The Food Safety Enhancement Program approach to a preventive control plan

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements are being phased in over the following 12 to 30 months. For more information, refer to the SFCR timelines.

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Introduction

The Food Safety Enhancement Program (FSEP) is one example of a type of preventive control plan (PCP). FSEP is based on the Hazard Analysis and Critical Control Point (HACCP) principles and, for many years, this program has been implemented by meat, dairy, processed fruits and vegetables, shell eggs, processed eggs, honey and maple food operators as well as hatcheries. FSEP specifies the requirements for an effective HACCP system to ensure food is prepared under sanitary conditions and is safe to eat.

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

  • review their FSEP plan against the preventive control requirements of the SFCR; and
  • verify that you are using control measures that are shown by evidence to be effective

Once reviewed and revised, as necessary, businesses may continue to use their written FSEP 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 is included

The document describes the key components of a written Food Safety Enhancement Program, as well as information on program changes to consider under the SFCR.

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

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 control measures 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 Food Safety Enhancement Program

  1. General
  2. Program Responsibilities
  3. Prerequisite programs
  4. Market fairness requirements
  5. HACCP plans
  6. Validation documentation/Evidence of effectiveness
  7. Maintaining your FSEP
  8. Forms

I. General

You prepare, keep and maintain a written FSEP plan that meets the requirements of section 89 of the SFCR. The plan outlines the control measures you develop and implement to ensure that your food is safe and fit for consumption and the measures you apply to ensure compliance with the consumer protection and animal welfare requirements, as applicable. Your FSEP outlines:

Requirements /critical limits

The criteria that have to be met or the critical limits that have to be met for each critical control point (CCP) in your HACCP plans.

Keep in mind

You need to review and update, as necessary, the requirements with the preventive control requirements in Part 4 of the SFCR.

Preventive controls

A description of the control measures to ensure compliance with the requirements set out in sections 47 to 84 of the SFCR. The written preventive controls describe:

  • the name or position title of the individual responsible for each control measure
  • the control measures (programs, standard operating procedures, tasks and activities) conducted to prevent, reduce or eliminate to an acceptable level any hazard
  • the process controls applied which contribute to the reduction of a hazard but are not designed to eliminate or reduce it to an acceptable level
  • the measures applied to comply with market fairness requirements (labelling, packaging, grading, standards of identity, net quantity)
  • the titles of the records completed to show that the preventive controls are implemented and effective

Monitoring procedures

A description of the monitoring procedures to ensure that the control measures are carried out correctly and consistently. The written monitoring procedures describe:

  • the prerequisite, CCP or process control measures being monitored
  • the requirements, criteria, critical limits or specifications (quantitative such as temperature in degrees Celsius or qualitative such as pooling of water) that have to be met and define the limit of acceptability
  • each monitoring activity (test, measurement or observation) conducted for each measure
  • name or position title of the person responsible to conduct each monitoring activity
  • detailed methods or instructions for conducting each monitoring activity
    • a frequency that can be measured and audited (for example, as required cannot be measured or audited)
    • a minimum frequency of once per year
  • names of the records completed to document the results of the monitoring activities
  • name or title of personnel responsible for the monitoring procedures and the assessment of the results
Note

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

Corrective action procedures

A description of the corrective actions when there's a deviation or deficiency with:

  • the control measures applied in a prerequisite program that compromises their effectiveness and compliance with the requirements/ criteria
  • the control measures and process controls of a CCP that compromises their effectiveness and compliance with the critical limits set for the CCP

The corrective procedures:

  • identify the name or title of the person responsible for the corrective action procedures
  • describe the assessment of deficiencies or deviations:
    • observed during your monitoring activities or verification procedures
    • identified by CFIA
    • revealed by unsatisfactory laboratory results received, a customer complaint or food recall
  • identify the name or title of the person responsible for assessing:
    • the cause and source of the deficiencies or deviations
    • whether additional control measures are needed when there are repeated deviations that indicate a trend toward a loss of control
  • describe the actions to be taken to:
    • address immediately a deficiency or deviation with the process controls or CCP
      • identify, control and assess the safety of the affected or potentially affected food for release or disposal
      • assess whether other products are implicated
      • prevent the on-going production of non-compliant food
      • prevent the re-occurrence of deficiencies or deviations
      • describe how potentially unsafe food is handled and assessed to determine whether it may be released or has to be disposed of
  • identify the name or title of the person responsible for implementing the corrective actions and putting in place additional control measures identified, as necessary
  • describe the verification of the effectiveness of the corrective actions taken and additional control measures implemented, if applicable
  • identify the name of the records used to document:
    • the deviation or deficiency that occurred and its cause
    • the corrective actions taken and interim measures taken when corrective actions can only be implemented in the long-term
    • the date the corrective actions and additional control measures implemented are to be taken or were taken, if applicable
    • the date the effectiveness of the corrective actions taken, and additional control measures implemented were verified, if applicable
Note

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

Keep in mind

Under the SFCR (section 89):

  • 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.

Verification procedures

A description of the verification activities to confirm and demonstrate that all preventive controls, monitoring activities and corrective actions outlined in your program are consistently implemented and are effective in achieving the intended outcome.

Verification procedures apply to the:

  • HACCP plan (to verify that all food safety hazards are identified)
  • CCPs and process controls applied (to ensure critical limits are met)
  • control measures for hazards that are not part of a CCP
  • measures taken to ensure that the requirements on the humane treatment of animals are met
  • monitoring procedures
  • corrective actions procedures

Your verification procedures:

  • identify who conducts the verification activities
    • You assign the verification activities to someone who is not responsible for or involved in the monitoring activities.
  • describe the verification activities such as:
    • direct observation of monitoring activities
    • interview of persons responsible for monitoring and deviation procedures
    • direct observation of corrective actions taken, if possible
    • review of records documenting the monitoring activities
    • review of records documenting the actions taken in response to a deviation
    • product testing to confirm that the CCP is properly implemented and achieves the intended outcome
  • describe the frequency of each verification activity
  • identify the records that are completed to document the verification activities completed and the results of those activities
Note

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

Keep in mind

Under the SFCR:

  • Verification procedures apply to your prerequisite program as well as the CCPs and process controls.
  • Verification activities provide evidence on the implementation and effectiveness of any preventive control you apply.
  • You may verify your program at a frequency appropriate for your business however it is recommended that you verify your program at least annually.

Record keeping

A description of the documents (records) completed to substantiate that your preventive control plan has been implemented and to provide evidence that your control measures are effective. You ensure the integrity of the records by:

  • keeping up-to-date the version of the records to be completed:
    • to demonstrate that the control measures are implemented
    • to capture the results of the monitoring procedures
    • to capture the corrective actions taken
  • providing instructions on how to complete the records that describes:
    • the fields to complete
    • how to complete the record:
      • objectively
      • factually
      • accurately
      • legibly
      • using permanent ink
    • the format for presenting the information in each field, for example:
      • numerical reading such as a temperature
      • a summary, on what was done or observed
      • a selection from a list of choices
    • the signing and dating of records by the person responsible for completing them
  • providing instructions on the filing and retention of records

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

Keep in mind

Under the SFCR:

  • The documents (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).
  • Documents (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.

II. Program Responsibilities

Developing, implementing and maintaining an effective program depends on knowledgeable, experienced and committed management and employees working together to identify food safety hazards and determine how to control them.

  • External consultants may provide expertise that is missing and assist in the development of your FSEP however you remain responsible for your program.

