| S.No. | Checkpoint | IS Requirement | Status |
|---|---|---|---|
| A. REGISTER COLUMN DEFINITIONS | |||
| A1 | Column 1: CAR NO — unique sequential identifier (CAR-YYYY-###) Acceptance: Format consistent; unique; chronological; no duplicates | Cl. 7.5.3 — Documented information | OK NC NA HOLD |
| A2 | Column 2: SOURCE — NCR / Internal Audit / External Audit / Mgmt Review / Customer Acceptance: Source documented; reference number from source (NCR no, audit ref) cited | Cl. 10.2 — Action source identification | OK NC NA HOLD |
| A3 | Column 3: DATE RAISED — date CAR initiated Acceptance: Within 7 days of source finding; SLA timer starts here | Cl. 10.2.1 — Timely action | OK NC NA HOLD |
| A4 | Column 4: NC DESCRIPTION — what was found, against which requirement Acceptance: Specific, factual; cites violated clause (ISO/IS/spec) | Cl. 10.2.1 — Description | OK NC NA HOLD |
| A5 | Column 5: ROOT CAUSE — output of formal analysis (5-Why, fishbone, etc.) Acceptance: True root cause (not symptom); method documented; cause categorized | Cl. 10.2.1(b) — Root cause | OK NC NA HOLD |
| A6 | Column 6: CORRECTIVE ACTION — what will be done to eliminate root cause Acceptance: SMART action; addresses root cause not just symptom; resources identified | Cl. 10.2.1(c) — CA implementation | OK NC NA HOLD |
| A7 | Column 7: OWNER & DUE DATE — accountable person and target date Acceptance: Named individual (not committee); realistic date; resources committed | Cl. 5.3 — Responsibility allocation | OK NC NA HOLD |
| A8 | Column 8: STATUS — OPEN / IN PROGRESS / IMPLEMENTED / VERIFIED / CLOSED Acceptance: Updated weekly; closure only after effectiveness verification | Cl. 10.2.2 — Status tracking | OK NC NA HOLD |
| A9 | Column 9: EFFECTIVENESS VERIFICATION — date, method, verifier Acceptance: Verification ≥30 days post-implementation; method (re-audit/inspection); signed | Cl. 10.2.1(d) — Effectiveness review | OK NC NA HOLD |
| A10 | Column 10: CLOSURE DATE & APPROVER — final closure Acceptance: QA Manager or above approves closure; date recorded; CAR file archived | Cl. 10.2.1 — Closure | OK NC NA HOLD |
| B. ROOT CAUSE ANALYSIS PROCEDURE | |||
| B1 | Root cause analysis applied: 5-Why, Ishikawa fishbone, or Pareto as appropriate Acceptance: Method evidenced (5-Why log, fishbone diagram); not stop at first answer | Cl. 10.2.1(b) — Cause analysis | OK NC NA HOLD |
| B2 | Root cause categorized: Material / Method / Machine / Manpower / Environment / Measurement Acceptance: 6M categorization; enables trend analysis across CARs | Cl. 9.1.3 — Cause classification | OK NC NA HOLD |
| B3 | Similar past CARs reviewed; systemic patterns identified for major actions Acceptance: Historical CAR search done; patterns flagged; system-level action if recurring | Cl. 10.2.1 — Recurrence prevention | OK NC NA HOLD |
| C. ACTION IMPLEMENTATION CONTROLS | |||
| C1 | Action plan approved by appropriate authority before implementation Acceptance: QA Manager (Minor) or PM (Major) signs action plan; resources confirmed | Cl. 10.2.1(c) — Authorization | OK NC NA HOLD |
| C2 | Implementation evidence captured: photos, training records, document revisions, inspection reports Acceptance: Each action has dated evidence file; cross-referenced in CAR record | Cl. 7.5.3 — Evidence | OK NC NA HOLD |
| C3 | Stakeholders informed when actions affect their processes (training, briefings) Acceptance: Affected staff briefed; training delivered if procedures changed; acknowledgment recorded | Cl. 7.4 — Communication | OK NC NA HOLD |