Chapter: Operations and Documentation
Section: Process Controls
Sub-Section: F.B.14.1 General

Elements

The regulatory requirements contained in this guideline will be met when:

F.B.14.1 (01) Current written recipes are available for each fish product prepared by the operation and they meet the requirements of the Fish Processing Regulation. (Risk Ranking: Medium)

F.B.14.1 (02) Effective written process control procedures are developed to identify and to prevent, eliminate or minimize identified risks of contamination of fish products, ingredients, labelling materials and packaging materials. (Risk Ranking: High)

F.B.14.1 (03) Fish products are prepared according to the written recipe and the written process control procedures are implemented and monitored to control hazards to prevent, eliminate or minimize identified risks of contamination of fish products, ingredients, labelling materials and packaging materials; if deviations from the process control procedures are found, then appropriate corrective actions are taken. (Risk Ranking: High)

F.B.14.1 (04) Calculations, records or laboratory analyses demonstrate that any food additives used in preparing fish products are permitted for use and used within the levels permitted by the federal Food and Drugs Regulations under the Food and Drugs Act. (Risk Ranking: High)

F.B.14.1 (05) At the time that process control procedures are performed and monitored, a record is created that includes the date the procedure was performed and monitored, the results of the monitoring, including any deviations from the process control procedures, and the actions taken in response to any deviations including disposing of the fish product or taking measures to produce a safe fish product. Records are kept for at least one year, are readily accessible, legible, complete, and kept in chronological order. (Risk Ranking: Medium)

F.B.14.1 (06) The written process control procedures are reviewed as needed to evaluate if they are being properly implemented and verify the effectiveness of the implemented procedures in producing a safe fish product. The process control procedures are updated as needed. (Risk Ranking: Medium)

F.B.14.1 (07) At the time the process control procedures are reviewed, a record is created that includes the date the review was performed, and the results of the review. Records are kept for at least one year are readily accessible, legible, complete, and kept in chronological order. (Risk Ranking: Low)

Rationale

Written recipes

Recipes shall:

  • be available, and up-to-date, for each fish product that is prepared,
  • list all ingredients in the product (including weights or volumes),
  • include the percentage by weight of fish in the final product,
  • include the processing instructions.

The processing instructions for preparing a fish product should include, but are not limited to, all processing steps (e.g. cooking and cooling methods), processing parameters (e.g. cooking temperature requirements), necessary equipment, storage instructions (e.g. refrigeration requirements) for final products.

Standard batch sizes should be reflected in the recipe to limit measurement error during formulation.

Recipes must be legible, complete, and readily accessible.

Written Process Control Procedures

Operators must control biological (e.g. Listeria spp.), chemical (e.g. food additives) and physical hazards (e.g. fish bones) that may present a risk of contamination to fish products.

To control these hazards and ensure the safety of the fish product, process control procedures must be developed, implemented and monitored to prevent, eliminate or minimize the risk of contamination that may occur during processing and handling of fish products, ingredients, labelling materials and packaging materials.

Written process control procedures should include:

  • who performs the procedure,
  • when or how often the procedure is performed,
  • what will be measured or evaluated (e.g. product temperature),
  • how the procedure is to be performed (e.g. use of specialized instruments),
  • where results/observations are recorded.

For details on specific process control requirements to be included in the written process control procedures, refer to the relevant FPG. In addition, when applicable, process control procedures should include controls for food additives and reprocessing of previously processed fish products (rework).

Process Control Records

Process control records must be made at the time the process control procedure is performed, and include:

  • date and time the procedure was performed and monitored,
  • monitoring results,
  • any deviations from the procedure,
  • and corrective actions taken in response to deviations.

Process control records should also include:

  • name or initials of the person(s) who performed the procedure and monitoring,
  • product name/identification,
  • product code/lot number,
  • size of product/quantity of product,
  • as applicable, use of rework including at minimum:
    • the date and time of rework inclusion
    • name of the material being added
    • quantity used
    • original lot or batch code
    • the name of the product, lot and batch code to which it was added
    • the reason for the addition

Process control records can include process logs or batch records from processing activities and packaging records.

Written records must be:

  • made at the time the procedure is performed and monitored,
  • readily accessible for at least one year,
  • legible,
  • complete,
  • kept in chronological order.

Food additives are chemical substances that are added to food during preparation or storage. These substances either become a part of the food or they affect the food’s characteristics (for example, colouring agents used to add colour to fish products). Food additives must be strictly controlled, because misuse or inappropriate control could result in biological, chemical or physical hazards in the food product being processed. Certain additives, such as phosphates, have prescribed maximum input levels.

Nitrites/nitrates are not permitted for use in fish products in Canada.

Health Canada maintains the Lists of Permitted Food Additives. Only additives found on these lists may be used in foods that are offered for sale in Canada. The lists name each approved additive and the corresponding foods it may be used in, as well as the permitted levels. Operators must ensure that additives are suitable for use in their products and are correctly used according to these lists.

