CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
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CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
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CAPA Officer
Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.
CAPA Officer, Process Owner, Subject Matter Expert
Minor
CAPA Officer, Process Owner
Evidence Collection Checklist
Problem description with specific details (what, where, when, who, how much)
Timeline of events leading to issue
Relevant records and documentation
Interview notes from involved personnel
Photos or physical evidence (if applicable)
Related complaints, NCs, or previous CAPAs
Process parameters and specifications
Root Cause Analysis
Select and apply appropriate RCA methodology based on problem characteristics.
RCA Method Selection Decision Tree
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
5 Why Analysis
Use when: Single-cause issues with linear causation, process deviations with clear failure point.
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.
Fishbone Diagram Categories (6M)
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.
Root Cause Validation
Before proceeding to action planning, validate root cause:
Root cause can be verified with objective evidence
If root cause is eliminated, problem would not recur
Allow adequate implementation period (minimum 30-90 days)
Collect post-implementation data
Compare to pre-implementation baseline
Evaluate against success criteria
Verify no recurrence during verification period
Document verification evidence
Determine CAPA effectiveness
Validation: All criteria met with objective evidence; no recurrence observed
Verification Timeline Guidelines
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
Verification Methods
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
Effectiveness Determination
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.
CAPA Metrics and Reporting
Monitor CAPA program performance through key indicators.
# 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:
Summary metrics (open, closed, overdue, cycle time, effectiveness)
Status distribution
Severity and source analysis
Aging report by time bucket
Overdue CAPA list
Actionable recommendations
Sample CAPA Input
{"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"}]}
Regulatory Requirements
ISO 13485:2016 Clause 8.5
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
FDA 21 CFR 820.100
Required CAPA elements:
Procedures for implementing corrective and preventive action
Analyzing quality data sources (complaints, NCs, audits, service records)
Investigating cause of nonconformities
Identifying actions needed to correct and prevent recurrence
Verifying actions are effective and do not adversely affect device
Submitting relevant information for management review
