Tag Archives: action

FDA Says No, CBD Does Not Cure COVID-19

By Aaron G. Biros
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Former NFL player Kyle Turley made headlines this week for some eye-catching remarks. The retired offensive lineman entered the cannabis industry in 2017, when he launched Neuro Armour (now called Neuro XPF), a brand of CBD products.

Turley and his Neuro XPF brand made claims in recent weeks, both on their website and in various social media posts on Facebook and Twitter, saying that their CBD products can cure COVID-19. Two quotes below, one from their website and one from a Facebook post, show how the company touted CBD as an effective medicine for treating COVID-19.

  • “Crush Corona . . . While scientists around the world are working 24/7 to develop a COVID-19 vaccine, it will take many more months of testing before it’s approved and available. However, there’s something you can do right now to strengthen your immune system. Take CBD . . . CBD can help keep your immune system at the stop of its game. . . . We want everyone to take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection. So, we’re making all of our products more affordable.”

  • “Crush Corona! Your best defense against the COVID-19 blitz starts with a strong immune system. It’s what protects your body from the everyday attacks of bacteria, viruses, parasites and a host of other nasties. Learn more here: https://neuroxpf.com/crush-corona/” FDAlogo

The U.S. Food & Drug Administration (FDA) got wind of these marketing tactics and sent Turley and his brand a warning letter. “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” reads the warning letter. “As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.”

Before entering the cannabis space, Turley was diagnosed with chronic traumatic encephalopathy (CTE) and then early onset Alzheimer’s as a result of sustaining head injuries while playing in the NFL. Turley has a reputation for being an outspoken cannabis activist, crediting cannabis with improving his quality of life and eliminating the need for prescription opiates.

In a tongue-and-cheek response to the FDA, Turley posted the following on twitter: “OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19!” Turley, making light of the situation, inserted the term “cheap” in there, almost challenging the FDA and disregarding their warning letter.

However, the FDA is not joking when they send these warning letters. According to the letter, Turley and his company have 48 hours to remediate the situation or face a federal court injunction.

Best Practices for Workforce Reduction

By Conor Dale
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Due to anticipated contractions in the industry and concerns over a potential nationwide recession, cannabis industry employers may be planning on implementing large scale reduction in force (RIF) layoffs or employee furloughs to reduce payroll. While RIFs can provide business-saving cost reductions, they can subject an employer to substantial potential legal liability, including but not limited to class action lawsuits and enforcement actions from state and federal agencies. Understanding and addressing potential legal pitfalls before implementing an RIF can help in materially limiting an employer’s potential legal exposure.

Employers should first consider potential cost saving alternatives to implementing mass employee layoffs. Such steps can include reducing the salaries and/or work hours for current employees, temporarily freezing company operations for limited periods, or placing non-critical positions in a limited paid leave of absence at reduced wages. While each of these steps bear their own risks, they may assist in avoiding mass employee layoffs.

Next, federal law and the laws of certain states require employers to provide written notice to employees and local governments at least 60 days before implementing mass layoffs. For example, under the federal Work Adjustment and Retraining Notification (WARN) Act, an employer must generally provide a written notice to employees regarding an impending reduction in force when it: (1) permanently or temporarily shuts down a worksite which results in an employment loss of 50 or more employees; (2) lays off between 50 to 499 workers at a single worksite when such layoffs constitute at least 33% of the employer’s workforce; (3) lays off at least 500 employees within a 30 day period; (4) implements a wide scale temporary layoff of more than 6 months; or (5) reduces the work hours of 50 or more employees by at least 50% during each month of any six month period. Please note that the WARN Act aggregates layoffs over 90 days; thus, an employer conducting a series of smaller layoffs may still need to provide employees with a WARN notice. An employer who fails to provide a required notice could owe each impacted employee up to 60 days’ back pay, which includes but is not limited to the cost of potential employment benefits.

An employer should also take steps to limit potential discrimination claims based on an RIF. It is illegal for an employer to select an employee for layoff because of their protected characteristics, including but not limited to race, religion, gender or age. The primary defense to such a discrimination lawsuit is to prove the legitimate, nondiscriminatory reason for the layoff decision. As a result, employers are strongly encouraged to create a formal RIF plan which documents the legitimate reasons for layoff decisions. The RIF plan should expressly articulate the cost-saving grounds for the RIF and the goals to be achieved by its implementation; these grounds and goals should be the sole reason for any subsequent layoff decision.

