Paradigms of Quality
Paradigms of Quality; Why Quality Control (QC) Testing and Review is Insufficient and How Quality Assurance (QA) Can Help Protect Against Product Liability in the Cannabis Industry
When I initially speak to prospective clients in the cannabis industry about compliance, almost everyone firmly states their companies are compliant and they are “good” in that department. What does the term compliance actually mean? As per the Merriam-Webster dictionary, compliance is defined as: a. The act or process of complying to a desire, demand, proposal or regimen, or to coercion; or, b. Conformity in fulfilling official requirements. When I explain to clients that compliance is a broad meaning term that doesn’t always tell the whole picture, they tend to give a confused and skeptical stare. Inevitably, after some further detailed explanation and discussion, they always get to that point where their face indicates the proverbial “light bulb” has turned on. And it’s at this point when they realize that just because a company meets regulatory compliance, it doesn’t always correlate to the manufacturing of safe and effective products. It also does not mean they have done all that can be done to protect the company from product liability risks. This is where Quality Assurance can be your company’s best friend.
Two questions I often challenge cannabis business owners to ask themselves are: 1. Does the status of “compliant” with any given regulations give my organization a sense of protection with respects to product liability risk? and, 2. Is the Quality Control testing of my end products truly sufficient as many in the industry purport? These two questions should be thought about by every license holder that manufacturers an ingestible or human contact cannabis product and by every one of their end-users. Not only are they directly correlated to the success and sustainability of your business in this pioneering industry, they directly impact your end-users; hence, your customers. They can also serve to protect your exposure to legal liability.
How compliance can be misleading when it comes to company product liability exposure?
Like food, pharmaceuticals and medical devices, companies are required to be compliant with the applicable, requisite regulations in order to operate their businesses. It is well known in the cannabis industry that variations between state regulations often cause significant harmonization problems for multi-state companies. One state might not even require product Quality Control testing, where some state regulatory bodies can’t even penalize a cannabis business if they are doing things improperly and putting their customers at risk. Such variation in regulations not only introduces ambiguity into the regulatory compliance process, but also potentially puts end-users and business owners at risk. With that said, if a company meets whatever regulations the state and/or municipality has mandated, they are deemed “in compliance” with regulations and free to conduct business.
However, when discussing product liability with business owners in the cannabis space, I oftentimes am asked “If I am compliant with state or local requirements, then I shouldn’t have anything to worry about, right?” The problem with that mindset is that even if you ultimately are protected from liability, which is no sure thing in such an ambiguous industry, the likely damage to your company’s reputation and the money spent on litigation could very well end up putting you out of business. Never mind the public relations resources that will be required to try and repair your reputation, whether you are found at fault or not. So, one may ask what can be done in order to protect their business against such detrimental actions? The answer is look for Quality.
Quality Control (QC) versus Quality Assurance (QA)
Most people in the cannabis industry acknowledge that lab testing of ingestible products should be a mandatory requirement. With QC testing, we can identify what's in the product, quantify the level of active ingredient(s), and generally ensure it is safe for use. Unfortunately, relying solely on QC testing, which is primarily a post-production reactive process, has historically been insufficient. Fortunately, QA principles consist of proactive steps that are completed throughout manufacturing processes and are thought about ahead of time, making them extremely valuable to an organization.
QC testing and reviews are evaluative processes. They are a set of activities or processes that are used to determine whether Quality was built into a product. It is completed after a product is made. These testing or review processes allow us to see where there might be deficiencies and possibly correct or reject the products before going to market. For this reason, QC testing is really the minimally acceptable (last chance) method for determining whether a product is safe for the market. If it is the primary, relied upon Quality determining process within an organization, then it is what Quality professionals consider attempting to test quality into a product. Though final product QC testing is a way to prevent defective or low quality from getting out to market, when solely relied upon, it frequently results in the organization suffering from gross process inefficiencies and a general lack of critical controls throughout. This often correlates to a significant impact on profitability, along with a necessity to complete a 100% final inspection and testing of critical specifications for manufactured finished products. More often than not this is not practical or cost efficient to a manufacturer. QC tests that are destructive (product is not usable after testing) do not realistically allow testing of 100 percent of all finished products, so here lies the conundrum with just relying on QC testing for Quality manufacturing.
Where QC is an evaluative reactive process, QA is an evaluative, proactive process. It consists of a set of activities that assures that Quality is designed or built into a product from the beginning of the manufacturing process. These activities take place before, during and after production of products. This is done via activities like in-process testing (tests/inspections that occur during the manufacturing process), qualification of raw material suppliers, qualification of manufacturing and critical equipment, validation of manufacturing and control processes, corrective and preventative actions for the things that go wrong, control of manufacturing and organization documents, etc. These activities or processes help assure that when a product does undergo QC testing or review, that a Quality end-product is expected with a high level of confidence. It’s expected because we designed the manufacturing processes to be in control and consistent. In Quality, this is what is known as validating or confirming the expectation of a quality product, so that QC final testing or inspection just ensures that the whole process is working as it was designed to.
QA activities are also used to learn from defects and errors within manufacturing or organizational processes, so as to prevent or mitigate their rates of occurrences. This is why a company’s Quality Management System (QMS) has a goal of establishing a continuously improving/learning environment. Establishing and monitoring quality metrics and data allows an organization to evaluate how it is performing and where improvements can be made in order to increase process controls and efficiencies.
Why should we have or even need QA?
One of the first questions companies ask when being made aware of how valuable Quality Assurance is, is how can they afford to implement such quality measures and policies? Unfortunately, the real question should not be how can they, but rather how can they not? Assurance of Quality allows for less defects and more accurate identification of an organization’s risks which in turn also helps the organization protect itself from product liability actions. Increasing overall process efficiencies leads to less waste of time (time is money), materials and general resources. Actions like qualifying your raw or in-process material suppliers helps assure that those suppliers are also manufacturing in a controlled, consistent and responsible manner.
This is no different than when someone goes to a quality grocery store, so they can make a meal for friends or family. Their past evaluative processes have identified where to go to get the best raw materials (food), so they can feel assured that their end product (meal) will come out with an expected level of quality. Things like systematically documenting your processes and actions allows your organization to easily repeat a process that is proven to work consistently. In the home, this is why recipes (directions to a process) are essentially a fail-safe way to cook; they provide concise directions that are step-by-step in nature. Documentation processes can also provide your organization visibility into what is going on throughout all facets of operations and where potential errors might occur.
It is for these reasons and more that Quality departments are mandated in highly regulated industries, such as Pharmaceuticals, Medical Devices, Biotechnology, Food, Dietary Supplements, Aerospace, Automotive, etc. With the cannabis industry being so new and vulnerable, there are even more reasons for companies to be proactive and set themselves up for sustainability. Most importantly though, it allows your organization to consistently produce a safe and effective quality product for your end-users - the paying (and hopeful repeat) customers.
For more information about Quality Assurance and Quality Control, and to learn more about how we can deliver a QMS at your business, visit us at www.QAcanna.com.
© 2017 QAcanna - All rights reserved.