Importance of Standard Operating Procedures for Cannabis companies

Medical and recreational cannabis is an exciting sector that continues making the headlines as Canada and several American states legalized medical and recreation marijuana. Unfortunately, not all the headlines were positive as some of the companies in the sector struggled with compliance, mold, equipment and other operations issues. Some of these growing pains are likely attributed to lack of standard process documentation, which results in result variance when executing these processes.

Standard operating procedures (SOP) are written, step-by-step instructions that describe how to perform a routine activity, often according to a defined standard or regulation. SOPs exist so that employees perform task the exact same way every time so that the business can meet compliance and quality requirements. SOPs play a critical role for maintaining safety and efficiency for departments such as: Production/operations, Sales and customer service, Employee training, Legal, Financial.

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Standard Operating Procedure Format

All SOPs must be documented in exact same format, as the lack of a standard format is likely to lead to result variance. Regulators usually define what content and sections are required in a standard operating procedure, so the first step on creating processes and documenting them as SOPs must be to consult regulatory requirements.

Best practices for creating SOPs include the following:

1. Define a standard naming convention for all SOP filenames and process names
2. Use a version control and version numeration standard
3. Include a change log which provides what sections changed, by whom and when
4. Require review, approval and sign-off for all SOP changes. In fact, this activity should be a Standard Operating Procedure
5. Include a description as to purpose of the work, explaining why the process is performed
6. List all participants who are involved in any of the process steps. This includes non-human participants such as equipment and systems
7. Equipment and software version numbers should be specified as part of participant list
8. Describe in detail each step performed in the process, including participant who is performing the process
9. Be specific and unambiguous, especially about measurable results, thresholds, amounts and etc
10. Adopt a visual standard for process diagrams
11. Include a process diagram which visualizes the process steps
12. Attach a glossary of terms required for the reader to follow the steps of an outline
13. Include a list of related SOPs whenever there a pre-conditions, dependencies or relationships associated with another SOP

Once an SOP has been written, it's important to validate the content of the SOP by monitoring the process that was captured and ensuring that results are consistent over several executions of the process. It's a safe practice to only approve SOPs that have been measured and have delivered consistent results over several executions.

Remember that safety, consistent product quality and compliance are key in the cannabis industry, and frequent self-auditing of your operations and SOPs is a sure way to ensure your business' longevity. Check out this case study to find out how our expertise with Standard Operating Procedures ensured PHARMYA's compliance with operations and process management standards set by the European Medicines Agency.

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QDC is a Toronto-based consultancy focusing on helping businesses achieve process excellence. Check out this case study to find out how our Business Process Management certified consultants helped a European drug safety company audit their SOPs and achieve compliance with regulatory requirements.