Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
Annex B: Elements of the preventive control plan

Each element of a preventive control plan has associated outcomes and performance criteria. A regulated party would address the criteria to support achieving the outcome.

Following the performance criteria listed below for each element are related lists of inspection activities that inspectors could use to assess compliance.

Element 1: Process and product control outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the process and product control outcomes.

1.1 Process control outcome: performance criteria

1. Incoming inputs (for example, ingredients, raw materials, plants and animals)
   • identification of incoming inputs and their source (for example, the immediate supplier)
   • identification of incoming inputs, with written specifications, if
     • there is a potential hazard
     • an input is critical to biosecurity, product composition, health status and/or nutrition profile
   • documented handling procedures for inputs to prevent hazard introduction, and contamination and maintain integrity
2. Product formulation and specifications
   • written formula for each product that is being prepared
   • written specifications for each final product
   • additives and chemicals (including medicating ingredients, drugs and vaccines) used are permitted in and on the commodity
3. Processing
   • written description of
     • processing steps (for example, mixing records), associated control measures and critical limits
     • commodity movement (for example, process flow diagram)
     • commodity changeover procedures
4. critical limits are validated using scientific data

1.2 Product control outcome: performance criteria

1. Packaging
   • There is a written specification for packaging materials that come in contact with commodities.
   • All packaging materials are suitable for the intended use.
2. Product identification
   • The information is complete, truthful and not misleading. It also accurately represents the commodity and its content, and meets regulatory requirements.
3. Finished Product
   • The finished product is evaluated for compliance with regulatory requirements.
   • Outgoing commodities and their destination are identified, including those destined for export (for example, the immediate purchaser is identified).

The additional performance criteria below would also have to be addressed by the regulated party to achieve the control outcomes for import and export.

1.3 Import control outcome: performance criteria

• Imported commodities meet Canadian regulatory requirements e.g. phytosanitary certificates, zoosanitary certificates.
• Control measures and sourcing are done to ensure that commodities meet Canadian requirements. Possible strategies include
  • selecting suppliers whose exports are certified by a foreign country competent authority,
  • selecting suppliers who are identified on a list of eligible exporters by a foreign country competent authority,
  • selecting suppliers who are subject to third-party audits by internationally-recognized accreditation or certification,
  • auditing to confirm suppliers can meet Canadian requirements,
  • selecting suppliers who conduct regular sampling and testing and provide certificates of analysis, or
  • using accredited or recognized sampling and testing laboratories to do testing at the time of importation.

1.4 Export control outcome: performance criteria

• Documentation that the exported commodity meets foreign country import requirements.
• Verification that the export requirements are being met, which includes records of rejected shipments to foreign countries including reasons for rejection.
  • When export certificates are issued by the CFIA, the regulated party would notify the CFIA when a shipment is rejected because of evidence of a human, animal or plant health concern in the importing country.
• Control and segregation of commodities destined for export that do not meet Canadian requirements and are not permitted to enter the Canadian marketplace.

Element 1: Inspection activities for process and product controls

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 1.1: Process controls

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.

1. Incoming inputs (for example, ingredients, raw materials, plants and animals)
   • Verify that traceability records are accurate and maintained.
   • Review records to determine if there is potential for any incoming inputs to contain hazards. Adjust the scope of the inspection, if necessary.
   • Check whether inputs that could contain hazards are properly identified and segregated.
   • Observe how inputs are received to verify that there is no cross-contamination and integrity is maintained.
2. Product formulation and specification
   • Review the types of products prepared and adjust the scope of the inspection to incorporate higher-risk processes.
   • Confirm that the current formula is available and documented for each product.
     • Assess any changes to product composition for any impact on product identification accuracy and safety.
   • Confirm that additives, drugs, chemicals and medicated ingredients are permitted for use in and on the commodity.
3. Processing
   • Select a product that is being processed at the time of inspection, and follow it through the processing steps to confirm that
     • the product formulation matches the recipe (written specifications) and note any product substitutions and appropriate adjustments to processing or product identification.
     • inputs are accurately measured and blended, and
     • processing controls are monitored and critical limits/tolerances are met.
   • Review process validation records to confirm that processes and parameters are current.
   • Observe product and process flow for potential cross-contamination.
   • Observe that procedures are being followed for the use of rework and product changeover and that there is no cross-contamination.

