Soapbox

When the Company’s Revenue Drops, Who’s to Blame?

By Dr. Ginette M. Collazo
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The ultimate goal of any business is to produce and generate revenue. Now, when the company’s revenues drop, who’s fault is it? This question, though silent, is in the minds of everyone in an organization, especially when things start to become difficult.

Working as a consultant in productivity with different industries around the world, I have come to realize that question is not openly discussed, but everyone wants to know the answer. To answer it, we will explore the most common areas of opportunity related to this problem.

When we talk about productivity, we are talking about final tangible results, because of the production process and the effort made by each one; when speaking of income, we are talking about the difference between the purchase price and the cost of entering the market. Seeing these definitions, we might conclude that the increase in income is directly related to the increase in productivity.

On the other hand, we must not lose perspective that the increase in productivity is also directly related to the decrease of losses.

First, we have to put into perspective the goals and objectives that a business or organization may have. Many companies go on believing that everyone is clear about the goals and organizational objectives and what is expected in each one of those roles that compose the organization. The reality is that, if we do not know where we are going, the chances of reaching the goal decrease.

When organization’s objectives are properly communicated, and documented, in such a way that the evaluation of the performance is directly linked to the expected results, the chances of success increase substantially.

On many occasions, I have heard phrases such as: “we work hard, we spend many hours, all sacrifice ourselves… we should be more successful”. The question then is: what are we encouraging, efforts or results?

It is hard for organizations to translate or differentiate between organizational goals and individual objectives (expected results) for each of those roles in the company. We all agree that we want to be the first in sales, the best in service and produce the highest quality, but how is that done?

To be the first in sales, what do I have to do as a seller? Get three customers in a three-month period? As secretary, process the orders in the first three days of receiving them? As a carrier, suggest three ideas be more useful in daily deliveries? How does that translate into individual performance?

We focus too much on telling people what they must do, but we forget to be clear on what we expect them to achieve. Hence, the effort versus result dissonance. The success of an organization is the collective behavior that arises from the conduct of individuals. If we align people, we align the organization.

Other elements that we must ponder, and that are directly related to productivity, are: how much of what we do holds value? How much of what we do does not have value? Moreover, how much of what we do, though it has great value, shall be performed by the requirements of law or regulation?

An analysis of productivity is critical, particularly in a time when we want to do more with less. Lately, an area of great success for many organizations is to streamline processes to make them more simple, efficient and with less risk of error. Human errors generated many losses. Defects, the re-process, the handling of complaints and lawsuits are costing companies money equivalent to the salary of 7,200 employees every day (according to statistics in the United States).

Human errors can be avoided. The idea that to err is human has led us to ignore this problem. We think that we can do nothing and lose an infinite number of opportunities for improvement that can help us to increase our income, reducing losses.

Only 16% of organizations measure the cost of human error. The remaining 84% do not measure it and are paying a high price without knowing it. In Puerto Rico, there are no statistics that could shed light on how many local companies lose because of human error, but it is very likely that the numbers are alarming. Human error can be reduced by 60% in less than a year when an intervention is done on systems. Approximately 95% of human errors are due to the design of the company’s systems, and they can be the simplest errors even in the most complex processes.

Today, we have more information, and we know that errors are symptoms of deeper problems in the processes created by the organizations. People play a crucial role regarding how robust methods are, but, we must not lose perspective that human beings operate according to the policies, procedures, and instructions which the same organization designs. Then, if people work according to the designs of the organization, is it not easier to modify designs than eliminating people?

So, who’s fault? Organizations are responsible for providing clear guidance to individuals in the right direction, and individuals have the responsibility of translating their efforts into results. Both have to work with the same objective in mind, and both employers and employees should communicate openly about these objectives. Only by working in partnership will achieve success. Forget who is to blame and focus on the processes and goals that help us be successful.

Soapbox

Budtenders: Providing Education and Customer Service

By Rachel Stires
1 Comment

Budtenders represent the front line of any cannabis dispensary, and as such they are responsible for fostering a valuable customer service experience that will have clients returning in the future. However, the role of budtender goes much deeper than simply providing customer service. If you want to develop a profitable business with deeply embedded customer loyalty, you can do no better than to hire an exceptional team of budtenders to provide your patrons with useful information and a memorable customer service experience that will keep them coming back for repeat sales.

Offering Education for All Customers

Perhaps the most important role the budtender plays in any dispensary is providing the customer with useful knowledge that will help them make an informed purchase. For many people, legal cannabis is still a very new concept, and there are a good deal of customers who have never tried cannabis products during prohibition. For these customers, it will be essential that an experienced budtender walk them through everything they need to know and help them choose a strain that will be best suited to their needs. In addition to dosing and strain advice, budtenders can help explain how various paraphernalia works, as pipes and bongs will likely be foreign to them.

