Have you paused to consider 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, 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 in the cannabis industry and specifically cannabis testing labs, quality assurance is critical to having an excellent 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 worked with multiple cannabis labs, says, “It is not really that frequently that you get a new testing industry born nowadays and individuals are scrambling to borrow processes using their company industries and apply those to the cannabis quality assurance plan.” Those within cannabis testing labs are searching towards established industries like water and food testing labs to work as a quality assurance beacon. Ross elaborates:
The cannabis sector is operating in the lack of federal oversight. If you feel about it, water, food, and pharmaceutical industries have federal oversight. Rather than that, it is up to states to adopt regulatory practices and enforcement techniques to uphold a degree of compliance and data defensibility that these types of regulators have witnessed in their careers employed in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, you have the 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 in nobody’s interest to fall behind or perhaps be a late adopter for the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets might have detrimental impacts on people and patients. Medical applications of cannabis require specific results to guarantee the safety of patients, a few of which are immunocompromised. Beyond harm to people and patients, businesses themselves may 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 example, you fail an item for microbiology according to false-positive results this incurs damages towards the client because now their product can’t visit market. Additionally, falsely inflated THC outcomes are also a huge problem in the business, and can result in downstream problems 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 quantities of money and time, both to control the situation on hand and stop future incidents. Not forgetting, the immeasurable damage completed to the company & industry when you are thought of as untrustworthy-especially as 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 top quality assurance system to get a laboratory.”
One common misconception is viewing quality assurance being a cost center instead of a profitability maximizer. A robust quality assurance product is a competitive advantage-especially if you are not even mandated to be compliant to particular standard, like ISO/IEC 17025, but choose to pursue that accreditation knowing it reflects reliability. In many ways, quality assurance could be summarized as “say what you do, and do whatever you say”, with a willingness to permit third-party confirmation of your commitment and practice. “Accreditation gives a neutral stamp of approval that helps ensure data defensibility within the laboratory,” affirms Ross.
Accreditation as a result of quality assurance ultimately contributes to reliable and trustworthy data sets. Ross shared: It could look like simple 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 actually an 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 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 as well as space where there is absolutely no standard methodology and this makes oversight by a 3rd party much more important,” shares Ross. Whenever a company opts to pursue accreditation these are indicating a willingness in all honesty and transparent making use of their business processes, procedures, outcomes and data. Accreditation, therefore, is necessary for this emerging industry. Having a robust, inclusive quality assurance system set up will ease and quicken their pursuit of accreditation.The anxiety on an audit day when there is a digitized method is vastly lower than a method which is printed and physically maintained.
Its not all quality assurance systems are the same. There are still 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 as well as in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are not a scalable backbone to get a quality system.
Past the accessibility and traceability that the digital system creates, additionally, it protects. “We can safeguard that data with credentialed logins for key personnel and have information at our fingertips to minimize the regulatory stress on all personnel,” says Ross. The strain upon an audit day if you have a digitized method is vastly lower than a process that is printed and physically maintained.
For those inside the cannabis industry, specifically cannabis testing labs, it comes with an unequivocal advantage to implementing a method that supports continuous improvement, reliable data sets and the most effective running a business practices. Accomplishing this can help sustain and grow the market, and can be pivotal in transforming the development, market and research of cannabis.