Stay Calm and Audit On
Audits can be nerve-wracking.
Your entire quality management system (QMS) is on display – and you hope the auditor doesn’t red-line anything as a non-conformance.
But if there is? You must mitigate it with your own internal quality improvement procedures AND those your notified body imposed.
Then, ANOTHER audit. Which is expensive and time-consuming.
But what if the auditor took one look at your quality system and declared the audit a success – without even looking through your system?
It can happen. It did! (Read on.)
“Wait – I know you!”
I recently had a client who was due for a full recertification audit.
With just two weeks to prep, we sent RAQA Whiz and Grief Counselor-in-Training, Ti, onsite to assist.
On audit day, the auditor took one look at the assembled support team, and immediately told the client that everything would be fine.
It seems the auditor recognized Ti as a leanRAQA team member, and also remembered auditing the quality management system Ti had developed years ago for a previous employer.
A QMS that I helped Ti build in the early days of leanRAQA’s growth.
The auditor had been so impressed with the excellence of the quality system and documentation that she still remembered it.
More importantly, she knew that any QMS created with help from me and my team would be top-notch and likely deficiency-free.
Maybe the Fastest audit ever
My client raved when his recertification audit started at 9:30 a.m. and concluded 50 minutes later!
But it just as well could have been an FDA audit, or an audit for:
- ISO 13485
- MDSAP
- MDR
- Internal Audits
- Supplier Audits
Ready to make your audits stress-free?
Put some time on my calendar and we’ll chat…I may even share another anecdote or two.
A Cautionary Tale….
Turns out, the client had kept their registration active. That meant FDA could come in at any time and do an inspection – or audit.
I said, “You need a quality management system.” They replied, “Thanks but no thanks. FDA hasn’t been here, ever. And we’ve had this cleared since 2010, so we’re not worried.”
I bet you know where this is headed, right?
We argued some more, I prevailed, we set something up.
And yessiree, Bob, FDA showed up on their doorstep ten months later, right out of the blue.
Don’t be the cautionary tale of the future. If you’ve got a burning audit preparation need or question, just ask me already.
Don’t Fear the Reaper
Through the wind and the sun and the rain, FDA inspections and MDSAP audits don’t have to be stressful. Proper preparation can make a world of difference.
But if you’re feeling like you couldn’t go on, pick an open half hour on my calendar. We’ll chat about bell bottoms and classic rock – and we may even come up with a plan to ace that inspection.
