Tag Archives: management

8 Mistakes Businesses Make When Managing Product Labels: Part 1

By Rob Freeman
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Editor’s Note: This article contains the first four common labeling mistakes that businesses can make. Click here to view the next four common labeling mistakes. 

Whether you’re a small business owner or a production manager of a large manufacturer, if you’ve ever experienced problems with your product labels you know it can quickly turn into a serious issue until that problem is resolved. From the time it’s applied to your product all the way to the POS (Point of Sale), labels always seem to be the least significant part of the production process- until something goes wrong. And when it does go wrong, it can create major branding issues and cost your company tens of thousands of dollars due to hefty supply chain late penalties and/or even government fines.

This article aims to provide insight as to how a company like Label Solutions Inc. helps businesses and manufacturers create new labels for their products as well as what to look for should you experience label failure at your retail locations. Topics discussed in this article do not cover all possible issues, but these common mistakes will hopefully help you better understand how creating a product label works, and how to possibly prevent your own problems in the future.

Mistake #1: Not Understanding the Importance Between the “Construction” Versus the “Artwork & Compliance” of the Label

This may seem like common sense, but it is often overlooked. Especially when dealing with fast-track projects.

Construction of the Label is the material selected and production process to produce the label. When creating a new label from the ground up, it is important to factor in how your product will be produced, necessary shipping and supply chain needs, how it is stored in inventory and how it will be presented at the POS. Understanding what environments your product will be exposed to throughout its life cycle will give you an advantage when approving substrate material, inks, and the strength of adhesive that might be necessary for your application.

The Artwork & Compliance of the Label refers to the overall design of the label, artwork, customer messaging, bar codes and regulatory requirements you need to follow in order to avoid serious government fines that might relate to your industry (Referring to agencies such as OSHA, DOT, and the FDA).In most cases the construction of the label does not apply to the compliance of the label.

Most label providers do not have the in-house expertise to offer compliance assistance. Although it is still the manufacturer who is liable for all final artwork approvals on their product, label providers that do offer advisory services can help update label content when regulatory changes are enacted. This “safety net” can save your company from extra production costs and, potentially, excessive legal time and material costs. In short, you should always review final label artwork approvals with your compliance team and/or legal expert, but it never hurts to have a “safety net” to help eliminate unnecessary orders or production delays.

In most cases the construction of the label does not apply to the compliance of the label. An exception to this statement would be industries such as the electronics industry that use UL (Underwriter Laboratories) labels that must meet UL specifications and be produced under recognized UL files. In other words, the compliance of a UL label is the construction of the label.

Best Method Approach: An excellent example of companies that understand the difference between the Construction vs. Artwork & Compliance of the label would be the compressed gas industry. Gas suppliers and distributors require long term regulatory compliant labels on their cylinders and micro-bulk tanks. These gas tanks are used in a wide variety of industries such as for manufacturing, welding, medical procedures, and specialty gas mixes for the micro-electronics industry.

The compressed gas industry requires that their labels follow strict, up-to-date OHSA and DOT compliance requirements. As for the construction of the label, it is common practice that the label remains legible on the cylinder for an average of five years. The 5-year duration is due to the millions of tanks that are in circulation throughout the US and Canada. What’s more, each label is produced to adhere to the cylinder’s metal surface during extreme outdoor weather conditions such as fluctuating temperatures, freezing rain, high winds, and direct sunlight year-round.

Mistake #2: Applying Labels Incorrectly to Your Products

Whether the label is applied to the product surface by hand or automatically with a label applicator, the label itself may not be applied level or evenly. Besides this being a major branding issue, this could also affect how the bar codes are scanned and could eventually impact your delivery times while trying to correct a batch.

Best Method Approach: There are construction alternatives that you can choose from to potentially reduce the impact of incorrect label application. For example, products with certain label adhesives allow your production team to reposition the label within a few minutes before the tack completely sets to the surface. The type of surface (cardboard, metal, plastic, glass, etc.) and the type of adhesive will determine how much time your production team will have before the tack sets.

The best practice is to apply labels prior to filling the bottles and cans as opposed to filling first and then applying the label in your production line.A good example of this best practice can be seen in the beverage market. Whether the client produces a uniquely crafted beer, or a rare ingredient infused into a new health drink, labels that are auto-applied to bottles and cans will sometimes experience equipment tension issues that need to be recalibrated. Once labels are applied off-alignment, a delayed tack setting can allow the label to be quickly repositioned by hand when needed. The best practice is to apply labels prior to filling the bottles and cans as opposed to filling first and then applying the label in your production line. The reason, excess spillage from filling can interfere with most adhesives.

This same repositionable adhesive is excellent to keep in mind for large equipment production assembly lines that apply prime (branding) labels and warning labels by hand. Even with large wide-format labels, the adhesive tack can be formulated so your employees have a few minutes to adjust, straighten, and smooth away trapped air bubbles once it has been placed on the surface. Knowing you have this option can help reduce label inventory waste, additional production material wastes and avoid delaying production time. More importantly, this option keeps your brand and your warning/instructional labels looking fresh.

Mistake #3: Not Sharing Your Production Run Schedules with Your Label ProviderSupply chain management (SCM) models are excellent examples of the best approach.

Some of Label Solutions’ largest accounts have the most efficient real-time tracking supply chain models in North America, but even they cannot avoid sudden increased orders for their products stemming from high customer demand or similar issues. It is a good problem to have, but it is a problem, nonetheless. Manufacturers utilize supply chain management tools to notify their suppliers of their monthly order forecasts, which in turn helps suppliers manage their materials and deliveries more efficiently.