For less seasoned smokers, information on dosing can be the difference between a positive and negative experience. This is primarily a concern with edibles due to the long lasting nature of their effects, but can benefit other methods of delivery as well. The effects and potency of different strains can vary widely, so it can be difficult to judge how much to ingest. Though it is impossible to overdose on cannabis, using too much can have a negative impact on the experience. By offering experienced insight into the product they are selling, budtenders can ensure that the customer will have a more positive experience with cannabis, leading to lasting relationships with your company.

Budtenders can provide plenty of value for more experienced consumers as well. The fact of the matter is, there is an endless sea of different types of cannabis products on the market, and learning all of them requires more research than many cannabis consumers are willing to invest. Whether a customer uses cannabis for medicinal or recreational purposes, they will likely have developed preferences when it comes to what they like to smoke. It is important that budtenders be knowledgeable enough to direct the customer to a product that will live up to their expectations.

A client suffering from anxiety shouldn’t be recommended towards an energetic sativa, for example, as this will likely give them a bad case of paranoia, resulting in a negative experience that could send their business elsewhere. Likewise, a daytime smoker probably won’t be happy with a relaxing Indica that will put them to sleep. Budtenders need to keep up with the various strains that are in stock at all times and be able to direct their customers to the right product.

Budtender Presentation and Service

Of course, being knowledgeable about cannabis is a necessity, but a good budtender must also be able to convey this information in a manner that educates the customer. The best budtenders will be approachable and prepared to answer any question thrown their way. They should be able to present the information like a teacher, a quality that will put customers at ease and leave them confident they are in good hands.

Dispensaries can set themselves apart from the competition by choosing their budtenders wisely. It is important to hire budtenders who present themselves in a highly professional manner including down to their manners and clothing. When a customer buys cannabis from a store, they may have preconceived notions about the budtenders working there. By hiring knowledgeable, personable and professional budtenders, businesses can tackle negative stereotypes surrounding the newly emerging cannabis industry and improve customer satisfaction.

If you’ve been to a lot of cannabis dispensaries, you’ll know that some of them might feel like a drug dealer just leased a building and set up shop, business as usual. With legalization comes the opportunity to legitimize cannabis consumption to a degree not possible before, and many dispensaries are helping to change the perception of the industry by catering to more refined crowds with attractive shops and a professional atmosphere. A good team of budtenders can go a long way towards establishing a dispensary as an upscale business.

Overall, A great budtender is an invaluable asset to any dispensary, and staffing your business with them is your best bet at building lasting relationships with your customers. Budtenders with expansive knowledge of cannabis strains, effects, and dosage, as well as a professional and personable demeanor are essential to the success of a dispensary, and without them a business might suffer.

Soapbox

Quality Controls and Medical Cannabis: What We Can Learn from Pharma

By Dr. Ginette M. Collazo
1 Comment

When we discuss growing and producing medical cannabis, we must think of it as a medicine. By definition, it is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and quality controls in medical cannabis production, there is still a lot to learn.

Are we waiting for the wake-up call? Well, ring! Recently Health Canada, the regulatory body overseeing Canada’s medical cannabis market, decided that “It will begin random testing of medical marijuana products to check for the presence of banned pesticides after product recalls affecting nearly 25,000 customers led to reports of illnesses and the possibility of a class action lawsuit.”

Proper quality controls help protect businesses from unforeseen issues like those massive recalls in Canada. These can assure that the product is safe (won’t harm you), has integrity (free of contamination), and that the product is what it says it is (identity). To achieve this important goal, we must have robust systems that will guarantee product quality. Why is this important? Quality controls can ensure a safer and more consistent product, helping build patient and consumer trust and brand loyalty, preventing a public relations nightmare like a recall due to pesticide contamination.

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

The FDA, among other regulatory bodies, has established excellent guidelines to implement these controls. So there is a lot we can learn from the pharmaceutical industry and that FDA guidance regarding quality controls and assurance. After all, we are all interested in the same thing: a safe and effective product.

So, let’s take a look at some of the controls included in the CFR (Code of Federal Regulation), Part 211 , which include Good Manufacturing Practices (GMPs) for finished products, and how you can implement them in the growing business of growing cannabis.

