Tag Archives: plan

Jennifer Whetzel

Branding for Cannabis Companies 101: Part 1

By Jennifer Whetzel
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Jennifer Whetzel

Busy entrepreneurs often skip steps in their business development process, particularly in the cannabis space. Since this is a new industry, there isn’t a long history of marketing/advertising efforts to look back on; the standards are still being developed. But more often, businesses simply may not have a budget large enough to pay an agency, and they may not feel confident executing these efforts on their own.

Fortunately, you can do a lot independently to get your name out there. This three-part series will give you a quick primer on branding – what it is, why it’s important and how to do it. But first, we need to discuss the differences between branding, marketing and advertising so that you know what kind of tools you have at your disposal.

What is Branding?

Branding should be considered a prerequisite to marketing and advertising.

Branding: Who
Marketing: What & Why
Advertising: Where & When

Branding is simply thinking about your company from the inside-out. It’s asking yourself questions about the kind of person your brand would be, down to its beliefs, personality and sense of style. Ultimately, we do this to build a deep emotional connection with potential customers. When you know who you are and put yourself out in the world, you’re signaling to them that you are a good match for each other.

When you have a brand that consistently forms emotional relationships with customers, that bond converts to both income and long-term company value, making your spending on marketing and advertising go further. It gives you a competitive advantage over companies with weak or non-existent branding (and in the U.S. cannabis industry, there are plenty of those). Moreover, it’s a key factor that venture capitalists and friendly Fortune 500s look for in potential investments.

So, what should you be asking yourself when it comes to branding? Start with exploring the fundamentals. Decide on the philosophical, emotional and visual characteristics of your brand.

As far as the philosophical questions go, it’s important to codify your mission, brand values, customer promise, core competency and future vision to build a strategic brand. Think about what you’re offering, how it will change lives, and what unique qualities will help you make it all happen.

The Four Ps: Product, Price, Place and Promotion.The philosophical characteristics help you decide who you are. Your emotional characteristics are the ones that connect you with the world. These would include your creation story, your brand personality and tone of voice. How does your brand see and respond to the world? Why? People love consistency. Having a consistent presentation makes your brand feel more authentic; in turn, people are more receptive to you.

The visual qualities are how the world should see you. These assets should include your color palette, fonts, imagery and logo. Making decisions about your brand’s appearance may feel subjective and overwhelming to people, but it doesn’t have to be. Basically, evaluate these ideas and assets in terms of how your audience is likely to respond to these elements. For example, how does your happy-go-lucky audience feel about a logo that is lime green versus corporate blue? Which color best reflects your brand sensibility? You know who you are; the visual characteristics are how you plan to show it.

Marketing

As a discipline, marketing traditionally involves making strategic decisions about the four Ps: Product, Price, Place and Promotion. These decisions become significantly easier once you have defined your brand.

Essentially, marketing addresses the way your brand lives in the world. It tells potential customers what you sell, and why they should choose your brand. It involves making thoughtful decisions and having a strategy for decisions such as product names and your corporate culture.

You also need to think about your pricing strategy and how that manifests in front of customers. For example, are you a high-end product with a premium price or the Walmart of weed? What’s your customer service strategy? Are your budtenders in flannel or lab coats?By now, you know who your brand is and how you want to present it to the world. Now you need to get consumers to see it that way. That’s where advertising comes into play.

Marketing also involves decisions about collateral—namely, your product packaging, brochures, signs and trade show booths. It also impacts your brand’s in-person presence. That could include experiences like events your company attends, trade shows where you have a booth or table, sensory experiences or even AR/VR experiences with your product.

By now, you know who your brand is and how you want to present it to the world. Now you need to get consumers to see it that way. That’s where advertising comes into play.

Advertising

Generally, advertising relates to paid campaigns that are carefully written and designed to tell potential customers where, when, why and how to connect with your brand and buy your products and services.

Fortunately, you have the tools to thrive by putting in the work to get to know your brand.These campaigns are often launched within the space of owned media, such as television commercials, radio and print ads and billboards. There are tons of digital and social media options. Your job is to find the ones that your customers interact with and decide what you want to say about yourself. For example, what kind of sites would you want to place ads on? What state of mind are customers in when they go to those sites? And what message do you want them to get from you in that moment?

Normally, answering these questions would be daunting. But since you’ve already decided who your brand is, you may already know what colors you want to use for this ad. You’ve already considered what your mission is. You know how your brand should appear to the world. And since you’ve unlocked these truths, you’ll be able to develop campaigns that feel genuine, unique, and memorable.

Connecting with consumers and making them remember you isn’t optional. It’s what will ultimately decide whether your business survives or not. Fortunately, you have the tools to thrive by putting in the work to get to know your brand. It’s tough, and it may not come easily at first. But we don’t start a business because it’s easy. We accept the risks and frustrations because we love what we do. Tell everyone why they should too.

HACCP

Implementing a HACCP Plan to Address Audit Concerns in the Infused Market

By Daniel Erickson
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HACCP

The increasing appeal and public acceptance of medical and recreational cannabis has increased the focus on the possible food safety hazards of cannabis-infused products. Foodborne illnesses from edible consumption have become more commonplace, causing auditors to focus on the various stages of the supply chain to ensure that companies are identifying and mitigating risks throughout their operations. Hazard Analysis and Critical Control Points (HACCP) plans developed and monitored within a cannabis ERP software solution play an essential role in reducing common hazards in a market currently lacking federal regulation.

What are cannabis-infused products?

