Tag Archives: document

June 14, 2023

The Sensory Branding Opportunity for Cannabis Products

By Dr. Ed Szczygiel

Cannabis brands are facing a proverbial fork in the road: determining whether their product evolves into a luxury consumable or affordable agricultural commodity. While it is reasonable to assume the cannabis market space will organically grow into a luxury goods industry such as wine and spirits, the luxury brands that serve as the foundation of these markets were built over years of engagement between consumers, connoisseurs and producers. If cannabis companies want to successfully market their products as luxury items, a concerted effort towards well-defined, consumer-accessible branding is required.

The first step towards evolving a cannabis brand towards luxury is overcoming the fixation on cultivar identity. Unregulated cultivar naming currently impedes creativity and craftsmanship, disrupting brands and salespersons’ abilities to clearly communicate strain aesthetics.

The good news is the alcohol, coffee and consumer packaged food (CPG) industries have done most of the heavy lifting, paving the way with robust sensory science and analytical approaches to product characterization. Cannabis stakeholders need only adapt their tools and apply them to cannabis with similar intention.

Research suggests that aroma is one of the strongest predictors of positive consumption experience. As adult use consumers become familiar with current product offerings and increasingly legal availability, they will seek products that consistently yield the best experience. The most successful brands will be those that most effectively communicate that experience and then deliver it. The status quo – describing aroma using strain names, top terpenes or THC content – is not effective at harmonizing a brand’s promise with consumer experience.

Figure 1: Illustration of both the conventional branding approach (top) and the sensory-based branding opportunity (bottom).

The conventional cannabis product branding approach leaves to be desired a tremendous opportunity to characterize cultivars (Figure 1). Sensory science, the discipline used to evoke, measure, analyze and interpret reactions to materials through human perception, has been used for decades to characterize CPGs from skin lotion to washing machines. Adapting these well-established techniques for use in cannabis can be challenging, but it is certainly worth the investment.

These shifts in the cannabis industry have already begun to occur. I recently was the principle investigator on a white paper that presented a novel cannabis aroma wheel derived from aroma descriptors and a panel of trained sensory experts. In the study, sensory scientists evaluated randomly sampled cannabis flower over a period of several months. The researchers combined qualitative focus panels, literature review and formal blinded sensory tests to develop a comprehensive lexicon that served as a tool for trained evaluators to characterize cannabis aroma. This novel and robust tool (Figure 2) was designed to be used by trained panels to characterize cannabis aroma, is freely available and is just the beginning of a collective development of a data-driven cannabis lexicon.

Much like the World Coffee Research Lexicon referenced here, the Cannabis Aroma Lexicon is a tool with a specific purpose: collecting an objective description of the product aroma. It is a living document that will grow along with the industry. In the future, we may have lexicons to describe more than just aroma. Tactile and appearance sensory attributes of cannabis will gradually be defined by sensory scientists, presenting more opportunities for deep craftsmanship in the cannabis industry.

The role that dispensaries play in adoption of standardized quality metrics is critical. The product features that position cannabis to be a craft product warrant the presence of a third-party expert to translate and guide consumers during the purchasing process. It’s intuitive to ask a waiter to recommend a pairing (i.e., a dry red wine to pair with a seafood dish), given the trust that consumers put in the restaurant to understand the properties of the food they are serving. Dispensaries have thus far filled the service structure role for cannabis, but the vast amount of unknowns regarding the physiological and sensorial effects of cannabis have resulted in inconsistent experiences that leave something to be desired in terms of consumer trust.

Application of sensory science in cannabis is an unparalleled opportunity for brands to build consumer trust and differentiate their products in a sea of strain names and high potency flower. Cultivars that can be established as measurably aromatic in a specific character can leverage that aroma profile to add significant value to the product. For example:

Cultivar name can be aligned with the perceived aroma (e.g., garlic is not bad, but expecting tropical and getting garlic can harm consumer trust).
Product catalog can be consolidated and optimized to avoid sales cannibalization by growing specific products to meet consumer group’s needs.
Guesswork is removed from breeding by measuring when a product is meeting sensory goals and ensuring it doesn’t drift over time.
Demonstrating transparency will win over ethical consumers. Utilizing controlled, blinded studies to profile aromas will add value to ethics-minded consumers.
Becoming a leader in connoisseurship. In the forefront of this shift in branding, one can position a brand to be ahead of the competition.
Elevating the dispensary experience. By utilizing aroma profiling, products can be more easily sold by budtenders and salespeople.
Opening doors to new application types (e.g., seasonal, occasion centered or geographically unique cultivars).

These are just some of the ways that aroma characterization will differentiate products and simultaneously contribute to cannabis brands’ ability to communicate craftsmanship and the maturity of the industry as whole. Not only will adoption of robust sensory-based branding improve the consumer experience by providing a means to compare products to one another, it will promote adoption of good manufacturing practices that simultaneously improve the quality and safety of cannabis products. Without consumer-accessible quality metrics, brands have little incentive to produce products of elevated quality and are conversely incentivized to prioritize quantity and meet minimum regulatory requirements.

Importantly, cannabis businesses will use this tool to adapt to an inevitable industry-wide shift towards connoisseurship and application of robust sensory science. While it may be challenging to shake off the “bad habits” that currently plague many brands, cannabis has significant potential as a luxury good. Consumers are eager for a better cannabis experience from purchase to consumption. How will your brand use sensory profiling to expand or evolve product offerings to succeed in a cannabis market full of luxury brands and what steps will you take now to prepare?

January 9, 2023

The 3-Legged Stool of Successful Grow Operations: Climate, Cultivation & Genetics – Part 6

By Phil Gibson

No Comments

This is Part 6 and the final chapter in The 3-Legged Stool of Successful Grow Operations series. Click here to see Part 1, here to see Part 2, here to see Part 3, here for part 4 and here for Part 5.

Standard Operating Procedures (SOPs)

Figure 1: Precision aeroponics at FarmaGrowers GMP Facility, South Africa

Every objective has to have a vision and a vector of where you want to go and what you want to achieve. “Winging it” is okay for an innovative artistic endeavor where creativity is spontaneous and one-of-a-kind art is produced. Unfortunately, that is not how one creates a top-quality cultivation operation.