Senior management commitment

The responsibilities of senior management include:

  • the maintenance and operation of the establishment in compliance with the SFCR
  • ensuring that food safety is fully embedded in every level of the food business

Senior management demonstrates commitment to their FSEP by:

  • providing the resources and time needed for the development, implementation and maintenance of the FSEP and training of staff. For example:
    • providing financial resources to ensure that the construction of the premises, its internal fittings, the installation of the equipment, the maintenance of the premises and equipment, as well as the supplies required to perform the above, meet regulatory requirements and support the program
    • providing designated personnel with the authority to initiate, implement and record corrective actions
    • communicating to employees the importance of complying with the program, including any regulatory requirements related to food safety, and the importance of reporting problems to the identified person(s)
    • allowing designated management personnel to enforce compliance of the food safety procedures identified in the establishment's FSEP for any person entering or working within the facility
    • allowing the continuous improvement of the program to ensure its effectiveness through the validation of control measures, by making changes to the system as a result of corrective actions or reassessment activities, and through the use of HACCP team meetings
    • providing sufficient time for HACCP team meetings
  • assigning a HACCP team leader responsible for the development, implementation, maintenance and re-assessment of the program
  • staying informed of the program's performance at all times
  • attending HACCP team meetings periodically and keeping those responsible for finances informed of items that will require financial support

A letter of commitment signed annually by a member of senior management confirms the:

  • support for the development and implementation of an effective program
  • commitment to the preparation of food in compliance with all regulatory requirements

HACCP team

The responsibilities of a HACCP team include:

  • providing assistance to the team leader for the development, implementation, maintenance and re-assessment of the program
  • holding meetings regularly to discuss matters such as:
    • amendments to the program
    • deficiencies with the program
    • root causes of deviations, deficiencies or non-compliances
    • action plans to correct deviations, deficiencies or non-compliances
  • informing senior management of the program's performance and the verification results on a regular basis and providing the information necessary to obtain the support and resources needed to correct the issues
    • The procedure followed to inform senior management outlines the:
      • name or title of person responsible for providing the information
      • name or title of the senior management who receives the information
      • frequency at which the information is communicated
      • method used to provide the information
      • process used to demonstrate that the communication took place

Keep in mind

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

FSEP document

Having the first page of the prerequisite programs, HACCP plans and process controls signed and dated by the HACCP team leader or a member of senior management provides the confirmation that the HACCP system is approved and will be implemented as specified. It is recommended that the document be signed:

  • upon implementation
  • after modifications are made that impact the control of a hazard
  • after verification activities

Dating all pages of the prerequisite programs, HACCP plans, process controls and supporting documentation such as standard operating procedures ensures that the correct version is implemented. It is recommended that the document be dated:

  • upon implementation
  • after modifications are made
Note

For the use of electronic signatures or signature stamps, it is a good practice to have measures to ensure their integrity and authorized access. You may incorporate the date with the electronic signature or signature stamps.

III. Prerequisite programs

The design and construction of an establishment and equipment, as well as the condition of the premises and equipment, have to be suitable for the production of safe food production. The establishment also has to be maintained and operated in a clean sanitary condition that prevents the contamination of a food. The requirements that apply to the maintenance and operation of an establishment can be found in Division 4, sections 49 to 81, of the SFCR. The following prerequisite programs address these requirements:

  1. Premises
  2. Food conveyances, purchasing, receiving and storage
  3. Conveyances and equipment in the establishment
  4. Personnel
  5. Sanitation and pest control
  6. Recall System
  7. Operational prerequisite programs

A. Premises

This prerequisite program is intended to address the requirements set out in sections 56 to 71 of the SFCR.

1. Outside property (section 56 of the SFCR)

The land that forms part of your establishment and the location of your establishment may be a source of hazards such as pests and airborne microbial or chemical contaminants. These hazards may enter your establishment and present a risk of contamination to your food. To prevent or eliminate the hazards you:

  • maintain the surrounding land/roadways free of debris, refuse and ensure it is well drained
  • keep the grass trimmed and remove dead vegetation
  • regularly clean and cover external waste containers with tight fitting lids that are resistant to the entry of animals and pests

If your establishment is located near a source of contamination such as livestock or agricultural activities, you can protect your food from the hazards these activities may present by:

  • using filters at the air intake points to remove airborne contaminants from the incoming air
  • including a buffer zone in the property
  • installing fences to separate your property from surrounding activities
2. Establishment (sections 57 to 71 of the SFCR)
2.1 Design, construction and maintenance (sections 57 to 58 and 60 to 62 of the SFCR)

The design and construction of your establishment prevents hazards that may be present from posing a risk of contamination to your food. For example:

  • walls, floors and ceiling joints are sealed to prevent the accumulation of contaminants such as dust, dirt, micro-organisms, and food particles and allows for effective maintenance, cleaning and sanitizing
  • walls, doors, windows, ceilings, overheads and other structures in rooms or areas where food is prepared, manufactured, stored, packaged, received or shipped are:
    • smooth
    • non-absorbent
    • impervious to moisture
    • cleanable
    • free of noxious constituents
    • durable
    • resistant to deterioration
  • hard-to-reach areas are sealed to prevent build-up of contaminants
  • the design allows for easy access to all areas for maintenance, cleaning and sanitizing activities
  • ceilings and overhead structures are designed to minimize the build-up of dirt and condensation
  • floors have a slope that directs wastewater to the drains
  • floor drains are readily accessible for maintenance, cleaning and sanitizing
  • floor drains are equipped with traps, allow the rapid removal of wastewater, prevent pooling and flooding of the surrounding areas
  • the drainage and sewage systems are equipped for the prevention of backflow, sewer gases, pests and other contaminants from entering the establishment through the plumbing system
  • the roof, air intakes, foundation, wall, doors and window prevent leakage and entry of contaminants and pests
  • air intakes are located away from potential contaminants
  • windows are constructed of, or protected with, unbreakable materials
  • windows have close-fitting screens and doors have a good seal protecting against the entry of contaminants from the outside

The size and layout of your establishment is adequate and accommodates the activities conducted. For example:

  • incoming materials (food, non-food, packaging) are received in an area separate from food processing areas
  • you have separate facilities for:
    • the storage of waste and inedible products
    • cleaning and sanitizing equipment used for waste/inedible products
    • cleaning the equipment used to prepare the food
  • incompatible operations are effectively separated, for example:
    • there's an enclosed area dedicated to the handling of inedible products
      • the inedible products area has a separate area for handling meat products that are a specified risk material, contain a specified risk material or are derived from a specified risk material
    • cleaning and sanitizing activities occur separately from food preparation activities
    • raw food is handled in an area separate from the handling of ready-to-eat food
    • shipping of finished food is conducted in an area separate from the receiving of incoming ingredients
    • inedible products and waste are stored away from food preparation areas
    • living quarters are separate from any food preparation area
    • food animals are handled in areas separate and away from the food preparation areas
    • laboratories that conduct microbiological and pathogen testing are separate from food preparation areas
    • storage of starter products and manure piles are kept away from water sources, fresh fruit or vegetable production sites and harvested fresh fruits or vegetables
    • agricultural chemical applicators are washed away from water sources, fresh fruit or vegetable production areas
    • food with allergens are handled separately from food without allergens
  • living quarters and areas where food animals are kept are separate from and do not open directly into food processing or packaging areas
  • washrooms, lunchrooms and change rooms are separated from and do not open directly into food processing areas
  • there are no cross-connections between:
    • potable water lines and non-potable water supply systems
      • non-potable re-circulated/reused/recycled water has a separate distribution system which is readily identifiable in the establishment
    • effluent from human wastes and production drainage wastes
Note
  • The document Preventing cross-contamination provides additional information on factors to consider that may help prevent cross-contamination.
  • If the design of your facility does not allow for the effective separation of incompatible operations, or prevent cross-contamination, control measures to prevent cross-contamination are needed as part of the General Food Hygiene Program and/or Sanitation Program.
Movement of persons and things (section 59 of the SFCR)

The movement of persons and things is controlled to prevent contamination of the food.

  • Access to the establishment is secure.
  • The traffic and process flow is designed to prevent cross-contamination and hygienic operations.
Note

The document Preventive control plan templates for domestic food businesses provides additional information on traffic and process flows.