Cannabis infusions come in a variety of forms including edibles (food and beverages), tinctures (drops applied in the mouth), sprays (applied under the tongue), powders (dissolved into liquids) and inhalers. Manufacturing of these products resembles farm-to-fork manufacturing processes common in the food and beverage industry, in which best practices for compliance with food safety regulations have been established. Anticipated regulations in the seed-to-sale marketplace and consumer expectations are driving cannabis infused product manufacturers to adopt safety initiatives to address audit concerns.

What are auditors targeting in the cannabis space?

The cannabis auditing landscape encompasses several areas of focus to ensure companies have standard operating procedures (SOP’s) in place. These areas include:

  • Regulatory compliance – meeting state and local jurisdictional requirements
  • Storage and product release – identifying, storing and securing products properly
  • Seed-to-sale traceability –  lot numbers and plant identifiers
  • Product development – including risk analysis and release
  • Accurate labeling –  allergen statements and potency
  • Product sampling – pathogenic indicator and heavy metal testing
  • Water and air quality –  accounting for residual solvents, yeasts and mold
  • Pest control – pesticides and contamination

In addition, auditors commonly access the reliability of suppliers, quality of ingredients, sanitary handling of materials, cleanliness of facilities, product testing and cross-contamination concerns in the food and beverage industry, making these also important in cannabis manufacturers’ safety plans.

How a HACCP plan can help

HACCPWhether you are cultivating, harvesting, extracting or infusing cannabis into edible products, it is important to engage in proactive measures in hazard management, which include a HACCP plan developed by a company’s safety team. A HACCP plan provides effective procedures that protect consumers from hazards inherent in the production and distribution of cannabis-infused products – including biological, chemical and physical dangers. With the lack of federal regulation in the marketplace, it is recommended that companies adopt these best practices to reduce the severity and likelihood of compromised food safety.

Automating processes and documenting critical control points within an ERP solution prevents hazards before food safety is compromised. Parameters determined within the ERP system are utilized for identification of potential hazards before further contamination can occur. Applying best practices historically used by food and beverage manufacturers provides an enhanced level of food safety protocols to ensure quality, consistency and safety of consumables.

Hazards of cannabis products by life-cycle and production stage

Since the identification of hazards is the first step in HACCP plan development, it is important to identify potential issues at each stage. For cannabis-infused products, these include cultivation, harvesting, extraction and edibles production. Auditors expect detailed documentation of HACCP steps taken to mitigate hazards through the entire seed-to-sale process, taking into account transactions of cannabis co-products and finished goods at any stage.

Cultivation– In this stage, pesticides, pest contamination and heavy metals are of concern and should be adequately addressed. Listeria, E. coli, Salmonella and other bacteria can also be introduced during the grow cycle requiring that pathogenic indicator testing be conducted to ensure a bacteria-free environment.

Harvesting– Yeast and mold (aflatoxins) are possible during the drying and curing processes. Due to the fact that a minimal amount of moisture is optimal for prevention, testing for water activity is essential during harvesting.

Extraction – Residual solvents such as butane and ethanol are hazards to be addressed during extraction, as they are byproducts of the process and can be harmful. Each state has different allowable limits and effective testing is a necessity to prevent consumer exposure to dangerous chemical residues.

Edibles– Hazards in cannabis-infused manufacturing are similar to other food and beverage products and should be treated as such. A risk assessment should be completed for every ingredient (i.e. flour, eggs, etc.), with inherent hazards or allergens identified and a plan for addressing approved supplier lists, obtaining quality ingredients, sanitary handling of materials and cross-contamination.

GMPFollowing and documenting the HACCP plan through all of the stages is essential, including a sampling testing plan that represents the beginning, middle and end of each cannabis infused product. As the last and most important step before products are introduced to the market, finished goods testing is conducted to ensure goods are safe for consumption. All information is recorded efficiently within a streamlined ERP solution that provides real-time data to stakeholders across the organization.

Besides hazards that are specific to each stage in the manufacturing of cannabis-infused products, there are recurring common procedures throughout the seed-to-sale process that can be addressed using current Good Manufacturing Practices (cGMP’s).  cGMPs provide preventative measures for clean work environments, training, establishing SOPs, detecting product deviations and maintaining reliable testing. Ensuring that employees are knowledgeable of potential hazards throughout the stages is essential.Lacking, inadequate or undocumented training in these areas are red flags for auditors who subscribe to the philosophy of “if it isn’t documented, it didn’t happen.” Training, re-training (if necessary) and documented information contained within cannabis ERP ensures that companies are audit-ready. 

Labeling

The importance of proper labeling in the cannabis space cannot be understated as it is a key issue related to product inconsistency in the marketplace. Similar to the food and beverage industry, accurate package labeling, including ingredient and allergen statements, should reflect the product’s contents. Adequate labeling to identify cannabis products and detailed dosing information is essential as unintentional ingestion is a reportable foodborne illness. Integrating an ERP solution with quality control checks and following best practices ensures product labeling remains compliant and transparent in the marketplace.

Due to the inherent hazards of cannabis-infused products, it’s necessary for savvy cannabis companies to employ the proper tools to keep their products and consumers safe. Utilizing an ERP solution that effectively manages HACCP plans meets auditing requirements and helps to keep cannabis operations one step ahead of the competition.