Inspection activities for sub-element 1.2: Product controls

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.

1. Packaging
   • Confirm packaging material meets the regulatory requirements.
   • Observe the packaging process to verify that contaminated, damaged or defective packaging material is not used, and that the commodity is not damaged or contaminated, nor is there a potential to contaminate other commodities or the environment.
2. Product identification
   • Select a commodity or commodities to verify that product identification accurately represents content and meets regulatory requirements. For example:
     • foods commodities containing priority allergens are labelled;
     • nutrition labelling requirements are met;
     • all nutrition claims are factual, not false and not misleading; and
     • any other product identification requirements are met, including mandatory information (such as heat treatment of wood, type size, bilingual requirements, net quantity declarations, ingredient declarations, health or product claims).
3. Finished product
   • Review sampling and testing results to see if any deviations are noted and, if so, review their associated corrective actions.
     • take samples of final product, if necessary/required, to confirm compliance with regulatory requirements.
   • Verify that traceability records are accurate and maintained.

Inspection activities for sub-element 1.3: Import controls

• Review imported product records to determine
  • what commodities were imported and from where, including in-transit information for animal and plant health.
  • the results of control measures and sourcing to verify compliance with Canadian requirements (for example, certificates of analysis, audit results, competent authority certification).
  • the results of quarantine facility observation and evaluation.
  • if any commodities were rejected and, if so, what was the issue and what corrective action was taken.

Inspection activities for sub-element 1.4: Export controls

• Review exported commodity shipment records to determine
  • to what countries shipments were conveyed.
  • the results of quarantine facility observation and evaluation.
• If any shipments were rejected and, if so, what was the issue and what corrective action was taken.

Element 2: Sanitation, biosecurity, biocontainment, pest control and chemicals outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the sanitation, biosecurity, biocontainment, pest control and chemical outcomes.

2.1 Sanitation, biosecurity and biocontainment outcome: performance criteria

• There is a schedule for cleaning and/or sanitizing, which includes the concentration of chemicals to be used, and temperature and pressure requirements (if applicable), for
  • the premises, including preparation and storage areas;
  • equipment; and
  • contact surfaces, including containers and utensils.
• Equipment used for cleaning and/or sanitizing is capable of delivering the requirements of the sanitation program.
• Cleaning and/or sanitizing is carried out in a manner that does not contaminate commodities or spread diseases, pests or pathogens, during or after cleaning and/or sanitizing.
• Effectiveness of cleaning, sanitizing is assessed visually or through sampling (for example, environmental, product, sentinel animals, plants) using accepted methods or procedures, as applicable.
• Contact surfaces are free from contamination (for example, the accumulation of dust, dirt, food residue and other debris).
• Environmental sampling is conducted in accordance with approved procedures (for example, Health Canada 2011 Policy on Listeria monocytogenes in Ready-to-Eat Foods; Plant Health directives and policies; Hatchery Program)

2.2 Pest control outcome: performance criteria

• There is a program for control and removal of pests, including vectors.
• There is a schedule for monitoring for evidence of pest activity, including vectors.

2.3 Chemicals outcome: performance criteria

• A listing of chemicals or specification sheets for chemicals used in biosecurity, biocontainment, sanitation, treatment, and pest control is maintained.
• The use of chemicals does not contaminate commodities, equipment, utensils or contact surfaces.
• Chemicals are suitable for their intended use.
• Chemicals are properly stored, controlled, and labelled.
• Chemicals are handled, used and applied by trained personnel.

Element 2: Inspection activities for sanitation, biosecurity, biocontainment, pest control and chemicals

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 2.1: Sanitation, biosecurity and biocontainment

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm cleaning and sanitizing is being done according to the procedures and schedule.
  • Review records
    • Review the regulated party's procedures for verifying that cleaning and sanitizing is effective.
    • Review procedures for verifying that cleaning or sanitizing equipment is functioning as intended.
    • Check whether any issues or deviations have been identified and note what actions were taken.
    • Review any results of sampling, if applicable.
  • Observe responsible employees performing the activity
    • Verify that cleaning and sanitizing are not sources of cross- contamination (for example, floor sprays are not contaminating food contact surfaces, foot baths are not contaminating barns), and that there are no other sources of cross-contamination.
    • Confirm temperature, chemical concentrations and pressures are being verified.
• Visually verify that cleaning procedures are effectively removing dirt and debris.
  • Look for evidence of dirt, debris and residual material on direct commodity contact surfaces, including containers and utensils.
• Take samples to determine effectiveness and compliance if necessary to confirm observations.

