A Fish and Seafood Processor's Step-by-step Guide
Step-by-Step Guide

Element 1: Management Roles and Responsibilities

The processor must identify the position responsible for the QMP Plan. As well, it is recommended that the processor describe how the QMP Plan was developed, and how it will be implemented. This element is important because management commitment is critical to the successful development, implementation and maintenance of the QMP Plan.

The requirements of this element must be met by:

  1. Providing the name, business address, business telephone number and the title of the person responsible for the QMP Plan.
  2. It is not mandatory, but is strongly recommended that senior management demonstrate their commitment to the QMP Plan in writing.

This can be done by producing:

  • an organization chart;
  • a written description of each manager's accountability;
  • a written description of company dispute-resolution processes, i.e., between production staff and quality management staff;
  • a vision statement or mission statement that emphasizes quality management;
  • a QMP Plan internal audit schedule, with management roles indicated;
  • documentation of management's role in corrective and preventive actions;
  • a written statement of commitment signed by all management staff;
  • Prerequisite Plan, RAP Plan and HACCP Plan procedure manuals; and/or
  • a signed statement of management commitment to quality management training, accompanied by a list of training opportunities for employees, broken down by job requirements.

In addition to a written commitment, managers can demonstrate their commitment by taking on responsibilities under the QMP Plan, supporting training activities, and motivating employees in the development, implementation and maintenance of the QMP Plan.

Managers can participate in the development of the QMP Plan by explaining it to employees, assigning quality management duties, or allocating equipment, materials, staff and space to QMP Plan activities, such as training.

Training is an effective way of involving employees in the process of developing a QMP Plan. Investment in training establishes management commitment. In addition, it is a valuable tool for the development and maintenance of a successful QMP Plan.

Contact local training schools and companies to find out whether any QMP courses are being held in the area or could be developed.

Element 2: Background Product and Process Information

Minimum Requirements

Processors are required to identify product and process information in the form of a product description for each type of product, a process flow diagram, and where necessary, a plant floor plan.

The product description must identify those product attributes and characteristics that are important in ensuring a safe and acceptable fish product.

The process flow diagram must outline all of the production steps and assists in identifying those steps that are important in processing a safe fish product meeting all regulatory requirements.

The plant floor plan is obligatory for plants with sanitary zones and restricted-access zones.

Product Description

A QMP Plan must include the necessary controls specific to the operations in place and the products produced. Therefore, before a QMP Plan can be written, information must be gathered about the attributes and characteristics of the products and processes that influence product safety and quality.

Step 1

Prepare a list of all products processed by the facility.

Step 2

For each product, record all relevant characteristics such as:

  • product name;
  • source of raw material;
  • important characteristics of the final product;
  • all ingredients;
  • product packaging;
  • end product use;
  • product shelf life;
  • market destination;
  • labelling instructions for safe product storage (where applicable);
  • special distribution controls or instructions (where applicable).

Figure 2 shows an example of a product description form that can be used to organize this information.

Step 3

Group the products according to their attributes and the controls they need.

Figure 2: Product Description Form

Note: A blank version of this form can be found in Appendix B.

1. Product Name(s)
Identify the species and method of processing; e.g. "Frozen sole fillets."
2. Source of Raw Material
State where it came from; e.g., "Locally caught" or "Imported from China."
3. Important Final Product Characteristics
List characteristics that affect product safety, especially those that influence pathogens, such as pH level or salt concentration.
4. Ingredients
List every substance added during processing; e.g., water, salt. Also list all ingredients of sauces and batter or crumb coatings.
5. Packaging
List all packaging materials; e.g., waxed cardboard, polyethylene wrapping. Only approved materials may be used.
6. How the End Product is Being Used
State how the final product is to be prepared for serving, especially whether it is ready to eat.
7. Shelf Life (If Applicable)
State the date when the product can be expected to begin to deteriorate if stored according to instructions; e.g., "Use within 21 days of shipping."
8. Where the Product Will be Sold
If the product is for export only - that is, it contains an ingredient or labelling not permitted in Canada - include this information so that the product goes only to a market where all its ingredients are permitted and the labelling is acceptable.
9. Special Labelling Instructions
List all instructions for safe storage and preparation; e.g., "Keep refrigerated."
10. Special Distribution Control
List all instructions for safe product distribution; e.g., "Keep refrigerated."