Customers expect guarantees of consistency; quality assurance means a purchase is safe to consume. Medicinal products around the world require Good Manufacturing Practices (GMP) certification. These are really just SOPs that document repeatable procedures to guarantee that the most recent batch offers the same results as the first certified effort. This brief covers the importance of documented operating procedures for a successful grow business with high quality customer results.

Figure 2: The objective – trichome covered flowers, DanCann, Denmark

Almost nobody gets excited about discussing quality, but experienced manufacturers know that quality control reduces waste and improves operations. Everyone learns that they have to implement feedback, improvement and quality control procedures to guarantee profitability and longevity in any business.

So, what is an SOP? A standard operating procedure defines ‘a task’ to be performed ‘at a location by a person or a role on a specific schedule.’ These definitions will include role definition, responsibilities, personnel training, equipment & service procedures, material handling, quality assurance controls, record keeping, approved procedures & instructions, documentation, references and appendices, all of which define your business and how it is to operate.

Now, you might ask, we are just growing plants, is all this really necessary? The short answer is, it depends. If you expect to export globally, do business in Europe and other markets, get licensed by Health Canada or some day be approved to ship to other States, then yes. If you are a regional craft cannabis supplier, maybe not, but there are many tasks that are required to grow where a better documented process can benefit your operation and the quality of the product delivered to your consumers.

Figure 3: Flower maintenance, DanCann, Denmark

We provide a bulleted list of recommendations in the full white paper but to touch on a few highlights that every operator should keep in mind, SOPs define the following structures for your business.

Personnel training is done for ‘this task, in this way’ & ‘this role is responsible’

Job descriptions reduce misunderstandings and increase worker ownership in your facility. Documenting your activities minimizes task overlap and conflicts that can lead to no one executing on something that may be important but not urgent. You want to eliminate employees thinking “I didn’t know it was my responsibility.”

Consultants or visitors must be aware of and follow the same requirements as your employees if you are to maintain the quality of your grow. Specific training should be given to anyone that handles or works around toxic chemicals. Safety sheets are not just paper; They keep people alive.

Equipment & Service Procedures

Be direct and specific in your task definitions, i.e., “Use 5ml of soap, clean until no plant matter or debris remains.”

Figure 4: Full GMP certified facility, FarmaGrowers, South Africa

Ideally, grow facilities, equipment and access will be designed with cleaning in mind from the start. This is not always possible but it is the mark of successful manufacturing or production companies.

Cleaning, cleaning, cleaning: think sterile, food safety and consumer consumption protections. SOPs should define cleaning methods and materials. This cleaning is done on schedule and aligned to your preventative maintenance and calibration requirements. Precise results require precise structure for any long-term operation.

We recommend that you integrate pictures and videos in the instructions for your procedures and training so that nothing is left to chance or misinterpreted.

Material Handling, Containers, Labels, Quality Assurance

Personnel contamination/cross-contamination are the death of any grow operation. Do everything you can to limit stray or wandering plant material, dust or debris from migrating from one grow room or area to another. Isolation is a good way to limit outbreaks to a specific room to minimize losses.

Figure 5: Documented SOPs must be followed & reviewed regularly

If something nasty happens to one of your rooms. Good labeling enforced by your quality assurance team is a simple way to increase the likelihood that employees will do a task as intended. This adds to your repeatability as people change jobs or roles are redefined.

Approved Procedures & Instructions

Quality assurance is all about repeatability and intended outcomes. Documenting procedures and intended use enables every new employee to follow the experience of the masters and duplicate their success. Testing, sampling and logging your results along the way enables you to know that you are on schedule and on process, so you can predict your results every time.

Part of your continuous improvement approach will be to deal with exceptions that are not covered by your procedures. Learning about those exceptions and capturing your experience with an improved method will lead to better outcomes the next time around.

Documentation, References, Appendices

You’ve done all of this hard work to capture your operation, so you need a complete library of your reference work and approach that employees can access. It does your operation no good if you capture your methods and no one ever looks at them again. Training cycles and reviewing your defined procedures is key to a consistent high-quality result.

Hero Award

Standard Operating Procedures (SOPs), Good Manufacturing Procedures (GMP) and Good Agricultural & Collection Practices (GACP), are all terms that will become more familiar as cannabis production joins into one global market. Professional results will be required and national or international certifications will be the guarantees that any global customer can trust that a product meets the standards they expect.

We have many customers in North America and around the world. but DanCann Pharma is the most aggressive when it comes to meeting international standards and results. Producing flower that is so pure that no irradiation is required for export, the DanCann operation is fully certified for production throughout Europe and they are sold-out of capacity for the coming year. They are currently expanding their operations in Denmark and are a solid example to follow for a well-defined repeatable operation. FarmaGrowers in South Africa is a close second in this race with multiple export certifications of their own. The future looks bright for both of these global operations.

For the complete white paper on Top Quality Cultivation Facilities, download the document here.

October 25, 2022

Soapbox

Five Reasons Everyone in Cannabis Should be Using RegTech

By Brooke Butler

No Comments

As the cannabis industry continues to grow, regulations will only get more onerous and complex, and enforcement will ramp up. In order to survive, it’s imperative for cannabis business owners and the ancillary companies that support them – such as banks, insurance agencies, law firms and marketers – to keep on top of regulations.

Due to cannabis’ fractured regulatory environment, confounding state and local laws, and the fact that regulations are constantly changing, keeping track of it all can nearly seem impossible at times. But companies don’t need to reinvent the wheel and handle compliance on their own.

There are a host of tools on the market today that can help cannabis related businesses (CRBs) streamline their operations. RegTech solutions can drastically reduce the challenges of navigating compliance, saving companies significant time and money so they can focus on their core competencies. Here, let’s take a look at five of the main reasons everyone in the cannabis ecosystem should seriously consider adopting RegTech solutions today.

1. Simplify the Complex

The heart of RegTech solutions is taking out the guesswork when tackling compliance while mitigating risk. Besides there being a vast number of regulations that vary by state, they’re also not easy to understand – they’re really written for lawyers, can be hundreds of pages long, and don’t offer implementation guidance. Thankfully through RegTech, operators and ancillary companies are alerted when regulations change and are given easy-to-follow implementation and remediation guidelines that can be as easy as checking a box.

