Buildings should be located, designed, constructed, adapted and maintained to suit the operations carried out in them and to facilitate the protection of materials and products from contamination or deterioration. Equipment should be designed, constructed, adapted, located and maintained to suit the processes and products for which it is used and to facilitate protection of the materials handled from contamination or deterioration. Consideration should be given where appropriate to segregation of personnel and equipment from high‐ and low‐risk food production. Physical separation of high‐ and low‐risk food production and physical segregation of production of foods containing major allergens (see Chapter 8) should also be considered as part of the design process.
19.1 Depending on the products being handled, reference should be made to the detailed requirements in respect of premises and equipment in EU Regulation (EC) No. 852/2004 on the hygiene of foodstuffs, and EU Regulation (EC) No. 853/2004 laying down specific hygiene rules for food of animal origin (or with any regulations that may at any future time supersede these regulations). This regulation is implemented in England by the Food Safety and Hygiene (England) Regulations 2013 (as amended) and equivalent legislation in other countries of the UK. An overall site plan should be available that defines the location of the manufacturing unit in terms of buildings and external activities and services, for example chemical storage, waste storage, raw material, packaging and production areas. The neighbouring businesses should also be identified, especially where they could pose a specific food safety risk, e.g. a farm, chemical manufacturer, waste treatment works etc. The site plan(s) should also identify personnel flow around the site, including internal and external access, staff facilities and pedestrian routes to work areas (see 19.18). Areas that may be subject to restricted access should also be highlighted (see 19.2). This is important with regards to food safety risk management and also wider food integrity management (see Chapter 7). High‐risk and low‐risk product areas for both food safety and food integrity should be identified together with the production and process flow, routes for waste, quarantine areas and the movement of reworked products. The FSA publication E. coli O157 – Control of cross‐contamination: Guidance for food business operators and enforcement authorities (2014) states that premises should be designed to ensure adequate physical separation; anything else ‘will involve a shift towards greater uncertainty regarding the stringency of risk reduction that can be achieved’. Where there is dual use of equipment in manufacturing for both raw and high‐risk products or low‐ and high‐risk products, suitable procedural controls must be in place. The procedural controls must be validated and then consideration should be ‘given to the monitoring and management arrangements required to ensure proper implementation of these procedures’.
19.2 Premises should be sited with due regard for the provision of services needed and to avoid contamination from adjacent activities. In existing premises, effective measures should be taken to avoid such contamination. Any measures introduced should be routinely reviewed to ensure that they remain effective. Examples include the provision of water, ice, compressed air, gas and air supply to the production area. The grounds surrounding the buildings should be maintained to minimise potential harbourage for pests that could be afforded by old pallets, packaging, waste, equipment and machinery or vegetation that is growing up the external walls of the building. Vegetation should be cleared on a regular basis, and there should be a minimum of a 1‐metre gap between vegetation and externally stored materials and buildings to prevent pest harbourage. Best practice would be to increase this distance further. Consideration should be given to adequate drainage in the yard and minimising pools of waste water through which vehicles may pass and then enter food manufacturing areas. The potential for flooding should also be considered, especially with regard to sudden storm events. If the drainage system may not cope with such events then appropriate emergency measures should be available in high‐risk areas. External traffic areas should be suitably surfaced to prevent contamination or damage (through concussion) of product and packaging. This is especially important when glass product containers are used.
Building integrity should ensure that there are no access points for pests to gain entry or allow ingress of water through seepage or poorly designed guttering. Site security should be reviewed and a risk assessment documented with regard to the potential for malicious tampering or criminal activity with a view to accessing the product and/or process. The need for restricted areas should be considered, including the need for swipe card or keypad entry. The requirement for closed‐circuit television (CCTV), infrared heat monitoring, security guards and/or fencing that fully encloses the site should also be considered as well as how staff, visitors and contractors are authorised to enter certain areas. Protocols for lone working should also be considered not only with regard to health and safety, but also with regard to product integrity and the potential for malicious tampering/sabotage. Guard dogs must only be allowed access to external areas and must be under the control of their handlers and not be allowed to run free. If guard dogs are used on the premises, then a risk assessment must be undertaken to determine the level of product risk and associated controls put in place. This must be documented.
