Element 5: The Hazard Analysis Critical Control Point (HACCP)

MINIMUM REQUIREMENTS

Processors must develop, document and implement a HACCP Plan to control any health and safety hazards related to the product or process. The processor must apply the seven principles of HACCP to identify any significant hazards and for those significant hazards identified, develop a HACCP Plan to prevent, eliminate, or reduce the hazard to an acceptable level.

The HACCP System consists of the following seven principles:

• Principle 1: Conduct a hazard analysis.
• Principle 2: Determine the Critical Control Points (CCPs).
• Principle 3: Establish the critical limit(s).
• Principle 4: Establish a system to monitor control of the CCP.
• Principle 5: Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
• Principle 6: Establish procedures for verification to confirm that the HACCP system is working effectively.
• Principle 7: Establish documentation concerning all procedures and records appropriate to these principles and their application.

The application of the HACCP principles must be consistent with the Recommended International Code of Practice - General Principles of Food Hygiene, CAC/RCP 1-1969, Rev-4-2003. (and as amended from time to time)

Every fish processor must analyze their products to determine what, if any, health and safety hazards are present. If any hazards are identified, appropriate controls must be put in place. HACCP is based on seven internationally recognized principles that will lead a processor through conducting a hazard analysis and developing controls as Critical Control Points for any significant hazards identified.

There are many approaches to hazard analysis and the development of a HACCP Plan. The following approach is presented as a guide and is not meant to be considered complete, as the exact method will vary depending on the product and process.

GETTING STARTED

Step 1 - Form your HACCP team.

Processors must take a team approach when developing their HACCP Plan. The development of the HACCP Plan can involve many technical issues and, therefore, at least one member of the team must understand the HACCP principles through formal education and work experience. Note: It is a good idea to assemble a HACCP planning team, especially in larger companies, to cover expertise in a every aspect of operations, including administration as well as production and maintenance.

Step 2 - Gather information.

1. Refer to the product descriptions completed for Element 2.

2. Refer to the process flow diagram developed for Element 2.

3. Review material such as consumer complaint data, and epidemiological and technical literature on your product and similar products.

DEVELOPING YOUR HACCP PLAN

Principle 1 - Conducting a Hazard Analysis

This identifies process steps where a significant hazard may be introduced, or increase to unacceptable levels. There are two steps involved in conducting a Hazard Analysis.

Step 1 - Identify potential hazards.

Processors must demonstrate that they have considered all process steps in conducting their hazard analysis and show their reasoning when a disagreement occurs. A hazard analysis worksheet can be used to organize and document the hazard analysis process followed by the HACCP team. A suggested format for a Hazard Analysis Worksheet is given in Appendix B.

1. For each product type, fill in the processing steps on a hazard analysis worksheet according to the process flow diagram.

2. At each step of the process, identify potential biological, chemical or physical hazards.

Step 2 - Analyze hazards.

The HACCP component of the QMP Plan focuses solely on significant hazards that are reasonably likely to occur and likely to result in an unacceptable health risk. It is important to maintain this focus, since if the HACCP Plan tries to control too many things, the hazards that are genuinely significant will not receive the attention they require, and the plant will lose control of the process.

1. Analyze each identified hazard by considering its severity and the risk or likelihood of occurrence, which determines its significance.

Analyze hazards in the context of existing programs, such as the Prerequisite Plan and the RAP Plan. Some hazards can be controlled by improving plant design and sanitation or personnel hygiene, and are therefore not considered significant.

2. Indicate on the hazard analysis worksheet whether each identified hazard is significant, and the reason for your decision.

3. Identify measures that can be used to prevent or eliminate the significant hazards, and record them on the hazard analysis worksheet.

Figure 7 gives an example of a hazard analysis for a processing step from a cooked shrimp operation.

Figure 7. Hazard Analysis Worksheet - Cooked Shrimp Operation

Click on image for text version

Principle 2 - Determine the Critical Control Points (CCPs)

For each significant hazard identified in Step 2 - Analyse hazards, there is an appropriate preventative measure in place to prevent or eliminate the hazard, or reduce it to an acceptable level. This principle determines where in the process these controls should be located to control the hazard effectively. The process step where hazard is controlled is known as the Critical Control Point (CCP).

Step 1 - Determine CCPs.

1. Record each processing step where a significant hazard was identified on the CCP Determination worksheet (Appendix B).

2. For each processing step, ask the following questions and record your answers on the worksheet. See Figure 8 for a sample CCP Determination worksheet.

Figure 8. CCP Determination Worksheet - Cooked Shrimp Operation

Click on image for text version

Question 1. Do control measure(s) exist?

If your answer is yes, ask Question 2.

If you cannot identify a preventative measure in the process that controls the hazard, answer no. Then ask:

Is control at this step necessary for safety?

If the answer to this question is also no, then this step is not a CCP and you can move on to the next identified hazard in the process. If yes is the answer, then a significant hazard has been identified that is not being controlled. In this case, the step, process or product must be modified to control the hazard.

Question 2. Is the step specifically designed to eliminate or reduce the likelihood of occurrence of a hazard to an acceptable level?

To answer this question, ask whether this step is the best step at which to control the hazard. If the answer is yes, then the step is a CCP; move to the next significant hazard. If the answer is no, ask question 3.

Question 3. Could contamination with identified hazard(s) occur in excess of acceptable level(s), or could it increase to unacceptable levels?

This question refers to contamination that exists, occurs or increases at this step. If the answer is no, then the step is not a CCP for that hazard. Move to the next hazard at that step, or the next step with a significant hazard.

Question 4. Will a subsequent step eliminate the identified hazard(s) or reduce its likelihood of occurrence to an acceptable level?

