4. Site Standards
4.1. Establish Critical Limits for Each CCP (equivalent to Codes Alimentarius Step 8, Principle 3)
FUNDAMENTAL
1
1
Clause 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.
Clause 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.
Clause 4.1.3
The building fabric shall be maintained to minimise potential for product contamination (e.g. elimination of bird-roosting sites, sealing gaps around pipes to prevent pest entry, ingress of water and other contaminants).
4.2. HACCP Documentation and Record-keeping (equivalent to Codex Alimentarius Step 12, Principle 7)
FUNDAMENTAL
1
1
Clause 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.
Clause 4.2.2
Where raw materials or products are identified as being at particular risk, the threat assessment plan shall include controls to mitigate these risks. Where prevention is not sufficient or possible, systems shall be in place to identify any tampering.
Clause 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).
Clause 4.2.4
Where required by legislation, the site shall maintain appropriate registrations with the relevant authorities.
4.3. High-Risk, High-Care and Ambient High-Care Production Risk Zones
FUNDAMENTAL
1
1
Clause 4.3.2
Contractors and visitors, including drivers, shall be made aware of all procedures for access to premises and the requirements of the areas they are visiting, with special reference to hazards and potential product contamination. Contractors working in product processing or storage areas shall be the responsibility of a nominated person.
Clause 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.
Clause 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.
Clause 4.3.5
Temporary structures constructed during building work or refurbishment etc. shall be designed and located to avoid pest harbourage and ensure the safety and quality of products.
4.4. Housekeeping and Hygiene
FUNDAMENTAL
1
1
Clause 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.
Clause 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.
Clause 4.4.5
Where suspended ceilings or roof voids are present, adequate access to the void shall be provided to facilitate inspection for pest activity, unless the void is fully sealed.
Clause 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.
Clause 4.4.8
Doors (both internal and external) shall be maintained in good condition. At a minimum:
Clause 4.4.10
Adequate ventilation and extraction shall be provided in product storage and processing environments to prevent condensation or excessive dust.
4.5. Housekeeping and Hygiene in High-Risk and High-Care Zones
FUNDAMENTAL
1
1
Clause 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.
Clause 4.5.2
An up-to-date schematic diagram shall be available of the water distribution system on site, including holding tanks, water treatment and water recycling as appropriate. The diagram shall be used as a basis for water sampling and the management of water quality.
Clause 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. Identify Intended Use (equivalent to Codex Alimentarius Step 3)
FUNDAMENTAL
1
1
Clause 4.6.1
All equipment shall be constructed of appropriate materials. The design and placement of equipment shall ensure it can be effectively cleaned and maintained.
Clause 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. Internal Audits
FUNDAMENTAL
1
1
Clause 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.
Clause 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.
Clause 4.7.5
Materials and parts used for equipment and plant maintenance shall be of an appropriate grade or quality.
Clause 4.7.6
Engineering workshops shall be kept clean and tidy, and controls shall be in place to prevent transfer of engineering debris to production or storage areas.
Clause 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.
Clause 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.
4.8. Labelling and Pack Control
FUNDAMENTAL
1
1
Clause 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).
Clause 4.8.2
Storage facilities of sufficient size to accommodate personal items shall be provided for all personnel who work in raw material handling, preparation, processing, packing and storage areas.
Clause 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.
Clause 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:
Clause 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:
Clause 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.
Clause 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.
Clause 4.8.8
Where catering facilities (including vending machines) are provided on the premises, they shall be suitably controlled to prevent contamination of products (e.g. as a source of food poisoning or introduction of allergenic material to the site).
4.9. Chemical and Physical Product Contamination Control: raw material handling, preparation, processing, packing and storage areas
FUNDAMENTAL
1
1
Clause 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:
Clause 4.9.1.2
Where strongly scented or taint-forming materials have to be used, for instance for building work, procedures shall be in place to prevent the risk of taint contamination of products.
Clause 4.9.2.1
There shall be a documented policy for the controlled use and storage of sharp metal implements including knives, cutting blades on equipment, needles and wires. This shall include a record of inspection for damage and the investigation of any lost items. Snap-off blade knives shall not be used.
Clause 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.
Clause 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.
Clause 4.9.3.2
Procedures for handling glass and other brittle materials (other than product packaging) shall be in place where open products are handled or there is a risk of product contamination. These procedures shall include, at a minimum:
Clause 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:
Clause 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.
Clause 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:
Clause 4.9.4.3
Records shall be maintained of all container breakages on the line. Where no breakages have occurred during a production period, this shall also be recorded. This record shall be reviewed to identify trends and potential line or container improvements.
Clause 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.
Clause 4.9.6.1
Procedures shall be in place to prevent physical contamination of raw materials by raw material packaging (e.g. during debagging and deboxing procedures to remove the packaging).
Clause 4.9.6.2
Pens used in open product areas shall be controlled to minimise the risk of physical contamination (e.g. designed without small parts and detectable by foreign-body detection equipment).
4.10. Product packaging shall be appropriate for the intended use and shall be stored under conditions to prevent contamination and minimise deterioration.
FUNDAMENTAL
1
1
Clause 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:
Clause 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.
Clause 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:
Clause 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.
Clause 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.
Clause 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.
Clause 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).
Clause 4.10.3.3
The site shall establish and implement procedures for the operation and testing of the metal detection or X-ray equipment. This shall include, at a minimum:
Clause 4.10.3.4
Metal detector testing procedures shall, at a minimum, include:
Clause 4.10.4.1
The type, location and strength of magnets shall be fully documented. Procedures shall be in place for the inspection, cleaning, strength testing and integrity checks. Records of all checks shall be maintained.
Clause 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.
