CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysi
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npx skills add alirezarezvani/claude-skills --skill capa-officer -a cursor -y
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
name: "capa-officer" description: CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization. triggers:
Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.
Conduct systematic CAPA investigation from initiation through closure:
| Trigger Type | CAPA Required | Criteria |
|---|---|---|
| Customer complaint (safety) | Yes | Any complaint involving patient/user safety |
| Customer complaint (quality) | Evaluate | Based on severity and frequency |
| Internal audit finding (Major) | Yes | Systematic failure or absence of element |
| Internal audit finding (Minor) | Recommended | Isolated lapse or partial implementation |
| Nonconformance (recurring) | Yes | Same NC type occurring 3+ times |
| Nonconformance (isolated) | Evaluate | Based on severity and risk |
| External audit finding | Yes | All Major and Minor findings |
| Trend analysis | Evaluate | Based on trend significance |
| CAPA Severity | Required Team Members |
|---|---|
| Critical | CAPA Officer, Process Owner, QA Manager, Subject Matter Expert, Management Rep |
| Major | CAPA Officer, Process Owner, Subject Matter Expert |
| Minor | CAPA Officer, Process Owner |
Select and apply appropriate RCA methodology based on problem characteristics.
Is the issue safety-critical or involves system reliability?
├── Yes → Use FAULT TREE ANALYSIS
└── No → Is human error the suspected primary cause?
├── Yes → Use HUMAN FACTORS ANALYSIS
└── No → How many potential contributing factors?
├── 1-2 factors (linear causation) → Use 5 WHY ANALYSIS
├── 3-6 factors (complex, systemic) → Use FISHBONE DIAGRAM
└── Unknown/proactive assessment → Use FMEA
Use when: Single-cause issues with linear causation, process deviations with clear failure point.
Template:
PROBLEM: [Clear, specific statement]
WHY 1: Why did [problem] occur?
BECAUSE: [First-level cause]
EVIDENCE: [Supporting data]
WHY 2: Why did [first-level cause] occur?
BECAUSE: [Second-level cause]
EVIDENCE: [Supporting data]
WHY 3: Why did [second-level cause] occur?
BECAUSE: [Third-level cause]
EVIDENCE: [Supporting data]
WHY 4: Why did [third-level cause] occur?
BECAUSE: [Fourth-level cause]
EVIDENCE: [Supporting data]
WHY 5: Why did [fourth-level cause] occur?
BECAUSE: [Root cause]
EVIDENCE: [Supporting data]
Example - Calibration Overdue:
PROBLEM: pH meter (EQ-042) found 2 months overdue for calibration
WHY 1: Why was calibration overdue?
BECAUSE: Equipment was not on calibration schedule
EVIDENCE: Calibration schedule reviewed, EQ-042 not listed
WHY 2: Why was it not on the schedule?
BECAUSE: Schedule not updated when equipment was purchased
EVIDENCE: Purchase date 2023-06-15, schedule dated 2023-01-01
WHY 3: Why was the schedule not updated?
BECAUSE: No process requires schedule update at equipment purchase
EVIDENCE: SOP-EQ-001 reviewed, no such requirement
WHY 4: Why is there no such requirement?
BECAUSE: Procedure written before equipment tracking was centralized
EVIDENCE: SOP last revised 2019, equipment system implemented 2021
WHY 5: Why has procedure not been updated?
BECAUSE: Periodic review did not assess compatibility with new systems
EVIDENCE: No review against new equipment system documented
ROOT CAUSE: Procedure review process does not assess compatibility
with organizational systems implemented after original procedure creation.
| Category | Focus Areas | Typical Causes |
|---|---|---|
| Man (People) | Training, competency, workload | Skill gaps, fatigue, communication |
| Machine (Equipment) | Calibration, maintenance, age | Wear, malfunction, inadequate capacity |
| Method (Process) | Procedures, work instructions | Unclear steps, missing controls |
| Material | Specifications, suppliers, storage | Out-of-spec, degradation, contamination |
| Measurement | Calibration, methods, interpretation | Instrument error, wrong method |
| Mother Nature | Temperature, humidity, cleanliness | Environmental excursions |
See references/rca-methodologies.md for complete method details and templates.
Before proceeding to action planning, validate root cause:
Develop effective actions addressing identified root causes:
| Type | Purpose | Timeline | Example |
|---|---|---|---|
| Containment | Stop immediate impact | 24-72 hours | Quarantine affected product |
| Correction | Fix the specific occurrence | 1-2 weeks | Rework or replace affected items |
| Corrective | Eliminate root cause | 30-90 days | Revise procedure, add controls |
| Preventive | Prevent in other areas | 60-120 days | Extend solution to similar processes |
ACTION PLAN TEMPLATE
CAPA Number: [CAPA-XXXX]
Root Cause: [Identified root cause]
ACTION 1: [Specific action description]
- Type: [ ] Containment [ ] Correction [ ] Corrective [ ] Preventive
- Responsible: [Name, Title]
- Due Date: [YYYY-MM-DD]
- Resources: [Required resources]
- Success Criteria: [Measurable outcome]
- Verification Method: [How success will be verified]
ACTION 2: [Specific action description]
...
