Tag Archives: management

March 21, 2018

Maintenance and Calibration: Your Customers Are Worth It!

By Vince Sebald

Ultimately, the goal of any good company is to take care of their customers by providing a quality product at a competitive price. You take the time to use good practices in sourcing raw materials, processing, testing and packaging to make sure you have a great final product. Yet in practice, sometimes the product can degrade over time, or you find yourself facing costly manufacturing stoppages and repairs due to downed equipment or instrumentation. This can harm your company’s reputation and result in real, negative effects on your bottom line.

One thing you can do to prevent this problem is to have a properly scaled calibration and maintenance program for your organization.

First, a short discussion of terms:

Balance Calibration — Figure 1– Periodic calibration of an electronic balance performed using traceable standard weights helps to ensure that the balance remains within acceptable operating ranges during use and helps identify problems.

Calibration, in the context of this article, refers to the comparison of the unit under test (your equipment) to a standard value that is known to be accurate. Equipment readings often drift over time due to various reasons and may also be affected by damage to the equipment. Periodic calibration allows the user to determine if the unit under test (UUT) is sufficiently accurate to continue using it. In some cases, the UUT may require adjustment or may not be adjustable and should no longer be used.

Maintenance, in the context of this article, refers to work performed to maximize the performance of equipment and support a long life span for the equipment. This may include lubrication, adjustments, replacement of worn parts, etc. This is intended to extend the usable life of the equipment and the consistency of the quality of the work performed by the equipment.

There are several elements to putting together such a program that can help you to direct your resources where they will have the greatest benefit. The following are some key ingredients for a solid program:

Keep it Simple: The key is to scale it to your operation. Focus on the most important items if resources are strained. A simple program that is followed and that you can defend is much better than a program where you can never catch up.

Written Program: Your calibration and maintenance programs should be written and they should be approved by quality assurance (QA). Any program should include the following:

Equipment Assessment and Identification: Assess each piece of equipment or instrument to determine if it is important enough to be calibrated and/or requires maintenance. You will probably find much of your instrumentation is not used for a critical purpose and can be designated as non-calibrated. Each item should have an ID assigned to allow tracking of the maintenance and/or calibration status.
Scheduling System: There needs to be some way to schedule when equipment is due for calibration or maintenance. This way it is easy to stay on top of it. A good scheduling system will pay for itself over time and be easy to use and maintain. A web-based system is a good choice for small to mid-sized companies.
Calibration Tolerance Assignment: If you decide to calibrate an instrument, consider what kind of accuracy you actually need from the equipment/instrument. This is a separate discussion on its own, but common rule of thumb is that the instrument should be at least 4 times more accurate than your specification. For very important instruments, it may require spending the money to get a better device.
Calibration and Maintenance Interval Assignments: Consider what interval you are going to perform maintenance for each equipment item. Manufacturer recommendations are based on certain conditions. If you use the equipment more or less often than “normal” use, consider adjusting the interval between calibrations or maintenance.
OOT Management: If you do get an Out of Tolerance (OOT) result during a calibration and you find that the instrument isn’t as accurate as you need. Congratulations! You just kept it from getting worse. Review the history and see if this may have had an effect since the last passing calibration, adjust or replace the instrument, take any other necessary corrective actions, and keep it up.
Figure 2- Maintenance engineers help keep your systems running smoothly and within specification for a long, trouble-free life.
Training: Make sure personnel that use the equipment are trained on its use and not to use equipment that is not calibrated for critical measurements. Also, anyone performing calibration and/or maintenance should be qualified to do so. It is best to put a program in place as soon as you start acquiring significant equipment so that you can keep things running smoothly, avoid costly repairs and quality control problems. Don’t fall into the trap of assuming equipment will keep running just because it has run flawlessly for months or years. There are many bad results that can come of mismanaged calibration and/or maintenance including the following:
Unscheduled Downtime/Damage/Repairs: A critical piece of equipment goes down. Production stops, and you are forced to schedule repairs as soon as possible. You pay premium prices for parts and labor, because it is an urgent need. Some parts may have long lead times, or not be available. You may suffer reputational costs with customers waiting for delivery. Some calibration issues could potentially affect operator safety as well.
Out of Specification Product: Quality control may indicate that product is not maintaining its historically high quality. If you have no calibration and maintenance program in place, tracking down the problem is even more difficult because you don’t have confidence in the readings that may be indicating that there is a problem.
Root Cause Analysis: Suppose you find product that is out of specification and you are trying to determine the cause. If there is no calibration and maintenance program in place, it is far more difficult to pinpoint changes that may have affected your production system. This can cause a very significant impact on your ability to correct the problem and regain your historical quality standards of production.

A solid calibration and maintenance program can go a long way to keeping your production lines and quality testing “boring”, without any surprises or suspense, and can allow you to put more sophisticated quality control systems in place. Alternatively, an inappropriate system can bog you down with paperwork, delays, unpredictable performance, and a host of other problems. Take care of your equipment and relax, knowing your customers will be happy with the consistent quality that they have become accustomed to.

February 12, 2018

Audit Finds Oregon Lacking Regulatory Oversight and Proper Security

By Aaron G. Biros

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Last week, Oregon Secretary of State Dennis Richardson published his office’s audit of The Oregon Liquor Control Commission (OLCC). The audit uncovered a number of inadequacies with the regulatory agency, most notably the problems with their tracking system, designed to prevent cannabis form being sold on the black market.

