Tag Archives: dispensary

Managing Supply Chain Challenges During a Crisis

By Daniel Erickson
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Discussion of supply chain disruption has permeated media reports almost daily since the advent of the current COVID-19 crisis – from shortages of toilet paper to cleaning products and meat. Cannabis businesses have not been immune to impacts on their supplies, and for an industry that faces unique challenges during normal times, a disrupted supply chain has emerged as one of the biggest issues to business due to the coronavirus. Deemed essential in many states, cannabis has weathered the storm relating to government-imposed restrictions only to face logistics problems or a scarcity of supplies necessary for manufacturing and/or distributing products to consumers. For many companies, cannabis ERP software has provided a necessary and supportive structure to efficiently manage and mitigate supply chain challenges during this unprecedented time – facilitating continuity and trust in the supply chain for their customers.

What is COVID-19’s impact on the cannabis supply chain?

During this pandemic, the global supply chain has been disrupted due to factory closures, worker illness, slowed production, closed ports and altered transportation routes – leading to shipping delays and fewer supplies available, from cultivating essentials and vaping accessories, to baking ingredients for edible manufacturers and packaging materials. A quarantined workforce, as well as a shortage of healthy crop care and production workers necessary to grow and harvest crops, has also had an effect. Similar to other current supply issues, there has been significant inventory depletion as consumers prepared to stock up on cannabis products for “stay at home” orders in anticipation of spending extended periods of time at their residence. Uniquely pertinent to the cannabis industry, due to the lack of federal legalization, regulation occurs at the state level and therefore each state governs its cannabis inventory available for sale. These factors have all led to the two biggest problems facing today’s cannabis industry – companies lacking visibility into their inventory and the fact that many do not have alternate vendors for their supplies to meet current consumer demands.

How a cannabis ERP software solution can help

During a disruption to the supply chain such as the COVID-19 outbreak, natural disasters, or other unexpected events, here are three ways an industry-specific ERP system supports effective supply chain management for the cannabis industry:

1) Continuous management and monitoring of inventory and effective material planning – With a real-time tracking system that monitors the movement and storage of inventory by managing and automating transactions and providing lot tracking and traceability, cannabis companies have up-to-the-minute access to crucial inventory data. Accurate analysis of future requirements, as well as procurement guidelines that include minimum order quantities and safety stock levels, ensure the proper planning and reordering of materials – avoiding lags in production due to inventory shortages. Using the information recorded in an ERP solution’s centralized database, such as vendor lead times, shelf life and production timelines, buyers and planners are able to effectively utilize materials requirements planning (MRP) functionality to factor supply, demand and forecasted requirements to plan production and purchasing. Customer purchasing fluctuations throughout the year for holidays and seasonal consumer trends are also tracked in the system, and its analytics software provides growers, cultivators and manufacturers with the visibility to mitigate supply shock and analyze previous periods of hardship to provide actionable insight.

An integral part of inventory control includes testing protocols and quality processes that are automated in an ERP solution. These workflows and approval processes ensure that specific quality standards are met and non-compliant raw materials are quarantined, removed from production and issues are rectified – keeping undeclared substances, harmful chemicals and impure ingredients from infiltrating the supply chain or ending up in finished goods. During these critical and trying times, assurances that materials and ingredients are safely managed and monitored is imperative.

2) Maintenance of supplier information and rankings – A cannabis ERP solution provides features for managing supplier and item specific details to monitor and control which materials can and should be purchased from each vendor. A strong relationship with each supplier is critical in gathering this information, as this helps assign and manage a risk level with each supplier. Current and accurate information (either provided by the vendor or acquired from on-site visits) regarding sanitation programs in place, security measures, physical distancing policies and other details ensures that a cannabis company starts with a foundation of quality raw materials for their products. An ERP solution maintains a list of these approved suppliers to provide already vetted and documented alternatives should a primary supplier’s materials be unavailable. Once vendors are recorded they can be ranked in order of preference and/or risk level so that if a supplier becomes unavailable, another can be quickly identified and used in its place. An ERP’s maintenance of approved supplier lists is an industry best practice that provides supply chain visibility to enhance the assurance of safety.

3) Establishment of supplier transparency through audit rights and communication – An ERP’s ability to manage and monitor all supplier transactions and communications helps facilitate audit rights to evaluate the financial viability of vendor partners. Data is collected regarding vendor price points, historical transactions, average lead times and quality control results in order to identify vendor trends and build a risk assessment with a scorecard rating system for each supplier. Potential supply chain issues can be identified in real-time – such as price increases or delivery delays – prompting communication with suppliers to address problems or triggering the change to an alternate source for materials. Transparency and open communication are key to vendor analysis by researching all suppliers. An ERP solution’s maintenance of current, accurate information is essential to keeping a consistent inventory.