19.3 Premises should provide sufficient space to suit the operations to be carried out, allow an efficient work flow and facilitate effective communication and supervision. The need to segregate high‐ and low‐risk operations and those involving major allergens should also be considered. Physical segregation of materials may be required or the premises may need to be designed to ensure that personnel cannot transfer from one area to another during their work activities, for example a raw and cooked meats factory, which requires personnel segregation. Segregation should consider the following: type and hazards associated with raw materials; in‐process and finished products, especially the control of allergens; the flow of product, rework, waste, packaging and materials, equipment (including maintenance tools), personnel, airflow, utilities and water; and transfer points between high‐ and low‐risk areas. If physical segregation, including barriers, is used, then consideration should be given to personnel health and safety in the event of an emergency, for example fire. Fire doors should therefore be alarmed or tamper evident so they cannot provide a personnel thoroughfare into and out of food areas. When designing or redesigning the premises, the following may have to be taken into account:
- the organisation must comply with regulations that require the site to be approved or registered in terms of hygiene and premises and processing standards with the local government authority;
- the availability or requirement for services such as electricity, power, sewerage, waste disposal, airflow, refrigeration plant and drainage;
- the requirements for effluent treatment prior to discharge, and provision for waste control, including material segregation for recycling, where deemed necessary;
- the condition of external infrastructure, including concrete and hardstanding and the potential for fugitive release of potential pollutants, and the condition of bunding and containment measures and whether they are suitable for the materials being stored;
- the need to define vehicle and pedestrian routes both internally and externally within the site (see 19.18);
- the availability or requirement for water, ice and/or steam within the process and its suitability for use. The source of the water, for example mains, borehole (well), surface water or recycled water systems, should be considered and its ability to meet potable water standards (see Chapter 20). The requirement for, and control of, cooling water systems should also be considered and the safety procedures that are required, especially with regard to Legionella. A water distribution plan should be available that includes all pipework and water‐holding tanks as well as the outlining the type of water that is in the location, i.e. potable or recycled. A cleaning schedule should also be in place for the water distribution system that has been validated, is monitored and is routinely verified. The water distribution map can be colour coded to aid differentiation of water systems;
- the raw material/ingredient storage and types of storage required whether frozen, ambient or chilled;
- the retail crate/tray and bulk container (field tray, fruit bin, etc.) storage facilities, especially if this is external. Procedures must be in place to ensure the material is adequately stored to prevent contamination, especially if the product is loose and could come into direct contact with the trays, and that the trays are visually inspected before use;
- the requirement for deboxing/debagging areas for removal of external packaging before items gain entry to the production areas;
- the availability of designated in‐process storage and the types of storage required whether frozen, ambient or chilled;
- the suitability of finished product storage prior to despatch and the types of storage required whether frozen, ambient or chilled;
- storage areas should be of sufficient size to enable all operations to be carried out under appropriate conditions;
- the location of inspection and quality control stations within the premises;
- the location of label and packaging printing room (where this task is undertaken off‐line);
- the material used for building fabrication and processing equipment. The presence of wood should be minimised and where possible eliminated;
- the production line and equipment layout to seek to maximise efficiency and minimise the risk of product contamination, especially with regard to allergen control and the packing of identity preserved materials such as conventional, assured and/or organic food products;
- the facilities for equipment and premises cleaning and disinfection;
- the cleaning chemical and cleaning equipment storage areas;
- the design of product flow to minimise the risk of contamination and/or cross‐contamination;
- the personnel flow in terms of personal health and safety, but also to minimise the risk of contamination and/or cross‐contamination;
- the location and siting of hand‐washing facilities, especially the location and design of doors after hand washing has been completed in order to access production areas;
- the siting of equipment so that there is adequate access, especially for cleaning and servicing, around it;
- the requirement for charging battery‐controlled equipment and the provision of suitable locations, for example charging forklifts away from food environments;
- the restroom and personnel facilities;
- the requirement for protocol areas with barrier control in high‐risk food premises; and
- the facilities for maintenance and equipment repairs.
For further information, refer to the Campden BRI Guidelines for the hygienic design, construction and layout of food processing factories (2003, Guideline G39; ISBN 0905942574) and the European Hygienic Engineering and Design Group Hygienic Equipment Design Criteria Guidelines (2004, or latest version),1BS EN ISO 14159:2008 Safety of machinery. Hygiene requirements for the design of machinery and BS EN 1672‐2:2005 + A1:2009 Food processing machinery. Basic concepts. Hygiene requirements.