On the other side of the spectrum, when small businesses share their production schedules with a supplier it means that both parties (the manufacturer and label provider) understand when to expect higher or lower order quantities each month. Label providers should back date their label production schedules, so they have the materials available to handle your busier months while ensuring on-time deliveries.

Best Method Approach: Supply chain management (SCM) models are excellent examples of the best approach. Although SCM’s are designed for scalability and real-time tracking, the benefit to you also helps your label supplier. For example, our large retail and industrial manufacturing clients notify the Label Solutions team to produce their labels according to their Supply Chain portal demand schedules. This, in turn, allows label suppliers to allocate production time and materials more efficiently for your last-minute rush orders.

Smaller companies can take a much more simplified approach (without the SCM tracking) to help their suppliers manage their orders – even if they do not use supply chain management. A simple Excel report of production runs over a 12-month time frame is ideal. If your label provider does not already practice this or similar methodology, it might be time to start looking for a more proactive label provider. If you’re unsure you want to share your information, then you might consider requiring your label provider to sign an NDA (Non-disclosure Agreement).

Mistake #4: Not Accepting Alternative Sizes of the Label to Allow for Better Pricing

If your product needs a label with, for example, a dimension of 5.25 X 6.75 inches, there might be a much better price point offered to you if you’re open to switching to a slightly different dimension label of, say, 5 X 7 inches.  Obviously, you need to make sure the new dimension would fit your product(s) and work with your production line. But, if alternate dimensions are within the scope of the project, a modified SKU could potentially cut down on cost and production time.

Best Method Approach: You might not have the time or ability to change your label if you already market that product in retail stores. But, if you are changing your branding, creating a new style of label, or releasing a completely new product, this is the ideal time to consider implementing better continuity between your products. This could include elements such as matching colors and label/packaging design.

In addition to updating your SKU’s, this might also be an opportunity for your company to consolidate multiple products onto a universal label size. By applying the same sized labels to multiple SKU’s, you can increase efficiency regarding repeated label orders, especially for label printers that use digital printers. Combine this approach with your expected annual quantity estimates and you’ll be positioned for very efficient ordering options as your company grows.

Editor’s Note: We’ll cover the next four most common labeling mistakes in Part Two coming next week. Stay tuned for more!

First Cannabis Clinical Trials All Set In UK

By Marguerite Arnold
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Beckley Canopy Therapeutics, based in Oxford, England has raised ₤7.4 million for the purposes of cannabinoid research and drug development. The new company is a unique partnership established between Canopy Growth Corporation and the Beckley Foundation, a research institute which examines the utilization of psychotropic drugs for the treatment of physical and mental conditions.

Studies focusing on the use of cannabinoids for the treatment of opioid addiction and cancer pain will be conducted in Europe, the UK and the US.

Why Is This Significant?

Here is the first reason: the woman behind it all. Her name is Lady Amanda Feilding, Countess of Wemyss and March. Born into a landed gentry family at Beckley Park (a Tudor hunting lodge with three towers and three moats) she also has a long history of engaging and supporting scientific endeavours that use stigmatized drugs in the treatment of both intractable disease and mental illness via the use of scientific research.

In 1998, Amanda Feilding set up the Beckley Foundation, a charitable trust which initiates, directs and supports neuroscientific and clinical research into the effects of psychoactive substances. She has also co-authored over 50 scientific papers in peer-reviewed journals.

The so-called “hidden hand” behind the rebirth of psychedelic science, Fielding’s contribution to global drug policy reform has been widely acknowledged in international drug policy circles. She was named as one of the bravest men and women in the history of science in 2010 by the British Guardian.

And here is the second reason: The foundation is now partnered with Canopy Cannabis, one of the leading cannabis firms in the world, which is also working closely with Spanish opioid manufacturer Alcaliber.

In other words, this coalition is almost the mirror opposite of the approach taken by the American Sackler family, makers of Oxycontin, who have fought cannabinoids as an alternative or even transition drug in multiple state legalization campaigns. Meanwhile the death rates from overdoses have quadrupled since 1999. In 2016, opioid-related drug overdoses killed about 116 people a day (or about 42,249 for the year). It is estimated that about 11 million people in the U.S. are currently misusing or dependent on opioids.

Amanda Fielding
Image credit: Robert Funke

Beyond The Politics of The Opioid-Cannabinoid War

While opioids clearly have a role particularly in chronic pain treatment, the question now at the global scientific table is this: Are cannabinoids a substitute for longer term chronic pain management? It is a fiercely battled scientific debate that has frequently, particularly in the U.S., crossed over into political drug reform questions.

The unique partnership of Beckley and Canopy is well placed both scientifically and culturally to take on a discussion which has languished for too long in the grass of political debate and reform.

Even better, it is taking place in a country where English is the first language, but outside the U.S. and further, in a country where cannabis has now been legally reclassified as a Schedule II drug.

Do not expect, in other words, the same trials and tribulations that faced noted U.S.-based researcher Sue Sisley, to slow down research, trials or findings.

Why Is A Cultural and Scientific Reset Required?

For the past forty years, since the end of the 1970s, cannabis in particular, has been pushed into a strange scientific territory in part, because of the culture surrounding the drug. This in turn, along with the schedule I classification of cannabis, has led to not only a dearth of research, but a reluctance on the part of prescribing doctors to examine its efficacy.