A centralized ERP system facilitates the maintenance and management of the supply chain when a crisis of the magnitude of COVID-19 hinders supplies from arriving or the safety of vendor materials comes into question. Inventory management best practices within the solution help to avoid production lags due to inventory shortages, materials planning provides insight into scheduling and production, and quality assurance procedures prevent harmful products from being sold to consumers. By utilizing features such as the approved supplier and alternative supplier processes within the system should a primary suppliers’ materials be unavailable, there is no need to scramble to find replacement vendors, as they are already vetted and documented within the solution. The system also provides transparency of supplier information to make key decisions regarding vendor rankings and risk level. While the cannabis supply chain is relatively new and untested, proactive companies have the technological tools available in an ERP solution at their disposal to weather the current crisis and face future industry challenges head-on.

The British Isles Sees Cannabis as an Economic Development Pathway

By Marguerite Arnold
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Cannabis as a tool of local or even regional economic development has rapidly gained traction in many jurisdictions within the United States and Canada. It has also caught on particularly in the poorer states of the EU (see Greece) and those countries hoping to enter the Union (North Macedonia).

These days, the concept is also spreading even to the UK, where reform has lagged significantly behind other countries both in North America and Europe. Indeed, two island communities are now investing heavily in the idea that cannabis is not only here to stay, but may invigorate communities and the economic health of islands looking for a new path, post-Brexit.

Cannabis so far, certainly in the United States and Canada, has proved to be a job creator just about everywhere for the past five years. Indeed, despite a few large corporate restructurings (see Aurora and Canopy Growth) of late, the industry itself has not slowed down, even with bumps in the road in terms of full and final legalization and the new challenges of a global pandemic.

House Of Green, Guernsey
This project is moving along, with its first harvest set for later in the year. The ₤2 million facility plans to be able to process up to 800 pounds every eight-hour day. Raw product is being grown at vineyards on the island itself by independent farmers and partners from other islands. Indeed, it is a unique facility on the European side of the Atlantic.

The company plans to process cannabis into tinctures, balms and salves as well as alkaline waters.

The idea is to create the base ingredients from which other products – bound both for the medical and recreational market – can be made.

Vecticanna, Isle of Wight
Just off the southern coast of the UK, Vecticanna is also embarking on an ambitious project – a fully solar-powered facility which plans to eventually employ 60 people. Their mission? To “unlock the therapeutic potential of cannabis” for the treatment of Fibromyalgia and related conditions.

Vecticanna has partnered with several large institutions, including the University of Southampton, and CAR Laboratories in Cambridge, and plans to produce its products in an R&D and research setting with the ambitious hope of furthering the potential of cannabinoid-based healthcare.

Where Goes UK and European Reform?

Reform across Europe has indeed been frustratingly slow. This includes the many hiccups in the German cultivation bid, which was first launched in 2017, and will only see the first nationally produced cannabis in the country sometime this fall. That amount is far too little for the patients who have already obtained prescriptions, and certainly will not be enough to serve the expected million plus patients in market here in just a few short years. Indeed, medical cannabis distributors in Germany are scouring the planet right now for properly certified product that comes from other European countries as well as South Africa, Australia, and even Latin America.

In the meantime, a new generic producer of dronabinol (synthetic THC) has just gained access to the German market.

In the UK, reform so far has also been torturously tortoise-like, with the National Health Service (NHS) favouring local producer GW Pharmaceuticals and forcing all other patients and their families to import pricey product from the Netherlands or Canada. While, it should also be added, excluding chronic pain patients.

Why Are The UK’s Island Cannabis Projects So Intriguing?

With a few exceptions (see Greece and Malta), European cannabis development remains mired in complications that include everything from a lack of reform and high prices to fights over basic regulations, including whether cannabis is a “novel” substance or not. This has slowed down the ability of growers to obtain the right certifications, find financing and actually go into business.

With two new producers on islands close to Europe and the UK however, there appear to be projects on the horizon which have jumped the regulatory queue, and are lining up for an intriguing future, supported from the ground up, by local policies that are looking at two simple things: the efficacy of the plant itself, and the economic well-being of their neighbors.

