ISO 22000: Getting Prepared for an Audit

What is an External Audit?

Can you imagine your collage days, when you were waiting for an exam? Now imagine you’re a student who is aware of a major exam scheduled for the end of the month. Instead of studying throughout the week leading up to the exam, you decide to cram the studying into the final 24 hours prior to the exam. You might be thinking to yourself, “That leaves far too much to chance; what if there isn't enough time to cover a certain concept in-depth, or to ensure a full understanding of the subject on the whole?” Those are the same concerns that come along with preparing for a third-party food safety audit. If a food safety manager leaves preparation for the last few weeks leading up to a food safety audit, it will most certainly affect for his or her food safety audit score. Because business success hinges on an outstanding audit score, it’s easy to understand the dangerous consequences when lack of audit-readiness can bring. Third-party auditors use relevant standards such as ISO 22000, BRC, FSSC 22000, HACCP or any other standard to ensure facilities are compliant with the criteria of the concerning standard which means your facility needs to meet or exceed audit standards every time.

With the changes from recent legislation and the numerous, occasionally competing, food safety standards in place, it can be daunting to know how to prepare for a food safety audit. ISO, FDA, USDA, GMPs, GFS I, HACCP, SQF, BRC, FSSC, IFS—the alphabet soup of shifting management programs and agency oversight—are enough to alarm even experienced quality assurance professionals. Though different standards can measure various aspects of the manufacturing and distribution process in different ways, each is designed to improve food safety by reporting and measuring controls and activities such as cleaning, sanitizing and worker hygiene. Depending on the facility and the standard under which it is being audited, specific requirements and their implementation will vary. However, manufacturers who have strong programs in place should think of audits as opportunities to identify how to further improve operations rather than something to be feared.

A Foundation in Good Manufacturing Practices

One overarching theme found in all of the Global Food Safety Initiative (GFS I)-recognized programs are suitability and cleanability to help assure the floors, walls, ceilings, equipment and personnel do not pose a potential risk to the food being produced. These food safety basics are not new; in many ways, they parallel to the requirements published in the Code of Federal Regulations and apply to food manufacturing facilities regardless of whether they fall under regulation by the U.S. Department of Agriculture (USDA) or the U.S. Food and Drug Administration (FDA). Industry-created standards, such as the GFS I-recognized programs like Safe Quality Food (SQF), British Retail Consortium (BRC), Food Safety System Certification (FSSC) and International Food Standard (IFS), lay out the rules that a manufacturer must follow in order to control the safety and quality of their product. The initial push for implementation and certification against these programs came primarily from the food retail community for their private label products, but in recent years, the push has extended to manufacturers of branded products as well as other players in the food production chain, such as ingredient manufacturers and manufacturers of food packaging materials, which come into direct contact with foods. A manufacturer must first implement the food safety management program and then have it audited and certified by a qualified, external, third party audit firm called a certification body. If the audit is successful, the facility is certified for 1 year.

Certification Audit Preparations

When you have implemented your program and have completed your internal verification of your program. As you prepare for your certification audit, here are some basic tips that can help you:

Review the standards – Think of audits like a test in which all of the answers are provided. The standards by which your facility will be judged are clearly laid out, but it never hurts to review them again to see if any have been updated or changed since the last audit.

Conduct an internal pre-audit – Using a checklist with the latest standards that apply to your operation, schedule a daylong walk through of your facility to observe your processes from start to finish. Have a marked-up copy available for review. Try to look at operations from an outside perspective. Whatever the result of the pre-audit, fix any problems that are noted.

Document – Make sure that logbooks, product labels, date stamps, invoices, customer lists and other documents and records prove that you can recall products quickly. Be sure to download any logs you might need; some can be modified to address recordkeeping requirements for the audit, but make sure they provide the information needed to show the auditor that you are consistently meeting the standard's requirements and your own internal requirements.

The Day of Audit – Facility Audit Agenda

Audit agendas are varying according to the standard, but the normal pattern of events are as follows:

Opening Meeting – Confirm the appointment details; introduce the auditor(s) and auditee contacts, confirm scope and the day’s agenda.

Tour of Operations – Areas toured depend of the type of facility, but might include raw material storage areas, production, finished goods storage, personnel facilities, maintenance, chemical storage, packaging storage and external areas e.g. where dumpsters are located. The auditor might interview some operators.