  1. Personnel selection and training: The GMPs establish that “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training… to enable that person to perform the assigned functions.” These include the creation of specific curricula per position and the establishment of requirements for specialized tasks. We all want to be successful so training, in this case, is what we call the vaccine for mistakes.
  2. Facilities: “Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.” This requirement includes segregation of spaces to avoid cross-contamination, housekeeping, the cleaning process and detergent types, material storage conditions, humidity levels, temperature, water, and even ventilation requirements to prevent contamination with microorganisms. All with the intention of protecting the product.
  3. Pest control: “There shall be written procedures for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed.” There have been many issues pertaining this requirement. In 2010, Johnson & Johnson received many complaints claiming that the product had a musty, moldy odor. Later, the firm identified the cause of the odor to be a chemical, called 2, 4, 6-Tribromoanisole or TBA; a pesticide used to treat wooden pallets. One of the specific requirements of this section is to avoid the use of wooden pallets, but if you decide to use them, the method of sterilization by heat treatment seems like the only safe option for sterilizing wooden pallets and wood cases.
  4. Equipment/Instrumentation: “Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.” The intention is to not alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. What would happen if lubricants/coolants or any other substance, not intended to be part of the product, comes in contact with the product?
  5. Procedures and documentation: “There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements of this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved. When we have followable, well written, clear, and specific procedures, we avoid possible errors that can get us in trouble.
  6. Defects Investigation: “Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.” We want to be successful, for that we need to learn from failures, understanding the root causes, correcting and preventing re-occurrence is what will keep you competitive. As you can see this requirement is essential for, quality, business and to evidence that such deviations did not adulterate the product.
  7. Process controls: Besides written procedures and deviations management, operation controls are pivotal in guaranteeing the quality as well as complete documentation of your process. These controls will vary depending on your technology and your product. If you do alcohol (ethanol) extraction, for example,  you want to keep an eye on the temperature, dissolution time, and even have color standards to be able to quickly and correctly identify possible abnormalities, while you can still correct the mistake. In-process product testing will allow you to monitor “performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the final product.”

Regardless of federal regulatory guidance, quality controls can be that one factor which can make or break your business. Why re-invent the wheel?

The Practical Chemist

Instrumentation Used for Terpene Analysis

By Tim Herring
2 Comments

Terpenes are a group of volatile, unsaturated hydrocarbons found in the essential oils of plants. They are responsible for the characteristic smells and flavors of most plants, such as conifers, citrus, as well as cannabis. Over 140 terpenes have been identified to date and these unique compounds may have medicinal properties. Caryophyllene, for example, emits a sweet, woody, clove taste and is believed to relieve inflammation and produce a neuroprotective effect through CB2 receptor activation. Limonene has a citrus scent and may possess anti-cancer, anti-bacterial, anti-fungal and anti-depression effects. Pinene is responsible for the pine aroma and acts as a bronchodilator. One theory involving terpenes is the Entourage Effect, a synergistic benefit from the combination of cannabinoids and terpenes.

Many customers ask technical service which instrumentation is best, GC or HPLC, for analysis of terpenes. Terpenes are most amenable to GC, due to their inherent volatility. HPLC is generally not recommended; since terpenes have very low UV or MS sensitivity; the cannabinoids (which are present in percent levels) will often interfere or coelute with many of the terpenes.

Figure 1: Terpene profile via headspace, courtesy of ProVerde Laboratories.

Headspace (HS), Solid Phase Microextraction of Headspace (HS-SPME) or Split/Splitless Injection (SSI) are viable techniques and have advantages and disadvantages. While SPME can be performed by either direct immersion with the sample or headspace sampling, HS-SPME is considered the most effective technique since this approach eliminates the complex oil matrix. Likewise, conventional HS also targets volatiles that include the terpenes, leaving the high molecular weight oils and cannabinoids behind (Figure 1). SSI eliminates the complexity of a HS or SPME concentrator/autosampler, however, sensitivity and column lifetime become limiting factors to high throughput, since the entire sample is introduced to the inlet and ultimately the column.

The GC capillary columns range from thicker film, mid-polarity (Rxi-624sil MS for instance) to thinner film, non-polar 100% polysiloxane-based phases, such as an Rxi-1ms. A thicker film provides the best resolution among the highly volatile, early eluting compounds, such as pinene. Heavier molecular weight compounds, such as the cannabinoids, are difficult to bake off of the mid-polarity phases. A thinner, non-polar film enables the heavier terpenes and cannabinoids to elute efficiently and produces sharp peaks. Conversely the early eluting terpenes will often coelute using a thin film column. Columns that do not contain cyano-functional groups (Rxi-624Sil MS), are more robust and have higher temperature limits and lower bleed.

