I’m not quite sure how to put this, but… we’re kind of a big deal.
In case you didn’t see it, Qualtrax recently had an article published in Cannabis Science and Technology, a leading scientific journal in the industry, articulating the challenges facing cannabis testing labs – specifically those pursuing ISO/IEC 17025:2017 accreditation.
We interviewed Julie Taylor, CEO of Northstar Scientific Solutions, a cannabis analytical lab development and consulting firm based in Denver, and Matthew Sica, accreditation manager with ANAB, to get the low down on what labs should be doing to prepare for accreditation and how to avoid some of the common pitfalls that newly-accredited labs face. Turns out that Kermit the Frog was right when he said, “It’s not easy being green.”
You can read the full article HERE, but since you’re already here, I’ll share some of the highlights with you.
Despite a loud cry of support for legalization from the majority of Americans – between 62-84 percent, depending on which poll you look at – cannabis remains on the list of Schedule I (i.e. illegal) substances on the federal register.
Currently, the regulation of the cannabis industry is occurring at the state level, meaning there is no overarching, national standard for monitoring quality or testing procedures. However, many states are looking toward ISO/IEC 17025:2017 as a requirement for cannabis testing labs under their jurisdiction.
As the industry grows, the spotlight is shining brightest on the testing labs. While some organizations are keeping their testing in-house, building labs on site, the majority of these labs are unaffiliated third parties – helping ensure transparent and unbiased evaluation of cannabis products.
One of the primary challenges the industry faces is the relative inexperience of the average employee in the cannabis space. As much as 80 percent of the current workforce is new to the industry – many do not even have a degree in science. The demographics tend to skew younger, so there are a lot of people who don’t have much practical work experience in general, much less in a regulated laboratory environment.
This can pose a significant obstacle for labs aspiring to the rigorous standards set forth in ISO 17025. Without a clear understanding of the complexity of the standard, quality personnel can underestimate the time, people and resources needed to design their processes and get the lab up and running. This can delay accreditation, as well as production timelines and profits!
The myriad requirements of ISO 17025 extend far beyond proficiency testing. New labs not only have to prove proficiency, but they must also show how they achieved it – think SOPs and Work Instructions. They must keep detailed records of these documents, among others, including when they were last updated, what changes were made, and why the update was required. They must document and validate their methods, ideally from a compendial source like USP or ICH, keeping in mind that one source of method validation may not fit all types of matrices.
Every step of this process must be documented. Labs must be able to identify risks, as well as track and monitor corrective actions, subsequent cause analysis and record the solutions that are put in place. All of these requirements are wrapped in the bow of continuous improvement – the heart of the standard.
In short, new cannabis labs and those pursuing ISO 17025 accreditation for the first time have a significant amount of work ahead of them. Many of these labs are starting out with a tight budget and a small head count of two to four employees. Lucky for you, Qualtrax is here to help.
According to Julie Taylor, implementing a QMS system as soon as possible can save a significant amount of time. Imagine starting with a list of 70-80 documents and SOPs that you know you need. If you are tracking them in a spreadsheet, you will quickly lose track of which version is the most current. You’ll have different people working on the same version of a document and then sending two separate versions back for approval. In short – it can get messy very quickly and your assessors will not be very forgiving.
Using Qualtrax, you can think about what processes you need to meet your compliance and develop your SOPs simultaneously – designing workflows that mimic your SOPs so you’re only writing them one time. When you create your processes independent of a QMS, you will ultimately have to go back and re-write your SOPs to match what you’re actually doing in the lab. By using Qualtrax to develop your SOPs from the beginning, you’ll save yourself one or two revisions and process development for everything.
In addition to helping you automate processes and eliminating paper in your lab’s compliance equation, Qualtrax serves as a central data repository, organizing and securing your documents, as well as tracking all changes. This helps ensure your audit runs smoothly and that your team always knows which is the most current version of a given SOP or work instruction. You can also manage testing and training for your employees through the system to prove competency.
Once you’re up and running, you don’t have the time to revisit your documents. Your priority becomes generating revenue, not document development. Implementing the organization and structure provided by Qualtrax right from the beginning saves so much time, and not just from a documentation perspective, but with your audit as well. When you’re going through your audit for ISO 17025, everything is organized, it’s easily accessible, you can run reports on all of your documents because they’re all centrally located, so it saves time on that front as well.
Many labs elect to hire a consultant to help walk them through the accreditation process, helping them understand what the regulations in ISO 17025 say and how to apply it to what’s actually being done in the lab. The standard is written fairly vague, so figuring out how each section applies to the day-to-day processes in the lab is something that people without experience in a regulated lab can have a difficult time doing. A consultant can prove invaluable when it comes to navigating compliance, evaluating instrumentation and other aspects of the process.
However, it’s critical for labs to be very thorough in their evaluation of potential consultants. There are charlatans and snake-oil salesmen in every industry, and in an industry growing as quickly as cannabis, there are people out there trying to capitalize. When evaluating potential consultants, make sure he or she truly understands the international requirements and interpretations of the standard. Choose someone who has worked in the ISO world – not just someone who’s set up their own lab and then turned to consulting.
A consultant who is not familiar with the ISO system can have problems trying to interpret the requirements for method validation, traceability and ensuring quality. If you’re going to spend the money, make sure your consultant is worth it.
Make sure you look beyond the perceived adversarial relationship with your accrediting body and assessors. They’re actually there to help you! Your accreditation manager won’t provide direct consultation, but they will either provide guidance or sources where you can get the information you’re looking for. Ideally, they see themselves as a resource and part of your lab’s improvement process and they hope you will see things the same way!
If you have more questions about the Qualtrax platform and how it can be an asset in helping your cannabis lab achieve ISO 17025 accreditation, please contact us! We’d be happy to answer your questions and show you a personalized demonstration of our solution. If you’d rather meet in person, please visit us at Emerald!