The Brand Marketing Byte

The Hottest Edibles Brands in the United States Right Now

By Cannabis Industry Journal Staff
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The Brand Marketing Byte showcases highlights from Pioneer Intelligence’s Cannabis Brand Marketing Snapshots, featuring data-led case studies covering marketing and business development activities of U.S. licensed cannabis companies.

In this week’s Byte, we’re taking a look at the top edibles companies in the country. Using a scoring methodology that factors in a wide variety of data sets, Pioneer’s algorithm tracks brand awareness, audience growth and engagement. Using more than 80,000 relevant data points per week, they analyze business activity across social media, earned media and web-related activities.

For April 2020, here are the top 25 hottest U.S. edibles brands:

  1. Kiva Connections
  2. Wyld
  3. Tyson Ranch
  4. Wana Brands
  5. Serra
  6. STIIIZY
  7. 1906
  8. Kushy Punch
  9. Coda Signature
  10. Kush Queen
  11. PLUS
  12. Theory Wellness
  13. Incredibles
  14. Kikoko
  15. Dixie Elixirs
  16. Fairwinds
  17. Deep Roots Harvest
  18. Willie’s Reserve
  19. Chalice Farms
  20. Care By Design
  21. Beboe
  22. District Edibles
  23. Bhang
  24. Satori
  25. Betty’s Eddies

PJRFSI Accredited for Cannabis Certifications

By Cannabis Industry Journal Staff
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In a press release published, last week, Perry Johnson Registrars Food Safety, Inc. (PJRFSI) announced they are now officially the first certification body to be granted accreditation for cannabis certification in the United States by ANAB.

PJRFSI has developed a cannabis certification standard that uses GMP- and GAP-based scheme to help growers, manufacturers and retailers meet a wide range of different state regulations. The goal of the standard, according to the press release, is to provide guidelines for cultivation, manufacturing and retail best practices across the country.

Because each state has very different rules and requirements for cannabis companies, the certification requirements can be confusing and vary widely from state to state. With the release of this new standard, PJRFSI wants to simplify cannabis markets in the United States and hopefully get various states on a same or similar page.

According to Terry Boboige and Lauren Maloney, president and accreditation manager at PJRFSI respectively, they have a lot of hope for what the future holds in terms of unifying cannabis rules and requirements. “The team at Perry Johnson Registrars Food Safety Inc. is incredibly excited to be the first company in the United States to achieve formal accreditation for our Cannabis and Hemp Certification Program,” says Boboige and Maloney. “We believe this nationally-recognized program will help the budding cannabis and hemp industries to strengthen, legitimize, and separate themselves from companies that do not have formal certification. Certification to this standard will forever help enhance companies’ image, credibility, and reliability. Accredited certification exemplifies to the public that certified organizations who supply cannabis and hemp products and services have internal safety systems that can inspire confidence.”

Navigating COVID-19 in the Cannabis industry in the UK

By Mike Barnes
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There is no doubt all industries are feeling the effects of the coronavirus pandemic; however, cannabis businesses face a unique set of challenges.

Business operations, consumer behavior and financials will be analysed more than ever as businesses seek to position themselves during the pandemic and beyond when lockdowns will eventually be alleviated. As Benjamin Franklin said, “Out of adversity comes opportunity.” COVID-19 is an opportunity for cannabis firms to restructure their business model from a direct, consumer, wholesale and partnership level; eradicate inefficiencies and reassess launch or expansion plans.

Like many other sectors, the cannabis market should still expect to lose revenue due to factors like store closures, disrupted supply chains and restricted transport.

The outlook may seem bleak, but it’s not all doom and gloom when looking at the CBD and medical cannabis markets in more detail.

CBD consumption  

With social distancing measures still in place, cannabis firms which offer an online sales platform are seeing a surge in business. During COVID-19, there has been a greater focus on staying healthy and boosting immune systems which is driving consumers to a variety of health-focused products including CBD.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Fortunately, many of the physical retailers who stock CBD products in the UK have been permitted to stay open, despite a nation-wide lockdown, so some consumers are bulk buying their usual products while others are turning to e-commerce and delivery services. This demonstrates how quickly some firms have adapted to keep their businesses afloat.

However, border restrictions have tightened and as many supply and logistics workers remain in quarantine, the CBD market could see challenges in maintaining supply lines as the pandemic continues.

This comes in addition to CBD firms working to process a Novel Food Application and fulfill the necessary requirements by March 31, 2021. Despite lobbying from the Cannabis Trades Association (CTA) and despite the impact the global pandemic is having on the sector, the deadline has not been extended.

