Skip to content
Jonah Krakow04/22/242 min read

eQMS best practices for simpler audits

Deciding on your company’s approach to audits can seem like a giant task, but tackling necessary updates sooner rather than later can make all the difference. We’re sharing some steps you can take to get your company in shape for a smoother year of audits.

Step #1: Perform an honest assessment of your operation

To get fit, you wouldn’t run into a new gym, jump on the closest weight machine, and hope for the best, would you? Instead, you’d likely identify what you’d like to work on ahead of time and then set actionable, achievable goals.

The same is true with audit prep. Performing regularly-scheduled risk-assessments is a low-stakes way to find out where you’re deficient before having to answer to an auditor. By setting (and meeting) benchmarks and holding people accountable before a regulatory audit takes place, when the time comes, you’ve already taken steps towards proving how you're keeping quality processes in a state of control. 

Step #2: Train your team on good audit etiquette 

Every great team needs a great coach. So before the regulator knocks on your door (or visits your company remotely) you should set aside time to instruct colleagues on proper audit etiquette. It’s a tall order to keep emotions in check when an inspector is firing direct questions at you and demanding to see specific SOPs, but it’s important to remember that they’re auditing the process, not the individual. So try not to take it personally.

The more you practice remaining calm and acknowledging that they’re performing an inspection, not a witch hunt, the better the chances are of a shorter audit that allows everyone to get back to business as usual.

That includes having all staff (not just QA) up-to-date on their training, familiar with potential issues and scenarios related to their job (workstation cleaning, equipment use, etc.), and informed about where to find relevant documents. They won’t be answering the majority of the inspector’s questions (nor should they!), but if they are asked a direct question, they should be prepared to answer honestly and succinctly.

201 cta

Step #3: Keep an open mind 

A perfect physique doesn’t happen overnight, and neither does a perfect quality process. For real results, you keep at it. Going into an audit, you should feel confident about the steps you’ve taken to make your company’s processes safer and be ready to defend them. But when you’re in an audit, you’re given the chance to see different perspectives that allow you to learn. An audit can reveal pathways to decrease risk and identify strategies for further improvement.