Ellice Ogle headshot

Designing a Recall Plan for Your Company

By Ellice Ogle
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Ellice Ogle headshot

Bearing through four voluntarily recalls in the first two months since the transition window ended, the California cannabis industry showed its commitment to providing safe goods for its consumers. Recalls are considered the removal of products deemed unsafe at the point of retail. With unsafe product already on shelves, it is that much more important to have a thought out strategy if a recall need arises. Currently, the California Department of Public Health-Manufactured Cannabis Safety Branch is the only regulatory agency in the state of California with recall stipulations for California cannabis companies. Thus, the onus is on individual cannabis companies to initiate their own recall plans.

Why establish a recall plan if one is not compulsory? To start, a cannabis product recall is more challenging than recalls in other industries because of the classification as a Schedule 1 drug and the misunderstanding and stigma of the drug that promotes fake news. These considerations affect the way both the government officials and consumers perceive cannabis recalls – not preparing ahead of time could be devastating to your brand. Furthermore, a recall is not just a one day headache – in December 2017, the Inspector General of Department of Health and Human Services  found that food companies took 57 days on average to initiate a recall after the Food and Drug Administration (FDA) first learned a product was potentially hazardous. Not only is a recall tricky to navigate and time intensive, a recall can also be costly – a joint study by the Food Marketing Institute (FMI) and the Grocery Manufacturers’ Association (GMA) in the USA found that 77% of the study respondents estimated the financial impact to be up to $30 million dollars; 23% reported even higher costs. One major factor of the financial impact to consider is that many retailers do not remove only the affected products, instead sweeping entire lines and brands. To estimate how much a food recall would cost your company, researchers Moises Resende-Filho and Brian Burr developed a model to estimate the direct costs of a food recall. To take a step back, it is true that, while recalls can be tricky to navigate, time intensive and costly, recalls are generally infrequent. At the same time, you never know where or when a recall could happen. For example, your manufacturing process might be flawless, but a supplier may suddenly issue a recall or the retail facility is compromised. Moreover, not all recalls are equal – imagine that consumers would react differently to an undeclared allergen on the label versus a life threatening pathogen in a product distributed to patients with weakened immune systems. Ergo, it is strategic for every cannabis company (grower, manufacturer, retail, etc.) to have a recall plan to be ready for any type of recall situation.

Take these 6 tips in designing a recall plan:

Food processing and sanitation
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers.

Before a Recall

1) Be familiar with how recalls work by staying up to date with recalls

2) Write a recall plan. Select a recall template and fill in your company information, but also take into consideration any regulations on recalls at the federal, state, and county levels.

During a Recall

3) Record everything that was said and done. If there was no prewritten recall plan, during a recall is a good time as any to begin documenting all actions and communication – internal within the management team and external with business partners (suppliers, retailers) and external with the consumers.

4) Find the flaw in the product. Why is the product being recalled? This is important to know, whether it was your item or not, to better answer the next question of “What happens with the recalled product?” The most common causes for a recall in the USA are identified in the joint study mentioned above by the FMI and GMA.

After a Recall

5) Reevaluate the recall plan. Compare to a reputable third-party auditing standard (example here is Safe Quality Food Institute’s SQF Food Safety Code for Manufacturing Edition 8). Updates to the recall plan are inevitable and constant. The changes may be due to updates in company products, adjustments in the recall network or the experience gained when going through a recall. Also keep an eye out for updates to templates of recall plans. Conduct mock recalls with different recall origins.

6) Reevaluate the food safety plan. After finding the flaw in the product, identify the flaw in the process and improve. Examples to improve the food safety plan may be to: amend the supplier approval program, refine process flow, polish the sanitation program or revise the preventative maintenance program. The foundation of a recall plan is having a robust food safety plan to minimize the risk of running a recall.

FSC logo

Edibles Discussion Comes To Food Safety Consortium

By Aaron G. Biros
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FSC logo

The Food Safety Consortium, taking place November 13-15 in Schaumburg, Illinois, will host a series of talks geared towards the cannabis industry this year. The newly launched Cannabis Quality Track features a number of panels and presentations designed to highlight the many intersections between food safety and cannabis.

Jenna Rice, Director of Operations at Gron Artisan Chocolates
Jenna Rice, Director of Operations at Gron Artisan Chocolates

The track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas.

Ben Gelt, board chair of the Cannabis Certification Council, is moderating a panel titled What’s In My Weed? that will delve into issues like supply chain, production and other difficulties in creating cannabis products and the challenges inherent in teaching consumers to be more discerning.

Ben Gelt, Board Chair of the Cannabis Certification Council
Ben Gelt, Board Chair of the Cannabis Certification Council

Panelists will include:

Kimberly Stuck, Founder of Allay Compliance Consulting
Kimberly Stuck, Founder of Allay Compliance Consulting

Ben Gelt and the Cannabis Certification Council orchestrated the development of this panel to help promote their #WhatsInMyWeed consumer awareness and education campaign. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”

Before Kim Stuck founded Allay Compliance Consulting, she was the first Marijuana Specialist for a public health authority in the nation, where she was working with regulators in Denver, Colorado. She is currently a cannabis food safety expert and a Certified Professional of Food Safety (CP-FS) through NEHA. She has helped Colorado and California develop cannabis food safety requirements. “I will discuss pitfalls we have experienced in the regulation of cannabis in Denver and what mistakes not to make,” says Stuck. “I’d also like to talk about how to be prepared for when those regulators start to come in to facilities.”