The report highlights the need for Oregon to implement a more robust tracking system, citing reliance on self-reporting, overall poor data quality and allowing untracked inventory for newly licensed businesses. The audit also found an insufficient number of inspectors and unresolved security issues. According to The Oregonian, the OLCC only has 18 inspectors, roughly one for every 83 licensed businesses.

Auditors also found inadequacies in the application system, saying the OLCC doesn’t monitor third-party service providers and doesn’t have a process in place for reconciling data between the licensing and tracking systems. The audit found there is a risk that decisions made for the program could be based on unreliable data. It also found a risk of unauthorized access to the systems, due to a lack of managing user accounts.

Oregon Secretary of State Dennis Richardson

This audit’s publication is very timely. Most notably because U.S. Attorney Billy Williams, who called Oregon’s black market problem “formidable,” convened a summit this week to examine how Oregon can prevent cannabis being exported to other states. According to the Oregonian, Williams said Oregon has an “identifiable and formidable overproduction and diversion problem.” The audit’s findings highlighting security issues are also very timely, given that in the same week, Oregon’s neighbor to the North, Washington, experienced a security breach in its own tracking system.

The problems with the Oregon tracking system’s security features are numerous, the audit says. They found that the OLCC lacks a good security plan, IT assets aren’t tracked well, there are no processes to determine vulnerabilities, servers and workstations not using supported operating systems and a lack of appropriately managing antivirus solutions. “Long-standing information security issues remain unresolved, including insufficient and outdated policies and procedures necessary to safeguard information assets,” reads the report’s summary.

The audit proposes 17 recommendations for the state to bolster its regulatory oversight. Those recommendations intend to address undetected compliance violations, weaknesses in application management, IT security weaknesses and weaknesses in disaster recovery and media backup testing. You can read the full audit here.

February 7, 2018

RJ Palermo Joins Innovative Publishing Company Team

By Cannabis Industry Journal Staff

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RJ Palermo has joined Innovative Publishing Co. (IPC) as Director of Sales – Events. In this newly created position at IPC, RJ will be managing the business development activities of the company’s food safety medical device and cannabis industries, working on both conference sponsorships and booth sales.

RJ will work side by side with Marc Spector, Director of Sales – Publishing. Marc had been responsible for all events and publishing sales, as well as for the year-after-year growth in these areas. The addition of RJ to the IPC team will support the company’s growth in sponsorship and exhibit sales, and allows Marc to continue supporting growth in digital advertising sales across all three of IPC’s digital publications, Food Safety Tech, MedTech Intelligence and Cannabis Industry Journal.

For many of IPC’s customers who leverage IPC’s unique position of conference sponsorships and digital advertising, they will be serviced in tandem by Marc and RJ.

“We saw a 25% growth in total revenue in 2017 and see tremendous growth potential in the three industries that we serve. Bringing RJ onto the team provides us the bandwidth to capitalize on the opportunities facing us,” said Rick Biros, president and co-founder of IPC. “Plus, RJ’s years of B2B conference and trade show management experience complements the IPC team’s current skill sets.”

RJ has more than 20 years of media, conference and agency experience. He was most recently a biopharmaceutical equipment contributor for the Pharma’s Almanac publication, and delivered several branding and research projects for pharmaceutical and medical device contract manufacturers. For 17 years RJ served as vice president of Interphex, the largest pharmaceutical manufacturing event in North America and was a key contributor of a successful launch of Medical Device Puerto Rico, which created the largest life sciences event in the Caribbean. RJ is an avid NY sports fan, and enjoys working out and spending time with his family and friends. RJ is married to his wife Beth, has a daughter Nora and dog Beau, and resides in Norwalk, CT.

February 7, 2018

Managing Cannabis Testing Lab Workflows using LIMS

By Dr. Susan Audino

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With the state led legalization of both adult recreational and medical cannabis, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug potency. Cannabis-testing laboratories receive high volumes of test requests from cannabis cultivators for testing quantitative and qualitative aspects of the plant. The testing market is growing as more states bring in stricter enforcement policies on testing. As the number of testing labs grow, it is anticipated that the laboratories that are now servicing other markets, including high throughput contract labs, will cross into cannabis testing as regulations free up. As the volume of tests each lab performs increases, the need for laboratories to make effective use of time and resource management, such as ensuring accurate and quick results, reports, regulatory compliance, quality assurance and many other aspects of data management becomes vital in staying competitive.

Cannabis Testing Workflows

To be commercially competitive, testing labs offer a comprehensive range of testing services. These services are available for both the medical and recreational cannabis markets, including:

Detection and quantification of both acid and neutral forms of cannabinoids
Screening for pesticide levels
Monitoring water activity to indicate the possibility of microbiological contamination
Moisture content measurements
Terpene profiling
Residual solvents and heavy metal testing
Fungi, molds, mycotoxin testing and many more

Although the testing workflows differ for each test, here is a basic overview of the operations carried out in a cannabis-testing lab:

Cannabis samples are received.
The samples are processed using techniques such as grinding and homogenization. This may be followed by extraction, filtration and evaporation.
A few samples will be isolated and concentrated by dissolving in solvents, while others may be derivatized using HPLC or GC reagents
The processed samples are then subjected to chromatographic separation using techniques such as HPLC, UHPLC, GC and GC-MS.
The separated components are then analyzed and identified for qualitative and quantitative analysis based on specialized standards and certified reference materials.
The quantified analytical data will be exported from the instruments and compiled with the corresponding sample data.
The test results are organized and reviewed by the lab personnel.
The finalized test results are reported in a compliant format and released to the client.

