Part II Appendices4.1 External standards and site security
4.3 Layout, product flow and segregation Fundamental
The factory layout, flow of processes and movement of personnel shall be sufficient to prevent the risk of product contamination and to comply with relevant legislation.
Interpretation
The physical layout and flow of processes, materials and personnel must be identified, designed, managed and maintained to protect product integrity and prevent contamination, whether physical, chemical or microbiological.
Clause Requirements
4.3.1 The site shall assess the production risk zones required for the products manufactured, processed or packed at the site, using the definitions in Appendix 2 of the Standard.
Interpretation Production risk zones
All sites need to ensure that the production facilities are suitable for the types of products they are manufacturing, processing or packing. This includes an assessment of the
production risk zones needed for the prevention of microbiological contamination.
Full details of the definitions of the production risk zones recognised by the Standard are given in Appendix 2 of the Standard. However, in summary, the Standard recognises six zones:
• high-risk and high-care zones for chilled or frozen and ready-to-eat products where there is a risk of contamination
• ambient high care for products where there is a risk of contamination with vegetative micro-organisms originating from raw materials and the products are stored in ambient conditions (rather than chilled or frozen)
• low-risk areas
• enclosed product areas (e.g. storage areas where products are fully enclosed within packaging and production areas where the product is fully enclosed within the equipment or pipework)
• non-product areas (i.e. areas such as offices, where products are not taken at any stage in their manufacture or storage).
Part II Appendic es
Interpretation
continued It is important to note that the high-risk, high-care and ambient high-care production zones usually only apply to part of a factory’s production processes. These zones typically start when products exit a microbiological kill step and include all the processes and steps until the products are enclosed in packaging.
The auditor will expect to see a documented assessment comparing the products manufactured, processed or packed on site with the definitions within Appendix 2 of the Standard.
Where a site identifies the need for a high-risk, high-care or ambient high-care production zone, the relevant clauses from section 8 will apply to those areas.
4.3.2 There shall be a map of the site. At a minimum, this map shall define:
• production risk zones, where product is at different levels of risk from pathogen contamination – for example, high-risk, high-care, ambient high-care, low-risk and enclosed product areas (see clause 4.3.1 and Appendix 2)
• 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
• any areas where time segregation is used to complete different activities (for example, time segregation for high-care areas).
Interpretation Site map
The aim of the site map is to provide an overview of all the locations within the site, areas where the product is at different levels of risk from the general environment and the movements of products, materials and people. It can then be used to support the site’s risk assessments and subsequent prevention of contamination; for example, by identifying the locations where potential hazards (e.g. allergen cross-contamination) can occur.
The site map will be expected to illustrate the locations of critical facilities and activities, as detailed in the requirement, including:
• production risk zones (e.g. high-risk areas, high-care areas, low-risk areas, and enclosed product areas; see clause 4.3.1). The object of identifying the production risk zones is to ensure that the standards of environmental hygiene, particularly those concerning equipment, buildings, cleaning and personnel hygiene, are appropriate for the work being undertaken. It also allows the product and personnel flows to be reviewed, to ensure they do not compromise product safety
• access points for personnel clearly showing the routes into, and out of the site and production areas
Interpretation
continued • access points for raw materials, semi-finished products and open products
• routes of movement for personnel. If it is necessary to allow access through production areas, good practice is to identify designated walkways that ensure there is adequate separation from materials. Wherever possible, all facilities should be designed and positioned so that the movement of personnel is by simple, logical routes
• routes of movement for raw materials
• routes of movement for the removal of waste
• routes of movement for rework
• the location of staff facilities, including changing rooms, toilets, canteens and smoking areas
• areas where time segregation is used; in other words, where the same production area is used as both a high-care and a low-risk production zone at different times, with time segregation being used to separate the products with different risks (see Appendix 1 for definitions).
Sites which have identified the need for high-risk, high-care or ambient high-care areas (see clause 4.3.1) will also need to include the location of the pathogen control step(s) on the map (see clause 8.1.1).
The Standard is not prescriptive on the format of the map, providing all of the relevant information is available. For example:
• It is often useful to put the required information on several overlapping maps rather than a single diagram.
• In complex sites a schematic diagram may be of greater benefit than a map.
4.3.3 Contractors and visitors, including drivers, shall be made aware of the requirements of the areas they are visiting, with special reference to hazards and potential product contamination.
