Element 4: The Regulatory Action Points (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 Points* (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.
* Under RAP, 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.
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 RAP. 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.

Figure 6: RAP Plan Worksheet - Cooked Shrimp Operation

Click on image for text version
RAP plan worksheet

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