Have you paused to consider that quality assurance is a moving target as opposed to a destination? It is culture within a company that will require constant improvement and change, rather than the work of a select few to achieve 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 critical to having an effective 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 dealt with multiple cannabis labs, says, “It is not that frequently that you will get a whole new testing industry born today and individuals are scrambling to borrow processes using their company industries and apply those to the cannabiscultivationconsulting.com.” Those within cannabis testing labs are seeking 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 think about this, water, food, and pharmaceutical industries have federal oversight. Rather than that, it depends on states to adopt regulatory practices and enforcement strategies to uphold a level of compliance and data defensibility that these sorts of regulators have witnessed inside their careers employed in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, there is the need to take care of 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 get behind or even be a late adopter for the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets can have detrimental impacts on people and patients. Medical applications of cannabis require specific results in order to ensure the safety of patients, a few of which are immunocompromised. Beyond harm to people and patients, businesses themselves can be hurt in case a cannabis testing lab were to present inaccurate or flawed data sets. Ross shared hypothetical examples of potential negative impacts:
If, as an example, you fail an item for microbiology based on false-good results this incurs damages for the client because now their product can’t visit market. Additionally, falsely inflated THC effects are another huge problem in the market, and may result in downstream issues 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 money, both to handle the issue at hand and prevent future incidents. Not to mention, the immeasurable damage done to the company & industry by being 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 an excellent assurance system for a laboratory.”
One common misconception is viewing quality assurance being a cost center instead of a profitability maximizer. A robust quality assurance method is a competitive advantage-especially for those who are not yet mandated to become compliant to particular standard, like ISO/IEC 17025, but choose to pursue that accreditation knowing it reflects reliability. In many ways, quality assurance may be summarized as “say whatever you do, and do everything you say”, having a willingness to permit third-party confirmation of the commitment and rehearse. “Accreditation gives an impartial stamp of approval that can help ensure data defensibility in the laboratory,” affirms Ross.
Accreditation because of quality assurance ultimately contributes to reliable and trustworthy data sets. Ross shared: It may appear to be easy to buy expensive instrumentation, accept samples, and provide data. There are numerous ways to do that, many of which are incorrect, and thus accreditation is absolutely an opportunity to have professionals evaluate methodology and post-analytical data processing to make sure that it really is scientifically sound. It is really an chance for a laboratory to get 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 some time and space where there is absolutely no standard methodology and this makes oversight by a 3rd party even more important,” shares Ross. When 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 emerging industry. Having a robust, inclusive quality assurance system set up will ease and quicken their search for accreditation.The stress upon an audit day should there be a digitized system is vastly lower than a process that is printed and physically maintained.
Its not all quality assurance systems are created equal. You may still find 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 and then in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are certainly not a scalable backbone to get a quality system.
Past the accessibility and traceability that the digital system creates, in addition, it protects. “We can safeguard that data with credentialed logins for key personnel and also have information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The anxiety with an audit day when there is a digitized product is vastly below a method which is 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 top in operation practices. Accomplishing this can help sustain and grow the business, and could be pivotal in transforming the development, market and research of cannabis.