Risk classification guide for controlled substances observations (CSP-GUI-017): Assignment of the risk
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Assignment of the risk to an observation
Important: Observations are defined as a deviation or deficiency (non-compliance) to the requirements of the regulations noted by an inspector during the inspection that is documented in writing in the inspection report.
Inspectors make observations when they find instances where you, as a controlled substances licensed dealer, are not meeting your regulatory requirements. Observations are classified as minor, major or critical according to the potential risk of diversion, and ultimately the risk to public health and safety of Canadians:
Critical observation
An observation of activities or procedures that identifies a significant and immediate risk to public health and safety, including the risk of diversion, that:
- prevents the detection of diversion or,
- involves fraud, misrepresentation, or falsification of information
The risk of diversion is immediate and high.
Major observation
An observation of activities or procedures that may increase the potential risk to public health and safety, including the risk of diversion, that:
- impairs the detection of diversion or,
- limits you from taking actions to address the potential risk of diversion
The risk of diversion is moderate.
Minor observation
An observation of activities or procedures that could increase the potential risk of diversion, but you are able to prevent, detect, and take actions to address the potential risks.
The risk of diversion is low.
Important: Some observations may be upgraded to a greater risk rating depending on the scope, frequency, and severity of the situation.
The inspectors share their findings with you during an inspection. In some instances, you may be able to correct some of the observations during the inspection; however, all observations will still be noted in the inspection report. Depending on the risk rating of the observation, you may be required to immediately identify and implement corrective actions. You must take corrective and preventative actions to address all the observations. In many cases, the corrective actions will be taken after the inspection.
Important: Repeat observations that are made in a subsequent inspection may be assigned a higher risk rating.
Refer to sample observations below for a list of observations that Health Canada considers critical, major, or minor. Please note that this list is not exhaustive, and other observations may be added where appropriate.