In order to ensure that cannabis testing laboratories function reliably, they are obliged to follow and execute certain organizational and regulatory protocols throughout the testing process. These involve critical factors that determine the accuracy of testing services of a laboratory.

Factors Critical to a Cannabis Testing Laboratory

Accreditations & Regulatory Compliance: Cannabis testing laboratories are subject to regulatory compliance requirements, accreditation standards, laboratory practices and policies at the state level. A standard that most cannabis testing labs comply to is ISO 17025, which sets the requirements of quality standards in testing laboratories. Accreditation to this standard represents the determination of competence by an independent third party referred to as the “Accreditation Body”. Accreditation ensures that laboratories are adhering to their methods. These testing facilities have mandatory participation in proficiency tests regularly in order to maintain accreditation.
Quality Assurance, Standards & Proficiency Testing: Quality assurance is in part achieved by implementing standard test methods that have been thoroughly validated. When standard methods are not available, the laboratory must validate their own methods. In addition to using valid and appropriate methods, accredited laboratories are also required to participate in appropriate and commercially available Proficiency Test Program or Inter-Laboratory Comparison Study. Both PT and ILC Programs provide laboratories with some measure of their analytic performance and compare that performance with other participating laboratories.
CloudLIMS Cannabis Testing LIMS: Multi-analyte Configuration for Cannabis Testing Services
Real-time Collaboration: Testing facilities generate metadata such as data derived from cannabis samples and infused products. The testing status and test results are best served for compliance and accessibility when integrated and stored on a centralized platform. This helps in timely data sharing and facilitates informed decision making, effective cooperation and relationships between cannabis testing facilities and growers. This platform is imperative for laboratories that have grown to high volume throughput where opportunities for errors exist. By matching test results to samples, this platform ensures consistent sample tracking and traceability. Finally, the platform is designed to provide immediate, real-time reporting to individual state or other regulatory bodies.
Personnel Management: Skilled scientific staff in cannabis-testing laboratories are required to oversee testing activities. Staff should have experience in analytical chromatography instruments such as HPLC and GC-MS. Since samples are often used for multi-analytes such as terpenes, cannabinoids, pesticides etc., the process often involves transferring samples and tests from one person to another within the testing facility. A chain of custody (CoC) is required to ensure traceability and ‘ownership’ for each person involved in the workflow.

LIMS for Laboratory Automation

Gathering, organizing and controlling laboratory-testing data can be time-consuming, labor-intensive and challenging for cannabis testing laboratories. Using spreadsheets and paper methods for this purpose is error-prone, makes data retrieval difficult and does not allow laboratories to easily adhere to regulatory guidelines. Manual systems are cumbersome, costly and lack efficiency. One way to meet this challenge is to switch to automated solutions that eliminate many of the mundane tasks that utilize valuable human resources.^. Laboratory automation transforms the data management processes and as a result, improves the quality of services and provides faster turnaround time with significant cost savings. Automating the data management protocol will improve the quality of accountability, improve technical efficiency, and improve fiscal resources.

Real Time Test Status in CloudLIMS

A Laboratory Information Management System (LIMS) is a software tool for testing labs that aids efficient data management. A LIMS organizes, manages and communicates all laboratory test data and related information, such as sample and associated metadata, tests, Standard Operating Procedures (SOPs), test reports, and invoices. It also enables fully automated data exchange between instruments such as HPLCs, GC-FIDs, etc. to one consolidated location, thereby reducing transcription errors.

How LIMS Helps Cannabis Testing Labs

LIMS are much more capable than spreadsheets and paper-based tools for streamlining the analytical and operational lab activities and enhances the productivity and quality by eliminating manual data entry. Cloud-enabled LIMS systems such as CloudLIMS are often low in the total cost of acquisition, do not require IT staff and are scalable to help meet the ever changing business and regulatory compliance needs. Some of the key benefits of LIMS for automating a cannabis-testing laboratory are illustrated below [Table 1]:

Key Functionality	Benefit
Barcode label designing and printing	Enables proper labelling of samples and inventory Follows GLP guidelines
Instant data capture by scanning barcodes	Facilitates quick client registration and sample access
360⁰ data traceability	Saves time and resources for locating samples and other records
Inventory and order management	Supports proactive planning/budgeting and real time accuracy
Custodian management	Promotes overall laboratory organization by assigning custodians for samples and tests Maintains the Chain-of-custody (CoC)
Test management	Accommodates pre-loaded test protocols to quickly assign tests for incoming samples
Accounting for sample and inventory quantity	Automatically deducts sample and inventory quantities when consumed in tests
Package & shipment management	Manages incoming samples and samples that have been subcontracted to other laboratories
Electronic data import	Electronically imports test results and metadata from integrated instruments Eliminates manual typographical errors
Report management	Generates accurate, customizable, meaningful and test reports for clients Allows user to include signatures and additional sections for professional use
21 CFR Part 11 compliant	Authenticates laboratory activities with electronic signatures
ISO 17025 accreditation	Provides traceable documentary evidence required to achieve ISO 17025 accreditation
Audit trail capabilities	Adheres to regulatory standards by recording comprehensive audit logs for laboratory activities along with the date and time stamp
Centralized data management	Stores all the data in a single, secure database facilitating quick data retrieval
Workflow management	Promotes better data management and resource allocation
High-configurability	Enables modification of screens using graphical configuration tools to mirror testing workflows
State compliance systems	Integrates with state-required compliance reporting systems and communicates using API
Adheres to regulatory compliance	Creates Certificates of Analysis (CoA) to prove regulatory compliance for each batch as well as batch-by-batch variance analysis and other reports as needed.
Data security & confidentiality	Masks sensitive data from unauthorized user access Cloud-based LIMS encrypts data at rest and in-transit while transmission between the client and the server
Global accessibility	Cloud-based LIMS provides real-time access to laboratory data from anytime anywhere
Real-time collaboration	Cloud-based LIMS enhances real-time communication within a laboratory, between a laboratory and its clients, and across a global organization with multiple sites

Table 1. Key functionality and benefits of LIMS for cannabis testing laboratories

Upon mapping the present day challenges faced by cannabis testing laboratories, adopting laboratory automation solutions becomes imperative. Cloud-based LIMS becomes a valuable tool for laboratory data management in cannabis testing laboratories. In addition to reducing manual workloads, and efficient resource management, it helps labs focus on productive lab operations while achieving compliance and regulatory goals with ease.

