4.1 External standards
The site shall be suitable size and construction, in a suitable location, and maintained to an appropriate standard to reduce the risk of contamination and facilitate the production of safe and legal products.
Consideration shall be given to local activities and the site environment, which may have an adverse impact on the safety or quality of the finished product or raw materials, and measures shall be taken to prevent contamination. Where measures have been put in place to protect the site, they shall be regularly reviewed to ensure they continue to be effective (e.g. flood controls).
4.1.2 The external areas shall be maintained in good order, any grassed or planted areas surrounding buildings shall be regularly tended and well maintained. External traffic routes under site control shall be suitably surfaced to avoid contamination of the product.
4.1.3 The building fabric shall be maintained to minimize potential for pest entry, ingress of water and other contaminants. External silos, pipework, or other access points for the product and/or raw materials shall be appropriately sealed and secured. Where possible, a clean and unobstructed area shall be provided along the external walls of the buildings used for production and/or storage.
4.1.4 Where natural external drainage is inadequate, additional drainage shall be installed. Drains shall be properly protected to prevent entry of pests.
4.1.5 Where external storage of raw materials is necessary, these shall be protected in order to minimize the risk of contamination.
4.2 Building fabric and interiors: Raw materials handling, preparation, processing, packing and storage areas.
The internal site, buildings and facilities shall be suitable for the intended purpose and shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination.
4.2.1 Walls, floors, ceilings and pipework shall be maintained in good condition and shall facilitate cleaning.
4.2.2 Where suspended ceilings exists, they shall be constructed, finished and maintained to prevent the risk of product contamination, and accessible for cleaning and inspection for pests unless the void is fully sealed.
All internal drain openings shall be suitably protected against the entry of pests and designed to minimize odor.
Where they constitute a risk to product, and based on the likelihood and risk of contamination, windows and roof glazing shall be protected against breakage.
Where the constitute a risk to product, and based on the likelihood and risk of non-production glass contamination, all bulbs and strip lights, including those o flying-insect control devices, shall be adequately protected.
4.2.6 Where elevated walkways are adjacent to or pass over production lines, based on risk they shall be:
• designed to prevent contamination of products and production lines
• easy to clean
• correctly maintained.
Suitable and sufficient lighting shall be provided to ensure a safe working environment, correct operation of processes, effective inspection of the product and cleaning.
Suitable and sufficient ventilation shall be provided.
All utilities to and within the production and storage areas shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination.
4.3.1 All water used in the processing of the products or equipment cleaning shall be potable or suitably treated to prevent contamination.
Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air, compressed air or other gases which come into direct contact with packaging shall be regularly monitored. These shall present no risk to product safety or quality and shall comply with relevant legal regulations.
4.4 Site security and product defense. A product defense plan shall be in place to ensure that there are systems to protect products, premises and brands from malicious actions while under the control of the site.
4.4.1 The company shall undertake a documented risk assessment (threat assessment) of the security arrangements and potential risks to the 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 product defense plan.
Areas shall be assessed according to risk; sensitive or restricted areas shall be defined, clearly marked, monitored and controlled.
This plan shall be kept under review to reflect changing circumstances and external influences. It shall be formally reviewed at least annually.
4.4.2 Measures shall be in place to ensure only authorized personnel have access to production and storage areas, and access to the site by employees, contractors, and visitors shall be controlled.
A visitor reporting system shall be in place. Staff shall be trained in site security procedures and encouraged t report unidentified or unknown visitors.
4.4.3 External storage tanks, silos and any intake pipes with an external opening shall be sufficiently secure to prevent unauthorized access.
4.5 Layout, product flow and segregation
The factory layout, flow of processes and movement of personnel shall be sufficient to prevent the risk of product contamination and to comply with all relevant legislation.
4.5.1 There shall be a current map or plan of the site which defines:
• access points for personnel
• travel routes for personnel, raw materials and intermediate or finished
• staff facilities
• routes for the removal of waste
• production and process flows
• storage areas.
4.5.2 The process flow from intake to dispatch shall be arranged to minimize the risk of contamination or damage to the product.
Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe and hygienic conditions.
4.5.4 Sorting or other activities involving the direct handling of the product shall take place in areas that have, as a minimum, the same standards as production areas.
Activities that could produce a contamination risk, such as the removal of outer packaging, shall be carried out in a designated, segregated area.
If it is .necessary to allow access through production areas, designated walkways shall be provided that ensure there is adequate segregation from materials.