Employers are strongly encouraged to consult with legal counsel before implementing an RIFFor example, an employer should identify all necessary positions and employee skills needed for a company’s current and future business operations in order to identify non-essential positions that may be subject to position eliminations or layoffs. Similarly, employers should create standards to select employees for a RIF when multiple employees hold the same or similar jobs. These standards commonly include considering employees’ education, skills, unique knowledge, previous job performance and seniority. Most importantly, an employer should make actual layoff decisions that are consistent with its articulated RIF plans; under both state and federal law, a termination decision that is inconsistent with or contradictory to the articulated reasons for a layoff decision may provide an employee with considerable evidence that that his or her termination was at least partly motivated by their protected characteristics.

Even when making and implementing a reduction in force plan based solely on legitimate business reasons, employers must be aware of the adverse impact those decisions have on certain groups of employees. It is illegal for an employer to implement policies and practices that are facially neutral but have an unintentional discriminatory effect on protected groups of employees if those policies and practices are not job related or required by business necessity. Before implementing an RIF, employers are strongly encouraged to perform a statistical analysis of the protected characteristics of individuals selected for layoffs to determine whether they are being selected for layoffs at a significantly higher rate than other employees. If an employer does discover that certain groups are being selected for layoffs at a disproportionate rate, an employer should review its layoff decisions to confirm that these decisions are in fact required by business necessity.

Finally, employers will commonly provide severance packages to laid off employees to assist in their transition to other employment. A key factor in these packages is an employee providing an employer with a full release of potential legal claims in exchange for a severance payment. Employers are strongly encouraged to ensure that they obtain full and complete legal releases in any severance agreements they provide. For example, under California law, an employee can only provide a full and complete release of legal claims when a separation agreement specifically cites and waives a specific provision of California’s civil code. Additionally, an employer cannot obtain a legal release of federal age discrimination claims when it offers a separation package to multiple employees over 40 during an RIF program unless it provides specific information regarding the job positions and ages of employees who were and were not selected for layoffs.

While a reduction in force layoff program may help ensure a business’ survival, employers are strongly encouraged to consult with legal counsel before implementing an RIF to detect and avoid potential future legal claims.

Practical Advice on How to Avoid a TCPA Suit

By Paul Gipson
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Texting consumers is a very effective means to drive engagement and ultimately sales. Text messages have outpaced emails when looking at conversion and click-thru rates. In fact, 95% of texts are read in ninety seconds or less! While text messages can be a great way to engage with prospects and customers, the FCC’s Telephone Consumer Protection Act (TCPA) is a regulation you need to be mindful of. In fact, the average cost of a TCPA settlement is over $6m dollars, which doesn’t include legal fees or reputational damage.

Over the past few years, there have been about 4,000 TCPA cases filed annually. Take a look at the growth:

Companies are being targeted for various reasons, but there are a few that I’ll cover below along with some advice on how to avoid TCPA suits.

See if you can spot the trend in these cases:

  • Papa Johns: $16.5m settlement due to texting pizza specials to consumers without their consent.
  • Abercrombie & Fitch: $10m settlement due to texting store promotions to consumers without their consent.
  • Rack Room Shoes: $26m settlement for texting their reward program members with various sales without their consent.

Do any of these campaigns sound like something your company is engaged in?

So, you’ve got someone who has signed up for a rewards program, wants to receive deals, or has provided their number to your company for other purposes, but you are concerned about the TCPA (hopefully). Based on my experience working with hundreds of clients at CompliancePoint, here’s where I think you should start. But first…

Quick assumption: Your company is using an automated system to send both informational and promotional texts. Examples include “blast campaigns” (upcoming sale) or “triggered campaigns” (signed up for rewards).

Quick point: Just because the text message says your store is having a sale but doesn’t ask the consumer to buy anything on the message, you may think it’s not considered “telemarketing”. This is wrong. Any plan to sell now or in the future through direct marketing is telemarketing and subject to the TCPA.

