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Capa Officer

  • 794 installs
  • 23.5k repo stars
  • Updated July 17, 2026
  • alirezarezvani/claude-skills

capa-officer is a quality-systems skill that guides Corrective and Preventive Action effectiveness verification, closure criteria, and documentation so developers in regulated industries confirm fixes actually resolved r

About

capa-officer is an effectiveness verification guide from alirezarezvani/claude-skills for CAPA (Corrective and Preventive Action) programs in regulated environments. It defines verification planning before corrective action implementation, verification methods, effectiveness criteria, closure requirements, and ineffective-CAPA escalation procedures with documentation templates. Developers and quality engineers use capa-officer when closing CAPA records and must prove corrective actions eliminated root causes rather than symptoms. The skill structures stage-gated planning across CAPA initiation, implementation, and closure with owner assignments. Output includes verification plans, effectiveness assessment records, and closure documentation aligned to ISO and FDA quality expectations.

  • Verification planning before corrective action implementation
  • Severity-based wait periods: 30 days for critical, 60 for major, 90 for minor
  • Four verification methods with effectiveness criteria
  • Closure requirements and documentation templates
  • Explicit guidance on what makes a CAPA process ineffective

Capa Officer by the numbers

  • 794 all-time installs (skills.sh)
  • +12 installs in the week ending Jul 28, 2026 (Skillselion tracking)
  • Ranked #175 of 1,356 Code Review & Quality skills by installs in the Skillselion catalog
  • Security screen: MEDIUM risk (skills.sh audit)
  • Data as of Jul 31, 2026 (Skillselion catalog sync)
npx skills add https://github.com/alirezarezvani/claude-skills --skill capa-officer

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repo stars23.5k
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Last updatedJuly 17, 2026
Repositoryalirezarezvani/claude-skills

How do you verify CAPA corrective actions are effective?

Systematically verify that corrective actions taken by agents actually solved the underlying problem before closing the loop.

Who is it for?

Quality engineers in regulated software or medical-device organizations closing CAPA records with documented effectiveness verification.

Skip if: General software bug triage without formal CAPA quality-system requirements should skip capa-officer.

When should I use this skill?

A developer or quality engineer asks about CAPA effectiveness verification, closure criteria, or corrective action documentation.

What you get

CAPA verification plan, effectiveness assessment record, and closure documentation package.

  • Verification plan document
  • Effectiveness assessment record
  • CAPA closure documentation

Files

SKILL.mdMarkdownGitHub ↗

CAPA Officer

Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.

---

Table of Contents

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CAPA Investigation Workflow

Conduct systematic CAPA investigation from initiation through closure:

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 TypeCAPA RequiredCriteria
Customer complaint (safety)YesAny complaint involving patient/user safety
Customer complaint (quality)EvaluateBased on severity and frequency
Internal audit finding (Major)YesSystematic failure or absence of element
Internal audit finding (Minor)RecommendedIsolated lapse or partial implementation
Nonconformance (recurring)YesSame NC type occurring 3+ times
Nonconformance (isolated)EvaluateBased on severity and risk
External audit findingYesAll Major and Minor findings
Trend analysisEvaluateBased on trend significance

Investigation Team Composition

CAPA SeverityRequired Team Members
CriticalCAPA Officer, Process Owner, QA Manager, Subject Matter Expert, Management Rep
MajorCAPA Officer, Process Owner, Subject Matter Expert
MinorCAPA 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.

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.

Fishbone Diagram Categories (6M)

CategoryFocus AreasTypical Causes
Man (People)Training, competency, workloadSkill gaps, fatigue, communication
Machine (Equipment)Calibration, maintenance, ageWear, malfunction, inadequate capacity
Method (Process)Procedures, work instructionsUnclear steps, missing controls
MaterialSpecifications, suppliers, storageOut-of-spec, degradation, contamination
MeasurementCalibration, methods, interpretationInstrument error, wrong method
Mother NatureTemperature, humidity, cleanlinessEnvironmental 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
  • [ ] Root cause is within organizational control
  • [ ] Root cause explains all observed symptoms
  • [ ] No other significant causes remain unaddressed

---

Corrective Action Planning

Develop effective actions addressing identified root causes:

1. Define immediate containment actions 2. Develop corrective actions targeting root cause 3. Identify preventive actions for similar processes 4. Assign responsibilities and resources 5. Establish timeline with milestones 6. Define success criteria and verification method 7. Document in CAPA action plan 8. Validation: Actions directly address root cause; success criteria are measurable

