Have you paused to consider that quality assurance is actually a moving target rather than a destination? It is culture in a company that will require 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 anyone within the cannabis industry and specifically cannabis testing labs, quality assurance is crucial to owning 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 also has worked with multiple cannabis labs, says, “It is not that often that you receive a new testing industry born today and folks are scrambling to borrow processes using their company industries and apply these to the cannabis quality assurance plan.” Those within cannabis testing labs are looking towards established industries like water and food testing labs to serve as a quality assurance beacon. Ross elaborates:
The cannabis industry is operating in the absence of federal oversight. If you feel about this, the 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 degree of compliance and data defensibility that these sorts 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 take care of the rapidly evolving industry climate as more and more states and governing bodies are setting requirements and expectations for quality and compliance. It is actually in nobody’s interest to fall behind or be a late adopter for the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets may have detrimental impacts on people and patients. Medical applications of cannabis require specific results to guarantee the security of patients, many of which are immunocompromised. Beyond injury to people and patients, businesses themselves can be hurt when a cannabis testing lab were to present inaccurate or flawed data sets. Ross shared hypothetical types of potential negative impacts:
If, for example, you fail an item for microbiology based upon false-great results it incurs damages for the client because now their product can’t go to market. Additionally, falsely inflated THC outcomes are additionally a huge problem in the industry, and may result in downstream difficulties with edible dosing or consumer satisfaction.
A quality assurance system can minimize risk and maximize adherences to proper procedure, resulting in reliable data. Recalls, product issues and lawsuits cost organizations tremendous quantities of time and money, both to manage the problem available and prevent 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 very important bit of a top quality assurance system for a laboratory.”
One common misconception is viewing quality assurance as being a cost center as opposed to a profitability maximizer. A strong quality assurance product is a competitive advantage-especially for those who are not yet mandated to become compliant to a particular standard, like ISO/IEC 17025, but decide to pursue that accreditation knowing it reflects reliability. In lots of ways, quality assurance can be summarized as “say whatever you do, and do everything you say”, having a willingness to permit third-party confirmation of your own commitment and exercise. “Accreditation gives a neutral stamp of approval that can help ensure data defensibility within the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately leads to reliable and trustworthy data sets. Ross shared: It might seem to be simple to buy expensive instrumentation, accept samples, and provide data. There are plenty of ways to do that, some of which are incorrect, and thus accreditation is really the opportunity to have professionals evaluate methodology and post-analytical data processing to ensure that it is actually scientifically sound. It is an chance for a laboratory to become certain that their processes and reporting procedures are robust and error free.
Remember: it is a new industry. There aren’t firmly established methods and operations like other legacy industries. “We are operating in a time and space where there is no standard methodology which makes oversight by a 3rd party much more important,” shares Ross. When a company opts to pursue accreditation these are indicating a willingness in all honesty and transparent using their business processes, procedures, outcomes and data. Accreditation, therefore, is necessary with this emerging industry. Having a robust, inclusive quality assurance system in position will ease and quicken their quest for accreditation.The anxiety upon an audit day when there is a digitized system is vastly below a method that is certainly printed and physically maintained.
Its not all quality assurance systems are created equal. There are still some companies wanting to implement systems that lack the modernization essential 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 sophisticated excel spreadsheets usually are not a scalable backbone to get a quality system.
Beyond the accessibility and traceability that the digital system creates, additionally, it protects. “We can safeguard that data with credentialed logins for key personnel and possess information at our fingertips to lessen the regulatory stress on all personnel,” says Ross. The strain upon an audit day when there is a digitized product is vastly lower than a system that is printed and physically maintained.
For all those in the cannabis industry, specifically cannabis testing labs, it comes with an unequivocal benefit to implementing a system that supports continuous improvement, reliable data sets and the most effective in business practices. Doing so may help sustain and grow the market, and could be pivotal in transforming the development, market and research of cannabis.