laboratory waste.
5.6.2.3 Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC 17025. Documented justification shall be available where accredited methods are not undertaken.
5.6.2.4 Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 5.6.2.3. These shall include: • use of recognised test methods, where available • documented testing procedures • ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required • use of a system to verify the accuracy of test results (e.g. ring or proficiency testing) • use of appropriately calibrated and maintained equipment.
5.6.2.5 The significance of laboratory results shall be understood and acted upon accordingly. Appropriate action shall be taken promptly to address any unsatisfactory results or trends. Where legal limits apply, these shall be understood and appropriate action taken promptly to address any exceedance of these limits.

5.7 Product release

5.7.1 Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorised.

6. Process control

6.1 Control of operations

6.1.1 Documented process specifications and work instructions/procedures shall be available for the key processes in the production of products to ensure product safety, legality and quality. The specifications/procedures as appropriate shall include: • recipes – including identification of any allergens • mixing instructions, speed, time • equipment process settings • cooking times and temperatures • cooling times and temperatures • labelling instructions • coding and shelf-life marking • any additional critical control points identified in the HACCP or food safety plan. Process specifications shall be in accordance with the agreed finished product specification.
6.1.3 Process monitoring, such as of temperature, time, pressure and chemical properties, shall be implemented, adequately controlled and recorded to ensure that product is produced within the required process specification.
6.1.5 Where variation in processing conditions may occur within equipment critical to the safety or quality of products, the processing characteristics shall be validated and verified at a frequency based on risk and performance of equipment (e.g. heat distribution in retorts, ovens and processing vessels; temperature distribution in freezers and cold stores).
6.1.6 In the case of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety status and quality of the product to determine the action to be taken.

6.2 Labelling and pack control

6.2.3 Procedures shall be in place to ensure that all products are packed into the correct packaging and correctly labelled. These shall include checks: • at the start of packing • during the packing run • when changing batches of packaging materials • at the end of each production run. The checks shall also include verification of any printing carried out at the packing stage including, as appropriate: • date coding • batch coding • quantity indication • pricing information • bar coding • country of origin • allergen information.

6.3 Quantity – weight, volume and number control

6.3.1 The frequency and methodology of quantity checking shall meet the requirements of the appropriate legislation governing quantity verification, and records of checks shall be retained.

6.4 Calibration and control of measuring and monitoring devices

6.4.2 All identified measuring devices, including new equipment, shall be checked and, where necessary, adjusted: • at a predetermined frequency, based on risk assessment • to a defined method traceable to a recognised national or international standard where possible. Results shall be documented. Equipment shall be readable and be of a suitable accuracy for the measurements it is required to perform.
6.4.4 Procedures shall be in place to record actions to be taken when the prescribed measuring devices are found not to be operating within specified limits. Where the safety or legality of products is based on equipment found to be inaccurate, action shall be taken to ensure at-risk product is not offered for sale.

7. Personnel

7.1 Training: raw material handling, preparation, processing, packing and storage areas

7.1.1 All relevant personnel, including agency-supplied staff, temporary staff and contractors, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period.
7.1.2 Where personnel are engaged in activities relating to critical control points, relevant training and competency assessment shall be in place.
7.1.4 All relevant personnel, including engineers, agency-supplied staff, temporary staff and contractors, shall have received general allergen awareness training and be trained in the site’s allergen-handling procedures.
7.1.6 Records of all training shall be available. These shall include, at a minimum: • the name of the trainee and confirmation of attendance • the date and duration of the training • the title or course contents, as appropriate • the training provider • for internal courses, a reference to the material, work instruction or procedure that is used in the training. Where training is undertaken by agencies on behalf of the company, records of the training shall be available.
7.1.7 The company shall routinely review the competencies of its staff. As appropriate, it shall provide relevant training. This may be in the form of training, refresher training, coaching, mentoring or on-the-job experience.