You maintain your facility in good repair to prevent the contamination of your food. For example:

  • the roof, air intakes, foundation, walls, doors and windows are intact and do not leak
  • floors, walls, ceilings, overheads, doors, windows, stairs, elevators and other structures do not show signs of degradation that could cause contamination
    • There's no flaking, peeling rust or paint, or loose materials.
  • the screens on windows are intact and close-fitting and the doors provide a good seal
  • ceilings and overhead structures do not have a build-up of dirt or condensation
  • water is not leaking from overhead pipes and debris is not falling from the ceiling
2.2 Lighting (section 63 of the SFCR)

The natural or artificial lighting you use in your establishment is appropriate for your food. For example, the lighting does not:

  • alter the natural colour of your food
  • cause nutrients in your food to deteriorate
  • affect the quality of your food

The placement and intensity of lighting in your establishment is appropriate for the activities conducted. For example, the lighting allows you to:

  • operate equipment safely and properly
  • identify potential defects in food and deviations
  • conduct inspections, examinations, and screening activities effectively
  • examine your establishment or food for evidence of visible contamination, unsanitary conditions and pests
  • clean and sanitize your establishment and equipment effectively

The artificial lighting you use does not present a risk of contamination to your food. For example, light fixtures are:

  • constructed from shatter-resistant materials
  • shielded with safety covers when they have materials like glass that could break

The guidance document Lighting in an establishment provides additional information on light intensity levels and colour known to be adequate for conducting activities.

2.3 Ventilation (sections 64 and 65 of the SFCR)

The natural or mechanical ventilation system in your facility provides a good air exchange. For example, the ventilation system:

  • brings in clean air, removes unclean air, that may contain airborne contaminants, and odours
  • prevents the flow of air from one area to another which may be a source of airborne contaminants
    • lowers the temperature and humidity to a level appropriate for the activities conducted by removing warm moist air from the facility
    • has close-fitting screens or filters at the air vents to prevent the entry of insects, dust, smoke, steam, odours, and contaminated air
  • is easily accessible and can be properly disassembled for cleaning, maintenance and inspection
  • is maintained in good operating condition by cleaning or replacing filters regularly, as appropriate for the effective exchange of air

The document condensation provides information on measures you may apply to prevent condensation and the contamination of your food with condensation that cannot be prevented.

2.4 Waste and inedible/food disposal (section 66 of the SFCR)

You handle and dispose of waste, such as garbage, discarded packaging, broken pallets, discarded construction materials, and inedible products or food waste in a manner that prevents the contamination of your food. For example:

  • the utensils and containers used to collect, hold and dispose of waste are identified
  • the frequency at which you remove the waste prevents its accumulation and the attraction of pests that may contaminate your food
  • the waste is stored and covered in a manner that prevents the release of objectionable odours
  • the equipment used to contain and store waste is leak proof
  • the drainage and sewage system can handle the volume and type of liquid waste created and prevents pooling
  • contaminated materials and waste are removed from the establishment by designated employees using predetermined routes
    • Employees wear appropriate clothing when removing contaminated materials and waste.
    • The route followed prevents cross-contamination of your food by the waste.
  • inedible meat products are stored in an enclosed area dedicated to the handling of inedible products
  • specified risk material is collected, stored in a dedicated area within the inedible meat product area, and disposed of in accordance with the Health of Animals Regulations

The document Specified risk material provides information on the handling of specified risk material to comply with the Health of Animals Regulations.

3. Sanitary facilities (section 67 of the SFCR)
3.1 Employee facilities

Your establishment has the necessary sanitary facilities for employees to maintain personal cleanliness such as:

  • hand cleaning and sanitizing stations
  • lavatories
  • showers
  • drinking water stations
  • break rooms and change rooms

The sanitary facilities:

  • are readily accessible
  • are maintained
  • are equipped appropriately
  • can accommodate the number of employees that could be using them at the same time

For example:

  • lavatories are equipped with:
    • well- functioning toilets
    • a continuous supply of toilet paper and liquid hand soap to meet the needs of the employees
    • faucets with hand-free water supply function
    • sanitary hand drying supplies or equipment
    • waste receptacles
    • hot and cold/warm potable running water
  • the location of the lavatories does not present a risk of contamination.
    • There is an anteroom or outer foyer that separates the lavatories from the areas where you conduct your food activities
  • hand washing notices are posted in the lavatories
  • the sinks are designed and of a size that makes the hand washing process easy and effective
  • there are change rooms with separate storage space for employee personal clothes and protective work clothes to prevent the risk of contamination the clothing worn by employees may present to a food
  • there are break room facilities for employees to prevent them from eating and drinking in areas that may present a risk of contamination to a food
3.2 Hand-washing stations and sanitizing installations

Your facility has and maintains the necessary installations for the cleaning and sanitizing of hands and footwear to prevent the contamination of a food. For example:

  • Hand washing and sanitizing stations are located in areas where employees need to wash their hands, such as entrances to food preparation areas, and of a quantity that can accommodate the number of employees that could be using them at the same time.
  • Hand-washing notices are posted in entrances to food preparation areas.
  • Potable water is used in the hand and footwear sanitizing stations and the sanitizing chemicals used are approved, appropriate for use and maintained at the concentration needed to be effective.
  • The water temperature is warm enough to soften residues on hands and allow the soap to produce the lather needed to remove waste and contaminants but comfortable for the hands.
  • The water pressure is strong enough to allow for dirt and contaminants to be easily removed from the hands.
  • Hand cleaning and sanitizing stations that do not use water are equipped with a solution that allows for the effective removal of waste and contaminants.
4. Water/ice/steam (sections 70-71 of the SFCR)

The water, ice and steam used that can come into contact with food do not present a risk of contamination to the food. For example:

  • you use potable water such as municipal water
  • you have water safety procedures that:
    • identify the name or title of personnel responsible for its implementation
    • identify the sources of water supply (municipality, private well(s), storage tank(s), etc.)
    • describes the water and ice sampling procedures, sampling sites, testing activities, testing schedule(s) and records to be completed
  • you apply a treatment such as filtration or ultraviolet lights to the water, including recirculated and reclaimed water
    • The treatments do not present a risk of contamination of the food.
    • You maintain the treatments to ensure their effectiveness.
  • you have a water treatment procedure that:
    • identifies the name or title of personnel responsible for its implementation
    • describes the water treatment activities performed, the method and frequency of treatment chemicals used and their concentrations
    • describes the proper handling and application of water treatment chemicals
    • describes the testing procedures and testing frequency to verify that the treatments were conducted properly and are effective
    • identifies the records to be completed
  • you take action to prevent the contamination of your food when there's a failure with the municipal water supply you use
  • cross-connections occur only between potable water systems that are protected against contamination, or that do not present a risk of contamination to the food
  • hoses and taps are equipped with back-flow or back-siphonage prevention devices
  • your water distribution system is enclosed and protected against contamination
    • In the case of wells, you ensure the well head is protected and securely covered.
  • you adjust the water pH, if needed, to a level adequate for the cleaning products you use for sanitation
  • you handle ice with clean utensils
  • the doors of the ice machines, used to make and store ice, are kept closed
  • the supply and pressure of steam available is sufficient for your cleaning and sanitizing activities and for you to conduct thermal treatments such as running retorts, as applicable
  • the boiler treatment agents used do not pose a risk for public health
Note

The following documents provide additional information:

B. Food conveyances, purchasing, receiving and storage

1. Food conveyances (sections 72-73 of the SFCR)

The conveyances used to transport food to and from your establishment do not present a risk of contamination to a food and protect the food from contamination from other food, dust, pests and the exterior environment. For example, the conveyances:

  • keep refrigerated food at a temperature between 0°C and 4°C and frozen food at −18°C or less
  • are equipped with instruments that control, indicate and record temperature and humidity levels where necessary
  • are never used to transport materials or substances that present a risk of contamination to a food
    • You request information on the previous materials or things that were carried in the conveyance and if necessary, proof that it was cleaned and sanitized.
  • can be and are maintained in a clean and sanitary condition
    • Conveyances are verified before you load or unload food to ensure they're clean, sanitary, in good condition and do not contain chemicals or substances that may contaminate the food.
    • Bulk transport tankers can be completely drained for cleaning.

