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 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 those in the cannabis industry and specifically cannabis testing labs, quality assurance is essential to owning a successful 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 has dealt with multiple cannabis labs, says, “It will not be that frequently that you will get a whole new testing industry born nowadays and individuals are scrambling to borrow processes from other 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 sector is operating in the absence of federal oversight. If you believe about it, the water, food, and pharmaceutical industries have federal oversight. In lieu of that, it is up to states to adopt regulatory practices and enforcement strategies to uphold a degree of compliance and data defensibility that these kinds of regulators have experienced within their careers doing work in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, there is the need to keep up with the rapidly evolving industry climate as more and more states and governing bodies are setting requirements and expectations for quality and compliance. It really is in nobody’s best interest to fall behind or perhaps be a late adopter for the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets can have detrimental impacts on people and patients. Medical uses of cannabis require specific results to make sure the protection of patients, many of which are immunocompromised. Beyond injury to people and patients, businesses themselves may be hurt in case a cannabis testing lab were to present inaccurate or flawed data sets. Ross shared hypothetical samples of potential negative impacts:
If, for instance, you fail a product for microbiology based upon false-good results then it incurs damages to the client because now their product can’t head to market. Additionally, falsely inflated THC outcomes are another huge problem in the market, and may result in downstream problems 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 quantities of time and money, both to control the situation on hand and prevent future incidents. In addition to, the immeasurable damage completed to the manufacturer & industry by being considered 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 robust quality assurance product is a competitive advantage-especially if you are not mandated to be compliant to a particular standard, like ISO/IEC 17025, but elect to pursue that accreditation knowing it reflects reliability. In several ways, quality assurance may be summarized as “say what you do, and do whatever you say”, with a willingness to enable third-party confirmation of your own commitment and rehearse. “Accreditation gives an impartial stamp of approval that assists ensure data defensibility inside the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately results in reliable and trustworthy data sets. Ross shared: It could look like easy to buy expensive instrumentation, accept samples, and create data. There are numerous ways to do that, many of which are incorrect, and therefore accreditation is actually the opportunity to have professionals evaluate methodology and post-analytical data processing to ensure that it really is scientifically sound. It is an chance of a laboratory to become positive 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 as well as space where there is absolutely no standard methodology and this makes oversight by a third party a lot more important,” shares Ross. Each time a company opts to pursue accreditation they may be indicating a willingness to tell the truth 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 set up will ease and quicken their quest for accreditation.The anxiety upon an audit day if you have a digitized product is vastly lower than a system that is certainly printed and physically maintained.
Its not all quality assurance systems are the same. There are still some companies trying 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 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 a digital system creates, in addition, it protects. “We can protect 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 anxiety with an audit day when there is a digitized system is vastly below a method that is certainly printed and physically maintained.
For all those 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 top in operation practices. Accomplishing this can help sustain and grow the market, and could be pivotal in transforming the development, market and research of cannabis.