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.
External traffic routes under site control shall be suitably surfaced and maintained in good repair to mitigate the risk of contamination of the product.
4.1.3 The building fabric shall be maintained to minimize potential for product contamination
Systems shall protect products, premises and brands from malicious actions while under the control of the site.
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.
a new risk emerges (e.g. a new threat is publicized or identified)
an incident occurs, where product security or food defense is implicated.
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 tamperin
These controls shall be monitored, the results documented, and the controls reviewed at least annually.
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 defense.
4.2.4 Where required by legislation, the site shall maintain appropriate registrations with the relevant authorities.
access points for personnel
access points for raw materials (including packaging), semi-finished products and open products
routes of movement for personnel
routes of movement for raw materials (including packaging)
routes for the removal of waste
routes for the movement of rework
location of any staff facilities, including changing rooms, toilets, canteens and smoking areas
production process flows.
Contractors working in product processing or storage areas shall be the responsibility of a nominated person.
shall be in place to minimize 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.
4.3.5 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.
4.4.1 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.
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.
4.4.5 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.
designed to prevent contamination of products and production lines
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.
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.
4.4.10 Adequate ventilation and extraction shall be provided in product storage and processing environments to prevent condensation or excessive dust.
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
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
represent a contamination risk. Compressed air that is in direct contact with the product shall be filtered at point of use.
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.
4.6.2 Equipment that is in direct contact with food shall be suitable for food contact and meet legal requirements where applicable.
4.7.1 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.
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 times
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.
4.7.5 Materials and parts used for equipment and plant maintenance shall be of an appropriate grade or quality.
Those materials (such as lubricating oil) that pose a risk by direct or indirect contact with raw materials (including primary packaging), intermediate products and finished products shall be food grade and of a known allergen status.
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.
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).
4.8.2 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.
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.
advisory signs to prompt hand-washing
a sufficient quantity of water at a suitable temperature
water taps with hands-free operation
single-use towels or suitably designed and located air driers.
basins with soap and water at a suitable temperature
adequate hand-drying facilities
advisory signs to prompt hand-washing
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
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).
Appropriate facilities and procedures shall be in place to control the risk of chemical or physical contamination of product.
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 authorized personnel
use by trained personnel only.
4.9.1.2 Where strongly scented or taintforming materials have to be used, for instance for building work, procedures shall be in place to prevent the risk of taint contamination of products.
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 los
This shall include a record of inspection for damage and the investigation of
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.
4.9.3.1 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.
a list of items detailing location, number, type and condition
recorded checks of the condition of items, carried out at a specified frequency that is based on the level of risk to the product
details on cleaning or replacing items to minimise the potential for product contamination.
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 authorizing production to continue
changing of work wear and inspection of footwear
specifying those staff authorized 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 flykiller devices) shall be adequately protected. Where full protection cannot be provided, alternative management such as wire-mesh screens or monitoring proc
4.9.4.1 The storage of the containers shall be segregated from the storage of raw materials, product or other packaging.
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. colourcoded) 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.
4.9.4.3 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 improve
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 c
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).
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).
The risk of product contamination shall be reduced or eliminated by the effective use of equipment to remove or detect foreign bodies
optical sorting equipment
X-ray detection equipment
other physical separation equipment (e.g. gravity separation, fluid bed technology).
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.
Action shall include a combination of isolation, quarantining and re-inspection of all products produced since the last successful test or inspection.
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.
4.10.2.1 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.
Where defective filters or sieves are identified this shall be recorded and the potential for contamination of products investigated and appropriate action taken.
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).
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.
responsibilities for the testing of equipment
the operating effectiveness and sensitivity of the equipment and any variation to this for particular products
the methods and frequency of checking the detector
recording of the results of checks.
use of test pieces incorporating a sphere of metal of a known diameter selected on the basis of risk. The test pieces shall be marked with the size and type of test material contained
tests carried out using separate test pieces containing ferrous metal, stainless steel and typically non-ferrous metal, unless the product is within a foil container where a ferrousonly test may be applicable
a test to prove that both the detection and rejection mechanisms are working effectively under normal working conditions
tests of the metal detector by passing successive test packs through the unit at typical line operating speed
checks of failsafe systems fitted to the detection and rejection systems.
n addition, where metal detectors are incorporated on conveyors, the test piece shall be passed as close as possible to the centre of the metal detector aperture. Wherever possible, the test piece shall be inserted within a clearly identified sample pack
Wherever possible, the test piece shall be inserted within a clearly identified sample pack of the food being produced at the time of the test.
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.
4.10.5.1 Each unit shall be checked in accordance with the manufacturer’s instructions or recommendations. Checks shall be documented.
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, cont
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
4.11.1 The premises and equipment shall be maintained in a clean and hygienic condition.
responsibility for 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.
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.
The site shall define the corrective action to be taken when monitored results are outside of the acceptable limits.
Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard, the cleaning and disinfection procedures and their frequency shall be validated and records maintained. This shall include the risk from cleaning c
Cleaning staff shall be adequately trained or engineering support provided where access within equipment is required for cleaning.
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
hygienically designed and fit for purpose
suitably identified for intended use (e.g. coldblooded or labelled)
cleaned and stored in a hygienic manner to prevent contamination.
validation confirming the correct design and operation of the system
an up-to-date schematic diagram of the layout of the CIP system
where rinse solutions are recovered and reused, an assessment of the risk of cross-contamination (e.g. due to the re-introduction of allergen).
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.
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.
identification of sample locations
target organism(s) (e.g. pathogens, spoilage organisms and/or indicator organisms)
test methods (e.g. settle plates, rapid testing and swabs)
recording and evaluation of results.
The program and its associated procedures shall be documented.
4.11.8.2 Appropriate control limits shall be defined for the environmental monitoring program.
The company shall document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate an upward trend of positive results.
changes in processing conditions, process flow or equipment
new developments in scientific information
failures of the programme to identify a significant issue (e.g. regulatory authority tests identifying positive results which the site program did not)
product failures (products with positive tests)
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.
designed for ease of use and effective cleaning
well maintained to allow cleaning and, where required, disinfection
emptied at appropriate frequencies.
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
4.13.1 Surplus customer-branded products shall be disposed of in accordance with customerspecific requirements. Customer brand names shall be removed from packed surplus products under the control of the factory before the product enters the supply chain,
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 ar
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.
Pest management programmes shall comply with all applicable legislation.
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.
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.
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 wit
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.
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.
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 flykilling extermination device and contaminating the product, altern
4.14.7 The site shall have adequate measures in place to prevent birds from entering buildings or roosting above loading or unloading areas.
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 pro
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-hous
review the existing pest management measures in place and make any recommendations for change.
in the event of an infestation.
managing chilled and frozen product transfer between temperature-controlled areas
segregation of products where necessary to avoid cross-contamination (physical, microbiological or allergens) or taint uptake
storing materials off the floor and away from walls
specific handling or stacking requirements to prevent product damage.
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 be
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 4hourly basis or at a frequency
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 shel
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.
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.
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.
any restrictions on the use of mixed loads
requirements for the security of products during transit, particularly when vehicles are parked and unattended
clear instructions in the case of vehicle breakdown, accident or failure of refrigeration systems, which ensure that the safety of the products is assessed and records maintained.
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