The food is loaded on and unloaded from a conveyance in a manner that does not present a risk of contamination to the food. For example:

  • you avoid using equipment that may damage and contaminate the food
  • you ensure there's a good seal, between the conveyance and the establishment, at the site where food is loaded and unloaded to prevent pests from coming into contact with the food
2. Purchasing, receiving and storage
2.1 Purchasing and receiving (section 47(2) of the SFCR)

The incoming ingredients, products and materials you receive in your establishment are suitable, permitted for use and do not present a risk of contamination to your food. For example:

  • the packaging materials that are or may come in direct contact with the food you prepare, such as paper wraps, waxed cardboard boxes, plastic films, synthetic casings, nettings, trays, absorbent pads, pouches and bags are suitable for their intended use and do not present a risk of contamination to your food
  • the food and ingredients received to prepare your food are not contaminated, are permitted for use, and do not present a risk of contamination to the food
  • the construction materials, coating and joint sealants used in your establishment do not contain noxious substances, are non-absorbent, impervious to moisture, cleanable, durable and resistant to deterioration
  • non-food chemical products that come into contact with your food, such as processing aids, and are used on food contact surfaces such as cleaners, disinfectants and sanitizers are safe and suitable for use

You verify the incoming ingredients, products and materials when they are received to ensure that they:

  • are properly labelled and identified
  • are in good condition, not damaged or soiled
  • meet purchasing specifications
  • are accompanied with a certificate of analysis or letter of guarantee, as applicable
Note

The documents Incoming ingredients, materials and non-food chemicals and Supplier food safety assurance program outline the control measures that may be used to ensure the incoming food, ingredients, materials and non-food chemicals are safe and suitable for use.

You identify and isolate, in a designated storage area, the food received as returns (food you prepared that has left your establishment) to prevent it from posing a risk of contamination to other food, as a result of mishandling and inadequate storage that may have occurred after the food left your establishment.

2.2 Storage (section 74 of the SFCR)

You store your food in a manner that protects it from contamination and you store non-food materials and chemicals in a manner that does not present a risk of contamination to your food. For example:

  • you store non-food chemicals, sanitizers and chemical agents:
    • in accordance to the manufacturer's instructions
    • in a designated, dry, ventilated area that prevents the risk of cross-contamination of your food, packaging material or food contact surfaces, from spillage or leakage that may occur
    • you follow "first in, first out" stock rotation principles to minimize deterioration which may make them ineffective for use
  • you store food on pallets or shelves off the ground to protect them against contamination from pests, including insects, rodents, and other vermin
    • If necessary, you install shelving units away from walls to allow for easy cleaning and to prevent pests from accessing the food.
    • You do not store food past the best before date.
  • you store conveyances and equipment:
    • in accordance to the manufacturer's instructions
    • in designated locations that are clean and away from employee traffic and food production areas
  • you store packaging materials:
    • under proper environmental conditions of temperature, humidity, and light to prevent their deterioration in accordance to the manufacturer's instructions
    • off the ground to prevent against contamination from pests, including insects, rodents, and other vermin
    • using "first in", "first out" principles to prevent their deterioration that may occur over time and make them a risk of contamination to the food
  • you store protective clothing in designated locations and off the floor so that they do not get contaminated and are accessible for use

C. Conveyances and equipment in the establishment

1. Equipment general (sections 53 to 55 of the SFCR)

The equipment you use is appropriate to the food and activity you conduct and function as intended.

  • Before using a conveyance or equipment, you verify that it is functioning as intended by the manufacturer.
  • If you use the same piece of equipment for more than one type of food, you ensure that the equipment is appropriate for all the types of food.
1.1 Design and installation

The conveyances or equipment you use are designed, constructed and maintained in a manner that prevents contamination of your food. For example:

  • the equipment and conveyances:
    • are properly installed:
      • have sufficient space around them for proper functioning
      • are accessible for maintenance, cleaning, sanitizing, inspection and disassembly for that purpose
    • are capable of delivering the requirements of the process and the sanitation program
    • are constructed of smooth, durable, cleanable, non-corrosive, non-absorbent materials free of noxious substances:
      • do not have pits, cracks and crevices where contaminants may accumulate and microorganisms can grow
      • do not have internal horizontal ledges with hidden or hard-to-clean areas
      • are made of materials that are not affected by the constituents of the food such as the salt or acids
    • are equipped with protective shields, lids or covers to prevent contamination
  • the equipment:
    • exhausts to the outside of the facility if necessary to prevent excessive moisture
    • permits proper drainage and connects directly to drains, if necessary
  • the utensils are constructed of non-toxic materials, are easy to clean and sanitize and do not present a hazard to the food
1.2 Equipment maintenance and calibration

The equipment and conveyances are maintained, and if necessary, calibrated, so that they function as intended and do not present a risk of contamination to the food. For example:

  • you have a preventive maintenance program to ensure continuous proper function as intended that:
    • lists the equipment that may impact on food safety and require regular maintenance such as pasteurizers and their location
    • describes the schedule or frequency of preventative maintenance activities
    • describes the maintenance procedures to perform for each preventative maintenance task and the records completed to demonstrate their completion
      • maintenance procedures are based on the equipment manufacturer's manual or equivalent
      • the oil used to lubricate equipment that come into contact with the food are food grade
  • you inspect the conveyances or equipment regularly and repair them using spare parts that are approved or recommended by the manufacturer and replace equipment and utensils that are not in a good condition and cannot be repaired.
  • you have a calibration program to ensure instruments used to control, indicate, and record parameters are accurate. For example:
    • measure accurately the addition of ingredients, preservatives or nutrients, additives, pH and sugar concentrations
    • detect metal fragments based on type of food, target metal, and anticipated size
    • record critical processing times and temperatures
  • the calibration program:
    • lists the equipment monitoring and controlling devices that may impact on food safety and requires regular calibration
    • describes the calibration schedule or frequency of calibration activities
    • describes the calibration procedures to perform for each calibration task and the records completed to demonstrate their completion
      • Procedures are based on the equipment manufacturer's manual or equivalent.

D. Personnel

1. Training (section 75 of the SFCR)

Your personnel have the competencies and qualifications necessary to carry out the tasks and duties assigned to them to deliver the control measures needed to prevent, reduce or eliminate hazards from presenting a risk of contamination to your food. This includes the procedures outlined in your prerequisite programs, CCPs, process controls and the monitoring and verification activities. To ensure your personnel are trained you:

  • identify the training and knowledge required for each position/employee based on the tasks and duties they perform such as:
    • monitoring CCPs
    • measuring ingredients
    • detecting defects in food
    • calibrating, maintaining and operating equipment
    • receiving and handling food animals
    • duties defined within a post-mortem examination program
    • operating a stunning device for food animals
  • verify the effectiveness of the training by evaluating employees on the training they received
  • provide training when changes to your food business occur or when deviations arise due to lack of competencies or qualifications.
  • maintain the competencies and qualifications of your employees by providing them refresher training as needed
  • keep a record of the training provided, the names of employees who received each training and the date they completed the training
1.1 General food hygiene training

Your employees are trained on food hazards, food hygiene, clean and sanitary conditions and the hygienic practices to follow to prevent the contamination of food. For example:

  • You have a General food hygiene program.
    • Refer to section 2 of this prerequisite program for more information.
  • Your employees are trained on:
    • good hygienic practices (GHP)
    • procedures for preventing cross-contamination
    • allergen prevention
    • HACCP principles
      • identifying food safety hazards and control measures
    • sanitation processes for the facility and equipment
    • maintenance of the facility and equipment
    • practical aspects of the food operations
    • flow of processes
1.2 Technical training

Your employees, including contractors, have the competencies, qualifications and accreditations necessary to carry out technical tasks. For example, they are trained on:

  • the technology or equipment used on processing lines
  • the development of a scheduled process for canned low-acid food
    • They have a valid retort operator's certification.
  • the operation of a thermal processing equipment (a pasteurizer or retorting equipment)
    • They have a valid retort operator's pasteurizer operator's certification.
  • performing pest control activities
  • performing grading activities
  • equipment calibration, service and repair
  • managing workplace hazardous materials
  • handling non-food chemical agents
  • purchasing and receiving food, ingredients, materials and non-food chemicals
2. General food hygiene program (sections 76 to 81 of the SFCR)

You have a food hygiene program that employees, contractors and visitors are expected to follow to prevent the contamination of your food. It describes, for example:

  • hygiene practices and behaviors that outline:
    • objects that may not be worn such as watches, necklaces, bracelets, earrings, fake nails, fake eyelashes, pens, paper clips, pins, and buttons are objects because they may present a risk of contamination to the food
    • the need to secure or cover objects worn that may present a risk of contamination but may not be removed such as religious apparel, wedding bands, medical alerts
    • substances that may not be used such as hand cream, nail polish or topical medicinal creams because they may present a risk of contamination to the food
    • storage of personal effects to prevent cross-contamination
    • methods for hand washing and sanitizing
    • proper use of protective clothing, hair coverings, gloves, footwear
  • prohibited practices at the establishment such as:
    • spitting
    • chewing gum
    • using tobacco products
    • eating
    • unnecessarily contacting the food
    • acting in any other way that presents a risk of contamination of the food
  • hygienic handling of food
  • proper use of utensils and equipment
  • procedures to prevent contamination as a result of the process flow, employee flow, product flow, equipment or incompatible operations
  • restricted access areas
  • procedures to follow to prevent cross-contamination when, for example:
    • product falls on the floor
    • product is exposed to dripping condensation
  • procedures for  the reporting of disease, illness, symptoms and lesions that:
    • inform employees, contractors and visitors of the requirement that they report, to the person designated by you, their state of health when they have a disease or illness, symptoms of a disease or illness, or have an open or infected lesion
    • describes the process for determining whether a person with a communicable disease or with an open or infected lesion presents a risk of contamination to the food and the measures taken to prevent contamination
      • employees that present a risk of contamination are prevented from working in areas where food is exposed and handled
      • employees with an open cut or wound are not permitted to handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering

E. Sanitation and pest control

1. Sanitation (sections 50 and 52 of the SFCR)

You have a sanitation program to maintain your establishment and equipment in a clean and sanitary condition, free from the accumulation of dust, dirt, food residue, grease and other debris that may contaminate your food. For example, you:

  • describe cleaning and sanitizing procedures including the:
    • methods used for cleaning and sanitizing equipment and rooms
    • instructions on the equipment disassembly
    • housekeeping and sanitation procedures required during operations
    • pre-operational inspection procedures
    • procedures to verify the effectiveness of the cleaning and sanitation procedures such as, visual inspection, chemical residue or microbiological testing of the food contact surfaces and finished food
    • schedule/frequency for the sanitation of all equipment, rooms and areas within the establishment
  • use sanitizers and cleaners on food contact surfaces that are suitable for use and would not contaminate the food
  • identify chemical sanitizers with labels, tags or color coded containers to be able to differentiate between them
  • follow the manufacturer's instructions so that the sanitation chemicals are applied at the correct concentration, proper temperature and contact time and removed or rinsed as required to prevent cross-contamination of your food by the chemicals used
  • remove unprotected food and packaging material and protect the food contact surfaces before you begin cleaning or sanitizing
Note

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

2. Pest Control (sections 51 and 52 of the SFCR)

You have a pest control program that protects your facility against the entry and presence of animals that present a risk of contamination to the food. For example:

  • your facility (such as the roof, air intakes, foundation, walls, floors, drains, doors and windows), is designed and maintained to prevent the entry of animals, such as insects, rodents, birds or other vermin
  • your facility and premises are kept in a clean condition to discourage pests from harbouring
  • pests that enter your facility are caught and removed immediately
Note

The document Pest control provides additional information on control measures for pests and information on pest control programs.

F. Recall System

A recall system outlines the procedures for receiving, investigating and responding to complaints and the procedures for recalling a food that presents a risk of injury to human health.

1. Recall Plan

You have a recall plan in place that describes the:

  • food complaint procedures you follow for:
    • receiving, investigating and responding quickly to complaints related to food you have sold that represents, or may represent, a risk of injury to human health
    • notifying immediately the CFIA when you determine that a food is to be recalled
  • procedures for conducting a recall to remove foods from distribution, retail sale or consumer use
  • procedures on recall simulations to test your recall procedures at least once every 12 months
  • documents you prepare to capture the details on:
    • the complaint received, the results of the investigation and the actions taken based on the findings
    • how you conducted the recall simulation and the results of the simulation
Note

The Recall procedure: A guide for food businesses provides a step-by-step approach to consider when developing recall procedures.

Keep in mind

Under the SFCR:

The requirements for investigation, notification, complaints and recall (do not form part of the PCP requirements. You can include these procedures in your FSEP or prepare, keep and maintain them separately from your FSEP.

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
2. Traceability System (Part 5 of the SFCR)

A traceability system includes the measures you take to ensure a food is labelled with the information necessary to trace it and to prepare and retain documents that allow you to trace the movement of a food one step back and one step forward.

2.1 Documents (sections 90 and 91 of the SFCR)

You prepare and keep documents (records) that:

  • identify your food:
    • the common name of your food
    • lot codes or other identifier, to allow for the food to be traced
      • The definition of the lot codes.
      • How to interpret the lot codes.
  • trace the food, you provide to someone else, one step forward:
    • name and address of the person to whom you provided the food
    • date you provided it
  • trace the food (ingredients), another person provided you, one step back:
    • name of the food
    • name and address of the person who provided you with the food
    • date on which it was provided to you
Note

You can obtain additional information on traceability requirements from CFIA's Traceability for food web page.

2.2 Labelling for traceability (section 92 of the SFCR)

You have measures in place that ensure the information necessary to trace a food is on your food label:

  • common name
  • lot code in the case of a consumer prepackaged food, or other unique identifier if not a consumer prepackaged food
  • name and principal place of business of the person by or for whom the food was manufactured, prepared, produced, stored, packaged or labelled
Keep in mind

Under the SFCR:

Traceability requirements are not part of the PCP requirements. You can include your traceability measures, and the documents you prepare, in your FSEP or keep them separate from your FSEP.

G. Operational Prerequisite Programs

1.1 Allergens, gluten and added sulphites

Food allergens, gluten and added sulphites are chemical hazards that you need to consider during your hazard analysis and when determining critical control points. You have control measures in place to:

  • prevent the risk of contamination of a food with allergens, gluten or sulphites which are not supposed to be present in the food
  • ensure allergens, gluten and added sulphites are properly declared on your food label

The document Preventive controls for food allergens, gluten and added sulphites provides guidance on measures that you may apply to:

  • prevent ingredients and food that are allergens or contain allergens, gluten or added sulphites, from contaminating a food in which they are not an intended ingredient
  • ensure that ingredients that are allergens or contain allergens, gluten or added sulphites, are properly declared in the list of ingredients on the food label

Preventing cross-contamination plays an important part in your preventive controls for allergens.

  • You identify the sources of cross-contamination with allergens during the hazard analysis and have control measures in place to prevent the cross-contamination of your food.

The document Preventing cross-contamination provides information on the factors that may result in cross-contamination and measures you can apply to prevent cross-contamination.

1.2 Food Additives, processing aids and added nutrients

Food additives permitted in Canada and their conditions of use are listed in the Lists of permitted food additives that are published on Health Canada's website.

Substances identified as processing aids are not mentioned in the Food and Drug Regulations and may be used as long as they do not result in an unsafe food. 

  • There are no regulatory requirements for preclearance of new processing aids by the Minister of Health.

