Look Behind You...Here Come the Standards and Regulations
As the cannabis industry grows, so does the need for standards and regulations at local, state and national levels beyond the current basic testing requirements. With more and more states legalizing cannabis for both medical and recreational use, the “cowboy” or “wild west” terms we often hear associated with the current state of processing and manufacturing may soon be removed from the cannabis dictionary. A fast-approaching realization is that like many other regulated industries, the only way to assure safe, effective, and high-quality cannabis products is to require companies to meet a consistent, concise level of standards for quality and compliance -- covering everything from growing, extracting and compounding to the manufacturing of edibles and topical creams, so that the end result is assuring the safety of the general public.
What are “Standards and Regulations”?
For decades now, regulated industries - such as pharmaceutical, medical device and food - must follow a specific set of rules created for each respective industry, covering all aspects of the manufacturing of products from receipt of materials from suppliers to approval of the finished products prior to shipping… and everything in between. These “rules” are administered in the form of “Standards and Regulations”; however, where regulations are administered by government and thus considered law, standards are administered by certified groups of experts and international organizations - whereby in some instances - require companies to meet these standards or risk not selling products internationally. Or even worse, preventing companies from being able to sell their products to their discerning customers who now expect these standards to be followed.
Most states have initiated draft “rules and regulations,” which although focus on facility safety, security and testing (quality control), often fall short with regards to processing requirements. This brings us to “standards,” which enhance these state regulations by focusing on quality assurance, compliance and control throughout all aspects of the cannabis manufacturing process. Once these standards are widely distributed and accepted at the state level, the expectation will be that companies must meet these “standards,” perhaps even requiring certification to them. In fact, these standards already exist and are soon to be adopted and facilitated by well known, credentialed organizations, such as ASTM International (www.ASTM.org) whose current standards in regulated industries are the considered the gold standard by which thousands of companies are expected to meet and follow.
Why follow Standards and Regulations? Beyond the obvious…
Once the standards and regulations are made mandatory by the participating states, it is logical to think that companies in the cannabis industry - that contribute to any part of the growing, extracting, processing, handling, labeling or any part of the manufacturing and distribution of cannabis - will need to follow these rules, which will undoubtedly be strictly and regularly assessed for adherence at varying intervals and levels. Any company that aims to become a part of or remain within this industry will need to comply. This is the obvious part. Yet what is not so obvious are the other reasons to do so, which are Quality and Compliance and their direct relation to and impact on profitability.
For example, in a saturated market where hundreds of new businesses are opening annually to take advantage of the “green rush,” we have seen the price per pound of cannabis go from the thousands down to the hundreds. These companies are now vying for a much smaller piece of the market, which means short cuts are being taken in every aspect of cannabis production. This naturally results in poor quality and efficacy of product, which ultimately produces deep monetary losses and upset customers. Frankly, the legitimacy and professionalism of the industry, which so many of us work hard to promote, will only then come further into question. When the proverbial smoke clears, those businesses producing high-quality and effective products by following the standards and regulations will be the only ones to remain standing, and hence, be profitable. Based on examples in other industries, it is nearly impossible to not produce high-quality products with greater efficiency if you control your processes based on the rules and best manufacturing practices.
How do the rules get followed?
Standards and regulations (rules) give the “you shall” aspect of Quality and Compliance. It is up to a company to interpret the standards and build processes that meet the intent of these rules, which then becomes a “we shall.” The framework of these processes is called a “Quality Management System” or “QMS.”
Most people make a product in their home under their own QMS. To make dinner, you have raw materials (food/ingredients) and your own “process” as to how to handle them - refrigeration, storage, carefully handling eggs from the market to the fridge, etc. But first, you have a process as to how to purchase them, even deciding which “supplier” you like based on your perceived quality and experience. Next you have a “production area,” or your kitchen, and you have your own methods and processes for keeping it clean and organized to prevent contamination. When people offer to help with dinner, you describe these “processes” to them and direct them accordingly to make sure your own set of “rules” are followed. In a nutshell, you have the beginnings of a QMS, and probably didn’t realize it. The only real difference between a product at home and one outside of your home is that someone else made the rules, but it is still up to you to implement those processes.
In the cannabis industry, understanding and implementing these processes now - instead of waiting for the standards and regulations light switch to be turned on - will assure you that your company will not be one of the many that will not survive, but instead one of those innovative, benchmark companies you will read about twenty years from now.
You will be glad you looked behind you…
In order to remain afloat, following the standards and regulations through the implementation of a well-defined QMS will be required. It will also demand a bit of work to implement and manage, while also requiring the learning of new processes to become well-versed in those standards and regulations. But instead of looking at this extra work as a necessary evil, look at it as a way of assuring your end-product will be safe and effective, on a consistent basis, which ultimately will protect your investment and garner profits. Moreover, your organization should strongly keep in mind the ethical and moral responsibilities your customers and public expect from you. At the end of the day, you need to ask yourself if you are “OK” with people you love ultimately using your products? And that answer must be yes. That mere fact that our customers are actually human beings, should make wanting to do the right thing, the right thing to do.
For more information about Quality systems, cannabis standards and regulations, and to learn more about how we can deliver a QMS at your business, visit us at www.QAcanna.com.
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