Have you paused to take into consideration that quality assurance is actually a moving target instead of a destination? It is culture in a company that needs 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 crucial to owning a successful and thriving business inside the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. in the University of Colorado in Molecular Biology, and also has worked with multiple cannabis labs, says, “It will not be that usually that you receive a brand new testing industry born today 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 looking 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 lack of federal oversight. If you feel about this, 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 techniques to uphold a level of compliance and data defensibility that these kinds of regulators have experienced in their careers doing work 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 and more states and governing bodies are setting requirements and expectations for quality and compliance. It really is in nobody’s best interest to get 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 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 examples of potential negative impacts:
If, as an example, you fail a product or service for microbiology based upon false-positive results it incurs damages to the client because now their product can’t visit market. Additionally, falsely inflated THC results are also a huge problem in the business, and can lead to 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 amounts of time and expense, both to manage the issue available preventing future incidents. Not to mention, 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 piece of a quality assurance system for a laboratory.”
One common misconception is viewing quality assurance as a cost center rather than a profitability maximizer. A strong quality assurance product is a competitive advantage-especially for those who are not mandated to be compliant to particular standard, like ISO/IEC 17025, but decide to pursue that accreditation knowing it reflects reliability. In lots of ways, quality assurance can be summarized as “say everything you do, and do what you say”, with a willingness to permit third-party confirmation of your commitment and exercise. “Accreditation gives an impartial stamp of approval that can help ensure data defensibility in the laboratory,” affirms Ross.
Accreditation because of quality assurance ultimately results in reliable and trustworthy data sets. Ross shared: It could seem to be easy to buy expensive instrumentation, accept samples, and create data. There are numerous ways to do that, a few of which are incorrect, and thus accreditation is actually the opportunity to have professionals evaluate methodology and post-analytical data processing to ensure it really is scientifically sound. It is really an chance for a laboratory to become positive that their processes and reporting procedures are robust and error free.
Remember: this is a new industry. There aren’t firmly established methods and operations like other legacy industries. “We are operating in a time and space where there is no standard methodology and that makes oversight by a third party even more important,” shares Ross. Each time a company opts to pursue accreditation they may be indicating a willingness to tell the truth and transparent making use of their business processes, procedures, outcomes and data. Accreditation, therefore, is necessary for this particular emerging industry. Possessing a robust, inclusive quality assurance system in position will ease and quicken their quest for accreditation.The stress upon an audit day when there is a digitized system is vastly below a process that is printed and physically maintained.
Not every quality assurance systems are the same. You can still find some companies wanting 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 a quality system.
Past the accessibility and traceability that the digital system creates, additionally, it protects. “We can protect that data with credentialed logins for key personnel and possess information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The strain with an audit day if you have a digitized product is vastly less than a process that is printed and physically maintained.
For anyone in the cannabis industry, specifically cannabis testing labs, it comes with an unequivocal advantage to implementing a system that supports continuous improvement, reliable data sets and the most effective running a business practices. Doing so will help sustain and grow the market, and could be pivotal in transforming the production, market and research of cannabis.