Understanding CAPA and Root Cause Systems
Situation:
EVERSANA’s leadership teams were struggling with CAPA creation and RCA quality. Reports showed frequent errors in CAPA submissions, both in framing root causes and in implementing sustainable corrective actions. These errors led to operational inefficiencies and compliance risks that even senior leaders were missing.
Task:
I was tasked with building a strategic training solution specifically for senior leadership that simplified complex CAPA processes and helped improve their ability to analyze failures, document them effectively, and implement meaningful, audit-ready corrective actions.
Action:
Using Rise 360, I created a concise, interactive course covering what CAPA is, why it matters (21 CFR 820/211), and the differences between Correction, Corrective, and Preventive Actions. I introduced RCA tools like 5 Whys, Fishbone Analysis, and Process Mapping, along with guidance on writing SMART-aligned problem statements. The course ended with a 10-question scenario-based assessment and was structured into short, 3–5 minute lessons to suit senior leadership schedules. For the ease of training, I had also provide a voice-over accessibility to the trainees.
Result:
The training resulted in a 72% reduction in CAPA creation errors by senior leadership and a 65% decrease in operational errors during CAPA implementation. The course became a cornerstone for internal audit preparedness and was praised for its clarity, interactivity, and direct relevance to leadership challenges.