Inspection activities for sub-element 2.2: Pest control

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Visually verify that there is no evidence of pests—particularly in processing, propagation/growing, storage and handling areas.
• If there is evidence of pests, review records to:
  • Identify if there are any trends, and
  • Confirm what actions have been taken to address the issue, including preventive measures to prevent reoccurrence.

Inspection activities for sub-element 2.3: Chemicals

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm there is a listing of chemicals used (including pesticides, for example rodenticides, nematicides), or specification sheets available.
  • Chemicals used on commodities or contact surfaces must meet the requirements of the Food and Drugs Act or Pest Control Products Act, as applicable.
• Confirm that chemicals are stored separately, clearly identified and dispensed with utensils or equipment that are not used for preparation.
• Confirm that label instructions for any chemicals used are being followed
• Confirm employee or applier is trained to apply the treatment or chemical.

Element 3: Hygiene, biosecurity and employee training outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the hygiene, biosecurity and employee training outcomes.

3.1 Hygiene and biosecurity outcome: performance criteria

• Effective biosecurity practices are in place, including
  • controlled access
  • employee facilities, hand-washing and sanitizing stations
  • use of sanitary clothing and footwear
• Hygienic practices are in place, including
  • proper hand-washing or use of sanitizers/gloves or boot wash
  • rules for employee conduct
  • precautions for personnel with open wounds or a communicable disease

3.2 Employee training outcome: performance criteria

• A written description of training requirements and training records for employees responsible for activities under the preventive control plan are maintained.
• Employees are trained to carry out the range of tasks and duties they are required to perform.
• Effectiveness of training is monitored and verified by the regulated party.

Element 3: Inspection activities for hygiene, biosecurity and employee training

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 3.1: Hygiene and biosecurity

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm that effective biosecurity practices are in place.
• Verify that biosecurity practices are being followed.
  • Movement of employees and access of visitors is controlled.
  • Footbaths and hand dips, if used, are properly maintained.
  • Any required clothing—including gloves, hair coverings, and footwear—is maintained and stored in a sanitary manner.
  • Employee hand-washing facilities are available and clean.
• Observe employee behaviours occurring in commodity preparation or handling areas.
  • Employees are washing hands when required (for example, when returning to the processing area).
  • Personal objects are prevented from contaminating the commodity (for example, falling into the commodity).
  • Unhygienic practices are not occurring or contributing to contamination of the commodity (for example, spitting, use of tobacco, chewing gum and consumption of food).
• Confirm that employees handling commodities do not have open wounds or exhibit signs of a communicable disease.

Inspection activities for sub-element 3.2: Employee training

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Review training records
• Confirm that employees are following procedures when carrying out duties and responsibilities.
• Observe and interview employees to confirm they have the appropriate technical knowledge to carry out their respective duties. For example, they may need an understanding of:
  • potential sources of contamination, infestation or infection
  • proper handling of food, plant, and animal commodities and inputs (for example, temperature control, segregation of animal, plant or food commodities)
  • personal hygiene
  • equipment maintenance and calibration
  • general sanitation and cleanliness
• Confirm that employees receive ongoing training to maintain current specialized knowledge; such as, knowledge of control measures and critical limits/tolerances or regulatory requirements.

Element 4: Equipment design and maintenance outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the equipment design and maintenance outcomes.

• All equipment, utensils, containers, and controlling and measuring devices used in commodity preparation and storage are:
  • used only for the premises' intended purpose,
  • functioning as intended,
  • maintained in a good state of repair,
  • cleanable, and
  • properly stored.
• Controlling or measuring devices used in the preparation of commodities are calibrated and maintained to ensure measurement accuracy and effectiveness.

Element 4: Inspection activities for equipment design and maintenance

• The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.
• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm that equipment is being used as per procedures and review maintenance records, if necessary.
• Confirm that equipment is being calibrated according to schedule.
• Check that equipment, containers and utensils are in good repair (for example, check for rust, peeling paint, leaking lubricants).

Element 5: Physical structure, surroundings and maintenance outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the physical structure, surroundings and maintenance outcomes.

