There is no quick fix with a QMS

On Friday, July 28, the Missouri Department of Cannabis Regulation (DCR) issued waivers and variances to the final Medical and Adult Use Cannabis Rules that were scheduled to take effect on July 30, 2023.

According to the document, DCR understands that licensees will need time to come into compliance with some requirements under the new rules. As such, they have granted multiple waivers and variances for specific requirements. A waiver indicates that a licensee is not obligated to adhere to the rule at the current time, while a variance necessitates compliance with an alternative requirement.

Most of the waivers and variances issued are related to analytical testing and reporting. Notably, there was no waiver or variance issued for packaging and labeling – the new requirement that has consumed the attention of the industry to date. However, DCR did provide a waiver for the requirement to implement a Quality Management System (QMS), extending the compliance deadline for licensees until December 1, 2023.

19 CSR 100-1.100(4)(D)

Licensees shall implement a quality management system using a published standard, such as those offered by International Organization for Standardization, ASTM International, Cannabis Safety and Quality, or Foundation of Cannabis Unified Standards, within one (1) year of the date the facility receives department approval to operate. The chosen standard shall be applicable to the licensee’s facility type and be implemented with emphasis on regulatory compliance.

Adult Use Rule Waiver 19 CSR 100-1.100(4)(D) DCR is waiving this requirement until December 1st, 2023.

As the former executive director of a vertically integrated cannabis company and founder of the original cannabis standard development organization mentioned in the regulations, I am pleased to see this waiver. I believe granting licensees a full year for initial compliance at the outset would have been more effective, as it would help underscore the magnitude of this new QMS requirement. Regardless, I am pleased to see the extension, and hope that licensees start now on implementation.

Drawing from numerous discussions with Missouri licensees, it is evident that a substantial knowledge gap persists regarding quality management systems overall, in addition to confusion about this specific regulatory requirement. It’s understandable in a new industry like cannabis, where most leadership lacks any formal training on quality and quality management, unless they came from a similar industry.

Licensees are generally seeking the least expensive option that ensures compliance and that’s about it.

What they don’t realize, is that by its very nature, a QMS is not a one-size-fits-all solution. A quality management system is exactly as the name implies – a system to manage quality.

How do you currently manage “quality” in your cannabis business? How do you define “quality”? What does that word “quality” mean to you? What does “quality” mean to your employees? What do your customers think the word quality means? How do you know when you have achieved “quality”? What happens when you don’t achieve “quality”?

Substantial, honest, and complete answers to these questions (and many more) are what form the basis of an impactful QMS. In our experience, the majority of cannabis operators, due to their already hectic schedules, require someone experienced to guide them through this process. Otherwise, they miss the real value- which comes from of taking an introspective look into the organization as a whole, not just a set of policies and procedures or a software solution.

A QMS focuses on what matters most. It centers on addressing the unique priorities of your individual business. There is no “quick fix” with a QMS. Rushed implementation will result in inadequate practices, incomplete documentation, and compliance violations that could end up costing the license.

   

While promises by companies and consultants may sound enticing, licensees should be cautious of any vendor claiming to provide instant or overly simple QMS solutions.

The cannabis industry moves at warp speed, and as an operator, there are never enough hours in the day. The mountain of urgent things to do can make implementing a QMS seem like an overwhelming endeavor.

I often describe the years I spent operating a medical cannabis business like “drinking from a firehose”. It was non-stop chaos, 24 hours a day, 7 days a week. Contamination issues, employee turnover, theft/loss, compliance violations, marketing rejections, supply challenges, customer complaints, banking headaches. And on, and on. We weren’t special. We went through all the typical growing pains that come along with becoming a business owner in this brand-new, fast-paced, quasi-legal, overly-regulated industry. The problems we experienced were both understandable and manageable if we only had to deal with them once. Our problem was, the fires we were putting out were the exact same fires we had dealt with a month ago.

After a decade in the pharmaceutical sector, with formal Lean/Six Sigma training, it wasn’t hard to identify we needed a quality system. However, back in 2013, there wasn’t a quality management system standard for cannabis in existence. After talking with other cannabis business owners, it was clear everyone was having a similar experience, which is why I left that role to start a cannabis standards development organization to help address this issue.

One of the primary advantages of a well-implemented QMS is that it shifts the focus from constantly firefighting daily issues to a proactive and systematic approach for managing a cannabis business.

FOCUS published the first QMS for the cannabis sector back in 2016 and we have been implementing cannabis quality management systems across this country and around the world, since.

A QMS provides the architecture to anticipate and address potential issues before they escalate. It is a true shift in mindset and approach – which can feel scary at first, without proper guidance and education.

There are enough regulatory changes to deal with on a daily basis in the cannabis industry. Why add to that forced chaos by reacting to never-ending problems as they occur, rather than anticipating and acting to prevent them in the first place?

One thing I enjoy about assisting cannabis businesses with QMS implementation is that in a short time, there are visible, tangible results. Companies can substantially curtail the expenditure of time and resources on rectifying avoidable problems, which translates into lower costs, quicker production, smoother operations, and happier employees.

To assist clients in achieving these types of results when implementing a QMS, FOCUS employs a tailored strategy. We offer custom resources paired with specific guidance and training to ensure cannabis businesses have the tools they need to implement effectively. Licensees undergo a risk-assessment and regulatory review at the outset, in addition to an internal culture exercise and a customer identification survey. Our experience has shown that this approach is best to help companies establish a purpose and scope for their Quality Policy and Quality Objectives that is meaningful to their specific goals and brings the results they are seeking.

Implementing an effective QMS doesn’t all happen at once, or overnight. Quality takes time and work. However, licensees who opt for thorough QMS implementation will streamline compliance, delight customers, and outpace competitors. In a new, and highly competitive cannabis market like Missouri, with interstate commerce on the horizon, smart licensees will use this new regulatory requirement to solidify their brand for the future – and skip the “quick fix” for this one.

Lezli Engelking is the Founder & President of Foundation of Cannabis Unified Standards (FOCUS). Established in 2014 as The Cannabis Health and Safety Organization, FOCUS is a nonprofit that addresses the many shortcomings in quality, safety, and consistency that have become evident with the explosive growth of the global cannabis industry. FOCUS is not a cannabis company, an industry trade association, nor is FOCUS an advocacy organization. FOCUS does not advocate on behalf of or push cannabis policy. FOCUS exists to help assure the rapidly growing global cannabis industry has the necessary protections in place for the health, safety, success, and welfare of everyone.  Our autonomy fosters a principled, objective organization that protects end users, and acts as the much-needed neutral, nonpartisan bridge between industry and regulatory.