As someone who works for a lab that is audited, and also performs audits, I feel I can relate to both sides of this equation. On the one side is the lab, who often has to decipher state regulations that might be purposely vague, or could be impractical for a high-throughput facility. For example, Pennsylvania requires a lab to store samples for stability testing at 6-month intervals for a 1-year period. One can understand how this, taken at face value, could lead to egregious extra testing, storage, and security needs.
A state’s regulatory code may sluggishly change with each winter blue moon, so if something impractical, from a scientific perspective, happens to find its way into the law, those seeking to be compliant, law-abiding laboratories may have to skirt around what they’d normally do to provide the most accurate, defensible data.
On the flip side are the representatives of each state tasked with managing the burgeoning industry surrounding, what may seem to them to be, the Devil’s Lettuce. Some states, like Colorado, have their Department of Revenue regulating their respective cannabis industry. Nevada’s industry is regulated by the Department of Taxation. The Department of Health oversees Pennsylvania’s nascent medical cannabis industry. This is a new task for workers at these state governmental bodies. They’ve been expected to cobble together ideas, opinions, scientific research and fact, and other standardized, or at least well-characterized, methods from other industries, or other states already brazen enough to enact legalized cannabis.
So, it’s easy to see why there might be tension. In the middle of all of this are the auditors – mortals asked to help enforce regulatory code, serve as liaisons between a lab and their regulatory body, and ultimately, and most importantly, to help labs enhance their science, documentation, and overall best practices.
An auditing body is not a collection of henchmen/henchwomen. Like the laboratory staff, and the regulators, they’ve been given a job to do. In Washington, for example, there is a checklist that auditors use to ensure compliance. It is essentially the rubric to which a lab is evaluated and graded. And, as is evident by the hyperlink, this test is freely available for anyone to see.
This checklist provides everything that the auditors will look at and for. A savvy lab will likely consult the checklist prior to their audit, perhaps even up to the eve before the auditors’ arrival, making sure solvents and standards are dated and logged, or that their standard operating procedures (SOPs) tally all of the required sections and information. Better yet, some labs will use their state’s version of a checklist to perform periodic internal audits.
Likely wanting the auditors out of their hair, such that the lab’s staff can go back to business as usual, many labs will compile all relevant documentation ahead of time, like staff training records and resumes, demonstration of competency data, proficiency tests (PTs), SOPs, or method validation data. If you take a peek at the checklist hyperlinked above, you’ll notice under line item #32, that the labs in Washington must provide method validation for all sample matrices that they test, such as flower, oils, or edibles.
Once the quality assurance and technical staff comb through this documentation, they’ll denote suggestions/recommendations, and deficiencies. What’s apparent, though, through chatting with other auditing agencies in the cannabis industry, is that there are some labs who actually like having auditors onsite, knowing full well that these people are not demons hell-bent on shutting a business down. Any laboratory worth sending your samples to will take pride in their work, and will strive to be compliant to a state’s requirements, no matter how chafing they may find some of the criteria, such that the lab management, their staff, and their clients can rest assured that all is well.
Occasionally, you’ll read stories regarding lab shut downs, and how that lab’s staff was out of work. The reality, is, however, a little less dramatic. After all, the end game is safe, ethical products for those who have found relief in cannabis. Those labs in the minority that don’t comply often have failed to see the utility in the assessments, have not been prepared, or have just lacked the scientific acumen to get the job done.
