Making a Technical Specifications Manual for Cannabis Analysis
When a client turns to a lab for analysis, the contract should include a Technical Specifications Manual (TSM). As Shannon Swantek, a senior quality chemist at Environmental Standards/Vitale Scientific Associates, explains, the TSM should “detail client expectations so that the laboratory can understand the sensitivity, precision and accuracy needed for each type of test.” The details of a TSM depend on how the lab data will be used. Still, a TSM should detail the overall expectations of the client, including the desired data accuracy and precision.
In a TSM, the details really matter, because it should be tailored to the project at hand. “The key features of the TSM are special requirements for how the service is to be conducted,” Swantek says. This should include “the analytical method options a laboratory is to apply, the detection limits required, the percent recoveries for quality-control samples, the percent recoveries for actual samples spiked with the test compound, the definition of how clean a blank sample needs to be, the method options for validation of the method in the laboratory, the minimum actions required when specific things go wrong, the content of the report, the format and units for the results, the QC results that are to be reported with the sample results, the turnaround times required and much more.”
As a relatively new industry, cannabis companies don’t always know their data needs. So, Swantek says, “TSMs were developed as a specific product of Environmental Standards, the parent company of Vitale Scientific Associates (VSA).”
The main reason for a TSM is that a client can use it to determine whether a lab is providing the agreed upon services. “The client does not have to become, for example, a laboratory expert to enforce expectations, and the client has a personalized resource for looking up what the vendor should be doing,” Swantek explains.
When contracting with a lab for analysis, Swantek encourages companies to combine a TSM with third-party laboratory audits and data validation. “These client audits can occur before the contract is signed as a way of determining the lab that bests fits the client’s needs—such as a readiness assessment—or they can be performed once the contract is in place to verify whether the client contract is being fulfilled,” she says. “While accreditation bodies can only audit to the accreditation standards, third-party companies, like VSA, can audit to specific client requirements that are clearly communicated in the TSM.” These advanced approaches to testing can increase the quality of analysis in the cannabis industry.
Having served as the director of the cannabis program at the Oregon Environmental Laboratory Accreditation Program, Swantek understands the challenges of testing. “I’ve witnessed the industry struggle to understand how to work with the laboratories and develop trust in their data,” she says. “My strongest hope for the industry is that the labs will soon be able to come up to good practice as it pertains to reporting quality control, such as duplicates to assess precision and blanks to assess any ‘external’ contamination introduced in testing.” She adds, “This information is invaluable in determining the ‘usability’ of the data, which is determined following validation.”
To keep the cannabis industry on par with other regulated industries, companies will need to turn to some of these tools that keep track of analysis, how it is performed and how it can be used.