Kristen Hill, MIP Director at Native Roots Dispensary
Kristen Hill, MIP Director at Native Roots Dispensary

Kristen Hill is the MIP Director at Native Roots, arguably one of the largest dispensary chains in the world. She oversees 30 employees in Native Roots’ MIP facility where product testing and quality assurance of products are all led under her guidance. Her background includes managing quality assurance and regulatory compliance with FDA regulations, among other areas. She said she’s particularly excited to talk about implementing manufacturing best practices in the cannabis space. “Cannabis is maturing and is beginning to shape operations around long standing best practices in other industries,” says Hill.

Leslie Siu, Founder and CEO of Mother & Clone
Leslie Siu, Founder and CEO of Mother & Clone

Leslie Siu brings to the panel 17 years of liquor, tobacco and pharma marketing and operational oversight plus global digital and experiential campaigns. Her company, Mother & Clone, produces infused, sublingual cannabis sprays. Based in Colorado, Mother & Clone’s team of biochemists are Merck alumni, currently working towards GMP standards in preparation for Canada, slated to be on shelf in the spring of 2019. Her main consideration for cannabis product development comes from what she has learned from the FDA in traditional industries- what they will and will not tolerate.

To learn more about the panel, other topics presented and see the full agenda for the upcoming Food Safety Consortium, click here.

Rob Adelson
Soapbox

Collaborative Health Model to Advance Cannabis Research

By Rob Adelson
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Rob Adelson

The projected growth of the legal cannabis market is astounding. According to a report from BDS Analytics, the industry is expected to grow from $9.2B to $47.3B in 2027 in North America, with medical cannabis contributing 33% of that overall growth. While this number is impressive for an industry still in its infancy, I have reason to believe it can be much higher.

In the pharmaceutical industry, treatment of pain and insomnia represent an annual revenue exceeding $140B; concurrently, studies have shown cannabis to be an effective treatment for both conditions. If medical cannabis can capture 10% of that revenue over the next ten years, it essentially doubles the current estimates mentioned above.

So, what stands in our way? Education.

To gain acceptance from the medical community, physicians need to better understand the plant and its therapeutic benefits. To do so, they need more substantial data to prove cannabis’ efficacy before prescribing it to their patients. However, federal illegalities have prevented government-mandated clinical studies, but I believe there’s another way.

By adopting a collaborative health care model, patients and caregivers can work together to track the effectiveness of their cannabis treatments and share their learnings with the larger medical community.  With the right tools in place, we can fast-track the research process and provide physicians and politicians with the information they need to make this medicine more approachable and accessible to those who could benefit from it.

By harnessing the power of the community, we can apply learnings from one patient’s cannabis use to help countless others.The Spine Patient Outcomes Research Trial (SPORT) was a five-year study consisting of approximately 2500 patients with back and spine conditions. Participants entered qualitative data into an online portal, including post-surgical results and patient outcomes, to provide a comprehensive insight into treatment methods and their efficacy. Today, others suffering with those same conditions can enter their personal information into an online calculator and receive a prospective treatment plan. Together, patients and their doctors can view results and build a customized plan using more informed decisions about the available treatment options.

Another example comes from OpenNotes– an exploratory study that provides patients with full access to their medical files and the opportunity to input comments about their doctor visits and prognosis and make corrections related to the care they received. Results showed that this process helped patients retain a better understanding of their condition which improved their decision making and resulted in increased adherence to treatment plan protocols because they had greater trust with their doctors.Not only will this improve the patient experience by providing a safer, more sustainable treatment option, it also provides a very significant financial opportunity.

I believe the cannabis industry can take a leadership role in empowering patients to become active participants in their own treatment, while also sharing knowledge with the larger patient and physician communities. In fact, this core belief was the reason I founded Resolve Digital Health. Data-empowered patients not only make better decisions but also enjoy a greater feeling of control over their treatment. The power of collaborative healthcare grows exponentially when the data is shared to educate a broader group. By harnessing the power of the community, we can apply learnings from one patient’s cannabis use to help countless others.

Businesses within the cannabis industry can also leverage this data to create new products and services. For example, insights as to what products work best for certain conditions can help LP’s improve their product offerings and guide recommendations from dispensaries. Through product innovation, companies can make cannabis more accessible to a larger group of patients, who may be currently taking pharmaceuticals. Not only will this improve the patient experience by providing a safer, more sustainable treatment option, it also provides a very significant financial opportunity.

Ultimately, knowledge is power. When patients are empowered to make educated decisions about their health care and doctors are more tuned into the patient-tested cannabis treatment options, it’s a win-win for everyone.

Steven Burton

3 Ways The Cannabis Industry Can Benefit By Adopting IoT Tech

By Steven Burton
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Steven Burton

The cannabis industry of the United States is unlike other horticulture markets in the country. It’s younger, less traditional and with roots in a black market, it’s no surprise that its forerunners aren’t afraid to experiment with new approaches and technology.

The rapid adoption of IoT (Internet of Things) technology is one way in particular that this new generation of producers is stepping up, and they’re beginning to reap the rewards. But to better demonstrate how significant the implementation of IoT tech can be, we’ll peek over the fence at other craft-oriented food industries—namely wine and chocolate—to discover how effective they can be long-term for serious players in the cannabis industry.

The results, as you can probably guess, are astounding.

