The cannabis industry culture is full of passion that many envy, and for good reasons. The roots of the cannabis plant go back thousands of years. As of this writing, there are no documented human deaths from phytocannabinoid overdose. Not all rainbows and unicorns are, however.
Before the groundbreaking ceremony, fundraising, proper facility design, competitive application, and approval requirements are just the beginning. After operations, companies struggle to keep up with the ever-evolving regulations. Cannabis growers struggle to expand while also alleviating the pest infestation that is a part of life in conventional agribusiness. A lack of consistent products frustrates consumers while regulators and policymakers continue to struggle over how best to regulate a commodity with seemingly endless demand. The reality is staggering!
With all the challenges and opportunities, however, one constantly overlooked tool stands out: a quality management system (QMS). Merriam-Webster defines a system as “an organized set of doctrines, ideas, or principles normally intended to explain the arrangement or operation of a systematic whole”.
A QMS documents processes, procedures and responsibilities to which a company’s activities ultimately relate Meet customers and regulatory requirements as well as continuously improve it is effectiveness and Efficiency. In other words – it steers innovation by collecting data while ensuring the safety of the products for the consumer. The American Society for Quality (ASQ), now over 70 years old, is an excellent resource and provider of resources and formal training programs recognized and revered around the world.
Step 1: Define your stakeholder requirements
It all starts with knowing the needs of your stakeholders (e.g. customers, regulators). For the sake of simplicity, let’s start with your client. on a fundamental level they expect for sure, consistent and reliable Products that convey a specific experience.
How does that translate into specifications? Let’s look at them one by one.
What does “safe” mean? For an edible, safe product, the product means that it is free from physical, chemical and microbial hazards. Understanding your raw materials (inputs) and the manufacturing process is important to understand what potential impurities your product may contain. For a deeper look, some aspects of safety and quality, product specifications, and testing considerations are discussed in this recent Cannabis Industry Journal article by Dr. Rye and Mr. Skrinskas discussed here.
An example of a compliant label in Oregon
What does “consistent” mean? This builds up and complements the security profile. This could mean a constant level, an acceptable range of cannabinoid concentration, etc. For example, in the peer-reviewed US Pharmacopeia article on quality features of cannabis inflorescence (commonly known as flower or bud), they recommend 20% as the acceptable variance in cannabinoid content. For a product with 25% THC, the product is actually tested for 20% to 30%. This may be surprising and uncomfortable for some, but the reality is that products on the market keep failing to meet what the label says.
What does “reliable” mean? This may mean that you always have stocks of certain products on your pharmacy shelves. Define “always” as a SMART goal – maybe that means you have your top 3 products in stock at least 90% of the time. Customers need to feel that they can rely on your company to provide the products they want. Take the time to gather the data your customers want and work to meet their needs and you will see your business really accelerate.
Step 2: create your processes to meet these expectations
This is where your written standard operating procedures (SOPs), forms and records come into play. Your SOPs are used to save your operations for the sake of consistency. Most SOPs in the cannabis industry are not written by the actual operators of a process. Rather, they are written by the legal and compliance team without operator review to verify that what they state reflects operational reality. The audience has to be Operator. Without effective SOPs used by your employees, your company will struggle to meet the established specifications. Cannabis companies in Colorado, the oldest regulated adult cannabis market in the US, continue to see 1 in 8 of their products fail final product testing! Cannabis companies that understand their processes, document them in SOPs, and have records to prove they are following their SOPs (see step 3) can reduce errors that ultimately lead to costly rework and product defects.
The consistency of quality standards requires careful SOPs
Step 3: monitor and improve
You have your requirements, you have your process, but how do you know they are being met? By the time you have results from a third-party lab, it’s too late. Look inside. Records and logs showing that preventive maintenance has been carried out, room and canopy temperature and humidity checks, inventory reports, production records, extraction equipment reports, and staff training records should not be populated just for filing. These records are data, that is Your most valuable tool. Unfortunately, records are one of the most overlooked assets in the cannabis business today. An operationally independent team (usually a quality unit) should regularly review them for inconsistencies and trends that can alert you to catastrophic failures before they occur.
The extra expense and learning curve may make this seem like an additional burden at first. Note, however, that to be successful in today’s cannabis industry requires long-term customer loyalty. By biting off bit by bit, you can slowly implement a QMS that will improve your business, increase customer satisfaction, and ensure your brand is a staple for years to come. Remember, quality and compliance is one Travel, not a situation where you set it and forget it.
The definition of a quality management system includes “continuous improvement”. Look forward to a future article that will discuss the importance of tools like a CAPA program – Corrective Actions Preventive Actions (which all Colorado cannabis license holders must have by January 1, 2021) and how to complete your QMS. Stay Compliant and Reduce Your Business Risks!