5.1 premises and surroundings outcome: performance criteria

• The surroundings/roadways are maintained to minimize refuse, dirt, dust, fumes and other environmental contaminants and pest harbourage areas.
• Isolation, buffer zones or vehicle disinfection practices are implemented to minimize the risk of contamination, infestation or infection, as applicable.

5.2 Buildings outcome: performance criteria

a. Exterior building structures

• The exterior of the building is maintained to prevent entry of pests and contaminants.

b. Interior building structures

• Floors, walls and ceilings are
  • cleanable
  • made of materials that will not contaminate regulated commodities
  • in good repair
• In preparation areas
  • floors are constructed and maintained to permit adequate drainage
  • glass, where breakage may contaminate commodities, is properly protected

c. Hygienic flow and separation

• Where there is potential for cross-contamination, incompatible operations are controlled by physical separation or other effective means.

d. Lighting

• There is sufficient light to allow the intended activity to be conducted effectively.
• Lighting equipment (bulbs and fixtures) that is located where breakage could contaminate commodities is protected, as needed.

e. Ventilation

• Ventilation provides sufficient air exchange to control moisture and minimize condensation.
• Ventilation systems are designed and constructed to prevent contamination (for example, air flow into clean areas is not contaminated).
• Ventilation systems are adequately maintained and cleaned.

f. Employee facilities

• When present, the location and design of employee facilities such as washrooms, lunch rooms and change rooms do not contribute to or cause contamination of commodities or production areas.
• An adequate means of hygienically washing and drying hands and personal protective equipment (for example, boots) is provided (including wash basins and a supply of safe water).
  • The location of hand-washing and sanitizing stations does not contribute to or cause contamination of commodities.

5.3 Water, ice and steam outcome: performance criteria

a. Water, ice and steam safety

• Water, ice and steam that come in contact with commodities or commodity contact surfaces are safe for intended use (for example, sea water used in rinsing and packing fish products, drinking water for animals).
• There is no cross-contamination between safe and unsafe water supplies.
• Safety of water must be confirmed using recognized methods at a frequency adequate to confirm its safety.
  • Where municipal sources are used, municipal test results may be accepted.

b. Water, ice and steam handling equipment

• Equipment is designed, installed and maintained in a manner that will not jeopardize the safety of water.

5.4 Waste disposal outcome: performance criteria

• Waste storage areas and containers are identified, of suitable capacity, secured and cleaned to avoid attracting pests.
• Waste disposal, including effluent lines, does not contaminate commodities, preparation areas or the environment.
• Drainage and sewage systems are adequate for the volume and type of effluent being produced during normal processing and cleaning operations, and backflow is prevented.

Element 5: Inspection activities for physical structure, surroundings and maintenance

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 5.1: Premises and surroundings

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Visually verify if there are any sources of external contamination (e.g. build-up of garbage, alternate pest hosts)

Inspection activities for sub-element 5.2: Interior and exterior building structures

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.

a and b. Exterior and interior building structures

• Review maintenance records for building interior and exterior, including the air filter replacement records.
• Check that floors, walls and ceilings are made of appropriate materials (for example, non-porous materials in food preparation areas) that will withstand cleaning, and that floors are draining properly.
• Check that glass is properly protected in places where breakage could contaminate commodities.
• Confirm that
  • openings to exterior areas are protected or effective control measures are in place;
  • air intakes and exhausts, as appropriate, are filtered or positioned to prevent the introduction of contaminants;
  • doors are tight-fitting and equipped with self-closing devices, if required; and
  • there are no signs of water leakage.

c. Hygienic flow and separation

• Confirm that incompatible operations are controlled by physical separation or other means (for example, sequencing of commodities to prevent introduction of allergens or cross-contamination).

d. Lighting

• Verify that lighting is adequate to accurately read instruments and record monitoring and verification results.

e. Ventilation

• Verify that there is positive air pressure, where necessary, to prevent contamination.
• Check whether there is condensation that could negatively impact the safety of the commodity (for example, dripping on food or food contact surfaces).
• for livestock barns, verify air quality supports maintenance of herd health.

f. Employee facilities

• Check that washrooms, lunch rooms and change rooms are properly located and maintained (for example, hot water, hand-washing and drying equipment, functional lavatories).

Inspection activities for sub-element 5.3: Water, ice and steam

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm that safe water is being used, such as
  • municipal water, or
  • tested water with available test results.
• If water is treated, confirm that any chemicals used are accepted for that use and that appropriate procedures are followed.