For the GC detector, a Mass Spectrometer (MS) can be used, however, many of the terpenes are isobars, sharing the same ions used for identification and quantification. Selectivity is the best solution, regardless of the detector. The Flame Ionization Detector (FID) is less expensive to purchase and operate and has a greater dynamic range, though it is not as sensitive, nor selective for coeluting impurities.

By accurately and reproducibly quantifying terpenes, cannabis medicines can be better characterized and controlled. Strains, which may exhibit specific medical and psychological traits, can be identified and utilized to their potential. The lab objectives, customer expectations, state regulations, available instrumentation, and qualified lab personnel will ultimately determine how the terpenes will be analyzed.

Biros' Blog

Regulate Marijuana Like Alcohol? Not So Fast

By Aaron G. Biros
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You’ve heard it in a lot of campaigns to legalize cannabis on a state level and even as the name of a bill in Congress for legalization on the federal level. The Marijuana Policy Project through their campaigns in several states, along with activists, politicians and lobbyists, have used the phrase “Regulate Marijuana Like Alcohol” as a rallying cry to pass legislation reforming cannabis laws. This isn’t an attack on them; those campaign names serve the cause well, moreover it was the name of successful campaigns in Massachusetts, Maine, California, Alaska and Colorado among others. It is a relatable and fair comparison, helping to normalize the concept of adults using cannabis in a legal environment.

But that feeling of validation is short-lived after lawmakers write the actual regulations. In reality, I don’t think a single state can confidently say they actually regulate cannabis like alcohol. Most states do not allow public or social consumption of cannabis; many people that would like to enjoy cannabis in a social setting are restricted to the confines of their home.

420 Rally at Civic Center Park, Denver, CO.
Photo: Cannabis Destiny

Voters in Colorado passed Amendment 64 in 2012 with this language in the very beginning of the bill: “In the interest of the health and public safety of our citizenry, the people of the State of Colorado further find and declare that marijuana should be regulated in a manner similar to alcohol.” If you look closely, you can see how important phrasing is when it comes to the specific regulations. The key words here are “a manner similar to alcohol,” not exactly like alcohol. That language is critical to understanding how regulators address the double standard.

The most obvious way lawmakers regulate cannabis like alcohol is through a tiered system of license holders: manufacturers, distributors or wholesalers and retailers. Many states might set a limit on potency, just like they do with alcohol, according to Pamela S. Erickson, former executive director of the Oregon Liquor Control Commission. Both of the drugs are taxed and there are usually regulations for both governing the advertising of products, such as preventing targeting youth or encouraging high consumption. Regulators might limit the store hours or locations for both cannabis and alcohol. Beyond those similarities, there are a number of areas where cannabis is over-regulated and alcohol is seemingly under-regulated. It is very possible that much of this has to do with the power of the alcohol lobby. In 2016, the alcohol industry spent over $26 million on lobbying efforts, according to the Center for Responsive Politics, a non-profit, nonpartisan group that tracks lobbying efforts. During election season, the alcohol industry spent more than $11 million on campaign contributions. There are several examples of the alcohol industry actively fighting legalization efforts, including paying for anti-cannabis ads in a Politico newsletter and even funding opposition campaigns. While this doesn’t exactly pertain to the regulation of cannabis versus alcohol, it gives you a glimpse of how deep their coffers go and the amount of influence they have on politics.

Last year, the city of Denver passed a ballot measure, Initiative 300, which will legalize the social consumption of cannabis in permitted venues. The Denver Social Consumption Advisory Committee met for the final time last week. That committee designed two styles of permits: one for events and one for established businesses, which would receive a designated consumption area permit (DCA). Those permitted venues must be 1,000 feet from schools, child-care centers or drug rehabilitation centers. They need a waste plan, compliance with the Indoor Air Quality Act and they cannot sell cannabis products. Rachel Gillette, attorney in the cannabis law group and shareholder at Greenspoon Marder, says the legal implications of the initiative are still up in the air. “This was a step in the right direction,” says Gillette. “You can’t pass a law to regulate marijuana like alcohol and then say people can only use it in their home. You are going to run into problems like people smoking on the street. This is why this initiative was introduced.”

Rachel K. Gillette, Esq., practicing at the cannabis law group in Greenspoon Marder

The general idea here is B.Y.O.P.- bring your own pot. They cannot have a liquor license, the location cannot be accessible to the general public, they have to submit a detailed security plan and patrons have to sign a waiver to get in, according to Westword. Signing a waiver to get into a bar should seem asinine to anyone, but I have been to some dive bars where a waiver could’ve definitely been useful. The point is that cannabis doesn’t lead to violence or destructive behavior, alcohol is the drug that does that. There is plenty of evidence to support that, including a comparative risk assessment of the drugs, which found alcohol’s danger to be strongly underestimated previously.