For more information on this, check out a webinar here: Webinar: How to Meet Cannabis Testing Standards and Regulatory Requirements with LIMS by Stephen Goldman, laboratory director at the State of Colorado certified Cannabis testing facility, PhytaTech.

November 10, 2017

Using Cloud-Based LIMS To Improve Efficiency In Cannabis Labs

By Shonali Paul

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Cannabis testing laboratories around the country are expanding quickly, taking on new clients and growing their business incrementally. Many of these labs are receiving a large number of test requests from growers for potency testing, terpene profiling, pesticide screening, residual solvent screening, heavy metal testing, microbial analysis and even genetic testing. To keep pace with the number of test requests received, efficient data, sample and test management is imperative.

Considering the magnitude of cannabis testing, data management using spreadsheets is a serious impediment to quality assurance. Data being recorded in spreadsheets is error-prone and difficult to manage. Furthermore, using spreadsheets does not allow labs to adhere to regulatory guidelines that demand strict accounting for every gram of the sample, right from reception, consumption for testing, to disposal.

Log samples, keep track of Chain of Custody(CoC), track samples from initial location in the lab through disposal by recording location, custodians and other metadata

To overcome such data management challenges and improve the operational efficiency of cannabis testing laboratories, a Laboratory Information Management System (LIMS) plays a significant role. LIMS are much more capable than spreadsheets and paper-based tools for managing analytical and operational activities. LIMS enhances the productivity and quality by eliminating the manual data entry. With its built-in audit trail capability, LIMS helps labs adhere to regulatory standards.

LIMS can provide companies with a method to manage samples, records and test results, and ensures regulatory compliance by increasing traceability. LIMS can also be integrated with other lab instrumentation and enterprise systems, enabling easier transmission of information across the lab and the organization, reducing manual efforts and improving decision-making.

Account for the entire quantity of sample received, used and disposed

Multiple resources are also available to assist labs in preparing for quality assurance and accreditation, LIMS being one of them. LIMS can help cannabis labs with instrument integration, and automate reporting to help improve efficiencies and reduce errors. LIMS, such as CloudLIMS Lite, a cloud-based LIMS, automates cannabis-testing workflows right from sample collection, data recording, managing test chain of custody, sample weight accounting to report generation. With data security and audit trails, a LIMS provides traceable documentary evidence required to achieve ISO 17025 accreditation for highly regulated labs. Above all, cloud-enabled systems are often low in the total cost of acquisition, have maintenance outsourced, and are scalable to help meet the ever-changing business and regulatory compliance needs.

Incorporate all tests, instruments, sample information and result data (etc.) in one place

Cloud-based products are secure, easy to deploy and scalable. A cloud product is typically hosted on a server with a guaranteed uptime of 99.5%, allowing for a reliable system, accessible 24×7. Cloud-based LIMS have automatic data backup mechanism that allow for quick turnarounds in case of a server failure or in the eventuality of a natural disaster.

With LIMS in place, cannabis labs can manage sample and requisition-centric records, track sample quantity and location, integrate the test data, and provide online reports to clients. This in turn, reduces the turnaround time for testing and improves the operational efficiency. Besides, audit trail of each and every activity performed by the lab personnel is recorded in the system to ensure that the lab follows regulatory compliance.

Editor’s Note: This is a condensed version of a poster that was submitted and displayed at this year’s Cannabis Science Conference in Portland, Oregon. The authors of the original poster are Arun Apte, Stephen Goldman, Aditi Gade and Shonali Paul.

October 18, 2017

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 2

By Aaron G. Biros

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In the first part of this series, Michelle Bradac, senior accreditation officer at the American Association for Laboratory Accreditation (A2LA), told us about the basics of laboratory accreditation, what it means and why it is such a cornerstone of product safety. In this next piece, we sit down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.

Brauninger has worked at A2LA since 1999. As the manager of their biosafety program, his focus is on developing and maintaining accreditation programs in the life sciences. Brauninger has conducted a number of management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role.

Roger Brauninger, A2LA biosafety program manager

He is A2LA’s point person for interacting with organizations working with food and drug safety, human and animal anti-doping, biological and chemical threat agents and since 2014 for issues related to cannabis testing. He is a member of the ASTM D37 Cannabis committee, a group focused on creating standards for cannabis products. He was also a member of the stakeholder panel on strategic food analytical methods (SPSFAM) cannabis potency working group when they were awarded the Official Methods Board (OMB) award for achievement in technical and scientific excellence at the AOAC’s Annual Meeting and Exposition in Atlanta, GA. Brauninger holds an M.S. degree in Cellular, Microbial and Molecular Biology from George Mason University and is a member of the Society for Toxicology, AOAC International and the International Association for Food Protection (IAFP).

