Have you paused to take into consideration that quality assurance is a moving target instead of a destination? It is culture in a company that requires constant improvement and alter, rather than the work of a select few to reach one defined end goal. Quality, therefore, is not a box that must just be checked but an overarching and driving force propelling organizations forward.
For all those in the cannabis industry and specifically cannabis testing labs, quality assurance is essential to getting an effective and thriving business in the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. in the University of Colorado in Molecular Biology, and has dealt with multiple cannabis labs, says, “It will not be that usually that you will get a whole new testing industry born these days and individuals are scrambling to borrow processes from other industries and apply those to the cannabis quality assurance plan.” Those within cannabis testing labs are seeking towards established industries like water and food testing labs to function as a quality assurance beacon. Ross elaborates:
The cannabis market is operating in the absence of federal oversight. If you believe about this, water, food, and pharmaceutical industries have federal oversight. Rather than that, it is perfectly up to states to adopt regulatory practices and enforcement approaches to uphold a level of compliance and data defensibility that these kinds of regulators have seen in their careers employed in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, there is a need to keep up with the rapidly evolving industry climate as increasing numbers of states and governing bodies are setting requirements and expectations for quality and compliance. It really is in nobody’s best interest to fall behind or be a late adopter to the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets might have detrimental impacts on people and patients. Medical applications of cannabis require specific results to guarantee the protection of patients, many of which are immunocompromised. Beyond damage to people and patients, businesses themselves may be hurt if a cannabis testing lab were to present inaccurate or flawed data sets. Ross shared hypothetical types of potential negative impacts:
If, as an example, you fail an item for microbiology based on false-positive results then it incurs damages for the client because now their product can’t head to market. Additionally, falsely inflated THC effects are also a huge problem in the industry, and can result in 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 quantities of time and expense, both to handle the issue at hand preventing future incidents. In addition to, the immeasurable damage done to the manufacturer & industry when you are thought of 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 part of a quality assurance system to get a laboratory.”
One common misconception is viewing quality assurance as a cost center rather than a profitability maximizer. A robust quality assurance system is a competitive advantage-especially for people who are not mandated to be compliant to a particular standard, like ISO/IEC 17025, but decide to pursue that accreditation knowing it reflects reliability. In many ways, quality assurance could be summarized as “say everything you do, and do everything you say”, having a willingness to allow third-party confirmation of your commitment and rehearse. “Accreditation gives an impartial stamp of approval that can help ensure data defensibility within the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately results in reliable and trustworthy data sets. Ross shared: It may look like 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 for that reason accreditation is really the opportunity to have professionals evaluate methodology and post-analytical data processing to ensure it really is scientifically sound. It is an opportunity for a laboratory to become certain 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 operations like other legacy industries. “We are operating in a time as well as space where there is no standard methodology which makes oversight by a third party much more important,” shares Ross. Whenever a company opts to pursue accreditation they may be indicating a willingness to be honest and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is important for this particular emerging industry. Using a robust, inclusive quality assurance system in place will ease and quicken their pursuit of accreditation.The strain with an audit day should there be a digitized product is vastly less than a method which is printed and physically maintained.
Not every quality assurance systems are created equal. There are still some companies seeking to implement systems that do not have the modernization necessary to truly propel them forward towards continuous improvement pxordk scalability. Quality assurance software with widespread use and adaptation across organizations is both scalable as well as in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are certainly not a scalable backbone for any quality system.
Past the accessibility and traceability which a digital system creates, in addition, 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 should there be a digitized system is vastly lower than a system that is printed and physically maintained.
For all those inside the cannabis industry, specifically cannabis testing labs, it comes with an unequivocal advantage to implementing a process that supports continuous improvement, reliable data sets and the very best in operation practices. Doing so may help sustain and grow the industry, and could be pivotal in transforming the development, market and research of cannabis.