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.

Free Webinar: CAPA on CAPA, Presented by MassMEDIC and R&Q - Register Now!

CAPA is often overlooked as an integral component of a quality system. More often than not, the FDA can trace deficiencies in a system directly back to the CAPA system. However, an effective quality system needs more than just a rework of the outcome of the ineffective CAPA system. It needs a rework of the system itself. 

Quality Systems Becoming the Culture of a Company

The culture of a company is what drives the organization – it can change and adapt, but ultimately, if a strong management team doesn’t drive a company’s culture – the company risks losing its identity. For medical device companies, establishing a culture around the Quality System is one effective way to set up for success. Everybody in the organization plays a part of the Quality System – so building the culture around Quality will include and impact everyone.

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a good kid, full of promise…..and he knows the boundaries. No phone while driving, no friends in the car, follow the law and safety first.

Architect of Quality – Part 2: The Human Dimension

Welcome to the second installment in our blog series featuring Joseph Juran, “Architect of Quality.”1 Today, we’re going to take a deeper look at one of his major contributions – the addition of the “human dimension” to management theory.

Some Things Never Change....

There are some things in life that never change. So, if they never change, let’s learn the rules. A teacher once told me “once you know the rules, embrace them.”

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