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Third-Party Cannabis Safety Audits & How to Prepare in 7 Steps

By Tyler Williams
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Unlike the food industry, the cannabis industry is still in its infancy. Which means there is not a push from retailers demanding cannabis farmers, extractors or manufacturers to get third-party audits. In fact, most grow operations supply into their own dispensaries. So why should a cannabis farmer, extractor or manufacturer get a third-party audit? Third-party audits are crucial to maintaining product safety and quality by providing a third set of eyes to verify what is working and what is not. Besides regulatory requirements and customers requiring your facility to get a third-party audit, there are numerous other benefits to receiving an audit. Some of these benefits include:

  • Improvement to product safety
  • Improvement to product quality and consistency
  • Meeting regulatory compliance
  • Eliminating potential risks and possible recalls
  • Marketing advantages over competitors who are not audited by a third-party
  • Improvement to consumer confidence and an increase to brand loyalty

How to Prepare for a Third-Party Audit

Working for a certification body, I am in the unique position to see numerous sites go through the certification process. In this position I have seen both extremes: Sites that spend 6-8 months and a lot of resources preparing for an audit, as well as sites that wait until the day before to even look at the audit standard. Unfortunately, the latter is almost always going to fail the audit. Here are seven steps for preparing for your next third-party audit.“By failing to prepare, you are preparing to fail.”– Benjamin Franklin

  1. Start Preparing Early

Think of your third-party audit as a college exam one month away. You could start studying for the exam now and get a real understanding of the material or you could wait until the day before to start your no-sleep, energy drink-fueled, 24-hour cram session. We all know which preparation method will get a better score on the exam. Now let’s apply that same strategy to your third-party audit. Once you have decided what audit is best for your site and have those specific standards in your hand, the clock starts ticking and you should already be preparing for the audit, whether it is one month or six months away.

  1. Get Management Commitment

It is essential to the entire cannabis safety and quality system to have commitment from top down. Without this, the site will not get the resources (people, equipment, money, time, etc.) they need to pass a third-party audit. Management commitment is so important that it is often seen as its own section in most modern audit standards. It is very easy for third-party auditors to identify when there is a lack of management commitment in a site. Therefore, if you don’t get management commitment, then you are already starting off the audit on a bad note.

  1. Create a To-Do-ListGMP

Think of the entire audit checklist or standard as your long to-do list. Some things, like attaining a certificate of analysis (COA) from a supplier, may only need to be done annually. While other things, such as ensuring employees are following Good Manufacturing Practices (GMPs), will need to be done continuously throughout day to day operations. Go through the audit checklist and separate what needs to be done annually, semiannually, quarterly, monthly and continuously throughout day to day operations. This will give you a list with all of the frequencies of each different requirement.

  1. Teamwork“Teamwork makes the dream work, but a vision becomes a nightmare when the leader has a big dream and a bad team.” – John C. Maxwell

The preparation of an audit should never rest on the shoulders of one person. Yet this is something I tend to see too often in both food and cannabis facilities alike. Your site should establish a cannabis safety and quality team of multidiscipline personnel that have an impact on product safety and quality. Once the team is established, various tasks from the to-do-list can be disbursed among all the members of the team. Collaboration is key to successfully preparing for a third-party audit, especially when the timelines are very stringent.

  1. Training

Training is essential to preparing for your third-party audit. This is what closes the gaps between what the safety and quality department have developed and what your front-line employees are applying. All employees should know what part of the audit standard applies to them. Additionally, employees should be trained on interview questions that the auditor might ask them during the audit. Helping them prepare for these types of questions will help ease their nerves and allow them to answer the questions with self-assurance when it comes time to the actual audit.

  1. Conduct Internal Audits

Conducting internal audits is not only a great way to prepare for your third-party audit, it’s a requirement. You should always use the audit checklist to observe your documents and facility to see where there are gaps. If possible, the person or team conducting the internal audit should never review their own work. Additionally, all issues or non-conformances should be noted, evaluated, corrected and closed out.

  1. Third-Party Pre-Assessment or Mock Audit (Optional)

A third-party pre-assessment or mock audit is the closest thing you can get to an actual audit. This is where a company would come in and evaluate your site to the specific standards and give a formal report over any deficiencies found during the assessment and how to fix them. This is a great way to test your preparedness before the actual audit.

Digipath Labs Now ISO 17025:2017 Accredited

By Aaron G. Biros
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According to a press release published in December, Digipath Labs, based in Las Vegas, Nevada, was recently accredited to the updated ISO standard, ISO 17025:2017. The laboratory received their accreditation from Perry Johnson Laboratory Accreditation (PJLA).

ISO 17025:2005 has long been the standard that labs seek accreditation to, but their newest 2017 edition was recently rolled out and introduced to the market. The new 2017 standard includes some broad changes to terminology, process approach, scope, and it importantly introduces the concept of risk-based thinking.

That concept of risk-based thinking is particularly relevant to the cannabis testing market, where many have argued for more transparency and uniformity in different state regulations and markets. Introducing risk-based thinking in the standard means that assessors also look at the risk of bias, impartiality and assessing measurement uncertainty, which certainly adds a layer of subjectivity to the accreditation.