Senate Bill 63 in the Colorado State legislature would have been very similar, issuing licenses for “marijuana consumption clubs.” However that bill was voted down last Thursday, largely due to the uncertainty of federal policy, according to ABC News.

Amendment 64 also has specific language saying you cannot consume cannabis in a public space, but that is not exactly the case with liquor, even when you consider open container and public intoxication laws. “In my previous interactions with the state and particularly the liquor licensing authority, they consider liquor-licensed premises to be de facto public spaces but you can’t consume cannabis there, which is why hotels, bars and restaurants explicitly prohibit cannabis consumption, they have a liquor license,” says Gillette. “There is a bit of conflict in the law here.”

Yet other rules, such as mandatory childproof containers for cannabis retailers, seem a bit draconian compared with buying a bottle of twist-off wine from the grocery store. “Childproof packaging isn’t required in liquor stores anywhere,” says Gillette. “Why cant responsible adults be trusted to keep it out of a child’s reach? Unfortunately there is a lot of trepidation to allow responsible adults to be responsible when it comes to cannabis.” In some ways, we are seeing states begin to regulate cannabis very closely to how they would alcohol, yet there is a long way to go. “There is still this nanny state mentality where we run the risk of regulating it to the point of absurdity,” says Gillette. For now at least, we need to be cognizant of the age-old stigma and work to normalize social cannabis use in a legal sense. Until that time comes, we will have to tolerate lawmakers regulating cannabis in a manner similar to alcohol, not exactly like alcohol.

Chris English
The Practical Chemist

Accurate Detection of Residual Solvents in Cannabis Concentrates

By Chris English
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Chris English

Edibles and vape pens are rapidly becoming a sizable portion of the cannabis industry as various methods of consumption popularize beyond just smoking dried flower. These products are produced using cannabis concentrates, which come in the form of oils, waxes or shatter (figure 1). Once the cannabinoids and terpenes are removed from the plant material using solvents, the solvent is evaporated leaving behind the product. Extraction solvents are difficult to remove in the low percent range so the final product is tested to ensure leftover solvents are at safe levels. While carbon dioxide and butane are most commonly used, consumer concern over other more toxic residual solvents has led to regulation of acceptable limits. For instance, in Colorado the Department of Public Health and Environment (CDPHE) updated the state’s acceptable limits of residual solvents on January 1st, 2017.

Headspace Analysis

Figure 1: Shatter can be melted and dissolved in a high molecular weight solvent for headspace analysis (HS). Photo Courtesy of Cal-Green Solutions.

Since the most suitable solvents are volatile, these compounds are not amenable to HPLC methods and are best suited to gas chromatography (GC) using a thick stationary phase capable of adequate retention and resolution of butanes from other target compounds. Headspace (HS) is the most common analytical technique for efficiently removing the residual solvents from the complex cannabis extract matrix. Concentrates are weighed out into a headspace vial and are dissolved in a high molecular weight solvent such as dimethylformamide (DMF) or 1,3-dimethyl-3-imidazolidinone (DMI). The sealed headspace vial is heated until a stable equilibrium between the gas phase and the liquid phase occurs inside the vial. One milliliter of gas is transferred from the vial to the gas chromatograph for analysis. Another approach is full evaporation technique (FET), which involves a small amount of sample sealed in a headspace vial creating a single-phase gas system. More work is required to validate this technique as a quantitative method.

Gas Chromatographic Detectors

The flame ionization detector (FID) is selective because it only responds to materials that ionize in an air/hydrogen flame, however, this condition covers a broad range of compounds. When an organic compound enters the flame; the large increase in ions produced is measured as a positive signal. Since the response is proportional to the number of carbon atoms introduced into the flame, an FID is considered a quantitative counter of carbon atoms burned. There are a variety of advantages to using this detector such as, ease of use, stability, and the largest linear dynamic range of the commonly available GC detectors. The FID covers a calibration of nearly 5 orders of magnitude. FIDs are inexpensive to purchase and to operate. Maintenance is generally no more complex than changing jets and ensuring proper gas flows to the detector. Because of the stability of this detector internal standards are not required and sensitivity is adequate for meeting the acceptable reporting limits. However, FID is unable to confirm compounds and identification is only based on retention time. Early eluting analytes have a higher probability of interferences from matrix (Figure 2).