19.4 All premises, including processing areas, laboratories, stores, passageways and external surroundings, should be maintained in a clean and tidy condition.
19.5 Premises must be constructed and maintained with the object of protecting against the entrance and harbouring of vermin, birds, pests and pets (see also 19.11 and Chapter 22).
19.6 Premises should be maintained in a good state of repair. The condition of buildings should be reviewed regularly and repairs effected where necessary. Special care should be exercised to ensure that building materials and construction, repair or maintenance operations are not allowed to affect adversely product safety, quality or integrity. Buildings should be effectively lit and ventilated to minimise dust and prevent condensation, with air control facilities (including temperature, humidity and filtration) appropriate both to the operations undertaken within them and to the external environment. Where appropriate to the type of food manufacture, positive air pressure systems should be installed (see 19.10).
19.7 There should be sufficient intensity of light to aid the activities being undertaken in the location, for example product inspection and/or cleaning. Areas should be lit to enable personnel to work safely, especially where there is no external light entering the building or personnel are expected to work in the location over a 24‐hour period. All light appliances should be suitably protected by either shatterproof plastic diffusers or the use of sleeve covers. Where this is not possible, a fine metal mesh screen must be used. The lights and covers (as appropriate) should be subject to brittle material control procedures (see 19.36).
19.8 Working conditions (e.g. temperature, humidity, noise levels) should be such that there is no adverse effect on the product, either directly or indirectly via the operator, or indeed effects on the staff themselves.
19.9 Fans should be sited to avoid contamination of the product being manufactured and conversely contamination of the local environment. Product contamination could be caused by intake of noxious solids, vapours or gases into the manufacturing unit, or the exhaust of air from the manufacturing unit could contaminate other materials. Due regard should be given to the local environment and the avoidance of nuisance to others, including neighbours to the manufacturing site. Nuisance from the use of fans could include odour, noise and/or dust emissions.
19.10 Air supply and extraction trunking should not introduce contaminants into products. For dry food products, dust extraction equipment may need to be installed. Ventilation and extraction systems must be suitably designed to meet processing requirements in terms of preventing condensation and pest ingress, and managing dust effectively. Systems should be sited to minimise contamination of the product or process. Air that comes into contact with the product should be filtered. The air‐handling system must be designed to address:
- the degree of variance in ambient air, for example temperature, humidity, level of dust and particulates;
- the process conditions in terms of temperature, humidity, air containment, air extraction requirements, levels of dust and particulates in the process air; and
- the air filtration cycle in terms of positive pressure, volume of air supply, number of air changes required and air balancing.
Air filtration equipment must be adequately maintained and regularly inspected, and air quality routinely monitored. A risk assessment should be undertaken to determine the need for positive air pressure between high‐ and low‐risk areas, the filter size/grade required to control airborne contamination and the potential for contamination, for example the product residency time in that area. If air socks are used, they must be inspected, cleaned and maintained at a designated frequency based on risk assessment. For further details, consult the air filters for general ventilation BS EN ISO 16890:2016 series of standards and the Campden BRI Guidelines on air quality standards for the food industry (2nd edition) (2005, Guideline G12; ISBN 0905942736).
19.11 Floor and wall surfaces, and all surfaces (including surfaces of equipment) in contact with food must be maintained in a sound condition, and be easy to clean and, where necessary, disinfect. Walls should be sound and finished with a smooth impervious and easily cleaned surface. Where walls are in areas of high traffic movement and there is the potential for damage, crash barriers should be installed. Floors in manufacturing areas should be made of impervious materials, laid to an even surface and free from cracks and open joints. They should be of adequate construction and material for the wear and tear and conditions of manufacture encountered. Floors should be designed so that liquid does not collect in certain areas, and the fall of the floor should be such that any water or waste product travels easily to a suitable drain (see 19.13). For further details, consult the Campden BRI Guidelines for the design and construction of floors for food production areas (2nd edition) (2002, Guideline G40; ISBN 0905942566) and Guidelines for the design and construction of walls, ceilings and services for food production areas (2nd edition) (2003, Guideline 41; ISBN 0905942590).