CBD businesses need to capitalise on the opportunities arising during this downturn; be creative and pin-point ways to keep CBD consumers engaged. By building on their brand and refreshing where necessary, they can attract consumers and develop a loyal customer base. Sustaining a strong online presence and enhancing social media and marketing strategies can lead to an increase of online sales. The brands which can leverage awareness and embody trustworthiness will be the winners.

CBD cannot cure COVID-19

As the epidemic continues into May, there has been no shortage of scammers attempting to try and short-change a fearful, confused population. Unfortunately, the cannabis industry has seen some shameful claims by CBD and hemp companies, notably in the US, who claimed their products could cure or fight off the symptoms of COVID-19.

CBD has been positioned as having several positive health effects by manufacturers and retailers – most notably in reducing pain and inflammation, decreasing anxiety and helping sleep – which may be on the rise within this unsettling environment.

The International Association for Cannabinoid Medicine (IACM), issued a statement on the coronavirus pandemic saying, “there is no evidence that individual cannabinoids or cannabis preparations protect against infection … or could be used to treat COVID-19.” Trials have been launched in Israel to explore whether CBD’s anti-inflammatory properties can be an effective COVID-19 treatment. Until this has been clinically proven, cannabis firms must not make unsupported claims.

Medical Cannabis

During COVID-19, health systems are under unprecedented pressure, which is impacting patient access to all medical treatments, including cannabis.

The medical cannabis industry has swiftly adapted to these challenges by rolling out video consultations and other online consultation services to enhance patient access.

While the Home Office activity for licencing will be limited during this time, companies must work with regulators to keep supply lines open, so that those in need receive their medicine without relying on black-market activity.  On April 29, the government published emergency legislation to allow patients to continue accessing controlled drugs for the duration of the epidemic, from pharmacies, without a prescription. This only applies to patients with ongoing NHS treatment, so there is still a long way to go, as private cannabis clinics must fill the gap in the meantime.

The global pandemic has impacted us all, and many patients are concerned about how they will access vital services. Many patients receiving medical cannabis have underlying health conditions which make them more susceptible to contracting COVID-19 and those with chronic neurologic conditions like epilepsy are in danger of suffering potential side effects.

Several of the qualities needed to survive the coronavirus pandemic – awareness, self-containment and support – are basic skill sets to carers. Beyond the pandemic, policy shifts, investment and education are needed to lift the barriers to medical cannabis access, and this will require all businesses operating in the cannabis industry to drive change.

2020 is a defining year for cannabis 

The cannabis industry is resilient against socio-economic, political and policy drivers- this we’ve seen time and time again. Now we must create an even stronger UK industry, where products are safely and readily available to those who need them. As the cannabis market matures and the competition things out, only quality cannabis products and services will be in play. Those that can innovate their approach to production, distribution and consumption during the pandemic can be the catalyst for long-lasting changes for the cannabis industry to operate for the better.

Some CBD Companies Are Getting Millions in Federal Aid

By Aaron G. Biros
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As we’ve covered previously, the coronavirus pandemic has impacted the cannabis industry in the United States in a number of ways. Many states with legal medical and recreational cannabis markets have deemed those cannabis businesses essential, allowing them to remain open during statewide stay-at-home orders. Congress passed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to help small businesses through the economic downturn, directing trillions of dollars to the Small Business Administration (SBA) to administer emergency loans, paycheck protection programs and other financial assistance to small businesses affected by the coronavirus pandemic.

CV Sciences received $2.9 million in federal aid from the SBA

However, pretty much all state-legal medical and recreational cannabis businesses are ineligible to receive money from the SBA because cannabis is designated as a Schedule 1 controlled substance. While Rep. Earl Blumenauer (D-OR) and Rep. Ed Perlmutter (D-CO) introduced legislation recently that would allow cannabis businesses to become eligible for federal assistance, it is unclear if that bill will become law. Furthermore, even if it does pass, cannabis businesses will likely receive little or no help at all, as a vast majority of the funds administered by the SBA have already been spoken for.

Enter the hemp and CBD products market. Thanks to the 2018 Farm Bill, which removed cannabis containing less than 0.3% THC from the list of controlled substances, hemp and CBD companies are not exempt from the SBA’s relief efforts.

According to VICE News, The Trump Administration has handed out millions of dollars to companies that sell CBD products. When VICE News looked into some SEC filings, they found more than $4 million in federal loans that have been granted to CBD products companies.

They found three CBD companies that scored big with federal assistance:

Despite state-legal medical and recreational cannabis businesses being left to fend for themselves, these large online CBD products retailers have received more than $4 million in federal aid money.