Where possible, all facilities shall be designed and positioned so that movement of personnel is by simple, logical routes.
Equipment shall be suitably designed for the intended purpose and shall be maintained and used so as to minimize the risk to the product safety, legality, and quality.
Production, storage and warehousing equipment shall be designed for the intended purpose and shall minimize the risk of contamination to the product. Lubrication points and application methods of any lubricant shall not be able to contaminate the product.
Equipment shall be constructed of suitable materials and be designed to ensure it can be effectively cleaned and maintained.
Newly installed equipment shall be properly specified before purchase. New equipment shall be tested and commissioned prior to use and a maintenance and cleaning program established.
4.6.3 Wooden equipment including desks, chairs, tables, etc. shall be properly sealed to enable effective cleaning. This equipment shall be kept clean, in good condition and free from splinters or other sources of physical contamination.
Notices on equipment shall be cleanable and secure.
An effective maintenance program shall be in operation for plant and equipment to prevent contamination and reduce the potential for breakdowns.
A documented program of maintenance shall be operated, covering all items of production equipment and plant critical to product safety, legality and quality, to prevent contamination and reduce the risk of breakdown.
4.7.2 Maintenance logs shall be maintained for all off-line testing equipment. This shall include, as a minimum:
• any adjustments
• the re-calibration date of any interventions.
4.7.3 In addition to any planned maintenance programs where there is a risk of product contamination by foreign bodies arising from equipment failure or damage, the equipment shall be inspected at predetermined intervals, inspection results documented, and appropriate action taken.
Maintenance work shall not place product safety, quality or legality at risk. Maintenance work shall be followed by a documented clearance procedure which records that contamination hazards have been removed and equipment cleared to resume production.
Tools and other maintenance equipment shall be cleared away after use and appropriately stored.
Temporary repairs/modifications using tape, cardboard, etc., shall only be permitted in emergencies and where product contamination is not at risk. Such modifications shall be subject to a time limit and shall be recorded and scheduled for correction.
Engineering workshops shall be controlled to prevent transfer of engineering debris to production or storage area (e.g. by provision of swarf mats).
4.7.8 Contractors involved in maintenance or repair shall be suitably monitored by a staff member who shall be responsible for their activities.
4.8 Housekeeping and cleaning
Housekeeping and cleaning systems shall be in place which ensure that appropriate standards of hygiene are maintained and that risk of contamination to the product is minimized.
Good standards of housekeeping shall be maintained, which shall include a condition based cleaning or "clean as you go" policy.
4.8.2 Documented cleaning procedures shall be in place and maintained for buildings, equipment and vehicles. Cleaning schedules and procedures shall include the following information:
• responsibility for cleaning
• item/area to be cleaned
• frequency of cleaning
• method of cleaning
• cleaning materials to be used
• cleaning record and responsibility for verification.
The frequency and methods of cleaning shall be based on risk.
The procedures shall be implemented to ensure that appropriate standards of cleaning are achieved.
Cleaning chemicals shall be fit for purpose, suitably labelled, and used in accordance with manufacturers’ instructions. They shall be stored in a secured, designated location, in closed containers. Chemicals that are strongly scented or could give rise to taint and odor contamination shall not be used.
Cleaning equipment shall be kept in a suitable designated location.
Materials and equipment used for cleaning toilets shall be differentiated from those used elsewhere, and physically segregated where necessary.
4.9 Product contamination control
All practicable steps shall be taken to identify,eliminate, avoid, or minimize the risk of foreign body or chemical contamination.
4.9.1 Glass, brittle plastics, ceramics and similar materials.
There shall be no unnecessary non-production glass, ceramics or brittle plastic present, which may pose a foreseeable risk of contamination.
Where non-production glass, ceramics or brittle plastics are required in production, packing or storage areas, and where there is a risk of product contamination, procedures for their handling shall be in place.
Glass or brittle plastics (other than the product) that pose a potential product contamination hazard shall be controlled and recorded on a register that includes, as a minimum:
• a list of items detailing location, number, type and condition
• recorded checks of 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 minimize the potential for product
Glass or brittle plastics not in the production or storage areas shall be included in the register on the basis of risk.
4.9.2 Sharps and metal control
There shall be a documented policy for the controlled use and storage of sharp implements, including knives, needles and wires, to prevent contamination.
The policy shall include control of these items into and out of the site.
