Is “improve quality audit performance” on your list of goals this year?
If so, you’re not alone. Between regulatory bodies, clients, and Sponsors, GxP-regulated life sciences organizations get audited a lot. It’s understandable for Quality teams to want those audits to be as positive, smooth, and stress free as possible.
But while your goal is on the right track, it’s not quite specific enough to actually help you navigate a year of quality audits. (Remember, quality management goals need to follow the SMART formula.)
Instead, break your audit management improvement plan into three key target areas – preparedness, efficiency, and effectiveness – and then set specific, measurable goals for each.
Keep reading and learn:
- How to better prepare for audits, improve their efficiency, and measure their effectiveness
- Examples of quality audit management goals
- The audit goal-setting mistakes to avoid
How to better prepare for quality audits
Logically, you know the auditor is there to confirm the safety of your organization and point out areas for improvement – not to scare you. But that doesn’t stop the process from being stressful for you and your team. It’s never fun to be scrutinized, no matter how necessary it is.
To combat the inevitable audit anxiety, double down on preparation. The more your team knows about what to expect, what to do, and what to say, the more successful – and less nerve-wracking – your audits will be.
With this in mind, your audit goals should help you:
Gain a deeper understanding of your organization.
The Quality team leads the way during audits, which means they have to understand how the organization operates at every level. Which SMEs know what information? Why are certain processes carried out a particular way? What quality standards does each department need to meet and more importantly, how do they meet them?
Without this understanding, you’ll struggle to provide auditors with the right information at the right time and potentially fail to provide evidence of compliance.
Because of this, at least one of your goals should focus on expanding your knowledge of your organization and the departments within it. For example, this might look like:
- Audit Example Goal #1: “Conduct in-depth discovery meetings to uncover each department’s roles and responsibilities, as well as how their work aligns with regulatory requirements by the end of Q2.”
- Audit Example Goal #2: “All Quality team members pass a training assessment covering the roles and responsibilities of each department within the organization.”
Understand exactly how audits work.
Sometimes, it’s fun to be surprised. An audit is not one of those times.
It’s better to know what the inspector is looking for, what they expect to see, and what questions they’re most likely to ask.
Thankfully, you don’t need a crystal ball to predict the auditor’s process. Instead, a program like ASQ’s Quality Auditor Certification can help your team learn to think like an auditor. Not only is this helpful as you prepare for audits, it also sets your team up for more effective internal audits and vendor inspections.
In this case, the example goal could be:
- Audit Example Goal #3: “At least one member of the Quality department achieves a quality auditor certification by the end of the year.”
How to improve quality audit efficiency
No matter how prepared your team is, if your QMS isn’t organized and efficient, your audits are going to be exponentially more difficult. Hence the next audit goal focus…
Get the best audit management tools for your quality team.
Unless your Quality team enjoys pulling all-nighters to prepare for an audit, you have to invest in the right quality management tools to streamline the process. An eQMS (electronic quality management system) is usually the right way to go and can make a world of difference.
There are a lot of benefits to an eQMS, but there are a few key features that are particularly useful for quality audits:
- Documents Management: The Documents module of an eQMS lets you store and organize all of your quality documents in one easy-to-search central hub. When the auditor asks to see a specific SOP and a complete list of its version updates, the Documents module should make it easy to find – and showcase – what you need in a matter of seconds. And that adds up. Just ask Jason Bissey, Senior Director of QA at Xerimis: “We’ve been able to reduce on-site audit time by more than 50% because we are able to provide auditors access to review documents in ZenQMS.”
- Audit Management: An inspector may want to know when you were last audited, the results of that audit, and the steps taken to mitigate any findings. With a robust Audits module, you can track and report on that information quickly. Plus, you can keep tabs on upcoming audit due dates for all of the certifications and standards you need to maintain (such as a ISO 9001 certification).
An example of the overview dashboard from the ZenQMS Audits module.
The audit goal here is simple:
- Audit Example Goal #4: “Evaluate and select an effective quality management tool to support audit management by the end of the year.”
This may not be a flashy goal, but it is critical for audit readiness. Just take it from a Quality leader who's been there:
(P.S. Sometimes quality leaders run into pushback when they ask for the tools they need. To prep yourself for the conversation, check out these resources to prove the ROI of an eQMS and get the tools you need.)
The audit goal-setting mistake to avoid
You’ll notice so far we haven’t mentioned “reduce the number of quality audit observations” or “prevent recurring quality audit observations” in our list of goals.
That’s because these should be organizational goals, not goals and KPIs that are solely the Quality department’s responsibility.
It might sound counterintuitive. After all, if your QMS is effective and followed, it should mean your organization sees fewer audit observations. But don’t get caught in this trap. “Followed” is the key word here. It’s everyone’s responsibility to learn, understand, and follow quality best practices within your organization. The Quality department can’t do it alone.
More importantly, attaching your Quality team's goals (and ultimately, their measure of success) to the number of observations found actually disincentivizes finding areas for improvement. The objectivity of your Quality Management team could be compromised and you may miss critical opportunities for growth.
Instead, your Quality team’s goals should focus on your ability to measure audit effectiveness and your overall audit efficiency, not the observation numbers themselves. Take these goals for example:
- Audit Example Goal #5:“Implement a data tracking tool to measure total number of observations, audit response speed, and number of recurring observations.”
- Audit Example Goal #6:“Conduct 90% of internal and supplier audits on or before their scheduled due date.”
How to measure the effectiveness of your audit management
The Quality team shouldn’t tie their success metrics around audit performance, but they should still be tracking this data. Some overarching organization audit goals might include:
- “Reduce the number of quality audit observations by X% compared to the previous year.”
- “Reduce the number of observations around [a recurring problem area for your organization] by X% compared to the previous year.”
- “Respond to all audit observations within X days.”
An example of the audit data that can be found in the ZenQMS Insights module.
Technically, you can track this data manually, but it’s much easier if you have the right QMS software in place. An eQMS with a robust Insights module, like the one shown above, makes it possible to manage these metrics, pull reports, and set benchmarks without spending hours wading through massive spreadsheets.
If you’re curious to see what other quality management data you can see with an Insights module, check out this 3-minute overview video here.