The Quality Management Program approach to a preventive control plan

Introduction

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:

• review your QMP against the preventive control requirements of the SFCR to ensure they align; and
• verify that you are using control measures that are shown by evidence to be effective

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.

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.

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.

• In this section of the QMP plan you identify the name, business address, business telephone number and the title of the person responsible for your QMP. It is recommended that senior management of the establishment demonstrate their commitment to the QMP in writing.
• It is also recommended to have a description of how the QMP was developed and how it will be implemented.

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:

• A product description for each product or group of products that identifies the product attributes and characteristics. The product description should include:
  • a descriptive product name
  • the source of raw material used in producing the product, such as wild caught or farmed
  • characteristics of the final product that may affect product safety, for example:
    • physical characteristics such as pH or water activity
    • composition
    • packaging
    • shelf-life attributes
  • all ingredients
  • product packaging
  • end-product use
  • product shelf life
  • market destination
  • labelling instructions for safe product storage (where applicable)
  • special distribution controls or instructions (where applicable)
• A process flow diagram that outlines all of the process steps, the RAPs and CCPs for each product or group of products.
  • This helps determine where and when control measures and monitoring procedures should be established.
  • The importance of the shipping step (usually the final step) will depend on the nature of the product, product-specific requirements and storage conditions. If this step is not included, a justification should be provided in the HACCP documents.
• An establishment floor plan that identifies sanitary zones or restricted access areas (when these are applied as a control measure for identified hazards) and clearly shows the flow of materials, personnel and product within the establishment.
  • Sanitary zone refers to that part of a processing area with sensitive processing steps or high risk products, for which a set of specified criteria have been established to control all vectors of potential contamination or cross contamination (this could include air movement, personnel hygiene and sanitation procedures).
  • Restricted access zone refers to that part of a processing area where personnel movements are restricted and personnel hygiene and sanitation procedures are in place to control potential contamination or cross contamination (these areas do not meet the specific criteria of a sanitary zone).

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:

• Establishment environment program
• Lot accountability and notification program

3.1 Establishment environment program

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

• standards that the condition, maintenance and operation of your establishment have to meet to comply with Canadian requirements
• control measures used to ensure compliance with the requirements
• monitoring procedures used to ensure that the control measures are carried out correctly and consistently that clearly specify:
  • each monitoring activity, and what is being monitored
  • how each monitoring activity is conducted
  • the frequency of each monitoring activity
  • who is responsible for conducting the monitoring activities
• the corrective action system in place to immediately address deficiencies identified and prevent their re-occurrence
• records used to document the corrective actions taken which describe the:
  • deviation that occurred
  • corrective action taken
  • person(s) responsible for the action
  • date the action was taken
  • date the effectiveness of the corrective actions was verified
  • person responsible for verifying that the corrective actions were taken
  • interim measures taken when corrective actions can only be implemented in the long-term
• records used to document the implementation and effectiveness of the control measures

3.1(a) Construction and equipment

In this element of the establishment environment program you:

• describe the control measures used to ensure that the establishment and equipment are suitably designed, built and maintained in a state appropriate for safe food processing, and
• describe the control measures used to ensure that fresh fish is unloaded, handled, held and transported in a manner to prevent contamination and deterioration of the fish

Guidelines

• The control measures could include:
  • training for personnel on the standard(s) applied to help them identify deficiencies
  • routine inspection of the establishment
  • maintenance schedules
  • procedures for scheduled maintenance and calibration of the equipment
  • controls for a safe water supply (the document Water for use in the preparation of food outlines measures that can help prevent the risk of contamination of a food by the water you use in your establishment)
• The control measures should ensure that construction materials used to build, renovate, and maintain the establishment are suitable, based on their chemical and physical characteristics, for the intended use.
• If ice is used for processing, as a processing aid or as an ingredient, the control measures should address the ice manufacturing equipment and ensure the ice is held and stored in a sanitary manner and protected from contamination.
  • The document Ice used in the preparation of food outlines the safe production of ice and the use of ice in food manufacturing.

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

• Control measures should prevent contamination of the fish by ensuring that non-food chemicals used are:
  • approved for their intended use
    • you keep a record as proof of the approved use
  • applied according to their intended use
  • stored to prevent unintentional contact with food products
  • kept away from the processing areas and areas where fish and/or input materials are handled or stored, when their intended use is for outside of the establishment

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.

