Chapter 3, Subject 4
QMP Reference Standard and Compliance Guidelines
Section 4

4. The Regulatory Action Points (RAP) Plan

Reference Standard Requirements:

4.1 The RAP Plan must describe the controls to ensure that:

• fish is handled properly during processing and results in a final product that is not tainted, decomposed or unwholesome and meets all applicable sections of the Fish Inspection Regulations;
• any ingredients added to the fish product or packaging material used are acceptable for food and meet all regulatory requirements as specified in the Fish Inspection Regulations and the Food and Drugs Act and Regulations; and
• labelling and coding of all fish products meet the requirements of the Fish Inspection Regulations and is not false, misleading or deceptive.

As part of the RAP Plan the processor must identify:

4.1.1 The fish product standard(s) and the ingredient and packaging requirements to which they must comply.

4.1.2 The controls that are implemented in production to ensure the standards and requirements are met.

4.1.3 The record keeping system to record corrective actions when problems are identified.

4.1.4 The corrective action system in place to address deficiencies when they are identified.

Intent:

Within the RAP Plan, processors are required to document and apply controls that ensure the fish is handled properly while under the control of the registered establishment and result in a final product that meets all requirements of the applicable sections of the Fish Inspection Regulations. The three areas that must be addressed are minimum acceptable product quality, input materials, and labelling.

Compliance Guidelines:

1. Minimum acceptable product quality

This section of the RAP Plan describes the controls to ensure that fish will be handled properly while under the control of the registered establishment and will result in final products that meet all applicable sections of the Fish Inspection Regulations.

2. Input materials (Ingredients and Packaging Material)

This section of the RAP Plan describes the controls to ensure that any ingredients added to the fish product and any packaging material used are acceptable for food and meet all regulatory requirements.

3. Labelling and Code Markings

This section of the RAP Plan describes the controls to ensure that the labelling and code markings of fish products is accurate, legible, and not misleading.

Each section must include:

a) The standard that is applied at the facility. The standard may be the CFIA standard as set out in the Fish Products Standards and Methods Manual, applicable sections of the Regulations, or another standard equivalent or superior to these. The standard must outline the accept/reject criteria which identifies compliance.

A copy of the standard must be included or, where the standard is a part of the laws, regulations or other documents published by the Government of Canada, it may simply be referenced. In either case, the standard must be in the establishment and readily available for review in printed or electronic format.

For minimum acceptable product quality, the standard identifies minimum compliance parameters for product safety (tainted, decomposed and unwholesome) and quality, if applicable.

For input materials (ingredients and packaging material), the standard identifies the minimum compliance parameters for input material acceptability for use in food processing or production and compliance to all applicable regulatory requirements specified in the Fish Inspection Regulations and the Food and Drugs Act and Regulations.

For packaging material, primary considerations include that all packaging materials must be new, clean and sound and approved for food use. Packaging material must not impart any undesirable substance to the food product, either chemically or physically and should protect food sufficiently to avoid contamination. The acceptability of packaging materials for their intended use must be documented in the QMP Plan. For packaging materials which contact (or may contact) food¹, the acceptability is substantiated by inclusion in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products.

¹ As an example: Fresh fish fillets wrapped in polyvinyl bags, inside insulated Styrofoam containers, inside waxed cardboard boxes. The polyvinyl bags have direct food contact, the Styrofoam containers may contact the fish through minor breakage of the Styrofoam material, the waxed cardboard does not contact the fish. The polyvinyl bags and Styrofoam boxes should be made of material substantiated as approved for food contact; the waxed cardboard boxes need not be substantiated.

Ingredients must be identified and acceptable for food use. Ingredient acceptability can be substantiated by several methods: a manufacturer's attestation; documentation from a recognised government or non-governmental authority; results of analysis from an accredited laboratory; and ingredients commercially prepared and labelled for food preparation use. Where product additives are used, their identity and concentration is in compliance with the Food and Drug Regulations. Guidance on additives for fish and fish products for sale in Canada can be found on the CFIA Internet site, in the Guide to Additives Permitted in Fish and Fish Products.