Process Flow Diagram

The purpose of the process flow diagram is to clarify and document the process and, eventually, to help the processor pick out the process steps where control measures and monitoring procedures would be most effective. Therefore, the process flow diagram should include all process steps and highlight the specific steps that are significant to product safety.

Step 1

Develop a process flow diagram for each of the products or groups of products that are produced at the facility. A plain block schematic, like the sample in Figure 3 for a fresh and frozen groundfish plant, is adequate.

Step 2

When the process flow diagram is finished, walk through the plant with it and verify that it is complete and accurate.

Step 3

When the QMP Plan is complete, indicate the RAPs and CCPs on the process flow diagram.

Plant Floor Diagram

If, during the development of a HACCP Plan, hazards are identified that can be controlled by using sanitary zones or restricted areas (for example, in cooked or canned fish products), the QMP Plan must show where these areas will be. This can be achieved with a schematic indicating the flow of materials, traffic and product that outlines the sanitary zones and restricted access areas. An example of a floor plan for a hot-pack cooked lobster operation is shown in Figure 4.

Step 1

If the application of sanitary zones or restricted access areas have been identified as a control measure in the development of the HACCP Plan, develop a plant floor diagram outlining these areas.

Step 2

When the plant floor diagram is finished, walk through the plant with the diagram and check that it is complete and accurate.

Element 3: The Prerequisite Plan

Minimum Requirements

Processors are required to identify controls on establishment design, construction and maintenance in order to provide assurance:

  • that the food will be produced under sanitary conditions;
  • of control of all potential sources of significant contamination;
  • that product can be rapidly recalled from first shipping destinations.

The prerequisite plan is divided into two programs:

1. Establishment Environment Program

As part of the Establishment Environment Program processors are required to identify:

  • the establishment environment standard that is applied in the facility (as a minimum the standard must meet the requirements of the Fish Inspection Regulations);
  • the actions that are taken by the processor to ensure the standard is met;
  • the record keeping system to record corrective actions when problems are identified;
  • the corrective action system in place to address deficiencies when they are identified.

2. Lot Accountability and Notification Program

  • for purposes of carrying out a product recall, processors are required to have a product identification and distribution system that allows for the rapid identification of the first shipping destination.
  • the processor is also required to have procedures to notify the CFIA of any valid health and safety complaints.

Note:
Under the Prerequisite Program, processors are not required to record the results of monitoring unless a problem is identified. In these cases, the processor must record the problem and the corrective action that was initiated.

Developing a Prerequisite Plan

Every fish processing operation must have a Prerequisite Plan, which covers the plant environment (facilities, sanitation and hygiene) and accountability and notification (removing from the market product that may be unsafe). A Prerequisite Plan should be specific to each individual operation.

This plan is called "Prerequisite" because it includes aspects of plant operations that are essential to the production of safe, healthy food that must be in place before processing begins.

3.1 Establishment Environment Program

The Establishment Environment Program is divided into two parts: Construction and Equipment and Sanitation and Personnel Hygiene. To aid in the development of an Establishment Environment Program, a worksheet is provided in the Appendices as an example. The Establishment Environment Program Worksheet is an effective tool because it relates standards to control measures and monitoring procedures to corrective actions. The worksheet summarizes in one document why the control measures are being applied and what to do when a problem arises. Figure 5 shows a sample of a completed Establishment Environment Program Worksheet for a cooked shrimp operation.

3.1.1 Plant Construction and Equipment

The Establishment Environment Program must include a documented program to ensure that plant facilities and equipment are:

  • suitably designed and built; and
  • maintained in a state appropriate for safe food processing.

