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Jonah Krakow01/16/245 min read

Pre-Audit Exercises: How to prepare for a new year of audits

It’s the time of year to focus on improvement and building better habits — a.k.a. the perfect time to get your audit processes in shape for the months to come! Improving the way you approach audits can seem overwhelming, but tackling these updates sooner rather than later can make all the difference.

That’s why we asked our own QA and Audit Specialist and ASQ Certified Auditor, Olivia Dattner, to share some pre-audit exercises that can help set life sciences companies up for a smoother year of audits.


Exercise #1: Perform an honest assessment of your operation

To get in shape, 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 achievable goals.

The same is true with audit prep. Olivia advises undergoing a thorough self-assessment by performing regularly-scheduled internal audits as a low-stakes way of mitigating risk before having to answer to an auditor.

“An internal audit will not only help you identify the areas of highest risk, but will provide insight into opportunities for improvement as well. Plus, you’ll have more visibility around the health of your organization related to the standards you’re measuring against.”

It’s one thing to identify your areas of highest risk, it’s another thing to correct them. The auditor will be looking for processes that are in a continuous state of improvement, so you’ll need to document how you’ve taken steps to correct any issues, and prevent them in the future.

By setting (and meeting) benchmarks and holding people accountable before a regulatory audit, when the time comes, you’ve already taken steps towards proving how you're keeping quality processes in a state of control.

Ironically, if you maintain a regular internal audit schedule that stresses continuous improvement, the majority of the actual “prep work” on the days leading up to the audit will be done by the inspector, not you. Aside from making sure you’re available on their requested dates, answering questions, and providing documents, your role is generally a supportive one.


Exercise #2: Train your team on good audit etiquette 

Every great team needs a great coach. So when it comes to quality inspections, your colleagues are looking to you to lead them. 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 as Olivia points out, “They’re auditing the process, not the individual. It’s not personal.” So the more you practice remaining calm and acknowledging that they’re performing an inspection, not a witch hunt, the better the chances of a shorter audit that allows everyone to get back to business as usual.

The good news is that you’ll have at least some idea of the scope of what the inspector is auditing against, which will allow you to get organized. You can then sit your team down, explain what’s going to happen, and set clear expectations ahead of time.

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.

And remember, it all starts from the top. “How management approaches an audit has a direct effect on the process,” says Olivia. “If they’re cooperative and treat it as a necessary step for company growth, it creates a lot less stress on everyone else.” 

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Exercise #3: Get the right equipment

Outdated, obsolete equipment isn’t going to get you the results you’re looking for, in a gym or in a regulated environment. So if your company doesn’t already have one, it might be time to invest in an electronic quality management system (eQMS). An eQMS provides more oversight about whether or not your company documents (training records, SOPs, etc.) are up-to-date, employees are fully compliant, and training procedures are clear.

An eQMS will also speed up your audit. Rather than having runners on-hand to fetch paper documents from a filing cabinet, an eQMS allows near-instantaneous access to the inspector’s requests, and there’s never a concern about lost documents. Plus, an eQMS can be configured in such a way as to allow the auditor to only see what you want them to see. Risks of them accidentally getting a hold of proprietary data or company secrets are eliminated.

Making sure you have an eQMS that aligns with your workflows & needs will make audits a LOT easier in 2024.


Exercise #4: Keep an open mind 

A perfect physique doesn’t happen overnight, and neither does a perfect quality process. That’s not the point. The point is to 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.

“The auditor isn’t looking to catch you in the act,” says Olivia. “Chances are, they’ve seen it all, good and bad, and it’s nothing personal. They’re just doing their job to make sure your organization and its operations and products are safe, up-to-date, and continuously improving.”

If you’re interested in more information, we invite you to take a look at a recent audit preparedness webinar, hosted by quality and systems expert Ed Morris, Managing Partner at The Morris Group, who offers additional tips for preparing for an audit.