Inspection activities for sub-element 5.4: Waste disposal

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Check that waste disposal does not contaminate commodity preparation areas (for example, leakage and spillage).
• Verify that waste containers are identifiable, secured and cleaned at regular intervals.
• Observe that waste does not accumulate in handling areas.
• Note any odours that are not characteristic of the commodity

Element 6: Receiving, transportation and storage outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the receiving, transportation and storage outcomes.

6.1 Receiving, transportation and storage: performance criteria

• Conveyances used for the transport of commodities
  • are clean and protect the commodity from contamination, damage, pest propagation and deterioration, (including temperature and humidity controls) and
  • are not being used to transport any material or substance that might cross-contaminate or adulterate the commodity.
• Commodity temperature and humidity controls (for example, refrigeration or freezing) are maintained (for example, not left out at ambient temperatures for prolonged periods).
• Conveyances are loaded, arranged and unloaded in a manner that prevents damage and contamination of the inputs and/or finished commodities.
• Storage areas allow the
  • separation of commodities and other materials, including returned commodities;
  • control of temperature and humidity to prevent deterioration and spoilage; and
  • stock to be rotated to maintain suitability, quality and safety.

6.2 Animal transportation: performance criteria

• Conveyances used for the transport of live animals, and animal handling and holding areas, are designed to:
  • provide adequate space and ventilation
  • protect the animals from inclement weather
• Animals are handled, loaded, transported, unloaded and held in a manner that prevents undue stress.
• Animal requirements for rest, food and water are met.

Element 6: Inspection activities for receiving, transportation and storage

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 6.1: Receiving, transportation and storage

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm, by visual observations or reviewing records, that commodities that require environmental control are transported and stored at an appropriate temperature and humidity.
  • Note if any commodities are left out in adverse conditions which would impact safety, health or quality (for example, freezing, thawing or sweating).
• Visually confirm that incompatible commodities are not transported or stored together unless there are appropriate controls (for example, separation)
  • Review records to confirm that conveyances that are used for multiple, incompatible purposes are cleaned between uses.
• Confirm that inputs and packaging materials are managed to minimize and maintain integrity at receiving.
• Review shipping records and visually verify that stock is being rotated.

Inspection activities for sub-element 6.2: Animal transportation

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection steps in Annex C.
• Confirm through visual observation or reviewing records that:
  • animals are transported in natural positions
  • note if any animals are transported under adverse conditions (for example, sweating, frost bite, panting)
  • animals are loaded with appropriate spacing
  • there is a schedule for rest, feeding and water and it is being followed

Element 7: Traceability, recall and complaints outcomes and performance criteria

The following performance criteria would have to be addressed by the regulated party to achieve the traceability, recall and complaints outcomes.

7.1 Traceability and recall outcomes: performance criteria

• The traceability and recall system must be able to:
  • identify sources of inputs (such as ingredients) for the implicated commodity,
  • stop any further distribution and sale,
  • trace commodities (including by-products, if implicated) to the next point of distribution,
  • contact customers and the CFIA,
  • retrieve the implicated commodity,
  • maintain accurate traceability records in accordance with applicable standards.

7.2 Complaints outcome: performance criteria

• Complaints are documented and investigated by the regulated party to determine if there is non-compliance with regulatory requirements.
• Corrective action is taken for non-compliance, to address
  • the implicated commodity, and
  • any changes required to processes or procedures to prevent recurrence.

Element 7: Inspection activities for traceability, recall and complaints

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-elements 7.1: Traceability and recall

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step in Annex C.
• Review records to identify any previous recalls and confirm that commodity was effectively recalled (quantity distributed and returned) and disposed of or handled as per procedures.
• Determine if the cause of the recall was identified and if this information was used to make adjustments to prevent recurrence.
• Review test results if the recall and/or traceability system has been periodically tested.
• If appropriate, request a mock recall or simulation (for example, disease outbreak).

Inspection activities for sub-element 7.2: Complaints

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step in Annex C.
• Review complaint records to determine if there are any trends that may require further investigation or if the scope of the inspection should be adjusted.
• Where complaints are substantiated, confirm that the root cause was determined and whether this information was used to prevent recurrence.
• Verify that the corrective action taken has addressed the issue.

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