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The Quality Management Program approach to a preventive control plan

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.

Introduction

What is a prerequisite plan?

It consists of the programs to ensure an acceptable environment for food processing, through controls for construction and equipment, sanitation and hygiene and an effective recall system.

What is a regulatory action points plan?

It consists of the programs to ensure:

  • compliance with minimum acceptable fish product quality
  • the acceptability and suitability of incoming materials and ingredients
  • labels are accurate and in compliance

The Quality Management Program (QMP) is one example of a type of preventive control plan (PCP). The QMP is based on the Hazard Analysis Critical Control Point (HACCP) approach to food safety and, for many years, this program has been implemented by food operators in the fish and seafood sector. The program provides assurance that fish products are prepared under sanitary conditions, are safe, wholesome and meet Canadian requirements, including those on labelling and standards of identity.

It is important for businesses operating under a QMP plan developed prior to the Safe Food for Canadians Regulations (SFCR) to:

Once reviewed and revised, as necessary, businesses can continue to use their QMP plan as their PCP and be in a good position to demonstrate compliance with the preventive control requirements of the SFCR.

Purpose

The Canadian Food Inspection Agency (CFIA) created this document as guidance to help regulated parties comply with the Safe Food for Canadians Regulations.

It's your choice

You may use other guidance developed by provincial governments, industry associations, international partners or academic bodies as long as they can achieve the outcomes identified in the regulations. Always ensure that the guidance you choose is relevant for your particular business, product or products, and market requirements.

What's included

The seven established components of a QMP plan, related guidelines and important points to keep in mind when reviewing the plan to ensure it complies with the PCP requirements of the SFCR.

Refer to the Tell me more! section for additional sources of information that may help you update your QMP.

What's not included

The document does not discuss the municipal and provincial processing requirements that may apply to your activities.

Roles and responsibilities

Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written PCP is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all preventive controls are effective.

CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

The QMP elements

On this page

  1. Management roles and responsibilities
  2. Background product and process information
  3. Prerequisite plan
  4. Regulatory action points (RAP) Plan
  5. Hazard analysis critical control point (HACCP) Plan
  6. Verification and maintenance of the QMP Plan
  7. Record keeping

1. Management roles and responsibilities

Management commitment lays the foundation for the successful development, implementation, and maintenance of a QMP Plan.

Keep in mind

While the SFCR do not include PCP requirements specific to management roles and responsibilities, it is a recommended practice and you are encouraged to outline these in your QMP.

2. Background product and process information

Full knowledge and a clear understanding of the product, process and establishment layout is needed for the hazard analysis, to determine critical control points (CCPs) and develop the prerequisite and regulatory action points (RAPs) sections of the QMP plan.

In this section of the QMP plan you provide:

3. Prerequisite plan

There are many hazards in an establishment that can present a risk of contamination. To prevent contamination, the conditions of the establishment (design, construction material and equipment) have to be suitable for safe food production and be maintained and operated in a sanitary condition.

The prerequisite plan has two parts:

3.1 Establishment environment program

In this part of the prerequisite plan you provide the following:

3.1(a) Construction and equipment

In this element of the establishment environment program you:

Guidelines

Note

If ice is manufactured elsewhere, your control measures should ensure the ice is manufactured from a safe water supply, transported in a sanitary manner and protected from contamination.

3.1(b) Sanitation and personnel hygiene

In this element of the establishment environment program you should describe the cleaning and sanitizing procedures, the hygiene procedures for personnel and visitors, as well as pest control measures and procedures used to ensure the establishment is operated and maintained in sanitary condition

Note

The document Cleaning and sanitation program provides additional information that can help you develop a cleaning and sanitation program.

Guidelines

Note

Non-food chemicals could include: bleach, 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.

Keep in mind

Under the SFCR:

  • Written monitoring and corrective actions procedures are required only for CCPs, however, these procedures help ensure the effective implementation of any control measure you apply and are recommended for your prerequisite programs as well.
    • Monitoring activities can provide evidence on the implementation and effectiveness of any control measure you apply.
  • You are required to maintain records to show that you are implementing your QMP, therefore, records by exception (where records are kept only when they pertain to a CCP) is no longer an option.
  • Schedules I, II and V of the Fish Inspection Regulations no longer apply. Similar requirements are found in Part 4 of the SFCR (preventive control requirements). It is important to update your QMP plan accordingly.

3.2 Lot accountability and notification program

This part of the prerequisite plan ensures the effectiveness and timeliness of food safety investigations and recalls. There are two elements:

3.2 (a) The lot accountability program

In this element:

Note

More information on the traceability requirements can be found in the Fact Sheet: Traceability, the interactive tool what would your traceability requirements be? and part 5 of the document Understanding the Proposed Safe Food for Canadians Regulations: A Handbook for Food Businesses.

Keep in mind

Traceability requirements are found in Part 5 of the SFCR. They are not part of the CCP requirements, however, you may choose to include your traceability procedures in your QMP.

To meet the traceability requirements you now have to also prepare and keep records that trace the food (ingredients) you receive from another person.

3.2(b) The notification program

In this element you:

Note

A "valid" complaint means that you established, from your initial investigation, that the food presents a risk

Keep in mind

Under the SFCR:

The requirements on investigation, notification, complaints and recall (found in part 4 of the SFCR) are not part of the PCP requirements, however, you may choose to include your procedures for receiving, investigating and responding to complaints as well as your recall procedures in your QMP. For information on how to develop recall procedures, consult the Recall procedure: A guide for food businesses.