Beyond just simplifying compliance, RegTech can substantially increase operational efficiency.

As the cannabis industry has been rapidly growing and maturing, we’ve been seeing a major uptick in M&A activity – M&A activity tripled in the sector from 2020 to 2021 – and with each new state a company enters, comes a host of new regulatory challenges. When expanding to a new state, RegTech solutions provide updates in real time, making sure, for example when you expand to Ohio, it’s not at the expense of complying with regulations in your core market of Illinois. Also, from an operations strategy perspective, RegTech solutions can be incredibly useful in helping companies decide what markets to pursue, as they can offer regulatory snapshots that compare tax laws, average margins, consumer segments, product stipulations, marketing restrictions and more. Thus besides simplifying compliance, RegTech can substantially increase operational efficiency.

Since cannabis is such a highly regulated industry, there are a ton of documents an operator has to keep on hand and be able to produce in a moment’s notice. Through RegTech, operators can store and organize all documents that are applicable to them electronically. So, when an inspector comes into a dispensary for a surprise inspection, rather than sweating bullets and digging through six filing cabinets trying to locate say a visitor log from three years ago, using RegTech a manager can quickly search records electronically, download and print the needed document, pass the inspection and go back to work.

2. Save Costs by Streamlining Compliance

While adopting RegTech solutions has a cost, the cost savings companies yield from RegTech way exceed the investment. RegTech providers have teams of dedicated analysts constantly tracking regulations and providing updates, making it so companies don’t need to hire much more costly lawyers to track regulations and amend policies and procedures. Rather, they can tap into RegTech solutions and leverage decades of experience and lean on the best regulatory experts in the field, while saving a lot of money.

RegTech providers have teams of dedicated analysts constantly tracking regulations and providing updates,

Just to give a small example of the cost savings RegTech can provide, on average a CRB spends over $20,000 to produce a new SOP package when using an attorney and nearly $8,000 when updating an SOP package using an attorney. Compare that to Simplifya’s fully customizable SOP package, where a CRB spends on average less than $1,600 to produce a new SOP package and less than $650 to update an SOP package – a 92% savings.

When considering costs, it’s important to think holistically and anticipate potential problems that could come up. One of the biggest pain points for companies starting up operations or entering new markets is complying with confusing tax codes – no industry is taxed to the degree cannabis is, and it’s easy to lose sight of tax obligations when planning operations. Unanticipated withholding requirements can create serious cash flow problems. RegTech solutions clearly outline requirements, as well as track updates, which help companies plan operations and expansion plans and prevent nasty tax surprises from creeping up, and they’re a much cheaper alternative to hiring tax lawyers.

While there are tremendous growth opportunities in cannabis, the industry is also facing significant headwinds, including the high cost of capital, supply and demand misalignments, and shrinking margins, and as we head towards recession, cost efficiency will become more and more important. Not only can RegTech help companies survive by helping ensure they stay compliant and don’t get fined or even shut down for breaching regulations, they also help companies run more efficiently and save major costs on operations.

3. Hold Your Employees Accountable

In addition to using RegTech to stay on top of compliance, it can be a powerful HR tool as well. Companies can utilize RegTech platforms to make and track assignments and tasks for employees. If you’ve already spent the time and money to create SOPs, RegTech tools are essential to making sure they’re actually being followed correctly.

As many cannabis companies are expanding rapidly and bringing new employees into their fold – particularly those that are engaging in M&A – it can be difficult to get employees up to speed and following SOPs. RegTech automation and tracking solutions help flatten the learning curve and ensure employees are completing tasks on time, boosting efficiency and preventing problems that may arise – and if problems do arise, the tools help pinpoint where and when for efficient remediation. And if you’re an MSO or a SSO with multiple locations, RegTech allows employers to keep track of their dispersed employees without having to be in 10 places at once. This holds employees accountable for their actions for smooth operations while reducing growing pains.

4. Identify Issues Before They Become an Issue

The most compelling reason for having strict regulations in the cannabis industry in the first place is to protect consumer and patient health. Given the long, brutal history of cannabis prohibition, where lies and misconceptions about cannabis consumption being “dangerous” were perpetuated in the mainstream, the last thing the industry needs is people consuming products that are in any way contaminated. If you skirt the rules and manage to put out compromised products without a regulator catching and dinging you first, consumers may get sick. This can lead to a recall and tarnish a brand’s reputation. Competition is steep in this industry and even one incident can be irrecoverable. If consumers have reason to believe you’re not putting out consistent, safe products, they’ll buy from your competitor instead.

RegTech helps companies track all processes and procedures so that they can spot problems before they occur and ensure nothing dangerous makes its way to the public, which in turn shields brand reputation. Also, it’s important to note – in the cannabis ecosystem, every company you work with has to be licensed. If you work with an entity that’s not, you are very liable. Tracking licensing information is burdensome, especially for retailers and ancillary businesses like lenders and insurers who work with many vendors. Luckly, RegTech providers have already done the heavy lifting, pulling APIs into state databases and creating tracking systems of licenses that make it easy for companies to ensure every entity they work with is operating with a valid license. This saves companies from having to hire people to track licensing information on a weekly or even daily basis, which can be very costly, and more importantly, keeps them compliant and prevents slip ups that could jeopardize consumer and patient health.

5. Looking Towards the Future, Regulations will Only Become more Complex – Only the Compliant Will Survive

A common misconception people have about the cannabis industry is thinking that federal policies like SAFE banking will be a catch-all to their banking woes, opening up the floodgate to institutional investment. The fact of the matter is, however, SAFE banking would be ineffective without RegTech. Cannabis companies need to demonstrate reliability and a history of compliance in order to attract investors and accumulate capital, and they do this through using RegTech platforms. Conversely, financial institutions also use RegTech to verify licenses, ensure legitimacy and assess lending risks based on the locations in which their borrowers operate. After SAFE banking is finally enacted, since larger institutional investors have so much on the line, they’re going to be particularly careful and only invest in those companies that can comprehensively demonstrate a history of compliance. This will also be the case for major CPG companies looking to acquire cannabis companies – they’ll want companies that have used RegTech to show compliance and optimize operations, since those companies will be more trustworthy and transitioning them under new management will be easier. In every major industry other than cannabis, RegTech solutions have been adapted. This is where cannabis is headed, and the companies that adopt solutions and demonstrate compliance will come out ahead.

