Have you paused to take into consideration that quality assurance is actually a moving target as opposed to a destination? It is culture in a company that requires constant improvement and change, 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 within the cannabis industry and specifically cannabis testing labs, quality assurance is essential to owning an excellent and thriving business in the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. in the University of Colorado in Molecular Biology, and has worked with multiple cannabis labs, says, “It is not really that frequently that you get a whole new testing industry born nowadays and folks are scrambling to borrow processes off their industries and apply those to the cannabiscultivationconsulting.com.” 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 lack of federal oversight. If you feel regarding 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 sorts of regulators have witnessed within their careers doing work 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 increasing numbers of states and governing bodies are setting requirements and expectations for quality and compliance. It is actually in nobody’s best interest to fall 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 safety of patients, a few of which are immunocompromised. Beyond harm to people and patients, businesses themselves could be hurt in case a cannabis testing lab would present inaccurate or flawed data sets. Ross shared hypothetical samples of potential negative impacts:
If, for instance, you fail an item for microbiology according to false-positive results then it incurs damages towards the client because now their product can’t go to market. Additionally, falsely inflated THC effects are another huge problem in the business, and can lead to downstream problems with edible dosing or consumer satisfaction.
A quality assurance system can minimize risk and maximize adherences to proper procedure, leading to reliable data. Recalls, product issues and lawsuits cost organizations tremendous quantities of time and money, both to manage the issue available preventing future incidents. Not to mention, the immeasurable damage completed to the manufacturer & industry because they are thought of 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 an excellent assurance system for a laboratory.”
One common misconception is viewing quality assurance as a cost center as opposed to a profitability maximizer. A strong quality assurance product is a competitive advantage-especially if you are not mandated to be compliant to particular standard, like ISO/IEC 17025, but decide to pursue that accreditation realizing it reflects reliability. In several ways, quality assurance may be summarized as “say what you do, and do whatever you say”, having a willingness to permit third-party confirmation of your commitment and exercise. “Accreditation gives an unbiased stamp of approval that assists ensure data defensibility within the laboratory,” affirms Ross.
Accreditation as a result of quality assurance ultimately results in reliable and trustworthy data sets. Ross shared: It might appear to be simple to buy expensive instrumentation, accept samples, and create data. There are plenty of ways to do that, many 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 scientifically sound. It is really an chance of a laboratory to be 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 procedures like other legacy industries. “We are operating in a time and 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 they are indicating a willingness to be honest and transparent making use of their business processes, procedures, outcomes and data. Accreditation, therefore, is important with this emerging industry. Having a robust, inclusive quality assurance system in position will ease and quicken their search for accreditation.The stress on an audit day should there be a digitized product is vastly lower than a process that is printed and physically maintained.
Not every quality assurance systems are the same. You may still find some companies trying to implement systems that do not have 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 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.
Beyond the accessibility and traceability which a digital system creates, in addition, it protects. “We can protect that data with credentialed logins for key personnel and also have information at our fingertips to lessen the regulatory stress on all personnel,” says Ross. The anxiety upon an audit day should there be a digitized method is vastly less than a method that is printed and physically maintained.
For those inside 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 may help sustain and grow the market, and may be pivotal in transforming the development, market and research of cannabis.