ISO 22000 Internal Audits: Auditing a Food Plant

ISO 22000 and Infrastructure Concerns for Prerequisite Programs

Nowadays, most of the companies which understand the seriousness of ISO 22000 Food Safety Management System (FSMS) plan to take ISO 22000 FSMS certificate. The hazards that cause food-related illnesses and how these hazards can be prevented in the food and beverage companies are both globally known. Today, food safety management system and practices stand out as the most prominent method of safe food production. Companies that implement systems such as the HACCP or ISO 22000 FSMS attain success in safe food production. The presence of communication all along the food chain is necessary to be able to identify all hazards related to food safety and to ensure sufficient control in every stage. The hazards and control measures defined in communication with consumers and suppliers will help generate requirements for the benefit of both consumers and suppliers (such the requirement for an expiration date and a label on the final product). It is also necessary for a company to know its role and position in the food chain to be able to deliver safe food products to the final consumers and to establish an effective communication with them. Consumer demand for safer food production is increasing. This demand led to the formation and development of various standards. It is important to have an international harmony in order to avoid confusion about such standards. This is exactly the need that the ISO 2000 FSMS aims to meet.

There are some requirements that a company should meet before implementing the ISO 22000. The first requirement is that the personnel should be provided all the necessary training about the system, and they should be cognizant of the significance of the system. It is much easier to establish and implement this system with informed personnel. The second major requirement and one of the highest costlier components of the ISO 22000 implementation is infrastructure. Thus you need to have a well-planned manufacturing facility well before you start to think about ISO 22000 FSMS implementation, where you have to consider good manufacturing practices and the risk level of the product manufactured. When considering the infrastructure requirements if a food facility it is mandatory to consider everything and how to link all these requirements match with varying food safety needs.

Layout of Premises and Workspace

Each production site must establish a program that monitors the external and internal building structure including floors, walls and ceilings. The program must include environment/vegetation controls, perimeter restrictions, parking lot maintenance, control of standing water and potential contaminations from the local environment (air, water, chemicals). The program must include temporary structures.

Exterior Controls

Each facility must maintain the building and building perimeter to avoid any potential for product contamination from the local environment.

Interior Layout

Each facility must maintain the walls, ceilings and floors to prevent potential contamination. Each facility must establish traffic patterns for product and personnel to minimize the potential for product contamination.

Laboratory Layout

All laboratories must be separated from production and must have restricted access. Microbiology laboratories must not open directly into production.

Temporary Structures

Prior to release for use, a risk assessment must be conducted, appropriate controls identified and applied.

Utilities

All production sites must have an established program for the handling and use of water, electricity/lighting, boilers/steam, gas and compressed air. The program must include the monitoring, maintenance and documentation.

Air Handling

Heating, ventilation and air conditioning, positive/negative pressure rooms, clean rooms (see the specifications below), filters, ventilation, testing of air, exterior air intake, etc. if applicable, must be monitored and recorded. All clean rooms where open product is handled must have positive pressure to avoid airborne contamination.

Clean Room specifications:

Contaminants must not be introduced into the controlled environment from the outside.

The equipment within the controlled environment must not generate or otherwise give rise to contaminants (for example as a result of friction, chemical reactions, or biological processes).

Contaminants must not be allowed to accumulate in the controlled environment.

Existing contaminants must be eliminated to the greatest extent possible, and as rapidly as possible.

Some clean rooms are kept at a positive pressure so that if there are any leaks, air leaks out of the chamber instead of unfiltered air coming in. Limits and positive/negative pressure in the clean rooms are determined by the Food Safety Team.

Water Usage

Potable and non-potable water usage must be monitored to minimize contamination risk. Potable water must be tested annually and comply with local regulation or WHO. Treated, chlorinated and deionized water must comply with local regulations regarding quality and microbiological requirements. Where applicable, backflow preventers must be in place. Dead end piping should be avoided, if in use, must be cleaned and monitored and must be included in the environmental program. Steam (culinary water) supply used for products or product surfaces must be potable and comply with local regulations regarding quality and microbiological requirements.

Lighting

The lighting must be sufficient enough to maintain hygienic conditions. Fixtures must be protected to prevent breakage. Bulbs must be safety coated or non-breakable. Each facility must have a glass breakage procedure.

Gas/Compressed Air

Oil free compressors are preferred; if not applicable oil must be food grade (safe for human consumption and must meet local regulation) or oil should not come in contact with the air. The compressor systems must be maintained to prevent contamination per the Preventive Maintenance (PM) Program.

Boiler Chemicals

Boiler chemicals must be approved food grade chemicals per local regulation. The chemicals must be stored separately.

New Equipment

All new equipment must be selected baseon food grade requirements and performance. Validated sanitation procedures, preventive/corrective maintenance must be established for all new equipment prior to release to production. This includes measuring and monitoring equipment.

Equipment Design

Equipment must be of hygienic design with approved food contact surfaces.

Approved Food Contact Surfaces: Stainless steel, new and repairs, must be a minimum of 1.4404 for food grade steel; resin/plastic per EU and US regulations and corporate procedure; gaskets must be for food grade use; filters, fabric, coated metals must be for food grade use.

Sanitation

Sanitation procedures must be defined by either the manufacturer or per a sanitation validation program.

Preventive Maintenance

A Preventive Maintenance (PM) Program must be established for all equipment; see Equipment Preventative Maintenance.

Measuring and Monitoring Equipment

Equipment, including scales, that measures or monitors quality or food safety of related processes or products, including laboratory equipment, must have a documented validation, verification and/or calibration schedule established. Scales must be calibrated at minimum annually or per local requirement. The frequency for revalidation and verification must be defined based on the equipment, use, and manufacturer recommended frequency.