To develop the plant construction and equipment component of the Establishment Environment Program, follow these steps:

Step 1 - Know the standard.
  1. Become familiar with the construction and equipment standard applied at the processing facility. Most companies apply the construction and equipment requirements set out in Schedule I of the Fish Inspection Regulations. These requirements are set out in Chapters 5 and 6 of the CFIA Facilities Inspection Manual.
  2. A copy of the standard must be included in the QMP Plan. The standards are the foundation of the QMP Plan. Without a standard, control measures will not be focused on a fixed target and it will not be known if the objectives are being met. The inclusion of standards is a demonstration to any party that audits your QMP Plan that it is based on clear, defined standards.
  3. Upon becoming familiar with the construction and equipment standard, document the control measures, monitoring procedures and corrective action system (as illustrated in the sample Establishment Environment Program in Figure 5) that will ensure the processing facility is maintained in compliance with the standard.
Step 2 - Document control measures and monitoring procedures.
  1. The control measures and monitoring procedures can be developed together.
  2. This step offers another opportunity to work in a team environment. Involve the personnel that are currently responsible for the inspection and maintenance of the plant.
  3. Review the present control measures and monitoring procedures, and discuss ways they can be improved and simplified.
  4. Refer to Figure 5 for an example of a Establishment Environment Program.
  5. Control measures are the actions that a company takes to maintain the processing facilities in compliance with the regulations. They can include:
    • training production personnel on the standard so that they can identify deficiencies when they occur;
    • routine inspection of the processing facility; or
    • scheduled plan maintenance.

    All of the above actions are effective control measures for ensuring the plant construction and equipment are maintained in a suitable condition for food processing.

  6. Monitoring procedures describe how the control measures are applied and verify that the standard is being met. The monitoring procedures describe how the inspections are carried out, the frequency of the inspections and who is responsible for the inspections.
  7. Record the control measures and monitoring procedures in the QMP Plan. The Plant Environment Worksheet, found in Appendix B is one way of recording this information.
Step 3 - Document the corrective action system.
  1. Once the control measures and the monitoring procedures have been developed, the team can focus on writing the corrective action systems.
  2. Corrective actions are actions that are taken when monitoring identifies a deviation from the standard.
  3. Corrective actions must be recorded.
  4. Corrective actions include two different kinds of activities: fixing the immediate problem and preventing the problem from happening again.
  5. Fixing the immediate problem includes:
    • correcting the deficiency that gave rise to the problem;
    • identifying and segregating the affected product;
    • sampling and inspecting the affected product to find out whether it is safe; and
    • reworking or destroying the defective product.
  6. Preventing the problem from happening again includes:
    • investigating the development of the problem;
    • determining the method most likely to eliminate the source of the problem (such as a new control measure, procedure, standard or critical limit);
    • writing or rewriting control measures or monitoring procedures, setting a new standard, or revising an established one; and
    • giving both processing and Quality Management staff training that specifically covers the source of the original problem.
  7. With the team, develop a corrective action system that captures these concepts and includes a record-keeping system.
  8. Document the general steps of the Corrective Action System in the QMP Plan. The Establishment Environment Program Worksheet, found in Appendix B is one way of recording this information.

Note:
The Corrective Action Record for correcting deficiencies should include the following information:

  • a description of the deficiency;
  • identification of which part of the standard is not being complied with;
  • a description of the corrective action;
  • who is responsible for taking the corrective action;
  • the date the corrective action was verified as effective;
  • the name and signature of the person who verified the corrective action; and
  • the long-term preventative steps (if any) that were implemented to ensure that the problem does not recur.

3.1.2 Plant Sanitation and Personnel Hygiene

The Plan Environment Program must include a plant sanitation and personnel hygiene component that covers:

  • clean-up - that is, ensuring that the plant is cleaned and sanitized in accordance with health and safety standards, using only materials approved for use in food processing areas;
  • hygiene procedures for all staff; and
  • pest control measures and procedures.

To develop the plant sanitation and personnel hygiene of the Establishment Environment Program, use the same process as that for developing the construction and equipment component.

