Episode description

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems.

Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions that not only ensure compliance but also drive meaningful improvement within medical device companies.

With over a decade of experience, Georg brings practical knowledge on avoiding common pitfalls such as "death by CAPA" or failing to recognize high-risk systemic issues. The episode also delves into the importance of verification of effectiveness (VoE) checks, the distinctions between corrective actions and preventive actions, and how to balance a proactive approach with pragmatic solutions.

• [03:15] – Defining CAPA and its critical role in Quality Management Systems
• [10:45] – Common CAPA triggers: Balancing overuse and underuse
• [18:20] – Root cause analysis vs. corrective action: A step-by-step approach
• [25:40] – Containment vs. correction: Key differences in addressing nonconformities
• [38:10] – Verification of effectiveness: Best practices for ensuring long-term solutions
• [50:30] – Continuous improvement through CAPA: Avoiding system overload
• [1:00:05] – Practical tips for balancing CAPA triggers with company priorities

• “CAPA isn't just about compliance; it's about driving real improvement in your organization." – Georg Digel
• “The worst thing that can happen is losing oversight on the serious issues because your system is flooded with trivial ones.” – Georg Digel
• “Root cause analysis isn’t about fixing the symptom, it’s about ensuring the issue never comes back.” – Etienne Nichols

1. CAPA as a Key to Continuous Improvement – How CAPA systems fuel company growth by addressing both high-risk and systemic issues.
2. Data-Driven CAPA Triggers – Integrating post-market surveillance and production data for more proactive corrective actions.
3. Regulatory Impact on CAPA – The importance of understanding evolving regulations and their influence on product safety and quality management.

1. Sharpen Your Triggers – Clearly define CAPA triggers to avoid flooding the system with low-risk issues.
2. Effective VoE – Ensure VoE checks are specific to root causes, not just symptoms, for long-term success.
3. Cross-Site CAPA Learning – Use internal audits and external findings from similar companies to prevent systemic failures across sites.

1. How will advances in AI and machine learning improve CAPA systems in the future?
2. Can companies move toward more preventive action frameworks, or is CAPA inherently reactive?
3. How will stricter global regulatory updates reshape CAPA strategies in medical device manufacturing?

1. FDA 483 and Warning Letters Database – A resource to monitor common CAPA violations and avoid systemic errors.
2. LinkedIn Profile - Georg Digel – Follow Georg Digel for daily insights...