Ceilings should be so constructed and finished that they can be maintained in a clean condition. Voids above false ceilings should be regularly cleaned and inspected so that they do not provide harbourage to pests. It is essential to ensure effective seals to walls and floor. The coving of junctions between walls, floors and ceilings in critical areas is recommended. Processing areas should be designed without windows. However, where windows are present in production and storage areas, they should be of toughened glass or plastic, protected against breakage, adequately screened to prevent pest entry and secured, and if ledges are present they must slope away from the glazing. Plastic film can be adhered to internal window surfaces as an extra control in the event of damage or breakage.
Doors, dock levellers and door frames should be of impervious, non‐corrodible material, smooth, crevice‐free and easily cleanable, and suitably protected to prevent ingress of pests when opened (see Chapter 22). Doors must be monitored to ensure that they remain close‐fitting and provide adequate pest‐proofing. External doors, especially pedestrian doors, should be designed to be automatic closing doors and, if deemed appropriate, air curtains should be installed. Consideration should be given to whether the design of doors is suitable for food preparation areas, especially where high‐risk products are produced. The design of personnel doors should minimise handles that can be a source of cross‐contamination between personnel, have kick plates to prevent damage when opening, be seamless where possible to prevent bacterial harbourage and be water resistant in areas of water use. Consideration should be given to whether sliding doors or roller doors are used. Roller doors are in contact with the floor and on lifting, depending on the food environment, can drip material onto product or equipment as it passes underneath. If roller doors are used, a risk assessment should be undertaken to determine the degree of risk of product contamination with such doors being in place. If sliding doors are used, it should be determined if there is any health and safety risk to personnel if they are working in close proximity to the doors when they are opening or closing. Automatic doors should be open for an appropriate time that allows access but prevents ingress of pests and other potential product contaminants. Where strip curtains or similar designs are used, they must be maintained so that they are effective against pest ingress, be cleaned at a prescribed frequency and otherwise controlled to prevent product contamination. Training of staff should include effective door management in order to prevent product contamination, ingress of pests and loss of temperature control.
Materials used for construction of ceilings, doors and doorways should be chosen to avoid tainting or otherwise contaminating food materials. More generally, for both food contact and non‐food contact surfaces such as walls, doors and ceilings, painted surfaces are not ideal because flaking may occur, which could pose a potential food contamination risk. Paint, where it cannot be avoided, should meet designated standards. Specialist paint is available for the food industry and advice should be sought. Relevant standards include BS 7557:1992 Specification for limits of metal release from painted surfaces of articles, liable to come into contact with food.
19.12 Pipework, suitably protected light fittings, ventilation points and other services in manufacturing areas should be of a material suitable for purpose and appropriate to the area where the services are located, and be sited to avoid creating recesses that are difficult to clean. The material should allow for cleaning and, where required, disinfection (see Chapter 21). Services should preferably run outside the processing areas. They should be sealed into any walls and partitions through which they pass to prevent pest ingress. Intake points where material is received from external deliveries through pipework, or other means, to internal tanks must be suitably designed and operated to be easy to clean, and where necessary disinfect, and prevent ingress or harbourage for pests. End caps should be fitted to all external points, or they should be otherwise enclosed, to prevent contamination, theft and/or malicious tampering (see Chapter 5). When not in use, end caps should be locked off to prevent entry or ingress. Fabrication joints must be sealed and not pose a product risk. The type of welding used should be appropriate for the product being manufactured. Pipework should be checked on a regular basis to ensure full integrity and that any potential for harbourage of harmful bacteria is minimised. Pipework should also be assessed for the potential build‐up of biofilms (see 21.13). If biofilms are identified, then appropriate action should be taken.
19.13 Drains should be of adequate size for the manufacturing operations undertaken and should have trapped gullies and proper ventilation. Any open channels should be shallow to facilitate effective cleaning. Machinery and sinks should be sited to ensure that process materials and other waste, including water, is discharged directly to a drain. Drains must flow from high‐ to low‐risk areas of the manufacturing site. A system must be in place to prevent back flow of liquid and air from drains. The siting of drains from laboratories should be considered to determine the potential for product contamination, and where required appropriate action taken to eliminate risk. Ideally, this review should be undertaken at the design stage of the manufacturing unit. A drainage plan should be available that maps both internal and external drainage on the site. This should be updated as changes occur and reissued. Based on current knowledge and the need for ongoing risk assessment in the future, drainage surveys, including the potential use of cameras, is needed to determine if the drainage system links to the treatment process prior to discharge and to confirm the flow of foul (dirty) and surface water drainage, and also to determine the current and future condition of the infrastructure, and the potential for seepage from drains and underground storage tanks into soil and groundwater. This is especially important if groundwater is extracted from below the manufacturing site and is then used as a potable water source for food production and staff facilities.
