Improved Food Inspection Model
Final Model
Annex C: Basic inspection steps
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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 improved food inspection model.
Step 1: Prepare for the inspection
a. Determine preliminary scope of inspection.
Once a facility has been identified for inspection, based on the work plan and priorities, the scope of the inspection may be adjusted in response to:
- changes in activity (for example, operation has begun exporting),
- triggers (for example, recalls, complaints),
- compliance history (for example, repeated non-compliance),
- any element of the preventive control plan that is a priority (for example, Element 1: Process and product control), and
- other elements that are not covered by a previous inspection.
Over time, the regulated party's entire system should be inspected to verify compliance with all food safety and other regulatory requirements.
b. 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 discuss and make prior 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 without prior notification. This may limit the scope of the inspection if certain personnel are not on site or certain activities are not being conducted.
c. Review the applicable Acts and regulations and other reference documents.
- Where required, technical advice or guidance may be sought from system assessment officers or the Centres of Expertise.
d. Gather inspection documents 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 evidence, such as physical samples, photographsFootnote 16 and copies of documents may also be gathered.
a. Opening meeting
- introduce all CFIA staff present and explain each person's role;
- outline the scope of the inspection, the process to be used, 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 since the last inspection and modify the scope of the inspection, if needed;
- confirm the operation's security and safety requirements (for example, 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.
b. 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 profile.
- Observe general conditions of the facility (including conditions outside and inside).
- Focus efforts on identifying potential sources of contamination of the food commodity, food contact surfaces or equipment that require further consideration.
When outside the facility observe the general cleanliness of the surrounding area and any conditions that could contribute to food contamination.
Consider:
- harbourage of pests
- environmental contaminants
- uncontrolled access points to preparation areas
- deterioration in condition of buildings that would permit entry of pests or other potential sources of contamination
When inside the facility, begin at the finished product area and progress towards incoming product and ingredients areas. Observe the general cleanliness and any conditions that could contribute to food contamination.
Consider:
- conditions of floors, walls, ceilings (for example, clean, in a good state of repair)
- employee hygiene and work practices
- appropriate temperatures
- evidence of pest activity
- lighting (for example, protective shields in food processing areas, none broken)
- ventilation (for example, odours that are not characteristic of the process or food commodity, visible condensation)
Document all observations. Make note of any questions to ask personnel that arise during the inspection or records that should be reviewed to help confirm observations.
c. Confirm the scope of inspection
Based on recorded observations from the walk-through, consider whether the scope of the inspection should be adjusted.
d. 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 performance over time. Focus on records for food commodities that will be prepared during the inspection so that employee actions can be observed and on-site interviews can be 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 (for example, 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 (for example, 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 food commodity or swabs of the equipment and environment to verify inspection observations and to help determine whether the regulated party is compliant. Send any samples collected to the appropriateCFIA 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 to using these techniques–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 section f. Inspection report. If non-compliance is identified, the level must be assessed.
e. Assign a level of non-compliance
Assign a level of non-compliance to each element, based on its potential impact on food safety.
There are three levels of non-complianceFootnote 17:
- critical: immediate impact on food safety or repeated serious non-compliance
- serious: potential impact on food safety
- technical: non-compliance with regulatory requirements that are not related to food safety
Any other observations that do not have an impact on food safety or regulatory requirements may be noted in the report as "opportunities for improvement".
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 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 food safety issues are observed, take the following steps:
- Communicate and discuss the issue with the key contact to determine if further action is required.
- If further action is required, request immediate action to control affected food commodity and correct the issue.
- Determine if all of the affected food commodity is under control.
- Initiate compliance or enforcement action (for example, seize and detain product, stop production) if the product is not effectively controlled.
f. 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 completed.
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 regulated party's commitment to address any corrective action requests issued, and note his/her proposed interim measures, if any
- inform the regulated party of any lab samples submitted for analysis and of 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 letting the CFIA know when corrective actions will be completed
- 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 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
- food safety is not compromised
When reviewing corrective actions:
- confirm what actions were taken and why, the appropriateness of the actions, including disposition of the affected food 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
Continued or repeated non-compliance | The inspector | The regulated party is required to |
---|---|---|
For a critical non-compliance | Initiates enforcement action (for example, suspension of licence) | Take immediate action to address the non-compliance, and control the affected food commodity, if necessary |
For a serious non-compliance | Elevates to a critical corrective action request | Control the affected food commodity immediately and address the non-compliance to prevent recurrence |
For a technical non-compliance | Initiates corrective action and appropriate enforcement (for example, AMPs, product seizure and detention) | Correct the affected food commodity |
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