7.2 Personal hygiene: raw material handling, preparation, processing, packing and storage areas

7.2.1 The requirements for personal hygiene shall be documented and communicated to all personnel. These shall include, at a minimum, the following: • watches shall not be worn • jewellery shall not be worn, with the exception of a plain wedding ring, wedding wristband or medical alert jewellery • rings and studs in exposed parts of the body, such as ears, noses and eyebrows, shall not be worn • fingernails shall be kept short, clean and unvarnished • false fingernails and nail art shall not be permitted • excessive perfume or aftershave shall not be worn. Compliance with the requirements shall be checked routinely.
7.2.2 Hand-washing shall be performed on entry to the production areas and at a frequency that is appropriate to minimise the risk of product contamination.
7.2.3 All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster that is different from the product colour (preferably blue) and contains a metal detectable strip. These shall be site-issued and monitored. Where appropriate, in addition to the plaster, a glove shall be worn.

7.3 Medical screening

7.3.1 The site shall make employees aware of the symptoms of infection, disease or condition which would prevent a person working with open food. The site shall have a procedure which enables notification by employees, including temporary employees, of any relevant symptoms, infection, disease or condition with which they may have been in contact or be suffering from.
7.3.2 Where there may be a risk to product safety, visitors and contractors shall be made aware of the types of symptoms, infection, disease or condition which would prevent a person visiting areas with open food. Where permitted by law, visitors shall be required to complete a health questionnaire or otherwise confirm that they are not suffering from any symptoms which may put product safety at risk, prior to entering the raw material, preparation, processing, packing and storage areas.
7.3.3 There shall be procedures for employees, contractors and visitors relating to action to be taken where they may be suffering from or have been in contact with an infectious disease. Expert medical advice shall be sought where required.

7.4 Protective clothing: employees or visitors to production areas

7.4.1 The company shall document and communicate to all employees (including agency and temporary personnel), contractors or visitors the rules regarding the wearing of protective clothing in specified work areas (e.g. production areas, storage areas etc.). This shall also include policies relating to the wearing of protective clothing away from the production environment (e.g. removal before entering toilets, and use of canteen and smoking areas).
7.4.2 Protective clothing shall be available that: • is provided in sufficient numbers for each employee • is of suitable design to prevent contamination of the product (at a minimum containing no external pockets above the waist or sewn-on buttons) • fully contains all scalp hair to prevent product contamination • includes snoods for beards and moustaches, where required, to prevent product contamination.
7.4.4 Protective clothing shall be changed at an appropriate frequency, based on risk.

8. High-risk, high-care and ambient high-care production risk zones

8.1 Layout, product flow and segregation in high-risk, high-care and ambient high-care zones

8.1.2 Where high-risk areas are part of the manufacturing site, there shall be physical segregation between these areas and other parts of the site. Segregation shall take into account the flow of product, the nature of the materials (including packaging), the equipment, the personnel, the disposal of waste, the flow of air, the air quality, and the provision of utilities (including drains). The location of transfer points shall not compromise the segregation between high-risk areas and other areas of the factory. Practices shall be in place to minimise the risk of product contamination (e.g. the disinfection of materials on entry).
8.1.3 Where high-care areas are part of the manufacturing site, there should be physical segregation between these areas and other parts of the site. Segregation shall take into account the flow of product, the nature of materials (including packaging), the equipment, the personnel, the disposal of waste, the flow of air, the air quality, and the provision of utilities (including drains). Where physical barriers are not in place, the site shall have undertaken a documented risk assessment of the potential for cross-contamination, and effective, validated processes shall be in place to protect products from contamination.
8.1.4 Where ambient high-care areas are required, a documented risk assessment shall be completed to determine the risk of cross-contamination with pathogens. The risk assessment shall take into account the potential sources of microbiological contamination and include: • the raw materials and products • the flow of raw materials, packaging, products, equipment, personnel and waste • air flow and quality • the provision and location of utilities (including drains). Effective processes shall be in place to protect the final product from microbiological contamination. These processes may include segregation, management of process flow or other controls.