19.14 An adequate number of flush lavatories must be available and connected to an effective drainage system. Lavatories must not lead directly into rooms in which food is handled or stored. The FSA publication E. coli O157 – Control of cross‐contamination: Guidance for food business operators and enforcement authorities (2014), Section 4, recommends that for extra protection against cross‐contamination a liquid hand wash that has disinfectant properties conforming to the European standard BS EN 1499:2013 is used. Hand‐sanitising gels can provide an additional level of protection when used after effective handwashing. Hand‐sanitising gels should conform to the BS EN 1500:2013 standard.
19.15 Protection from the weather should be provided for receiving and despatch areas, and for materials or products in transit. External material or product storage is not recommended, but where external storage is necessary, procedures must be in place to minimise deterioration and the risk of contamination, particularly pest infestation.
19.16 Where raw materials or packaging materials arrive in external packaging, a separate deboxing/debagging area should be provided where the packaging may be removed before the materials enter the production area.
19.17 Waste material should not be allowed to accumulate. It should be collected in suitably constructed and identified receptacles, designated for the purpose, for removal to collection points outside the buildings. Waste material should be disposed of at regular and frequent intervals. Disposal of printed packaging materials or raw materials and rejected products should be carefully controlled (see Chapter 24).
19.18 Design of premises should provide separate routes of entry and movement for vehicles and personnel. Designated walkways should be marked in internal and external areas. Where walkways or steps cross over production lines, storage areas or workstations they must be fitted with backplates and/or be suitably enclosed to prevent contamination of the product, packaging or people beneath. The material utilised to make the stairs must be suitably controlled to prevent contamination. Ideally, wood would not be used in such areas. If wood has been used, an appropriate risk assessment must have taken place to determine the degree of contamination risk. The use of ladders or scissor lifts in production and processing areas should also be considered and appropriate action taken to minimise the potential for contamination of both the physical manufacturing area and the food being manufactured itself. When designing premises, it must be considered that manufacturing areas should not be used as a general right of way for personnel or materials, or for storage. Sufficient storage space must be available so that material storage at no time prevents or limit access to fire exits. This would not exclude materials temporarily standing for a brief time in transit from storage to a production area, but its temporary standing should not preclude safe exit from the building if required. The space required for temporary storage must also be considered in premises design and appropriate space provided.
19.19 All operations should be carried out on the manufacturing site in such a way that the risk of contamination of one product or material by another is minimised.
19.20 There should be documented cleaning procedures and cleaning schedules for external, manufacturing and storage areas (see Chapter 21).
19.21 Vacuum or wet cleaning methods are to be preferred. Compressed air, hoses, pressure cleaners, brooms and brushes should be used with care so as not to incur the risk of product contamination. Where compressed air is used, the potential for air contamination, e.g. with oil, should be considered and appropriate action taken.
19.22 Surfaces in contact with food should be inert to the food under the conditions of use and should not yield substances that might migrate or be absorbed into the food. A certificate or other written declaration of compliance should be held for all food contact surfaces to demonstrate that the materials are ‘food grade’ and comply with Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food, Regulation (EC) No. 10/2011 on plastic materials and articles intended to come into contact with food, as amended, Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food, and Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with foods, as then amended. These regulations lay down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs and all material testing must comply with the requirements laid down in this directive or as subsequently superseded. The list of groups of materials and articles involved (see EC No. 1935/2004 Annex I) include not only food grade material used in equipment design, but the following 17 materials and processing aids:
- active and intelligent materials and articles
- ion‐exchange resins
- metals and alloys
- paper and board
- printing inks
- regenerated cellulose
- varnishes and coatings
Compliance with this legislative requirement should be a prerequisite that is built into the process design phase of a new process line or piece of equipment. (For more information on specific migration levels associated with food contact materials see Chapter 24). Surfaces should be durable and able to sustain the activities undertaken without cracking or deterioration, for example inspection tables, conveyor belts and elevators. Where food contact surfaces are liable to wear, they should be of a contrasting colour to the food and raw materials used in manufacturing and should be inspected regularly for evidence of damage.
