This tutorial article outlines some of the steps that cannabis testing laboratories can take to prepare ahead of a third-party safety audit. It discusses several practical measures that facilities can take to boost their chances of passing an audit, including advice on time management, essential employee training, and laboratory management systems that can ensure a smooth and seamless audit process.
Step 3: Focus on Teamwork
Preparing for a third-party audit is a large undertaking, especially if this is the first audit a laboratory has had to prepare for. Having a quality or a compliance manager who is responsible for overseeing and directing audit preparation can be of great help.
However, to maximize the chance of performing well in an audit, it is essential to work in a team with the support of management. Passing the first third-party audit or achieving a first independent accreditation requires significant resources, and so having the committed support of those in high-level managerial positions ensures there is sufficient manpower, equipment, and financing behind the effort.
Supportive management will also make it easier to implement staff training and awareness programs, which are essential to ensure quality. To ensure that testing laboratory results are valid and reliable, it is important to have staff who have received proper training and hold the necessary qualifications to carry out their job role effectively. Similarly, to ensure quality and good performance in an audit, it is important to make sure that all staff are well trained and aware of what will be expected of them when operating at this standard.
It may also be advisable to do extra preparation work with staff who will be interacting with the auditors, to ensure that they feel comfortable confidently answering questions about the operation of the testing laboratory in a formal and professional manner—an employee answering with “normally, what we do is…” might leave an inspector with the impression that these quality standards are not normally kept to.
As well as questioning the present operation of the laboratory, the auditor may also ask questions about why a laboratory does not carry out a certain test or test method. In this case, employees should be able to defend these choices using their training, knowledge, and understanding of the laboratory’s goals and capabilities.
Step 4: Have an Internal Audit
Once all documentation is prepared and all laboratory operations are brought in-line with the requirements of the department or accreditation body, the next step in ensuring a successful third-party audit is to carry out an internal audit.
The internal audit is an opportunity to make sure that all audit preparations can be reviewed and deemed acceptable before bringing in an external assessor. In an ideal circumstance, the person or team conducting the internal audit should not be reviewing their own work, to make sure that all parts of the laboratory’s operation are assessed with fresh eyes. Ideally, the internal auditor, or auditing team, should work from a copy of the official audit checklist. This helps to ensure that the internal audit holds the laboratory to approximately the same high standards as the third-party audit when reviewing documentation and inspecting the laboratory apparatus.
The internal audit is also a good opportunity to plan and walk-through the laboratory tour. It is advantageous to know in advance where in the laboratory would be best to stop and discuss with the auditor about the instrument calibration or operation methods being used. Walking the route also helps in making the team more mindful of what might be visible to the final auditor and shed light on restructuring badly organized shelves.
Once the route is decided, it is also advisable to make a note to empty all bins (both physical laboratory bins, and the trash folder on laboratory computers) on the route. It is not unknown for auditors to inspect the contents of paper bins (5) to check for batch records or certificates that have been disposed of before the inspection.
Step 5: Consider an External Preassessment
A less essential—but still beneficial—step in preparations is to consider whether the laboratory would benefit from a third-party preassessment or a mock audit.
There are a number of external consultancy firms who offer audit services for laboratories and other facilities who are preparing for an upcoming regulatory inspection. External preassessment mock audits have several additional advantages to an internal audit. Firstly, the consultant mock auditors bring a wealth of experience in carrying out audits and may be able to spot deficiencies that a less experienced internal inspection team might miss. Additionally, the act of bringing in an external presence to the laboratory—even though it is not the official audit team—could intensify the seriousness of employees that are involved with the mock audit. This can work as a practice session for employees to answer questions from an auditor, and correct gaps, if any, to be filled in employee training.
ISO/IEC 17025:2017 accreditation is becoming increasingly significant for cannabis testing laboratories to demonstrate their technical competency. To prepare your cannabis laboratory for an ISO/IEC 17025 audit by an accreditation body and to get successfully accredited, the cannabis laboratory should obtain an audit checklist and conduct an internal audit to understand if there are any gaps between their systems and the requirements of the standard. Additionally, cannabis testing laboratories should implement quality management systems such as a LIMS to manage documents, training, changes, inspections, nonconformance, and corrective actions, which save significant time of the laboratory staff and in turn, avoid costly mistakes. The success of an audit depends on adequate preparation, the effectiveness of the quality management system, and the laboratory personnel’s training and experience as well as the overall efficiency of processes.
- A. Beadle, Analytical Cannabis, (2019), https://www.analyticalcannabis.com/articles/maintaining-regulatory-compliance-in-the-cannabis-lab-311940.
- Colorado Department of Public Health and Environment, “Inspection of marijuana testing facilities,” https://www.colorado.gov/pacific/cdphe/inspection-retail-marijuana-testing-facilities.
- Clinical Lab Products, “Exploring Risk Management in the Lab,” http://www.clpmag.com/2016/05/exploring-risk-management-lab/.
- CloudLIMS, “Preparing for an ISO 17025 Audit: What to expect from a LIMS?”, https://cloudlims.com/blog/preparing-for-an-iso-17025-audit-what-to-expect-from-lims.html.
- Agilent, “Laboratory Audit Preparation,” https://www.agilent.com/cs/library/slidepresentation/Public/Laboratory%20Audit%20Preparation.pdf.
About the Author
Arun Apte is the CEO of CloudLIMS in Wilmington, Delaware. Direct correspondence to: [email protected]
How to Cite This Article
A. Apte, Cannabis Science and Technology 3(1), 52-55 (2020).