Validation: Quality assurance process of establishing evidence that a product, service, or system accomplishes its intended requirements and documenting that a process or system meets its pre-determined specifications and quality attributes.

Verification: Quality control process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase, scale-up, or production, including support departments.

Calibration: Calibration is accomplished by a formal comparison to a standard which is directly or indirectly related to national standards, international standards, or certified reference materials.

New Equipment Release

The corporate new equipment release form must be used for release to production and filed with supporting equipment documentation.

Maintenance

All production sites must have an established Facility Preventive Maintenance Program. Each production site must have an established preventive/corrective maintenance program, temporary repairs procedure, reconciliation of tools/ utensils and release to production.

Facility Preventive Maintenance

A Facility Preventive Maintenance (FPM) Program must be established for the maintenance of the building, exterior and interior, at a required frequency based on the facility, age and environmental conditions. A facility inspection must be conducted at least annually and corrective actions must be documented to support the FPM Program and food safety requirements.

Equipment Preventative Maintenance

An Equipment Preventive Maintenance (EPM) Program must be established for all food contact, monitoring and measuring equipment. An EPM Program, as defined by the manufacturer or maintenance/engineering department, must be established for all product related equipment that may have an impact on quality and food safety. The program must include frequency, replacement inventory requirements, release requirements for preventive and corrective maintenance and allowable temporary repairs based on the EPM criteria per equipment. The release must include a reconciliation of tools used for the EPM.

Reconciliation of tools: The maintenance responsible must account for all tools used during the PM or temporary repair of equipment, assure that no tools remain behind and all tools are returned to the appropriate maintenance storage location.

Temporary Repairs

Temporary repairs must follow release-to-production criteria per equipment.

Temporary repairs of the facility must follow release criteria. A description of the repair, a risk assessment and corrective action must be documented. The release must include a reconciliation of tools used for the repair.

Maintenance Personnel Training

Authorized maintenance personnel must be trained or licensed to perform in the maintenance and technical areas. Training records must be documented and available for review.

References

ISO 22000: 6.3, 6.4, 8.3;

Rationale for Preparing and Executing PRP for ISO 22000

The following example will help you to understand how an auditor thinks about food safety practices and the way he audited your facility. It will help to plan and document the PRP according to standard guidelines which will ease your workload and satisfy the auditor while comply with exact requirements in a way which auditors looking at. It will help to minimize the work load while eliminating the noncompliance in your facility. There are various points that you must consider against the General Principles of Food Hygiene of the Codex and evaluate the standard in following way to understand how to do it and when to do it with what records and preventive actions.

1. Building facility must not located in close proximity to any environmental contaminants and the surrounding/roadways are free of debris and refuse, adequately drained and maintained to minimize environmental hazards.

Standard – Criteria associated with debris and refuse, possible contamination from neighbours, property drainage and maintenance/cleanliness of property.

Site plan demonstrates building location and property layout.

2. Building exterior designed, constructed and maintained to prevent entry of contaminants and pests, eg., no unprotected openings, air intakes are appropriately located, and the roof, walls and foundation are maintained to prevent leakage.

Standard - “description of” or exterior building plan indicates material “make-up” and condition of the exterior of the building (includes roof, walls and foundation) and air intakes/vents. Criteria must address the need to prevent pest and contaminant entry into the building.

Who: position or person doing the “what”

Who: Position “X”

What/how:

Duties, limits, forms completed and any references to additional manuals e.g. sanitation manual. It also documents, how the “what” is carried out

What/how:

Walk around the building exterior and perform a visual inspection to ensure that, as per specific program requirements, the building facility not located in close proximity to any environmental contaminants and the surrounding/roadways are free of debris and refuse, adequately drained and maintained to minimize environmental hazards. The site plan from the blueprints is utilized and confirmed to be accurate.

Walk around the building and perform a visual inspection to ensure that, as per the specific program requirements, the building exterior is designed, constructed and maintained to prevent entry of contaminants and pests.

The position x will check that there are no unprotected openings, air intakes are appropriately located, and the roof, walls and foundation are maintained to prevent leakage. In addition a check will be performed against the blueprints for the building exterior to ensure accuracy.

Records, signs/dates on form xxx.

When: (Frequency): How often the “who” does the “what”

When: Once per 6 months

Deviation:

Procedures to be followed by the “who” when a deviation occurs, including corrective action

Deviation:

The position x makes an assessment as to whether food safety has been compromised and records findings on form xxx. If food safety has been compromised the product is held, tested and subsequently released, reworked or destroyed and recorded on form xxx

The position x records the description of the deviation, the corrective action and the date of completion on form xxx. Where required, preventative & corrective actions are developed by performing a root cause analysis, describing the preventative measures, date for completion and person responsible and are recorded on form xxx.

Verification:

Includes who does the verification, how it is done and at what frequency.  Ensures that the “what” is carried out.

Verification:

Once every x, the position y observes the position x in the performance of his monitoring function and reviews all records that have been completed since the last verification. All records are signed and dated by the position y at the time of verification. If deviations are encountered, an assessment is made, by the position y, as to whether food safety has been compromised and recorded on form xxx.

If food safety has been compromised the product is held, tested and subsequently released, reworked or destroyed and recorded on form xxx. The position y records the description of the deviation, the corrective action and the date of completion on form xxx.

Where required, preventative corrective actions are developed by performing a root cause analysis, describing the preventative measures, date for completion and person responsible and are recorded on form xxx.

Records:

- What/how

- Systems check

- Corrective actions (If different from above)

Records:

Form xxx

Site plan

Building blue prints

As above it is your duty to examine the standard and prepare your own program to match your facility’s compliance requirements against GMP as shown in the above example.