ISO 22000: WHAT IS ISO 22000 GAP ANALYSIS? – Section II

Gap Analysis II 

As we discussed about the importance of Gap Analysis in ISO 22000 implementation projects, it is mandatory to have a good design and facilities to implement effective ISO 22000 Food Safety Management System (FSMS). Design and facilities are one of the cornerstones in good manufacturing practices, because you can’t achieve a good production line with preventive maintenance practices without a proper infrastructure facility. Thus it is one of the main prerequisite programs in ISO 22000, HACCP and all other FSMS available, which is derived from GMP which is also a part of the general requirements of food hygiene published by Codex Alimentarius.

Accordingly, section II explains the requirements of design and facilities of the organization been audited, as well as the environment for production in terms of cross contamination, pest ingestion, physical, chemical or biological hazards and their mixing up with foods due to the defects of the production facility, its location and the design.  There are many ways to conduct gap analysis, but if you are a beginner, no one will teach you to look at specific points until your eye start focusing on the exact requirements, where this will be a focusing lesson to train your observation process in to right direction.    
     

Section II – Establishment: Design and Facilities

2.1 Location and Surrounding (GMP and Codex Requirement)

Establishments should normally be locates away from:

Environmentally polluted areas and industrial activities which pose a serious threat of contaminating food;

Areas subject to flooding unless sufficient safeguards are provided;

Areas prone to infestations of pests;

Areas where wastes, either solid or liquid, cannot be removed effectively;

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. The production facility need be located away from polluted areas;
2. Review the history of the flooding around the factory area and the risk of contamination;
3. Pest infestation patterns and availability of the pest populations;
4. Waste removal effectiveness and suitability;

Writing example of specific criteria against control points;

Production facility:

The current location of the facility is not appropriate as it is located in the center of a residential area and not well isolated, the possibility of the pests infestations is very high due to the low level of cleanliness in the surrounding areas and corners.

Storage Facilities:

The current location of the storage facilities is acceptable; however the surrounding areas need to be cleaned preventing any accumulation of materials such as pallets and old equipment which leads to pests infestation.

Recommendation:

The company is highly recommended to move its operations to a new area taking into consideration the above mentioned requirements in selecting the location.

2.2 Design and Layout (GMP and Codex Requirement)

Where appropriate, the internal design and layout of food processing establishments should permit good food hygiene practices, including protection against cross-contamination between and during operations by foodstuffs.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

Writing example of specific criteria against control points;

The company has no documented layouts and design plans in place to check the flow of people, materials products and to check the potential cross contamination.

By having a tour into the plant it was clear that the current design and layout is not complying with the basic hygiene requirements and is a clear source of cross contamination.

As agreed with the company representative we will not to go into the details of the findings of the existing design, but we will give the basic recommendations to be taken into consideration in designing any new premises in the future.

The Control Points

1. The company need to have a documented factory layout and plan describing production and process flows in the factory areas, flow of raw materials, personnel, finished products, packaging and wastes.
2. A clear perimeter should be maintained around the facility to prevent rodent attraction sites.
3. The flow of raw materials, work in progress, finished product, personnel and equipment through the factory should be as linear as possible.
4. The company needs to separate the activities before cooking (Raw and dirty areas) from the activities after cooking (cooked and clean areas) to avoid any potential for cross contamination. There must be complete physical separation of the high (Raw and dirty areas) and low risk (cooked and clean areas) areas in terms of raw materials, products and personnel. The incorporation of filtered air supplies, positive air pressure and appropriate personnel controls are recommended to maintain the integrity of high-risk areas. This includes facilities to change clothing on entering the department.
5. Storage of raw materials and packaging must be segregated to avoid cross contamination and must be separated from the product in production areas.
6. The final layout and design plans need be reviewed with the related Ministry and to be consulted with food safety experts’ prior commencing the constructions.
7. The company needs to take into consideration the types of equipment, technology, range of products, future expansions in designing the premises.
8. The storage facilities need to be designed taking into consideration the type of materials and products to be stored, storage conditions, and storage capacities needed based on forecasting.
9. The personnel facilities, laboratory and other service areas should be included in the design with specifications related to the size of the premises, types and scope of production.
10. All operatives must enter the factory by a specific entrance, to a dedicated changing area where showering, hand washing and toilet facilities are available, and where outer garments are exchanged for work wear.
11. At the entrances to process areas, personnel should be guided to hand wash stations using appropriate means e.g use of guard rails, guard rail supervisor.
12. Hand-washing facilities must be suitably trapped and plumbed directly to drains. Design of wash basins and plumbing. Plumbing of hand-wash facilities directly to drains with suitable traps. This should lead directly into the drain and not allow splash, spillage or standing pools of liquid to form.
13. Movement between different areas of the factory must be minimized, and constantly monitored by management. Recommended that the use of process areas as corridors from one area to another should be controlled.
14. To reduce the risk of cross contamination, boot washing facilities of adequate size and capacity shall be provided at entry points to processing areas and at transfer points between dirty and clean areas. Transfer of operatives across these boundaries limited.
15. The numbers and capacities of the facilities will be calculated according to the total No. of employee and the scope of production.
16. Visitors should enter the facility from clean area (cooked and clean areas) and exit towards raw processing area (Raw and dirty areas).