Step 1 - Know the standard.
  1. Become familiar with the plant sanitation and personnel hygiene standard applied at the processing facility. Once again, most companies follow the requirements set out in Schedule II of the Fish Inspection Regulations. These requirements are set out in Chapters 5 and 6 of the CFIA Facilities Inspection Manual.
  2. A copy of the standard must be included in the QMP Plan.
  3. Upon becoming familiar with the plant sanitation and personnel hygiene standard, document the control measures, monitoring procedures and corrective actions that will ensure the processing facility is maintained in compliance with the standard.

Note:
The CFIA Reference Listing of Approved Construction Materials and Non-food Chemicals identifies acceptable materials. It can be found at: http://www.inspection.gc.ca/eng/1375038742229/1375038784748

Step 2 - Document control measures and monitoring procedures.
  1. The control measures and monitoring procedures can be developed together.
  2. Once again, the team approach is recommended. Involve the personnel that are currently responsible for performing plant cleanup and sanitation, and those that inspect the processing facility to ensure it is kept clean and sanitary.
  3. Also include those responsible for supervising on-line employees. Discuss the overall hygiene practices of personnel in the plant, and compare these practices with the standard.
  4. Review the present control measures and monitoring procedures, and discuss ways that they could be improved and simplified.
  5. Review the training (if any), direction, instructions and supervision that all company personnel receive, and determine if they are effective and whether improvements can be made.
  6. Refer to Figure 5 for a partial example of an Establishment Environment Program.
  7. Refer to the appropriate example QMP Plans to get an idea of different control measures and monitoring procedures that can be applied.
  8. Control measures are the actions a company takes ensure that the processing environment is maintained in a clean and sanitary condition appropriate for processing food. They include the training and instruction provided to all company employees on proper hygienic practices and behaviour in a food processing facility, and the implementation of a daily plant sanitation regime.
  9. In developing the control measures, provide a written description of:
    • plant sanitation and clean-up procedures;
    • facility pest control program; and
    • standard operating procedures for personnel hygiene.
  10. Monitoring procedures describe how the control measures are applied and verify that the standard is being met. For example, if you choose to provide instruction to on-line employees on specific hygiene rules, the monitoring procedure could be to observe the personnel, hygiene practices periodically and correct poor practices. The control measure - performing a daily plant sanitation and clean-up - can be monitored by inspection before the plant starts up.
  11. Record the agreed-on control measures and monitoring procedures in your QMP Plan. One way of recording this data is with a Establishment Environment Program worksheet, which can be found in Appendix B.
Step 3 - Document the corrective action system.

The corrective action system that has been developed for the plant construction and equipment component can also be applied to the plant sanitation and personnel hygiene component.

3.1.3 Documentation and Records for the Establishment Environment Program

The Establishment Environment Program must include sufficient documentation to explain how the program is delivered. The following documents are recommended to be part of the Establishment Environment Program :

  • the Prerequisite Program linking standards, control measures, monitoring procedures and corrective actions;
  • the standards (as set out in the Fish Inspection Regulations);
  • standard operating procedures (SOPs);
  • manufacturers' literature on any purchased materials that come into contact with processing equipment and product, such as cleaning agents and sanitizers; and
  • examples of documents used to record corrective actions.

The Establishment Environment Program must also include examples of the written records of:

  • corrective action taken when a system failure is found; and
  • preventive action taken against recurrence of a system failure.

3.2 Lot Accountability and Notification Program

Processors must provide a written description of the system used to trace fish to their first shipping destination. For each shipment of fish, this program must outline how the following information will be recorded:

  • the name and address of the person to whom each shipment was sent;
  • the type of fish;
  • the quantity of fish;
  • the method of transportation, including manifest and container numbers or other information that is sufficient to identify or trace the location of the fish;
  • the date on which the fish was shipped; and
  • the date on which the fish was processed.

Processors should establish specific procedures to address the requirement for notification of CFIA, within 24 hours, in the event of any valid health and safety complaints.

For health and safety complaints, the following records must be kept:

  • the date and time when the processor received information questioning the safety of fish processed or exported by the registered establishment, and a description of the information;
  • in cases where the complaint is confirmed:
    • the date and time it was confirmed;
    • the name, address and telephone number of the informant;
    • the method of investigation and the results obtained;
    • the corrective actions taken; and
    • the date and time when the CFIA was notified.

