ISO 22000: THE GENERAL PREREQUISITE PROGRAM REQUIREMENTS OF ISO 22000

ISO 22000 Prerequisite Programs Requirements - Part II

When you start building your ISO 22000 food safety management system, it is mandatory to consider the premises and its facilities which may be mandatory to upgrade to enable the implementation of ISO 22000 FSMS. The prerequisite programs are designed according to the requirements of the facility, but those requirements must be in line with ISO 22000 standard to comply with external audits. accordingly it is mandatory to conduct a gap analysis before you start to develop your ISO 22000 FSMS which will gives you an in-depth understanding of the relevant requirements.   

The prerequisite programs can be define as the basic conditions and activities, that are necessary to maintain a hygienic environment throughout the food chain suitable for production, handling and provision of safe end products and safe food for human consumption.

According to the standard how ISO 22000 does define Prerequisite program(s) ?

7.2 Prerequisite program(s)

7.2.1 General requirements

7.2.1 General requirements

The organization shall establish, implement and maintain PRP(s) to assist in the following:

1. Controlling the likelihood of introducing food safety hazards to the product through the work environment;
2. Controlling biological, chemical and physical contamination of the product(s) including cross contamination between products;
3. Controlling food safety hazard(s) levels in the product and product processing environment.

The PRP(s) shall be appropriate to the organizational needs with regard to food safety, be approved by the food safety team, and their relevance and appropriateness for controlling food safety hazards shall be included in the hazard analysis (ISO 22000: Clause 7.4).

The PRPs consist of two types:

a) Infrastructure and maintenance programs (see ISO 22000: Clause 7.2.2);

b) Operational PRP(s) (see ISO 22000: Clause 7.2.3).

When selecting and designing PRP(s), the organization shall consider and utilize appropriate existing information (e.g. regulations, customer requirements, guidelines, Codex principles and codes of practices, national, international or industrial standards) that is relevant for the design of the PRP(s).

7.2.2 Infrastructure and maintenance programs

The organization shall establish and maintain the infrastructure needed to achieve conformity to the food safety needs including as applicable

1. Lay-out, design and construction of buildings and facilities, including work-space, employee facilities, and associated utilities;
2. Supplies of air, water, energy and other utilities;
3. Equipment including its preventative maintenance, sanitary design and accessibility for maintenance and cleaning for each unit, and
4. Supporting services including waste and sewage disposal.

Verification of the fulfillment of these requirements shall be planned (see see ISO 22000: Clause 7.8). The infrastructure shall be modified as necessary, taking into account the results of the hazard analysis (see ISO 22000: Clause 7.4) and the capability of the selected control measures to control the identified food safety hazards (see see ISO 22000: Clause 7.5 and 7.6). Such modifications shall be recorded.

However when you develop you prerequisite programs for the ISO 22000 FSMS, use the criteria outlined in each of the sub-elements below, and any commodity-specific program requirements, to develop your company’s written prerequisite programs as part of ISO 22000 FSMS. You must meet all the requirements outlined in Guidelines for a Complete Written Program.

A Premises

Building and surroundings are designed, constructed and maintained in a manner to prevent conditions that may result in the contamination of food. “Premises” includes all elements in the building and building surroundings: the outside property, roadways, drainage, building design and construction, product flow, sanitary facilities, and water/ice/steam quality and supply.

A 1 Building Exterior

A 1.1 Outside Property and Building

Land is free of debris, refuse and is not close to environmental contaminants (e.g. objectionable odours, smoke, dust or other contaminants).

Roadways are properly graded, compacted, dust proof and drained. Premises, shipping and receiving areas provide or permit good drainage.

Buildings are of sound construction, are maintained in good repair, and do not present any chemical, biological or physical hazards to the food. Each building is designed to:

Provide suitable environmental conditions;

Allow adequate cleaning and sanitation;

Minimize contamination by extraneous materials;

Prevent access by pests; and

Provide adequate space for conducting all operations.

The construction and layout of buildings reflect the approved blueprints, where applicable.

A 2 Building Interior

A 2.1 Design, Construction and Maintenance

Floors, walls and ceiling materials (as well as various coatings and joint sealants) must be Accepted Construction Materials, published by government, EU, FDA, CODEX or any other reputed statutory and regulatory organization. If this is not the case, the manufacturer must obtain a “letter of no objection” from relevant authorities.

All mandatory places of the establishment are provided with conveniently located hands-free hand wash stations, where required or appropriate.

Waste pipes connected to hand wash stations are adequately trapped. Sanitizer hand-dips are available, where appropriate.

Floors, walls and ceilings are constructed of material that is durable, smooth, cleanable and suitable for the production conducted in the area. Where appropriate, joints are sealed and angles are coved to prevent contamination and to facilitate cleaning. Floors are sufficiently sloped for liquids to drain to trapped outlets.

Windows are sealed or equipped with close-fitting screens. Where it is possible that glass windows might break and glass particles might contaminate the food, windows are constructed of alternate materials or are adequately protected.

