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Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
Why do so many CAPA systems pass their metrics while the same problems keep coming back? Dan Eagles, a medical device quality VP and longtime CAPA mentor, breaks down where these systems quietly fail and how to rebuild them into tools that actually drive improvement.
Dan discusses why the problem statement is where most CAPAs go wrong, how teams back-engineer root cause analysis to match a fix they've already chosen, and why "retrain the operator" is usually the wrong answer.
A few of Dan's key takeaways:
- A closed CAPA that fails again for the same reason was never successful, repeat offenders are the clearest sign of a broken-but-compliant system
- Most CAPA trouble starts with a poorly worded problem statement, train your owners to write good ones and you get value across NCRs too
- Humans back-engineer root cause analysis to justify the fix they already wanted, the J&J forklift story shows how that goes wrong
- Trade retrospective "wait three months and see" verification for process validation that proves capability with objective evidence
- Know the difference between a correction (fixes the immediate problem) and a corrective action (prevents recurrence)
- Without leadership buy-in across functional groups, CAPA becomes a hot potato, but a recall costs far more time and money
- Track whether your VOEs are effective, not just whether CAPAs closed on time
About Dan Eagles
Dan Eagles is Vice President of Quality Assurance at NeuraSignal, a company developing robotic transcranial Doppler ultrasound technology for stroke detection. He has over 20 years in the medical device and pharmaceutical industries, with 23 years in quality assurance and prior roles at NuVasive, Dendreon, Endologix, and Edwards Lifesciences. He is a CAPA and NCR mentor and is listed on 21 ophthalmic device patents.
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
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By The FDA Group
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Why do so many CAPA systems pass their metrics while the same problems keep coming back? Dan Eagles, a medical device quality VP and longtime CAPA mentor, breaks down where these systems quietly fail and how to rebuild them into tools that actually drive improvement.
Dan discusses why the problem statement is where most CAPAs go wrong, how teams back-engineer root cause analysis to match a fix they've already chosen, and why "retrain the operator" is usually the wrong answer.
A few of Dan's key takeaways:
- A closed CAPA that fails again for the same reason was never successful, repeat offenders are the clearest sign of a broken-but-compliant system
- Most CAPA trouble starts with a poorly worded problem statement, train your owners to write good ones and you get value across NCRs too
- Humans back-engineer root cause analysis to justify the fix they already wanted, the J&J forklift story shows how that goes wrong
- Trade retrospective "wait three months and see" verification for process validation that proves capability with objective evidence
- Know the difference between a correction (fixes the immediate problem) and a corrective action (prevents recurrence)
- Without leadership buy-in across functional groups, CAPA becomes a hot potato, but a recall costs far more time and money
- Track whether your VOEs are effective, not just whether CAPAs closed on time
About Dan Eagles
Dan Eagles is Vice President of Quality Assurance at NeuraSignal, a company developing robotic transcranial Doppler ultrasound technology for stroke detection. He has over 20 years in the medical device and pharmaceutical industries, with 23 years in quality assurance and prior roles at NuVasive, Dendreon, Endologix, and Edwards Lifesciences. He is a CAPA and NCR mentor and is listed on 21 ophthalmic device patents.
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
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