Element 4: The Regulatory Action Point (RAP) Plan

Minimum Requirements

Processors are required to establish, document and apply controls that ensure the final product meets the requirements of the Fish Inspection Regulations.

The Regulatory Action PointsFootnote 1 (RAP) Plan must describe the controls to ensure that:

As part of the RAP Plan the processor must identify:

  • the fish product standard(s) and the ingredient and packaging requirements to which they must comply;
  • the controls that are implemented in production to ensure the standards and requirements are met;
  • the record keeping system to record corrective actions when problems are identified; and
  • the corrective action system in place to address deficiencies when they are identified.
Relevant Regulations
Processing Element Regulations
Minimum acceptable product quality Paragraph 6. (1) (a) Fish Inspection Regulations. Sets a minimum standard that fish shall not be tainted, decomposed or unwholesome. This regulation is interpreted through fish product standards for many common species.
Input materials Paragraph 6. (1) (a) and Section 7, Fish Inspection Regulations; Food and Drugs Act and Regulations. All packaging material must be new, sound and clean, and all packaging material and ingredients must be acceptable for food use.
Labelling Fish Inspection Regulations, including all sections on specific fish species. Labels must be accurate, legible, and not misleading or deceptive.

Developing a RAP Plan

Regulatory Action Points (RAPs) are the processing steps where control measures are applied to ensure that the product complies with the Fish Inspection Regulations. The RAP Plan addresses three areas:

  • minimum acceptable product quality;
  • input materials; and
  • labelling.

The minimum standard is set in the Fish Inspection Regulations; however, processors are encouraged to adopt standards above the minimum. Processors are responsible for developing and applying control measures, monitoring procedures and corrective actions for each RAP.

As with the Establishment Environment Program, a RAP Plan worksheet is provided in Appendix B as a sample. The worksheet is an effective tool because it relates regulations to control measures, to monitoring procedures, to corrective actions. It summarizes in one document why the control measures are being applied and what to do when a problem arises. Figure 6 shows a sample of a RAP Plan worksheet for a cooked shrimp operation. Note that the layout of the RAP Plan worksheet is similar to that of the Plant Environment Plan worksheet for ease of comparison. This worksheet gives an example of one way to format this information.

4.1 Minimum Acceptable Product Quality

To develop the minimum acceptable product quality component, follow these steps:

Step 1 - Identify the fish products the company produces.

Refer to the product description documents and ensure that this information is done for each of the products that will be covered under the QMP Plan.

Step 2 - Know the standards.

  1. Find and get copies of the standards for each of the fish products. It may be the company's specific standard, or the minimum government standards set out in the CFIA Fish Products Standards Manual.
  2. This provides another opportunity to work in a team environment. Involve the individuals responsible for ensuring that the final fish products meet your standards and your customer's expectations. Review the standards to ensure they are valid.
  3. In most cases, a company may wish to identify Paragraph 6. (1) (a) of the Fish Inspection Regulations as the minimum standard for acceptability Refer to Figure 6 for a sample RAP Plan Worksheet. Using this worksheet to format the information is optional.
  4. A copy of the product standards must be included in the QMP Plan. As mentioned previously, the standards are the foundation of the QMP Plan. Without a standard, control measures will not be focused on a fixed target, and it will not be known if objectives are being met.
  5. Once the product standards have been identified, document the control measures, monitoring procedures, and corrective action systems that are in place to ensure the products meet the standards.

Step 3 - Document your control measures and monitoring procedures.

