Audit. The one word that strikes fear in many a clinical trial professional’s hearts. While we have the IRS to thank for giving the word “audit” a bad name, it doesn’t have to be scary or sinister. It’s common knowledge that part of any compliant Quality Management System (QMS) in the clinical trial space involves the implementation of Internal Audits. It should be QMS 101 in any industry to review internal processes and ensure that policies and procedures are being followed correctly. However, it doesn’t need to be a painful process, and it doesn’t always have to be a negative experience. There really can be a silver lining – improvement.
- Prepare. Like anything in life, preparation for an internal audit is crucial to its success. Creating a plan or agenda to define the scope and objectives of the assessment will ensure that risk evaluations are comprehensive. This includes the review of prior audit findings if there are any. Preparation can give an overhead view of improvement over time, which is valuable for continuous improvement efforts.
- Objectivity & Communication. Both the Auditor and the Auditee are simply doing their respective jobs. Nothing should be taken personally in the context of an audit. Once this realization is met, increased productivity and improvement can happen. An Internal Audit is a perfect time to pitch process improvements or policy changes that can help all workgroups or employees, or even make your product better. These types of suggestions inevitably make the company better as a whole.
- Follow-up. If issues do arise during an Internal Audit, proper monitoring is crucial to the improvement process. Whether it be the completion of activities in a CAPA, or an update to a policy, without following through – change can’t happen.
Completing successful and meaningful Internal Audits is a large part of Datatrak’s compliance QMS. Without them, our external audits with Clients would fail miserably. We would flunk every GxP review out there. So, sure, every company needs to maintain oversight of internal processes, but surveillance without improvement in some capacity is completely meaningless. Indeed something can always be gleaned from a review of your team’s inner workings. Even if the only improvement is a better understanding of where your cog fits into your company’s machine, that’s an Internal Audit win.
-Amy L. Boukair, CQIA
Director, Quality Assurance @Datatrak