The input CAPA runs on
Every corrective action opened through CAPA management is grounded in a completed root cause analysis, not a guess at what went wrong.
What's included
What goes into a root cause analysis
- The finding restated in specific, evidence-based terms before analysis starts, so the investigation isn't chasing a vague description
- A structured method applied to trace the finding back through contributing factors — process, training, system, or resourcing — to the actual root cause
- Related records and prior findings checked for a recurring pattern, so an isolated-looking issue isn't missed as a systemic one
- The distinction drawn explicitly between root cause and contributing factors, so the corrective action targets the right one
- Findings and conclusions documented and handed to CAPA management as the basis for the corrective action
Confirmed at closure
The effectiveness check at closure verifies the corrective action actually addressed the cause identified here.