Analytical testing is often regarded as an important requirement in terms of health and safety for consumers. It is often seen as part of the checks and balances that help build trust between the consumer, the industry and governing bodies. Deficiencies in this system can have serious consequences. For example, the use of non-specific methodologies for measuring protein in milk in China eventually led to the melamine-spiked milk scandal. The Hinton Drug Lab scandal, where a lab technician was found falsifying results, led to the dropping more than 20 000 judiciary cases and the release of more than 300 individuals from prison due to wrongful convictions. Closer to home, the Bre-X scandal in the late 90’s was also caused by lab results being falsified, creating one of the largest stock scandals in Canada.
Each of the cases cited above differ in the scope at which analytical testing was involved, but each case had an underlying financial motive, whether it was to increase the value of a product, such as with the milk scandal, increase the value of a business, such as with the Bre-X scandal, or to increase the value of oneself, such as with the Hinton Drug Lab scandal. Each case also highlighted accreditation and its importance in the system of checks and balances put in place to regulate and level the industry playing field.
The Bre-X scandal brought new regulations in Canada that require labs doing analytical testing to establish the potential value of a mining site to be ISO 17025 accredited. In the case of other industries, such as pharmaceuticals, drinking water, and environmental testing, this requirement has already been in place for a longer period. In Ontario, drinking water testing labs have needed to be accredited since the Walkerton report in 2003. In Québec, accreditation has been required to do environmental testing since 1985. Pharmaceutical laboratories have been required to be accredited for even longer due to their direct impact on human health.
Currently, the cannabis industry has no such requirement.
The main goal of accreditation is consistency. It ensures that the service provider has put in place systems and tooling that allow it to produce consistent results. To achieve this, they need to be able to have written procedures, tools to track potential problems, and methods to address them. Laboratory accreditation also has an additional requirement with specific implication: proficiency.
A very important thing to be aware of regarding laboratory accreditation standards such as ISO 17025 is that they have a limited scope. Accreditation does not cover all activities and results given by the laboratory, but only the methodologies that are listed under its scope of accreditation. The reason for that is, to be accredited for a methodology, the laboratory must demonstrate that it has a good understanding of the work it does, and that the results it generates are consistent with the results given by other laboratories. This is very important: since the results given by the lab can have an impact on the value of a product or a project, there are economic incentives to wish for a higher or lower value.
Passing regular proficiency testing challenges means that a lab has demonstrated that its results are in line with the average.
Part of this requirement can be satisfied through proficiency testing. Proficiency testing is a comparison method where a third party, itself accredited for this kind of work, will send identical samples to participating labs with no specification regarding their composition. Labs are then requested to anonymously submit their results which are then statistically evaluated. Labs receive a pass or fail mark based on the results given. While the exact calculation for this mark is a bit complicated and may depend on each test, it is roughly equivalent to the standard deviation of the lab’s results compared to the mean. To pass, results need to be within less than 2 standard deviations from the mean, and ideally as close as possible to the center. Proficiency testing is used to determinate “how average” a laboratory is in term of results, which is very important to demonstrate consistency. A failure mark means that the root cause of the failure needs to be identified and addressed, and sometimes further actions are to be taken. If you are interested in learning more, check out the following article: What Happens When a Lab Fails PT?
Historically, for the Cannabis industry, this kind of testing was difficult to do because of regulations around the transport of cannabis. The complexity of legally transferring material was a large hindrance for developing methods and ensuring that results were accurate across laboratories. This is no longer the case. Since 2019 there have been proficiency test rounds in Canada at least once every year. While being ISO accredited is not a requirement for participating in proficiency testing rounds, the ISO 17025 standard requires proficiency testing as part of its accreditation. Passing regular proficiency testing challenges means that a lab has demonstrated that its results are in line with the average.
For a laboratory, the accreditation process is first and foremost a self-introspection tool. It forces a business to put in place a culture of self-improvement by requiring reviews and audits of its process to identify potential problems and correct flaws. For a third-party partner, accreditation is a sign that the company has been able to demonstrate that they are in control of their workflows. This is a part of the system of checks and balances ensuring that everyone is adhering to the same consistency goal.
These accreditations are not foolproof: error, omissions, rogue actions, and corruption can still happen. How strong the written procedures are enforced internally will vary based on the company culture. While this process is an important part of the trust relationship between a lab and its customers, it is still important to have further checks to ensure that no collusion occurs that would defraud someone down the chain. These checks need to come from a governing body. And governing bodies must have tools in place to monitor and respond to potential fraudulent situations, both to protect the economical interests of industry participants and to protect the health and safety of the population.
If you compare the cannabis industry to other industries previously mentioned, it is easy to notice that the cannabis industry is a lot younger, with a lot less history. Most regulations are implemented in response to identified problems, sometimes following scandals or other major events. It is important for the industry to identify potential problems and discuss them with regulators before they become too important to miss.
Hubert Marceau, Chemist.
C45 Director
Directeur du Développement
Laboratoire PhytoChemia
