Have you paused to think about that quality assurance is actually a moving target as opposed to a destination? It is culture within a company that requires constant improvement and alter, as opposed to the work of a select few to arrive at 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 those inside the cannabis industry and specifically cannabis testing labs, quality assurance is critical to owning an excellent and thriving business in 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 receive a whole new testing industry born these days and people are scrambling to borrow processes off their industries and apply those to the cannabis quality assurance plan.” 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 industry is operating in the absence of federal oversight. If you believe regarding it, this type of 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 level of compliance and data defensibility that these kinds of regulators have witnessed in 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 is in nobody’s welfare to get behind or perhaps be a late adopter for 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 make sure the security of patients, a few of which are immunocompromised. Beyond injury to people and patients, businesses themselves may be hurt when a cannabis testing lab would present inaccurate or flawed data sets. Ross shared hypothetical types of potential negative impacts:
If, as an example, you fail a product or service for microbiology according to false-good results it incurs damages to the client because now their product can’t visit market. Additionally, falsely inflated THC outcomes are additionally a huge problem in the industry, and can lead to downstream issues with edible dosing or consumer satisfaction.
A top quality assurance system can minimize risk and maximize adherences to proper procedure, causing reliable data. Recalls, product issues and lawsuits cost organizations tremendous levels of money and time, both to control the situation at hand and stop future incidents. Not forgetting, the immeasurable damage completed to the brand & 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 piece of an excellent assurance system for any laboratory.”
One common misconception is viewing quality assurance being a cost center instead of a profitability maximizer. A robust quality assurance system is a competitive advantage-especially for people who are not yet mandated to become compliant to a particular standard, like ISO/IEC 17025, but elect to pursue that accreditation realizing it reflects reliability. In many ways, quality assurance can be summarized as “say everything you do, and do whatever you say”, with a willingness to permit third-party confirmation of your commitment and practice. “Accreditation gives an unbiased stamp of approval that can help ensure data defensibility within the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately leads to reliable and trustworthy data sets. Ross shared: It could look like easy to buy expensive instrumentation, accept samples, and provide data. There are numerous ways to do that, a few of which are incorrect, and for that reason accreditation is absolutely the opportunity to have professionals evaluate methodology and post-analytical data processing to ensure it is scientifically sound. It is an chance of a laboratory to become confident that their processes and reporting procedures are robust and error free.
Remember: this can be a new industry. There aren’t firmly established methods and procedures like other legacy industries. “We are operating in a some time and space where there is not any standard methodology and that makes oversight by a third party a lot more important,” shares Ross. Whenever a company opts to pursue accreditation they may be indicating a willingness in all honesty and transparent using their business processes, procedures, outcomes and data. Accreditation, therefore, is important with this emerging industry. Having a robust, inclusive quality assurance system in place will ease and quicken their pursuit of accreditation.The stress on an audit day when there is a digitized product is vastly less than a process that is printed and physically maintained.
Not all quality assurance systems are the same. There are still some companies trying 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 complicated excel spreadsheets usually are not a scalable backbone for any quality system.
Past the accessibility and traceability that a digital system creates, additionally, it protects. “We can safeguard that data with credentialed logins for key personnel and possess information at our fingertips to minimize the regulatory stress on all personnel,” says Ross. The stress upon an audit day when there is a digitized system is vastly less than a method that is printed and physically maintained.
For all those within the cannabis industry, specifically cannabis testing labs, there is an unequivocal benefit to implementing a system that supports continuous improvement, reliable data sets and the most effective in operation practices. Doing this will help sustain and grow the industry, and may be pivotal in transforming the development, market and research of cannabis.