Have you paused to take into consideration that quality assurance is a moving target rather than a destination? It is culture within a company that will require constant improvement and change, instead of the work of a select few to achieve 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 within the cannabis industry and specifically cannabis testing labs, quality assurance is crucial to owning an effective and thriving business inside the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. on the University of Colorado in Molecular Biology, and has dealt with multiple cannabis labs, says, “It is not that usually that you get a whole new testing industry born these days and people are scrambling to borrow processes using their company industries and apply these to the cannabiscultivationconsulting.com.” 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 market is operating in the absence of federal oversight. If you believe about this, this type of water, food, and pharmaceutical industries have federal oversight. Rather than that, it is perfectly up to states to adopt regulatory practices and enforcement approaches to uphold a level 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 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 in nobody’s interest 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, many of which are immunocompromised. Beyond harm to people and patients, businesses themselves can be hurt in case a cannabis testing lab would present inaccurate or flawed data sets. Ross shared hypothetical samples of potential negative impacts:
If, as an example, you fail an item for microbiology based upon false-positive results then it incurs damages towards the client because now their product can’t head to market. Additionally, falsely inflated THC results are another huge problem in the market, and can lead to downstream issues 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 expense, both to manage the problem available and prevent future incidents. Not forgetting, the immeasurable damage done to the company & industry because they are 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 a quality assurance system for a laboratory.”
One common misconception is viewing quality assurance being a cost center rather than a profitability maximizer. A strong quality assurance system is a competitive advantage-especially for those who are not even mandated to get compliant to a particular standard, like ISO/IEC 17025, but elect to pursue that accreditation realizing it reflects reliability. In lots of ways, quality assurance could be summarized as “say what you do, and do everything you say”, having a willingness to enable third-party confirmation of your commitment and rehearse. “Accreditation gives an unbiased stamp of approval that can help ensure data defensibility in the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately contributes to reliable and trustworthy data sets. Ross shared: It may seem to be easy to buy expensive instrumentation, accept samples, and produce data. There are numerous ways to achieve that, some of which are incorrect, and therefore accreditation is actually an opportunity to have professionals evaluate methodology and post-analytical data processing to ensure it is actually 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 procedures like other legacy industries. “We are operating in a time and space where there is no standard methodology which makes oversight by a 3rd party a lot more important,” shares Ross. Whenever a company opts to pursue accreditation these are indicating a willingness in all honesty and transparent using their business processes, procedures, outcomes and data. Accreditation, therefore, is essential for this emerging industry. Having a robust, inclusive quality assurance system in place will ease and quicken their quest for accreditation.The strain with an audit day if you have a digitized method is vastly less than a process which is printed and physically maintained.
Not all quality assurance systems are created equal. There are still some companies wanting 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 in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are certainly not a scalable backbone for any quality system.
Past the accessibility and traceability which a digital system creates, it also 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 stress with an audit day when there is a digitized product is vastly less than a method that is printed and physically maintained.
For those inside the cannabis industry, specifically cannabis testing labs, it comes with an unequivocal benefit to implementing a system that supports continuous improvement, reliable data sets and the very best running a business practices. Accomplishing this will help sustain and grow the business, and can be pivotal in transforming the development, market and research of cannabis.