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:

• You describe the system you use to trace your fish products to their first destination and the food (ingredients) you receive to the person who provided them.
• The information recorded for each shipment of fish you provide to another person should identify:
  • the common name of the fish product
  • the lot code
  • date you provided it
  • name and principal place of business of the person to whom you provided your fish
• The information recorded for each food (ingredient) you receive from another person should identify:
  • the name of the food
  • date on which it was provided to you
  • name and address of the person who provided you with the food

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.

3.2(b) The notification program

In this element you:

• describe the procedures for receiving, investigating and responding to complaints and notifying the CFIA of valid health and safety complaints.
  • these are the procedures you follow when conducting a recall simulation
• keep a record of each complaint that describes:
  • the date and time you received information questioning the safety of the fish
  • a description of the issue
• record for each valid complaint:
  • the date and time you confirmed that the complaint as valid
  • the name, address and telephone number of the person who informed you of the complaint
  • the method used to investigate the complaint and the results obtained
  • the corrective actions taken
  • the date and time when you notified the CFIA

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

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:

• Canadian requirements that have to be met
• measures applied to ensure compliance with the requirements
• monitoring procedures used to ensure that the measures are carried out correctly and consistently, clearly specifying:
  • each monitoring activity, and what is being monitored
  • how each monitoring activity is conducted
  • the frequency of each monitoring activity
  • who is responsible to conduct the monitoring activities
• corrective action system in place to immediately address deficiencies identified and prevent their re-occurrence, as well as how all products not meeting the standard are identified, segregated, culled, and reworked or disposed of in an appropriate manner.
• records used to document the corrective actions taken which describe the:
  • deviation that occurred
  • section of the QMP that is not met
  • corrective action taken
  • person(s) responsible for the action
  • date the action was taken
  • date the effectiveness of the corrective actions was verified
  • person responsible for verifying that the corrective actions were taken
  • interim preventative measures taken when corrective actions can only be implemented in the long-term
• records used to document the implementation and effectiveness of the measures used to prevent the hazards you identified

4.1 Minimum acceptable product quality

In this part you describe the measures applied to ensure:

• proper handling of the fish and ingredients to prevent contamination and deterioration
• final products comply with Canadian requirements and are:
  • not contaminated
  • edible
  • not filthy, putrid, disgusting, rotten or decomposed

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.

• The ingredients and substances used are suitable for use, for example:
  • ingredients used are edible and are not contaminated, filthy, putrid, disgusting, rotten or decomposed
    • vessels handling and transporting the fish:
      • are of suitable construction, maintained and operated in a clean and sanitary condition
      • protect the fish from spoilage and contamination from the sun, bilge, fuel and human waste
      • keep the fish refrigerated or well iced to ensure adequate temperature control
    • shellfish vessels have a designated human waste receptacle or holding tank to prevent the discharge of human waste in shellfish harvesting areas and the contamination of the shellfish
  • additives used are permitted for the intended use and applied correctly at the appropriate levels permitted for use
  • substances such as processing aids, ice and wood chips used to produce smoke that comes into contact with fish, are suitable, food grade quality and safe for their intended use
• The packaging materials are suitable for use, for example:
  • are clean and sound
  • do not impart any undesirable substance to the food product, either chemically or
  • protect the fish from contamination physically

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:

• grading
• code markings
• standards of identity
• net quantity declaration

Guidelines

Control measures for the RAP plan can include:

• inspections, sampling and evaluations of the final product and incoming ingredients
• obtaining a manufacturer's attestation
• having a Supplier Food Safety Assessment Program (also known as a Supplier Quality Assurance Program) to ensure ingredients are suitable and not contaminated, including:
  • produced under sanitary conditions
  • handled, stored and transported properly to prevent contamination and deterioration
• obtaining documentation from a recognized government or non-governmental authority, in the case of imported ingredients
• obtaining reports of analysis from an accredited laboratory
• using ingredients commercially prepared and labelled for food use
• reviewing labels before printing, before use and as part of the final product assessment

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.

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

• The measures applied to prevent or reduce hazards associated with the maintenance and operation of your establishment are described in your pre-requisite program

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.

