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

3. The Prerequisite Plan

Reference Standard Requirements:

3.1 Establishment Environment Program

Processors are required to identify:

3.1.1 the establishment environment standard that is applied in the facility; as a minimum the standard must meet the requirements of the Fish Inspection Regulations;

3.1.2 the actions that are taken by the processor to ensure the standard is met;

3.1.3 the record keeping system to record corrective actions when problems are identified;

3.1.4 the corrective action system in place to address deficiencies when they are identified.

3.2 Lot Accountability and Notification Program

3.2.1 For the 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.

3.2.2. As part of the Lot Accountability and Notification Program the processor is also required to have procedures to notify the CFIA of any valid health and safety complaints.

Intent:

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, and that will allow the rapid recall of product from first shipping destinations.

Compliance Guidelines:

The Prerequisite Plan has two components: the Establishment Environment Program; and the Lot Accountability and Notification Program

The Establishment Environment Program includes Construction and Equipment and Sanitation and Personnel Hygiene.

1. The Construction and Equipment section describes the controls to ensure that the establishment facilities and equipment are suitably designed and built and maintained in a state appropriate for safe food processing.
2. The Sanitation and Personnel Hygiene section describes the cleaning and sanitizing procedures, the hygiene procedures for personnel and visitors, as well as pest control measures and procedures.

Each section must include:

1. the standard that is applied in the facility. At a minimum, the standard must meet the requirements of Schedules I and II of the Fish Inspection Regulations as described in the Facilities Manual. 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.

   Where fresh fish is unloaded, handled, held or transported at a registered establishment, conveyances and equipment must comply with Schedule V of the Fish Inspection Regulations, "Requirements For Conveyances And Equipment Used For Unloading, Handling, Holding And Transporting Fresh Fish".

2. the control measures that are employed to ensure the processing facility is in compliance with the standard.

   For the Construction and Equipment section, the control measures ensure that the processing facility is suitably designed, built, and maintained. Control measures can include: training production personnel on the standard so that they can identify deficiencies; routine inspection of the facility; maintenance schedules; procedures for scheduled equipment maintenance and calibration; controls for a safe water supply.

   For the Sanitation and Personnel Hygiene section, the control measures ensure the facility is operated and maintained in compliance with the standard. Control measures must include written sanitation, personnel hygiene, and pest control programs. Guidelines for developing these written programs can be found in the Appendices of this document.

3. The monitoring procedures that are 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 of each monitoring action must be sufficient to ensure that the standard is being met.

   In the Prerequisite 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.

4. The corrective actions to be taken when monitoring identifies a deviation from the standard. The corrective action should include actions to fix the immediate problem and to prevent a recurrence of the problem.
5. The record-keeping system for recording the results 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, the date it was verified as effective, the person responsible for verifying and, if applicable, any interim preventative measures for long-term corrective actions. A copy of the corrective action record must be included.

Lot Accountability and Notification Program

a) Processors must provide a written description of the system used to trace fish to their first shipping destination. For each shipment of fish this must include:

• 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.

b) 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. A "valid" complaint means where the initial investigation indicates the health of consumers is at risk.

c) 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.

Compliance Notes

1. Construction Materials

Where the suitability of construction materials is in question, the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products (also called the Reference Listing) should be consulted.

Construction materials used for construction, renovation, and maintenance should be selected on the basis of chemical and physical suitability of the materials in relation to their intended use.

2. Chemicals

All non-food chemicals are controlled under the Establishment Environment Program. Non-food chemicals include, bleaches, cleaners, deodorizers, desiccants, disinfectants, denaturing agents, floor-drying compounds, industrial antifreeze, inks, lubricants, pesticides, protective oils, refrigerating brine additives, refrigerants (immersion freezing), sanitizers, and water-treatment compounds. These compounds include chemicals which may be acceptable for food contact and those that are not.

Processors must ensure that these chemicals are approved for their intended use and must have controls to ensure that these chemicals are applied according to their intended use and stored to prevent unintentional contact with food products. The acceptability of chemicals for their intended use must be documented in the QMP Plan. Chemical acceptability is substantiated by inclusion in the Reference Listing.

Non-food chemicals used outside of the fish processing and support areas need not be substantiated in the Reference Listing; however, the processor must have controls in place to ensure these products do not enter into, or contaminate, areas where fish and/or input materials are handled or stored.

Examples of chemicals exempt from the requirement for inclusion on the Reference Listing include, pesticide products for outdoor use only, products used in offices or similar non-regulated areas, products used in cafeterias or lunch rooms, products used in heating systems, products used outdoors only for sewage or waste water systems, products used in cooling towers or evaporator condensers, products used for the cleaning or maintenance of the exterior of vehicles, and products for use in the maintenance shop on non-food contact equipment.

3. Ice

When ice is used for processing, as a processing aid or as an ingredient, and that ice is manufactured in the registered facility, the processor will set out control measures under the Establishment Environment Program. Control measures to address requirements for the ice manufacturing equipment, holding, storage, and the quality of the water source and supply should be considered.

When ice is used for processing, as a processing aid or as an ingredient, and that ice is manufactured outside of the registered processing establishment, the controls under the QMP are two-fold. The processor will set out controls under the Establishment Environment Program for requirements relating to the holding and storage of the ice. Secondly, the processor will establish controls for the transport and the quality of ice under the RAP Plan.

4. Standard Operating Procedure (SOP)

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.

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