In the present, this means that doctors are still (beyond insurers who demand medical evidence before approving payment) the biggest hurdles in every medical system where cannabis is becoming legal. See the debate in Canada, the UK and of course, Germany, where patients frequently report asking for a drug their doctors refuse to prescribe.

This is exactly the kind of high-placed, societally influential effort in other words, that might finally break the medical taboo at the most important remaining logjam– at the point of prescription and approval for patients.

Radojka Barycki picture

Food Safety Planning for Cannabis Companies

By Radojka Barycki
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Radojka Barycki picture

Food safety incidents can be prevented. However, prevention requires planning, which requires the effort of everyone in a company to create a culture of quality and food safety. How exactly do you plan for food safety? Food safety planning implies the building of a food safety management system. Food safety management systems allow for an efficient management of hazards that may be present in the food by the development and implementation of pre-requisite programs (PRPs) and a food safety plan, while supported by management commitment. So, let’s take a closer look at each of these building blocks:Radojka Barycki will lead a plenary session titled, “Cannabis: A Compliance Revolution” at the 2018 Food Safety Consortium | Learn More

Management Commitment

The development and implementation of a food safety management system requires financial, equipment, and technically sound personnel in order to be successful and sustainable. The management team of any cannabis product manufacturer must be committed to food safety, so the needed resources to develop and implement a food safety management system are provided. Management commitment creates a culture within the operation that supports, sustains and continuously improves food safety. 

Pre-Requisite Programs (PRPs) 

Pre-requisite programs are procedures that establish the minimal operations conditions to produce safe and quality products. Pre-requisite programs are the foundation of food safety and must be developed and implemented prior to creating a food safety plan. They keep potential hazards from becoming serious enough to adversely impact the safety of products produced. Pre-requisite programs include but are not limited to:

  • Document Control
  • Supplier Verification Programs
  • Raw Material Receiving (ingredients, processing aids and packaging)
  • Good Manufacturing Practices (GMPs)
  • Preventative Maintenance (PM) Program
  • Calibration Program
  • Integrated Pest Management (IPM)
  • Environmental Monitoring Programs (EMPs)
  • Water Management Programs (WMPs)
  • Allergen Management Program
  • Standard Sanitation Operating Procedures (SSOPs)
  • Standard Operating Procedures (SOPs)
  • Storage and Transportation Procedures
  • Crisis Management
  • Traceability
  • Recall
  • Record keeping
  • Waste Management
  • Training

Food Safety Plan (FSP)As you can see, food safety planning requires the development and implementation of a lot of programs.

A food safety plan is a documented systematic approach that follows the Codex Alimentarius HACCP Principles to identify, prevent and minimize to an acceptable level or control hazards that may be present in food and that can cause an illness or injure the consumer. The first step in this systematic approach is the formation of a food safety team, which main responsibility is to identify the scope of the food safety plan and to oversee all of the activities associated with the plan (e.g. monitoring, verification, validation, etc.) After the food safety team is formed, the steps outlined below are followed in order (systematically):

  1. Product Description
  2. Product Intended Use
  3. Development of the flow diagram
  4. Verification of the flow diagram
  5. Conduct a Hazard Analysis
  6. Identify Critical Control Points (CCPs) or Preventive Controls
  7. Establish Critical Limits
  8. Monitor Critical Limits
  9. Establish Corrective Actions
  10. Establish Verification Procedures
  11. Establish Record Keeping Procedures

As you can see, food safety planning requires the development and implementation of a lot of programs. Therefore, I highly recommend that you hire a food safety consultant that can guide you through this process.

Logistics and Supply Chain Management in California

By Aaron G. Biros
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Just a couple weeks away, the California Cannabis Business Conference, taking place in Anaheim, CA October 22-23, will host a series of panel discussions where attendees can expect to learn from industry leaders on a variety of topics. As businesses in the state adjust to new regulations and the market matures, one particular topic seems to highlight a challenging new space: distribution.

Track 1 at the CA Cannabis Business Conference, Distribution, Retail and Delivery, will begin early afternoon on Monday at the show, where a panel discussion titled State of Cannabis Distribution: Scaling Cannabis Distribution and Expectations of a Distributor, will tackle a range of issues involving logistics and supply chain management in California’s cannabis industry.

Michael Wheeler, vice president of Policy Initiatives at Flow Kana, will host the panel, joined by Chris Coulombe, CEO of Pacific Expeditors, Jesse Parenti, programs director of Nine Point Strategies and Brian Roth, vice president of sales at KUDU Technologies. According to the agenda, the session will cover inventory management, shipping and transport, managing product data, order fulfillment, manifest creation and reporting on it all. Michael Wheeler says regulatory compliance is one issue they plan on discussing. “Currently the biggest pressure on compliance is the desire by some operators to live under the proposed regulations, instead of the current emergency regulations,” says Wheeler. “Add to this recently signed legislation and we have lots of opportunistic actions each with their own perception of compliance.”

Another important topic they plan on discussing is driver training and hiring practices. According to Chris Coulombe, drivers are one of the top two most important customer-facing teams in the organization. “Between the sales team and the fleet operation, drivers represent half of the face of your company,” says Coulombe. “Much like the sales team, they interface with your retail partners directly, and subsequently provide a sizable portion of the foundation that retailers will use to judge your company’s competency and efficiency.”