Food Safety File (paperwork section) – New auditees should have at least three months’ worth of paperwork available (unless a short season crop packing facility i.e. in operation less than three months of the year). Please note that the auditor cannot accept documentary evidence after the audit has ended e.g. if on the audit, a pest control document is missing and the auditee tries to fax it the next day, it cannot be used to alter the score.

HACCP Section (if relevant) – The auditor might look at the HACCP file in the opening meeting in order to orientate him or herself about the site program and CCPs. Auditor will interview CCP operators.

Food Security Section – The auditor will have made notes about physical security aspects when carrying out the tour of the operation. These questions are scored.

Miscellaneous Questions and New Questions – Might be covered at any point in the audit, as the topics arise.

Auditor "Quiet" Time – Time required for the auditor to collate notes before delivering the closing meeting.

Closing Meeting – Discuss findings with the auditee team. Auditors are not able to provide either a final score or pass/fail commentary at the end of the audit due to the high number of questions that are asked in the template and the scoring system that is applied. Auditors however do expedite audit reports very quickly and auditees should contact audit firm if reports have not been received within two weeks after the audit has occurred.

It is imperative that the facility is running product i.e. processing, packing, cooling (whatever functions are usually occurring as on a “normal” day) and that a normal compliment of personnel are on site when the audit occurs in order for the auditor to complete a valid assessment. If the facility is not running and/or there are no production employees or product on site, then the audit will have to be terminated and cancellation charges will be applied or the audit can continue as a pre-assessment audit. Please ensure that auditee personnel are available to follow the facility tour and are well versed in the areas that are being inspected.

Documentation Requirements

New Facility Auditees/First Time Facility Auditees

In operation for more than three consecutive months – Auditee should have at least three months of documentation available for review. If the facility has less than three months of most of their documentation available for review a pre-assessment audit is strongly advised. If the auditee has less than three months of most of their documentation available for review and decides to have a regular audit, they should be aware that they cannot receive full conformance for paperwork questions relating to monitoring and that the down score will be based on the amount of paperwork available.

Short season operation, in operation for less than three consecutive months – Auditee should have at least three months of documentation available for review (this may include last season’s documentation). Where an operation does not have three months of records available (e.g. one month of operation per year) auditee should have at least the previous season’s records available for review. If the auditee has less than three months of most of their documentation available for review and decides to have a regular audit, they should be aware that they may not receive full conformance for paperwork questions relating to monitoring and that the down score will be based on amount of paperwork available.

Management Reviews – There must be two consecutive management review data available for the auditing, basically you can have a management review after you start preparing your facility for a certification against a given food safety standard (i.e. ISO 22000) and when you complete the process of implementing your system and after the internal audit is completed.

Existing Facility Auditees

In operation for more than three consecutive months – Auditee should have at least three months of documentation and documentation at least since the last audit.

Short season operation, in operation for less than three consecutive months – Auditee should have at least three months of documentation and documentation at least since the last audit (which includes the last season). Where an operation does not have three months of records available (e.g. 1 month of operation per year) auditee should have at least the previous season’s records available for review.

Visual versus Verbal Confirmation

Visual confirmation is the default method of auditing, whether on the plant tour or the paperwork section. Scores and comments are assumed to have been visually confirmed unless otherwise stated. Verbal confirmations should be the exception to the rule and if auditing properly, these should be rarely used. If a verbal confirmation is accepted, then the auditor should write this in the comments on the question.

Hygiene Zone Demarcation for Food Manufacturing Facilities

Good Hygienic Practices

Food can be contaminated at many stages during a production process. There is a global trend in the food industry towards minimal food processing and preservation. Consumer demand for “fresh-like” additive-free foods, that maintain their nutritional and sensorial properties during preparation, conservation, packaging, storage and finally consumption, is on the rise. But the general tendency to apply mild processing and conservation techniques to achieve that purpose, often shortens the shelf-life of food, may put foods at risk and may compromise consumer health. Therefore, more than ever, good hygienic engineering and design practice is one of the tools to reduce or exclude microbial (e.g. pathogens), chemical (e.g. lubricating fluids, cleaning chemicals) or physical (e.g. glass, wood) contamination of food. Proper hygienic design also may eliminate product 'held-up' within the process equipment where it could deteriorate and affect product quality on rejoining the main product flow. As such, good hygienic design may prevent that one batch cross-contaminates a subsequent batch. Good hygienic design further reduces the downtime required for an item of process equipment to be cleaned, while at the same time allowing to increase the time to produce. Therefore, although initially more expensive than similarly performing poorly designed infrastructure and equipment where, hygienically designed facilities and equipment will be more cost effective in the long term.

