Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
Annex C: Basic steps for the inspection of the licence holders' preventive control plans

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Details of basic inspection steps for inspectors

The following outlines the basic inspection steps that may be used by CFIA inspectors. It provides a consistent approach to performing inspections under the integrated Agency Inspection Model. Outcomes and performance criteria against which inspectors verify compliance can be found in Annex B.

Step 1: Prepare for the inspection

  1. Determine preliminary scope of inspection.
    • Once a facility has been identified for inspection, the scope of the inspection may be adjusted in response to:
      1. changes in activity (e.g. operation has begun exporting),
      2. triggers (e.g. recalls, complaints, clinical signs),
      3. company records, previous inspection reports and compliance history (e.g. repeated non-compliance),
      4. any element of the preventive control plan that is a priority (e.g. Element 1: Process and product control), and
      5. other elements that are not covered by a previous inspection.

    With time, the regulated party's entire system should be inspected to verify compliance with all regulatory requirements.

  2. Determine whether the inspection will be announced or unannounced.

    Inspections may be announced or unannounced, at the inspector's discretion. Both approaches will be used.

    • announced inspections provide inspectors with the opportunity to make arrangements with the operator and key personnel for interviews and to obtain a commitment that relevant documentation will be available.
    • unannounced inspections provide the opportunity to view operations as they are performed. This may limit the scope of the inspection if certain personnel are not on site or certain activities are not being conducted.
  3. Review the applicable Acts and regulations, other reference documents and other applicable sources of information.
  4. Gather inspection documents (e.g. relevant regulations, procedure manuals) and tools, sampling equipment, protective wear, safety equipment and applicable supplies.

Step 2: Conducting the inspection

During the inspection, record all findings, including any discussions. Additional objective information, such as physical samples, photographs and copies of documents may also be gathered.

  1. Opening meeting
    • introduce all CFIA staff present and explain each person's role;
    • outline the scope of the inspection, the process to be used, the estimated amount of time required and the date and time of the closing meeting;
    • identify any staff or resources required to support conducting the inspection and confirm the key contact;
    • update the regulated party on any changes to the inspection process and/or relevant regulations;
    • confirm any changes to the information in the company profile;
    • confirm any changes to the preventive control plan or deviations since the last inspection and modify the scope of the inspection, if necessary;
    • confirm the status of any unresolved CARs,
    • confirm the operation's security and safety requirements (e.g. hygienic measures, people flow restrictions, protective equipment, etc.);
    • indicate that the operation will be advised of any changes to the scope during the inspection; and
    • for inspections longer than one day, advise that an end-of-day meeting may be conducted to notify of any non-compliance(s) that may have been observed.
  2. Initial walk-through inspection

    This part of the inspection serves to identify areas that should be added to the scope of the inspection or targeted for more intensive inspection. It can also confirm the accuracy of the premises profile.

    • Observe the general conditions of the premises (including conditions both outside and inside).
    • Focus efforts on identifying potential sources of contamination, infestation or infection that require further consideration.
    • Conduct the flow of the walk-through in a manner that does not introduce hazards.

    When outside the facility, observe the general cleanliness of the surrounding area and any conditions that could contribute to contamination, infestation or infection.

    Consider:

    • harbourage of pests
    • environmental contaminants
    • uncontrolled access points to preparation areas
    • deterioration in condition of facilities (e.g. buildings, and external structures such as fences) that would permit entry of pests or other potential sources of contamination

    When inside the premises, observe the general cleanliness and any conditions that could contribute to contamination, infestation or infection.

    Consider:

    • conditions of floors, walls, ceilings (e.g. clean, in a good state of repair)
    • employee hygiene, biosecurity and biocontainment practices
    • evidence of pest activity
    • lighting (e.g. protective shields in food or feed handling processing areas, none broken)
    • ventilation (e.g. odours that are not characteristic of the process or commodity, visible condensation)
    • waste management (liquid and solid)

    Document all observations. Make note of any questions to ask personnel that arise during the walk-through or records that should be reviewed to help confirm observations.

  3. Confirm the scope of inspection

    Based on recorded observations from the walk-through, consider whether the scope of the inspection should be adjusted.

  4. Complete the inspection

    Review records

    Review the preventive control plan and records for the elements that fall within the scope of the inspection. The number of records selected reflects long term performance. Focus on records for commodities that will be prepared during the inspection so that employee actions can be observed and on-site interviews conducted.

    Address the following for each element examined:

    • the responsible employee(s)
    • the outcome
    • the control measures
    • the monitoring procedures for each control
    • any corrective actions for deviations
    • the verification activities
    • the required records

    Review monitoring records to determine if:

    • control activities are performed as specified (e.g. equipment calibration, processing times, temperature checks, sanitation checks)
    • the controls are met
    • deviations are identified and appropriate actions are taken

    Review verification records to determine if:

    • monitoring activities are performed as specified
    • the operation's control measures are effective
    • deviations are identified and appropriate actions are taken

    If there are repeated deficiencies, determine if the regulated party has implemented additional measures or made changes to the preventive control plan.