Here are my top 5 things to consider:

  1. Obtain consent. This is not achieved by simply having a number provided by the consumer. Instead, the consumer must affirmatively agree to receive promotional calls/texts by automated means. This is done through a clear disclosure and often accompanied by an unchecked checkbox.
  2. Honor opt-outs. This seems obvious right? Provide instructions on how to opt-out and look for other phrases like “stop/quit/cancel”. Opt-outs should occur immediately with most common texting platforms.
  3. Keep records. If you receive a complaint, you want to be able to respond confidently and records help you do that. The key records to maintain are your texting records (the phone numbers you texted, the date/time of the text, and the content of the text), your consent opt-in forms, and opt-out requests from consumers with dates. Ask yourself: what records do you need to prove you had consent, and what records prove you didn’t text a consumer after they opted out.
  4. Only text consumers between the hours of 8AM and 9PM according to their time zone. I always recommend going off address and not phone number due to cellphone mobility. If you text a California number at 8PM, but the phone owner lives in New York, you might get a few complaints.
  5. Monitor compliance with these items. Another one that seems obvious, yet most companies fail to do so, and you see above what happens. I guarantee you’ll find issues with most audits.

Bonus – here is a more comprehensive checklist on how to achieve a Safe-Harbor defense.

This article is not intended to be a scare tactic. The TCPA legal landscape is rampant and consumers are more aware now than ever of their rights. A quick Google search of “Cannabis TCPA” helps to illustrate the fact that this industry, like most, is not immune. However, with proper compliance parameters in place, your company can enjoy the benefits of texting with consumers with peace of mind.

Consumer Protection Laws & CBD Products—What You Need to Know Before Going to Market

By Jonathan C. Sandler, Alissa Gardenswartz
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By now, cannabis companies have heard that the Food and Drug Administration (FDA) has issued a slew of warning letters to sellers of CBD products for selling unapproved and mislabeled drugs and illegally adulterated food, as prohibited by the Federal Food, Drug and Cosmetic Act. However, companies marketing CBD products should know that making any health-related claims about their products also exposes them to liability under state and federal consumer protection laws. These laws additionally prevent CBD sellers from misrepresenting how much CBD is contained in their products, and even govern how companies communicate with their customers via text message. As the former head of consumer protection enforcement in Colorado and a lawyer routinely defending consumer protection class actions in California, we have seen firsthand how not considering these laws when developing a sales and marketing strategy can result in protracted and expensive litigation.

Consumer Protection Laws – Federal and State

Section 5 of the Federal Trade Commission (FTC) Act provides that “unfair or deceptive acts or practices in or affecting commerce . . . are declared unlawful.”1 The FTC enforces this law, and has clarified that “deceptive” practices involve a material representation, omission or practice that is likely to mislead a reasonable consumer under the circumstances.2 In other words, a claim is deceptive if an average consumer would believe and rely on the misleading claim to buy something. With the rise of social media marketing, the FTC has also issued disclosure guidelines for companies and influencers promoting products online.3 Every state has some form of consumer protection statute that similarly prevents deceptive marketing, and is typically enforced by the state’s attorney general. Many state laws also allow for consumers to bring actions themselves.

Both the FTC and state attorneys general have used these laws for decades against companies making scientifically unsupported health claims about their products. Just this month, the FTC and the Maine attorney general filed a lawsuit against two dietary supplement companies who were claiming that their products were a “miraculous natural solution” for life-threatening diseases. According to the lawsuit, the companies violated a 2018 settlement that required them to not make any health claims about their products without first conducting at least one randomized, double-blind, placebo-controlled trial to support the claims.4 While much of the enforcement around dietary supplements has focused on unsubstantiated health claims, other actions have been brought for improper “expert” endorsements as well as misrepresenting the amount of active ingredient contained in the supplement.5 In other words, these laws are used to police all manner of labelling and marketing of products, including those containing CBD. The FTC has already issued warning letters to CBD companies several times this year, and has stated that CBD sellers could be subject to enforcement for making unsubstantiated health claims.6

While consumer protection laws are largely focused on the content of advertisements, there are also laws that address how sellers can communicate with consumers. The Telephone Consumer Protection Act (TCPA) restricts telemarketing and the use of automated systems to contact consumers, and applies to both voice calls and text messaging. Both the FTC and state attorneys general can enforce the TCPA, and consumers can bring private TCPA actions as well. Because the TCPA allows for courts to award $500 per violation—that is, per illegal call or text—companies can face judgments into the millions of dollars.