Vitamins, minerals and amino acids can be added to certain foods.

  • The foods to which they can be added and the vitamins, minerals or amino acids that can be added to them, are listed in Part D – Vitamins, Minerals and Amino Acids of the Food and Drug Regulations (FDR).
    • The minimal levels to be added and maximal levels that can be added are specified in Part B of the FDR.

You have control measures in place that ensure you add, to a food, only:

  • food additives that are permitted in accordance to their condition of use
  • nutrients that are permitted in accordance to the levels established in the FDR
  • processing aids that do not result in an unsafe food

You have control measures that:

  • ensure a food additive, vitamin, mineral or amino acid is permitted to be used or added to your food
  • confirm a substance you use as a food processing aid:
    • meets the definition of a processing aid set out in Health Canada's Policy for Differentiating Food Additives and Processing Aids
    • is identical in composition and use to a substance or product that has already been assessed for safety and accepted by a food regulatory agency or food safety assessment body recognized by Health Canada.
    Note

    You can request a voluntary pre-market review of a food processing aid by Health Canada in order to obtain a letter of no objection (LONO). A LONO helps demonstrate that the composition and your use of the substance, as a food processing aid, is acceptable. For further information please consult Health Canada's Policy for Issuing an Interim Letter of No Objection (iLONO) for a Food Processing Aid.

  • describe, for each product formulation and each food additive, nutrient, mineral or processing aid:
    • the name of the substance added or used
    • the level at which it is added to comply with the minimal levels required and not exceed the maximum levels permitted
    • the processing step at which the substance is added
    • the procedures followed to apply or add the substance to the food
      • Processing aids are used in the same manner and at the same level for which a LONO was issued by HC
  • verify the level of food additive, vitamin, mineral or amino acid present in the final food product
2 Foreign material control program

Foreign materials are physical hazards that may present a risk of contamination to your food.  You prevent the contamination of your food with foreign materials by having procedures on:

  • the maintenance of equipment such as knives, needles and cheese wires
  • handling of glass, brittle plastic, ceramic and or other similar materials which present a risk of breakage
  • glass breakage when you have food packed in glass or other brittle materials
  • the visual inspection of food for the presence of foreign materials
  • the use of wood where wood cannot be avoided
  • the maintenance of monitoring equipment (such as filters, sieves, magnets, metal detectors, x-ray equipment, optical sorting equipment, scanner technology, in-line container cleaning) used to detect and remove foreign materials which describes:
    • all the equipment used to detect and remove foreign material and, as applicable:
      • the sensitivity of the detectors and the specifications on which it's based (for example, type of food, quantity/size of food, food packaging, location of equipment, speed of lines, potential environmental effects)
      • the mesh and/or gauge size of filters and sieves
      • the strength of magnets
      • how tasks are performed and their frequency
  • the measures to be followed when food is rejected by the equipment for the presence of foreign material and when foreign materials are removed by the equipment:
    • controls/mechanisms in place to ensure that the rejected product is effectively segregated and managed
    • examination procedures for rejected products
Note

When you determine that a foreign material detector is not working properly, all the food that has passed through the detector, since it was last tested to be working properly, is segregated and visually inspected or passed through a working detector.

When filters, sieves or magnets are found to be defective, the potential for contamination of products shall be assessed and appropriate actions taken.

The rejection of food by the detectors is assessed to determine if trends exist, such as, multiple false rejections that may suggest a malfunction or a calibration issue with the detector.

IV. Market fairness requirements

You describe the measures you apply to meet the consumer protection requirements referred to in section 89(1)(a) and (b) of the SFCR that apply to your food:

  • labelling
  • packaging
  • grading
  • standards of identity
  • net quantity

Your measures ensure the labels applied to your foods are accurate, legible and not misleading. For example, as part of your control measure you:

  • review the labels before they are printed
  • verify the labels before they are used and applied to the food
  • inspect the label on the final products

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 and grades requirements. Refer to CFIA's Labelling, standards of identity and grades web page for additional information on these requirements and the Industry labelling tool for information on the labelling requirements.

V. HACCP plan

You conduct a hazard analysis to identify the biological, chemical, and physical hazards that present a risk of contamination of your food and to determine the control measures needed to prevent, eliminate or reduce to an acceptable level the hazards identified, as required under section 47 of the SFCR.

To develop the HACCP plan for a food, required under section 89(1)(c) of the SFCR, you follow the 12 steps below.

  • Steps 1 to 5 are preliminary steps that enable you to conduct a hazard analysis.
  • Steps 6 to 12 incorporate the 7 principles of HACCP developed by the Codex Alimentarius Commission.

Note

Several foods may share similar hazards, processing steps or equipment. In this case, the foods or processes may be grouped into one HACCP plan.

1. Assemble the HACCP team

Assemble a HACCP team to develop the HACCP plans. The HACCP team:

  • has experienced personnel from different areas of the operation knowledgeable in:
    • food safety hazards common to the food prepared and processes applied
    • regulatory requirements
    • FSEP components
    • HACCP principles
  • is trained and qualified to carry out the work
  • has the necessary resources and time to deliver the HACCP system

2. Describe the product and identify its intended use

Describe the food and its intended use:

  • Name of process/food product type
    • The generic or common name of the product family or process covered by the HACCP plan.
  • Food product name
    • The brand name and/or common name of the individual food covered by the HACCP plan.
  • Important product characteristics
    • The physio-chemical characteristics of the product (such as, pH, aw, salt content, concentration of preservatives) that could affect food safety if not properly controlled.
  • Intended use
    • Based on the expected uses of the product by the end user (for example, ready-to-eat, ready-to-cook, for further processing.)
  • Packaging
    • All types of packaging used for the final food product (for example, drums, pails, cryovac bags, modified atmosphere, hermetically sealed).
    • The size of packaging (for example, consumer-size, bulk packs destined for further processing).
  • Intended shelf life and storage conditions
    • The intended shelf life such as the best before date of the food under normal marketing conditions at a given storage temperature.
    Note

    The document Shelf life studies provides an overview of the process for conducting a shelf life study.

  • Where the product will be sold
    • The points of sale, target groups of users such as retail and restaurants or more specific groups of consumers such as groups more vulnerable to food safety hazards, for example, infants and hospital patients.
  • Labelling instructions relating to food safety
    • Labelling instructions on handling, storage, preparation and usage of the food (such as cooking) which are important to ensure the food is safe to eat.
  • Special distribution control
    • Special controls required during transportation and storage (for example, temperature and humidity).

You may use Form 1. Product description to document this information.

3. List product ingredients and materials that come into contact with the food

List all ingredients used in the food and materials that come into contact with the food or are used in preparing the food such as:

  • composition of formulated ingredients (including second generation ingredients)
  • additives
  • processing aids and incoming materials that come in contact with the product

You may use Form 2. List of product ingredients and incoming material to document this information and indicate whether there are biological (B), chemical (C) or physical (P) hazards associated with them using the letters B, C or P.

4. Construct a process flow diagram

Prepare a flow diagram for each food or process category covered by the HACCP plan.

A flow diagram helps identify the possible occurrence or introduction of and/or increase in food safety hazards.

Your flow diagram shows:

  • the sequence and interaction of all steps in the operation from receiving to final shipping;
  • the introduction of ingredients and intermediate products into the process flow
  • the introduction of product for reworking.

You may use Form 3: Process Flow Diagram to document this information and indicate whether there are biological, chemical or physical hazards associated with each processing step using the letters B, C or P.

The accuracy and completeness of the flow diagrams may be verified on-site.

5. Construct a schematic of the establishment

Prepare a schematic of the establishment for the foods or process categories covered by the HACCP plan. Schematics provide a basis for evaluating potential areas where cross-contamination by pathogens, foreign materials, chemicals or allergens may occur.