Farm Productivity and Precision is on the Rise

IoT tech isn’t just a cool new thing for experimental growers – it’s as necessary as air in the 21st century. New and veteran farms alike are discovering ways to streamline production and enhance the quality of their crops. One of the most common implementations of IoT tech in agriculture is the installation of smart measurement tools. Remote sensors can monitor soil acidity, humidity, salt concentrations, temperature and a variety of other metrics, automating the collection of data and providing a clear picture of plant health. For many farms, like E. & J. Gallo Winery, this is a game-changer.By installing hundreds of sensors per block and upgrading to a more precise irrigation system, Gallo was able to connect moisture measurements to a central system

Before placing sensors in over 250 acres of their vineyard, Gallo could only make irrigation adjustments at the large block level. Even with careful monitoring of moisture levels, the grape yield was inconsistent in size and flavor. By installing hundreds of sensors per block and upgrading to a more precise irrigation system, Gallo was able to connect moisture measurements to a central system. The system collects the data, considers the weather forecast, and automatically irrigates small areas of the vineyard as needed to ensure all plants are optimally watered. This resulted in a more uniform crop, less water waste and more desirable grapes.

Cannabis farms are starting to pick up on this simple approach as well. Organigram, one of Canada’s leading Cannabis producers, is well aware of the benefits of this kind of automation and data collection. “All our grow rooms are helping us learn all the time,” says Matt Rogers, head of production at Organigram. “With 20 grow rooms going, we can gather as much information about these plants as you would get in a century of summers.”

Automation and precision have enabled by Gallo and Organigram to improve yield and increase precision, which has helped them achieve their well-respected status in the wine and cannabis industries.

The Supply Chain is Becoming More Transparent

As much as we would like the industry to be free of scams and crooks, there’s more than a few producers stretching the truth when it comes to labeling product. MyDx, a cannabis chemical analyzer, recently revealed that the label on the package often does not totally coincide with the product within.Protecting your brand’s reputation is a necessity and IoT tech is helping some pioneering industries do that.

For example, the most frequently tested cannabis strain, “Blue Dream”, averages a 64% difference in chemical makeup from sample to sample. Similarly, “Gorilla Glue” and “Green Crack” show as much as 83% variation from sample to sample—largely because there’s no regulation of these names.

While variation is inevitable from grower to grower, plant to plant, and even between different parts of the same plant, misleading labels and the addition of ‘fillers’ is a growing issue for edible cannabis producers, and the threat it poses to your brand isn’t minor. Protecting your brand’s reputation is a necessity and IoT tech is helping some pioneering industries do that.

Wine in China is a powerful example of how improved traceability can reduce large-scale mislabeling. Brand-name winemakers in the country face a massive problem: 70% of imported wines are counterfeits. To combat this, winemakers are attaching near-field communication (NFC) labels to imported and domestic bottles. It’s a dramatic solution, but one that’s protecting the brand of winemakers dedicated to quality and transparency.

As the legalization of cannabis spreads and coveted strains emerge, so will the availability of counterfeits—or, at the very least, less-than-truthful labeling. This has proven to be true in almost every specialty market, and adopting improved traceability tech will defend your brand and reputation from the consequences of selling a product that’s discovered to be more ‘filler’ than cannabis.

Compliance is Easily Achieved

The conversation of cannabis regulation generally revolves around age restrictions and driving while impaired, but government compliance is far more complicated – especially for facilities that create cannabis-infused food products. And here’s the frustrating part for those who must (and should) maintain a food safety plan: every time a regulation is adjusted (or every time a new variation is added in another state), facilities must be able to document changes in procedures, recipes and hazard controls. It gets complicated quickly, especially if all the documentation is kept manually.

There’s a lot to be gained by connecting your systems and products to the Internet of ThingsA central, connected system is the best way for food manufacturers to streamline and automate a variety of documentation and food safety tasks, which can mean thousands of dollars saved over months or years. Using software like Icicle, facilities can create a comprehensive data environment that’s dynamic and accessible from anywhere. Incoming measurements from connected equipment and employee records are collected and an admin dashboard allows you to see what food safety systems are thriving and which need revisiting. The records – transformed into a compliant food safety plan – can then be pulled up during audits and inspections on the spot, saving the months that companies usually spend preparing documentation.

According to Mitchell Pugh of Chewter’s Chocolates, their system “gives me a great peace of mind in the sense to know we have all our information prepared and anything that an inspector is going to ask for – whether they’re looking for one product, a general system, a certain hazard, or a bill of ingredients or materials or an allergen – is easy for us to search for it, pull it up, and find exactly what they’re looking for.”

Considering that most food manufacturers still record measurements and create food safety plans manually, this is an area where progressive companies can quickly outpace their non-automated rivals.

Whether you’re a grower, dispensary, food producer, or some other kind of cannabis professional, there’s a lot to be gained by connecting your systems and products to the Internet of Things. Which direction will you take?

The Necessity of Food Safety Programs in Cannabis Food Processing

By Gabe Miller
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When processing cannabis, in any form, it is critical to remember that it is a product intended for human consumption. As such, strict attention must also be paid to food safety as well. With more and more states legalizing either medical or recreational cannabis, the potential for improper processing of the cannabis triggering an illness or death to the consumer is increasing.

The FDA Food Safety Modernization Act (FSMA) is the new food safety law that has resulted in seven new regulations, many which directly or indirectly impact the production and processing of cannabis. Under FSMA regulations, food processors must identify either known or reasonably foreseeable biological, chemical or physical hazards, assess the risks of each hazard, and implement controls to minimize or prevent them. The FSMA Preventive Controls for Human Foods (PCHF) regulation contains updated food “Good Manufacturing Practices (cGMPs) that are in many cases made a requirement in a state’s medical or recreational cannabis laws. These cGMPs can be found in 21 CFR 117 Subpart B.