2.3 Drainage and Waste Disposal (GMP and Codex Requirement)

Adequate drainage and waste disposal systems and facilities should be provided.

They should be designed and constructed so that the risk of contaminating food or the potable water supply is avoided.

Suitable provision must be made for the removal and storage of waste. Waste must not be allowed to accumulate in food handling, food storage, and other working areas and the adjoining environment except so far as is unavoidable for the proper functioning of the business.

Waste stores must be kept appropriately clean.

The external facility for the disposal of waste should be located well away from production areas, preferably in its own enclosed building, thus minimizing the danger of pest infestation or other hazards affecting the factory.

Internal waste collection systems must be clearly identified as such and be used specifically for that purpose. Containers similar to those used for food, ingredients or packaging are not acceptable for waste collection.

A designated operative should be responsible for maintaining the waste control system and ensuring that collection, containers and handling systems are kept scrupulously clean.

All waste materials should be removed as often as possible and should not be allowed to accumulate in any production or service area within the factory.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. The capacity of the drains must be sufficient to cope with the maximum process requirements placed on them; this will depend on the types of production and the types of technology used.
2. The floors must be adequately drained with the fall of the floors carefully designed to ensure that all liquids flow towards proper drainage channels, this will need a proper slope in the design of the floors towards the pools or the channels. There shall be no standing pools of liquid.
3. Drainage channels that are half round in section with both the drains and gullies covered with removable easily cleaned grids are recommended.
4. Size of apertures in grid should be suitable to prevent large gross debris from entering main drain, but does not restrict flow to and through drainage channels.
5. Frequency and maintenance of drain covers / grids prevents drain blockage and formation of standing pools of liquid.
6. In high-risk premises (meat processing), the flow of the drains shall be from high (cooked clean areas) to low risk (raw dirty areas) to avoid contamination of the clean environment.
7. Positioning of machinery in relation to access to drains shall not compromise regular cleaning.
8. Positioning of equipment does not create blockage of drains nor does it create an unsafe working environment.
9. Use of cleaning schedule to ensure cleaning of drains and their maintenance.
10. Adequate debris traps should be fitted to all drains and any manhole covers properly greased and sealed. Positioning of debris traps ensure effective retention of heavy / gross debris Located outside the working environment and properly sealed and maintained to ensure safe access.
11. Drainage entry and exit points into the building must be pest proofed. Fumigation of drains is acceptable.
12. Damaged drains must be repaired as quickly as possible to prevent any blockages or accumulation of debris.
13. Up to date records of inspection and maintenance of the drains. This may be covered within appropriate cleaning activities.

2.4 Sitting of Equipment (GMP and Codex Requirement)

Equipment should be located so that it:

Permits adequate maintenance and cleaning;

Functions in accordance with its intended use; and

Facilitates good hygiene practices, including monitoring.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. All machinery should be positioned to give easy access to all parts for cleaning. Equipment must be at least 50cm from adjacent walls.
2. Equipment must be designed and laid out to minimize any possible contamination from external sources.
3. All frameworks in and around equipment should be in tubular sections to minimize accumulation of debris and to facilitate cleaning and reduce the risk of infestation e.g. with maggots, molds and ants.
4. Machinery mounted on the floor must be installed on a foundation of easily clean-able, non-absorbent material. It must be either properly sealed to the floor with sealing material which is resistant to the environment or raised off the floor to allow access underneath for cleaning purposes, particularly to drains.
5. Use of food grade materials in design.
6. Electrical trunking and cable trays must be kept free of dust, cobwebs etc.
7. Use of appropriate cleaning plans and schedules with maintenance and inspection records. 

