Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
About this episode
Dan Eagles discusses the failures of CAPA systems and how to effectively improve them.
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)…
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