8.4 Staff facilities for high-risk and high-care zones

8.4.1 Where an operation includes a high-risk or high-care area, personnel shall enter via a specially designated changing facility at the entrance to the area. The changing facilities shall incorporate the following: • clear instructions for the order of changing into and out of dedicated protective clothes to prevent the contamination of clean clothing • protective clothing that is visually distinct from that worn in other areas and which shall not be worn outside the area • a hand-washing routine during the changing procedure to prevent contamination of the clean clothing (i.e. hand-washing after hair covering and footwear have been put on, but before handling clean protective clothing) • provision and use of hand-washing and disinfection facilities. At a minimum these shall be: - prior to entry for high-risk areas - on entry for high-care areas • dedicated site footwear that is provided by the site and which shall not be worn outside the factory • an effective control of footwear to prevent the introduction of pathogens into the area. Control may be by segregation and a controlled change of footwear before entering the area (such as a barrier or bench system) or by the use of controlled and managed boot-wash facilities where these demonstrably provide an effective control of footwear to prevent the introduction of pathogens into the area. A programme of environmental monitoring shall be used to assess the effectiveness of footwear controls.

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1. Senior management commitment

1.1 Senior management commitment and continual improvement

1.2 Organisational structure, responsibilities and management authority

2. The food safety plan – HACCP

2.1 The HACCP Food Safety team (equivalent to codex Alimentarius Step 1)

2.2 Prerequisite programmes

2.3 Describe the product (equivalent to Codex Alimentarius Step 2)

2.5 Construct a process flow diagram (equivalent to Codex Alimentarius Step 4)

2.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards (equivalent to Codex Alimentarius Step 6, Principle 1)

2.8 Determine the critical control points (CCPs) (equivalent to Codex Alimentarius Step 7, Principle 2)

2.9 Establish critical limits for each CCP (equivalent to Codes Alimentarius Step 8, Principle 3)

2.10 Establish a monitoring system for each CCP (equivalent to Codex Alimentarius Step 9, Principle 4)

2.11 Establish a corrective action plan (equivalent to Codex Alimentarius Step 10, Principle 5)

2.12 Establish verification procedures (equivalent to Codex Alimentarius Step 11, Principle 6)

2.13 HACCP documentation and record-keeping (equivalent to Codex Alimentarius Step 12, Principle 7)

2.14 Review the HACCP plan

3. Food safety and quality management system

3.1 Food safety and quality manual

3.2 Document control

3.3 Record completion and maintenance

3.4 Internal audits

3.5 Supplier and raw material approval and performance monitoring

3.5.1 Management of suppliers of raw materials and packaging

3.5.2 Raw material and packaging acceptance, monitoring and management procedures

3.5.3 Management of suppliers of services

3.5.4 Management of outsourced processing

3.6 Specifications

3.7 Corrective and preventative actions

3.8 Control of non-conforming product

3.9 Traceability

3.10 Complaint-handling

3.11 Management of incidents, product withdrawal and product recall

4. Site standards

4.1 External Standards

4.2 Site Security and Food Defence

4.3 Layout, product flow and segregation

4.4 Building fabric, raw material handling, preparation, processing, packing and storage areas

4.5 Utilities – water, ice, air and other gases

4.6 Equipment

4.7 Maintenance

4.8 Staff facilities

4.9 Chemical and physical product contamination control: raw material handling, preparation, processing, packing and storage areas

4.9.1 Chemical control

4.9.2 Metal control

4.9.3 Glass, brittle plastic, ceramics and similar materials

4.9.4 Products packed into glass or other brittle containers

4.9.5 Wood

4.10 Foreign-body detection and removal equipment

4.10.1 Selection and operation of foreign-body detection and removal equipment

4.10.2 Filters and sieves

4.10.3 Metal detectors and X-ray equipment

4.10.6 Container cleanliness – glass jars, cans and other rigid containers

4.11 Housekeeping and hygiene

4.11.7 Cleaning in place (CIP)

4.12 Waste/waste disposal

4.14 Pest management

4.15 Storage facilities

4.16 Dispatch and transport

5. Product control

5.1 Product design/development

5.2 Product labelling

5.3 Management of allergens

5.4 Product authenticity, claims and chain of custody

5.5 Product Packaging

5.6 Product inspection and laboratory testing

5.6.1 Product inspection and testing

5.6.2 Laboratory testing

5.7 Product release

6. Process control

6.1 Control of operations

6.2 Labelling and pack control

6.3 Quantity – weight, volume and number control

6.4 Calibration and control of measuring and monitoring devices

7. Personnel

7.1 Training: raw material handling, preparation, processing, packing and storage areas

7.2 Personal hygiene: raw material handling, preparation, processing, packing and storage areas