The schematic of your establishment shows the:

  • flow of all ingredients and the finished products
  • flow of packaging materials
  • employee traffic patterns throughout the establishment including change rooms, washrooms and lunchrooms
  • flow of wastes, inedible products, chemicals, and other non-food products that could cause a cross-contamination
  • hand/boot washing and sanitizing installations

You may use Form 4. Plant Schematic to document this information and indicate whether there are biological, chemical or physical hazards associated with cross-contamination points using the letters B, C or P.

The accuracy and completeness of the plant schematic may be verified on-site.

6. Identify and analyze hazards (HACCP principle 1)

Conduct a hazard analysis to identify the biological, chemical, and physical hazards that present a risk of contamination of your food, based on:

  • the information gathered in steps 1 to 5
  • employees' knowledge and experience on practical aspects of the establishment operations
  • documented production issues such as files on production rework, returned products, product complaints and recalls
  • external information including reference texts, scientific publications, and government guides such as the CFIA's Reference Database for Hazard Identification

You may use:

  • Form 5: Biological Hazard Identification to list the biological hazards related to ingredients, materials that come into contact with the food, processing steps and points where cross-contamination may
  • Form 6: Chemical Hazard Identification to list the chemical hazards related to ingredients, materials that come into contact with the food, processing steps and points where cross-contamination may
  • Form 7: Physical Hazard Identification to list the physical hazards related to ingredients, materials that come into contact with the food, processing steps and points where cross-contamination may
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.

7. Determination of Critical Control Points (CCPs) (HACCP principle 2)

Identify each step at which control measures may 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 may use Form 8 Decision tree – CCP determination to:

  • list each ingredient, material and process step for which a hazard has been identified and the cross-contamination points identified
  • describe the hazards identified for each ingredient, material, process step, and cross-contamination point
  • identify the control measures applied in the prerequisite programs or process controls that prevent or reduce the hazards to an acceptable level, if applicable
    • Conduct a record review and on-site observations to ensure that the control measures provide effective control over the hazards.
  • determine the likely occurrence of the hazard and the severity of possible adverse health effect associated with the hazards which are not controlled by the prerequisite programs or process controls
  • identify each CCP step, a step at which control measures may be applied and are essential to prevent, eliminate or reduce a hazard to a level that does not compromise food safety
    • It is recommended to number each CCP sequentially and identifying the hazards (B, C or P) controlled by the CCP.

You may use Form 9. Hazards not controlled by the establishment to identify the hhazards that are out of your control and describe how the hazard is controlled before or after the processing steps shall be documented on form 9 or equivalent.

Note

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

8. Critical limits (HACCP Principle 3)

Critical limits are clear and measurable criteria that distinguish between what is acceptable and/or unacceptable for a hazard identified by a CCP. The effectiveness of the control measures applied to prevent, eliminate or reduce to an acceptable level a hazard depends on their ability to keep the hazard within critical limits. One or more critical limits may be applied to control the identified hazards.

Establish critical limits that:

  • are supported by scientific data
  • meet Canadian requirements (for example, concentration of nitrates in dry sausage)

You may use Form 10 Critical control points to document:

  • each CCP and the hazards controlled at each CCP
  • the control measure(s) applied at each CCP to prevent, eliminate or reduce to an acceptable level the hazards
  • critical limits for each CCP
  • monitoring procedure(s)
  • corrective action procedures
  • verification procedure(s)
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.

9. Monitoring procedures (for CCPs) (HACCP principle 4)

Establish monitoring procedures for each CCP, as outlined in the General sections of a prerequisite program and HACCP plan, to ensure the control measures applied are functioning as intended.

  • The monitoring activities and their frequency are able to detect a loss of control at the CCP in time for the food to be segregated and isolated before it leaves your establishment.
  • The monitoring devices/equipment that require maintenance and calibration for accuracy are maintained through the prerequisite program C.1.2 Equipment maintenance and calibration.
Note

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

10. Corrective action procedures (for CCPs) (HACCP principle 5)

Establish corrective action procedures for each CCP, as outlined in the Sections of a prerequisite program and HACCP plan. They specify planned or appropriate corrective actions to be taken when monitoring results demonstrate that:

  • critical limits or not met
  • control measures are not functioning as intended

When there's a deviation at a CCP, as a corrective action you:

  • assess the process controls supporting the CCP
  • control and assess the affected food and record your actions
    • You release the food for sale or distribution only when:
      • there's evidence, other than from the monitoring data, showing that the control measures at the CCP remained effective
      • there's evidence showing that the combined effect of the different control measures, applied at the CCP for that food, were effective in eliminating or reducing the hazards of concern to an acceptable level within the critical limits established
      • sample analysis results and/or other verification activities demonstrate that the hazards of concern were eliminated or reduced to an acceptable level within the critical limits established
    • You reprocess or further process food you determine to be unsafe only when the hazards of concern can be eliminated or reduced to an acceptable level, and there's no risk of contamination to other food.
    • You destroy and/or dispose as waste the food you determine to be unsafe for consumption.
Note

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

11. Verification procedures (for CCPs) (HACCP principle 6)

Establish verification procedures for each CCP, as outlined in the section Elements of a written prerequisite program and HACCP plan.

The frequency of your verification activities provides the evidence you need to show that the CCP(s) remain in control of the hazards.

Note

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

12. Record keeping (for CCPs) (HACCP Principle 7)

Keep records, as outlined in the section Record keeping procedures to demonstrate the effective application of a critical control point.

Note

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

Process controls

You may apply process controls, a series of steps that contribute to the reduction of a hazard(s), prior to the CCP step at which the hazard(s) are controlled. These process controls are linked to the CCP.

You may use Form 11 Process controls to document your process controls and describe the following information:

  • food safety hazard(s) to be controlled at the process control
  • the CCP to which the PC is linked
  • monitoring procedures
  • deviation procedures
  • verification procedures

VI. Validation documentation/Evidence of effectiveness

You validate, prior to implementing your HACCP plan, the effectiveness of the critical limits established for each CCP in controlling the hazard(s) identified. You have evidence showing that all the control measures you apply, to prevent, reduce or eliminate hazards, are effective.

The information used to conduct a validation includes:

  • scientific or technical publications, regulatory guidelines and standards on the critical limits or control measures applied
  • commissioned testing data specific for a piece of equipment (for example, pasteurizer) to demonstrate that the equipment is capable of meeting the selected critical limit
  • records you generate and maintain during the implementation of your FSEP
  • results of your monitoring and verification activities

Note

The document Evidence showing a control measure is effective outlines the general steps involved in obtaining evidence of effectiveness for control measures, as outlined in Codex Alimentarius.

Keep in mind

Under the SFCR, you must have and document evidence showing that all the control measures you apply to eliminate, prevent or reduce a hazard(s) to an acceptable level, are effective.

VII. Maintaining your FSEP

Reassess and update your FSEP when there's a change or situation that could affect the hazard analysis or the effectiveness of your FSEP, such as when:

  • an unforeseen hazard is identified to determine whether it needs to be included in the HACCP plan
  • there is a new regulatory requirement related to food safety
  • you prepare a new food
  • a noncompliant situation is identified during monitoring and verification activities
  • there's a consumer/client complaint
  • there's a food safety recall affecting your food
  • you obtain unsatisfactory laboratory results
  • there's a non-compliance identified during CFIA's regulatory verifications
  • you add a new product line that may cause cross-contamination
  • new ingredients or new materials are used or may come in contact with your food
  • you have a new process step
  • you use new technology or piece of equipment that impacts on the level of a hazard
  • there is construction or a change in the product flow and or employee traffic patterns that may result in cross contamination
  • you implement a new control measure for a hazard
  • you make change to the formulation or preparation of a food
  • there's a change in the production volume which impacts, for example, the product flow, sanitation schedule, employee training
  • there's a change in the application of a CCP (such as a change in critical limits)

Your reassessment activities include a review of the written program, records completed as well as on-site assessments. You review:

  • the changes or situations that occurred that may have triggered an update to your FSEP
  • the measures taken in response to situations indicating a trend toward or a loss of control to ensure the applicable sections of the FSEP were updated
  • the HACCP plans: product descriptions, list of ingredients and incoming materials, process flow diagrams and schematic diagrams
  • the Process control(s) and CCP(s)
  • prerequisite programs
  • the templates for the records used to document monitoring, corrective actions and verification activities results to ensure it is designed to capture all information needed

Your reassessment procedures describe the:

  • individual(s) responsible for the reassessment activities
  • frequency of reassessment activities or "details and specifics" of reassessment activities (for example, you may specify that certain activities be conducted at various times over the course of the year)
  • title of record(s) used to document:
    • results of the reassessment
    • amendments to your FSEP
    • corrective actions taken

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 FSEP program at least annually.