  1. The control measures and monitoring procedures can be developed together.
  2. Using the team approach, review the process flow diagram and identify the best point in the process to apply control measures to ensure that the product meets the company standard.
  3. Refer to Figure 6 (sample RAP Plan) to get an idea of different control measures and monitoring procedures that can be applied.
  4. Indicate on the process flow diagram where these control measures or RAPs are located. Number the RAPs 1,2,3, etc.
  5. Control measures are the actions that a company takes to ensure that the final product meets the company standards. These could include inspecting the product according to raw fish standards when it is landed, or training on-line personnel to recognize and remove sub-standard fish.
  6. Monitoring procedures describe how the control measures are applied, and ensure that the standard is being met. Develop and document the monitoring procedures used to ensure that control measures are correctly and consistently applied. If inspecting incoming fish will be a control measure, then the monitoring procedures will describe how this is carried out.
  7. Monitoring procedures should specify:
    • what will be monitored;
    • how monitoring will be done;
    • how often (or when) monitoring will be done; and
    • who will do the monitoring.
  8. Identify the RAPs in the RAP Plan and then describe the control measures and monitoring procedures for each. Again, refer to Figure 6 for a sample RAP Plan worksheet. This is just one way of formatting the required information.

Step 4 - Document a corrective action system.

  1. The corrective action system for the RAP Plan can be developed and documented in the same way as the corrective action system for the Prerequisite Plan.
  2. The corrective actions related to product require not only that the problem be rectified, but also that any potentially affected product be inspected to ensure that it is in compliance.
  3. Any portion of the product that does not meet the standard must be reworked or disposed of. The corrective action record must indicate the status of the deficient product.
  4. With the team, develop a corrective action system that includes these concepts and a record-keeping system.
  5. Document the general steps of the corrective action system in the RAP Plan and provide a copy of the document used to record Corrective Actions.

4.2 Input Materials

Follow these steps to develop the input material component of your RAP Plan:

Step 1 - Identify all of the input materials for each product.

Referring to the product description, identify all of the input materials, including packaging material and product ingredients such as salt, pickling spices and food additives.

Step 2 - Know the standards.

The minimum standard is defined in the Fish Inspection Regulations and states that "all packaging material must be new, sound and clean, and all packaging material and ingredients must be acceptable for food use". The acceptability of food additives used in fish products is defined in the Food and Drug Regulations.

Step 3 - Document control measures and monitoring procedures.

  1. Using the team approach, review the process flow diagram and identify the best point in the process to apply control measures to ensure that the input materials meet the standard. Involve the people who purchase packaging materials and ingredients, and those who are responsible for mixing and applying the ingredients. Review the input materials and confirm that they meet the standard.
  2. Develop and document the control measures to be applied to ensure that the input materials are acceptable for food. Ask the question, "What control measures can be implemented to ensure compliance with the standard?"
  3. Refer to Figure 6 and the appropriate example of QMP Plans to get an idea of different control measures and monitoring procedures that can be applied.
  4. Indicate on the process flow diagram where these control measures or RAPs are located. Number the RAPs 1, 2, 3, etc.
  5. Identify the RAPs in the RAP Plan and describe the control measures and monitoring procedures for each. Refer to Figure 6 for ideas.

Step 4 - Document the corrective action system.

  1. Identify the corrective action system that will be taken when monitoring indicates that the ingredients or packaging materials do not meet the standard.
  2. Document the general steps of the Corrective Action System in the RAP Plan and provide a copy of the document used to record the Corrective Actions.

4.3 Labelling

To develop the labelling component of a RAP Plan, follow these steps:

Step 1 - Know the regulatory requirements.

The regulatory requirements covering fish products are found in the:

The processor is required to implement controls to ensure that the regulatory requirements of the Fish Inspection Regulations are met. These include the species specific requirements found in the body of the regulations, and the requirements set out in Part II - Labelling of the regulations. In general, these sections require that product labelling is accurate, legible and not misleading. Review and understand these regulations.

Step 2 - Document control measures and monitoring procedures.

  1. Once the regulatory requirements are understood, document the control measures and monitoring procedures to ensure that the labels meet the applicable regulatory requirements.
  2. Review the existing controls with the staff responsible for label development and printing.
  3. The controls should ensure that no label is sent to printing until it meets the regulatory requirements, that the printed labels have been inspected before being accepted, and that all labels are double checked before they are applied.
  4. Refer to Figure 6 to get an idea of different control measures and monitoring procedures that can be applied.
  5. Indicate on the process flow diagram where these labelling control measures or RAPs are located. Number the RAPs 1, 2, 3, etc.
  6. Identify the RAPs in the RAP Plan, then describe the labelling control measures and monitoring procedures for each RAPs. Refer to Figure 6 for ideas.