Emergency Cannabis Small Business Health and Safety Act – A Legislative Update

By Steve Levine, Megan Herr, Meghan Brennan
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On Thursday April 23, 2020, Representatives Earl Blumenauer (D-OR) and Ed Perlmutter (D-CO) introduced the “Emergency Cannabis Small Business Health and Safety Act” in the House. Blumenauer and Perlmutter have been influential in protecting state-legal cannabis businesses from federal interference, most recently under the 2020 federal appropriations rider.

If passed, the Act would allow state-legal medical and recreational cannabis businesses to take advantage of the multi-trillion dollar stimulus packages designed to help small businesses harmed by COVID-19.

As we previously discussed, cannabis businesses harmed by COVID-19 remain ineligible to receive federal financial assistance due to their engagement in “federally illegal” activities. Consequently, cannabis businesses cannot receive assistance from the Small Business Administration (SBA) thereby making them ineligible to receive Paycheck Protection Program (PPP) loans and other SBA financial assistance, including Economic Injury Disaster Loans (EIDLs), traditional 7(a) loans, 504 loans, and microloans.

To provide the industry with much needed economic relief, the legislation states that cannabis businesses would no longer be prohibited from (i) participating in the PPP, (ii) receiving EIDL loans, or (iii) receiving emergency EIDL grants purely on the basis that the business is a “cannabis-related legitimate business”1 or “service provider.”2

Additionally, the Act clarifies that the SBA and its officers, directors and employees would “not be held liable pursuant to any Federal law or regulation solely for providing a loan or a loan guarantee to a cannabis-related legitimate business or a service provider.”

Even though states have varied in their approach to continue medical and retail cannabis operations amid the coronavirus outbreak, a majority of states that allow some form of sale and consumption of cannabis have designated the cannabis industry as “essential” and open for operation.3 Some states have gone as far as allowing home delivery, curbside pick-up, and telemedicine consultations.

Nonetheless, despite the cannabis industry’s designation as “essential,” cannabis businesses (including those who service the cannabis industry) will continue to be precluded from receiving federal financial assistance until the Emergency Cannabis Small Business Health and Safety Act, or similar legislation, is passed. It is important to note that, even if passed, the Emergency Cannabis Small Business Health and Safety Act would likely provide little relief, as the majority of the funds to be administered by the SBA have already been accounted for.

What does this mean to you?

Although the COVID-19 pandemic has highlighted the need for the heavily-taxed and financially burdened cannabis industry to receive assistance under the stimulus packages, the Act, even if passed by Congress, faces an uphill battle in the Republican-held Senate.


References

  1.  The term “cannabis-related legitimate business” means a manufacturer, producer, or any person that – (A) engages in any activity described in subparagraph (B) pursuant to a law established by a State or a political subdivision of a State, as determined by such State or political subdivision; and (B) participates in any business or organized activity that involves handling cannabis or cannabis products, including cultivating, producing, manufacturing, selling, transporting, displaying, dispensing, distributing, or purchasing cannabis or cannabis products.”
  2. The term “service provider” (A) means a business, organization, or other person that – (i) sells goods or services to a cannabis-related legitimate business; or (ii) provides any business services, including the sale or lease of real or any other property, legal or other licensed services, or any other ancillary service, relating to cannabis; and (B) does not include a business, organization, or other person that participates in any business or organized activity that involves handling cannabis or cannabis products, including cultivating, producing, manufacturing, selling, transporting, displaying, dispensing, distributing, or purchasing cannabis or cannabis products.”
  3. State-by-State COVID-19 Announcements Impacting Marijuana Businesses.

Essential Cannabis Businesses Must Protect Employees and Customers During COVID-19 With Sanitation and Social Distancing Practices

By David Laks
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Unlike their retail neighbors who have been forced to move inventory online to survive, many cannabis businesses are considered essential and remain open during the current pandemic. With that, though, comes a tremendous responsibility to maintain optimal protocol for safe operations and customer shopping.

Whether you run a retail or production operation, allow only essential vendors (i.e. delivery, service companies) into the facility and have non-essential staff telecommute, when possible. Some businesses may want to consider splitting shifts for the management team as well.

Each state and local municipality will have their own rules when it comes to protocols for open retail establishments. Where those are more stringent than the following recommendations, adhere to the more stringent rule.