In this part of the series, we sit down with Brauninger to learn specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories. Stay tuned for part three.

CannabisIndustryJournal: Do all states with legalized medical cannabis require the testing to be performed by an ISO/IEC 17025 accredited laboratory?

Roger Brauninger: No not at present, while most of the states where cannabis is legal do require accreditation; there are some states that have no requirements dealing with ensuring the competence of the testing laboratories, some that require the labs to be accredited to state environmental and drinking water standards, some that require laboratories adhere to Good Laboratory Practices (GLP) requirements and some have no requirements in place currently. Now, there are roughly 13 states that require or recommend accreditation of the testing laboratory to ISO/IEC 17025.

CIJ: If and when cannabis use is accepted federally, how is ISO/IEC 17025 accreditation of testing laboratories beneficial?

Roger: The accreditation process provides a uniform platform to allow for comparability of test results between states. This would also allow for these laboratories to benefit by being able to expand their customer base, if state borders were not an artificially imposed barrier to trade. This could also help to raise the quality of the testing services by allowing for greater participation in realistic accredited proficiency testing programs, which can create greater comparability of methods and results.

CIJ: What are the benefits to the states by choosing to require ISO/IEC 17025 accreditation as a basis for competence of testing laboratories?

Roger: States face the unique challenge, due to the federal illegality of cannabis, that they must craft their own regulatory cannabis program requirements. The ISO/IEC 17025 requirements provides a means upon which to recognize laboratory competence. This saves the states from having to come up with their own laboratory quality management requirements detailing the necessary activities a laboratory must address with respect to documentation, chain of custody, method validation, etc. Because these items are already considered in the standard. ISO/IEC 17025 helps to creates a baseline consistency amongst laboratories between states. And It also helps to provides for the legal defensibility of the test results. If and when cannabis is legalized on a federal level, a uniform 50 state recognition is possible using ISO/IEC 17025 as the basis of recognition. In short accreditation can help to ensure that test results have greater comparability and reliability; It also provides greater trust and confidence in the labels and the stated ingredients.

CIJ: Many of the laboratories are “starting up”, how is A2LA equipped to deal with the influx of novice laboratories in this field of testing?

Roger: A2LA offers many different relevant training classes, including those on the ISO/IEC 17025 standard itself, (as well as ones that also contain cannabis-specific content), internal auditing, documenting your quality system, etc. for the laboratories. A2LA also is knowledgeable regarding various states’ cannabis regulatory requirements and can help guide the labs through some of the many obstacles they face in order to perform testing in their state.

CIJ: Does A2LA provide any technical assistance to laboratories that are starting up in this industry?

Roger: A2LA has numerous technical assessors who are experts in the analytical technology associated with cannabis testing. Assessors can be hired in a consulting role and act independently of the assessment process (and independent of A2LA). As a consultant, they can also assist in setting up a quality management system in compliance with ISO/IEC 17025.

CIJ: What benefits can be gained from a laboratory seeking accreditation or from a state that requires cannabis testing laboratories to be accredited?

Roger: Accreditation can provide legal defensibility and increased confidence in the test results being able to stand up in court. It also may help to lower the cost of doing business because it helps to ensure that the test methods are in control by the laboratory and has been shown to be able to reduce the need for repeat testing. Laboratory accreditation has also led to reduced insurance rates in some cases.

July 12, 2017

Marketing Automation for Dispensaries

By Arnab Mitra

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What is Marketing Automation?

Typically when most people think of marketing automation, they imagine a platform that automates activities such as lead scoring, customer segmentation, cross-selling and campaign management. Well that type of automation is primarily for B2B companies, who are looking to reach a mass audience at once. Plus, B2B marketing automation platforms usually only provide one channel, which is email, to reach their customers.

B2C companies are looking to grow their brand and reach their customers through personalized messages. A B2C marketing automation platform helps businesses understand where each individual customer is in their journey and determine what actions need to be taken to move each customer forward. Plus they get the option of multiple channels to reach their customer, including email, text message, IM, push notifications and more.

Why is Marketing Automation Important for Dispensaries?

The first obvious reason why marketing automation is important is for the simple fact that reaching your customers is now automated; you don’t have to send out messages yourself. Thus helping save time and scale your reach at once. But marketing automation is much more important than the simple reason of saving time and scaling your reach. At SailPlay, we believe the automation of these activities helps dispensaries be able to deliver the right message at the right time to the right customer, helping the long-term success of the business.

For example, knowing where each of your customers are in their journey helps you to not only segment them into different groups, but also create specific campaigns per group. Through marketing automation you will know if you have a new lead, repeat customer and loyal customer, helping you tailor a campaign for each group.

New Lead Campaign

Each time a new lead visits your dispensary or your website, run an email or SMS campaign to provide them with a discount code to entice them to make a purchase. And after their first purchase, send a communication one day later to ask them about their experience and the product purchased.

Repeat Customer Campaign

For any repeat customers, you know which products they have purchased in the past. Run campaigns that are specific to the product groups they have purchased before. These customers are more likely to engage in your campaign if they are interested in the product.

Loyal Customer Campaign

For loyal customers, run exclusive campaigns based on their specific past purchases. For example, if John prefers to purchases edibles, run a campaign for John about an exclusive offer on a new edible.

The more personalized your campaigns are for your customers, the more engagement you can expect. According to Experian, there is a 26% increase in engagement with a personalized campaign when compared to a non-personalized campaign.

Plus with more engagement, your chances of increased sales greatly rise. According to a VB Insight study, 80% of businesses that use marketing automation have seen an increase in leads, with the majority being quality leads.