If the answer is no, then this step is a CCP. If you answer yes, then this step is not a CCP for this hazard. In this case, be sure that the hazard is controlled by a subsequent processing step.

Step 2 - Record the CCPs on the process flow diagram.

Indicate the CCPs on the process flow diagram developed for Element 2.

Step 3 - Record on HACCP Plan table.

If there were any CCPs identified, then a HACCP Plan must be developed.

For an example of a HACCP Plan table, see Appendix B.

1. Record each of the identified CCPs for the product on this table, or in the format chosen.

2. Record the preventative measure to be used to control the hazard.

Principle 3. Establish Critical Limits

Critical limits must be established for each CCP identified in Principle 2. A critical limit represents the values that are used to separate acceptable product from unacceptable product. The critical limit is measured during the monitoring procedures; and if anyone deviates from these procedures, the appropriate corrective action must be taken.

Step 1 - Determine critical limits.

1. Determine critical limits for each identified CCP.

In many cases, the appropriate critical limit may not be readily apparent. Tests may need to be conducted or information gathered from scientific publications, regulatory guidelines, experts or experimental studies. One example of critical limits are the critical factors determined by a recognized process authority for a canned product.

2. Validate the critical limits by providing the scientific or regulatory reference.

Principle 4. Establish a System to Monitor Control of the CCP

The processor must establish procedures to monitor each CCP, determining its operation within the critical limits. To design a proper monitoring system, the HACCP team determines:

• what will be monitored;
• how the critical limits and preventative measures will be monitored;
• how frequently monitoring will be performed; and
• who will perform the monitoring.

Step 1 - Establish monitoring procedures.

1. Determine what will be monitored and record it in the HACCP Plan table. This is usually a measurement or observation, such as:

• measurement of cold-storage temperature;
• measurement of processing line speed; or
• verification that the harvest area listed on a container of raw molluscan shellfish is in approved waters.

2. Determine how the critical limits and preventative measures will be monitored, and record this information in the HACCP Plan table.

These are usually physical or chemical measurements, or observations that must be designed to provide rapid (real time) results. Lengthy analytical testing is not appropriate, as the product will be distributed before the results are received.

3. Determine the frequency of the monitoring and record this information in the HACCP Plan table. The frequency must be appropriate to the CCP and the critical limits being monitored, and can be continuous or intermittent. Continuous monitoring can include:

• recording the time and temperature of a batch sterilization process on a temperature recording chart; and
• using a metal detector.

If continuous monitoring is conducted, then the equipment used must be checked periodically to make sure it is operating correctly. This should be addressed in the verification section of the HACCP Plan. If continuous monitoring is not possible, then intermittent measurements must be made at appropriate intervals. The frequency of measuring depends on how much the process varies, how close the measured values are to the critical limits, and how much risk the processor is prepared to take. Examples of intermittent monitoring include:

• temperature checks of the core temperature of a pasteurized product;
• can seam integrity checks for canned products; and
• belt speed checks for a continuous cooker.

4. Determine who will be responsible for monitoring a CCP. Record this information in the HACCP Plan table. Examples include line personnel, equipment operators or quality control personnel. The person responsible for monitoring must:

• be trained to perform the specific monitoring activity;
• fully understand the importance of CCP monitoring;
• have ready access to the monitoring activity;
• accurately report each monitoring activity; and
• immediately report any deviations so that the appropriate corrective action can be taken.

Principle 5. Establish a Corrective Action System

Corrective action must be taken whenever monitoring indicates that the process is operating outside the defined critical limits. There are two activities associated with corrective action: the first is to determine the immediate, short-term action that must be taken to deal with the product that may have been affected, and the second is to determine the long-term action that should be taken to prevent recurrence. The corrective action system developed in the Establishment Environment Program or the Regulatory Action Point Plan may also be applicable here.

The immediate action to be taken when a process deviation is found can be predetermined or decided on a case-by-case basis. For example, if the critical limits for a cooking operation are not met then the predetermined corrective action may be to immediately re-cook the product. If there is no predetermined corrective action, then there must be procedures in place to isolate any potentially affected product until it can be assessed to determine its appropriate disposition.

1. Establish a corrective action system for each CCP, and record it in the HACCP Plan table.

Figure 9. HACCP Plan Table - Cooked Shrimp Operation

Click on image for text version

MONITORING PROCEDURE

Principle 6. Establish Verification Procedures

For each monitoring activity, tests must be performed to ensure that the HACCP system is working as designed. Tests are done on a schedule, less frequently than monitoring procedures. Verification can include:

• a review of monitoring records generated as a result of monitoring;

• calibrating monitoring equipment; and

• additional testing, such as microbiological tests.

These activities are limited to the monitoring procedures for the CCPs and are to be done by someone other than the person responsible for monitoring the CCP. Other verification requirements for the QMP Plan are discussed in the following section.

1. Establish verification procedures for each monitoring activity, and record them in the HACCP Plan table.

Principle 7. Establish Documentation and Record-keeping Requirements.

Accurate documentation and record-keeping is an essential part of the HACCP program. Documentation is the physical record of the procedures or activities that are to be followed (HACCP Plans, SOPs, etc.); records are generated by the procedures or activities performed, or if any corrective actions are taken. Maintaining records is mandatory for all CCP monitoring and verification activities. Records should include all pertinent information and be signed and dated by the person in charge of monitoring and reviewing the HACCP process.

The maintenance of documents is covered in Element 6 of this guide.

1. Decide where records will be collected.

2. Design documents to record all pertinent information.

3. Identify the documents needed for the HACCP Plan, and include a copy of each one with the plan.

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