It is imperative that cannabis manufacturers have a number of controls in place including management of suppliers providing the raw material.Food safety risks in cannabis processing could originate from bacteria, cleaning or agricultural chemicals, food allergens or small pieces of wood, glass or metal. The hazards that must be addressed could be natural, unintentionally introduced, or even intentionally introduced for economic benefit, and all must be controlled.

It is unlikely that high heat, used in other food products to remove bad bacteria would be used in the processing of cannabis as many of its desirable compounds are volatile and would dissipate under heating conditions. Therefore, any heat treatment needs to be carefully evaluated for effectiveness in killing bacterial pathogens while not damaging the valuable constituents of cannabis. Even when products are heated above temperatures that eliminate pathogens, if the raw materials are stored in a manner that permits mold growth, mycotoxins produced by molds that have been linked to cancer could be present, even after cooking the product. Storage of raw materials might require humidity controls to minimize the risk of mold. Also, pesticides and herbicides applied during the growth and harvesting of cannabis would be very difficult to remove during processing.

It is imperative that cannabis manufacturers have a number of controls in place including management of suppliers providing the raw material. Other controls that must be implemented include proper cannabis storage, handling and processing as well as food allergen control, and equipment/facility cleaning and sanitation practices. Processing facilities must adhere to Good Manufacturing Practices (GMP’s) for food processing, including controls such as employee hand washing and clothing (captive wear, hair nets, beard nets, removal of jewelry, and foot wear) that might contribute to contamination. A Pest Control plan must be implemented to prevent fecal and pathogen contamination from vermin such as rodents, insects, or birds.

Processing facilities must be designed for proper floor drainage to prevent standing water. Processing air should be properly filtered with airflow into the cannabis processing facility resulting in a slightly higher pressure than the surrounding air pressure, from the clean process area outwards. Toilet facilities with hand washing are essential, physically separated from the process areas. Food consumption areas must also be physically separate from processing and bathroom areas and have an available, dedicated hand sink nearby. Employee training and company procedures must be effective in keeping food out of the processing area. Labels and packaging must be stored in an orderly manner and controlled to prevent possible mix-up.Cleaning of the processing equipment is critical to minimize the risk of cross contamination and microbial growth.

Written food safety operational procedures including prerequisite programs, standard operating procedures (SOP’s), etc. must be implemented and monitored to ensure that the preventive controls are performed consistently. This could be manual written logs, electronic computerized data capture, etc., to ensure processes meet or exceed FSMA requirements.

A written corrective action program must be in place to ensure timely response to food safety problems related to cannabis processing problems when they occur and must include a preventive plan to reduce the chance of recurrence. The corrective actions must be documented by written records.

Supply chain controls must be in place. In addition, a full product recall plan is required, in the event that a hazard is identified in the marketplace to provide for timely recall of the contaminated product.

Cleaning of the processing equipment is critical to minimize the risk of cross contamination and microbial growth. The processing equipment must be designed for ease of cleaning with the minimum of disassembly and should conform to food industry standards, such as the 3-A Sanitary Standards, American Meat Institute’s Equipment Standards, the USDA Equipment Requirements, or the Baking Industry Sanitation Standards Committee (BISSC) Sanitation Standards ANSI/ASB/Z50.2-2008.

Serious food borne contaminations have occurred in the food industry, and cannabis processing is just as susceptible to foodborne contamination. These contaminations are not only a risk to consumer health, but they also burden the food processors with significant costs and potential financial liability.

Anyone processing cannabis in any form must be aware of the state regulatory requirements associated with their products and implement food safety programs to ensure a safe, desirable product for their customers.

Steven Burton

Top 4 Food Safety Hazards for the Cannabis Industry

By Steven Burton
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Steven Burton

As many US States and Canadian provinces approach legalization of cannabis, the question of regulatory oversight has become a pressing issue. While public awareness is mainly focused on issues like age restrictions and impaired driving, there is another practical question to consider: should cannabis be treated as a drug or a food product when it comes to safety? In the US, FDA governs both food and drugs, but in Canada, drugs are regulated by Health Canada while food products are regulated under the CFIA.There are many food safety hazards associated with cannabis production and distribution that could put the public at risk, but are not yet adequately controlled

Of course, there are common issues like dosage and potency that pharmaceutical companies typically worry about as the industry is moving to classifying its products in terms of percentage of chemical composition (THC, CBD, etc. in a strain), much as we categorize alcohol products by the percentage of alcohol. However, with the exception of topical creams and ointments, many cannabis products are actually food products. Even the herb itself can be brewed into teas, added to baked goods or made into cannabis-infused butters, oils, capsules and tinctures.

FDAlogoAs more people gain access to and ingest cannabis products, it’s only a matter of time before food safety becomes a primary concern for producers and regulators. So when it comes to food safety, what do growers, manufacturers and distributors need to consider? The fact is, it’s not that different from other food products. There are many food safety hazards associated with cannabis production and distribution that could put the public at risk, but are not yet adequately controlled. Continue reading below for the top four safety hazards for the cannabis industry and learn how to receive free HACCP plans to help control these hazards.

Aflatoxins on Cannabis Bud

Just like any other agricultural product, improper growing conditions, handling and storage can result in mold growth, which produce aflatoxins that can cause liver cancer and other serious health problems. During storage, the danger is humidity; humidity must be monitored in storage rooms twice a day and the meter must be calibrated every month. During transportation, it is important to monitor and record temperatures in trucks. Trucks should also be cleaned weekly or as required. Products received at a cannabis facilities should be tested upon receiving and contaminated products must always be rejected, segregated and disposed of safely.

