3 Tips to a Successful Audit
So you've got an external audit coming up? Here's 3 tips to successfully prepare for, and navigate your next external audit:
Pre-prep your responses
These days if you're under the Medical Device Single Audit Program (MDSAP), audits are like having the questions to the final exam beforehand. So why not take advantage?
Sure, the details of each request may change, but many items can be predicted. You can prepare things like lists of CAPAs and Complaints, training records for key employees, evidence of internal audits etc. Preparing these items ahead of time will take some of the stress off of your support staff, allowing them to focus on more important activities.
Storyboard your messiest and most “interesting” items
Remember that complaint where someone said "if this happens again, it could be a huge risk and might even kill someone!"… or that CAPA that spawned two other CAPAs, but then you had to withdraw one of them, but there was also an associated recall? Ya. Those. Do yourself a favor and storyboard them.
As humans we're all a bit different. Some of us are more auditory, some more visual; but we all get confused. Taking the time to show where your actions take place on timeline, or explain context that may not have been appropriate for your formal records but would greatly aid in a front room conversation might save you some very uncomfortable back and forth.
Expert witnesses only
You know that phrase 'too many cooks in the kitchen'? Don't let it be appropriate for your front room. We've seen many a simple topic go left when the wrong person attempts a technical explanation, or a technical expert nervously word vomits in front of the auditor.
You can avoid this by taking time to prep your Subject Matter Experts (SMEs) before they step in front of an auditor. Sometimes that looks like making sure the person with the technical depth understands what is/is not appropriate information for your auditor, or how phrases that may be a part of your workplace culture could be problematic for an outside audience. Other times it could be making sure that your sales/marketing guru knows the audit is not the place to wing it or for good ‘ol marketing fluff ;). The point is, audits are very uncomfortable and rare experiences for all but the folks who always sit in the front room and sit there all day. Make sure your broader team gets your pointers for success.
BONUS TIP:
External audits provide a unique value because they provide that necessary objective and truly outside point of view on your activities. Every now and again it's a good idea to supplement your internal audit program with an external audit to not only give you a solid assessment of your operations, but also put your employees through their paces in a scenario as close to what they might expect in their next FDA, Notified Body, ANVISA… audit.
That’s why we advice clients pursue a ‘sanity check’ audit from outside their typical auditors whenever internal audit results are consistently good, or records are being approved without much discussion.