Clause 4.10.6.2
The effectiveness of the container-cleaning equipment shall be checked and recorded during each production. Where the system incorporates a rejection system for dirty or damaged containers, the check shall incorporate a test of both the detection and effective rejection of the test container.
Clause 4.10.6
Container Cleanliness - Glass jars, cans and other rigid containers
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
Clause 4.10.1
Selection and Operation of Foreign-Body Detection and Removal Equipment
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
Clause 4.10.3
Metal Detectors and X-Ray Equipment
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
Clause 4.10.4
Magnets
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
Clause 4.10.5
Optical Sorting Equipment
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
4.11. External Standards
FUNDAMENTAL
1
1
Clause 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:
Clause 4.11.3
Limits of acceptable and unacceptable cleaning performance shall be defined for food contact surfaces and processing equipment. These limits shall be based on the potential hazards relevant to the product or processing area (e.g. microbiological, allergen, foreign-body contamination or product-to-product contamination). Therefore, acceptable levels of cleaning may be defined by visual appearance, ATP bioluminescence techniques (see glossary), microbiological testing, allergen testing or chemical testing as appropriate.
Clause 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.
Clause 4.11.5
The cleanliness of equipment shall be checked before equipment is released back into production. The results of checks on cleaning, including visual, analytical and microbiological checks, shall be recorded and used to identify trends in cleaning performance and to instigate improvements where required.
Clause 4.11.7.1
All CIP equipment shall be designed and constructed to ensure effective operation. This shall include:
Clause 4.11.7.2
Limits of acceptable and unacceptable performance for key process parameters shall be defined to ensure the removal of target hazards (e.g. soil, allergens, micro-organisms, spores). At a minimum these parameters shall include:
Clause 4.11.7.3
The CIP equipment shall be maintained by suitably trained staff to ensure effective cleaning is carried out. This shall include:
Clause 4.11.7.4
CIP facilities, where used, shall be monitored at a defined frequency based on risk. This may include:
Clause 4.11.8.1
The design of the environmental monitoring programme shall be based on risk, and at a minimum include:
Clause 4.11.8.2
Appropriate control limits shall be defined for the environmental monitoring programme.
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
Clause 4.11.7
Cleaning In Place (CIP): The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
Clause 4.11.8
Environmental Monitoring Risk-based environmental monitoring programmes shall be in place for pathogens or spoilage organisms. At a minimum, these shall include all The company shall have procedures in place to ensure that employees, agency staff, contractors or visitors are not a source of transmission of food-borne diseases to products. production areas with open and ready-to-eat products.
| Outcome | Docs | Actions | Notes | |||||
|---|---|---|---|---|---|---|---|---|
| Yes | No | N/A |
4.12. Filters and Sieves
FUNDAMENTAL
1
1
Clause 4.12.2
Internal and external waste collection containers and rooms housing waste facilities shall be managed to minimise risk. These shall be:
Clause 4.12.3
If unsafe products or substandard trademarked materials are transferred to a third party for destruction or disposal, that third party shall be a specialist in secure product or waste disposal and shall provide records which include the quantity of waste collected for destruction or disposal.
4.13. Food Safety and Quality Management System
FUNDAMENTAL
1
1
Clause 4.13.1
Surplus customer-branded products shall be disposed of in accordance with customer-specific requirements. Customer brand names shall be removed from packed surplus products under the control of the factory before the product enters the supply chain, unless otherwise authorised by the customer.
Clause 4.13.2
Where customer-branded products which do not meet specifications are sold to staff or passed on to charities or other organisations, this shall be with the prior consent of the brand owner. Processes shall be in place to ensure that all products are fit for consumption and meet legal requirements.
Clause 4.13.3
By-products and downgraded/surplus products intended for animal feed shall be segregated from waste and protected from contamination during storage. Products for animal feed shall be managed in accordance with the relevant legislative requirements.
4.14. Food Safety and Quality Manual
FUNDAMENTAL
1
1
Clause 4.14.1
If pest activity is identified, it shall not present a risk of contamination to products, raw materials or packaging.
Clause 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.
Clause 4.14.3
Where a site undertakes its own pest management, it shall be able to effectively demonstrate that:
Clause 4.14.4
Pest management documentation and records shall be maintained. At a minimum, this shall include:
Clause 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.
Clause 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.
Clause 4.14.7
The site shall have adequate measures in place to prevent birds from entering buildings or roosting above loading or unloading areas.
Clause 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.
Clause 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.
Clause 4.14.10
An in-depth, documented pest management survey shall be undertaken at a frequency based on risk, but at least annually, by a pest control expert to review the pest management measures in place. The survey shall:
Clause 4.14.11
Results of pest management inspections shall be assessed and analysed for trends on a regular basis. At a minimum, results of inspections shall be analysed:
Clause 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. Foreign-Body Detection and Removal Equipment
FUNDAMENTAL
1
1
Clause 4.15.1
Procedures to maintain product safety and quality during storage shall be developed on the basis of risk assessment, understood by relevant staff and implemented accordingly. These may include, as appropriate:
Clause 4.15.2
Where appropriate, packaging shall be stored away from other raw materials and finished product. Any part-used packaging materials suitable for use shall be effectively protected from contamination and clearly identified to maintain traceability before being returned to an appropriate storage area.
Clause 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.
Clause 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.
Clause 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.
Clause 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. Glass, Brittle Plastic, Ceramics and Similar Materials
FUNDAMENTAL
1
1
Clause 4.16.1
Procedures to maintain product safety and quality during loading and transportation shall be developed and implemented. These may include, as appropriate:
Clause 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:
Clause 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.
Clause 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.
Clause 4.16.6
Where the company employs third-party contractors, all the requirements specified in this section shall be clearly defined in the contract or terms and conditions and verified, or the contracted company shall be certificated to the Global Standard for Storage and Distribution or similar GFSI-recognised scheme.