Petri dish containing the fungus Aspergillus flavus. It produces carcinogenic aflatoxins, which can contaminate certain foods and cause aspergillosis, an invasive fungal disease.
Photo courtesy of USDA ARS & Peggy Greb.

Chemical Residues on Cannabis Plants

Chemical residues can be introduced at several points during the production and storage process. During growing, every facility should follow instructions for applying fertilizers and pesticides to crops. This includes waiting for a sufficient amount of time before harvesting. When fertilizer is being applied, signs must be posted. After cannabis products have been harvested, chemical controls must be in place. All chemicals should be labelled and kept in contained chemical storage when not in use to prevent contamination. Only food-grade chemicals (e.g. cleaners, sanitizers) should be used during curing, drying, trimming and storage.

Without a comprehensive food safety program, problems will inevitably arise.There is also a risk of excessive concentration of chemicals in the washing tank. As such, chemical concentrations must be monitored for. In general, water (obviously essential for the growing process) also carries risks of pathogenic bacteria like staphylococcus aureus or salmonella. For this reason, city water (which is closely controlled in most municipalities) should be used with an annual report and review. Facilities that use well water must test frequently and water samples must be tested every three months regardless.

Pathogenic Contamination from Pest Infestations

Insects, rodents and other pests spread disease. In order to prevent infestations, a pest control program must be implemented, with traps checked monthly by a qualified contractor and verified by a designated employee. It is also necessary to have a building procedure (particularly during drying), which includes a monthly inspection, with no holes or gaps allowed. No product should leave the facility uncovered to prevent fecal matter and other hazards from coming into contact with the product. Contamination can also occur during storage on pallets, so pallets must be inspected for punctures in packaging material.

Furthermore, even the best controlled facility can fall victim to the shortcomings of their suppliers. Procedures must be in place to ensure that suppliers are complying with pest and building control procedures, among others. Certifications should be acquired and tracked upon renewal.

Pathogenic Contamination Due to Improper Employee Handling

Employee training is key for any food facility. When employees are handling products, the risk of cross-contamination is highest. Facilities must have GMP and personnel hygiene policies in place, with training conducted upon hiring and refreshed monthly. Employees must be encouraged to stay home when sick and instructed to wear proper attire (gloves, hair nets, etc.), while glass, jewelry and outside food must not be allowed inside the facility. Tools used during harvesting and other stages may also carry microorganisms if standard cleaning procedures are not in place and implemented correctly by employees.

As the cannabis industry grows, and regulatory bodies like the FDA and CFIA look to protect public safety, we expect that more attention will be paid to other food safety issues like packaging safety (of inks and labels), allergen control and others. In the production of extracts, for example, non-food safe solvents could be used or extracts can be mixed with ingredients that have expiration dates, like coconut oil. There is one area in which the cannabis industry may lead the way, however. More and more often, risks of food terrorism, fraud and intentional adulteration are gripping the food industry as the global food chain becomes increasingly complex. It’s safe to say that security at cannabis facilities is probably unparalleled.

All of this shows that cannabis products, especially edibles (and that includes capsules and tinctures), should be treated the same as other food products simply because they have the same kinds of hazards. Without a comprehensive food safety program (that includes a plan, procedures, training, monitoring and verification), problems will inevitably arise.

Soapbox

Human Error? No Problem

By Dr. Ginette M. Collazo
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If you are in the business of growing cannabis, you should be aware of the common reasons for production losses, how to address root causes and how to prevent future occurrences in a sustainable way. Human error is the number one root cause identified in investigations for defects in the cultivation business. Sadly, little is known about the nature of these errors, mainly because our quest for the truth ends where it should begin, once we know it was a human error or is “someone’s fault.”

Yes, human error usually explains the reason for the occurrence, but the reason for that error remains unexplained and consequently the corrective and preventive actions fail to address the underlying conditions for that failure. This, in turn, translates into ineffective action plans that result in creating non-value added activities, wasting resources and money as well as product.

Human error can occur when workers are in direct contact with the plant

So after investigating thousands of human error events and establishing systems to improve human reliability in manufacturing facilities, it became even clearer to me, the need to have good, human-engineered standard operating procedures (SOPs).

In the cannabis growing process, there are different types of mistakes that, when analyzed, all can be addressed in the same manner. For example, some common errors that we see are either overwatering or nutrient burn, which can occur when the plant is overfed. The same is true in the opposite scenario; underfeeding or under watering lead to problems as well. If your process is not automated, the reason for these failures was most likely human error. Now, why did the person make that mistake? Was there a procedure in place? Was the employee trained? Is there a specific process with steps, sub-steps, quantities and measures? Were tools available to be able to do the task correctly? There is so much that can be done about these questions if we had clear, well-written and simple, but specific instructions. The benefits greatly outweigh the effort required.

Also, besides providing step-by-step instructions to avoid commission errors (to perform incorrectly as opposed to omit some step), there are other types of errors that can be avoided with SOPs.

Decision making like detecting nutrient deficiencies can lead to human error.

Decision-making is another reason why we sometimes get different results than the ones expected. If during your process there are critical, knowledge-based decisions, workers need to be able to get all the information to detect as well as correct situations. Some decisions are, for example, when (detection) and how (steps) should I remove bud rot? Is there a critical step in the process (caution) to avoid other plants from becoming affected? Any information on the what, how, when, where and why reduces the likelihood of a decision error, later described as obvious.