2.5 Condition of Floor (GMP and Codex Requirement)

   

Floors should be constructed to allow adequate drainage and cleaning;

The surfaces of floors should be made of impervious materials with no toxic effect in intended use;

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. Floors should be designed to withstand the rigours of the production processes that are being conducted.
2. Floors must be in good condition and must be laid using impervious materials with an even, easily cleaned surface which is free from cracks, pitting and open joints.
3. The floor surface must be impervious to moisture and grease, resistant to chemicals and food materials to which it may be exposed and safe to walk on when wet, dry or greasy i.e non-slip surface.
4. Floors must be kept clean and free from the accumulation of water or other spillage’s, especially in corners and areas hidden by equipment, materials etc.
5. Cleaning schedule and records to ensure cleaning of potential harbourage areas.
6. Coved wall and floor junctions should facilitate cleaning. Wall and floor ‘joints’ are coved to prevent inaccessible cleaning and harbourage of pests.
7. Damaged flooring must be repaired as quickly as possible with materials compatible with the original flooring and in a permanent fashion. Temporary measures must be rectified with an action plan in a specified time.
8. There are different options available in the market for the floors; this will depend on the types of products toe produced and the financial ability feasibility to the company.

2.6 Condition of Walls, Doors and Windows (GMP and Codex Requirement)

   

The surfaces of walls, partitions and floors should be made of impervious materials with no toxic effect in intended use;

Walls and partitions should have a smooth surface up to a height appropriate to the operation;

Door should have smooth, non-absorbent surfaces, and be easy to clean and, where necessary, disinfect;

Windows should be easy to clean, be constructed to minimize the buildup of dirt and where necessary, be fitted with removable and cleanable insect-proof screens. Where necessary, windows should be fixed;

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. All interior walls in rooms where open food is stored or processed must be in good condition and finished with a hygienic, easy to clean surface, which does not pose a foreign body hazard e.g. walls should be finished with a continuous, bonded surface and protected from damage. Corners, joints between cladding sheets or ceramic tiles must be sealed with a suitable impervious sealant. (Hygienic and Food Grade Material, No decomposition, Protection for wall cladding against damage, Food grade impervious sealant used to seal joints).
2. Walls and wall surfaces should be free from shelves and other protruding attachments wherever possible. The design must be such as to avoid any horizontal surface, which could act as a dust trap, or impromptu shelf space.
3. All wall-wall and wall-floor junctions should be coved. Wall-ceiling junctions and other junctions should be coved or sealed to facilitate cleaning. Food grade impervious sealant used to seal joints.
4. All signs of deterioration and damage should be dealt with immediately and the repairs should be compatible with the original finish.
5. Where notices are required they should not be nailed, pinned or taped to walls, self adhesive notices or food grade painted notices are preferred in production areas. Where they are required they should be self adhesive and no material which may cause foreign body and cross contamination should be used. Notices should only be used where required to meet legislative needs.
6. Recommended that walls must be protected in vulnerable areas by the use of guard-rails.
7. Services must be sealed into any walls through which they pass e.g. electrical fittings, plumbing etc.. Where fabricated walls are used, services must be sealed onto them e.g. electrical fittings.
8. Services (i.e. electric / water) provided into factory: Entry point into factory complies with food safety and hygiene requirements Suitable seals are provided and maintained through records and inspection.
9. Where temporary walls are constructed, they must give adequate protection from contamination and they must not present a hazard to the process or the product which complies with Health & Safety requirement and food hygiene requirement
10. All external-opening doors must be kept closed. Where frequent use makes this impractical then either automatic doors, rubber swing doors, plastic strip curtaining or air curtain should be provided to prevent bird and insect ingress
11. All doors to production areas should be self-closing to maintain the necessary atmospheric conditions. They should be close fitting on all sides and the door-frames and corners must be given protection against damage.
12. All windows should be kept closed. Those required to be opened to provide additional ventilation, should have the total opening area screened with a mesh small enough to exclude flying insects. no windows or glass should be in food production areas
13. All exterior windows must be clear, complete and properly fixed. Their frames must be of sound fitting and completely sealed to prevent insect ingress.
14. Broken or cracked windows must be replaced immediately before production recommences. Approved shatterproof materials must used.
15. Records of Inspection, cleaning and maintenance should be available. 

2.7 Condition of Ceilings and Lights (GMP and Codex Requirement) 

   

Ceilings and overhead fixtures should be constructed and finished to minimize the buildup of dirt and condensation, and the shedding of particles;

Adequate natural or artificial lighting should be provided to enable the undertaking to operate in a hygienic manner. Where necessary, lighting should not be such that the resulting colour is misleading.