Cannabis Production Facility Best Practices

While not being face-to-face with cannabis customers on a daily basis, production facilities are the first and possibly only ones to handle the raw product the customer will eventually consume. For this reason, it’s important to conduct a refresh training session on sanitation procedures and new COVID-19 protocol for all production employees. Consider the following critical procedures for cannabis production facilities:

  • Review current production sanitation procedures and adjust accordingly, focusing on high touch points and potentially contaminated surfaces. Include office items such as keyboard, phones, and kitchen areas.
  • Review the business’ call-in sick policy and make sure employees know they can – and should – do so if they’re under the weather.
  • Sanitize high touch points every 30 minutes or less.
  • Instruct employees to wash hands with soap and water for 20 seconds after blowing their nose, coughing, sneezing, going to the bathroom, before eating and when touching any communal surface, including door handles and surfaces. Wear personal protective equipment (PPE) at all times while working with raw product, including gloves and masks.

    control the room environment
    PPE can reduce the risks of spreading disease
  • If an employee coughs or sneezes in a production area, instruct them to do so into the elbow of their outer garment, and immediately change following proper donning techniques. Instruct them to avoid touching their face.

Cannabis Retail Facility Best Practices

Retail cannabis establishments must realize first and foremost that those with compromised immune systems may be frequenting their store to purchase medical cannabis. Consider, evaluate and appropriately publicize protocol relative to employee interactions with customers, including:

  • Enable mobile or order-ahead features along with curbside pickup and contact-less delivery, when possible. Where this isn’t an option, limit the number of customers in the store at a time.
  • Consider moving to appointment-only operations, or restricted hours for those over 65.
  • Reduce store visits by recommending patients order their prescription for the maximum allowable 60 days.
  • Designate an employee to champion personal sanitation and social distancing. Create an entry sanitation station and require all customers to use it upon entry. Maintain social distance of 6-ft. minimum between customers. Place markings on the floor to designate this.
  • Limit sales to only sealed products.
  • Sanitize high touch points twice an hour, including ID check booths, display cases, phones, keyboards, etc. and provide adequate PPE for all, including gloves, masks, etc.
  • Install separation barriers, like thick plastic or plexiglass at each cashier station.

The requirements of keeping an essential business open will vary by location and will likely change as the COVID-19 pandemic evolves. Regularly check for changes to the rules of your local jurisdiction and adapt accordingly.

HACCP

HACCP for Cannabis: A Guide for Developing a Plan

By Radojka Barycki
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HACCP

Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that evaluates hazards that may potentially be present in food products that can harm the consumer. The process used to manufacture the product is evaluated from raw material procurement, receiving and handling, to manufacturing, distribution and consumption of the finished product1. The documented process is what is known as HACCP plan. Although HACCP was designed to evaluate hazards in foods, it can be used to assess or evaluate hazards that may potentially be present in cannabis consumable products (edibles and vaping) that can cause harm to the consumer.

HACCP plan development requires a systematic approach that covers 5 preliminary steps and 7 principles. A systematic approach means that each step must be followed as outlined. Skipping a step will result in a HACCP plan that most likely will be ineffective to control potential hazards in the product.

The 5 preliminary steps are:

  1. Establish a HACCP team
  2. Describe the product
  3. Establish the intended use of the product
  4. Develop a flow diagram
  5. Verify the flow diagram

The 7 Principles are:HACCP

  1. Conduct a hazard analysis
  2. Identify the critical control points (CCPs)
  3. Establish critical limits (CL)
  4. Establish monitoring procedures
  5. Establish corrective actions
  6. Establish verification procedures
  7. Establish records and record keeping procedures1,2

It is important to mention that HACCP plans are supported by programs and procedures that establish the minimum operational and sanitary conditions to manufacture safe products. These programs and procedures are known as pre-requisite programs (PRP) or preventative controls1,2.

Figure 1. Flow Diagram

A multidisciplinary team must be established in order to ensure that all inputs of the product manufacturing process are considered during the hazards analysis discussions. The description of the product and its intended use provides detail information on ingredients, primary packaging material, methods of distribution, chemical characteristics, labeling and if any consumer might be vulnerable to the consumption of the product. A verified flow diagram is an accurate representation of the different steps followed during the product manufacturing process and will be used to conduct a hazard analysis. An inaccurate flow diagram will set the stage for an inadequate HACCP plan. Therefore, it is important that the HACCP team members verify the flow diagram. Figure 1 is a flow diagram for a fictional infused apple juice manufacturing plan that I will be using as an example.

