medical device 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.

1. Top management is responsible for the success of the Quality Management System (QMS).

Their involvement is becoming a bigger focus in the regulations and it is up to them to lead by example. If Top Management truly believes that a solid QMS will enable them to run a successful business and embrace it wholeheartedly, then there is nothing to be scared of. The QMS will be embodied in the daily work of all their employees and that will shine through during the audit.

2. Your customer wants you to have a successful audit.

They are relying on consistently receiving the quality product you supply them with. If you don't pass this audit, then it is more work and more money for them in the end to find a replacement supplier and validate that new product. It doesn’t mean that the auditor is not going to thoroughly look through a lot of documentation and hold an extensive audit, but they are rooting for you to do well.

3. You know your stuff, so relax!

You, as the auditee, are here on a daily basis doing this job every day. You know this product and company like the back of your hand, so be confident in your responses when speaking with the auditor. The auditor is looking for a quick and straight to the point response to their questions and if you give that, they will feel confident you are doing the right thing and will move on to another area. And it's okay to say that you don't know something. You can always offer to follow up or bring someone else in that knows the answer to their question.

4. Audits are built into the QMS requirements for a reason - to help companies continuously improve and deliver a quality product to their customers.

It’s a common saying that there is always room for improvement and audits are a great tool you can take advantage of. Sometimes you can become blind to problem areas because you have found easy workarounds, or you have been doing it the same way for 15 years and never thought to do it differently. Having a new set of eyes come in and look at your process is a huge advantage that you should be embracing to help make your company better.

5. Conducting Internal Audits is a part of the regulations but it is really a built-in check of your QMS that can add a lot of value.

These are a great tool if you are conducting thorough audits, rather than just going through the motions to meet a requirement. Isn’t it true that we are always our own worst critics? Take advantage of this and follow through with completing corrective actions and addressing any major business issues. 



So those are the five reasons not to fear a supplier audit, and if there were a sixth it might be to just remember that auditors are human, too. You can talk to them and they are typicallyreasonable. If you explain things in a straightforward way, they are almost always willing to listen to your explanations and take that into consideration.  

So, we encourage you to think about these things the next time you hear that someone is coming in to audit you. Companies should be taking advantage of the huge opportunities that arise from an audit instead of treating it like coming down with the plague. They aren't so bad as long as you relax and explain what you know in a clear and confident way.

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