What Dispensaries Should Focus On For Marketing Automation

With there being so many marketing automation software companies to choose from, we thought we would help you focus on a couple of key features.

B2C Marketing Automation

Be sure to choose a B2C marketing automation platform. When you search for “Marketing Automation” through Google or any search engine, you will find many B2B marketing automation platforms. B2B marketing automation platforms are different because B2B platforms are interested in bulk marketing and messaging, while B2C platforms are focused on the personalization and customer journey. And as an FYI, some B2B platforms will say they have a B2C platform as well, but they will be focusing most of their features to B2B since there are more B2B companies using marketing automation.

Selecting More Than Just an Email Service Provider

If your goal is to just send out emails, then choosing an email service provider is the way for you to go. But if your goal is to go beyond that, then choose a B2C marketing automation platform. With a B2C marketing automation platform you should expect the following:

Loyalty Platform: Through a loyalty platform, you can build out a customer loyalty program that will help increase customer retention. Through the loyalty platform, you can create a rewards system, providing your customers for points for various actions, including purchases and social media actions.
Communication Platform: Within the communication platform, you can create powerful email, SMS, IM and push notification campaigns to reach each customer with the right message at the right time.
CRM Platform: The CRM platform helps you manage your entire customer list from one place. Through the CRM you can create customer segments, dive deep into each customer and more.
Analytics Platform: Within the Analytics platform, you can analyze your clients’ actions, their purchases, and socio-demographic data. Plus you can measure the effectiveness of your loyalty program, marketing campaigns, promotions and more to improve future results.

Before it gets too saturated, dispensaries need to invest in marketing automation. As stated, marketing automation can help your dispensary create a personalized experience for each of your customers, leading to higher engagement and ideally more sales.

May 31, 2017

Human Resources and the Cannabis Workforce

By Aaron G. Biros

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Cannabis businesses encounter a variety of problems when hiring and managing employees. Some of those are issues that every business runs into and some of them are quite specific to the cannabis industry. Chris Cassese, co-founder and managing director of Faces Human Capital Management, has some solutions for cannabis businesses facing seemingly daunting workforce management issues.

Cassese co-founded Faces HCM with Caela Bintner after two decades of working in the human resources and sales strategy across a variety of financial institutions. He oversees software platform development, daily operations, sales, and business development for their organization. Before co-founding the company, Cassese held a variety of operational and product development roles during his ten-year tenure at Merrill Lynch, worked in marketing at HSBC and was a sales and performance advisor at Insperity, a professional employment organization. Faces HCM is a professional employment organization that handles workforce compliance, education, and other HR needs for cannabis companies. They work with companies like Dixie Elixirs, LivWell and Women Grow, among other cannabis businesses.

Chris Cassese, co-founder and managing director of Faces Human Capital Management

According to Cassese, the cannabis industry faces a roughly 60% turnover rate, which is on par with the turnover rates in retail and call centers. Those are industries that typically have high turnover rates simply because the nature of the business. However, Cassese says it doesn’t have to be so high for the cannabis industry. “It is easy to say it is just high turnover by nature, but we found there are some steps that we can put in place that seem relatively easy, but are key tenants of Fortune 500 companies’ hiring strategies,” says Cassese. “Engaging in a needs-based analysis with companies will help us figure out exactly what’s going on.” They start by looking at the onboarding process, or what happens immediately after an employee is hired. “We start by looking at their pay rate, employee handbook and the paid time off policy, which are some of the points that a lot of the owners are familiar with coming from other high-end industries outside of cannabis.” He says things like swag bags, free ski passes after reaching quotas and other perks can keep employees engaged on the team. “Things like that go a long way and can reduce turnover by up to 20 or 30 percent,” says Cassese. “Sometimes [business owners] are so stressed with regulatory compliance that they don’t have time to tackle these issues so employee dissatisfaction often starts with onboarding procedures.” That can include anything from analyzing the overall compensation structure to making a video displaying the company’s vision, mission and values. “There is no panacea for reducing turnover. It requires conducting a needs-based assessment, taking pieces of what we know works well in other companies and bringing that to the cannabis industry.” Making an employee feel like they are part of the team can help boost retention and keep turnover low.

One area they often help companies with is performance reviews. “Performance reviews are a big part of any business,” says Cassese. “You can’t make progress if you don’t know where you’re going. If you don’t know how you’re doing you can’t get better.” Looking at the supervisor level, they have often found employees have never given a performance review before. “We implement processes to teach them how to deliver positive or negative performance reviews and help make them feel comfortable delivering that,” says Cassese. They might have employees perform a DISC analysis (dominance, influence, steadiness and conscientiousness), a personality test akin to the Meyers-Briggs test. “From this we can help figure out the stressors and motivators of people and create effective teams,” says Cassese. “If an employee might be more outgoing or humble, high-spirited, results-oriented, analytical or good working on teams.” These are approaches to workforce management that have been adopted from Fortune 500 companies.

Caela Bintner, Co-Founder and Managing Director of Faces Human Capital Management

Cassese says one of the most overlooked items for companies are proper I-9 verification forms. This goes back to basic record keeping and documentation, but if overlooked, companies can get hefty fines for improper record keeping. “You are supposed to have a separate binder, in a separate locked drawer where your I-9 forms are housed, but a lot of people don’t know about that, which could come back to bite them in the form of large fines” says Cassese. “Businesses can’t afford to have sloppy record keeping. We help businesses take a look at their process and how they put their files in the cloud or physical locations, which is an area where companies often need guidance.” Civil fines can reach up to $20,000 for mistakes on I-9 forms.

