Have you paused to take into consideration that quality assurance is actually a moving target rather than a destination? It is culture within 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 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 crucial to having an excellent and thriving business within 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 will get a whole new testing industry born these days and individuals are scrambling to borrow processes using their company industries and apply these 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 industry 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 is 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 witnessed within their careers working 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 in nobody’s best interest 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 to guarantee the security of patients, many of which are immunocompromised. Beyond harm to people and patients, businesses themselves could 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 example, you fail an item for microbiology according to false-positive results then it incurs damages for the client because now their product can’t visit market. Additionally, falsely inflated THC effects are also a huge problem in the industry, and can lead to 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 levels of money and time, both to manage the problem at hand and stop future incidents. Not forgetting, the immeasurable damage completed to the company & industry by being viewed as untrustworthy-especially being a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a very important part of a top quality assurance system for a laboratory.”
One common misconception is viewing quality assurance as being a cost center instead of a profitability maximizer. A strong quality assurance system is a competitive advantage-especially if you are not even mandated to be 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 may be summarized as “say whatever you do, and do everything you say”, with a willingness to enable third-party confirmation of your commitment and practice. “Accreditation gives an impartial stamp of approval that helps ensure data defensibility inside the laboratory,” affirms Ross.
Accreditation as a result of quality assurance ultimately contributes to reliable and trustworthy data sets. Ross shared: It might seem to be easy to buy expensive instrumentation, accept samples, and create data. There are so many ways to achieve that, some of which are incorrect, and for that reason accreditation is actually the opportunity to have professionals evaluate methodology and post-analytical data processing to ensure that it is actually scientifically sound. It is really an chance of a laboratory to get certain 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 time as well as space where there is no standard methodology and this makes oversight by a third party even more important,” shares Ross. Whenever a company opts to pursue accreditation they may be indicating a willingness to tell the truth and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is important for this emerging industry. Having a robust, inclusive quality assurance system set up will ease and quicken their pursuit of accreditation.The strain upon an audit day if you have a digitized product is vastly below a process that is printed and physically maintained.
Not every quality assurance systems are the same. There are still 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 then in support of continuous improvements. Binders, rows of filing cabinets and sophisticated excel spreadsheets are not a scalable backbone to get a quality system.
Past the accessibility and traceability that a digital system creates, in addition, it protects. “We can protect that data with credentialed logins for key personnel and have information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The anxiety with an audit day should there be a digitized method is vastly less than a process which is printed and physically maintained.
For anyone in the cannabis industry, specifically cannabis testing labs, there is an unequivocal advantage to implementing a system that supports continuous improvement, reliable data sets and the most effective in business practices. Doing so can help sustain and grow the business, and may be pivotal in transforming the development, market and research of cannabis.