HACCP production/processing operations

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A Hazard Analysis and Critical Control Point (HACCP) Plan should be documented and in place (or implemented) for each product line. The plan should include:

  • Accurate flow charts (depicting all processes and inputs) and risk assessments/decision trees.
  • Identification of Critical Control Points (CCPs), including critical limits and supporting evidence (e.g. ANZDAC heat treatment guidelines or scientific studies).
  • A variation (significant change which impacts food safety, Importing country requirements (ICR’s), etc.) must be advised in writing to your regulator who audits you for exports. Your State Regulatory Authority (SRA) must then notify the department.
  • Documented HACCP responsibilities, work instructions, training, and records.
  • Having a verification system in place which includes internal audits/HACCP reviews.
  • Internal auditing of hazards and a corrective action register, with evidence to support implementation and verification of corrective actions.
  • HACCP team must be defined.
  • The HACCP plan should be developed under the guidance of Codex requirements for HACCP plans, which sets out the seven principles of HACCP.
  • Operations and methods must follow the documented HACCP program – this will be observed and verified at audit.
  • Methodology is documented including risk decision trees, risk matrix, HACCP review requirements, etc.
  • Product descriptions must be in place.

It is important that your potential hazards, their causes, control measures and corrective actions are sufficiently described in your risk assessment. A common issue is having causes of potential control measures and corrective actions not aligning for the hazard identified.

For the relevant legislative references in the Export Control (Milk and Milk Products) Rules 2021, please refer to the department’s, Approved Arrangement Checklist.

HACCP is a well-established hazard analysis technique adopted by the food industry to ensure all potential hazards to the manufacturing process are identified, risk assessed and controlled, so that the identified hazards do not pose an unacceptable risk to food safety.

Any hazards which present a risk to product quality and regulatory or customer compliance can also be identified and managed through your company’s HACCP plan, but the priority of HACCP is food safety.

A HACCP system is designed so that any changes, such as new equipment design, processing procedures or technological developments are risk assessed and incorporated into the HACCP plan.

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.

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Self Assessment

How much do you know about HACCP?

Take this short assessment to find out.

Question 1

Neha is the site quality manager of a dairy manufacturing plant that pasteurises raw milk. Six months ago, the establishment was granted export approval. The demand for export products has continued to increase since they began exporting, and the business is considering upgrading its production capability.

The site is looking to add two additional milk storage tanks and a new production line to keep up with the demand.

As the site already has milk storage tanks in the HACCP food safety plan, does Neha need to update the HACCP flow chart and the plan to reflect the new equipment and production process?

Question 2

Neha has updated her site HACCP food safety plan to capture the new equipment and process changes. She is considering going ahead with the proposed upgrades in the coming months. The changes will have an impact on exported products.

As an approved export manufacturer, is the establishment required to report the proposed changes made to the processing lines and new equipment to the department, before proceeding with the plant upgrade?

Question 3

Jason is working in the High Temperature Short Time pasteurisation plant. His colleague, Mark, is on his lunch break. Jason is undergoing training to become a competent pasteurisation operator and is not yet compliant with the specific monitoring and controls of the plant. The HTST pasteurisation operation is a Critical Control Point (CCP) for the plant, and the system is programmed to run in automatic cycles.

As Jason is a trainee operator, should he have been left alone to monitor the HTST pasteurisation plant, which is a CCP step?

Question 4

As Jason has been training with Mark this week, he is aware the pasteurisation cycle should approximately take 2 hours, and should not end before Mark returns from his meal break. Upon inspecting the milk feed in tank, Jason notices there is not enough milk left, and the process is taking less time than usual. He suspects the process will end before Mark returns from his break. Jason checks the pump settings and notices the pump is set to CIP. He was instructed by Mark to change the pump speed, but he has forgotten to do so.

As a trainee operator, what actions should Jason take with the HTST plant and product?

Question 5

As the quality manager, Neha has decided to reprocess the milk products through a further pasteurisation cycle to ensure food safety compliance. As the issue was internally detected, rectified and the end products do not pose a food safety issue, Neha does not believe this incident requires an internal corrective actions report.

Is Neha correct in her assumption?