Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
5.0 Overview of inspection
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The purpose of the inspection process is to assess whether a regulated party meets regulatory requirements and permission conditions, with or without a PCP. Inspection activities related to a PCP will be organized according to the seven elements of the preventive control plan.
Inspectors will use a combination of traditional inspection (where the focus is on the end-product and processing environment) and audit techniques (such as record review, interviews, and observation) for assessing compliance and evaluating the impact of non-compliance.
5.1 Inspection planning and priorities
Inspection activities will be based on risk, compliance data, and capacity and could consider:
- inspection and surveillance data
- environmental scanning
- recalls and investigations
There are a number of situations that could cause the CFIA to initiate an inspection. These include but are not limited to:
- complaints or pest/disease or contamination events, or illness investigations
- results of an inspection process or sampling
- information about a potential issue received from:
- a third party
- another government department
- an international trading partner
- a request for inspection by the regulated party (for export or marketing purposes)
5.2 Inspection procedures
Inspection procedures provide a systematic way to approach inspections. Inspection activities can include making visual observations, evaluating records, interviewing personnel, sampling and testing.
The procedures will provide inspectors with the flexibility to adapt to different situations that may arise during an inspection; the inspector will be able to assess the potential impact of non-compliance to determine whether further actions are required and what those actions will be.
There are four basic steps to Inspection:
Step 1: Preparing for an inspection
Preparation for an inspection will include determining a preliminary scope. Scope can be based on the CFIA plan but may be adjusted for a variety of reasons (e.g. changes in activity, compliance history). Preparation will also include determining whether an inspection will be announced or unannounced, reviewing the applicable Acts, regulations and other reference materials and gathering all tools, equipment and supplies needed.
Step 2: Conducting an inspection
During an inspection, all findings would be recorded, including any discussions. Additional objective information, such as physical samples, photographs, and copies of documents or records will also be collected. The process of conducting inspections will include the following activities:
- Opening meeting: An opening meeting will introduce CFIA staff and outline the scope of the inspection. It will provide the regulated party with the opportunity to confirm any changes to the company profile and preventive control plan (since last inspection). It will also provide the CFIA with an opportunity to update the regulated party on any changes to the inspection process and/or relevant regulations.
- Initial walk-through inspection: This part of the inspection will serve to identify areas that should also be added to the scope of the inspection or targeted for more intensive inspection.
- Confirmation of scope: Based on recorded observations from the initial walk-through inspection, the scope will be confirmed or amended accordingly.
- Completion of inspection: Conducting an inspection will include using traditional inspection and audit techniques (e.g. visual inspection, record review, interviews, sampling, etc.)
- Assigning a level of non-compliance: There are three levels of non-compliance that can be used:
- 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
The table below demonstrates the difference between critical and serious non-compliance through the use of examples. It is not intended to be an exhaustive list. Type of non-compliance Examples Critical
- records show that a commodity has been processed outside of critical limits (time, temperature or pressure deviations) with no corrective action taken
- inspector observes cleaning, sanitizing, disinfection operations that generate spray resulting in direct contact with the commodity
- seed treated with a pest control product is not labelled with the appropriate warning statement
- premise exports product that does not meet requirements
- records show that medications have been added to a feed but it is not indicated on the product identification
- premises is found to be infected with tuberculosis, a regulated animal disease
- movement of a regulated commodity out of a regulated area without permission
- condensation is dripping onto food contact surfaces, but no processing or preparation is taking place
- dead animal is moved without appropriate permit
- records show that not all measuring instruments are calibrated
- export of greenhouse plants in used containers
- lack of segregation of treated forest products from untreated
- Failure to notify of a suspected pest
If serious or critical non-compliance is detected, a corrective action request will be issued, indicating which regulatory requirements have not been met. When a regulated plant pest or animal disease is identified, an appropriate notice/order may be issued as per the regulations. Technical non-compliances will be recorded in the inspection report and must be corrected by the regulated party, but a corrective action request does not need to be issued. Technical non-compliances can be enforced by CFIA through graduated enforcement actions, up to and including prosecution.
- Completion of inspection report: The report will include the inspection findings, corrective action requests issued, technical non-compliance observed and actions taken.
Step 3: Communicating the inspection results
A closing meeting will be held with the regulated party to discuss the outcomes of the inspection, including any incidents of non-compliance, corrective action requests issued and next steps. The inspection report will be shared once complete.
Step 4: Conducting a follow-up inspection:
A follow-up inspection will be conducted to confirm that any corrective action has been completed and is effective, and that any change in the preventive control plan is documented.
For additional information on the basic inspection steps see Annex C.
For details on inspection activities in relation to the elements of the preventive control plan, see Annex B.
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