Action Types

TypePurposeTimelineExample
ContainmentStop immediate impact24-72 hoursQuarantine affected product
CorrectionFix the specific occurrence1-2 weeksRework or replace affected items
CorrectiveEliminate root cause30-90 daysRevise procedure, add controls
PreventivePrevent in other areas60-120 daysExtend solution to similar processes

Action Plan Components

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: _______

Action Effectiveness Indicators

IndicatorTargetRed Flag
Action scopeAddresses root cause completelyTreats only symptoms
SpecificityMeasurable deliverablesVague commitments
TimelineAggressive but achievableNo due dates or unrealistic
ResourcesIdentified and allocatedNot specified
SustainabilityPermanent solutionTemporary fix

---

Effectiveness Verification

Verify corrective actions achieved intended results:

1. Allow adequate implementation period (minimum 30-90 days) 2. Collect post-implementation data 3. Compare to pre-implementation baseline 4. Evaluate against success criteria 5. Verify no recurrence during verification period 6. Document verification evidence 7. Determine CAPA effectiveness 8. Validation: All criteria met with objective evidence; no recurrence observed

Verification Timeline Guidelines

CAPA SeverityWait PeriodVerification Window
Critical30 days30-90 days post-implementation
Major60 days60-180 days post-implementation
Minor90 days90-365 days post-implementation

Verification Methods

MethodUse WhenEvidence Required
Data trend analysisQuantifiable issuesPre/post comparison, trend charts
Process auditProcedure compliance issuesAudit checklist, interview notes
Record reviewDocumentation issuesSample records, compliance rate
Testing/inspectionProduct quality issuesTest results, pass/fail data
Interview/observationTraining issuesInterview 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.

Key Performance Indicators

MetricTargetCalculation
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 quality100% root cause validatedRoot causes validated / Total CAPAs

Aging Analysis Categories

Age BucketStatusAction Required
0-30 daysOn trackMonitor progress
31-60 daysMonitorReview for delays
61-90 daysWarningEscalate to management
>90 daysCriticalManagement intervention required

Management Review Inputs

Monthly CAPA status report includes:

  • Open CAPA count by severity and status
  • Overdue CAPA list with owners
  • Cycle time trends
  • Effectiveness rate trends
  • Source analysis (complaints, audits, NCs)
  • Recommendations for improvement

---

Reference Documentation

Root Cause Analysis Methodologies

references/rca-methodologies.md contains:

  • Method selection decision tree
  • 5 Why analysis template and example
  • Fishbone diagram categories and template
  • Fault Tree Analysis for safety-critical issues
  • Human Factors Analysis for people-related causes
  • FMEA for proactive risk assessment
  • Hybrid approach guidance

Effectiveness Verification Guide

references/effectiveness-verification-guide.md contains:

  • Verification planning requirements
  • Verification method selection
  • Effectiveness criteria definition (SMART)
  • Closure requirements by severity
  • Ineffective CAPA process
  • Documentation templates

---

Tools

CAPA Tracker

# 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-clauseRequirementKey Activities
8.5.2 Corrective ActionEliminate cause of nonconformityNC review, cause determination, action evaluation, implementation, effectiveness review
8.5.3 Preventive ActionEliminate potential nonconformityTrend analysis, cause determination, action evaluation, implementation, effectiveness review

FDA CAPA authority — ISO 13485 §8.5.2/8.5.3 under the QMSR (legacy QSR 820.100, historical)

⚠️ 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):

  • 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

Common FDA 483 Observations

ObservationRoot Cause Pattern
CAPA not initiated for recurring issueTrend analysis not performed
Root cause analysis superficialInadequate investigation training
Effectiveness not verifiedNo verification procedure
Actions do not address root causeSymptom 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.

Related skills

How it compares

Use capa-officer for formal CAPA quality closure; use generic debugging skills for non-regulated bug fixes without audit trails.

FAQ

When should CAPA verification planning happen?

capa-officer requires verification planning before corrective action implementation begins. Planning at CAPA initiation defines methods, effectiveness criteria, and owners so closure evidence is collected proactively.

What does capa-officer produce at closure?

capa-officer produces effectiveness assessment records, verification evidence, and closure documentation templates. Quality teams use these artifacts to prove corrective actions resolved root causes before formally closing CAPA records.

Is Capa Officer safe to install?

skills.sh reports 2 of 3 security scanners passed. Review the Security Audits panel on this page before installing in production.

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