Recent Consumer Protection Lawsuits in the Cannabis Industry

Cannabis is proving to be an attractive target for consumer protection litigation.All companies need to navigate consumer protection laws when they market their products, but class action lawyers may be pursuing cannabis companies in particular because of the products’ legal uncertainty, and because they provide opportunities for unique claims of deception. For example, a nationwide class of consumers recently filed a lawsuit in California against a CBD company that had received a warning letter from the FDA in November of this year, alleging that they would not have purchased the company’s CBD products if they knew selling the items was illegal.7 The consumers claimed violations of a variety of California and Arizona consumer protection laws, including those related to breach of warranty and unfair competition. Other lawsuits have been brought because products did not contain the amount of CBD as represented on the label, or because the product claimed to not contain THC when it did.8

Cannabis companies have been subject to TCPA class actions as well. Florida’s largest medical marijuana company has been accused of spamming customers with unwanted texts in violation of the TCPA.9 A dispensary with multiple locations in Colorado was also the subject of a TCPA class action complaint in Florida alleging that it did not obtain prior consent from consumers prior to texting them.10

Cannabis is proving to be an attractive target for consumer protection litigation. However, companies can head off lawsuits by thoroughly vetting their marketing strategies with experienced consumer protection lawyers before going to market.

References

 

  1.  15 U.S.C. Sec. 45(a)(1).
  2. See FTC Policy Statement on Deception, October 14, 1983.
  3. See Disclosures 101 for Social Media Influencers at https://www.ftc.gov/tips-advice/business-center/guidance/disclosures-101-social-media-influencers.
  4. See https://www.ftc.gov/news-events/press-releases/2019/12/ftc-state-maine-file-contempt-action-against-dietary-supplement.
  5. See FTC v. Nobetes Corp., Case No. 2:18-cv-10068 (C. D. Cal) (complaint against supplement company for using deceptive endorsements); “New York Attorney General Targets Mislabeled Herbal Supplements,” https://www.npr.org/2015/02/03/383578263/new-york-attorney-general-targets-mislabeled-herbal-supplements. (detailing the New York attorney general’s investigation of herbal supplements, and finding that they did not contain the ingredients as advertised).
  6. See https://www.ftc.gov/news-events/blogs/business-blog/2019/09/making-cbd-health-claims-careful-disseminating.
  7. Fausett et al. v. KOI CBD, LLC., Case No. 2:19-cv-10318 (C. D. Cal).
  8. Potter et al v. PotNetwork Holdings, Inc., Diamond CBD, Inc., and First Capital Venture Co., Case No. 19-cv-24017, (S. D. FL); Horn v. Medical Marijuana, Inc., Case No. 15-cv-701-FPG, (W.D.N.Y.).
  9. Jaslow v. Trulieve, Inc., Case No. 4:19-cv-RH-CAS (N.D. Fla.).
  10. Stinnett v. Hobby Farms, LLC d/b/a A Cut Above, Case No. 9:18-cv-81449-RLR (S.D. Fla.)
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Preparing Your Recall Strategies

By Radojka Barycki
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Radojka Barycki picture

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

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

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

There are several phases when preparing a recall strategy:

Planning Phase

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

  • Definitions of the type of products recalls. According to federal regulations, there are three types of recalls. The company should know what type of recall they are performing to understand the risk the consumer is facing.
  • A Recall Team. The recall team is the key stakeholders that are responsible for different processes within the company. A good recall team will be multidisciplinary. A multidisciplinary team is a group of people that have different responsibilities within the manufacturing site (i.e. Receiving Manager, QA Manager, etc.) and/or outside (i.e. Legal Counsel, Public Relations, etc.) 
  • A description of the recall team member’s responsibilities must be outlined. A recall coordinator and a backup should be assigned to ensure that there is one person organizing all activities during the recall. 
  • A Communication Plan. It is important that only the appointed person that has the responsibility of external communications (i.e. media, regulators, customers, key stakeholders, etc.). In addition, there should be only one person appointed to handle all the communication within the team (internal communications.)
  • Documents to be used during the recall are:
    • Communication documents: Letters to customers, regulators and media must be drafted and kept on hand for use during the crisis.
    • Forms that will be used to keep track of product inventory on hand (still in the site), product being returned and product being destroyed.
  • A Traceability Procedure should be in place to ensure that materials used in the manufacturing of the finished good can be traced from the time of the delivery to the facility and throughout the product manufacturing process. In addition, traceability must also be provided for finished goods from the manufacturing site to its first point of distribution. This is known as traceability one step back (materials used) and one step forward (first point of distribution.)