Employee education is another crucial aspect of managing the workforce. Faces HCM has a learning management system that gives companies the ability to push education to their employees. Education is of course a broad term and can cover a wide variety of needs for employees. “We can help them take leadership, teamwork, excel, OSHA, safety classes and more,” says Cassese. “Training that shows you active listening, empathy skills and other types of training can really help budtenders deal with customers appropriately.” They have developed customized training programs for cannabis companies expanding beyond their own state too. “As you find certain cannabis companies growing in different states they want to create a repeatable, consistent and predictable experience,” says Cassese. “Putting those standard operating procedures online is important to streamline the process and ensures that you are creating a learning or education plan to meet your employees’ needs.” That can look like requiring employees to take an online course once every quarter, or offering them books on subjects pertaining to their specific job function.

Little things like improving the employee experience, implementing an education program and keeping up with employee records can make or break a business. They all add up to solid workforce management, which if done correctly, can enhance a business’ bottom line and keep employees working for you.

May 23, 2017

Implementing a HACCP Plan in Cannabis Processing

By Aaron G. Biros

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Hazard analysis and critical control points (HACCP) is a robust management system that identifies and addresses any risk to safety throughout production. Originally designed for food safety through the entire supply chain, the risk assessment scheme can ensure extra steps are taken to prevent contamination.

The FDA as well as the Food Safety and Inspection Service currently require HACCP plans in a variety of food markets, including high-risk foods like poultry that are particularly susceptible to pathogenic contamination. As California and other states develop and implement regulations with rigorous safety requirements, cannabis cultivators, extractors and infused product manufacturers can look to HACCP for guidance on bolstering their quality controls. Wikipedia actually has a very helpful summary of the terms referenced and discussed here.

The HACCP system consists of six steps, the first of which being a hazard analysis. For Dr. Markus Roggen, vice president of extraction at Outco, a medical cannabis producer in Southern California, one of their hazard analyses takes place at the drying and curing stage. “When we get our flower from harvest, we have to think about the drying and curing process, where mold and bacteria can spoil our harvest,” says Dr. Roggen. “That is the hazard we have to deal with.” So for Dr. Roggen and his team, the hazard they identified is the potential for mold and bacteria growth during the drying and curing process.

The next step in the HACCP system is to identify a critical control point. “Correct drying of the flower will prevent any contamination from mold or bacteria, which is a control point identified,” says Dr. Roggen. “We also have to prevent contamination from the staff; it has to be the correct environment for the process.” That might include things like wearing gloves, protective clothing and hand washing. Once a control point is identified, the third step in the process is to develop a critical limit for those control points.

A critical limit for any given control point could be a maximum or minimum threshold before contamination is possible, reducing the hazard’s risk. “When we establish the critical limit, we know that water activity below 0.65 will prevent any mold growth so that is our critical limit, we have to reach that number,” says Dr. Roggen. The fourth step is monitoring critical control points. For food manufacturers and processors, they are required to identify how they monitor those control points in a written HACCP plan. For Dr. Roggen’s team, this means using a water activity meter. “If we establish the critical control point monitoring, water activity is taken throughout the drying process, as well as before and after the cure,” says Dr. Roggen. “As long as we get to that number quickly and stay below that number, we can control that point and prevent mold and bacteria growth.”

One of the cultivation facilities at Outco

When monitoring is established and if the critical limit is ever exceeded, there needs to be a corrective action, which is the fifth step in a HACCP plan. In Dr. Roggen’s case, that would mean they need a corrective action ready for when water activity goes above 0.65. “If we don’t have the right water activity, we just continue drying, so this example is pretty simple,” says Dr. Roggen. “Normal harvest is 7 days drying, if it is not dry enough, we take longer to prevent mold or bacteria growth.”

The sixth step is establishing procedures to ensure the whole system works. In food safety, this often means requiring process validation. “We have to double check that our procedure and protocols work,” says Dr. Roggen. “Checking for water activity is only a passive way of testing it, so we send our material to an outside testing lab to check for mold or bacteria so that if our protocols don’t work, we can catch those problems in the data and correct them.” They introduced weekly meetings where the extraction and cultivation teams get together to discuss the processes. Dr. Roggen says those meetings have been one of the most effective tools in the entire system.

Dr. Roggen’s team identified worker safety as a potential hazard

The final step in the process is to keep records. This can be as simple as keeping a written HACCP plan on hand, but should include keeping data logs and documenting procedures throughout production. For Dr. Roggen’s team, they log drying times, product weight and lab tests for every batch. Using all of those steps, Dr. Roggen and his team might continue to update their HACCP plans when they encounter a newly identified hazard. While this example is simplistic, the conceptual framework of a HACCP plan can help detect and solve much more complex problems. For another example, Dr. Roggen takes us into his extraction process.

Dr. Roggen’s team, on the extraction side of the business, uses a HACCP plan not just for preventing contamination, but for protecting worker safety as well. “We are always thinking about making the best product, but I have to look out for my team,” says Dr. Roggen. “The health risk to staff in extraction processes is absolutely a hazard.” They use carbon dioxide to extract oil, which carries a good deal of risks as well. “So when we look at our critical control points we need to regularly maintain and clean the extractor and we schedule for that,” says Dr. Roggen.

Gloves, protective clothing, eyewear and respirators are required for workers in the extraction process.

