The Importance of Internal Audits for Cannabis Testing Laboratories

An internal audit is a kind of self-assessment conducted to identify critical issues and helps determine the effectiveness of a laboratory’s risk management capabilities. Internal audits provide insights into a laboratory’s culture, operations, and compliance with applicable laws and regulations. The data is precisely analyzed in internal audits to provide recommendations for improvement.

It is essential to conduct an internal audit if your laboratory is preparing for a third-party audit. An internal audit is instrumental in identifying the operational gaps, minimizing the chances of failure. An internal audit provides you an opportunity to check audit preparations before an external assessor arrives at your facility. An internal auditor, or an auditing team, should conduct an audit impartially, keeping in mind the requirements of an external audit. Conducting an internal audit also makes laboratory managers more mindful of the loopholes that an external auditor may identify, enabling laboratories to work on the areas of improvement.

Few benefits of internal audits for cannabis testing laboratories are as follows:

• Ensure compliance with industry standards, statutory and regulatory requirements, such as ISO 17025:2017, 21 CFR part 11, GLP, and state and local regulations.
• Prevent expensive mistakes and improve operational efficiency.
• Determine if the QA/QC processes implemented are effective in generating accurate and repeatable results.
• Be better prepared to answer the questions of external auditors and face them with confidence.
• Determine the effectiveness of the quality management system in place.
• Determine if laboratory staff members follow pre-defined standard operating procedures (SOPs).

An internal audit is typically done under a CAPA (Corrective and Preventive Actions) program. CAPA is a part of the quality management system which controls and detects errors in laboratory processes so that corrective measures can be taken to prevent their recurrence. The CAPA program enables you to thoroughly investigate and determine the root cause of potential issues. It allows you to record customer complaints and aids in continuous improvement. An effective CAPA program enables laboratories to pinpoint the factors responsible for cross-contamination, such as improper environmental controls, poorly designed laboratory infrastructure. High-quality laboratory supplies are imperative for generating accurate test results. A CAPA program enables cannabis testing laboratories to monitor the performance of suppliers to determine if they are consistently meeting the specified requirements. Ideally, cannabis testing laboratories should procure supplies from vendors certified to specific standards.

Role of a Cannabis LIMS in Internal Audits

A laboratory information management system (LIMS) facilitates not only external audits but also internal audits. A LIMS maintains a read-only audit trail to track all laboratory activities along with a date and time stamp and other details, such as who made the change, the reason for making the change. A LIMS maintains ongoing training and competency records of analysts and helps assign analytical tasks only to the competent staff, assuring the accuracy of test results. A LIMS enables cannabis testing laboratories to record customers’ complaints and corrective and preventive actions taken for non-conforming activities. A LIMS automates enforcement of SOPs, maintains a decisive chain-of-custody to track sample custodians through the sample lifecycle, and manages suppliers and laboratory inventory. A LIMS manages all internal and external documents such as validated standard test methods, drawings, manuals and ensures version control. A Cannabis LIMS ensures timely calibration and maintenance of instruments, records calibration results, and flags instruments that are unsuitable for analysis. Furthermore, a LIMS automates laboratory processes to reduce human errors and flags samples that fail testing.

Conclusion

Cannabis testing laboratories should plan and conduct internal audits from time to time to identify potential drawbacks in their operational workflows. Internal audits are time-consuming and resource-intensive, however; they offer innumerable benefits. A successful internal audit ensures standardization of processes and increases the chances of surviving external audits. To prepare your cannabis testing laboratory for an external or third-party audit, you should prepare an audit checklist and conduct an internal audit to understand if there are any gaps between your current processes and the requirements of the standard, such as ISO/IEC 17025:2017. Cannabis testing laboratories should implement automated systems, such as a LIMS, to digitally manage samples, test results, SOPs, staff training records, certificates of analysis (CoAs) and increase operational transparency. A Cannabis LIMS saves significant time and minimizes transcription errors. A successful audit calls for effective preparation, a good quality management system, trained laboratory personnel, and foolproof processes.