19.23 Any surfaces in contact with food should be easily cleanable and disinfected, smooth, washable, corrosion resistant and made of non‐toxic materials. Surfaces must also be non‐porous so that particles are not caught in microscopic surface crevices and become difficult to dislodge. Welds should be continuous, and all welds and joints should be smooth and impervious (see 19.12). Routine swabbing of food contact surfaces should be undertaken to determine the efficiency of cleaning and disinfection activities.
19.24 Surfaces in contact with food should be readily accessible for manual cleaning and disinfection or if not readily accessible, then easily dismantled for manual cleaning and disinfection. If clean‐in‐place (CIP) techniques are used, it should be demonstrated by the food business operator that the results achieved in terms of cleaning and disinfection without disassembly are the equivalent of those that would be obtained with full disassembly and manual cleaning, and can ensure safe food. The type of food contact surface should also be considered when designing the cleaning and disinfection programme, i.e. flat surfaces without joints or seals between sections will be easier to clean than pipework or moving elements.
19.25 Interior surfaces in contact with food should be so arranged that the equipment is self‐emptying or self‐draining.
19.26 All equipment should be purchased in accordance with specified requirements. It should be suitably tested and commissioned before the line is approved for full‐scale production. This could include small production runs with a microbiological sampling plan and shelf‐life testing to validate key processes (see 3.12). Equipment should be cleaned and serviced before use and any faults rectified. During commissioning, equipment should be tested to ensure that it meets the purchasing specification, is fit for its intended purpose and can be effectively cleaned, and where required disinfected, and maintained.
19.27 Equipment should be so arranged as to protect the contents from external contamination and should not endanger any materials or product through contamination from leaking glands, condensate, lubricant drips and the like, or through inappropriate modifications or adaptations.
19.28 Exterior surfaces of equipment not in contact with food should be so arranged to prevent harbouring of soils, microorganisms or pests in and on the equipment, floors, walls and supports.
19.29 Equipment should be designed and constructed to allow efficient cleaning and maintenance. There should be detailed written instructions for cleaning and disinfection. Specified materials, methods, safety precautions and suitable facilities should be provided (see Chapter 21).
19.30 Plant and equipment should be cleaned and serviced immediately after use. Any faults should be recorded. Missing parts, such as nuts, bolts, springs and clips, should be reported immediately to the quality control manager or designate.
19.31 The structure of the building, including walls, floors, ceilings and doors, should be maintained in a sound condition (see 19.11). Plant and equipment should be checked for cleanliness and integrity before every use and to this end should be designed with sound, secure, quick‐release systems for inspection and disassembly. Appropriate precautions for ventilating fumes from power‐driven equipment, heaters and so on should be taken with consideration for both product safety and personnel health and safety. Temporary repairs should be controlled to ensure they do not impact on the safety or legality of the product. Temporary engineering measures such as by‐pass pipework should be permanently repaired as soon as feasible, subject to processing constraints.
19.32 A documented maintenance procedure should be developed that addresses both preventive and responsive maintenance. The procedure should be based on risk assessment and ensure that all servicing and breakdown work undertaken on equipment is carried out, that food safety, legality and quality requirements are achieved and that any potential risk to the product is minimised. Preventive maintenance should be considered for all equipment and components that contribute to product safety. The frequency of servicing should be determined by the maintenance manager using factors such as manufacturer’s recommendations, equipment and plant history in terms of failure or breakdowns, proposed hours of use and production requirements. This should be documented on a planned maintenance schedule. The planned maintenance schedule needs to be reviewed on a prescribed frequency and amended as required. It should include all equipment and plant in the manufacturing unit and storage areas that ensures that the environment and the food products are manufactured to comply with legislative requirements. The fabric, plant, equipment and machinery should be serviced/maintained according to the maintenance schedule and any actions required documented in a machine log or other such internal document. This will then provide a service history for the piece of equipment, plant or area. The planned maintenance schedule may need to be updated in the event that hygiene audits or other internal audits identify problems with poor maintenance, for example cracking floor joints, peeling or flaking paint, damage or wear. Maintenance and machine servicing contractors must be made aware of the organisation’s maintenance procedure before they commence work, and particular attention must also be paid to personnel hygiene, premises hygiene and food contamination procedures that are in force to ensure the contractors’ compliance at all times. Waste control procedures must also be formally agreed with contractors to ensure adequate control and compliance with relevant legislation and to minimise the risk of product contamination.