One GHP method to manage the risk of contamination is to divide a food producing facility into zones in which different hygiene levels apply and ensuring that products flow only from levels of basic hygiene in direction of levels of higher hygiene.

Deciding upon how to apply these zones is done by

1. Identifying process steps where products or intermediate products are easily contaminated, for example because they are still unpacked.
2. Deciding on how to demark or enclose those rooms/areas so that strict hygiene rules can be applied. This might require some reorganization of the flow of process.
3. Deciding on rules that need to be applied in each defined zone.

The ideal production plant would be designed in such a way that raw material would enter at one end of the building and follow a linear path through zones of increasing hygiene before exiting as a final product at the other end. This ideal situation would minimize cross-contamination and should be applied to the design of new food plants. In reality, businesses often have to make do with less than ideal buildings.

However, most processes can be (re)arranged in order to comply as much as possible with the ideal flow of product through a plant. In addition, identification of potential cross-contamination in the flow of material and processes and taking actions to prevent contamination will significantly enhance the level of product safety.

Not all production types require exactly 3 hygiene zones. In certain cases only 2 zones are required whereas in others perhaps 4 might be more appropriate. What is important is to understand and follow the principle of differentiating between process steps where contamination is more likely to occur and defining the necessary design and corresponding behaviour to prevent contamination from happening at these steps.

Zoning – A Cornerstone in Prevention of Food Contamination

Zone B:

Zone B is an area in which a basic level of hygienic design requirements suffices. It encompasses areas in which products are produced that are not susceptible to contamination or that are protected in their final packages. A B0 zone is the area outside the buildings within the perimeter of the site where the objective is to control or reduce hazards created by unauthorized personnel entry and hazards created by water, dirt, dust and presence of animals. B1 zones include warehouses that store both raw materials and packed processed products, offices, workshops, power supply areas, canteens and redundant buildings/rooms. The objective for a B1 zone is to control or reduce hazards created by birds and pests.

Zone M:

Zone M is an area in which a medium level of hygiene suffices. It includes process areas where products are produced that are susceptible to contamination, but where the consumer group is not especially sensitive and where no further microbial growth is possible in the product in the supply chain. In this area, product might be exposed to the environment, during sampling and during the opening of equipment to clear blockages. The objective for zone M is to control or reduce the creation of hazardous sources that can affect an associated area of higher zone classification. Another objective is the protection of the interior of food processing equipment from contamination when exposed to the atmosphere.

Zone H:

Zone H applies to an area where the highest level of hygiene is required. A “High Hygiene” room, which, in food processing is the equivalent of a cleanroom, must be completely contained. Zone H is typical for open processing, where even short exposure of product to the atmosphere can result in a food safety hazard. Products and ingredients that are processed or stored and are destined for a highly susceptible consumer group (e.g., infant nutrition), are instant in nature or ready for consumption. They must be handled in a refrigerated supply chain, as they are susceptible to growth of pathogenic microorganisms. The objective for H zones is to control all product contamination hazards and to protect the interior of food processing equipment from exposure to atmosphere. Filtered air must be supplied to this area.

These areas should be limited in size, must have a simple equipment layout to facilitate process, cleaning and maintenance operations and should have utilities located outside. However, investing in an enclosed line that brings barriers very close to the product is more logical than trying to create a complete cleanroom around a partially open line.

Zoning and the establishment of barriers to ensure that product of acceptable hygienic quality is produced should only be applied where their use will help significantly to protect products. Designing the entire factory as a cleanroom is not the purpose of food area segregation to protect both product and consumer. Zoning and barrier technology must be applied in an appropriate and consistent way, thereby avoiding unnecessary investment.