    PlantTag
    A plant tagged with a barcode and date for tracking
  • A description of (or reference to) product quarantine (product hold) procedures that must be followed to ensure that the product that is still at the site do not leave the facility. 
  • Product Destruction The company must outline (or reference) how product will be destroyed during a recall process.

Implementation Phase

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

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

Improvement Phase

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

California Suspends Almost 400 Licenses

By Cannabis Industry Journal Staff
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On November 1st, the Bureau of Cannabis Control (BCC) sent notices to 394 businesses in California that their licenses will be suspended until they comply with certain traceability system requirements. This story was first reported by John Schroyer at Marijuana Business Daily.

On Wednesday, November 6th, the number of licenses suspended dropped to a total of 385, including 63 retailers, 61 delivery services, 47 microbusinesses, 185 distributors and 29 transportation licenses. That’s almost 5% of all the cannabis business licenses in California.

According to Alex Traverso, spokesman for the BCC, licensees were given plenty of opportunities to fix their errors. Businesses were given notice that they needed to enroll in Metrc within five days following their provisional licensing. The BCC gave those businesses a reminder roughly three months ago and sent an additional warning in late October regarding the deadline.

It’s a relatively easy fix for those trying to get back in compliance. The rationale behind suspending the licenses is that those businesses need to undergo a mandatory traceability system training so they know how to use Metrc and get credentialed. Enroll in the Metrc system, get credentialed and your license should be restored.

“It’s relatively simple to get your license out of suspension,” Traverso told KPBS News. “These are growing pains. I think we knew it was going to be a process and it was going to take some time, and that it was going to be an adjustment period for a lot of people who have been doing things one way for some time now.”

Traverso added that about 80 businesses enrolled in the Metrc system as soon as they received the notice that their license is suspended. Those licenses should be restored to active shortly, Traverso said.

Documentation: Are You Prepared?

By Radojka Barycki
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Documents play a key role in the world of regulations and global standards. Documents tell a story on programs development, implementation and verification during an inspection or audit. Documents are used as evidence to determine conformance to the law or standard. However, do you know what kind of documents may be reviewed during a regulatory inspection or a food safety audit? Are you prepared to show that the implementation of regulatory requirements or a standard is done efficiently at your facility?

Inspectors and auditors will look for compliance either to regulations or to a standard criterion. Regulations and standards require that documentation is controlled, secured and stored in an area where they cannot deteriorate. Therefore, writing a Document Management Program (DMP) will help a business owner ensure consistency in meeting this and other requirements.Radojka Barycki will host a a plenary session titled, “Cannabis: A Compliance Revolution” at the 2018 Food Safety Consortium | Learn More

A well-developed and implemented DMP provides control over documents by providing a number sequence and revision status to the document. In addition, ownership for development, review and distribution of the documents are assigned to specific individuals within the company to ensure that there are no inconsistencies in the program. Documents must also have the name of the company in addition to a space to write the date when the record is generated. It is recommended to include the address if there are multiple operational sites within the same company.

There are different types of documents that serve as support to the operations:

  1. Program: A written document indicating how a business will execute its activities. When it comes to the food industry, this is a written document that indicates how quality, food safety and business activities are controlled.
  2. Procedures: General actions conducted in a certain order. Standard Operational Procedures (SOPs) allow the employee to know what to do in general. For example, a truck receiving procedure only tells the employee what the expected conditions are when receiving a truck (cleanliness, temperature, etc.) However, it doesn’t tell the employee how to look for the expected conditions at the time of the truck arrival.
  3. Work Instructions: Detailed actions conducted in a certain order. For example, truck inspection work instruction tells the employee what steps are to be followed to perform the inspection.
  4. Forms: Documents used to record activities being performed. 
  5. Work Aids: are documents that provide additional information that is important to perform the job and can be used as a quick reference when performing the required activities within the job. 
Are you prepared to face document requirements now and in the future?