Chris Coulombe, CEO of Pacific Expeditors
Chris Coulombe, CEO of Pacific Expeditors

When hiring new drivers, Coulombe recommends the standard background and driver record checks, but urges looking for experience in sales and driving as well. “Find those that have leadership experience and are comfortable operating in quasi-structured environments,” says Coulombe. “To that end, we seek solution oriented candidates that are personable, experienced in troubleshooting on their feet, and understand how to operate inside the structure of an organization.”

Coulombe also emphasizes the importance of driver training in any distribution company. “We built our driver training from scratch based on collective experiences from the military,” says Coulombe. “However, creating this from scratch is not necessary at this point, some insurance companies, such as our broker, Vantreo, provide in house driver training and certification solutions as a risk mitigation measure for companies that they represent. We recommend speaking with your insurance company to find what packages they have available.” Proper training for your drivers can help increase efficiency in operations, decrease maintenance and insurance costs and provide for better employee engagement. Coulombe also says many insurance companies have standard operating procedures for drivers to help supplement your company’s protocols.

Chris Coulombe and the other panelists will dive much deeper into this issue and other supply chain topics at the upcoming California Cannabis Business Conference, taking place in Anaheim, CA October 22-23.

Ellice Ogle headshot

Concentrate On a Food Safety Culture In Your Workplace

By Ellice Ogle
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Ellice Ogle headshot

In A Culture of Food Safety: A Position Paper (2018), the Global Food Safety Initiative (GFSI) defines food safety culture as the “shared values, beliefs, and norms that affect mind-set and behavior toward food safety in, across, and throughout an organization.” In other words, food safety culture in your workplace is the “this is how we do things around here.”

A food safety culture needs to be relentlessly communicated – everyone needs to know it is his or her job, not just a dusty slogan on the wall or a whisper down the halls.Building a strong food safety culture is particularly relevant to the cannabis workplace because of the unique history of the workers and the unique needs of the consumers. The cannabis industry is special in that it was an industry before it became regulated. As such, there are many workers in the industry who have a deep passion for cannabis products, but with experience rooted in working within only a few official standards. Thus, the behavior and mind-set of workers in the cannabis industry must adjust to new regulations. However, even currently, standards are ever changing and vary from state to state; this causes further confusion and inconsistency for you and your workers. On top of that, now that cannabis is legalized in certain pockets, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant or the young. These consumers in particular need and deserve access to safe cannabis products every experience. Therefore, it is that much more important to develop a strong food safety culture in the workplace to promote safe, quality cannabis large-scale production for the larger, wider audience.

To achieve a food safety culture, GFSI emphasizes the vision and mission of the business, the role of the leaders in the organization, and the continuity of communication and training. GFSI also emphasizes that these components are interrelated and all are needed to strengthen a food safety culture. Food safety culture components can be simplified into: 1) things you believe, 2) things you say, and 3) things you do.“this is how we do things around here.”

Things You Believe

Food safety culture starts from the top, with the executive team and senior managers. It is this group that dictates the vision and mission of the business and decides to include food safety and quality as a part of this guiding star. Moreover, it is this group that commits to the support for food safety by investing the time, money and resources. The message then has to spread from the executive team and senior managers to an interdepartmental team within the workplace. That way, the values of food safety can be further shared to front-line workers during onboarding and/or continuous training. To restart a food safety culture, a town hall can be a useful tool to discuss priorities in the workplace. Overall, it is important to have every worker believe in producing safe food and that every worker is a part of and has ownership of contributing to the food safety culture at your workplace (GFSI, 2018).

Things You Say

A food safety culture needs to be relentlessly communicated – everyone needs to know it is his or her job, not just a dusty slogan on the wall or a whisper down the halls. The Food and Drug Administration (FDA) has a saying that “if it’s not written down, it didn’t happen.” Thus, the guidelines for a food safety culture need to be embedded in the policies, programs and procedures; and these guidelines need to be a part of training from day one and supplemented with periodic reminders. For effectiveness, make the communication engaging, relevant and simple – use your workers to pose for posters, use digital tools such as memes. In his presentation at the 2015 Food Safety Consortium, Frank Yiannas, vice president of food safety at Walmart, says “How many of you created training videos that you show the desired behavior once? You should probably show the behavior more than once and by a few different employees so that when they see it, they see multiple people in the video doing it and that’s the social norm.” By sending a consistent message, a food safety culture can flourish in your workplace.A food safety culture does not happen once; a food safety culture is a long-term commitment with continuous improvement.

Things You Do

A food safety culture does not happen once; a food safety culture is a long-term commitment with continuous improvement. Periodic evaluation of food safety metrics and alignment with business goals contribute to maintaining a food safety culture – it is useful to learn from successes as well as mistakes. In the same presentation mentioned above, Yiannas discusses “Learning from the wrong way [mistakes] lessens the likelihood that we will become complacent” where he defines complacency as “a feeling of quiet security, often while unaware of some potential danger or defect that lurks ahead.” Without the constant commitment, businesses can falter in their food safety and cause costly mistakes – whether that be recalls or illnesses or worse. By not becoming complacent and emphasizing constant accountability, a food safety culture can thrive at your workplace and make your workplace thrive.

With the regulated cannabis industry still in its infancy, the time is now for every cannabis workplace to instill a food safety culture. Before being mandated, the cannabis industry can rally for food safety because it is the right thing to do. With participation from each workplace, the industry as a whole can be united in producing safe product and be better positioned to change stigmas.