Construction of Facilities: Appropriate Layout

The layout and design of the food factory must be adapted to the hygienic requirements of a given process, packaging or storage area. The interior of the factory must be designed so that the flow of material, personnel, air and waste can proceed in the right direction. As they become incorporated into food products, raw materials and ingredients should move from the ‘dirty’ to the ‘clean’ areas. However, the flow of food waste and discarded outer packaging materials should be in the opposite direction. Before building begins, simulation of the flow of people, materials, products and waste can help the designer determine the most appropriate place for installing the process equipment and where the process and utility piping should enter the process area. Even the simulation of maintenance and cleaning operations can be useful to determine the most appropriate factory layout. Graphical computer-aided design and 3D visualization programs can help in the hygienic design, positioning and routing of processes, process supports and utility systems. These programs allow the observer to “walk through” the facility, seeing the inside of the facility from different angles and locations. To save building and renovation costs, potential problems can be solved before the onset of construction. Additionally, in the development of high hygiene areas, computational fluid dynamics can help simulate and visualize expected air-flows.

To meet a possible increase of processing activities within the food plant in the future, the building and its food processing support systems should be designed so they can either be expanded, or another building and/or utilities can be added. Over-sizing the main utility systems is a common practice. If possible, the factory should also be made adaptable (i.e., the ability to modify the production area for other manufacturing purposes) and versatile (i.e., the ability to do different things within the same room).

Construction of Facilities: Pest Prevention

To exclude flooding and the entry of rodents, factories should be built at a higher level than the ground outside. Exterior doors should not open directly into production areas, and windows should be absent from food processing areas. The number of loading docks should be minimal and be 1–1.2 m above ground level. Preferably, outside docks should have an overhanging lip, with smooth and uncluttered surfaces that are sloped slightly away from the building to encourage water run-off. Areas beneath docks should not provide harborages for pests, should be paved and should drain adequately. To provide protection for products and raw materials, docks can be shielded from the elements by roofs or canopies. However, these structures can become a serious sanitation problem due to roosting or nesting of birds. Bird spikes or nets can solve that problem. To prevent the entry of insects, dock openings should be provided with plastic strips or air curtains, and external lighting to illuminate these factory entrances should be placed in locations away from the factory building. Intruding insects can still be attracted and killed within the food factory by strategically positioned ultraviolet (UV) light electric grids or adhesive glue board traps.

Construction of Facilities: Interior Hygienic Design and Construction Materials

Construction materials for equipment and utility piping should be hygienic (smooth, non-absorbent, non-toxic and easily cleanable), chemical-resistant (to product, process chemicals, cleaning and sanitizing agents), physically durable (unbreakable, resistant to steam, moisture, cold, abrasion and chipping) and easy to maintain. Materials used to construct process and utility systems located in the non-food contact area may be of a lower grade than those applied in the food contact zone. Surfaces that are frequently wet should not be painted as the paint can crack, flake and chip.

Lead, mercury and cadmium should not be used within the factory. However, as part of many electric components, it is very difficult to exclude their presence. In the food contact area, electric components must always be enclosed in junction boxes, casings, closed cable housings, cabinets, etc. or should be installed in non-product contact zones or in technical corridors. Alloys for food contact may only contain aluminum, chromium, copper, gold, iron, molybdenum, nickel, platinum, silver, titanium, zinc, carbon, etc. However, zinc, copper, aluminum, bronze, brass, carbon and galvanized and painted steel have poor resistance to detergents, disinfectants, acidic food and steam and must be avoided in food contact areas.

Polytetrafluoroethylene, polyethersulfone, polyvinylidene fluoride, phenol-formaldehyde, urea-formaldehyde, melamine-formaldehyde, epoxy and unsaturated polyester resins are used in the construction of electric components, while other plastics like polypropylene (PP), low-density polyethylene (PE), polyvinyl chloride (PVC), polyurethane (PU), ethylene propylene diene monomer (EPDM), silicone, etc. are applied as jacket materials for electrical cables or for the construction of pneumatic hoses and compressed air tubing. PP, PE and PVC are also used to construct drain pipes, while shields of polycarbonate can protect the food area below light sources from shattered glass after accidental breakage of lamps. Silicone, nitrile, PU, EPDM and butyl rubber are largely used as materials for gaskets, seals, etc. Epoxy is widely used as floor, wall and ceiling coatings. Remember that many plastics perform differently at -25 °C than they do at 20 °C.

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.