The hazard analysis is the backbone of the HACCP plan. There are two elements that must be considered when conducting the hazard analysis:

  • Identification of the hazard associated with the ingredient(s) and/or the product manufacturing steps. These hazards have been categorized as: Biological, chemical (including radiological) and physical. Biological, chemical and physical hazards should be considered for each ingredient, primary packaging and process step. Also, it is important that the team is specific as to what hazard they are referring to. I often find that biological hazards are identified as “pathogens” for example. The team has to be specific on which pathogen is of concern. For example, if you are processing apple juice, the pathogens of concern are pathogenic coli and Salmonella sp. However, if you are processing carrot juice, you need to add Clostridium botulinum as a biological hazard also. If the choice of method to eliminate the hazards is pasteurization for example, the processing temperature-time combinations will differ greatly when manufacturing the apple juice vs. the carrot juice as C. botulinum is an organism that can sporulate and, therefore, is harder to kill.
  • Characterization of the hazard. This implies determining the significance of the potential hazard based on the severity of the consequence if it is consumed and the likelihood of occurrence in the ingredient or process step. Only steps in the process that has significant hazards should be considered further.
Table 1. Ingredient Hazard Analysis

In my professional experience, the hazard analysis is one of the most difficult steps to achieve because it requires the expertise of the multidisciplinary team and a lot of discussion to get to the conclusion of which hazard is significant. I find that a lot of teams get overwhelmed during this process because they consider that everything in the process may represent a hazard. So, when I am working with clients or providing training, I remind everyone that, in the bigger scheme of things, we can get stricken by a lighting in the middle of a thunderstorm. However, what will increase our chances would be whether we are close or not to a body of water for example. If I am swimming in the middle of a lake, I increase my chances to get stricken by the lighting. In comparison, if I am just sitting in my living room drinking a cup of coffee during the thunderstorm, the likelihood of being stricken by a lighting is a lot less. The same rationale should be applied when conducting the hazard analysis for manufactured products. You may have a hazard that will cause illness or death (high on the severity chart) but you also may have a program that mitigates the likelihood of introducing or having the hazard. The program will reduce the significance of the hazard to a level that may not need a critical control point to minimize or eliminate it.

Table 2. Process Hazard Analysis (1)

Clear as mud, right? So, how would this look like on the infused apple juice example? Table 1 shows the hazard analysis for the ingredients. Tables 2 and 3 show the hazard analysis for the part of the process. In addition, I have identified the CCPs: Patulin testing and pasteurization. There is a tool called the CCP decision tree that is often used to determine the CCPs in the process.

Once we have the CCPs, we need to establish the critical limits to ensure that the hazard is controlled. These limits must be validated. In the case of Patulin, the FDA has done several studies and has established 50 ppm as the maximum limit. In the case of pasteurization, a validation study can be conducted in the juice by a 3rd party laboratory. These studies typically are called thermal death studies (TDS) and provide the temperature and time combination to achieve the reduction of the pathogen(s) of concern to an acceptable level that they do not cause harm. In juice, the regulatory requirement is a 5-log reduction. So, let’s say that the TDS conducted in the infused apple juice determined that 165°F for 5 seconds is the critical limit for pasteurization. Note that the 5 seconds will be provided by the flow of the product through the holding tube of the pasteurizer. This is measured based on flow in gallons per minute.

Table 3. Process Hazard Analysis (2)

Monitoring is essential to ensure that the critical limits are met. A monitoring plan that outlines what, how, when and who is responsible for the monitoring is required.

Ideally, the system should not fail. However, in a manufacturing environment, failures can happen. Therefore, it is important to pre-establish steps that will be taken to ensure that the product is not out of the control of the facility in the event of a deviation from the HACCP plan. These steps are called corrective actions and must be verified once they are completed. Corrective actions procedures must address the control of the product, investigation of the event, corrective actions taken so the deviation doesn’t reoccur and product disposition.

Table 4. HACCP Plan Summary

Verification activities ensure that the HACCP plan is being followed as written. Typically, verification is done by reviewing the records associated with the plan. These records include but are not limited to monitoring records, calibration records, corrective action records, and preventive maintenance records for equipment associated with the CCPs. Record review must be done within 7 working days of the record being produced.

Finally, establishing records and record keeping procedures is the last step on developing HACCP plans. Records must be kept in a dry and secure location.

Table 4 show the summary of the HACCP plan for the infused apple juice example.