EVIO Logo

EVIO Labs Massachusetts Accredited to ISO 17025

By Aaron G. Biros
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EVIO Logo

EVIO Inc.’s Massachusetts lab announced yesterday they received ISO/IEC 17025 accreditation from the American Association for Laboratory Accreditation (A2LA). According to the Massachusetts Cannabis Control Commission, the body in charge of regulating the state’s cannabis industry, accreditation to ISO/IEC 17025: 2017 is a requirement for cannabis testing labs.

The press release says this makes EVIO Labs Massachusetts one of only a few operating and accredited testing laboratories serving the state’s medical cannabis industry. With recreational sales coming shortly to the state, EVIO is preparing for a higher demand in their lab testing services. “We are very proud of all of the teams’ hard work that resulted in this advanced accreditation,” says James Kocis, lab director of EVIO Labs Massachusetts. “With the state-mandated laboratory regulations, EVIO upholds the high standards of testing and plays a pivotal role in ensuring consumer safety and confidence in the states burgeoning marijuana market.”

According to Adam Gouker, general manager at A2LA, EVIO Labs Massachusetts, based in Southborough, MA, is the first cannabis laboratory they accredited in the state. “A2LA is excited to expand our cannabis accreditation program into yet another state, promoting the value of independent third-party accreditation to support quality products in the industry,” says Gouker. “Having the opportunity to work with a prominent name in the industry such as EVIO Labs and assess their exceptional Massachusetts laboratory has been an additional bonus.”

EVIO LogoAccording to the A2LA press release, by achieving ISO/IEC 17025 accreditation, EVIO Labs Massachusetts demonstrates that they “have management, quality and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to ensure that all aspects related to the sample, the analysis, and the reporting are standardized, measured, and monitored.” It also requires that personnel are competent to perform each analysis.

EVIO Inc. operates in the cannabis testing market with lab services in a number of states, including Oregon, California and Florida among others. Their Florida location was the first accredited cannabis lab in the state and they recently earned the same accreditation for their Berkeley, California location.

Top 10 Common Findings Detected During Cannabis Laboratory Assessments: A Guide to Assist with Accreditation

By Tracy Szerszen
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With the cannabis industry growing rapidly, laboratories are adapting to the new market demand for medical cannabis testing in accordance to ISO/IEC 17025. Third-party accreditation bodies, such as Perry Johnson Laboratory Accreditation, Inc. (PJLA), conduct these assessments to determine that laboratories are following relevant medical cannabis testing standard protocols in order to detect potency and contaminant levels in cannabis. Additionally, laboratories are required to implement and maintain a quality management system throughout their facility. Obtaining accreditation is a challenge for laboratories initially going through the process. There are many requirements outlined in the standard that laboratories must adhere to in order to obtain a final certificate of accreditation. Laboratories should evaluate the ISO 17025 standard thoroughly, receive adequate training, implement the standard within their facility and conduct an internal audit in order to prepare for a third-party assessment. Being prepared will ultimately reduce the number of findings detected during the on-site assessment. Listed below is research and evidence gathered by PJLA to determine the top ten findings by clause specifically in relation to cannabis testing laboratories.

PJLA chart
The top 10 findings by clause

4.2: Management System

  • Defined roles and responsibilities of management system and its quality policies, including a structured outline of supporting procedures, requirements of the policy statement and establishment of objectives.
  • Providing evidence of establishing the development, implementation and maintenance of the management system appropriate to the scope of activities and the continuous improvement of its effectiveness.
  • Ensuring the integrity of the management system during planned and implemented changes.
  • Communication from management of the importance of meeting customer, statutory and regulatory requirements

4.3: Document Control

  • Establishing and maintaining procedures to control all documents that form the management system.
  • The review of document approvals, issuance and changes.

4.6: Purchasing Services and Supplies

  • Policies and procedures for the selection and purchasing of services and supplies, inspection and verification of services and supplies
  • Review and approval of purchasing documents containing data describing the services and supplies ordered
  • Maintaining records for the evaluation of suppliers of critical consumables, supplies and services, which affect the quality of laboratory outputs.

4.13: Control of Records

  • Establishing and maintaining procedures for identification, collection, indexing, access, filing, storage and disposal of quality and technical records.
  • Providing procedures to protect and back-up records stored electronically and to prevent unauthorized access.

4.14: Internal Audits

  • Having a predetermined schedule and procedure for conducting internal audits of its activities and that addresses all elements that verify its compliance of its established management system and ISO/IEC 17025
  • Completing and recording corrective actions arising from internal audits in a timely manner, follow-up activities of implementation and verification of effectiveness of corrective actions taken.

5.2: Personnel

  • Laboratory management not ensuring the competence and qualifications of all personnel who operate specific equipment, perform tests, evaluate test results and sign test reports. Lack of personnel undergoing training and providing appropriate supervision
  • Providing a training program policies and procedures for an effective training program that is appropriate; identification and review of training needs and the program’s effectiveness to demonstrate competence.
  • Lack of maintaining records of training actions taken, current job descriptions for managerial, technical and key support personnel involved in testing

5.4: Test and Calibration Methods and Method Validation

  • Utilization of appropriate laboratory methods and procedures for all testing within the labs scope; including sampling, handling, transport, storage and preparation of items being tested, and where appropriate, a procedure for an estimation of the measurement of uncertainty and statistical techniques for analysis
  • Up-to-date instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing
  • Introduction laboratory-developed and non-standard methods and developing procedures prior to implementation.
  • Validating non-standard methods in accordance with the standard
  • Not completing appropriate checks in a systematic manner for calculations and data transfers

5.6: Measurement Traceability

  • Ensuring that equipment used has the associated measurement uncertainty needed for traceability of measurements to SI units or certified reference materials and completing intermediate checks needed according to a defined procedure and schedules.
  • Not having procedures for safe handling, transport, storage and use of reference standards and materials that prevent contamination or deterioration of its integrity.