Cannabis companies need to demonstrate reliability and a history of compliance in order to attract investors and accumulate capital

The other major misconception some people have about the cannabis industry is that once cannabis is legalized on a federal level, state and local regulations will somehow just go away, so current RegTech solutions may become ‘obsolete.’ This couldn’t be further from the truth. In no world is there going to a federal legalization system that says states can no longer create their own rules around cannabis. Think about the alcohol or gambling industries. Alcohol and gambling are federally legal, but every state – and even some counties and cities within those states – can have very different rules. Federal legalization will just mean additional regulations will be piled on and thus RegTech will only become more important.

While many companies in the cannabis space have already adopted RegTech solutions, there are still many others that have taken a reactive rather than proactive approach towards compliance. When major legislation like SAFE banking or federal legalization is approved, there will be a paradigm shift and RegTech will be deemed more essential quickly. Those who have implemented RegTech will have distinct advantages. To survive and thrive in the industry going forward, it’s prudent to proactively handle compliance and adopt RegTech solutions today.

November 2, 2021

Cannabis Recalls: Lessons Learned After Three Years of Canadian Legalization

By Steven Burton

1 Comment

Three years ago, Canada became one of the first countries in the world to legalize and regulate cannabis. We’ve covered various aspects of cannabis regulation since, but now with a few years of data readily available, it’s time to step back and assess: what can we learn from three years of cannabis recalls in the world’s largest legal market?

Labelling Errors are the Leading Cause of Canadian Cannabis Recalls

Our analysis of Health Canada’s data revealed a clear leader: most cannabis recalls since legalization in October 2018 have been due to labelling and packaging errors. In fact, over three quarters of total cannabis recalls were issued for this reason, covering more than 140,000 units of recalled product.

The most common source of labelling and packaging recalls in the cannabis industry (more than half) is inaccurate cannabinoid information. Peace Naturals Project’s recall of Spinach Blue Dream dried cannabis pre-rolls this year is a good example. Not only did the packaging incorrectly read that the product contained CBD, but the THC quantity listed was lower than the actual amount of THC in the product. The recall covered over 13,000 units from a single lot sold over 10 weeks.

In another example, a minor error made a huge impact. British Columbia-based We Grow BC Ltd. experienced this firsthand when it misplaced the decimal points in its cannabinoid content. The recalled products displayed the total THC and CBD values as 20.50 mg/g and 0.06 mg/g, respectively, when the products contained 205.0 mg/g and 0.6 mg/g.

Accurate potency details are not just crucial for compliance. For many customers, potency is a deciding factor when selecting a cannabis product, and this is especially important for medicinal users (including children), people who are sensitive to certain cannabinoids and consumers looking for non-psychoactive effects. In this case, at least six consumer complaints were submitted to Peace Naturals Project, the highest number for any cannabis recall in Canada.

Frequent, integrated lab testing, an effective and robust traceability system, smaller lot sizes during production and consistent quality checks could have helped Peace Naturals Project and We Grow BC limit the scope of their recall or avoid them altogether.

Pathogens are the #2 Cause of Cannabis Recalls in Canada

Pathogens are the second most common cause of recalls in Canada, claiming 18% of total cannabis recall incidents. And while that doesn’t sound like much compared to the recalls caused by labelling errors, it affects the highest volume of product recalled with over 360,000 units affected.

Canadian Cannabis Recalls – Total number of affected units and noted causes

A primary cause of allergens and microbiological contamination of cannabis products is yeast, mold and bacteria found on cannabis flower (chemical contaminants like pesticides can also be a major concern). Companies like Atlas Growers, Natural MedCo and Agro-Greens Natural Products have all learned this lesson through costly recalls.

These allergenic contaminants pose an obvious health risk, often leading to reactions such as wheezing, sneezing and itchy eyes. For people using cannabis for medical conditions and may be more susceptible to illness, pathogens can cause more serious health complications. Moreover, this type of cannabis recall not only drives significant cost since microbiological contamination of flower could easily affect several product batches processed in the same facility and/or trigger downstream recalls, but also affect consumer confidence for established cannabis brands.

Preventive control plan requirements for cannabis manufacturers mandate that holders of a license for processing that produce edible cannabis or cannabis extracts in Canada must identify and analyze the biological, chemical and physical hazards that present a risk of contamination to the cannabis or anything that would be used as an ingredient in the production of the edible cannabis or cannabis extract. Biological hazards can come from a number of sources, including:

Incoming ingredients, including raw materials
Cross-contamination in the processing or storage environment
Employees
Cannabis extract, edible cannabis and ingredient contact surfaces
Air
Water
Insects and rodents

To mitigate risks, addressing root causes with preventative measures and controls is essential. For instance, high humidity levels and honeydew secreted by insects are common causes of mold on cannabis flowers. Measures such as leaving a reasonable distance between plants, using climate-controlled areas to dry flowers, applying antifungal agents and conducting regular tests are necessary to combat such incidents.

control the room environment — Preventative measures and controls can save a business from extremely costly recalls.

Of course, placing all the necessary controls into action is not as simple as it may sound. Multiple facilities and a wide range of products in production mean more complexity for cannabis producers and processors. Any gaps in processing flower, extracts or edibles can result in an uncontrolled safety hazard that may lead to a costly cannabis recall.

These challenges are not just limited to cannabis growers. The food industry has been effectively mitigating the risk of biological hazards for decades with the help of food ERP solutions.

Avoid Recalls Altogether with Advanced ERP Technology

An effective preventative control plan with regular quality checks, internal audits and standardized testing is important to minimize the threats evident from Canada’s recall data. If these measures ever fail, real-time traceability systems play a pivotal role in the event of a cannabis recall by enabling manufacturers to trace back incidents to the exact point of contamination and identify affected products with surgical precision.