The inspectors and auditors base their role on the following saying: “Say what you do. Do what you say. Prove it!” The programs say what the company do. The procedures, work instructions and work aids provide information on implementation (Do what you say) and the forms become records that are evidence (prove) that the company is following their own written processes.

Regulatory requirements for cannabis vary from state to state. In general, an inspector may ask a cannabis business to provide the following documentation during an inspection:

  1. Business License(s)
  2. Product Traceability Programs and Documents
  3. Product Testing (Certificate of Analysis – COAs)
  4. Certification Documents (applicable mainly to cannabis testing labs)
  5. Proof of Destruction (if product needs to be destroyed due to non-compliance)
  6. Training Documents (competency evidence)
  7. Security Programs

As different states legalize cannabis, new regulatory requirements are being developed and modeled after the pharma, agriculture and food industries. In addition, standards will be in place that will provide more consistency to industry practices at a global level. The pharma, agriculture and food industries base their operations and product safety in programs such as cGMPs, GAPs, HACCP-based Food Safety Management Systems and Quality Management Systems. Documents required during an inspection or audit are related to:

  1. Good Agricultural Practices (GAPs)
  2. Current Good Manufacturing Practices (cGMPs)
  3. Food Safety Plan Documents
  4. Ingredient and Processing Aids Receiving
  5. Ingredient and Processing Aids Storage
  6. Operational Programs (Product Processing)
  7. Final Product Storage
  8. Final Product Transportation
  9. Defense Program
  10. Traceability Program
  11. Training Program
  12. Document Management Program

In the always evolving cannabis industry, are you prepared to face document requirements now and in the future?

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

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.

Green Man Cannabis Recalls Due to Pesticide Residue Detection

By Aaron G. Biros
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Denver-based Green Man Cannabis last week voluntarily recalled batches of cannabis sold to both medical patients and recreational consumers. The recall comes after the discovery of off-label pesticides during inspections in both dry-flower cannabis and infused products.

Photo: Sheila Sund, Flickr
Photo: Sheila Sund, Flickr

According to the Denver Department of Environmental Health (DEH), the products have labels that list an OPC License number of 403-00738, 403-00361, or 403R-00201. The cannabis in question is not a specific batch, rather, “All plant material and derived products originating from these cultivation facilities are subject to the recall.” The DEH’s statement includes contact information for the company (email: recall@greenmancannabis.com) and the DEH Public Health Inspections Division (email: phicomments@denvergov.org or 720-913-1311).

The DEH statement does not mention which pesticides were detected or the levels at which they were detected. Christian Hagaseth, founder of Green Man Cannabis, says the chemical detected was Myclobutanil. “We had used Eagle 20 in the past, [the pesticide that contains Myclobutanil] but we stopped using it as soon as it was banned,” says Hagaseth. “The DEH found the residues in the growing environment so we immediately performed a voluntary recall.” Green Man has three cultivation facilities, one of which they suspect is contaminated from pesticides sprayed a few years ago.

Christian Hageseth, founder of Green Man Cannabis
Christian Hageseth, founder of Green Man Cannabis

As far as corrective actions being taken, Hagaseth says they are doing a thorough cleaning and sanitation in two of their grows and a complete remediation plan in the suspected contaminated grow. “This was a good learning experience- the key takeaway for us is we need to clean these environments more consistently,” says Hagaseth. “I am grateful that the system is working; public health and environmental safety are being looked after here.” Hagaseth says the facility in question was operating almost without interruption since 2009, but they adjusted and learned to implement preventative actions following the recall.

The DEH says there have been zero reports of illness related to the recall. “The possible health impact of consuming marijuana products with unapproved pesticide residues is unknown,” the statement reads. “Short and long-term health impacts may exist depending on the specific product, duration, frequency, level of exposure and route of exposure.” The DEH advises consumers that may be concerned to reach out to their physician.

The DEH performs routine inspections of cannabis infused product manufacturers and retail locations in Denver, as well as investigating complaints. “I am sorry that it happened to us, but I am happy the system is working and we are more than happy to comply,” says Hagaseth.