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.

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.

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.

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.

Figure 5: Establishment Environment Program Worksheet
Sample Controls Construction and Equipment - Cooked Shrimp Operation

Click on image for text version

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.

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