Instead of starting from zero, savvy cannabis industry leaders turn to the proven solutions from the food industry and take advantage of data-driven, automated systems that deliver the reliability and safety that the growing industry needs. From automated label generation to integrated lab testing to quality checks to precision traceability and advanced reporting, production and quality control systems are keys to success for the years ahead.

September 1, 2021

Best Practices for Training New Hires and Documenting Operations

By Dede Perkins

No Comments

Let’s just say it. There is an undeniable chaos in the cannabis industry. It doesn’t matter if you’re a big or small operator, it’s likely that you don’t have a documented system for creating and managing ever-changing SOPs or for consistently training all employees on the most current versions of those SOPs. This chaos is often the result of rapid growth, mergers and acquisitions, and the ever-present turnover in our industry. When department leadership changes, and it often does, established policies and procedures are often left behind. In some cases, this is a positive sign of growth. As a company outgrows SOPs and as it develops more sophisticated ways to cultivate, extract, process, manufacture, package and sell cannabis and cannabis products, inevitably, the old ways of doing business need to be replaced. For those operators who have prioritized operational excellence, whether they want to position their company for new investment, merger or acquisition, or just want to create a consistent and standardized, branded product, it’s critical to get control of SOPs, training and documentation.

Food processing and sanitation — By standardizing and documenting safety procedures, manufacturers mitigate the risk of cannabis-specific concerns

As with most big goals, to obtain operational excellence, you need to break the goal into manageable steps. Assuming you have accessible quality policies and procedures in place, properly training employees when they first start work and on an ongoing basis as policies and procedures change is the number one key to successful operations. When employees know how to do their job and understand what is expected of them, they are positioned for success. When employees are successful, it follows that the company will also be successful. Documenting operations is a second important step in obtaining operational excellence. While training and documentation appear to be different, in best-practice organizations, they are inextricably linked.

One Set of SOPs

Those of us who have been in the cannabis industry for a while have experienced firsthand or heard stories of facility staff working off of two sets of SOPs. There’s the set of SOPs that are printed or digitally available for the regulators, let’s call them the “ideal” set, and then there are the SOPs that actually get implemented on a day-to-day basis. While this is common, it’s risky and undermines the foundation of operational excellence. Employees often know there are two sets of SOPs. Whether they express it or not, many are uncomfortable with the intentional or unintentional deception. When regulators arrive, will they have to bend the truth or even lie about daily operations? Taking the time to establish and implement one set of approved SOPs that is compliant with both external regulations and internal standards is good for employee morale, productivity and ultimately, profits.

What’s the best way to get control of a facility’s SOPs? Again, break it into manageable steps:

First, task someone with reviewing all SOPs that are floating around. Determine if any are non-compliant, which ones need to be tossed and which ones need to be revised so they work for the company as well as outside regulatory authorities.
At a minimum, establish a two-person team to draft, review, publish and distribute the final SOPs. Ensure that at least one member of the team has management level authority. Assign that employee the responsibility of reviewing the SOPs before “publication” and distribution.
Archive, delete, or actually throw away outdated or non-compliant SOPs
Revise or create new best-practice SOPs that are in compliance with external regulations and internal standards
Establish a system to update SOPs when external regulations and internal standards change
Use a naming convention that distinguishes draft SOPs from final SOPs, for example, “Post-Harvest Procedure, FINAL”
Inform employees that they will be retrained on the new SOPs and that approved SOPs will always have the word “Final” in the title
Store the final SOPs in an easily accessible location and give employees access, not only during training, but on an ongoing basis

Centralized Repository for Final SOPs

Storing final, approved SOPs in one easily accessible, centralized location and giving employees access sounds simple, but again, this is the cannabis industry, so this often doesn’t happen. Many of us have or are currently working for an organization that stores SOPs in multiple places. Each department may have its own way of updating, disseminating and storing SOPs. Some SOPs are stored in a printed binder stuffed in a drawer or left on a bottom shelf. Others are stored digitally. Some use both systems, which creates confusion. Who knows if the digital versions or the printed versions are the most current? Surely someone knows, but often the front-line staff do not.“Once you’ve established a single set of compliant SOPs and have stored them in one accessible location, it’s time to train your employees.”

Establishing a centralized repository for final, approved SOPs is the foundation of operational excellence. It lets employees know that operations are organized and controlled, and it reassures regulatory authorities and external stakeholders—think insurers, bankers, investors—that the company prioritizes compliance and organization. And external stakeholders who believe that an organization is proactive and well-run tend to be more forgiving when the inevitable missteps occur. Companies that are organized, have effective training systems, regularly conduct internal audits to identify potential issues and take identifiable action steps when necessary to remediate issues, receive fewer deficiency notices, violations and fines than their less organized competitors.

Train Employees

Many states require cannabis operators to provide a specific number of training hours prior to an employee beginning work, and a specific number of continuing and refresher training hours annually. Once you’ve established a single set of compliant SOPs and have stored them in one accessible location, it’s time to train your employees. To do so, set clear expectations and decide who is responsible for what. Is the HR manager responsible for initial onboarding and training? Are department managers responsible for ongoing and annual training? Create a training responsibility chart that works best for your company; write it down and share with all stakeholders.

The next step is to figure out how to train your employees. Individuals have different learning styles, so ideally, you’ll offer multiple ways for them to master the requirements of their position. Assign written materials and if possible, attach short videos showing the best way to complete a task. Follow up with a quiz to determine comprehension and a conversation with a department lead or manager to answer questions and review the key take-aways. Ideally, the department manager or lead employee will work with the employee until they are competent and comfortable taking on new assigned tasks and responsibilities.

Sum It Up

Operational excellence begins with:

Knowledge of and access to current external rules and regulations and internal standards
One set of approved and easily accessible policies and SOPs that comply with both external and internal standards
An initial training system with clearly assigned roles, responsibilities, and goals
An ongoing training system with clearly assigned roles, responsibilities, and goals
Systems to:
- Test knowledge before employees begin unsupervised work
- Stay up-to-date with all changes to external rules and regulations and internal standards
- Control policy and SOP revision process
- Inform all stakeholders when policies and SOPs change
- Test that employees understand new standards
- Document all key areas of operation on a recurring basis
- Address deficiencies and evaluate whether SOP revisions are warranted
- Document and implement necessary remediation when necessary

For those of you rolling your eyes and thinking you don’t have time for this, ask yourself, “Can you afford not to?”

