May 7, 2025
At its core, corrective and preventive action (CAPA) is about systematically evaluating problems and enacting permanent solutions that minimize risk—for both customers and the business.
That’s the goal, in theory. But in practice? It can get a little messy.
In our discussion on CAPA Engagement Process initiatives, we focus on practical, team-oriented approaches.
Employees treat CAPA like another box to check. There’s no shared sense of ownership over outcomes. Closure times are longer than they should be because people don’t see how the process adds value to their day-to-day work.
These are what we call human factors, and if we don’t address them, we risk undermining the entire purpose of the process.
In the first part of our Human Factors in CAPA series, we explore why employee engagement matters and share creative ways to help supercharge your team.
Learn more about automating your process with AssurX CAPA Software
Why Employee Engagement in CAPA Matters
Employee engagement isn’t just fluffy corporate-speak—it’s actually foundational to quality. The CAPA Engagement Process is designed not just to comply with regulations but to foster a proactive quality culture. Companies with engaged teams see significant benefits when engagement is high, including:
- Proactive problem-solving: Engaged employees actively seek out and report potential risks before they become issues.
- Better data quality: Higher engagement results in more accurate and thorough data on problems.
- Cross-functional collaboration: When employees from multiple departments come together to solve a problem, you’ll have more robust solutions because you’re drawing from different perspectives.
- Reduced turnover: Employees who feel their efforts are part of something bigger are more likely to stay with the company.
Why Traditional Approaches Don’t Work
Before we jump into strategies for getting your team engaged, let’s talk about what doesn’t work (no judgment—we’ve all tried these).
Standard Compliance Training
This is your classic “let’s bring everyone into a room and remind them CAPA is an FDA requirement” training. While quality leaders may love creating these presentations, most people find them incredibly boring.
Worse, this approach emphasizes obligation over inspiration. People leave thinking, “I have to do this because the FDA says so,” not “I want to do this because I care about quality.”
Fear-Based Motivation
Scare tactics, such as telling compliance horror stories or reminding people of the consequences of not doing their part, can create urgency in the short term. In the long term, however, it backfires.
People become more focused on avoiding punishment than solving problems and driving continuous improvement. They disengage. And once that happens, it’s hard to get them back.
Creative Strategies to Boost Employee Engagement in CAPA
So, what does work when it comes to getting employees engaged in your process? Here are a few things to try that can actually make a difference.
CAPA Hackathons
The idea is simple: bring together cross-functional teams to evaluate real (or hypothetical) CAPA cases, encouraging them to be as creative as possible with their solutions.
In small groups, teams work together to investigate, perform root cause analysis, propose corrective and preventive actions, and present their findings.
It’s collaborative, it’s creative, and it’s actually fun. You can even incorporate a theme such as “CAPA Olympics” or have everyone come in costume for a Halloween edition. Where I’ve used this strategy, we gave out awards and prizes for things like the most innovative solution or the most efficient root cause analysis.
CAPA Ambassador Program
One strategy I’ve used with great success is a CAPA ambassador program. It’s something we originally started with summer interns, but it was so fun we had full-time employees who wanted to sign up as ambassadors to keep the program going.
The idea is that you have designated ambassadors who act as a bridge between teams and the CAPA process. These people are trained to help monitor progress, spot issues, and give feedback to leadership on where to improve.
You can create challenges, like giving out a gift card or company swag for whoever completes the most challenges or offers the best solutions. One group even created collectible cards similar to baseball cards for each ambassador with their photo and special strengths related to the process. Team members would then collect the cards as they worked with different ambassadors to close out their open CAPAs.
Gamification & Recognition
A little friendly competition can go a long way. You can create leaderboards for improving CAPA KPIs or give shout-outs in meetings for well-written investigations. It doesn’t have to be expensive or elaborate—just make sure people feel seen when they do good work.
Communicating CAPA Wins
One of the best ways to get folks engaged is to show them a real example where a well-executed corrective action prevented something bad from happening. Even better if it came from someone on the shop floor or in their department.
Conclusion
If you want to improve engagement, you have to shift the culture away from the mindset of “you must comply” to “you can make a difference.”
It also requires integrating corrective actions into daily work. Solutions like AssurX make the process visible, streamlined, and easy to collaborate on. That’s key if you want people to see CAPA as a catalyst for improvement rather than a burden.
When you design systems—and quality culture—to foster engagement, you move beyond checking boxes. You create a team that’s empowered to solve problems, improve quality, and contribute to something bigger.
Free case study: Learn how Highline Warren automated its paper-based corrective action process
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
