Flipping CAPA on Its Head with Prevention and Root Cause Analysis

Problems happen and an enormous amount of time, money and energy is spent on reacting to these issues rather than preventing them from happening. The most effective method of ensuring safety and quality management and reducing quality issues is a closed-loop corrective and preventive action system (CAPA).

In this episode of Forging Connections, Sparta’s Bethany Kearney, Director of Enablement, and Zillery Fortner, Product Advisor, QA/RA Life Sciences, joined host Michelle Dawn Mooney to discuss flipping corrective and preventive action (CAPA) on its head through preventive measures.

Fortner discussed the seven fundamental elements to an effective CAPA process, which include:

  • Identifying the problem
  • Evaluating the problem
  • Developing and investigating
  • Analyzing the problem
  • Creating an action plan
  • Implementing the action plan
  •  Analyzing its effectiveness

This podcast dove into some examples of just how costly quality events can be. Fortner and Kearney gave real-world examples of problems that can arise when finding the true root cause, including incorrectly classifying the cause as human error. Taking the time to dig deeper to find the true root cause may be more time consuming but that’s where the value is.

Kearney stated, “Finding the true root cause is very complex. It's easy to blame a human. And if the firm is 100 percent focused on metrics, then finding the true root cause is going to be very challenging because in some cases it is costly. But it's much more costly to not know that true root cause. So, I understand that it's a paradigm shift for organizations but putting in the time to do it right is really where the value is.”

Getting CAPA right doesn’t just benefit the organization; it is also beneficial from a patient standpoint.

“The medical device industry spends around 5 billion dollars a year on recalls,” said Fortner. “It is expensive. And this expense, we can't ignore it because lives are literally at risk. Every minute that a defective product stays out on that market is another opportunity for somebody to be injured. I always tell people to think if that was your loved one, would you be quick to act, would you want to do this right? So, the payoff to get a CAPA right? I don't think you can measure it. It's huge.”

Fortner added, “People have to change their thinking on CAPA. They can't think that CAPAs are burdensome or take too much time. They have to see how powerful, how proactive this tool is and how it can shape the future of quality in your company.”

Listen to the podcast for more insights and to hear real-world examples of getting CAPA right—and why it matters.