Step 3 - Document the corrective action system.

  1. Identify the corrective action that will be taken when monitoring indicates that a label does meet the regulatory requirements.
  2. Document the general steps of the Corrective Action System in the RAP Plan and provide a copy of the document used to record the Corrective Actions.

4.4 Documentation and Records for the RAP Plan

The RAP Plan must include sufficient documentation to explain how the controls are delivered. The following documents are recommended to be part of the RAP Plan:

  • the RAP Plan linking standards, control measures, monitoring procedures and the corrective action system;
  • the fish product standards;
  • the ingredient and packaging standards (as set out in the Fish Inspection Regulations);
  • SOPs, such as ingredient mixing instructions; and
  • proof that ingredients and packaging material are acceptable for food use (this may include manufacturers' literature).

The RAP Plan must also include examples of documents used to record corrective actions.

In many cases, the Corrective Action Records developed for the Prerequisite Plan can be used in the RAP Plan.

Element 5: The HACCP Plan

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.
Biological hazards:
  • pathogenic microorganisms (bacteria, viruses)
  • parasites
  • decomposition (related to safety only, e.g., bacteriological formation of histamine)
Chemical hazards:
  • natural toxins
  • chemical contaminants, cleaning agent residues
  • pesticides
  • drug residues
  • unapproved food additives
Physical hazards:
  • metal, glass, shell fragments, etc.
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. Hazard Analysis Worksheet - Cooked Shrimp Operation
Table Summary

example hazard analysis worksheet for a cooked shrimp operation. For further information, contact the Fish, Seafood and Production Division at 613-225-2342.

Ingredient/Processing Step Potential Hazard Introduced or Controlled Is the Potential Hazard Significant? Justification for Inclusion or Exclusion as a Significant Hazard Preventative Measures of the Significant Hazards
8. Cooking (Steam) Biological
Pathogen survival (Listeria)
Yes Processing time and temperature may not be sufficient to kill vegetative pathogens. 1. Cooking
2. Employee training
Chemical
Industrial chemicals
No Controlled by prerequisite program (SOP plant clean-up and sanitation).
Physical
None identified
n/a
1. Processing Step corresponding to process flow diagram 2. Potential hazards identified 3. Significance of each identified hazard is determined 4. Preventive measures are identified to control hazards

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
Table Summary

example of critical control point determination worksheet identifying the steps to follow to determine control points. For further information, contact the Fish, Seafood and Production Division at 613-225-2342

Process Step Hazard Question 1 Question 2 Question 3 Question 4 CCP: Yes or No
Do control preventive measures exist?

No - Not a CCP (However, if preventive measures are required to ensure safety, then modify the step, product or process.)

Yes - to Q. 2

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

No - to Q. 3

Yes - CCP

Could contamination with identified hazards occur in excess of acceptable levels or could these increase to unacceptable levels?

No - Not a CCP

Yes - to Q. 4

Will a subsequent step eliminate identified hazards or reduce the likelihood of occurrence to an acceptable level?

No - CCP

Yes - Not a CCP

Yes or No?
8. Cooking Pathogen survival (Listeria) Yes Yes Yes
1. Processing step and the identified hazard from the hazard analysis worksheet. 2. Answer each question in sequence. 3. Determine if processing step is a CCP.
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.

Note:
FIR 14.2 No person shall, unless they have the job experience or qualifications that meet the applicable sections of the Facilities Inspection Manual, (a) perform or supervise a product preservation process.

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.

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 activitfies 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.

Element 6: Verification and Maintenance of the QMP Plan

Minimum Requirements

Processors are required to perform the following verification activities to ensure that their QMP Plan is functioning correctly:

1. Before implementation the processor will be required to:

  • validate the critical limits of CCPs, where appropriate; and
  • verify the QMP Plan to ensure that all the necessary controls are in place and that it meets the requirements of the QMP Standard.