  • Note the requirements to:
    • Immediately investigate a complaint when you suspect on reasonable grounds that a food presents a risk of injury to human health
    • Immediately notify the CFIA of the results of your investigation and take immediate actions to mitigate any risk of injury to human health when the results indicate that the food presents a risk
    • conduct a recall simulation, based on your procedures, once every 12 months, document the results of the simulation, and keep that document for two years

4. The Regulatory Action Points (RAP) Plan

Regulatory Action Points are the processing steps where measures are applied to ensure that the fish produced complies with Canadian requirements.

There are 3 parts to the RAP plan. Each part describes the:

4.1 Minimum acceptable product quality

In this part you describe the measures applied to ensure:

4.2 Input materials (ingredients and packaging and labels)

In this part you describe the measures applied to ensure ingredients and packaging materials are not a source of contamination to the food.

Note

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.

4.3 Labelling and code markings

In this part you describe the measures applied to ensure that the label on your food is accurate, legible, is not misleading and complies with Canadian requirements on:

Keep in mind

Under the SFCR:

These are measures required in a PCP to meet the applicable market fairness provisions of the Safe Food for Canadians Regulations which are the food labelling, standards of identity and grades requirements. Refer to CFIA's Labelling, standards of identity and grades web page for additional information on these requirements.

Guidelines

Control measures for the RAP plan can include:

The document Incoming ingredients, materials and non-food chemicals provides additional information on control measures that can help you ensure the incoming ingredients and materials are safe and suitable for use.

Keep in mind

Under the SFCR:

  • Written monitoring and corrective actions procedures are required only for CCPs.
  • You are required to maintain records to show that your QMP is implemented, therefore, records by exception is no longer an option.
  • The need for controls on minimal acceptable quality is found in section 8 of the SFCR. Fish products cannot be filthy, putrid, disgusting, rotten or decomposed. While you can continue to include your related procedures in your QMP plan, they could be captured elsewhere.

5. The hazard analysis critical control point (HACCP) plan

In this section of the QMP you apply the seven principles of a HACCP system:

Principle 1

Conduct a hazard analysis

You conduct a hazard analysis to identify the biological, chemical, and physical hazards that are reasonably likely to contaminate your food

Note

The document Conduct a hazard analysis provides additional information on how to conduct a hazard analysis, identify all potential hazards and evaluate the significance of a hazard identified.

Principle 2

Determine the critical control points (CCPs)

You identify each step at which control measures can be applied and are essential to prevent a food safety hazard or reduce its occurrence to a level that would not compromise food safety.

Note

The document Determining critical control points and their critical limits provides additional information on the steps involved in determining CCPs.

Principle 3

Establish critical limit(s)

You determine the critical limits to which each significant hazard, at a critical control point, has to be controlled to ensure food safety.

Note

The document Determining critical control points and their critical limits provides additional information on the steps followed to establish critical limits for the CCPs.

Principle 4

Establish a system to monitor control of the CCP

You establish the procedures and activities conducted to assess whether a CCP or a control measure is correctly and consistently carried out and is effective.

Note

The document Monitoring procedures provides additional information on elements to consider in the development of monitoring procedures and the types of monitoring procedures.

Principle 5

Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control

You establish the steps taken to address non-compliance, control the affected product, determine the root cause and prevent recurrence.

Note

The document Corrective actions outlines the steps for establishing corrective action procedures and preparing corrective action records.

Principle 6

Establish procedures for verification to confirm that the HACCP system is working effectively

You establish the procedures and activities used to confirm and demonstrate that all control measures outlined in your QMP plan are consistently implemented and effective in achieving the intended outcome.

Note

The document Verification procedures outlines the steps for developing verification procedures.

Principle 7

Establish documentation and record keeping

Note

The document Record keeping provides guidance that can help you establish records and ensure the integrity of all the records you generate.

6. Verification and maintenance of the QMP Plan

Verification

In this section of the QMP you establish procedures for verifying that the control measures are implemented, up to date and effective in preventing, eliminating or reducing to an acceptable level food safety hazards. You keep records of the verification activities performed and the findings.

Verification activities are conducted independently and in addition to the monitoring activities such as:

Verification activities allow you to confirm that:

The verification procedures describe:

Note

Some verification activities require the establishment to be in typical production mode. For example, environmental swabbing to assess the effectiveness of sanitation control measures. Other verification activities, such as equipment calibration, need to be scheduled during shutdown periods.

Verification of the establishment environment program

The verification activities can include:

Verification of the HACCP plan

The verification activities can include the review of records to ensure that:

Keep in mind

Under the SFCR, you can verify that your control measures are consistently implemented and are effective at a frequency appropriate for your food business. It is recommended that you verify your entire QMP plan at least annually.

Maintenance

You maintain your QMP plan by amending, and keeping a record of the amendments, when:

Keep in mind

Under the SFCR, you are not required to keep a list of the amendments you make to your QMP plan, however is considered a good practice.

7. Record keeping

Records are a tool used to confirm that things are working effectively and provide evidence that:

In this element of the QMP you establish a record-keepin g system to ensure:

Keep in mind

Under the SFCR:

  • The records you generate to show your preventive controls are implemented and effective have to be retained for a period of 2 years (rather than 36 months).
  • Records on the treatment of low-acid foods packed in hermetically sealed package, that are not kept refrigerated or frozen, have to be retained for 3 years.

Tell me more! Further reading

The following references contain information that helps explain food safety controls, demonstrates how to develop them, and provides examples. The Canadian Food Inspection Agency is not responsible for the content of documents that are created by other government agencies or international sources.

CFIA references

Other references

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