As a Licensed Cannabis Operator in Missouri, a Quality Management System (QMS) isn’t merely a regulatory hurdle—it’s an opportunity, a pathway to increased efficiency, lower operational risk, and unparalleled customer experiences.
At its core, a QMS is a system that facilitates continuous improvement by recording and governing the policies, procedures, and controls necessary for your company to consistently deliver high-quality products and services. The State of Missouri requires cannabis licensees to implement a QMS. The regulation and the related waiver states:
DIVISION 100—DIVISION OF 19 CSR 100-1—DEPARTMENT OF HEALTH AND CANNABIS REGULATION SENIOR SERVICES
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.
We recommend a QMS based on the state approved International Organization for Standardization (ISO). Specifically, ISO 9001-2015. When we make reference to ISO we are referring to 9001-2015.
There are 10 “clauses” in ISO. The first three explain the QMS Scope, terms and definitions, which are very important to understand. Clauses 4 through 10 are the actual implementation clauses your operation will meet.
The Clauses are divided into sub-clauses. The clauses do not have the same number of sub-clauses so each will take differing requirements of your time.
Simply described, each clause will require you to do something. This might be a review of your policies and procedures, testing equipment, assessing your employee teams, or identifying risks and opportunities. At each action, you will be required to keep records of the results or findings. These records may be classified as Mandatory or Recommended.
At the very minimum for you to successfully implement your QMS, you will need absolute support from your Executive Leadership. And you will need a Quality Manager to coordinate the activities required.
A question we are often asked is how much QMS implementation will cost. We can’t give you a definitive answer because we don’t know what companies charge, because you will have to visit with them to receive a quote for their services, but we will identify some variables that will affect your costs.
- Do you have a team member that is qualified to act as your Quality Manager. If yes, will you have to hire someone to cover your manager’s diverted hours? If not, please see Option 1below
- You may have some additional expenses depending on your operation. As an example, if you routinely have your weight measurement devices certified, you won’t have to pay additional for that activity. If you have not had them certified, you will have to.
- The largest expense will be your actual QMS implementation. You have two options.
Option 1 is to have a team member take one or more of the myriads of QMS training courses, so they have the knowledge to manage the process.. If your manager is not already familiar with Quality Management Systems, the training period can be frustrating and lengthy. When you complete the QMS process, you will have to obtain approval from the State.
Option 2 is to hire an external company to help coach you through the process. Again, depending on what type of implementation certification you desire (implementation or audit), this will vary considerably among providers. Once your QMS is fully implemented, the provider will issue you a certificate verifying your compliance, that you can provide to the State.
As you go through the process of choosing your QMS coaching partner, please remember that the State does not require you to conduct an internal or external “audit”. The requirement is for you to “implement” the QMS.
A factor to consider if you choose an external provider is their familiarity with the Cannabis industry. Companies may have a wealth of experiences working with hospitals and banks but know little about cannabis. Obviously, their learning curve is factored into your cost.
Another factor in choosing an external coach is the time it will require to create the many documents, templates, SOP’s, logs and records the QMS requires. This may not sound like much, but the time requirement can be very consuming. We recommend choosing a provider that has a suite of fully customizable templates ready for your use. Be aware that many providers charge extra for documents “kits”.
How long will it take to implement your QMS? Again, depending on if you choose implementation or audit, it will vary. A certified “implementation” might take as little as a couple of months. An “audit” may take several months.
A final suggestion is to embrace QMS and not fight it. If you have an “opposition” mindset, it will delay your implementation process.
With a state-imposed timeline to implement a QMS, we understand the pressure you may feel. However, this process can be simplified with strategic planning and an experienced Internal Implementation partner. If desired, The Advisory Academy™ can assist you in this journey, ensuring your team can stay focused on daily operations.
Our team, with decades of experience in commercial cannabis operations, corporate coaching, and organizational development, understands the unique challenges and opportunities in the marijuana industry. Our solutions will help you avoid excessive non-compliance fines and penalties, business interruptions, and loss of revenue and customers.
Through our partnership with ReadyLXP, an award-winning educational systems provider, we have developed an on-line learning platform exclusively focused on Licensed Marijuana Operators. AdvisoryLXP™ provides a simplified framework for formalizing your compliance, standardizing your processes, and delivering role-specific team training.
Written By: Ferrin Kilby, Founding Partner / Chief Learning Officer The Advisory Academy
We offer Legalized Marijuana Operators a mobile and online platform for staff training, compliance, and quality management that is unique to our industry and built by experienced industry pros who know how to help your business thrive in the tight regulatory environment of legalized marijuana.
To learn more about partnering with The Advisory Academy, please contact us to schedule a visit with a coach.