Have you paused to consider that quality assurance is actually a moving target instead of a destination? It is culture in a company that will require constant improvement and change, rather than the work of a select few to arrive at 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 within the cannabis industry and specifically cannabis testing labs, quality assurance is critical to getting an excellent and thriving business in the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. at the University of Colorado in Molecular Biology, and has dealt with multiple cannabis labs, says, “It will not be that frequently that you receive a brand new testing industry born these days and individuals are scrambling to borrow processes from other 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 function as a quality assurance beacon. Ross elaborates:
The cannabis sector is operating in the lack of federal oversight. If you believe about it, this type of water, food, and pharmaceutical industries have federal oversight. Rather than that, it depends on states to adopt regulatory practices and enforcement techniques to uphold a level of compliance and data defensibility that these types 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, 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 interest to get behind or perhaps be a late adopter to 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 guarantee the protection of patients, many of which are immunocompromised. Beyond damage 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-great results it incurs damages for the client because now their product can’t head to market. Additionally, falsely inflated THC effects are another huge problem in the industry, and can result in 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 amounts of time and expense, both to handle the situation available preventing future incidents. In addition to, the immeasurable damage completed to the company & industry when you are considered untrustworthy-especially as being a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a very important bit of a top quality assurance system to get a laboratory.”
One common misconception is viewing quality assurance as being a cost center as opposed to a profitability maximizer. A strong quality assurance method is a competitive advantage-especially for those who are not yet mandated to be compliant to particular standard, like ISO/IEC 17025, but choose to pursue that accreditation knowing it reflects reliability. In several ways, quality assurance could be summarized as “say whatever you do, and do everything you say”, having a willingness to allow third-party confirmation of the commitment and rehearse. “Accreditation gives an impartial stamp of approval that helps ensure data defensibility within the laboratory,” affirms Ross.
Accreditation due to quality assurance ultimately contributes to reliable and trustworthy data sets. Ross shared: It could appear to be easy to buy expensive instrumentation, accept samples, and create data. There are so many ways to achieve that, some of which are incorrect, and thus accreditation is absolutely a chance to have professionals evaluate methodology and post-analytical data processing to make sure that it is scientifically sound. It is really an chance of a laboratory to become certain that their processes and reporting procedures are robust and error free.
Remember: it is a new industry. There aren’t firmly established methods and operations like other legacy industries. “We are operating in a some time and space where there is no standard methodology which makes oversight by a third party much more important,” shares Ross. Whenever a company opts to pursue accreditation they may be indicating a willingness to be honest and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is essential for this particular emerging industry. Possessing a robust, inclusive quality assurance system in position will ease and quicken their quest for accreditation.The anxiety upon an audit day when there is a digitized product is vastly less than a method that is certainly printed and physically maintained.
Not all quality assurance systems are the same. There are still some companies seeking 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 as well as in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are certainly not a scalable backbone for a quality system.
Past the accessibility and traceability which a digital system creates, additionally, it protects. “We can safeguard that data with credentialed logins for key personnel and also have information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The strain upon an audit day when there is a digitized system is vastly less than a process which is printed and physically maintained.
For those inside the cannabis industry, specifically cannabis testing labs, there is an unequivocal advantage to implementing a method that supports continuous improvement, reliable data sets and the most effective running a business practices. Doing so will help sustain and grow the business, and may be pivotal in transforming the production, market and research of cannabis.