Hygienic operations are promoted throughout the facilities by means of a regulated flow in the process, from the arrival of raw material to the final product. Physical or operational separation occurs to prevent contamination of food via employee traffic patterns, product flow and equipment. The traffic pattern of personnel and visitors prevents cross-contamination of food products. Blueprints or drawings are available as required.

Living quarters, and areas where animals are kept, are separated and do not open directly into food handling, processing or packaging areas. Incompatible operations are physically and operationally separated to prevent cross-contamination of food.

A 2.2 Lighting

Lighting is appropriate, permits the intended production or inspection activity to be conducted effectively, and does not alter food colour. Lux requirements meet the respective program standards.

In areas containing exposed food or packaging materials, light bulbs and fixtures are of a safety-type or are protected in order to prevent contamination of food in case of breakage.

A 2.3 Ventilation

Ventilation prevents build-up of heat, steam, condensation or dust and removes contaminated air. In microbiologically sensitive areas, positive air pressure is maintained. Ventilation openings are equipped with tight-fitting screens or are otherwise protected with non-corrodible material. Air intakes are located to prevent the entry of contaminated air. Air used as a processing technique (e.g. pneumatic conveying, air agitation, air blows, air dryers, etc.) is appropriately sourced and treated (air intakes, filters, compressors) to reduce any source of contamination.

A 2.4 Waste Disposal

Drainage and sewage systems are equipped with appropriate traps and vents. Establishments are designed and constructed to prevent cross-connection between the effluent of human wastes and any other wastes in the establishment. No drainage pipes pass directly over or through production areas, unless they are controlled to prevent contamination.

Facilities are provided for the storage of waste and inedible material prior to their removal from the establishment. These facilities are designed to prevent contamination.

Containers used for waste are clearly identified and are leak proof.

A 2.5 Inedible Areas

A separate facility is provided for cleaning and sanitizing all equipment used for inedible materials.

A sufficient number of inedible areas are provided and are located, ventilated and refrigerated (where necessary) in such a way as to prevent cross-contamination of edible products.

Inedible products are isolated and denatured as per program requirements.

A 3 Sanitary Facilities

A 3.1 Employee Facilities

Washrooms with self-closing doors are provided. Washrooms, lunchrooms and change rooms are adequately ventilated and maintained. They are separate from and do not lead directly into food processing areas.

Washrooms have hand wash facilities with a sufficient number of maintained sinks that are properly trapped to drains. Hand wash facilities are adequately maintained and have hot and cold running potable water, soap, sanitary hand-drying supplies or devices and, where required, a cleanable waste receptacle.

Hand wash stations, hand dips and footbaths are maintained in all applicable areas of the facility.

Notices to wash hands are posted at all hand wash stations.

A 3.2 Equipment Cleaning and Sanitizing Facilities

Equipment cleaning and sanitizing facilities are constructed of corrosion-resistant materials that can be cleaned easily. Potable water is provided at temperatures appropriate for the cleaning chemicals used.

Equipment cleaning and sanitizing facilities are adequately separated from food storage, processing and packaging areas to prevent contamination of food.

A separate facility is provided for cleaning and sanitizing equipment used for inedible materials. Where required, cleaning and sanitizing equipment is designed for its intended use and is properly maintained.

A 4 Water/Ice/Steam Quality and Supply

A 4.1 Water/Ice/Steam

Water meets the requirements of your country’s/WHO Guidelines for Drinking Water Quality. Water from sources other than municipal supplies must be treated as necessary and tested to ensure portability.

Water, ice and steam are analyzed by the establishment at a frequency adequate to confirm their portability, or as per regulatory and program requirements. Records of water and ice portability include:

• The water source sampling site
• The analytical results
• The analyst’s name
• The date of the analysis

Records of water portability, and of the water treatments applied, are maintained, filed, and made available upon request.

Boiler treatment chemicals used must be Accepted Materials and Non-Food Chemical Products, published by government, EU, FDA, CODEX or any other reputed statutory and regulatory organization.

Steam coming into direct contact with food or food contact surfaces is generated from potable water with no harmful substances added. Steam supply is adequate to meet operational requirements.

Only potable water is used in all food processing, handling, packaging or storage areas. No cross-connections occur between potable and non-potable water supply systems. Hoses, taps, cross-connections or similar sources of possible contamination are equipped with back-flow prevention devices, if required.

In areas for food processing, handling, packaging and storage, water temperatures and pressures are adequate for all operational and clean-up needs.

Where water filters are used, they are changed or maintained effectively as required.

Where required, facilities for storage and distribution of water (e.g. water storage tanks) protect the water from contamination.

The treatment process for and the use of re-circulated water has been accepted by the regulatory agency having jurisdiction.

Re-circulated water is treated and maintained in a condition such that no health hazard results from its use. Re-circulated water has a separate distribution system, which is readily identified in the facility.

Water treatment chemicals must be Accepted Materials and Non-Food Chemical Products, published by government, EU, FDA, CODEX or any other reputed statutory and regulatory organization.

Ice used as an ingredient or coming into direct contact with food is made from potable water and is handled and stored to protect it from contamination.