Reprocessing of previously processed fish products (rework) is the inclusion of one prepared or finished fish product into another fish product.

Whenever rework is used, all components and ingredients of the rework material must be permitted in the product to which they are being added. Controlled ingredients must be considered so that the end-product contains amounts that comply with federal Food and Drug Regulations.

The label must reflect all allergens included in the finished product.

Written recipes and process control procedures should be accessible to appropriate employees and employees must be competent in performing the process control procedures they are responsible for (Refer to FPG – Training).

Review of written process control procedures

The written process control procedures must be periodically reviewed to:

  1. Evaluate if they are being properly implemented.

    This could be achieved through on-site observations of employees performing the control procedure, review of process control records, etc.
  2. Verify that the procedures are effective to produce a safe fish product.

    This could be achieved through end-product testing or other product testing to confirm process control parameters continue to meet requirements to ensure food safety, referencing validated studies, etc.

At the time that the written process control procedures are reviewed, a record must be created that includes the date and the results of the review (for example product testing records that are received from accredited laboratories).

A best practice would be to review written process control procedures at minimum annually, or whenever changes to processes are made.

Corrective Actions/Disposition of Unsafe Fish Products

If a product is suspected to be unsafe for any reason (such as adverse laboratory results, processing deviations, etc.), the operator should have a written control procedure in place. The control procedure should include, but is not limited to:

  • employees responsible for carrying out corrective actions,
  • holding procedures,
  • testing procedures,
  • description of corrective actions,
  • disposal or release procedures,
  • record-keeping practices and requirements.

Regulatory References

Food Safety and Quality Act, 2001; O. Reg. 465/19 s. 1, 5, 51, 52, 53, 56, 61

contaminated means,

  1. in respect of food,
    1. containing or having been treated with or exposed to a substance not permitted by or in an amount in excess of limits prescribed under the Canadian Environmental Protection Act, 1999 (Canada), the Food and Drugs Act (Canada) or the Pest Control Products Act (Canada),
    2. containing or having been treated with or exposed to an ingredient, a food additive or any source of ionizing radiation not permitted by or in excess of limits prescribed under the Food and Drugs Act (Canada),
    3. containing or having on it any decomposed matter, foreign matter or visible extraneous material, or
    4. containing or having been exposed to a biological, chemical or physical agent or factor that may cause a fish product to be unsafe for human consumption, or

ready-to-eat fish product means a fish product that does not require any cooking, heating, processing or preparation to make it safe; (produit de poisson prêt à manger)

    1. No operator, employee or contractor of a fish processing operation in respect of which a licence is required under this Regulation shall sell, offer for sale, hold in possession for sale, transport or distribute any fish product processed, packaged, labelled, stored or handled at a fish processing plant that is intended for human consumption if the fish product is contaminated.
    2. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that no employee or contractor of the operation sells, offers for sale, holds in possession for sale, transports or distributes any fish product described in subsection (1).
    1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that written process control procedures are developed, implemented and monitored to effectively identify any risk of contamination of fish products, ingredients, labelling materials and packaging materials and to prevent, eliminate or minimize any identified risk.
    2. The operator shall ensure that at the time the process control procedures referred to in subsection (1) are performed and monitored, a record is created that includes,
      1. the date the procedure was performed and monitored;
      2. the results of the monitoring, including any deviations from the process control procedures; and
      3. he actions taken in response to any deviations from the process control procedures, including disposing of the fish product or taking measures to produce a safe fish product.
    3. The operator shall ensure that the process control procedures referred to in subsection (1),
      1. are reviewed as needed in order to,
        1. evaluate whether the procedures are being properly implemented, and
        2. verify the effectiveness of the implemented procedures with respect to producing a safe fish product; and
      2. are updated as needed.
    4. The operator shall ensure that at the time a review referred to in clause (3) (a) is undertaken, a record is created that includes,
      1. the date the review was performed; and
      2. the results of the review.
    5. The operator shall ensure that every record created under this section,
      1. is kept for at least one year from the date the record is created; and
      2. is readily accessible.
  2. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that any regulatable activities engaged in by the operation are performed in a manner that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials and produces fish products that are safe.
    1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that an up-to-date recipe is maintained in written form for each fish product prepared by the operation.
    2. The operator shall ensure that each recipe referred to in subsection (1) is,
      1. legible;
      2. complete;
      3. includes the percentage by weight of fish in the final product;
      4. includes the processing instructions; and
      5. is readily accessible.
    3. The operator shall ensure that each fish product referred to in subsection (1) is prepared in accordance with its corresponding recipe.
  1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that every fish product processed, labelled or packaged by the operation is,
    1. processed, packaged, labelled or stored in accordance with this Regulation; and
    2. safe.
  1. Any records required to be created and stored under this Regulation must be legible, complete and kept in chronological order.