Have you paused to take into consideration that quality assurance is actually a moving target instead of a destination? It is culture in a company that needs 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 simply be checked but an overarching and driving force propelling organizations forward.
For those within the cannabis industry and specifically cannabis testing labs, quality assurance is critical to getting an effective and thriving business within the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. on the University of Colorado in Molecular Biology, and also has dealt with multiple cannabis labs, says, “It is not really that frequently that you will get a 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 looking 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 lack of federal oversight. If you believe about it, water, food, and pharmaceutical industries have federal oversight. Rather than that, it depends on states to adopt regulatory practices and enforcement approaches to uphold a level of compliance and data defensibility that these types of regulators have seen within their careers doing work 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 welfare to get behind or be a late adopter towards the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets might have detrimental impacts on people and patients. Medical uses of cannabis require specific results to guarantee the protection 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 types of potential negative impacts:
If, as an example, you fail a product for microbiology according to false-positive results it incurs damages to the client because now their product can’t go to market. Additionally, falsely inflated THC outcomes are also a huge problem in the market, and may result in downstream issues with edible dosing or consumer satisfaction.
An excellent assurance system can minimize risk and maximize adherences to proper procedure, resulting in reliable data. Recalls, product issues and lawsuits cost organizations tremendous amounts of time and expense, both to manage the situation on hand and prevent future incidents. Not forgetting, the immeasurable damage performed to the manufacturer & 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 really important bit 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 method is a competitive advantage-especially for people who are not even mandated to become compliant to a particular standard, like ISO/IEC 17025, but choose to pursue that accreditation realizing it reflects reliability. In several ways, quality assurance may be summarized as “say what you do, and do everything you say”, with a willingness to permit third-party confirmation of the commitment and practice. “Accreditation gives a neutral stamp of approval that helps ensure data defensibility within the laboratory,” affirms Ross.
Accreditation because of quality assurance ultimately results in reliable and trustworthy data sets. Ross shared: It might look like very easy to buy expensive instrumentation, accept samples, and provide data. There are plenty of ways to do that, some of which are incorrect, and therefore accreditation is really an opportunity to have professionals evaluate methodology and post-analytical data processing to ensure that it really is scientifically sound. It is really an opportunity for a laboratory to be confident 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 that makes oversight by a third party much more important,” shares Ross. Whenever a company opts to pursue accreditation these are indicating a willingness to tell the truth and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is important for this particular emerging industry. Possessing a robust, inclusive quality assurance system in position will ease and quicken their pursuit of accreditation.The anxiety on an audit day when there is a digitized system is vastly lower than a system which is printed and physically maintained.
Not all quality assurance systems are created equal. You can still find some companies wanting to implement systems that lack 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 complicated excel spreadsheets are certainly not a scalable backbone for any quality system.
Beyond the accessibility and traceability that a digital system creates, additionally, 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 strain on an audit day when there is a digitized system is vastly lower than a process that is certainly printed and physically maintained.
For all those within 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 most effective in operation practices. Doing so will help sustain and grow the business, and can be pivotal in transforming the development, market and research of cannabis.