Have you paused to think about that quality assurance is a moving target instead of a destination? It is culture within a company that will require constant improvement and alter, instead of the work of a select few to achieve 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 in the cannabis industry and specifically cannabis testing labs, quality assurance is critical 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 worked with multiple cannabis labs, says, “It is not that often that you get a brand new testing industry born nowadays and individuals are scrambling to borrow processes off their industries and apply these to the cannabiscultivationconsulting.com.” Those within cannabis testing labs are looking 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 think regarding it, the water, food, and pharmaceutical industries have federal oversight. In lieu of that, it depends on 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 employed 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 states and governing bodies are setting requirements and expectations for quality and compliance. It really is in nobody’s welfare to get behind or be a late adopter to the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets might have detrimental impacts on people and patients. Medical applications of cannabis require specific results in order to ensure the security of patients, a few of which are immunocompromised. Beyond injury to people and patients, businesses themselves may be hurt if 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 an item for microbiology based on false-positive results this incurs damages to 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 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 quantities of time and money, both to manage the issue on hand and prevent future incidents. Not forgetting, the immeasurable damage performed to the company & industry because they are viewed as untrustworthy-especially being a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a very important part of a top quality assurance system for a laboratory.”
One common misconception is viewing quality assurance as being a cost center instead of a profitability maximizer. A strong quality assurance product is a competitive advantage-especially for those who are not mandated to be compliant to a 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 everything you do, and do everything you say”, having a willingness to allow third-party confirmation of your own commitment and rehearse. “Accreditation gives a neutral stamp of approval that can help ensure data defensibility in the laboratory,” affirms Ross.
Accreditation as a result of quality assurance ultimately leads to reliable and trustworthy data sets. Ross shared: It may appear to be easy to buy expensive instrumentation, accept samples, and produce data. There are numerous ways to do that, many of which are incorrect, and thus accreditation is really a chance to have professionals evaluate methodology and post-analytical data processing to ensure it 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: it 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 not any standard methodology and this makes oversight by a 3rd party much more important,” shares Ross. Each time a company opts to pursue accreditation they may be indicating a willingness to be honest and transparent using their business processes, procedures, outcomes and data. Accreditation, therefore, is important for this emerging industry. Using a robust, inclusive quality assurance system in place will ease and quicken their search for accreditation.The strain with an audit day if you have a digitized method is vastly below a method that is printed and physically maintained.
Its not all quality assurance systems are created equal. 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 and in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are not a scalable backbone for any quality system.
Beyond the accessibility and traceability which a digital system creates, it also protects. “We can safeguard that data with credentialed logins for key personnel and have information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The anxiety on an audit day should there be a digitized product is vastly less than a system that is printed and physically maintained.
For all those within the cannabis industry, specifically cannabis testing labs, there is an unequivocal advantage to implementing a process that supports continuous improvement, reliable data sets and the very best running a business practices. Doing so will help sustain and grow the industry, and could be pivotal in transforming the production, market and research of cannabis.