5.10: Reporting the Results

  • Test reports not meeting the standard requirements, statements of compliance with accounting for uncertainty, not providing evidence for measurement traceability, inaccurately amending reports.

SOP-3: Use of the Logo

  • Inappropriate use of PJLA’s logo on the laboratories test reports and/or website.
  • Using the incorrect logo for the testing laboratory or using the logo without prior approval from PJLA.
Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 2

By Dr. Edward F. Askew
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Dr. Ed Askew

Editor’s Note: The views expressed in this article are the author’s opinions based on his experience working in the laboratory industry. This is an opinion piece in a series of articles designed to highlight the potential problems that clients may run into with labs. 

In the previous article, I discussed the laboratory’s first line of defense (e.g. certification or accreditation) when a grower, processor or dispensary (user) questions a laboratory result. Now let us look behind this paperwork wall to the laboratory culture the user will encounter once their complaint is filtered past the first line of defense.

It is up to the client (processor, grower or dispensary) to determine the quality of the lab they use.In an ISO 17025 (2005 or 2017) and TNI accreditation, the laboratory must be organized into management, quality and technical areas. Each area can overlap as in the ISO 17025-2017 standard or be required to remain as separate sections in the laboratory as in the ISO 17025-2005 or TNI 2009 standards. ISO 17025 standards (e.g. 2005 and 2017) specifically require a separation of monetary benefits for laboratory results as it applies to the technical staff. This “conflict of interest” (CoI) is not always clearly defined in the laboratory’s day-to-day practices.

One example that I have experienced with this CoI separation violation goes back to my days as a laboratory troubleshooter in the 1990s. I was called into a laboratory that was failing to meet their Department of Defense (DoD) contract for volatile organic hydrocarbon analyses (VOAs) of soil samples by purge trap-gas chromatography-mass spectroscopy. I was required to “fix” the problem. What I determined was:

  • The analytical chemists performing the VOAs analyses were high school graduates with no coursework in chemistry or biology.
  • There was no training program in place for these analysts in instrument use, instrument troubleshooting and interpretation of the analytical results.
  • The only training the analysts received was for simple instrument set-up and basic instrument computer software use. (e.g. Push this button and send results to clerks)
  • Clerks with a high school degree and no analytical chemistry training in the business office generated the final reports and certified them as accurate and complete.

None of the staff was technically competent to perform any in-depth VOAs analytical work nor was the clerical staff competent to certify the results reported.

When I pointed out these discrepancies to the laboratory management, they declined to make any changes. The laboratory management had a direct monetary interest in completing all analyses at the lowest costs within the time limit set by DoD. If the laboratory did not complete the analyses as per the DoD contract, DoD would cancel the contract and not pay the laboratory.

The DoD, in a “Double Blind” test sample, later caught this laboratory.. A Double Blind test sample is used to check to see if the laboratory is performing the tests correctly. The laboratory does not know it is a test sample. So if the laboratory is cheating, they will be caught.This does not mean that all laboratories have staff or management issues

Once the laboratory was caught by DoD with the Double Blind, laboratory management claimed they were unaware of this behavior and management fired all analytical staff performing VOAs and clerical staff reporting the VOAs results to show DoD that it was a rogue group of individuals and not the laboratory management. The fired staff members were denied unemployment benefits as they were fired with cause. So, the moral to this story is if the analytical staff and specifically the clerical staff had wanted to hold the laboratory management accountable for this conflict of interest, they may have been fired, but without cause. The staff would have kept their reputation for honesty and collected unemployment benefits.

I have witnessed the “CoI above repeatedly over the last 30+ years both in laboratories where I have been employed and as a consultant. The key laboratory culture problems that lead to these CoI issues can be distilled into the following categories:

  • Financial CoI: In the financial CoI, the laboratory management must turn out so many analytical test results per day to remain financially solvent. The philosophical change that comes over management is that the laboratory is not producing scientific results, but is instead just churning out tests. Therefore, the more tests the laboratory produces, the more money it makes. Any improvement in test output is to be looked upon favorably and anything that diminishes test output is bad. So, to put this in simple terms: “The laboratory will perform the analyses quickly and get the report sent to the user so the laboratory can be paid. Anything that slows this production down will not be tolerated!” To maximize the Return on Investment (RoI) for the laboratory, management will employ staff that outwardly mirrors this philosophy.
  • I Need This Job CoI: This is the CoI area that poor quality lab technical staff and clerical staff most readily falls into. As outlined in the example above, both the analytical staff and clerical staff lacked the educational credentials, the technical training to be proficient in the use of the analytical instruments, ability to identify problems performing the analytical methods or complications in reporting analytical results. That means they were locked into the positions they held in this specific laboratory. This lack of marketable skills placed pressure on these staff members to comply with all directives from management. What happened to them in the end was regrettable, but predictable. Management can prey on this type of staff limitation.
  • Lack of Interest or Care CoI: This form of CoI is the malaise that infects poor quality laboratories, but can reach a level in management, quality and technical areas as to produce a culture where everyone goes through the moves, but does not care about anything but receiving their paycheck. In my many years of laboratory troubleshooting this type of CoI is the most difficult to correct. Laboratories where I had to correct this problem required that I had to impress on the staff that their work mattered and that they were valued employees. I had to institute a rigorous training program, require staff quality milestones and enforce the quality of work results. During my years of laboratory troubleshooting, I only had to terminate three laboratory staff for poor work performance. Unfortunately after I left many of these laboratories, management drifted back to the problems listed above and the laboratory malaise returned. This proves that even though a laboratory staff can achieve quality performance, it can quickly dissolve with lax management.

