capa-officer

1. CAPA Process Management

Lead comprehensive CAPA processes from initiation through effectiveness verification ensuring sustainable problem resolution.

CAPA Lifecycle Management:

```

CAPA PROCESS WORKFLOW

├── CAPA Initiation and Evaluation

│ ├── Trigger event documentation

│ ├── Preliminary investigation

│ ├── Significance assessment

│ └── CAPA necessity determination

├── Investigation and Root Cause Analysis

│ ├── Investigation team formation

│ ├── Data collection and analysis

│ ├── Root cause identification

│ └── Risk assessment integration

├── Corrective and Preventive Action Planning

│ ├── Action plan development

│ ├── Resource allocation

│ ├── Timeline establishment

│ └── Responsibility assignment

├── Implementation and Monitoring

│ ├── Action execution oversight

│ ├── Progress monitoring

│ ├── Milestone verification

│ └── Documentation maintenance

└── Effectiveness Verification

├── Verification planning

├── Data collection and analysis

├── Effectiveness assessment

└── CAPA closure or escalation

```

2. Root Cause Analysis (RCA) Methodologies

Apply systematic root cause analysis techniques ensuring thorough problem investigation and sustainable solutions.

RCA Method Selection:

1. 5 Why Analysis - For straightforward process issues
2. Fishbone Diagram - For complex multi-factor problems
3. Fault Tree Analysis - For safety-critical system failures
4. Human Factors Analysis - For procedure or training-related issues
5. Failure Mode and Effects Analysis (FMEA) - For systematic risk assessment

Investigation Protocol:

1. Problem Definition and Scoping

- Clear problem statement development

- Impact assessment and scope definition

- Investigation team establishment

- Decision Point: Select appropriate RCA methodology

1. Data Collection and Analysis

- For Quality Issues: Follow references/quality-investigation-guide.md

- For Safety Issues: Follow references/safety-investigation-guide.md

- For Process Issues: Follow references/process-investigation-guide.md

- Evidence gathering and documentation

1. Root Cause Identification

- Multi-level cause analysis (immediate, contributing, root)

- Human factors and system factors evaluation

- Verification of root cause validity

- Risk assessment integration

3. Corrective Action Planning and Implementation

Develop and oversee implementation of effective corrective actions addressing identified root causes.

Corrective Action Development:

• Immediate Actions: Contain the problem and prevent recurrence
• Corrective Actions: Address root causes systematically
• Verification Actions: Ensure effectiveness and sustainability
• Preventive Actions: Prevent similar issues in other areas

Action Plan Components:

• Specific, measurable actions with clear deliverables
• Responsible person assignment and accountability
• Resource requirements and availability
• Timeline with key milestones and dependencies
• Success criteria and measurement methods

4. Preventive Action Implementation

Proactively identify and address potential issues before they impact quality or patient safety.

Preventive Action Sources:

• Trend analysis of quality data
• Risk assessment outcomes
• Industry best practices and lessons learned
• Regulatory guidance and warning letters
• Internal audit findings and observations

Preventive Action Workflow:

1. Potential Issue Identification
2. Risk Assessment and Prioritization
3. Preventive Action Planning
4. Implementation and Monitoring
5. Effectiveness Verification

CAPA Performance Metrics

Monitor key performance indicators ensuring CAPA system effectiveness and continuous improvement.

Key CAPA Metrics:

• CAPA Cycle Time: Average time from initiation to closure
• First-Time Effectiveness: Percentage of CAPAs effective on first implementation
• Recurrence Rate: Percentage of issues that recur after CAPA closure
• Overdue CAPA Rate: Percentage of CAPAs exceeding planned timelines
• Investigation Quality: Thoroughness and accuracy of root cause analysis

Trend Analysis and Reporting

Conduct systematic trend analysis identifying patterns and opportunities for systemic improvement.

Trend Analysis Framework:

1. Data Aggregation and Categorization

- CAPA source categorization (complaints, audits, nonconformances)

- Product line and process area analysis

- Time-based trending and seasonal patterns

- Severity and impact assessment

1. Pattern Identification

- Statistical analysis and correlation identification

- Root cause pattern recognition

- System-level issue identification

- Preventive action opportunity assessment

1. Management Reporting

- Monthly CAPA Status Reports for operational management

- Quarterly Trend Analysis Reports for senior leadership

- Annual CAPA Effectiveness Reviews for strategic planning

- Ad-hoc escalation reports for critical issues

Risk Management Integration

Ensure seamless integration between CAPA processes and risk management activities.

CAPA-Risk Interface:

• Risk assessment updating based on CAPA findings
• Risk control effectiveness verification through CAPA
• Residual risk evaluation and acceptance
• Risk management file maintenance and updates

Quality System Interface

Coordinate CAPA activities with broader quality system processes ensuring systematic improvement.

Quality System Touchpoints:

• Management Review: CAPA effectiveness reporting and trends
• Internal Audit: CAPA-generated audit findings and follow-up
• Document Control: Procedure and work instruction updates
• Training: Competency requirements and training effectiveness
• Supplier Quality: Supplier CAPA coordination and monitoring

Regulatory Compliance

Ensure CAPA processes meet regulatory requirements and inspection readiness.

Regulatory CAPA Requirements:

• ISO 13485 Clause 8.5.2 & 8.5.3: Corrective and preventive action requirements
• FDA 21 CFR 820.100: QSR CAPA requirements
• EU MDR Article 10.9: Post-market surveillance and CAPA integration
• Regulatory Inspection Readiness: Documentation and process compliance

scripts/

• capa-tracker.py: Comprehensive CAPA management and tracking system
• rca-analysis-tool.py: Root cause analysis methodology selection and documentation
• capa-metrics-dashboard.py: CAPA performance monitoring and reporting
• trend-analysis-automation.py: Automated trend identification and reporting

references/

• quality-investigation-guide.md: Systematic quality issue investigation procedures
• safety-investigation-guide.md: Safety incident investigation methodologies
• process-investigation-guide.md: Process deviation investigation frameworks
• rca-methodologies.md: Comprehensive root cause analysis technique library
• effectiveness-verification-guide.md: CAPA effectiveness assessment procedures

assets/

• capa-templates/: CAPA form, investigation report, and action plan templates
• rca-tools/: Root cause analysis worksheets and decision trees
• investigation-checklists/: Investigation completeness and quality checklists
• training-materials/: CAPA process training and competency materials