Revisions to your FSEP

You have procedures for amending your FSEP that describe:

  • name/title of personnel responsible for making the changes to your FSEP
  • name/title of personnel responsible for ensuring that the changes are implemented effectively
  • how you identify the revisions to your FSEP such as:
    • using a log book describing the revisions made:
      • Where the amendments were made in your program.
      • When (date) the changes were implemented.
        • You provide the revision date or number that correlates with the document you changed.
      • When the changes were reassessed and validated as implemented effectively.
        • Signed or initialed by a responsible person.

New HACCP plan

When you include a new HACCP plan or a new process to an existing HACCP plan, document:

  • the name of the new process/product
  • the risk category of the new process (high or lower risk category)
Keep in mind

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

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 CFIA is not responsible for the content of documents that are created by other government agencies or international sources.

CFIA references

Other references

VIII. Forms

Form 1: Product description

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Description of Form 1: Product description

Form 1 can be used to provide a description of each process or product type. The name of the process or product is described on the first line. You should describe the following:

  • Product name
  • Important product characteristics
  • Intended use
  • Packaging
  • Intended shelf life and storage conditions
  • Where the product will be sold
  • Labelling instructions relating to food safety
  • Special distribution control.

Form 2: List of ingredients and incoming materials

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Description of Form 2: List of ingredients and incoming materials

Form 2 can be used to list all ingredients, including composition of formulated ingredients (with reference to other documents if needed), additives, processing aids and incoming materials that come in contact with or are used in preparing a food. The name of the process or product is described on the first line.

Form 3: Process flow diagram

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Description of Form 3: Process flow diagram

Form 3 can be used to illustrate the flow of your operation using a diagram. The name of the process or product is described on the first line. Your process flow diagram on line 2 should illustrate:

  • the sequence and interaction of all steps in the operation from receiving to final shipping
  • the introduction of ingredients and intermediate products into the process flow
  • the introduction of products for reworking

Form 4: Plant schematic

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Description of Form 4: Plant schematic

Form 4 can be used to illustrate the plant schematic. The name of the process or product is described on the first line. Your plan schematic should illustrate:

  • the flows of raw products, ingredients and finished products
  • the flows of packaging materials
  • the employee traffic pattern throughout the establishment including change rooms washrooms and lunchrooms
  • the flows of the waste, inedible products and other non-food products that could cause cross-contamination
  • the hand/boot washing and sanitizing installations

Form 5: Biological hazard Identification

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Description of Form 5: Biological hazard Identification

Form 5 can be used to describe the biological hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the biological hazards identified.

Column 2
In column 2 you identify the processing step at which each biological hazard (listed in column 1) is controlled.

Form 6: Chemical hazard identification

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Description of Form 6: Chemical hazard identification

Form 6 can be used to describe the chemical hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points you identify. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the chemical hazards identified.

Column 2
In column 2 you identify the processing step at which each chemical hazard (listed in column 1) is controlled.

Form 7: Physical hazard identification

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Description of Form 7: Physical hazard identification

Form 7 can be used to describe the chemical hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points you identify. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the physical hazards identified.

Column 2
In column 2 you indicate the processing step at which each physical hazard (listed in column 1) is controlled.

Form 8: CCP determination and other control measures

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Description of Form 8: CCP determination and other control measures

Form 8 can be used to determine CCPs and other control measures. The name of the process or product is described on the first line.

Column 1
Under column 1 you list each ingredient and incoming material, process step and cross-contamination point for which a hazard or hazards were identified. Use one line per hazard.

Column 2
In column 2 you identify the category of each hazard identified (biological, chemical or physical) and fully describe each hazard. Where multiple hazards exist, each one is subject to the questions that follow.

You determine if each hazard is controlled by one or more prerequisite program. If the answer is "yes", for each hazard you identify the prerequisite program and the control measures applied in that program that controls the hazard.

If the HACCP team determines that the hazard is not fully controlled by a prerequisite program, proceed to Question 1.

Question 1
For each hazard you ask the questions:

  • Could you apply a control measure at a process step?
  • Could a control measure be applied at this step, or at any other process step, to control the hazard? Do you have or could you add a process step to control the hazard?
    • If the answer is "yes", describe the control measure and proceed to Question 2.
    • If the answer is "no" (a control measure cannot be implemented at a process step), identify how the hazard will be controlled before or after the manufacturing process (see form 9) and proceed to the next identified hazard.

Question 2
For each hazard you ask the questions:

  • Can the hazard increase to an unacceptable level and present a risk of contamination to the food?

If information gathered suggests that the hazard could increase to an unacceptable level and present a risk of contamination to the food, the answer is "yes". Proceed to Question 3.

If the hazard is not likely to increase to an unacceptable level, or does not pose a risk of contamination to the food, the answer is "no". Proceed to the next hazard.

Question 3
For each process step you ask the following question:

  • Is the process step specifically designed to prevent, eliminate or reduce to an acceptable level the hazard?
    • If yes then the answer is "yes" and you designate this process step as a critical control point and indicate this in the last column.
    • If the answer is no, proceed to Question 4.
Note

Question 3 applies only to processing steps. For incoming materials, write "not applicable"and proceed to Question 4.

Question 4
You ask the following question:

  • Will a subsequent step eliminate the identified hazard or reduce it to an acceptable level?
    • If the answer is "no, " designate this process step a critical control point and identify it in the last column. Proceed to the next identified hazard.

If the answer is "yes", identify the subsequent step or steps that control the hazard. Then proceed to Question 5.

Question 5
You ask the following question:

  • Does this step provide partial control of the identified hazard?
    • If the answer is "yes", this process step is a process control. Enter the process control number in the last column then proceed to the next identified hazard.
    • If the answer is "no", proceed to the next identified hazard.

Form 9: Hazards not controlled by the establishment

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Description of Form 9: Hazards not controlled by the establishment

Form 9 can be used to list hazards that cannot be controlled by the establishment for each process or product. Identify the name of the process or product on the first line.

Column 1
In column 1 you list all the hazards that you can`t control.

Column 2
In column 2 you describe how the hazard can be controlled before or after the production process.

Form 10: Critical control points

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Description of Form 10: Critical control points

Form 10 can be used to document each critical control point. Identify the name of the process or product on the first line.

Column 1
In column 1 you indicate the critical control point number

Column 2
In column 2 you indicate the hazard(s) controlled at the critical control point and describe the control measure(s) applied

Column 3
In column 3 you indicate the critical limit(s).

Column 4
In column 4 you describe the monitoring procedures.

Column 5
In column 5 you indicate the corrective measures.

Column 6
In column 6 you describe the verification procedures.

Column 7
In column 7 you identify the HACCP records.

Form 11: Process controls

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Description of Form 11: Process controls

Form 11 can be used to document your process controls. Identify the name of the process or product on the first line.

Column 1
In column 1 you identify the process control number and the number of the critical control point associated to that process control.

Column 2
In column 2 you describe the hazard(s) controlled at the process control.

Column 3
In column 3 you indicate the standards that need to be met for the hazard (s).

Column 4
In column 4 you describe the monitoring procedures.

Column 5
In column 5 you describe the corrective measures.

Column 6
In column 6 you describe the verification procedures.

Column 7
In column 7 you identify the HACCP records.

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