Production equipment that incorporates blades or sharps shall be monitored. Blades or other sharp implements shall not be allowed to contaminate the product.
Snap-off blade knives shall not be used.
Where open noticeboards are present in production, packing and storage areas, loose fastenings, such as drawing pins and staples, shall not be used.
4.9.3 Chemical and biological control
220.127.116.11 Processes shall be in place to manage the use, storage and handling of non-production chemicals, to prevent chemical contamination. These shall include, as a minimum:
• a list of approved chemicals for purchase
• availability of material safety data sheets and specifications
• avoidance of strongly scented products
• the labelling and/or identification of containers of chemicals at all times
• designated storage area with access restricted to authorised personnel
• use by trained personnel only.
Hazard and risk analysis shall be used to identify, control and manage any potential risks from microbiological contamination and any potential allergens.
4.10 Waste and waste disposal
Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, risk of contamination and the attraction of pests.
4.10.1 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.
4.10.2 Process wast shall be managed to minimize release to the environment. This shall include, but is not limited to, pellet, flake, powder, dust and off cuts.
4.10.3 Suitable and sufficient refuse and waste containers shall be provided, which shall be emptied at appropriate frequencies and maintained in an adequately clean condition.
4.10.4 Where appropriate, waste shall be categorized according to legislative requirements based on the intended means of disposal (such as recycling), and sorted, segregated, and collected in appropriate designated waste containers.
4.10.5 Substandard trademarked materials shall be rendered unusable through destructive process. All materials disposed of shall be recorded.
4.10.6 If substandard trademarked materials are transferred to a third party for destruction or disposal, that third party shall be a specialist in appropriate waste disposal and shall provide records of material destruction.
4.10.7 External storage of refuse shall be in designated areas and designed or maintained to minimize the risk of pest harborage
4.11 Pest management In order to minimize the risk of infestation and risk to products, the whole site shall have an effective preventive pest management program in place and the resources available to respond immediately to any issues which occur.
4.11.1 A preventive pest management program shall be maintained, covering all areas of the site under the site's control.
The site shall assess the suitability of its pest management program to address variation in pest activity through different seasons, and consider any additional preventive activity required.
The site shall document and implement any required additional activity.
4.11.2 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 in order to deter and eradicate infestation. The frequency of inspections shall be determined by risk assessment and documented.. The risk assessment shall be reviewed whenever:
1) There are changes to the building or production processes which could have an impact on the pest management program. 2) There has been a significant pest issue.
Where the services of a pest management contractor are employed, the service contract shall be clearly defined and reflect the activities of the site.
4.11.3 Where a site undertakes its own pest control, it shall be able to demonstrate that:
1) pest control 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 the use, relevant to the biology of the pests associated with the site
2) Staff undertaking pest control activities meet any legal requirements for training or registration
3) sufficient resources are available to respond to any infestation issues
4) There is ready access to specialist technical knowledge when required
5) Legislation governing the use of pest control is understood
6) Dedicated locked facilities are used for the storage of pesticides.
4.11.4 Equipment such as bait stations, traps, or electric fly-killing devices shall be appropriately located and operational
4.11.5 Effective precautions shall be in place to prevent pests entering the premises. The building shall be suitably proofed against the entry of all pests via doors, windows, ducts and cable entry points.
This shall include measures to prevent birds and flying mammals from entering buildings or roosting above loading or unloading areas.
4.11.6 In the event of infestation, immediate action shall be taken to eliminate the hazard. Action shall be taken evaluate the potential for contamination or damage, and authorize the release of any product potentially affected.
4.11.7 In the event of an infestation, and at appropriate intervals, the site shall request a catch analysis from flying-insect control devices to help identify problem areas.
In the event of increase in activity, the site shall use risk assessment to determine the activity required to eliminate the hazard.
4.11.8 Documented procedures and detailed records of pest activity, pest management inspections, and recommendations shall be maintained. These shall include, as a minimum:
1) an up-to-date signed and authorized site plan identifying numbered pest control device locations
2) identification of the baits and'or monitoring devices on site
3) clearly defined responsibilities for the site management and the contractor.
4) details of pest control products used and instructions for their effective use
4) detailed records of inspections, recommendations and of any pest infestation.
It shall be the responsibility of the site to ensure that all the relevant recommendations made by the contractor or in-house expert are implemented in a timely manner and monitored for efficacy
4.11.9 Employees shall understand the signs of pest activity and be aware of the need to report any evidence to a designated manager