F-QM-011-A-V0 — Corrective and Preventive Action (CAPA) Record & Master Log
Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.
Parent document: LAB-QM-011 — Corrective and Preventive Action (CAPA) Policy (parent is encoded in the form number)
Rendered in-browser from the project's Word file F-QM-011-A-V0-corrective-and-preventive-action-capa-record.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.
| Document # | F-QM-011-A-V0 | Parent Document | LAB-QM-011 — Corrective and Preventive Action Policy |
|---|
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# SECTION A — CAPA RECORD & INVESTIGATION DOSSIER
Part 1 — CAPA Initiation & Classification
| Field | Details |
|---|---|
| CAPA Ref. No.: | CAPA-YYYY-____ |
| Date Initiated: | YYYY-MM-DD |
| Initiated By: | Full Name: ____________________________________ [ ] CMT / LQM [ ] RMT [ ] Pathologist |
| Section Involved: | [ ] Hematology [ ] Clinical Microscopy [ ] Serology [ ] Pre-Analytical [ ] Cross-Sectional |
1.1 Action Category
- [ ] CORRECTIVE ACTION (Reactive): Eliminates root cause of an identified nonconformity, audit finding, or clinical error to prevent recurrence.
- [ ] PREVENTIVE ACTION (Proactive): Eliminates potential failure mode or unfavorable trend identified through risk assessment to prevent occurrence.
1.2 Primary Source Trigger
- [ ] Internal Quality Audit Finding / Deficiency (Internal Audit)
- [ ] Regulatory Inspection Finding (DOH / HFSRB licensing visit)
- [ ] External Quality Assessment / PT Discordant Result (Proficiency Testing Policy)
- [ ] Occurrence or Incident Escalation (Occurrence Management Policy)
- [ ] Repeated Internal QC Failure or Out-of-Control Westgard Trend (Quality Control Policy)
- [ ] Risk Assessment or Proactive Vulnerability Identification (Risk Management)
- [ ] Formal Client / Clinical Complaint Escalation
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Part 2 — Problem / Vulnerability Description & Immediate Containment
2.1 Statement of Nonconformity or Potential Problem
(Clearly describe the nonconformance or vulnerability, citing objective evidence and affected processes): ____________________________________________________________________________________________________ ____________________________________________________________________________________________________
2.2 Immediate Containment / Correction Taken
(Steps immediately implemented to isolate affected results, quarantine reagents, or protect patient care): ____________________________________________________________________________________________________
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Part 3 — Root Cause Analysis (5-Whys Inquiry)
| Level | 5-Whys Diagnostic Question & Investigation Finding |
|---|---|
| Why 1: | Direct problem manifestation: _________________________________________________________________ |
| Why 2: | Underlying process breakdown: _________________________________________________________________ |
| Why 3: | Methodological or procedural failure: _________________________________________________________ |
| Why 4: | Control, training, or maintenance deficiency: _________________________________________________ |
| Why 5 (Root Cause): | Systemic or management root failure mode: ___________________________________________________ |
Root Cause Category: [ ] Human Factors & Training [ ] Equipment & Maintenance [ ] Reagents & Kits [ ] Environment & Facility [ ] Procedure & Policy
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Part 4 — Action Plan & Implementation Milestones
| Step # | Corrective / Preventive Action Details | Responsible Owner | Target Date | Actual Completion Date | Evidence of Completion |
|---|---|---|---|---|---|
| 1 | |||||
| 2 | |||||
| 3 |
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Part 5 — Follow-Up Effectiveness Verification & Closed-Loop Sign-Off
Conducted after an operational monitoring interval (typically 30–90 days) to confirm nonconformity has not recurred:
| Verification Criterion | Evaluation Result | Supporting Evidence / Audit Findings |
|---|---|---|
| 1. Have all planned actions been fully implemented? | [ ] Yes [ ] No | |
| 2. Has the nonconformity or root cause recurred? | [ ] Yes [ ] No | |
| 3. Are internal QC / PT / daily performance indicators stable? | [ ] Yes [ ] No | |
| Effectiveness Determination: | [ ] EFFECTIVE (Close CAPA) [ ] INEFFECTIVE (Re-open RCA) |
| Role | Name | Signature | Date |
|---|---|---|---|
| Assigned CAPA Owner: | |||
| Verified by (CMT / LQM): | Junry, RMT | ||
| Approved & Closed by (Pathologist): |
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# SECTION B — CAPA MASTER TRACKING LOG
The Chief Medical Technologist / Laboratory Quality Manager maintains this log to track all CAPAs through verified closure:
| CAPA Ref. No. | Date Opened | Type (CA/PA) | Source Trigger | Section | Brief Summary of Root Cause | Action Owner | Target Due Date | Follow-up Date | Effectiveness (Pass/Fail) | Status | Date Closed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CAPA-26-01 | [ ] Open [ ] Closed | ||||||||||
| CAPA-26-02 | [ ] Open [ ] Closed | ||||||||||
| CAPA-26-03 | [ ] Open [ ] Closed | ||||||||||
| CAPA-26-04 | [ ] Open [ ] Closed |
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Semi-Annual CAPA Performance & Trend Review
Reviewed semi-annually by the CMT / LQM and Pathologist as an input to Management Review per LAB-QM-013:
| Review Period | Total CAPAs Opened (CA / PA) | Closed On-Time | Overdue / Extended | Repeat Occurrences Detected | Effectiveness Pass Rate (%) | Reviewer Initials | Date Reviewed |
|---|---|---|---|---|---|---|---|
| Jan – Jun 2026 | |||||||
| Jul – Dec 2026 |