Question: Are audit findings, non-conformities, and corrective actions tracked through a structured CAPA process?
Why This Matters
Without tracking and verification, audit findings remain paper records. A formal CAPA cycle ensures root causes are addressed and controls strengthened.
Maturity
0 — Unaware
No system for tracking findings.
No system for tracking findings.
1 — Ad Hoc
Spreadsheets with manual updates.
Spreadsheets with manual updates.
2 — Defined
CAPA form and approval workflow documented.
CAPA form and approval workflow documented.
3 — Managed
Root cause analysis performed and closure verified.
Root cause analysis performed and closure verified.
4 — Integrated
CAPA linked to risk register and management reviews.
CAPA linked to risk register and management reviews.
5 — Optimized
Automated tracking and CAPA effectiveness scoring.
Automated tracking and CAPA effectiveness scoring.
How to Level Up
| From → To | Actions |
|---|---|
| 0 → 1 | Collect all findings into single log. |
| 1 → 2 | Adopt CAPA form with owner and deadline. |
| 2 → 3 | Perform root cause analysis for each major finding. |
| 3 → 4 | Review CAPA status in management meetings. |
| 4 → 5 | Automate reminders and measure CAPA effectiveness. |
Enablers
- People: Quality Manager, CISO, Audit Lead
- Process: Record → Analyze → Correct → Verify
- Technology: GRC tool or shared workflow system
Evidence
- CAPA log with root cause column
- Closure evidence
- Management review notes
KPIs
- Number of CAPAs open vs closed
- Average closure time (days)
- CAPA effectiveness score
Low-Cost / Open-Source Options (MSME)
| Purpose | Tool | Notes |
|---|---|---|
| Workflow | Odoo Community / Airtable | Approval and status |
| Analytics | Metabase | Trend and aging |
| Storage | Nextcloud | Evidence repository |
Common Pitfalls
- CAPAs closed without verification
- No root cause identified
- Actions not linked to risks
Compliance Mapping
| Standard | Clauses / Notes |
|---|---|
| ISO/IEC 27001 | 10.1 (Non-conformity and CAPA) |
| DPDP Act 2023 | Sec 10 (Accountability) |
| NIST CSF 2.0 | GV.MA-03 / IM.ME-03 |
| NIRMATA Mapping | CA-Q04 closes the loop on audit findings. |