Have you paused to think about that quality assurance is 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 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 anyone within the cannabis industry and specifically cannabis testing labs, quality assurance is crucial to getting an effective and thriving business in the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. on the University of Colorado in Molecular Biology, and has worked with multiple cannabis labs, says, “It is not that usually that you get a new testing industry born these days and folks 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 serve as a quality assurance beacon. Ross elaborates:
The cannabis market is operating in the absence of federal oversight. If you feel about 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 witnessed inside their careers working 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 more and more states and governing bodies are setting requirements and expectations for quality and compliance. It really is in nobody’s best interest to get behind or perhaps be a late adopter towards the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets can have detrimental impacts on people and patients. Medical applications of cannabis require specific results to make sure the security of patients, many of which are immunocompromised. Beyond harm 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 samples of potential negative impacts:
If, for instance, you fail a product for microbiology according to false-good results it incurs damages to the client because now their product can’t go to market. Additionally, falsely inflated THC results are also a huge problem in the market, and may result in downstream problems with edible dosing or consumer satisfaction.
A top 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 manage the situation available and stop future incidents. Not to mention, the immeasurable damage completed to the company & industry because they are viewed as untrustworthy-especially as being a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a really important piece of an excellent assurance system for any laboratory.”
One common misconception is viewing quality assurance as a cost center as opposed to a profitability maximizer. A strong quality assurance method is a competitive advantage-especially if you are not mandated to become compliant to a particular standard, like ISO/IEC 17025, but decide to pursue that accreditation realizing it reflects reliability. In lots of ways, quality assurance could be summarized as “say whatever you do, and do what you say”, having a willingness to allow third-party confirmation of your own commitment and exercise. “Accreditation gives an unbiased stamp of approval that can help ensure data defensibility in the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately leads to reliable and trustworthy data sets. Ross shared: It could appear to be simple to buy expensive instrumentation, accept samples, and provide data. There are numerous ways to achieve that, many of which are incorrect, and therefore accreditation is absolutely an opportunity to have professionals evaluate methodology and post-analytical data processing to ensure it is scientifically sound. It is really an chance for a laboratory to get positive that their processes and reporting procedures are robust and error free.
Remember: this is a new industry. There aren’t firmly established methods and operations like other legacy industries. “We are operating in a some time and space where there is absolutely no standard methodology which makes oversight by a 3rd party even more important,” shares Ross. Each time a company opts to pursue accreditation they are indicating a willingness to tell the truth and transparent making use of their business processes, procedures, outcomes and data. Accreditation, therefore, is important for this particular emerging industry. Having a robust, inclusive quality assurance system set up will ease and quicken their quest for accreditation.The strain with an audit day when there is a digitized system is vastly lower than a process which is printed and physically maintained.
Its not all quality assurance systems are the same. You may still find some companies seeking to implement systems that do not have 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 are certainly not a scalable backbone to get a quality system.
Beyond the accessibility and traceability that the digital system creates, it also protects. “We can safeguard that data with credentialed logins for key personnel and also have information at our fingertips to minimize the regulatory stress on all personnel,” says Ross. The stress on an audit day if you have a digitized product is vastly below a process that is certainly printed and physically maintained.
For all those within the cannabis industry, specifically cannabis testing labs, there is an unequivocal benefit to implementing a method that supports continuous improvement, reliable data sets and the very best in operation practices. Doing so will help sustain and grow the market, and may be pivotal in transforming the production, market and research of cannabis.