Have you paused to consider that quality assurance is actually a moving target rather than a destination? It is culture in a company that requires constant improvement and change, as opposed to the work of a select few to achieve one defined end goal. Quality, therefore, is not a box that must simply be checked but an overarching and driving force propelling organizations forward.
For all those inside the cannabis industry and specifically cannabis testing labs, quality assurance is critical to getting an effective and thriving business in the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. at the University of Colorado in Molecular Biology, and also has worked with multiple cannabis labs, says, “It is not really that frequently that you get a new testing industry born today and people are scrambling to borrow processes from other industries and apply those to the cannabis quality assurance plan.” Those within cannabis testing labs are searching towards established industries like water and food testing labs to work as a quality assurance beacon. Ross elaborates:
The cannabis market is operating in the lack of federal oversight. If you feel regarding it, water, food, and pharmaceutical industries have federal oversight. Rather than that, it depends on states to adopt regulatory practices and enforcement techniques to uphold a level of compliance and data defensibility that these types of regulators have seen in their careers employed in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, you have the need to keep up with the rapidly evolving industry climate as more states and governing bodies are setting requirements and expectations for quality and compliance. It is actually in nobody’s welfare to get behind or be a late adopter to the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets may have detrimental impacts on people and patients. Medical uses of cannabis require specific results in order to ensure the security of patients, many of which are immunocompromised. Beyond harm to people and patients, businesses themselves could be hurt when a cannabis testing lab would present inaccurate or flawed data sets. Ross shared hypothetical types of potential negative impacts:
If, for instance, you fail a product for microbiology based on false-good results this incurs damages for the client because now their product can’t go to market. Additionally, falsely inflated THC results are another huge problem in the market, and can lead to downstream problems with edible dosing or consumer satisfaction.
A quality assurance system can minimize risk and maximize adherences to proper procedure, causing reliable data. Recalls, product issues and lawsuits cost organizations tremendous amounts of money and time, both to control the problem on hand and prevent future incidents. Not to mention, the immeasurable damage performed to the manufacturer & industry when you are viewed as untrustworthy-especially as a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a very important bit of a quality assurance system for any laboratory.”
One common misconception is viewing quality assurance as a cost center instead of a profitability maximizer. A strong quality assurance system is a competitive advantage-especially for people who are not mandated to get compliant to particular standard, like ISO/IEC 17025, but elect to pursue that accreditation realizing it reflects reliability. In several ways, quality assurance can be summarized as “say whatever you do, and do what you say”, with a willingness to allow third-party confirmation of the commitment and practice. “Accreditation gives an unbiased stamp of approval that can help ensure data defensibility in the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately contributes to reliable and trustworthy data sets. Ross shared: It might look like very easy to buy expensive instrumentation, accept samples, and create data. There are plenty of ways to do that, a few of which are incorrect, and therefore accreditation is actually a chance to have professionals evaluate methodology and post-analytical data processing to ensure that it really is scientifically sound. It is an chance of a laboratory to become positive that their processes and reporting procedures are robust and error free.
Remember: this can be a new industry. There aren’t firmly established methods and procedures like other legacy industries. “We are operating in a some time and space where there is not any standard methodology and that makes oversight by a 3rd party even more important,” shares Ross. When a company opts to pursue accreditation they are indicating a willingness to be honest and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is essential for this emerging industry. Using a robust, inclusive quality assurance system in position will ease and quicken their pursuit of accreditation.The strain on an audit day should there be a digitized product is vastly below a system that is printed and physically maintained.
Not all quality assurance systems are the same. There are still some companies wanting to implement systems that lack the modernization required to truly propel them forward towards continuous improvement pxordk scalability. Quality assurance software with widespread use and adaptation across organizations is both scalable and in support of continuous improvements. Binders, rows of filing cabinets and sophisticated excel spreadsheets usually are not a scalable backbone for any quality system.
Beyond the accessibility and traceability that a digital system creates, additionally, it protects. “We can safeguard that data with credentialed logins for key personnel and have information at our fingertips to lessen the regulatory stress on all personnel,” says Ross. The stress with an audit day if you have a digitized method is vastly less than a method that is printed and physically maintained.
For anyone inside the cannabis industry, specifically cannabis testing labs, there is an unequivocal advantage to implementing a process that supports continuous improvement, reliable data sets and the very best running a business practices. Accomplishing this can help sustain and grow the business, and could be pivotal in transforming the production, market and research of cannabis.