CAPA Officer

Corrective and Preventive Action (CAPA) management within Quality Management Systems.

CAPA Investigation Workflow

1. Document trigger event with objective evidence
2. Assess significance and determine CAPA necessity
3. Form investigation team with relevant expertise
4. Collect data and evidence systematically
5. Select and apply appropriate RCA methodology
6. Identify root cause(s) with supporting evidence
7. Develop corrective and preventive actions
8. Validation: Root cause explains all symptoms; if eliminated, problem would not recur

CAPA Necessity Determination

Trigger Type	CAPA Required	Criteria
Customer complaint (safety)	Yes	Any involving patient/user safety
Internal audit finding (Major)	Yes	Systematic failure or absence
Nonconformance (recurring)	Yes	Same NC type 3+ times
External audit finding	Yes	All Major and Minor findings
Customer complaint (quality)	Evaluate	Based on severity and frequency
Trend analysis	Evaluate	Based on significance

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Root Cause Analysis

Select methodology based on problem characteristics:

• 5 Why Analysis — Single-cause issues with linear causation
• Fishbone Diagram (6M) — Complex systemic issues with 3-6 factors
• Fault Tree Analysis — Safety-critical or system reliability issues
• Human Factors Analysis — Human error as suspected primary cause
• FMEA — Proactive risk assessment

Root Cause Validation Checklist

• Root cause verified with objective evidence
• If eliminated, problem would not recur
• Within organizational control
• Explains all observed symptoms

For complete RCA method details, decision tree, 5-Why template with example, and fishbone categories, see references/rca-methodologies.md.

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Corrective Action Planning

Type	Purpose	Timeline
Containment	Stop immediate impact	24-72 hours
Correction	Fix specific occurrence	1-2 weeks
Corrective	Eliminate root cause	30-90 days
Preventive	Prevent in other areas	60-120 days

For action plan template, effectiveness indicators, and implementation timeline, see references/effectiveness-verification-guide.md.

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Effectiveness Verification

1. Allow adequate implementation period (30-90 days minimum)
2. Collect post-implementation data
3. Compare to pre-implementation baseline
4. Evaluate against success criteria
5. Verify no recurrence during verification period
6. Validation: All criteria met with objective evidence

Verification Timeline

CAPA Severity	Wait Period	Verification Window
Critical	30 days	30-90 days
Major	60 days	60-180 days
Minor	90 days	90-365 days

For verification methods, effectiveness determination decision tree, and closure requirements, see references/effectiveness-verification-guide.md.

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CAPA Metrics

Metric	Target
CAPA cycle time	<60 days average
Overdue rate	<10%
First-time effectiveness	>90%
Recurrence rate	<5%

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Tools and References

Tool	Purpose
capa_tracker.py	Generate CAPA status reports and metrics

Document	Content
rca-methodologies.md	5-Why, Fishbone, FTA, Human Factors, FMEA templates
effectiveness-verification-guide.md	Verification planning, methods, action plans, closure

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Regulatory Requirements

ISO 13485:2016 Clause 8.5

• 8.5.2 Corrective Action: Eliminate cause of nonconformity
• 8.5.3 Preventive Action: Eliminate potential nonconformity

FDA 21 CFR 820.100

Required elements: procedures, quality data analysis, cause investigation, action identification, effectiveness verification, management review submission.