So, what are the conclusions of this article?

  • Laboratory culture can place profit over scientific correctness, accuracy and precision.
  • Laboratory management sets the quality of staff that determines the analytical results and report quality the user receives.
  • Laboratory quality can vary from acceptable performance to unacceptable performance over the lifetime of the laboratory depending on management.
  • This does not mean that all laboratories have staff or management issues. It is up to the client (processor, grower or dispensary) to determine the quality of the lab they use.

The next article in this series will introduce the user to the specific Quality Control (QC) analyses that an acceptable laboratory should perform for the user’s sample. These QC analyses are not always performed by accredited laboratories as the specific state that regulates their cannabis program does not require them. The use of these QC samples is another example of how laboratory’s with poor quality systems construct another paper work wall.

HACCP

Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 4

By Kathy Knutson, Ph.D.
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HACCP

In Part 3 of this series on HACCP, Critical Control Points (CCPs), validation of CCPs and monitoring of CCPs were defined. When a HACCP plan identifies the correct CCP, validates the CCP as controlling the hazard and monitors the CCP, a potential hazard is controlled in the manufacturing and packaging of cannabis-infused edibles. The food industry is big on documentation. If it’s not documented, it did not happen. The written hazard analysis, validation study and monitoring of CCPs create necessary records. It is these records that will prove to a customer, auditor or inspector that the edible is safe. Here in Part 4, more recordkeeping is added on for deviation from a CCP, verification and a recall plan. 

Take Corrective Action When There Is a Deviation from a Critical Control Point

Your food safety team conducts a hazard analysis, identifies CCPs and decides on monitoring devices, frequency and who is responsible for monitoring. You create an electronic or paper record of the monitoring for every batch of edible to document critical limits were met. Despite all your good efforts, something goes wrong. Maybe you lose power. Maybe the equipment jams. Nothing is perfect when dealing with ingredients, equipment and personnel. Poop happens. Because you are prepared before the deviation, your employees know what to do. With proper training, the line worker knows what to do with the equipment, the in-process product and who to inform. In most cases the product is put on hold for evaluation, and the equipment is fixed to keep running. The choices for the product include release, rework or destroy. Every action taken needs to be recorded on a corrective action form and documents attached to demonstrate the fate of the product on hold. All the product from the batch must be accounted for through documentation. If the batch size is 100 lb, then the fate of 100 lb must be documented.

Verify Critical Control Points Are Monitored and Effective

First, verification and validation are frequently confused by the best of food safety managers. Validation was discussed as part of determining CCPs in Part 3. Validation proves that following a CCP is the right method for safety. I call validation, “one and done.” Validation is done once for a CCP; while verification is ongoing at a CCP. For example, the time and temperature for effective milk pasteurization is very well known and dairies refer to the FDA Pasteurized Milk Ordinance. Dairies do not have to prove over and over that a combination of time and temperature is effective (validation), because that has been proven.

I encourage you to do as much as you can to prepare for a recall.A CCP is monitored to prove the safety parameters are met. Pasteurization is an example of the most commonly monitored parameters of time and temperature. At a kill step like pasteurization, the employee at that station is responsible for accurate monitoring of time and temperature. The company managers and owners should feel confident that CCPs have been identified and data are being recorded to prove safety. Verification is not done by the employee at the station but by a supervisor or manager. The employee at the station is probably not a member of the food safety team that wrote the HACCP plan, but the supervisor or manager that performs verification may be. Verification is proving that what was decided by the food safety team is actually implemented and consistently done.

Verification is abundant and can be very simple. First, every record associated with a CCP is reviewed by a supervisor or manager, i.e. someone who did not create the record. This can be a simple initial and date at the bottom of the record. Every corrective action form with its associated evaluation is verified in the same way. When HACCP plans are reviewed, that is verification. Verification activities include 1) testing the concentration of a sanitizer, 2) reviewing Certificates of Analysis from suppliers, 3) a review of the packaging label and 4) all chemical and microbiological testing of ingredients and product. The HACCP plan identifies CCPs. Verification confirms that implementation is running according to the plan.

Verification is like a parent who tells their child to clean their room. The child walks to their room and later emerges to state that the room is clean. The parent can believe the word of the child, if the child has been properly trained and has a history of successfully cleaning their room. At some frequency determined by the parent, the room will get a parental visual check. This is verification. In the food industry, CCP monitoring records and corrective action must be reviewed within seven days after the record is created and preferably before the food leaves the facility. Other verification activities are done in a timely manner as determined by the company.