For those of you committed to operational excellence and doing what it takes to get there, congratulations on being a visionary leader. Your efforts will pay dividends for your own company and will help the cannabis industry grow into a well-respected, profitable industry that improves lives.

August 18, 2021

ASTM Proposes New Standard on Change Control Process Management

By Cannabis Industry Journal Staff

No Comments

Change control, when it comes to quality management systems in manufacturing, processing and producing products such as cannabis edibles or vape pens, is a process where changes to a product or production line are introduced in a controlled and coordinated manner. The purpose of change control process management is to reduce the possibility of unneeded changes disrupting a system, introducing errors or increasing costs unnecessarily.

ASTM International, the international standards development organization, is developing a new standard guide that will cover change control process management for the cannabis and hemp market. The guide is being developed through the D37 cannabis committee.

The WK77590 guide will establish a standardized method for change control process management for cannabis companies so that they can document and track important decisions in manufacturing and quality systems.

For example, an edibles manufacturer would utilize change control process management if they want to use a different type of processing equipment or introduce a new shape or design of their product. Without change control process management, that edibles producer might switch to a new piece of processing equipment without knowing that it requires more energy or uses different raw materials, thus making production unexpectedly more expensive.

While that’s a very cursory example, the premise is simple: Before you undergo a change to your process, plan it out, analyze it, review it, test it out, implement it and make sure it works.

Change control process management can often be summarized in six steps:

Plan/Scope
Assess/Analyze
Review/Approval
Build/Test
Implement
Close

Maribel Colón, quality assurance consultant and vice chair of the ASTM subcommittee on cannabis quality management systems, says producers and testing labs will benefit the most from the guide. “As the cannabis industry grows, the quality, expectations, and control challenges grow within,” says Colón. “The creation and implementation of this standard guide will increase cannabis business efficiency and minimize risk, time, and potential cost of poorly managed changes.”

According to a press release, ASTM International is open to collaboration on this as well. Specifically, they are looking for professionals with change control who might be interested in helping advance and develop this guide.

July 22, 2021

Quality Systems 101: CAPA Programs Drive Improvement & Prevent Costly Mistakes

By David Vaillencourt

No Comments

No business is perfect, especially when humans are part of the equation. But, how do you tackle fixing quality issues as they arise? The goal of this article is to shed some light on the value of a CAPA program and why many states are making them mandatory for cannabis businesses.

Let’s consider the following situations:

Analytical lab results for a production batch test above the limit for a banned pesticide or microbial contamination
You open a case of tincture bottles and some are broken
A customer returns a vape pen because it is leaking or ‘just doesn’t work’

Do you…

Document the issue?
Perform some sort of an investigation, asking questions of the people involved?
Ask for a retest? Then, if the test comes back positive, move on?

Let’s go through each one of these and understand why the suboptimal answer could be costing your business money:

You don’t document the issue

I hear excuses for skipping on documentation all the time.

“It’s not a big deal”
“It was a one off”
“The glasses probably broke in transit”
“They are cheap and easily replaceable”
“It’s not worth the time”

Tracking and documenting supplier shipments can help you identify supply chain issues.

In the situation of a couple of broken bottles in a shipment, what if it was the seventh time in the last two months? If you haven’t been documenting and tracking the issue, you have no way of knowing if it was a single occurrence. Remember when you were surprised that your filling team did not have enough bottles? Those broken bottles add up. Without documenting the incident, you will never know if it was truly a one-time mistake or the sign of a deeper issue. The reality is, it could be sloppy handling on the production line, issues with the shipper or even a sign of poor quality coming from the supplier.

Have you ever compared the number of fills vs the number of bottles ordered? How much money have you already lost due to those broken bottles adding up? Do you have the ability to answer this question?

You perform an investigation

Let’s say a customer returns a leaky vape pen. You perform an investigation by asking the production workers what they think went wrong. They say that it’s very difficult to get the seal for the cartridge into place. Their supervisor tells them to try harder, refunds the customer and moves on. But, why is it difficult to get the seal into place? Is it a design flaw? Should a special tool be used to assemble the cartridge properly? Without getting to the root cause of why the seals are leading to leaking cartridges, you are doomed to have repeat issues. Numerous studies have found that less than one in twenty dissatisfied customers will complain, and that approximately one in ten will simply leave for another brand or provider. How much is this unresolved issue truly costing your business?

Asking for a retest and if it passes, releasing the product and moving on.

labsphoto — In Colorado, 15% of the final tested cannabis flower products continue to fail.

Suppose a major producer of cereal received test results for its most popular cereal that were positive for levels of heavy metals that research has shown to be linked to cancer or developmental issues in children. Now, suppose the company stated that it was an isolated incident and a retest showed that the product met acceptable limits. Further investigation showed no paperwork, save for a couple of emails and a phone call between the lab and the producer. Would that give you peace of mind? This is known as “testing into compliance” and was the subject of a landmark lawsuit in 1993 that Barr Laboratories lost.

For many the answer would be a hard NO. But this happens every day. In Colorado, 12.5% of cannabis batches failed final product testing in 2018 and 2019. That’s one in eight batches! What happened to those products? Good question.

Enter: CAPA (Corrective Action and Preventive Action) programs! For people with a background in quality and GMPs (Good Manufacturing Practices), CAPA is a household name. And, it’s quickly becoming a requirement that cannabis regulatory bodies are looking at. Colorado was the first state to explicitly require CAPA programs for all license holders effective January of this year and has provided a free resource for them. But, for the large majority of people, including those in the cannabis industry, it’s just another acronym.

What does a CAPA program do?

The benefits are numerous but two major ones are:

An effective tool for investigating the true root cause

First of all, a CAPA program provides the framework for a tool for investigation – as Murphy’s Law posits – things go wrong all of the time. Whether you have a manual, labor-intensive process or a highly automated operation, the equipment is programmed, maintained and monitored by humans. The logical sequence of problem solving within a CAPA program allows you to thoroughly investigate and determine the root cause of the issue. With a complete understanding of root cause, you are then able to eliminate it and prevent future occurrences – not just in the one area investigated, but in all similar situations throughout the company.

