R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


5 Reasons Not to Fear a Supplier Audit

The following post is written by R&Q Senior Engineer, Michelle Mahoney.

One of the toughest things to experience when walking in to audit a company is the tension, anxiety, and fear emanating from those in the room. Taking a look around the room, I notice heads are turned away, eyes are up counting the ceiling tiles, and no one will even make eye contact with me. I already felt like an outsider walking into this company alone, but now I feel it even more so. I realize it's up to me to break the ice and try to settle the nerves of everyone in the room.

"So how 'bout them Red Sox?"

Ok, there's a smile. A chuckle. Some eye contact. Success!

...alright, so that only works when I’m in New England... but you get the idea. 

It's really up to me, as the auditor, to set the mood of the audit within the first few minutes of walking through the door. As much as I hope that the company will be comfortable and relaxed with hosting an audit, there are almost always nerves and anxiety running wild.

One potential reason? The auditees feel the pressure to have a successful audit because if they don't, top management might have a word or two about it. But what the auditees need to realize is that there is nothing to be scared of, and here's why.

Audit Training

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.

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