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

Write a Recall Plan

In the food industry, auditors and FDA inspectors require a written recall plan. Mock recalls are recommended and always provide learning and improvement to systems. Imagine your edible product contains sugar, and your sugar supplier notifies you that the sugar is recalled due to glass pieces. Since you are starting with the supplier, that is one step back. Your documentation of ingredients includes lot numbers, dates and quantity of sugar.You keep good records and they show you exactly how much of the recalled lot was received. Next you gather your batch records. Batches with the recalled sugar are identified, and the total amount of recalled sugar is reconciled. You label every batch of your edible with a lot code, and you identify the amount of each affected lot and the customer. You have a press release template in which you add the specific information about the recall and affected lots. You notify every customer where the affected edible was shipped with a plan to return or destroy the edible. When you notify your customers, you go one step forward.

How would your company do in this situation? I have witnessed the difficulties a company faces in a recall when I was brought in to investigate the source of a pathogen. Food safety people in my workshops who have worked through a recall tell me that it was the worst time of their life. I encourage you to do as much as you can to prepare for a recall. Here are two good resources:

Please comment on this blog post below. I love feedback!

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From The Lab

The Case for ISO/IEC 17025 Accreditation in Cannabis Testing Laboratories

By Amy Ankrum
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Government regulations keep millions of Americans safe every year by controlling what companies can put in their products and the standards those products must meet to be sold to consumers.

Enter the strange case of legal cannabis: In order for cannabis to be legally distributed by licensed medical professionals and businesses, it must be tested. But unlike other consumable goods, cannabis is not regulated by the FDA. Without an overarching federal policy requiring cannabis testing laboratory accreditation, the testing and laboratory requirements differ greatly across state lines.For medical cannabis specifically, accredited testing facilities are especially important. 

To be federally regulated, cannabis would first have to be federally legalized. It turns out that states and businesses alike are not willing to wait for a federal mandate. Many states have begun to adopt standards for cannabis testing and some, such as Ohio, have even announced mandatory ISO/IEC 17025 accreditation for all cannabis testing laboratories. As the industry evolves, increased compliance expectations are certain to evolve in tandem.

Some cannabis labs have even taken the initiative to seek ISO/IEC 17025 accreditation of their own volition. Seth Wong, President of TEQ Analytics Laboratories, shared in a press release:

“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with State required tests that are accredited by an international standard.”

Other laboratories, such as DB Labs in Las Vegas and EVIO Labs in Florida are also leading the accreditation charge in their respective states, ahead of any state mandates.

There are key reasons why accreditation in cannabis testing labs is important. First and foremost, cannabis is a consumable product. Like fruits and vegetables, cannabis is prone to pesticides, fungi and contaminants. The result of putting a potentially hazardous material on the market without proper and documented testing could lead to a public health crisis. An accredited testing lab, however, will ensure that the cannabis products they test are free from harmful contaminants.

By utilizing role-based trainings, labs can trust employees are receiving proper onboarding.

For medical cannabis specifically, accredited testing facilities are especially important. Because many consumers of medical cannabis are immuno-compromised (such as in the case of chemotherapy patients), ensuring that products are free from any and all contaminants is critical. Further, in order to accurately determine both short- and long-term effects of prescribed cannabis consumption, accredited and compliant laboratories are necessary.

Accreditation standards like ISO/IEC 17025 also provide confidence that testing is performed properly and to an internationally accepted standard. Rather than returning a “pass/fail” rating on products, the Cannabis Safety Institute reports that an ISO/IEC 17025 laboratory is required to produce numerical accuracy percentages in testing for “at a minimum, cannabinoids, pesticides, microbiology, residual solvents, and water activity.” Reliable data sets that can be reviewed by both accreditors and the public foster trust between producers and consumers.

Finally, ISO/IEC 17025 accreditation demonstrates that a laboratory is properly staffed and trained. The Cannabis Safety Institute’s “Standards for Cannabis Testing Laboratories” explains that conducting proper analytical chemistry on cannabinoids (the chemical compounds extracted from cannabis that alter the brain’s neurotransmitter release) requires personnel who have met specific academic and training credentials. A system to monitor, manage and demonstrate proficiency is necessary to achieve and maintain accreditation. With electronic systems in place, this management and documentation minimizes risk and also minimizes administrative time tracking and maintaining training records.

Following the proper steps of a standardized process is key to improving and growing the cannabis industry in coming yearsFor cannabis testing labs, utilizing a comprehensive software solution to achieve and maintain compliance to standards such as ISO/IEC 17025 is key. Absent of a software solution, the necessary compliance requirements can become a significant burden to the organization. Paper tracking systems and complex spreadsheets open up organizations to the likelihood of errors and ultimately risk.

Because ISO/IEC 17025 has clearly defined expectations for training, a software solution also streamlines the training process while simultaneously documenting proficiency. By utilizing role-based trainings, organizations can be confident employees are receiving proper onboarding and in-service training. Additionally, the effectiveness of training can be proven with reports, which results in smoother audits and assessments.

Following the proper steps of a standardized process is key to improving and growing the cannabis industry in coming years- which means utilizing technology tools such as electronic workflows to ensure proper process controls. Beyond adding critical visibility, workflows also create efficiencies that can eliminate the need to increase staffing as companies expand and grow.

For an industry that is changing at a rapid pace, ensuring traceability, efficient processes and visibility across organizations is paramount. Using a system that enables automation, process control, document management and documented training procedures is a step in the right direction. With the proper software tools in place, cannabis testing labs can achieve compliance goals, demonstrate reliable and relevant results and most importantly ensure consumer safety.