2. Once the QMP Plan is implemented, the processor is required to:

  • perform routine verification of the HACCP Plan to ensure it is functioning effectively (e.g. Record reviews, Corrective Action reviews, review of calibration of equipment);
  • verify or validate any changes to QMP controls or CCP critical limits that may occur in the ongoing development of the QMP Plan; and
  • verify the QMP Plan at least once per year.

To ensure that the QMP Plan is accurately documented, processors are required to maintain records of any changes to their QMP Plan. There are five main activities involved in verifying a QMP Plan. The first two must take place before the implementation of and operation under the QMP Plan. These activities are the validation of the critical limits at the CCPs (covered in Element 5) and the initial verification. These activities happen once only.

The next three verification activities are performed once the QMP Plan is implemented and include: the routine verification of the CCPs (covered in Element 5), the verification or validation of changes to the QMP Plan to ensure that it is still adequate, and verify the QMP Plan at least once per year.

Changes to a QMP Plan must be documented in the form of an amendment log to ensure that the written QMP Plan reflects the controls that are being applied in the processing operation.

6.1 Initial QMP Plan Verification

Once the QMP Plan is completed, it must be verified. That is, reviewed to ensure that it complies with the QMP Reference Standard. Once it has been verified that the plan meets all the requirements of the standard, it and the other information required will be submitted to the CFIA for review.

Verifying Your Initial QMP Plan

Step 1 - Perform verification using a checklist.
Step 2 - Prepare the submission.

Prepare a QMP submission package with the completed QMP Plan including:

  • background information on the plant;
  • the date the company wishes to begin processing;
  • the operations the company is requesting registration for; and
  • the products the company intends to process.
Step 3 - Submit the QMP submission package to the local CFIA inspector.
Step 4 (Performed by CFIA staff)

Once the QMP submission package has been received, CFIA inspection staff will:

  • review the QMP submission;
  • ask the processor to explain anything in the QMP submission that is unclear;
  • tell the processor whether the QMP Plan must be amended or expanded; and
  • inform the processor when the QMP Plan has been accepted.

6.2 Annual QMP Plan Verification

The processor must verify their QMP Plan once each year. The processor must ensure that the QMP Plan is still effective and that it is still being correctly applied by the staff. This annual verification must be documented, and the records must be available for the inspector to review.

For the annual verification, check that:

  • all CCPs are still being controlled;
  • the controls implemented for each CCP are adequate;
  • any amendments made to the processing line have been documented; and
  • the QMP Plan, including the Prerequisite and RAP Plans are complete and functioning effectively.

6.3 Maintaining the Record of Amendments to a QMP Plan

When amending a QMP Plan, or any QMP documentation, record the changes and when they were made. The most efficient way to do this is to include an amendment record in all permanent QMP documentation (see Figure 10).

This documentation must also be made available to the inspector.

Figure 10: Sample Amendment Record
Date Page Amendment made Signature

Element 7: Record Keeping

As with the HACCP Plan, there are two types of records kept as components of the QMP Plan - "documents" and "records". Documents are kept as a record of the development of a QMP Plan. Records are taken as a result of the implementation of the QMP Plan.

It is important to balance the volume of record keeping with the true needs of the organization, and the resources available to deliver the system. Records are developed, used and maintained to provide sufficient evidence that the system was developed properly. Records also prove that the plan is being implemented as written, and that it can demonstrate trends to identify a problem. Record keeping for all verification activities and results is mandatory. As well, records of amendments or changes to the QMP Plan must be maintained.

Record keeping for Prerequisite and RAP Plans may be performed "by exception", meaning records are only required when a deficiency is identified during monitoring procedures. For the HACCP Plan, however, record keeping is mandatory for all testing, measurements, and monitoring at CCPs, and for corrective actions when the critical limits are exceeded.

It is recommended the processor ensures that personnel understand why they are taking records, when, and how to complete them accurately. The processor should also review records periodically to confirm accuracy and relevance. These steps will increase the effectiveness of the establishment's record keeping.

Records must remain current, legible, readily identifiable, and retrievable. The location of all QMP Plan files and records must be identified. Records must be retained for at least 36 months, and should be retained for a longer period of time if relevant to the product shelf life, such as for canned fish.

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