Elements of an Approved Arrangement

The HACCP plan should be developed under the guidance of Codex requirements for HACCP plans, which sets out the seven principles of HACCP.

The seven principles are: Hazard analysis; Determination of CCPs; Critical Limits; Monitoring of CCPs; Corrective action; Verification; Recording.

The very first step in developing your site’s documented HACCP or food safety plan is to have a designated HACCP team that is responsible for creating, managing and reviewing the HACCP plan.

The HACCP team leader should be knowledgeable about the principles of HACCP and be able to demonstrate competence, experience and training. Your HACCP team should have some knowledge of HACCP, and members shall have relevant knowledge of products, processes and associated hazards. Ideally, the HACCP team should be multidisciplinary. Your HACCP plan must identify the HACCP team.

If your company does not have the required knowledge, external resources may be used but it is your site’s responsibility to manage your HACCP plan.

The purpose and scope of your HACCP plan must be clearly defined. Product descriptions are considered as part of the scope of a HACCP plan, as they describe the products being made at the site, and information relevant to the products that can help identify potential hazards (e.g. ingredients composition, pH, water activity, allergens, packaging, shelf life, the intended use of the product, any sensitive consumer groups, as well as finished product handling, storage and distribution requirements).

A HACCP flow diagram should be developed by your HACCP team. It must describe the steps of your process from receival of raw materials (including packaging) through to manufacturing, storage, and distribution of finished product. You must ensure all process steps and inputs are included in the diagram, even the steps that may seem insignificant like transfer of materials. By clearly and accurately documenting the process flows relevant to your site, you will have a much clearer picture of what hazards may be present at each step.

Your flow diagram must be verified by your HACCP team by physically following it through each step. It should be revised annually to ensure it remains current, and reviewed whenever changes are made to your processes.

Your HACCP team must determine all known hazard types so they can be either reduced to an acceptable level or be eliminated. Hazard types include physical hazards, microbiological hazards, chemical hazards and where applicable, radiological hazards. Each hazard must be risk assessed and the likely causes identified. A risk matrix table is an example tool that can be used to assess the likelihood and severity of a hazard. You must document your risk assessment method and outcomes in you HACCP plan.

Some hazards can be readily managed through existing parts of your food safety plan (e.g. pre-requisite programs such as pest control or training programs). Other hazards may require specific controls implemented at a specific step in order to manage the hazard, because no other steps in the process effectively manage the hazard. These types of hazards are considered Critical Control Points, or CCPs. A CCP demonstrates a significant hazard that can only be eliminated or controlled via this measure. As part of your hazard analysis and risk assessment, you must identify any CCPs. A common tool for doing this is a CCP decision tree. Depending on your operations, you may find that you have no CCPs or several CCPs. For example, if you receive and pasteurise raw milk, you would have different CCPs compared to a site that cuts or shreds cheese from pre-made blocks.

Each CCP must have a summary table (commonly referred to as a HACCP audit table) which includes:

• The process step and what the hazard is
• What is the control measure and what the critical limit is
• Where does the monitoring activity occur and where is it recorded
• How often is the monitoring activity to be recorded
• Who is responsible for monitoring, recording activities, and making decisions
• Instructions for corrective actions to be implemented should a failure be identified

Your CCP Critical limits need to have supporting scientific evidence to validate the set limit. You must validate the critical limits for your CCP process (using reputable scientific/regulatory evidence) and how your systems will allow these limits to be met (e.g. through set-up trials of key equipment). For example, if you form a hypothesis to control a specific microbiological hazard by heating up the product to a set temperature for a certain time, you must have evidence from a reputable source to back up your hypothesis. You must be able to verify these in your own manufacturing plant. The proof must come from reputable sources, and you must be able to verify these in your own manufacturing plant. Validation refers to external evidence of a set limit, whilst verification refers to your practical evidence to prove the set limit was acceptable in achieving the desired result. Validation usually occurs prior to you setting up your production CCP limit (example: finding out what temperature could be used to kill a specific pathogen) while verification occurs after the fact (example: testing the product for presence of the same pathogen after it has been heated to the validated limit, confirming your target pathogen has been killed).

A good example is milk pasteurisation. Your goal is to reduce pathogens present in the milk to a defined acceptable level, so you must validate your pasteurisation process by adopting scientifically valid critical limits for parameters like holding time and temperature and flow rate, and then trialling the pasteuriser as part of its commissioning to ensure that the critical limits are reached when operating. You must document your validated limits and justification (e.g. referencing literature, summarising trials or commissioning) in your Approved Arrangement. You must also keep evidence to support your validation justifications. For example, you should have copies of relevant literature and any validation reports containing trial data available at all times.

Once you have a validated process in place, you need to monitor the process by keeping records that demonstrate that the critical limits are being met on an ongoing basis. You also need to regularly verify that the process is effective at achieving the defined result. Using the pasteurisation example, you can verify that your pasteurisation process was effective at reducing pathogens to an acceptable level by testing samples of the pasteurised milk for target pathogens. You must document your ongoing monitoring and verification methods for each significant hazard in your HACCP plan.

In some cases, especially in novel and innovative technologies, repeated verification results may be used to validate a CCP limit. However, these still must accompany a scientific hypothesis, sound logical explanation and a peer review process to become valid.

CCP limits can be set well above minimum requirements to allow some degree of tolerance between food safety limits and site operating limits. Deviations from critical limits and all corrective actions must be documented and include how the process has been brought back under control. Any affected product should be reviewed and disposed of if necessary.

Your CCP summary table must also document the corrective actions that are taken if there are deviations from critical limits, including how the process is brought back under control. Any affected product should be reviewed and disposed of if necessary.

All monitoring records and documents for your CCPs must be signed by the person(s) doing the monitoring and should also be verified by the responsible supervisor. The records must be legible and must be able to be traced back to the person responsible for signing them.

The export legislation uses Codex HACCP as the basis of expectations for its HACCP programs. For more information on the principles of HACCP and its implementation, refer to FAO/WHO Codex Alimentarius Commission’s HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS APPLICATION.