For more information on how to develop a HACCP plan for your facility, read the resources below:

  1. HACCP Principles and Application Guidelines – The National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
  2. ASTM D8250-19: Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) Systems for Cannabis Consumable Products

How to Streamline Labeling from Seed to Sale in The Time of COVID-19

By Travis Wayne
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As if the cannabis industry doesn’t regularly go through enough rapid change, with COVID-19, cultivators, processors and dispensers of all sizes are trying to do more with less. Lower operational headcount and unpredictable production volume, along with a rapidly-changing supply chain – make eliminating manual steps a necessity. Labels include barcodes or various barcode symbologies to help companies manage inventory, identify products and ultimately ensure that the right products get to the right customers at the right time. By eliminating manual steps in your labeling environment, you can address these issues through automation, scalability, efficiency and accuracy: benefits that will last through the pandemic and position you well for the recovery period.

Automation

Automation of many kinds is being implemented from seed to sale including barcode label printing automation. Integration of labeling software and seed to sale traceability systems including METRC, BioTrack, Leaf Data and others enables streamlined barcode label data population and high-volume label printing to counteract the decreasing operational headcount and eliminate manual touchpoints.

Print automation can be defined as “a centralized technology that replaces the manual process of triggering a print job within a labeling environment.” Look for a labeling software solution that allows you to:

    • Completely automate your label printing process
    • Print to a greater number of printers
    • Initiate printing directly from any business system
Integrating your label printing system with your seed to sale traceability system can minimize errors, increase print speeds and maximize your ROI.

By integrating your label printing system with your seed to sale traceability system, you can expect to minimize errors, increase print speeds and maximize your ROI. Your business system already holds the variable data such as product names, license number, batch or lot codes, allergens, net quantity, cannabis facts, warning statements and more. By systematically sending this data to the right label template at the right time, labeling becomes an efficient and cost-effective process.

Scalability

One of the most important considerations for cannabis cultivators, processors and dispensers is to invest in solutions that can grow and pivot quickly as the business changes. Whether you are responding to temporary requirements or changes, or your business needs to scale up quickly to respond to a spike in demands as a result of COVID-19 or to prepare for coming out of this pandemic. Whatever your needs are, think about short-term and long-term goals for sustainable business solutions. Scalability includes:

Printing to a greater number of printers

As needs and automation requirements change, and your printer inventory has the possibility of increasing, make sure your labeling design software can be licensed per simultaneous user, with cost-effective, multi-user networking licenses. That way, you don’t run the risk of paying for more printers as you grow or going over budget with each additional printer.

Print documents and labels from the same application

If you use the same data for your documents (like order receipts, bills of materials or packing lists) and labels, moving document printing into your label design software makes sense logistically. An advanced label creation and integration software enables label and document printing standardization by allowing multiple database records to be on one file. That means when new documents or labels come into your database, your software can seamlessly integrate.

Efficiency and accuracy

In a time where responding to the changing market needs to happen very quickly, where costs are being scrutinized and when errors cannot happen – you need to set up your labeling environment to have high levels of accuracy and control. With increased accuracy you will reduce waste, eliminate returns due to mislabeled product, efficiently track product and gain more efficiencies that will save you money and time.

Cutting manual steps out of the process

Removing manual steps in your printing process is a sure-fire way to gain efficiency and accuracy in your labeling environment. Look for labeling software features that allow you to add variable data from a device to your labels automatically, which limits the human interaction with your labels and in turn helps minimize human errors. Other efficiencies include:

On-demand color labeling streamlines efficiency and accuracy across a wide variety of labeling needs.
  • Increased print speed within your labeling environment
  • Reduced label waste
  • Collection of data from several devices such as:
    • Scanners
    • Scales
    • Keyboards

On-demand color labeling

On-demand labeling is specifically helpful in the cannabis labeling world because of all the regulations you must comply with. Each state has its own regulations, which means each label throughout the cannabis supply chain must be compliant with whichever state they are located. With on-demand labeling, cannabis companies print labels as needed and make changes as they go without the risk of wasting obsolete pre-printed label stock. This is beneficial as pre-printed labels often have large minimum order quantities. On-demand labeling also helps companies maintain better control of their own branding and graphics.

With on-demand labeling, label information can be populated by using pre-approved label templates in order to save you time with the variations of cannabis labels. This gives you the ability to print the specific label you need without having to waste your pre-printed label stock, or spend time switching out your pre-printed label stock in your printer.

Cannabis cultivators, processors and dispensers are faced with many obstacles during these challenging times due to COVID-19 – ensuring workers are safe, keeping operations at 100% capacity with potentially fewer people, creating contingency plans that may be changing daily. In an environment that is changing very quickly, consider how labeling solutions can evolve. You may also need to lean more on your partners than you ever have in the past.