Interpretation Contractors and visitors
Contractors and visitors (including drivers) must be made aware of all access restrictions and procedures related to them. Visitors should be told when they sign in and the information should be specific to the areas they will be visiting.
Contractors who visit regularly should be trained to a similar level as employees, and a record of the training retained.
4.3.4 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.
Part II Appendic es
Interpretation Movement of personnel, raw materials, packaging, rework and waste
The HACCP or food safety plan must identify the potential risks associated with all production risk zones and the appropriate controls (including the level of prerequisite programmes) for the safe production of the products.
A combination of process flow and procedures (e.g. the prerequisite programme and work instructions) will be used to minimise risk to raw materials, packaging and products.
Particular attention needs to be paid to the movement of personnel, raw materials,
packaging, rework and waste, to ensure that the routes taken are defined and product safety is not compromised. For example, the removal of unnecessary packaging, such as debagging or removing outer boxes, should take place in a designated area, usually prior to transfer to production areas, in order to avoid potential foreign-body risks from discarded packaging.
The procedures developed to ensure product safety must be documented and validated as effective, and the appropriate staff must be trained. For example, where sites are receiving packaging through ‘hole in the wall’ operations, suitable controls should be in place to ensure that there is no risk to the product and the materials are treated appropriately. For example, an adjacent factory might deliver packaging materials on a conveyor or belt, as is often the case in dairy packing and carbonated beverages.
4.3.5 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe hygienic conditions.
Interpretation Work and storage space
Premises must be designed to allow sufficient working space and storage capacity so that all operations are carried out properly under safe, hygienic conditions, thereby reducing the potential for cross-contamination between activities because of close proximity. For example, overfull refrigerated storage may lead to doors being left open for extended lengths of time because of difficulties in accessing required materials. This would lead to a non-conformity.
Consideration should be given to all activities, including inspection, cleaning, pest control and maintenance, as well as manufacturing operations.
4.3.6 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.
Interpretation Temporary structures
Temporary structures (e.g. those constructed during building work or refurbishment) must be designed and located to avoid pest harbourage, unsanitary conditions and potential contamination of products. For example, where walls have to be knocked through during installation or expansion work, the integrity of the unit must be preserved to avoid pest entry, and scaffolding used in open product areas must be of the appropriate hygienic standard.
Risk assessment of temporary activities or structures should be completed prior to their introduction.
The fabrication of the site, buildings and facilities shall be suitable for the intended purpose.
Interpretation
The design, construction and maintenance of the interior of the facility must support effective cleaning and protect products from contamination.
The type of finish to walls, floors and ceilings must, at a minimum, meet the requirements laid down in any applicable legislation for the industry, and be suitable for the intended purpose.
Where a site has different production risk zones (see clause 4.3.1), good practice is to consider whether there are different facility requirements for each zone.
Clause Requirements
4.4.1 Walls shall be finished and maintained to prevent the accumulation of dirt, minimise condensation and mould growth, and facilitate cleaning.
Interpretation Walls
This clause refers to the condition of the internal surfaces of the walls (other aspects of the wall’s condition are covered separately in clause 4.1.3).
The walls in areas handling raw materials and preparing, processing, packing or storing product must be kept in a sound condition and must be easy to clean and, where necessary, to disinfect. For example, walls must have a smooth, impervious finish with sealed surfaces, be in a good state of repair and be free from flaking paint.
Tiling of walls is best avoided but, if present, must be in good condition, with no cracks or loose tiles. Ledges (e.g. from ducting or piping) should be kept to a minimum or designed to facilitate cleaning (e.g. with a slope to avoid dust collection).
Vulnerable wall surfaces or corners (e.g. where vehicles pass in close proximity) should be protected from damage (e.g. with properly sealed metal plating or barriers). Junctions (including ‘wall to floor’, ‘wall to ceiling’ and ‘wall to wall’) should be maintained in good condition to facilitate cleaning (e.g. by being appropriately sealed).
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.
Interpretation Floors
The floors in areas handling raw materials and preparing, processing, packing or storing product must be kept in a sound condition and be easy to clean and, where necessary, to disinfect. Floors must be constructed of materials that are impervious, hard-wearing, repairable and resistant to chemical attack so that they can withstand appropriate cleaning procedures.