IN ONE SIMPLE SENTENCE
Finding root cause, taking action, and checking effectiveness.
What is this service?
CAPA is a controlled quality process.
GOAL
Control, correct, prevent and verify.
What can MICT do here?
Structured CAPA workflow.
TYPICAL INPUTS
- Feedback / vigilance event
- Nonconformity or audit finding
- Laboratory failure
- PMS / PMCF signal
- Risk-management update
TYPICAL OUTPUTS
- Problem statement and containment
- Root-cause analysis
- Corrective / preventive action plan
- Owner and deadline
- Effectiveness check and closure/reopen decision
Workflow
Source→Containment→Root cause→Corrective / preventive action→Implementation→Effectiveness check→Close / Reopen
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
Example CAPA.