“My team needs respirators, protective clothing, eyewear and gloves to prevent contamination of material, but also to protect the worker from solvents, machine oil and CO2 in the room.” That health risk means they try and stay under legal limits set by the government, which is a critical limit of 3,000 ppm of carbon dioxide in the environment. “We monitor the CO2 levels with our instruments and that is particularly important whenever the extractor is opened.” Other than when it is being opened, Dr. Roggen, notes, the extractor stays locked, which is an important worker safety protocol.

The obvious corrective action for them is to have workers leave the room whenever carbon dioxide levels exceed that critical limit. “We just wait until the levels are back to normal and then continue operation,” says Dr. Roggen. “We updated our ventilation system, but if it still happens they leave the room.” They utilize a sort of double check here- the buddy system. “I took these rules from the chemistry lab; we always have two operators working on the machine on the same time, never anyone working alone.” That buddy check also requires they check each other for protective gear. “Just like in rock climbing or mountain biking, it is important to make sure your partner is safe.” He says they don’t keep records for employees wearing protective gear, but they do have an incident report system. “If any sort of incident takes place, we look at what happened, how could we have prevented it and what we could change,” says Dr. Roggen.

He says they have been utilizing some of these principles for a while; it just wasn’t until recently that they started thinking in terms of the HACCP conceptual framework. While some of those steps in the process seem obvious, and it is very likely that many cannabis processors already utilize them in their standard operating procedures and quality controls, utilizing the HACCP scheme can help provide structure and additional safeguards in production.

November 16, 2016

Operational Inefficiencies in Commercial Cannabis Cultivation

By Drew Plebani

2 Comments

From the perspective of sustainable cannabis cultivation models, it seems clear that outside of the particular cultivation methodology adopted, that operational efficiency and the implementation of lean manufacturing principles will be necessary for successful and truly “sustainable” businesses, in the current, ever growing, cannabis space.

Implementing lean manufacturing principles as an integral part of the cannabis cultivation facility just makes sense- it is a manufacturing operation after all. From a lean perspective, doing away with the non-value-added costs in the supply chain and production model are quite important.

Let’s look at this case study as evidence for the necessity of operational efficiency:

A 300-light flowering, indoor cultivation facility in Colorado.

The system was purchased with ongoing pest/disease issues, recent updates to Colorado’s approved pesticide list, had prompted the implementation of an updated integrated pest management (IPM) program, which had been moderately successful in developing an albeit short-term solution to keeping ongoing root aphids, powdery mildew, and botrytis, to name a few, at bay.

This existing facility was producing roughly 60 pounds of trimmed cannabis per week, equivalent to almost $6M annual gross, however they were losing a percentage of their yields to product that did not pass Colorado’s contaminant testing requirements.

It is important to note that any deviation from the existing manufacturing schedule and system would create a change to the potential productivity of the system, for better or worse.

At the most basic level, one would hope that a new operator taking over an existing facility would analyze the system and implement incremental or perhaps major changes to create more efficient and profitable outcomes. That being said, currently the average grower likely doesn’t have much understanding of the lean manufacturing process. That will undoubtedly change.

When we look at basic manufacturing facility operations, on an annual gross potential basis, each daily task not completed on the existing manufacturing timeline is, at least, a 0.3% (1/365) loss in potential productivity. In monetary terms, for this particular facility, each 0.3% equates to a potential $18,000 in lost productivity.

The information that follows is taken from observations during the first week of this facility ownership transition and below is a generalized outline representing just one aspect of the operational inefficiencies (created or existing) that were observed :

Plant group A put into flowering 4 days behind schedule (4 days x 0.3%) =1.2%
Plant group B transplanted 3 days behind =0.9%
Plant group C transplanted 7 days behind =2.1%
Plant group D (clones) taken 7 days behind =2.1%
IPM applications not completed for 7+ days

That equals a 6.3% loss in potential annual productivity, which translates into a rough estimate of up to $378,000 in lost revenue.

Changes to the nutrient program in the midst of the plant’s life cycle had created nutrient deficient plants in all stages of vegetative and flowering growth, coupled with changes to the existing IPM program, all add to the potential losses incurred. Deviations in the plant nutrition program and IPM scheduling are hard to quantify mid-cycle, but will certainly be quantifiable when the hard numbers come home to roost.

These inefficiencies, once compounded, could potentially equal more than a 20% loss in potential productivity during the subsequent 3.5 month plant cycle. The current 60 pounds-per-week would likely be reduced for the next 2 months, down to roughly 50 pounds, or even much less, per-week. This could become a loss upwards of $500,000 in annual potential revenue in the first quarter of operation alone.

These seemingly small and incremental delays in the plant production cycle are all greatly compounded. The end result is that each subsequent cycle of plants is slightly smaller due to delays in transplanting and less days at maximized vegetative growth, etc. Undoubtedly, the cumulative effect of these operational inefficiencies creates a significant drop in the existing level of productivity, with the end result being a significant, undesired loss of revenue.

The sum of the lessons learned from this cultivation facility, is this: a sustainable operation, in the most pragmatic sense, is an efficient one both in terms of productivity and in terms of the carbon footprint and waste generated. The more streamlined and successful the operations are, the greater likelihood of success. Perhaps all of this is to say don’t forget about all the little parts that make up the whole, and strive to create a work environment/corporate culture that empowers your employees, your managers and all involved to participate and contribute to the process of improving the operations for mutual benefit.

Lessons learned from the aerospace manufacturing industry: Even the smallest zip tie on a spaceship matters! Some food for thought: If it’s truly beneficial it should stick around… If it is beneficial and it’s not sticking around, then there are limiting factors in the system that need to be addressed.