Compliance & Audit · CA-Q04

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.
1 — Ad Hoc
Spreadsheets with manual updates.
2 — Defined
CAPA form and approval workflow documented.
3 — Managed
Root cause analysis performed and closure verified.
4 — Integrated
CAPA linked to risk register and management reviews.
5 — Optimized
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

Evidence

KPIs

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

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.