When we face manufacturing challenges like nutrient deficiency in a particular stage, mold, fungus, gnats or even pollination of females, we want to do whatever we can to prevent it from happening again. So consider that from avoiding to detecting errors, procedures are a critical factor when improving human performance.

Here are some guidelines when writing procedures to prevent human error.

  1. Use them. Enforce the use of procedures at all times. As humans, we overestimate our abilities and tend to see procedures as an affront to our skills.
  2. Make sure it is a helpful procedure and users are involved in the process. People that participate in writing rules are more likely to follow them.
  3. Make sure they are available for their use.
  4. All critical activities should have a procedure.
  5. The procedure needs to be clear, have a good format, clear graphics, appropriate level of detail and specific presentation of limits.
  6. Make sure that facts, sequence and other requirements are correct and all possible conditions are considered e.g. “what if analysis”.

Human error won’t be eradicated unless we are able to really identify what is causing humans to err. If eliminating or “fixing” the actual individual eliminates or potentially reduces the probabilities of making that mistake again, then addressing the employee would be effective. But if there is a chance that the next in line will be able to make the same mistakes, consider evaluating human factors and not the human. Take a closer look and your process, system and ultimately your procedures.

Ask the Expert: Straight Talk on Safety, Defense and Security, Part II

By Aaron G. Biros, Bruce E. Lesniak, Lezli Engelking
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In this week’s Straight Talk on Safety, Defense and Security, we answer a reader’s question about traceability in quality processes and offer some practical advice for building a safety and security strategy. Travis Lodolinsky from Gleason Technology submitted this week’s question. For a response, we sit down with Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), to help answer your questions. If you have questions about safety, defense and security in cannabis, please ask them in the comments section below and we will address them in the next edition of Straight Talk on Safety, Defense and Security.

T. Lodolinsky: How are safety processes being tracked in the industry to ensure regulations and quality assurance are being uniformly enforced throughout?

Lezli Engelking: In related industries, such as herbal products or pharmaceuticals, the FDA has created guidelines, or current good manufacturing processes (CGMP) that control for the quality, consistency and safety of the products being produced. Businesses must be certified by independent third parties to demonstrate they are following CGMP to protect public health and consumer safety. CGMP is a proactive approach to quality assurance. A basic tenant of CGMP is that quality cannot be tested into a product after it is made; quality must be built into the product during all stages of the manufacturing process. One common misconception is that CGMP only covers the process of manufacturing itself. CGMP actually covers all aspects of the production process including materials, premises, equipment, storage, staff training and hygiene, how complaints are handled and record keeping.

Because cannabis is federally illegal in the US, the FDA has not developed cannabis-specific CGMP guidelines, so lawmakers do not have the benefit of having those guidelines available to base regulations on. So to answer your question, state cannabis regulations do not track processes and procedures used by cannabis businesses to control for safety or quality because they do not have the federal guidelines. Instead, most state cannabis regulations currently take a reactive approach to safety, mandating only for testing of the final product. While testing is an extremely important and valuable part of any quality management program, just analytics is not enough.

This is precisely why FOCUS was created and how they assist business owners and regulators, while fulfilling the mission of protecting public health, consumer safety and safeguarding the environment. The FOCUS standards are a cannabis-specific system of guidelines (cannabis-specific current good manufacturing practices) to ensure products are consistently produced according to quality standards. FOCUS provides detailed guidance and independent, third party auditing services for all key aspects of the cannabis industry including cultivation, extraction, infusion, retail, laboratory, security, packaging, labeling and sustainability.

CannabisIndustryJournal: What advice can you offer to cannabis businesses for product safety, defense and security prior to standardization?

Bruce E. Lesniak: Businesses that make products infused with cannabis (I call these businesses “plus one” companies because they produce products that include one more ingredient than traditional food products), require a carefully written master plan that specifically addresses the unique qualities, sensitivities and critical areas of the business. When building a comprehensive plan I address three questions:

  • Why (identify the why, this is your preventative, overarching strategy)?
  • How (addresses the “why question” with products, services and training)?
  • What (what is your reactive strategy that addresses actions and activities to be performed in the event of a breech)?

First and foremost, consumer-facing businesses must safeguard their products to the public. One product recall or illness related incident could spell disaster. Build your plan correctly the first time. Contact an industry expert to review your facility and help build and implement your plan. This will save you money by quickly exposing vulnerabilities and providing corrective measures specific to your business needs and requirements. Even though product safety and defense are closely related to security and should share a complementary strategy, product safety and defense are unique (due to standards and regulations), and should be treated as such.

Banks not accepting industry money complicates normal business operations and security planning, causing retail operations to handle and store large sums of cash. I asked industry expert and security professional, Tony Gallo of Sapphire Protection LLC, what is the single most important piece of security equipment you are currently providing for the retail and dispensary owner? “Design an air tight policy of handling money,” says Gallo. “Remove money often from cash registers and place it into the best safe for your application!”

Spend time familiarizing yourself with all things product safety and defense (there are volumes written on food safety and food defense, thus the “plus one” reference). This a great starting point and protecting the consumer protects your business. When it comes to designing your security application, consult an expert! Take into account that the cannabis industry is unique due to its “plus one” ingredient. Therefore you need to build your security systems, applications and policies to systematically protect your employees, facility, suppliers, transportation, manufacturing, distribution, warehousing, supply chain and brand.