Forging Connections: Flipping CAPA on Its Head with Prevention

Waste and lost money run rampant in various sectors, and healthcare and pharmaceuticals are no exception. Bethany Kearney, Director of Enablement for Sparta Systems, and Zillery Fortner, Product Advisor, QA/RA Life Sciences at Sparta Systems, joined Forging Connections Host Michelle Dawn Mooney to discuss flipping corrective and preventive action (CAPA) on its head through preventive measures.

Fortner provided an example of how reusable medical devices like gowns would rip after 40 uses or so when they were supposed to last for 100 lifecycles. The safety complaints stopped at a high level instead of digging down deep to find the root cause. Issues were accredited to “human error” or incorrect repair. “There wasn’t global communication between the different facilities. There were multiple issues going on. Multiple times it was closed in CAPA, saying it was fixed. When it came down to it, the true root cause was a chemical reaction,” Fortner stated. Addressing the actual cause would have saved millions of dollars.

“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,” Kearney explained. She added, “It’s much more costly to not know that true root cause,” and that “putting in the time to do it right is really where the value is.”

The key is to follow the seven steps of the CAPA process. Fortner listed them as identifying the problem, evaluating the problem, developing and investigating, analyzing the problem, creating an action plan, implementing it, and analyzing the effectiveness.

Fortner added that prevention is essential, and companies should plan, do, check, act…Lacking support from the right stakeholders will cause you to struggle and make the process difficult. It is also imperative not to play the blame game and to understand why the mistake happened, fix it, and ensure the fix works.

When CAPAs go awry, this can cause incredibly costly issues. “A recall is just one part of doing something wrong or not really, truly understanding the problem,” stated Fortner. “A recall process can cost up to 600 million dollars, according to research from McKinsey. The medical device industry spends around 5 billion dollars a year on recalls. This expense we can’t ignore because lives are at risk. Every minute that a defective product stays out on the market is another opportunity for someone to be injured.”

“The payoff to doing CAPA right, I don’t think you can measure,” stated Fortner.

For more podcasts from Forging Connections, visit Apple iTunes or Spotify.

Follow us on social media for the latest updates in B2B!

Image

Latest

Next generation of security solutions
The Future of Security: Discovering the Next Generation of Security Solutions at ISC West
April 23, 2024

The recently concluded International Security Conference & Exposition West 2024 (ISC West) proved to be an indispensable platform for discovering the next generation of security solutions, providing attendees with invaluable insights into the future of the industry. At a recent episode of MarketScale’s roundtable show Experts Talk, Cathal Walsh, Vice President and Chief Security […]

Read More
Cyber Resilience: To Protect Corporate Assets, Businesses Must Invest in Cybersecurity Training
April 23, 2024

As cyberattacks occur at increasing frequency, cybersecurity has become a cornerstone of corporate security strategies across all sectors. With businesses increasingly reliant on digital infrastructures, the quality of a company’s cybersecurity training is no longer just an operational requirement — it is a strategic asset. The stakes are high, as a breach can lead […]

Read More
Forming Relationships with Industry Insiders Can Quell Sales Cycles and their Length of Time
April 23, 2024

New companies are facing more and more challenges in the security industry as sales cycles are experiencing lengthier times. One of those reasons is due to the complexity of the security industry itself, along with the unique and special business models every new company will come in with. But there is a solution to […]

Read More
Cyber-first approach
From Bollards to Bytes: Why Security Firms Need to Adopt a Cyber-First Approach
April 23, 2024

How can the security industry effectively navigate the shift from traditional physical security measures to adopting a cyber-first approach in its sales and integration strategies? The transition from physical to digital security solutions was a major theme at the International Security Conference & Exposition West 2024 held earlier this month. On a recent episode of […]

Read More