The intensity should be adequate to the nature of the operation. Lighting fixtures should, where appropriate, be protected to ensure that food is not contaminated by breakages.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. In any room where open food is stored or processed, the condition of the ceiling must be smooth, easily cleaned and kept in good repair. It must not pose a foreign body hazard to the area below.
2. Ceilings may be under drawn or suspended, however, access must be provided to the void above to enable adequate cleaning and pest control inspections. Adequate walkways must be provided for this purpose and also for access to services.
3. All junctions between walls and ceilings should be sealed and impermeable to facilitate cleaning. Additionally eaves and ridges must be sealed to prevent access to birds, insects and rodents.
4. Where painted surfaces are unavoidable, both these and underlying surfaces must be sound and free from flaking, and repainted as necessary with a paint approved for use in food preparation areas.
5. Throughout production and inspection areas, good artificial lighting must be provided. Fluorescent strip lights should be protected by shatterproof diffusers or sleeve covers in production areas.
6. Any other form of lighting must be protected such that glass contamination of product is rendered impossible.
7. Natural daylight tubes must be used in inspection areas, otherwise adequate lighting must be provided for operations.
8. Where special lighting conditions are required, for example on inspection belts, lighting of the correct colour and intensity must be provided.
9. All light units must be kept clean, and bulb replacement or any other maintenance programme carried out when the department is not in production.
10. Sky lights should be designed to prevent access by pests, and must not be directly above any exposed raw material or finished product. If movement of production lines results in them was being placed below skylights, then a canopy should be provided to protect the product or the light screened.
11. Completed Cleaning plan and records should be available.

2.8 Air Quality and Ventilation (GMP and Codex Requirement)

Adequate means of natural or mechanical ventilation should be provided, in particular to:

Minimize air-borne contamination of food, for example, from aerosols and condensation droplets;

Control ambient temperatures;

Control odours which might affect the suitability of food; and

Control humidity, where necessary, to ensure the safety and suitability of food and ventilation systems should be designed and constructed so that air does not flow from contaminated areas to clean areas and, where necessary, they can be adequately maintained and cleaned.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. Adequate temperature and dust control must be provided in all areas.
2. In steamy atmospheres, extraction fans must be provided to give adequate ventilation and minimize condensation. This will help to prevent mould formation on walls and ceilings and could also reduce the level of corrosion on fabric and equipment.
3. In dry areas, dust extractors should be installed where necessary. These units must be regularly inspected and maintained to ensure that they are functional and that there are no signs of infestation.
4. Frying or other fume producing processes must be provided with adequate extractor facilities, trapped to prevent condensate falling back into the process.
5. Condensate from extraction systems and from evaporators must be plumbed direct to drain, and the collection system sanitized daily.
6. Both ventilation systems and extraction systems must be kept scrupulously clean to avoid introducing contaminants into the process environment.
7. Cleaning records and programs should be in place.

2.9 Water Supply (GMP and Codex Requirement) 

    

An adequate supply of potable water with appropriate facilities for its storage, distribution and temperature control, should be available whenever necessary to ensure the safety and suitability of food.

Potable water should be as specified in the latest edition of WHO Guidelines for Drinking Water Quality, or water of a higher standard. Non-potable water (for use in, for example, fire control, steam production, refrigeration and other similar purposes where it would not contaminate food), shall have a separate system. Non-potable water systems shall be identified and shall not connect with, or allow reflux into, potable water systems.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically. 

The Control Points

1. All water used in food factories whether for processing, cooling or pre-cleaning of cans, bottles or jars and for rinsing process equipment must be of potable quality and free from discoloration or taint. Its microbiological and chemical quality must be regularly checked.
2. Water tanks must be kept covered, frequently inspected to ensure that there has been no contamination and must be regularly cleaned.
3. Where chlorination is necessary, contact time and free chlorine levels must be routinely monitored. Indicator of Quality. Records of chlorination by suitably trained personnel and use of correct equipment, Monitor of free chlorine and contact time, Microbiological results verify effectiveness of chlorination versus possible pathogens and spoilage organisms
4. All compressed air supplies must be filtered and passed across water and oil traps which should be drained regularly.
5. Maintenance and Inspection of air supplies, Records of maintenance and inspection to ensure no harbouring of possible contaminants to the production area.
6. All services should ideally be routed down from ceilings, structures and services running below the ceiling must be kept to a minimum and be regularly cleaned.
7. Hoses must be kept in clean and hygienic condition. Wall mounted reels should be fitted for storage and they should always be kept off the floor.
8. Steam hoses must never be immersed in product. If live steam heating is required, the hose must be fitted with a stainless extension tube.
9. Regular audits of service lines, particularly water must be carried out to eliminate dead legs.
10. Documentation of portability must be available for city water, documentation of portability for well water at least semiannually.
11. Water treatment units when used, must be controlled with clear documented programs and inspection and monitoring.