IMPLEMENTATION TIMELINE:
Week 1: [Milestone]
Week 2: [Milestone]
Week 4: [Milestone]
Week 8: [Milestone]
APPROVAL:
CAPA Owner: _____________ Date: _______
Process Owner: _____________ Date: _______
QA Manager: _____________ Date: _______
| Indicator | Target | Red Flag |
|---|---|---|
| Action scope | Addresses root cause completely | Treats only symptoms |
| Specificity | Measurable deliverables | Vague commitments |
| Timeline | Aggressive but achievable | No due dates or unrealistic |
| Resources | Identified and allocated | Not specified |
| Sustainability | Permanent solution | Temporary fix |
Verify corrective actions achieved intended results:
| CAPA Severity | Wait Period | Verification Window |
|---|---|---|
| Critical | 30 days | 30-90 days post-implementation |
| Major | 60 days | 60-180 days post-implementation |
| Minor | 90 days | 90-365 days post-implementation |
| Method | Use When | Evidence Required |
|---|---|---|
| Data trend analysis | Quantifiable issues | Pre/post comparison, trend charts |
| Process audit | Procedure compliance issues | Audit checklist, interview notes |
| Record review | Documentation issues | Sample records, compliance rate |
| Testing/inspection | Product quality issues | Test results, pass/fail data |
| Interview/observation | Training issues | Interview notes, observation records |
Did recurrence occur during verification period?
├── Yes → CAPA INEFFECTIVE (re-investigate root cause)
└── No → Were all effectiveness criteria met?
├── Yes → CAPA EFFECTIVE (proceed to closure)
└── No → Extent of gap?
├── Minor gap → Extend verification or accept with justification
└── Significant gap → CAPA INEFFECTIVE (revise actions)
See references/effectiveness-verification-guide.md for detailed procedures.
Monitor CAPA program performance through key indicators.
| Metric | Target | Calculation |
|---|---|---|
| CAPA cycle time | <60 days average | (Close Date - Open Date) / Number of CAPAs |
| Overdue rate | <10% | Overdue CAPAs / Total Open CAPAs |
| First-time effectiveness | >90% | Effective on first verification / Total verified |
| Recurrence rate | <5% | Recurred issues / Total closed CAPAs |
| Investigation quality | 100% root cause validated | Root causes validated / Total CAPAs |
| Age Bucket | Status | Action Required |
|---|---|---|
| 0-30 days | On track | Monitor progress |
| 31-60 days | Monitor | Review for delays |
| 61-90 days | Warning | Escalate to management |
| >90 days | Critical | Management intervention required |
Monthly CAPA status report includes:
references/rca-methodologies.md contains:
references/effectiveness-verification-guide.md contains:
# Generate CAPA status report
python scripts/capa_tracker.py --capas capas.json
# Interactive mode for manual entry
python scripts/capa_tracker.py --interactive
# JSON output for integration
python scripts/capa_tracker.py --capas capas.json --output json
# Generate sample data file
python scripts/capa_tracker.py --sample > sample_capas.json
Calculates and reports:
{
"capas": [
{
"capa_number": "CAPA-2024-001",
"title": "Calibration overdue for pH meter",
"description": "pH meter EQ-042 found 2 months overdue",
"source": "AUDIT",
"severity": "MAJOR",
"status": "VERIFICATION",
"open_date": "2024-06-15",
"target_date": "2024-08-15",
"owner": "J. Smith",
"root_cause": "Procedure review gap",
"corrective_action": "Updated SOP-EQ-001"
}
]
}
| Sub-clause | Requirement | Key Activities |
|---|---|---|
| 8.5.2 Corrective Action | Eliminate cause of nonconformity | NC review, cause determination, action evaluation, implementation, effectiveness review |
| 8.5.3 Preventive Action | Eliminate potential nonconformity | Trend analysis, cause determination, action evaluation, implementation, effectiveness review |
⚠️ STATUS — QMSR transition (effective 2026-02-02): FDA's Quality Management System Regulation (QMSR) final rule (89 FR 7496) amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference and removed the legacy QSR subsection structure. The CAPA section number 820.100 no longer exists in the CFR — it is retained below only as a familiar index. The current FDA authority for CAPA is ISO 13485:2016 §8.5.2 (corrective action) and §8.5.3 (preventive action) (see clause table above), with complaint-handling additions in retained 21 CFR 820.35. Cite the ISO 13485 clauses — not 820.100 — in current compliance documentation.
CAPA elements required under ISO 13485 §8.5.2/§8.5.3 (legacy QSR 820.100, historical):
| Observation | Root Cause Pattern |
|---|---|
| CAPA not initiated for recurring issue | Trend analysis not performed |
| Root cause analysis superficial | Inadequate investigation training |
| Effectiveness not verified | No verification procedure |
| Actions do not address root cause | Symptom treatment vs. cause elimination |
Decision discipline: The tools in this skill structure investigations and track CAPA status — they do not certify CAPA closure or compliance. CAPA effectiveness conclusions and closure decisions are yours to make and must be reviewed and signed off by the named CAPA owner and Quality function; route regulatory-classification questions (e.g., reportability, 21 CFR 803 MDR, recall under 21 CFR 806) to Regulatory Affairs.