Figure 2: Resolution of early eluting compounds by headspace – flame ionization detection (HS-FID). Chromatogram Courtesy of Trace Analytics.

Mass Spectrometry (MS) provides unique spectral information for accurately identifying components eluting from the capillary column. As a compound exits the column it collides with high-energy electrons destabilizing the valence shell electrons of the analyte and it is broken into structurally significant charged fragments. These fragments are separated by their mass-to-charge ratios in the analyzer to produce a spectral pattern unique to the compound. To confirm the identity of the compound the spectral fingerprint is matched to a library of known spectra. Using the spectral patterns the appropriate masses for quantification can be chosen. Compounds with higher molecular weight fragments are easier to detect and identify for instance benzene (m/z 78), toluene (m/z 91) and the xylenes (m/z 106), whereas low mass fragments such as propane (m/z 29), methanol (m/z 31) and butane (m/z 43) are more difficult and may elute with matrix that matches these ions. Several disadvantages of mass spectrometers are the cost of equipment, cost to operate and complexity. In addition, these detectors are less stable and require an internal standard and have a limited dynamic range, which can lead to compound saturation.

Regardless of your method of detection, optimized HS and GC conditions are essential to properly resolve your target analytes and achieve the required detection limits. While MS may differentiate overlapping peaks the chances of interference of low molecular weight fragments necessitates resolution of target analytes chromatographically. FID requires excellent resolution for accurate identification and quantification.

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.

From The Lab

QuEChERS 101

By Danielle Mackowsky
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Sample preparation experts and analytical chemists are quick to suggest QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) to cannabis laboratories that are analyzing both flower and edible material for pesticides, mycotoxins and cannabinoid content. Besides having a quirky name, just what makes QuEChERS a good extraction technique for the complicated matrices of cannabis products? By understanding the chemistry behind the extraction and the methodology’s history, cannabis laboratories can better implement the technology and educate their workforce.

QuEChERS salt blends can be packed into mylar pouches for use with any type of centrifuge tubes
QuEChERS salt blends can be packed into mylar pouches for use with any type of centrifuge tubes

In 2003, a time when only eight states had legalized the use of medical cannabis, a group of four researchers published an article in the Journal of AOAC International that made quite the impact in the residue monitoring industry. Titled Fast and Easy Multiresidue Method Employing Acetonitrile Extraction/Partitioning and “Dispersive Solid-Phase Extraction” for the Determination of Pesticide Residues in Produce, Drs. Michael Anastassiades, Steven Lehotay, Darinka Štajnbaher and Frank Schenck demonstrate how hundreds of pesticides could be extracted from a variety of produce samples through the use of two sequential steps: an initial phase partitioning followed by an additional matrix clean up. In the paper’s conclusion, the term QuEChERS was officially coined. In the fourteen years that have followed, this article has been cited over 2800 times. Subsequent research publications have demonstrated its use in matrices beyond food products such as biological fluids, soil and dietary supplements for a plethora of analytes including phthalates, pharmaceutical compounds and most recently cannabis.

QuEChERS salts can come prepacked into centrifuge tubes
QuEChERS salts can come prepacked into centrifuge tubes

The original QuEChERS extraction method utilized a salt blend of 4 g of magnesium sulfate and 1 g of sodium chloride. A starting sample volume of 10 g and 10 mL of acetonitrile (ACN) were combined with the above-mentioned salt blend in a centrifuge tube. The second step, dispersive solid phase extraction (dSPE) cleanup, included 150 mg of magnesium sulfate and 25 mg of primary secondary amine (PSA). Subsequent extraction techniques, now known as AOAC and European QuEChERS, suggested the use of buffered salts in order to protect any base sensitive analytes that may be critical to one’s analysis. Though the pH of the extraction solvent may differ, all three methods agree that ACN should be used as the starting organic phase. ACN is capable of extracting the broadest range of analytes and is compatible with both LC-MS/MS and GC-MS systems. While ethyl acetate has also been suggested as a starting solvent, it is incompatible with LC-MS/MS and extracts a larger amount of undesirable matrix components in the final aliquot.

All laboratories, including cannabis and food safety settings, are constantly looking for ways to decrease their overhead costs, batch out the most samples possible per day, and keep their employees trained and safe. It is not a stretch to say that QuEChERS revolutionized the analytical industry and made the above goals tangible achievements. In the original publication, Anastassiades et al. established that recoveries of over 85% for pesticides residues were possible at a cost as low as $1 per ten grams of sample. Within forty minutes, up to twelve samples were fully extracted and ready to be analyzed by GC-MS, without the purchase of any specialized equipment. Most importantly, no halogenated solvents were necessary, making this an environmentally conscious concept. Due to the nature of the cannabis industry, laboratories in this field are able to decrease overall solvent usage by a greater amount than what was demonstrated in 2003. The recommended starting sample for cannabis laboratories is only one gram of flower, or a tenth of the starting volume that is commonly utilized in the food safety industry. This reduction in sample volume then leads to a reduction in acetonitrile usage and thus QuEChERS is a very green extraction methodology.

