What to expect during a cannabis inspection

Who is this for?

This information is for cannabis licence holders of:

micro-cultivation, nursery, and standard cultivation
micro-processing and standard processing
sale for medical purposes

For guidance on the access to cannabis for medical purposes program, refer to the Guidance on personal production of cannabis for medical purposes.

Overview

Health Canada conducts inspections to assess your compliance with the Cannabis Act (the Act) and the Cannabis Regulations(the Regulations). Sections 85 and 86 of the Cannabis Act gives Health Canada inspectors their authorities to conduct inspections.

An inspection may be scheduled or unannounced. It may happen at your licensed site, virtually through video communications, or both.

The inspectors may:

check rooms and equipment used for cannabis production
examine and take copies of records and take pictures or recordings
take samples to help assess your compliance

You are expected to help the inspectors by showing them how your cannabis processes meet the requirements of the Act and the Regulations through:

answering questions from the inspectors
producing requested records
providing access to electronic systems
guiding inspectors around the licensed site

The general steps of an inspection are:

Introductory meeting
Site tour and site verification
Record review
Exit interview
Receiving the inspection report
Responding to the inspection report

These steps may change depending on the circumstances, such as:

the method of conducting the inspection (for example, on-site or video communications)
finding an issue during the inspection that requires a change in focus
pre-determining the need for sampling
other factors that inspectors may come across during their inspection preparation or on-site activities

Introductory meeting

For a scheduled inspection, inspectors will contact the responsible person to:

talk about the details of the inspection
schedule the introductory meeting
ask for documents in advance of the inspection to help with inspection preparation

The introductory meeting will confirm administrative details about the inspection. The inspectors will introduce themselves and present their Health Canada designation cards. Inspectors may verify details about:

your cannabis licence
your business model
your cannabis production activities
types of cannabis available at your site
types of cannabis packaged for retail sale that you produce

The inspectors will also address any potential health and safety concerns related to the inspection with you. They will give you information on how they will conduct their inspection. The inspectors may also ask for documents to review before starting the site tour.

Site tour

After the introductory meeting, the inspectors may ask you to guide them around the site. They will ask you to explain and provide specific details on the flow of activities occurring at your site. For example, inspectors may ask about your procedures or records related to good production practices during the site tour.

Site verification

During the site tour, the inspectors will verify that you are meeting the requirements of the Act and the Regulations.

The inspectors may:

visually assess room or equipment sanitation
examine bins, totes, or other storage containers
interview employees related to the activities they are conducting
access any electronic systems or review any records related to cannabis production activities

If the inspectors identify any critical items not meeting the Act or Regulations, they will let you know as soon as they are aware of it. You must take immediate actions to address the identified risks.

The inspectors may also collect samples for examination or testing. This may include:

samples of in-process cannabis, such as bulk fresh, bulk dried, bulk extracts
packaged cannabis for retail sale
substances or products used in your cannabis production

Record review

After the site tour, the inspectors may ask for more documents to complete their assessment of the regulatory requirements. For example, they may ask for standard operating procedures or room sanitation records to assess room sanitation.

The scope of the documents requested will generally align with the inspection plan, as discussed in the introductory meeting. They may also relate to processes observed during the site tour and verification.

During the inspection, the inspectors might encounter information or situations that require changing their inspection plan as discussed in the introductory meeting. Consequently, inspectors may request further documents to make a thorough assessment of your licensed site's compliance.

Exit interview

At the end of an inspection, the inspectors will conduct an exit interview. The inspector will review their findings and verbally communicate their observations to you.

Observations are:

based on information obtained during the inspection
things identified that do not meet the requirements of the Act or Regulations
to be addressed through your corrective and preventive action plan, which you will be asked to develop after receiving the inspection report

You may need to address observations while inspectors are on site if there's an immediate risk. You will also have the opportunity to ask questions about the observations.

The inspectors will then provide you with the next steps. These include:

when you will receive the inspection report
the expected timeframe to complete your corrective and preventive action plan

The inspectors may highlight areas of concern that may lead to observations in the future. The inspectors may also provide guidance documents related to your licensed site's activities or the inspection findings.

Inspection report

Following the exit interview, you will receive an inspection report through the Cannabis Tracking and Licensing System (CTLS). This report will:

link the observations identified during the inspection to the relevant sections of the Cannabis Act or Cannabis Regulations
provide ratings for each observation
provide an overall rating of the inspection

The inspectors will assign each observation a rating of minor, major, or critical. The rating will consider the observation's risk to health and safety, or risks of diversion or fraudulence. Items discussed during the exit interview may or may not remain as observations in the inspection report.

The inspection will also receive an overall rating of Compliant or Non-Compliant. This rating is based on:

the number and severity of inspection observations
your ability to demonstrate compliance during the inspection

For more information on sending responses and supporting documents through the CTLS, refer to the Getting Started Guide for CTLS.

Responding to the inspection report

Once you receive the inspection report through the CTLS, you can review the observations your licensed site received during the inspection. You must provide a corrective action and preventive action (CAPA) plan for each observation.

Note: A CAPA plan is a set of measures or actions to determine the causes of the observation, to correct the observations, and to develop and implement a plan to prevent the observations from reoccurring.

You must ensure that the proposed CAPAs fully address each observation cited in the inspection report. Your plan should also include a proposed date of when the plan will be fully implemented. You should consider how the observation and proposed plan might involve or affect other parts of your operation. For example:

Is there any underlying root cause for the observation?
What other records or practices might be affected if a standard operating procedure (SOP) is lacking information or missing?
Does the observation relate to more than one process?

You will be given 10 business days from receipt of the inspection report to create and send your CAPA plan to the inspectors. In extenuating cases, the inspectors may grant you an extension upon request.

You will send your completed response through the CTLS. You may also send supporting documents that demonstrate how you're addressing the observations. For example, responses can include updated SOPs in response to an observation.

The inspectors will review your CAPA plan and any supporting documents you've sent through the CTLS. Once the review is finished, the inspectors will issue one of the following:

a monitoring report (MR) if your first response is not sufficient or does not adequately address the observations. In this case, you will be requested to submit a new CAPA plan.
a final monitoring report (MRF) if your response includes sufficient detail to ensure that the identified observations will be resolved within your proposed appropriate timeframe. The inspection is then considered closed.

References

For more information about the compliance and enforcement approach and policy for cannabis, please see the following:

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Date modified:: 2023-12-19

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