PJLATracy Szerszen, president/operations manager of PJLA, says the newer standard also includes a provision for a quality management system review among other changes. “We are making sure they are following the standard from a technical standpoint, meaning they have the right equipment, the appropriate personnel and also have a quality management system,” says Szerszen. “November 29, 2020 is the deadline for moving to the new 2017 standard.”

According to Todd Denkin, CEO and founder of Digipath, obtaining the new ISO accreditation poises them for future growth and expansion. “Digipath Labs has now brought its standard of excellence in cannabis testing under the updated ISO-17025:2017 umbrella as we seek to expand our dominance in cannabis testing markets,” says Denkin. “This is a major step in positioning Digipath as a global leader in testing services.”

Designing Your Continuing Cannabis Education Program

By RJ Starr
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As many states’ medical cannabis programs are already in full swing and several are launching or nearing their one-year or biennial maturation periods, medical cannabis dispensaries and cannabis cultivation and processing facilities should be fine-tuning their Continuing Cannabis Education Program, or CCEP, and be ready for inspection by state agencies.

While states with medical cannabis programs administer them through various agencies such as Department of Medicine/Health, Department of Pharmacy, Department of Commerce, Alcoholic Beverage Control, each has their own minimum requirements for continuing education in the medical cannabis space, and each structures their program in the direction within which that particular regulatory agency leans. Each state’s personality also brings an influential component as well; for example, a state with a highly visible opioid crisis may place greater emphasis on substance abuse training.

Suffice it to say that while there is certainly insight to be gained from knowing your particular state, there are certain elements of an ongoing professional development program that should be considered in each CCEP. This article will explore a few of the elements integral to any successful human capital and professional development plan from a vantage of compliance, and will offer some insight into the exceptional training methodology designed by Midwest Compassion Center and Bloom Medicinals.

There are a number of key considerations in developing a Continuing Cannabis Education Program, and a thoughtful CCEP should be developed specifically to meet the needs of both the organization and its employees. This can be done by a needs assessment consisting of three levels: organizational, occupational, and individual assessments.

  1. Needs assessment and learning objectives. This part of the framework development asks you to consider what kind of training is needed in your organization. Once you have determined the training needed, you can set learning objectives to measure at the end of the training.
    1. Organizational assessment. In this type of needs assessment, we can determine the skills, knowledge and abilities our cannabis dispensaries need in order to meet their strategic objectives. This type of assessment considers things such as changing laws, demographics and technology trends. Overall, this type of assessment looks at how the organization as a whole can handle its weaknesses while promoting strengths.
    2. Occupational (task) assessment. This type of assessment looks at the specific tasks, skills, knowledge and abilities required of our employees to do the jobs necessary within our dispensaries.
    3. Individual assessment. An individual assessment looks at the performance of an individual employee and determines what training should be accomplished for that individual.
  2. Consideration of learning styles. Making sure to teach to a variety of learning styles is important to development of training programs.
  3. Delivery mode. What is the best way to get your message across? Is classroom or web-based training more appropriate, or should one-on-one mentoring be used? Successful training programs should incorporate a variety of delivery methods.
  4. How much money do you have to spend on this training? This does not only include the cost of materials, but the cost of time. Consideration should also be given to the costs associated with not investing in training: CFO asks CEO, “What happens if we invest in developing our people and then they leave us?” CEO: “What happens if we don’t, and they stay?”
  5. Delivery style. Will the training be self-paced or instructor led? What kinds of discussions and interactions can be developed in conjunction with this training? The delivery style must take into account people’s individual learning styles. A balance of lectures, discussions, role-playing, and activities that solidify concepts are considered part of delivery style.
  6. Audience. Who will be part of this training? Do you have a mix of roles, such as accounting people and marketing people? What are the job responsibilities of these individuals, and how can you make the training relevant to their individual jobs? The audience for the training is an important aspect when developing your CCEP. This can allow the training to be better developed to meet the needs and the skills of a particular group of people.
  7. Content. What needs to be taught? How will you sequence the information? The content obviously is an important consideration. Learning objectives and goals for the training should be established and articulated before content is developed.
  8. Timelines. How long will it take to develop the training? Is there a deadline for training to be completed, and if so, what risk analysis can be used to determine the consequences of not meeting that deadline? After content is developed, understanding time constraints is an important aspect. Will the training take one hour or a day to deliver? What is the timeline consideration in terms of when people should take the training?
  9. Communication. How will employees know the training is available to them? Letting people know when and where the training will take place is part of communication.
  10. Measuring effectiveness. How will you know if your training worked? What ways will you use to measure this? The final aspect of developing a training framework is to consider how it will be measured. At the end, how will you know if the trainees learned what they needed to learn?

A thorough review of your state’s rules and regulations should take place quarterly, with one or more specific employees designated to stay abreast of changes. If your regulatory authority has implemented requirements that trainings must be approved in advance, know that as well, and keep your Continuous Cannabis Education Program up-to-date and ready for inspection.