System for continuous improvement

Gathering info from a customer complaint like batch or product IDs can be crucial in a CAPA system

Anyone who is in the market for a new car lately can appreciate the technological advances. In the 1980s, it was air bags and ABS brakes (those of you that drive in snowy climates and remember having to pump your brakes can appreciate technological advancements). Bluetooth technology for hands-free communication and radio control is another example of continuous improvement in cars.

This is one of the biggest predictors and differentiators between profitable and successful companies with satisfied clients and one that is barely scraping by. The cost of poor quality adds up!

Key inputs in a CAPA system

If the output is an improved system and lower cost of quality, we need to make sure we’re considering the potential inputs.

Information that feeds into your CAPA system:

Customer complaints

Every complaint must be recorded. Gather as much information as possible, but at a minimum: the product type/SKU, the customer name and date of purchase. If possible, the batch or product ID.

This is not necessarily to identify products for a recall, but to prevent…

Laboratory test results

This should not be restricted to final product testing, but include any in-process inspections. Say you have a product repeatedly failing final testing, what if it’s actually been consistently failing or very close to failing at the very first in-process inspection? It’s also important to work with your laboratory to understand their method validation process, including the accuracy, precision, robustness, etc.

Infrastructure & environmental controls/monitoring

Most people consider “environmental controls” to be things like temperature and humidity control. While that is true, it can also include pest and contamination control. Poorly designed infrastructure layouts are major contributors to product cross contamination as well.

Supplier information

Undetected supply chain issues (remember the broken bottles?) can add up fast! CAPAs for suppliers cannot just include supplier monitoring, but improvement in how you communicate your needs to your suppliers. It’s easy to overlook non-cannabis raw materials as sources of microbiological and chemical contamination. Conduct a risk assessment based on the type of contact with your product and the types of contamination possible and adjust your supplier qualification program accordingly.

Are you ready to recognize the benefits of a CAPA program?

One more major benefit of CAPA programs to mention before we go is … Preventive via predictive analytics.

In Colorado, 15% of the final tested cannabis flower products continue to fail, mostly due to mold and mildew. A quality system, with effective data capture that is funneled into a CAPA program can easily reduce this by 75%. For even a small business doing $2M per year in revenue, that equates to a revenue increase of nearly $200,000 with no additional expenses.

Whether you are operating in the State of Colorado or elsewhere, a CAPA and Recall program will provide immense value. In the best case, it will uncover systemic issues; worst case, it forces you to fix mild errors. What are you waiting for?

April 7, 2020

Heightened EPL Exposure Hits Cannabis Businesses When Laying Off Employees

By Patrick Ryder

No Comments

Even though it’s valued at more than $15 billion, the burgeoning global cannabis industry has experienced recent layoffs. By the end of 2019, more than 600 cannabis employees got pink slips. Industry experts expect more of the same in 2020 as investigations, lawsuits and slumping valuations plague the industry.

Unfortunately for employers, layoffs are where the issues begin – not end. Especially for those without established policies and procedures. Without rules and regulations governing employment practices, business owners and operators are at considerable risk.

The 11 states where cannabis is legal for recreational use and the 33 where it’s medically legal tend to have more onerous employment practices liability (EPL) laws, where liability is often assumed by the employer for mistakes like poorly handled layoffs. This is further compounded by the fact that HR departments at fledgling cannabis companies tend to be small or non-existent and often ill prepared to deal with the legalities that come with termination.

Ensuring the right practices are in place prior to any layoffs is critical. Is your company facing employee terminations? Are you knowledgeable of how to handle it? Consider the following best practices:

Document problematic employees. Create a folder for each employee and document the details when problematic situations escalate to the point they need to be addressed. Should employees of a protected class engage in an EEOC, class action or personal lawsuit after they’re terminated, you’ll need this documentation to support your actions.
Create a formal termination procedure. Make sure the procedure includes well-thought-out details of your review process, including how employee performance is evaluated and what happens when those standards aren’t met. Spell out which behaviors are grounds for dismissal. When talking to the employee about a termination, have another employee or manager in the room to avoid claims of mishandling later on, typically their direct manager, someone from HR or your in-house attorney. Determine how the distribution of final compensation such as medical insurance or PTO will be handled so you’re prepared to answer those questions. These procedures should be spelled out in an employee handbook given to all at onboarding so there are no surprises.
Retain a qualified EPL attorney. Create a relationship with a qualified EPL attorney (not your cousin who does divorce law) to help you set policies and procedures initially and to consult with when a unique or particularly difficult situation arises.
Get the right EPL coverage. An EPL policy will defend a business from claims of breach of employment contraction, negligent evaluation, failure to employ or promote, wrongful termination, deprivation of career opportunity and mismanagement of employee benefits plans. Your EPL coverage will be determined by your location, clientele, employee profile and what you see as your biggest risks. When discussing the policy with your broker, weigh the following considerations to EPL coverage:
- Reimbursement coverage versus pay on behalf. Should the policy pay your defense costs directly, or will you lay out the money and they’ll reimburse?
- The definition of a claim and wrongful act will be different for each EPL policy.
- EPL policy’s limit structure. Do you want defense limits to be outside or inside the coverage?

Having to lay off employees is never an easy choice for an employer. Make sure you and your business do everything right before and during the process so that the aftermath isn’t even more difficult, filled with lawsuits and liability claims.

January 20, 2020

How Cannabis Businesses Can Prepare for Tax Season

By Melissa Diaz

4 Comments

A Little About 280E

The 280E statute bans businesses from deducting business expenses for gross income associated with the trafficking of Schedule I or II substances. While other businesses can deduct any number of expenses when filing their taxes — employee salaries, rent, equipment, electricity, etc. — 280E limits cannabis companies to only expensing deductions directly related to earning a profit, or the cost of goods sold (COGs).

For example, a dispensary whose square footage is split between 60% sales floor and 40% lobby may only deduct 60% of rent expenses because that’s the portion dedicated to COGs. Transactions do not occur in the lobby, so that portion of the rent is not deductible.

