I recently had the opportunity to receive some training in auditing of medical device companies. In this training I was able to gain experience from an auditor's perspective as well as an auditee's perspective on how an audit is performed. This training was important to me because auditing is a huge part of the regulated medical device industry whether it is internal audits, audits from notified bodies or the FDA coming in and auditing products and processes. One of my goals during the training session was to see from both the auditor and auditee's perspective how questions are asked and then answered as well as what specifically an auditor looks for and how they write up findings or observations.

The training was great because it involved starting an audit from scratch. This involved creating an initial plan for the audit, an outline/checklist of what would be covered during the audit and how that related to the relevant standards and then the execution and report writing of the audit.

Before the training, I was really hoping to learn more about how an audit flows and the communication skills that are necessary in order to create a good environment during an audit. One important thing that I did learn was that the intent of the audit is never to find flaws in a company or a person being audited. It is always to verify compliance and that might result in finding areas for improving compliance. I think this perspective is very important because it helps improve the safety and effectiveness of the devices used on patients and it is for the greater good. The next steps in my training will be to participate as an auditor or to perform an audit on my own. I will gain valuable experience in how to audit different medical device companies. Does anyone have auditing experiences of their own? Any tips on how to perform better audits?

--Jillian F. Walker

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