The complexity of the cannabis matrix can cause great extraction difficulties if proper techniques are not used
The complexity of the cannabis matrix can cause great extraction difficulties if proper techniques are not used

As with any analytical method, QuEChERS is not perfect or ideal for every laboratory setting. Challenges remain in the cannabis industry where the polarity of individual pesticides monitored in some states precludes them from being amenable to the QuEChERS approach. For cannabis laboratories looking to improve their pesticide recoveries, decrease their solvent usage and not invest their resources into additional bench top equipment, QuEChERS is an excellent technique to adopt. The commercialization of salt blends specific for cannabis flowers and edibles takes the guesswork out of which products to use. The growth of cannabis technical groups within established analytical organizations has allowed for better communication among scientists when it comes to best practices for this complicated matrix. Overall, it is definitely worth implementing the QuEChERS technique in one’s cannabis laboratory in order to streamline productivity without sacrificing your results.

The Practical Chemist

Pesticide Analysis in Cannabis and Related Products: Part 3

By Julie Kowalski
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As mentioned in Part 1, pesticides residue analysis is very challenging especially considering the complexity of cannabis and the variety of flower, concentrates and infused products. In addition, pesticides are tested at low levels typically at parts-per-billion (ppb). For example, the food safety industry often uses 10 ppb as a benchmark limit of quantification. To put that in perspective, current pesticides limits in cannabis range from 10 ppb default (Massachusetts Regulatory Limit) to a more typical range of 100 ppb to 2 ppm in other states. Current testing is also complicated by evolving regulations.

Despite these challenges, adaptation of methods used by the food safety industry have proved successful for testing pesticides in cannabis. These methods typically rely on mass spectrometric detection paired with sample preparation methods to render the sample clean enough to yield quality data.

Pesticide Analysis Methods: Sample preparation and Analytical Technique Strategy

Generally, methods can be divided into two parts; sample preparation and analytical testing where both are critical to the success of pesticide residue testing and are inextricably linked. Reliance on mass spectrometric techniques like tandem mass spectrometry and high resolution accurate mass (HRAM) mass spectrometry is attributed to the substantial sensitivity and selectivity provided. The sensitivity and selectivity achievable by the detector largely dictates the sample preparation that will be required. The more sensitive and selective the detector, the less rigorous and resource intensive sample preparation can be.

Analytical technique: Gas and Liquid Chromatography Tandem Mass Spectrometry 

The workhorse approach for pesticide residue analysis involves using gas chromatography and liquid chromatography tandem mass spectrometry (MS/MS) in the ion transition mode. This ion transition mode, often referred to as multiple reaction monitoring (MRM) or selected reaction monitoring (SRM), adds the selectivity and sensitivity needed for trace level analysis. Essentially, a pesticide precursor ion is fragmented into product ions. The detector monitors the signal for a specified product ion known to have originated from the pesticide precursor ion. This allows the signal to be corrected, associated with the analyte and not with other matrix components in the sample. In addition, because only ions meeting the precursor/product ion requirements are passed to the detector with little noise, there is a benefit to the observed signal to noise ratio allowing better sensitivity than in other modes. Even though ion transitions are specific, there is the possibility a matrix interference that also demonstrates that same ion transition could result in a false positive. Multiple ion transitions for each analyte are monitored to determine an ion ratio. The ion ratio should remain consistent for a specific analyte and is used to add confidence to analyte identification.

The best choice for pesticide analysis between gas chromatography (GC) and liquid chromatography (LC) is often questioned. To perform comprehensive pesticide screening similar to the way the food safety market approaches this challenge requires both techniques. It is not uncommon for screening methods to test for several hundred pesticides that vary in physiochemical properties. It may be possible that with a smaller list of analytes, only one technique will be needed but often in order to reach the low limits for pesticide residues both GC and LC are required.

Modified QuEChERS extraction using 1.5 grams of cannabis flower. Courtesy of Julie Kowalski (Restek Corporation), Jeff Dahl (Shimadzu Scientific Instruments) and Derek Laine (Trace Analytics).
Modified QuEChERS extraction using 1.5 grams of cannabis flower. Courtesy of Julie Kowalski (Restek Corporation), Jeff Dahl (Shimadzu Scientific Instruments) and Derek Laine (Trace Analytics).