For labelling and code markings, the standard identifies the minimum compliance parameters to ensure that the labelling and coding of all fish products is accurate, legible, not misleading and meets the requirements of the Fish Inspection Regulations. These requirements include any specific species requirements found in the body of the regulations, as well as those set out in Part II – Labelling.

b) The control measures applied to ensure that final product will meet the standard(s) and that any product not meeting the standard will be removed from production.

Control measures can include inspections, evaluations, sampling, pre-printing label evaluations, pre-use review and final product label and coding inspections. For information on supplier quality assurance (SQA) as a control measure, refer to the Appendices of this document. Sampling plans must be at least equivalent to those used by the CFIA.

c) The monitoring procedures used to ensure that the control measures are being correctly and consistently carried out. The monitoring procedures must clearly specify what is being monitored, how it is being monitored, at what frequency, and by whom. The frequency identified for each monitoring activity must be sufficient to ensure that the standard is being met.

Under the RAP Plan 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 information.

d) The corrective actions to be taken when monitoring identifies a deviation from the standard. These actions must include both fixing the immediate problem and preventing the problem from happening again. This section must describe how all product not meeting the standard is identified and segregated, culled, and reworked or disposed of in an appropriate manner.

e) The record-keeping system for recording the result of monitoring and corrective actions when problems are identified. The corrective action record should allow for the recording of a description of the deviation, the part of the standard not complied with, the corrective action taken, the person(s) responsible for the action, the date the action was taken and the long-term preventative steps (if applicable). A copy of the corrective action record must be included.

Compliance Notes

Note 1. Receipt of incoming fish and other input materials from suppliers

Where the processor receives fish from suppliers, the processor must establish control measures to ensure, protect, and preserve the quality of that fish. An effective type of control measure is the use of a Supplier Quality Assurance (SQA) agreement. A SQA can be an effective control measure to address many types of situations where an understanding between business parties is required. For example, for transport requirements (i.e., transport vehicles are clean, proper care has been taken, and the vehicles have not been used to transport hazardous materials), temperature control requirements, withdrawal from medicated feeds (i.e., for cultured species) as well as many other requirements.

Guidelines for developing a SQA as a control measure are outlined in the Appendices of this document.

Note 2. Standard Operating Procedures

A standard operating procedure (SOP) is an effective means for establishing, documenting and communicating a control measure associated with the Prerequisite Plan, RAP Plan, or HACCP Plan. A SOP is a detailed set of instructions which describes how to carry out a repetitive task. Trained personnel can use a SOP for a specific task to carry out that task with little further direction.

Note 3. Identification of Input Materials (ingredient and packaging materials)

Processors should consider all processing steps to identify ingredients. Some components to the final product may not be immediately recognisable as "an ingredient" because they are added to the product indirectly (i.e., as a processing aid) rather than by formulation. For example, when wood chips or sawdust is used in smoking fish product, the processor must identify and consider the input material (sawdust) which is the precursor to the ingredient, natural wood smoke. Also, when ice used for processing is received from facilities outside of the registered establishment (i.e., the ice is not under the Establishment Environment Program), the processor must identify and consider the input material (ice) which is the precursor to the ingredient, added water or ice.

Packaging material includes cartons, wrapping materials, films, synthetic casings, netting, trays, pouches, bags and any other material used in the shipping of food products which may come into contact with the food product shipped.

Note 4. Regulatory requirements other than the FIR

Processors are not required to establish controls within the QMP Plan to ensure that regulatory requirements outside of the FIR are met. Nonetheless, processors must ensure all final products are in compliance with all applicable regulations including, Food and Drug, Consumer Packaging and Labelling, and Weights and Measures, and foreign country legislation for exported products.

Note 5. Documentation associated with the RAP Plan

Documents must be included in the QMP Plan which substantiate the acceptability of the packaging materials. (e.g., their listing in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products).

Processors must document any specialised packaging requirements, such as oxygen permeable packaging for ready-to-eat chilled products, set out in the Food and Drug Regulations.

Next page: Chapter 3 Subject 4 – The HACCP Plan | Previous page: Chapter 3 Subject 4 – The Prerequisite Plan