• You describe the control measures applied to prevent, eliminate or reduce to an acceptable level the hazards at each critical control point you identify.
• You describe the instruments or equipment that requires calibration for accurate monitoring of CCPs.
  • The frequency of calibration should depend on the likelihood that an instrument loses its precision or accuracy and the likelihood that this would result in a deviation from the critical limits.

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.

• For example, you conduct additional sampling, tests and measurements, and review monitoring procedures and records at a frequency sufficient for you to be able to assess the implementation and effectiveness of the control measures.

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

Principle 7

Establish documentation and record keeping

• You document the following information in your HACCP plan:
  • hazard analysis
  • CCP determination
  • critical limit determination
  • corrective action procedures
  • monitoring procedures
  • control measures and the evidence showing that they are effective
• You describe the procedures to generate and maintain records that show you have implemented your QMP and that it is effective.
• You keep records of the:
  • documents supporting the development your QMP:
    • information you used to determine your hazards
    • your rational for determining CCPs
    • scientific data, Canadian standards and guidelines used to establish the critical limits
    • evidence showing that each critical limit and your control measures are effective
  • CCP monitoring activities
  • Deviations and associated corrective actions
  • Modifications to your HACCP system

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:

• reviewing records to verify that they are completed as required, are filled out properly and are up-to-date
• on-site assessments of preventive controls
• observations
• employee interviews
• dismantling equipment to verify the effectiveness of the cleaning process
• measurements and analytical tests

Verification activities allow you to confirm that:

• all corrective actions were completed
• all problems or consumer complaints were analyzed
• all records were completed correctly
• the QMP plan is maintained and was amended when something was new or changed and when a problem was identified
• amendments made to the QMP are effective

The verification procedures describe:

• what the verification activities are
• how the verification activities are conducted
• when each verification activity is to be conducted
• who is responsible for carrying out each verification activity
• the records to be completed on the verification activities conducted and the findings
• the corrective actions to be taken

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:

• visual observations
• review of records
• surface swabs or other methods of microbiological analysis of surfaces such as contact plates, or adenosine triphosphate (ATP) bioluminescence

Verification of the HACCP plan

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

• the hazard analysis reflects current products and processing steps
• CCPs are being controlled
• control measures applied for each hazard identified are effective and instruments remain calibrated
• critical limits are monitored at the established frequency and are continuously respected
• monitoring activities are always conducted and at a frequency sufficient to ensure products are consistently in compliance
• corrective action procedures work efficiently and effectively
  • all deviations were followed up immediately with Corrective Actions
  • affected products were controlled and dealt with appropriately

Maintenance

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

• something is new or has changed
  • For example, an updated or new food standard, product formulation, processing step, production flow, ingredient, product or equipment.
• a problem is identified
  • For example, a deficiency or deviation observed during monitoring or verification procedures, non-compliance identified by CFIA or third party auditors, customer complaints that reveal a problem with the QMP, food recalls or unsatisfactory product test results.

7. Record keeping

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

• the measures you have in place are effective in preventing the contamination of your food with the hazards you identified
• you are implementing your QMP plan

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

• records on the development of your HACCP Plan and records generated by the procedures or activities performed in the implementation of the HACCP plan and any corrective actions taken are kept
• records are complete, accurate, legible, intialed/ signed and dated and are available for review
• the latest version of a record is being used
• the integrity and authenticity of records is protected during the retention period

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

• A guide for domestic food businesses and exporters: preparing a preventive control plan
• Evidence showing a control measure is effective
• Food safety standards and guidelines
• Preventive Controls for food businesses
• Preventive control plan
• Preventive control plan templates for domestic food businesses
• Recall procedure: A guide for food businesses

Other references

• Codex Alimentarius Commission, Code of Practice for Fish and Fishery Products
• Codex Alimentarius Commission, General Principles of Food Hygiene, CXC 1-1969, 2020
• Health Canada, Food allergies
• Public Health Agency of Canada, Food illnesses
• Health Canada Food Packaging
• Health Canada, Lists of permitted food additives
• International Commission on Microbiological Specifications for Foods (ICMSF). Microorganisms in foods 4: Application of the hazard analysis critical control point (HACCP) system to ensure microbiological safety and quality, Oxford: Blackwell Scientific Publications,1988
• U.S. Food and Drug, Fish and fishery products hazards and controls guidance – fourth edition