Analytical technique: Sample Preparation

Less extensive sample preparation is possible when combined with sensitive and selective detectors like MS/MS. One popular method is the QuEChERS approach. QuEChERS stands for Quick, Easy, Cheap, Effective, Rugged and Safe. It consists of a solvent extraction/salting out step followed by a cleanup using dispersive solid phase extraction. Originally designed for fruit and vegetable pesticide testing, QuEChERS has been modified and used for many other commodity types including cannabis. Although QuEChERS is a viable method, sometimes more cleanup is needed and this can be done with cartridge solid phase extraction. This cleanup functions differently and is more labor intensive, but results in a cleaner extract. A cleaner extract helps to secure quality data and is sometimes needed for difficult analyses.

Biros' Blog

2016 Year in Review: Why the Cannabis Industry Needs Resiliency

By Aaron G. Biros
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2016 was a tumultuous, but productive year for the cannabis industry. Larger companies began to take interest in the fledgling market, like Microsoft and Scotts Miracle-Gro. This year brought major innovations in technology like market data tools, advances in LED tech, efficient cultivation tech and patient education tools. The Supreme Court set an important precedent by shutting down a challenge to Colorado’s cannabis market.

Voters legalized cannabis in 8 states last month Photo: Nicole Klauss, Flickr
Voters legalized cannabis in 8 states on Election Day.
Photo: Nicole Klauss, Flickr

Election Day brought a renewed sense of vigor to the market with voters in eight states legalizing forms of cannabis. California, Nevada, Maine and Massachusetts passed recreational cannabis measures, making legalization’s momentum seem exponential.

But November 8th also gave Donald Trump the presidency, and his cabinet appointments, namely Sen. Jeff Sessions as Attorney General, gave many a feeling of uncertainty for the future of federal legalization. Adding insult to injury, the DEA repeatedly stood by their antiquated and ludicrous judgment for cannabis to remain a Schedule 1 narcotic.

Gage Skidmore, Flickr
Trump nominated Sen. Jeff Sessions (R) for Attorney General Photo: Gage Skidmore, Flickr

A lot of the fervor surrounding public safety could be described as overdramatic or somewhat unwarranted. 2016 was the year of misinformation. Fake news spread like wildfire with people sharing stories like this or this that turned out to be very misleading or just downright false.

States with legal cannabis came under heavy public scrutiny and addressed problems like consumer education, public safety and lab testing. Pesticides became a highly publicized and persistent issue in a number of areas, with some states regulating it heavily and addressing public health concerns. Plenty of new rules were formed surrounding labeling and testing, with Oregon, Colorado and Washington experiencing some regulatory growing pains.

Those growing pains shed light on the need for regulators to craft rules that allow for changes, adding rules where necessary and getting rid of cumbersome rules that might thwart market growth. Rules need to be able to adapt as the industry grows, much like businesses need to adapt to a changing market climate to stay afloat. This is all the more reason why cannabis businesses need to make their voices heard and work with regulators to move things forward.

Pesticide Use was a major issue of 2016 Photo: Michelle Tribe, Flickr
Pesticide use was a major issue in 2016
Photo: Michelle Tribe, Flickr

With so much uncertainty surrounding the future of legal cannabis in America, the word of the year for 2017 should be resiliency. In a social-ecological context, resiliency is “the capacity of a system to absorb or withstand perturbations and other stressors such that the system remains within the same regime, essentially maintaining its structure and functions. It describes the degree to which the system is capable of self-organization, learning and adaptation.”

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A warning label for cannabis in Oregon after the October 1st compliance deadline

Self-organization, learning and adaptation are three very important attributes of a resilient system. Without knowing what will happen when Trump’s cabinet takes the reigns of federal agencies, it is important to prepare for the unexpected. Adhering to standards like FOCUS allows cannabis businesses to prepare for unexpected events like recalls or product safety failures.

Those standards could also become the law down the road, as government officials often look to an industry’s voluntary consensus-based standards when deciding how to regulate it. In 2017, a number of state governments will embark on the heavy undertaking of writing the regulatory framework for legal cannabis.

2017 will bring opportunities and challenges to the cannabis industry. The industry’s rapid growth juxtaposed with political, economic and regulatory uncertainties create a climate that requires resilience to be built into the system at all levels. It is critical, now more than ever, that cannabis businesses build strong relationships with industry groups, advocacy groups and regulators to craft the institutional capacity and mutual trust needed to weather the uncertainty ahead.