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When you undergo a Health Canada audit, auditors carefully examine a variety of records to make sure you're following the rules they've set. These documents give them a closer look at how your cannabis operation is running and how well you're sticking to the Cannabis Regulations. Maintaining accurate and up-to-date records across all these areas is crucial to demonstrate your adherence to regulatory compliance.
But here's the twist: Health Canada auditors aren't always on the same page. This can be frustrating for the cannabis industry because different auditors tend to look at things in different ways. This lack of consistency has caused some discussions around fairness and how evaluations should be more uniform. Still, no matter the approach, keeping your records in tip-top shape remains a requirement for all licence-holders and a key part of proving that you're all about playing by Health Canada’s rules.
Need more personalized support? Reach out to our team and we will be happy to help support you through your Health Canada audit!
Definitions of Observations
During a Health Canada audit, auditors review your operations, any issues that they find get presented to you as an “observation”. They categorize their findings into three tiers: minor, major, and critical observations. Each level offers a distinct glimpse into the health of your compliance efforts, from minor deviations to more significant concerns that could influence the fate of your license.
These observations represent deviations from regulatory standards that are considered relatively minor in nature. While they don't immediately jeopardize your license, addressing them is important to ensure that your operations remain consistent with regulatory requirements. A minor observation describes "a situation that is neither critical nor major, but is a deviation or deficiency from the act or its regulations. Minor observations will likely not increase the risk of diversion, prevent the detection of diversion or health risk." (source)
Moving up the scale, major observations indicate more significant deviations that could impact the overall compliance and safety of your operations. These deviations warrant prompt attention and corrective action to rectify the issues and bring your operations back in line with the regulations. A major observation describes "a situation that may result in a risk to public health or public safety, or may involve fraud, or may increase the risk of diversion, prevent the detection of diversion or health risk. " (source)
At the apex of observation severity lies the critical category. "A critical observation represents the most serious deviation or deficiency of the act or its regulations. Critical observations are those that are likely to:
- increase the immediate risk of diversion
- prevent the detection of diversion
- present an imminent health risk
- may also involve the possibility of deliberate fraud, misinterpretation, or falsification of information." (source)
Keep Your Record-Keeping Meticulous
One of the main focal points of a Health Canada audit is a thorough review of your records to ensure you are adhering to Part 11 of the Cannabis Regulations. Part 11 outlines the specific documentation (paperwork) that cannabis-related businesses are required to maintain in order to demonstrate compliance with regulatory standards.
If record-keeping and paperwork isn’t your thing, then this can be a daunting task and can make for a stressful audit experience. If that is the case for you, consider using Canada’s only compliance-centric seed-to-sale platform, CertiCraft. Our system ensures that you capture all the data required by the government, and generates all the records you need for a Health Canada audit in less than a minute. Learn more about it here.
Write Clear SOPs and Stick to Them
Health Canada places significant emphasis on your Standard Operating Procedures (SOPs). Crafting SOPs is only half the battle – adhering to them consistently is equally crucial. During a Health Canada audit, the auditor will likely ask to review some of your SOPs and have you show how you’ve been adhering to them. Make sure that if you update your SOPs, you adhere to the requirements to have previous versions of the same SOPs available for a minimum of 2 years from the moment you updated them!
The Challenge of Subjective Auditors
Navigating a Health Canada audit presents a notable challenge: the absence of an official rubric to objectively evaluate a given facility’s operation. This critical aspect introduces an element of subjectivity, leaving cannabis businesses uncertain about the potential results of an audit. Since there is no official publicized rubric, an aspect of your operation that could net you a major observation from one auditor could receive no observation whatsoever from another.
Emphasis on Progress and Improvement
Health Canada values improvement. If you're handed a list of observations in one audit and address the majority of what’s on there prior to the subsequent one, that's seen as a positive. What resonates with Health Canada is your genuine commitment to addressing their concerns, showcasing an unwavering dedication to continuous enhancement.
The journey through a Health Canada audit demands meticulous record-keeping, unwavering adherence to SOPs, and a steadfast commitment to addressing observations for improvement. With CertiCraft by your side, you can tackle the compliance puzzle with confidence.