Stay Calm and Audit On
Quality audits can be nerve-wracking. Your entire quality management system (QMS) is on display – and you hope the auditor doesn’t red-line everything as a non-conformance.
If the auditor does find a non-conformance, our team can help find a solution that both your CFO and the auditory will be happy with. We specialize in creative compliant solutions to leverage resources on hand without breaking the bank. Need to comply with both 21 CFR 820 and ISO 13485? We’ve got it covered.
Don’t worry, our team will be with you year after year to manage audits and their outcomes.
An Auditor Walks into a bar and Says “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 she 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 quality management system 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 quality management system created with help from me and my team would be top-notch and likely deficiency-free.
Another amazing audit
My client raved when their audit concluded without any non-conformities and a recertification recommendation from the Notified Body.
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.
How About Another Tale, But This Time a Cautionary One…
Turns out, the client had kept their registration active which means the 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, and 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.
The leanRAQA Team has Qualified Auditors, Too!
You may need to hire our internal auditors if…
If you haven’t done an internal audit yet and it’s come time to do your first, a DIY internal audit is often overwhelming. Not to mention, you might be challenged on your auditing qualifications. Do you have your certification yet?
Hire the leanRAQA team to do your internal audits and get a real, unbiased review of your quality management systems. We’ll find any potential problems and help fix them–before those pesky fines from the FDA or spending hours of manpower, not to mention money, documenting corrections. (If you do choose to hire us, we may even let you in on our little secret for lengthening the time between required audits and lessening your internal audit stress load.)
If the thought of an FDA audit or a Notified Body audit keeps you up at night, the leanRAQA team may have just the trick to keep the boogeyman at bay. Because we have years of experience handling major audits and the auditors that run them, we know the ins and outs as well as the back of our own hands. So, who else could be more qualified to run a mock audit as a test run for you and your employees? In our opinion, no one.
Even if you have had an ISO audit or MDSAP audit before, an FDA audit may catch you by surprise when it comes to the differences. These audits follow the QSIT structure, and there are certain records the auditor can not review, such as management reviews and internal audits. Hiring leanRAQA for a trial run audit can prepare you for the nuances of many different audit types and let you and your employees rest easier feeling prepared for what may come.
If you need a qualified team of auditors to run a supplier audit, leanRAQA can fill the role in these scenarios as well. Our team can help ensure that your contract manufacturer is legitimate before jumping into business with them. We know the right questions to ask and the most important areas in their records to scrutinize.
If you fall into one of these categories (or a different category that requires an internal auditor), do not hesitate to meet with us and learn more about how we can help. The leanRAQA team of auditors is certified to handle EU MDR audits, EU MDD audits, MDSAP audits (all countries including Japan, U.S., Brazil, Australia, and Canada), ISO 13485 audits, and 21 CFR 820 audits. Add your name to my calendar (button), and let’s chat about how we can help keep the audit boogeyman from wrecking your day/month/year/business.
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.