So long as cannabis remains a Schedule I substance, companies that produce, sell and otherwise touch the plant in their operations must comply with 280E.

Tips for Tax Success

While taxes can be complex and stressful for cannabis businesses, it is possible to limit the headaches. With tax season right around the corner, here are a handful of tips to ensure a successful filing.

Close Out Your Books. Before tax preparation can even start, cannabis businesses want to make sure to close out their financials for the previous year. It may sound like a no-brainer, but with the extra scrutiny facing companies in the industry and the nuances of 280E, it’s extremely important to have fully reconciled and closed-out books to work from when preparing taxes. Incomplete books can cause delays and add unnecessary extra stressors to the process that could result in penalties or additional liabilities.
Consult a Cannabis Tax Professional. Once books are ready to go, it’s time to consult a tax professional who has experience in the cannabis industry. A cannabis-focused tax pro will be familiar with the intricacies of 280E and and will be able to identify relevant business expenses to ensure compliance and limit liabilities. In addition to 280E issues, a competent accountant will also be able to highlight any other tax code changes that may impact a business. Every business is different — even in the cannabis industry — and since the tax code is large, complex and prone to new rules and interpretations, it’s important to have a strong accountant guiding the way.
Justify Your Numbers. After consulting with a tax professional and identifying relevant business expenses, it’s time to back up the numbers. This is where strong record-keeping comes into play. Ongoing regulatory hurdles limit cannabis firms’ ability to participate in the financial system where, generally, record creation is inherent with each transaction. But in a cash-heavy industry like cannabis, record creation and retention fall on the businesses themselves. This is because cash transactions don’t come with any built-in records. That inherent lack of documentation is yet another potential pitfall for cannabis businesses and taxes since large amounts of cash often raise eyebrows at the IRS. It is up to businesses to provide adequate proof of their tax numbers. Since the IRS will put zero effort into investigating the accuracy of your numbers, it will likely assume the worst when reviewing your filing.

Preparation is King

Taxes can be stressful. But they don’t have to be. Navigating tax season as a cannabis business is all about preparation. By putting in the work and partnering with an experienced tax professional, cannabis operators will be able to avoid penalties, limit their audit risk and stay on track with their business goals.

December 30, 2019

Preparing Your Recall Strategies

By Radojka Barycki

No Comments

A product recall is the removal of a defective product from the market because it can cause harm to the consumer or place the manufacturer at risk of legal action.

Although a recall is not something that companies want to be related to, preparing for it is very critical and it is an important part of crisis management.Product recalls can cost companies million dollars in profit loss and civil damages. The company senior management and employees can also face criminal action, if the investigation shows negligent acts. The company will also face loss of reputation and the trust of its customers.

Although a recall is not something that companies want to be related to, preparing for it is very critical and it is an important part of crisis management.

There are several phases when preparing a recall strategy:

Planning Phase

During the planning phase, a recall plan is developed. A recall plan is the procedure that will be followed by an appointed company’s team during an actual recall. A good recall plan will have the following components:

Definitions of the type of products recalls. According to federal regulations, there are three types of recalls. The company should know what type of recall they are performing to understand the risk the consumer is facing.

A Recall Team. The recall team is the key stakeholders that are responsible for different processes within the company. A good recall team will be multidisciplinary. A multidisciplinary team is a group of people that have different responsibilities within the manufacturing site (i.e. Receiving Manager, QA Manager, etc.) and/or outside (i.e. Legal Counsel, Public Relations, etc.)

A description of the recall team member’s responsibilities must be outlined. A recall coordinator and a backup should be assigned to ensure that there is one person organizing all activities during the recall.

A Communication Plan. It is important that only the appointed person that has the responsibility of external communications (i.e. media, regulators, customers, key stakeholders, etc.). In addition, there should be only one person appointed to handle all the communication within the team (internal communications.)

Documents to be used during the recall are:
- Communication documents: Letters to customers, regulators and media must be drafted and kept on hand for use during the crisis.
- Forms that will be used to keep track of product inventory on hand (still in the site), product being returned and product being destroyed.

A Traceability Procedure should be in place to ensure that materials used in the manufacturing of the finished good can be traced from the time of the delivery to the facility and throughout the product manufacturing process. In addition, traceability must also be provided for finished goods from the manufacturing site to its first point of distribution. This is known as traceability one step back (materials used) and one step forward (first point of distribution.)
A plant tagged with a barcode and date for tracking

A description of (or reference to) product quarantine (product hold) procedures that must be followed to ensure that the product that is still at the site do not leave the facility.

Product Destruction The company must outline (or reference) how product will be destroyed during a recall process.

Implementation Phase

There are three processes that need to be followed when implementing the recall plan:

Training: The recall team must be trained on their roles and responsibilities. Employees working at the site will be receiving directives from the appointed recall team members. It is also important that they are aware about the recall plan and understand the importance of urgency during the situation.
Exercise: It is important that the company doesn’t wait until the incident occurs to ensure that everyone in the team understands their roles and responsibilities during the recall. Therefore, annual testing of the procedure is imperative. This implies creating a “mock recall” situation and providing the information to the team to evaluate if they fully understand their role and responsibilities. This also allows the testing of the traceability protocols and systems that have been put in place by the site. Ensure that the team understands that this is an exercise and not an actual recall. You don’t want the team members going through the emotions that an actual recall gives. However, stress the importance of their participation during this exercise. You do not communicate to customers, media or regulators during a recall exercise.
Execution: This is the actual recall and full implementation of the plan. During the actual recall, you communicate to the regulators, customers and media. The company must also conduct daily recall effectiveness checks by using the forms developed for tracking product inventory, recovery and destruction.
Identify root cause and implement corrective actions. Root cause(s) will be identified during the recall process by analyzing the information resulting from the investigation of the incident. Regulatory agencies will actively participate in the discussion for identifying in the implementation of corrective actions.

Improvement Phase

The recall team should always meet after the recall exercise or the actual recall incident. The team must evaluate what positive or negative outcomes resulted from the process. If there are gaps identified, these need to be closed, so the process is improved.