    Any records supporting the preventive control plan can be checked during an inspection (e.g. training records, consumer complaints). Be clear in describing the types of records to which access is required.

    Use judgement to decide whether it is necessary to take samples of the commodity or swabs of the equipment and/or the environment to verify inspection observations and to help determine whether the regulated party is compliant. Send any samples collected to the appropriate laboratory for analysis.

    Observe activities and conduct interviews

    Use judgement to decide what to do first: observe operations or conduct interviews. There is no prescribed order — the objective is to collect the most accurate information possible.

    During observations, confirm that the employees are following the preventive control plan procedures. Interview employees to gather further information to support the observations. Use open-ended questions such as:

    • What are you doing and/or recording?
    • What is the purpose of what you are doing?
    • How does it help to confirm that the control is effective?
    • What do you do when there is a deviation?

    If compliance is achieved with regulatory requirements, go to subsection f. Inspection report. If non-compliance is identified, the level must be assessed.

  5. Assign a level of non-compliance

    Assign a level of non-compliance to each element, based on its potential impact.

    There are three levels of non-compliance:

    • critical: immediate impact on human, animal or plant health or the environment or repeated serious non-compliance
    • serious: potential impact on human, animal or plant health or the environment
    • technical: non-compliance with regulatory requirements that are not related to human, animal or plant health or the environment

    If any serious or critical non-compliance is detected, issue a corrective action request that indicates which regulatory requirement(s) have not been met. Record the technical non-compliance. Though these must be corrected, a corrective action request need not be issued. All non-compliance, including technical, must be corrected by the regulated party.

    Where critical non-compliance with impact on human, animal or plant health, or environment issues are observed, take the following steps:

    • Communicate and discuss the issue with the regulated party's key contact to determine if further action is required.
    • If further action is required, request immediate action to control the affected commodity and correct the issue.
      • Determine if the entire affected commodity is under control.
      • Initiate compliance or enforcement action (e.g. seize and detain product, stop production, initiate recall) if the commodity is not effectively controlled.
  6. Inspection report

    The inspection report includes the inspection findings, corrective action requests issued, technical non-compliance observed and actions taken.

    Documentation of the records reviewed includes the following:

    • information that identifies the specific records assessed
    • date of record

    Documentation of observations and interviews includes the following:

    • name, title and area of responsibility of personnel interviewed and/or observed
    • area of the facility/procedure observed
    • description of any non-compliance observed

    Record all incidents of non-compliance in the final inspection report. The nature of the non-compliance must be described in clear, factual and concise terms.

Step 3: Communicate the inspection results

Hold closing meeting with the regulated party to discuss the outcomes of the inspection, including any incidents of non-compliance and next steps. Share the written inspection report, once complete.

At the closing meeting:

  • discuss overall findings of the inspection, including any trends
  • report any incidents of non-compliance, and issue any corrective action requests
  • provide clarification to any questions or concerns
  • obtain the regulated party's commitment to address any corrective action requests issued, and note the proposed interim measures, if any
  • inform the regulated party of any lab samples submitted for analysis and when the results are expected
  • provide a copy of the inspection report and associated documents if completed, or note when they will be available
  • discuss next steps, including timelines for completing corrective actions
  • advise of any follow-up activities or inspections

Step 4: Conduct a follow-up inspection

A follow-up inspection may be needed to confirm that the corrective action has been completed, is effective, and that any changes to the preventive control plan are properly documented. An extension of the deadline for completing corrective actions may be granted in certain circumstances, including the following:

  • a written request for an extension is submitted, with reasons and the proposed new completion date
  • human, animal, or plant health or the environment is not compromised

When reviewing corrective actions:

  • confirm what actions were taken and why, the appropriateness of the actions, including disposition of the affected commodity
  • review any records that demonstrate the effectiveness of the corrective actions
  • observe the changes, if any
  • review any amendments to the preventive control plan

If the corrective actions have been implemented effectively, close the corrective action request.

If the corrective actions have not been implemented effectively and an extension is not granted, take the appropriate compliance and enforcement action.

a. Continued or repeated non-compliance

The following table shows guidelines for compliance and enforcement action in the case of continued or recurring incidents of non-compliance.
Continued or repeated non-compliance The inspector The regulated party is required to
For a critical non-compliance Initiates enforcement action (e.g. suspension of licence, product seizure and detention) Take immediate action to control the affected commodity, if necessary, and address the non-compliance to prevent recurrence
For a serious non-compliance Elevates to a critical corrective action request Take immediate action to control the affected commodity, if necessary, and address the non-compliance to prevent recurrence
For a technical non-compliance Initiates appropriate enforcement action (e.g. AMPs, product seizure and detention) Correct the non-compliance
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