19.33 Responsive maintenance may be required during production following identification of a machine fault. Minor adjustments could be carried out without interruption to the production line where the appropriate personnel have deemed that it does not present a risk to the safety and integrity of the product. Major repairs or adjustments would require the production line/area to be closed down and if necessary screened off. Any parts that are removed should be logged and accounted for by maintenance personnel prior to the line starting up again or the area going back into production. A cleaning procedure should be defined for the activities to be undertaken before a machine/production line is deemed suitable to go back into production. A hygiene clearance production record where the equipment is formally “signed off” back to production for use should be maintained detailing, as applicable, the equipment, brief details of the task undertaken and any parts that have been removed or replaced. The record should be signed off by the maintenance personnel concerned to confirm their work has been completed and by production personnel to authorise, on that basis, the recommencement of production. All maintenance and servicing activities, including the use of contractors, must be undertaken by competent individuals who can demonstrate by training or other means that they are competent to undertake the task required and are aware of and comply with internal organisational procedures.
19.34 Consideration should be given to the potential for cross‐contamination between low‐ and high‐risk areas by maintenance personnel, their tools and equipment. Consideration should also be given to managing the contents of tool boxes and similar storage equipment belonging to maintenance staff to ensure that all items taken into the production area are removed and/or accounted for before production can commence/recommence. Tools must present no contamination risk to the product and must be clean and, where required, disinfected and well maintained. They should be checked after use for any signs of damage and deterioration and appropriate action taken in the event that there is concern of a risk of product contamination. There should be information available that demonstrates that all materials, oils and lubricants utilised during maintenance are food grade and do not present a risk to product safety.
19.35 All engineering workstations/workshops must be controlled so that they do not present a risk to product safety or legality. They must be maintained in a suitable hygienic status, and controls should be put in place such as the use of swarf mats and other waste control measures to reduce risk to product safety.
Brittle Material Procedures
19.36 Wherever possible, the use of glass should be avoided and suitable alternatives sought. There are three different sources of glass: glass packaging, fixtures and fittings such as glass windows, light bulbs and dials, and imported glass such as spectacles, watches and drink bottles. Windows should be secured and laminated to contain any glass in the event of a breakage. Light bulbs and fluorescent tubes should be completely covered to contain any pieces of glass in the event of shattering, or be made of shatter‐resistant material. A register should be maintained, and updated as necessary, of all glass, ceramic and hard plastic items in the production area and more widely on the manufacturing site that are deemed following formal risk assessment to present a product contamination risk. A risk assessment should be undertaken to determine the frequency of inspection of all items whether each shift, daily, weekly or other prescribed interval. Items should be regularly inspected and the results of the inspection recorded with any required corrective action. This corrective action must be followed up to ensure completion and the removal of a potential product contamination risk. The use of glass and ceramic storage containers should be prohibited in all production areas. If glass or ceramic packaging is used for the final product, then breakage procedures should be in place for the packaging itself as well as other items of risk, for example these procedures should encompass as a minimum delivery, storage, transfer, dispatch and visual inspection on‐line and filler breakage procedures. A written procedure must be in place for the replacement of brittle items detailing the measures that are in place to prevent breakage and to minimise product contamination.
Consideration should be given to the use of equipment/items that are made with brittle materials being present in offices, quality control work stations or rest rooms that open directly into storage and production areas. A risk assessment should be undertaken and recorded that outlines the potential for contamination and the controls in place to minimise the risk of occurrence and the risk of contamination.
19.37 Any breakage of glass lenses in spectacles should be treated as a glass breakage incident and must be controlled by relevant procedures. Procedures should also be in place in the event that a contact lens is lost by person(s) on site where this poses a risk to product.
19.38 All personnel must report immediately to their line supervisor or management any broken or damaged glass/hard plastic or ceramic items. This applies to any location within the production unit or site. Any incident of broken glass or hard plastic components on processing equipment or other glass, ceramic or hard plastic breakage that could in any way have affected the product should result in production being stopped and the product immediately held. Any product/part‐processed product or ingredients that could be contaminated must be rejected and a thorough search of the area made before any more product is packed/processed. The area and all equipment within a designated predetermined radius of the breakage incident must be isolated immediately and thoroughly searched for fragments. The size of the area should be determined by risk assessment.
19.39 Depending on the type of material of concern, all personnel in the area at the time of the incident should have their clothing and the soles of their footwear checked for glass, ceramic or hard plastic fragments before leaving the area. All remaining fragments should be removed immediately using dedicated equipment for removing brittle material and disposed of carefully. Colour‐coded equipment is often used, for example red bins and red brushes and equipment, which is designated ‘GLASS ONLY’. Production equipment that may have been affected must be dismantled for in‐depth inspection and cleaning. Broken or cracked windows should be removed from the outside, with heavy‐duty polythene sheeting taped to the inside of the production area to prevent glass spillages. The glass must be replaced with a suitable alternative. Where practical, fragments should be pieced back together to try and account for all the pieces of glass, ceramic or hard plastic. A sample fragment should be retained for reference in the event of a subsequent customer complaint and for further analysis if necessary.
19.40 The area must be closely inspected again after cleaning and when the area has been declared free of glass, ceramic or hard plastic formal documentation should be completed and signed off by the appropriate manager to formally clear the area for recommencement of production.
19.41 For glass/hard plastic or ceramic breakages in areas remote from the production and storage area, for example offices and restrooms, a thorough inspection of the area should still be made by appropriate personnel in order to assess the potential risk to product. The breakage procedure must be followed as stated above.
19.42 Where other brittle items present a potential contamination risk to the manufacturing process, they should be addressed by a similar procedure.
19.43 Knives, scissors and blades are generally used for the following activities:
- opening outer packaging;
- cutting through shrink wrap and cardboard;
- cutting packaging fastenings; and
- food preparation.
Food contact cutting equipment should be identified, made of food‐grade material and kept separate from equipment used for other activities, for example designated colours for specific activities or departments, such as goods inwards, production or quality control. Knives (and all other sharp equipment) should be company issued and only be allowed in defined areas. Special protected blades are ideal, which are designed for safety and do not have an exposed blade. Knives should be controlled by suitable documented procedures, including the signing out of equipment to an individual and the signing back in again at the end of the production shift on the equipment’s return. Where possible, knives should be chained or otherwise securely fastened in a location to prevent their unintentional loss. Knives should be uniquely identified so that they can be assigned to individuals. On return, they should be checked to ensure there are no signs of damage and the blade is intact. Where appropriate, knives should be sterilised to minimise cross‐contamination. In the event that a knife is ‘lost’ or unaccounted for, the management of incidents procedure should be implemented (see Chapter 27).
Consideration should be given to monitoring the condition of knives that form an integral part of machinery. They should be inspected on a regular basis for integrity, and this inspection should be recorded. Consideration should also be given to implementing metal detection as a measure to ensure the potential for metal contamination is adequately controlled.
Where knives are used in the preparation of food items during manufacture, for example vegetable and meat trimming, due consideration should be given to implementing an effective disinfection programme. In order for such treatments to be effective, a cleaning procedure must be in place to remove soil and organic matter, otherwise disinfection by hot water above 82 °C or the use of chemical disinfectants will not be effective. Routinely the effectiveness of the cleaning and disinfection process should be verified by swabbing the knives. It should be noted that spores produced by pathogenic organisms may survive disinfection and present a food safety risk. This risk is both process and product specific.
19.44 The risk of contamination from premises and equipment has been explored in depth in this chapter. The need for appropriate risk assessment and mitigation processes has also been outlined. This risk assessment approach must be inclusive and utilise experience across the management team and staff within the manufacturing operation. Risk assessment at a formal level is important, but risk assessment by individuals as part of routine work tasks on a day‐to‐day basis is also essential as formal processes can never be exhaustive in terms of identifying the hazards that can occur and the remedial action that then needs to be taken to prevent contamination should the event arise. As such training of all staff needs to address their need to be vigilant with regard to the potential contamination of food products from the premises itself and equipment.