CAPA (Corrective and Preventive Actions) Management

Learn how to manage Corrective and Preventive Actions within Masetra Quality Management System

📋 What are CAPAs?

CAPA (Corrective and Preventive Actions) is a quality management process used to identify, investigate, and eliminate the root causes of deviations, non-conformances, and other quality issues. The goal is to prevent recurrence of problems and improve overall quality systems.

🚀 Creating a CAPA

Automatic CAPA Creation

CAPAs can be automatically generated from:

  • Closed Deviations with unresolved root causes
  • Audit Findings requiring corrective actions
  • Complaint Investigations identifying systemic issues

Manual CAPA Creation

  1. Navigate to “CAPA” module
  2. Click “New CAPA” button
  3. Select source (Deviation, Audit, Complaint, or Manual)
  4. Enter CAPA details:
    • Title: Clear, descriptive title
    • Description: Detailed problem statement
    • Priority: Low, Medium, High, Urgent
    • Department: Responsible department
    • Target Completion Date: Expected resolution date

🔧 CAPA Workflow

Phase 1: Initiation

  • Problem Statement definition
  • Immediate Actions documentation
  • Assignment to responsible personnel
  • Timeline establishment

Phase 2: Investigation

  • Root Cause Analysis using 5 Whys, Fishbone, or other methods
  • Impact Assessment on products, processes, and systems
  • Evidence Collection and documentation
  • Investigation Summary preparation

Phase 3: Action Planning

  • Corrective Actions to address immediate issues
  • Preventive Actions to prevent future occurrences
  • Resource Allocation assignment
  • Milestone Definition with due dates

Phase 4: Implementation

  • Action Execution by responsible parties
  • Progress Tracking through milestone updates
  • Documentation of implementation activities
  • Evidence Collection for effectiveness verification

Phase 5: Effectiveness Check

  • Verification Testing of implemented actions
  • Performance Monitoring over time
  • Data Analysis to confirm problem resolution
  • Final Assessment documentation

Phase 6: Closure

  • Management Review and approval
  • Final Documentation completion
  • Archive for future reference
  • Lessons Learned capture

📊 CAPA Tracking and Monitoring

Dashboard Views

  • Open CAPAs: Currently active CAPAs
  • Overdue CAPAs: CAPAs past due dates
  • Completed CAPAs: Recently closed CAPAs
  • Effectiveness Status: Verification results

Progress Indicators

  • Completion Percentage: Overall progress
  • Milestone Status: Individual task completion
  • Timeline Adherence: On-time performance
  • Resource Utilization: Team workload

📈 Reporting and Analytics

Standard Reports

  • CAPA Summary Report: Monthly CAPA statistics
  • Effectiveness Report: Action success rates
  • Department Performance: CAPA completion by department
  • Trend Analysis: Recurring issues identification
  • Cost Analysis: Resource allocation tracking

Custom Reporting

  • Date Range Selection: Flexible reporting periods
  • Filter Options: Department, priority, status filters
  • Export Formats: PDF, Excel, CSV
  • Scheduled Reports: Automated delivery

⚙️ Configuration Options

CAPA Categories

  • Process Improvement: Systematic process enhancements
  • Equipment Maintenance: Equipment-related actions
  • Training Enhancement: Personnel development needs
  • Procedure Update: Documentation improvements
  • Supplier Management: Vendor-related actions

Priority Levels

  • Low: Routine improvements, no immediate impact
  • Medium: Important improvements, moderate impact
  • High: Significant issues, major impact potential
  • Urgent: Critical issues, immediate attention required

Approval Workflow

  • Single Approval: Direct management approval
  • Multi-Level Approval: Department head + QA + Management
  • Custom Workflow: Configurable approval chains

🔒 Compliance Features

Audit Trail

All CAPA activities are comprehensively logged:

  • User Actions: Who performed what action
  • Timestamps: When actions occurred
  • Change History: Before/after values
  • Comments: Explanatory notes

Regulatory Compliance

  • FDA 21 CFR Part 11: Electronic signature and record compliance
  • ISO 9001: Quality management system requirements
  • GMP Guidelines: Good Manufacturing Practice adherence
  • EMA Standards: European Medicines Agency compliance

Documentation Requirements

  • Traceability: Link to source deviations/audits
  • Evidence Management: Attachment and version control
  • Approval Records: Digital signature tracking
  • Retention Policies: Automated archive management

🤝 Integration with Other Modules

Deviations Module

  • Automatic Linking: CAPA creation from deviations
  • Shared Data: Common reference information
  • Workflow Integration: Seamless process flow

Audit Management

  • Finding Resolution: CAPA generation from audit findings
  • Compliance Tracking: Regulatory requirement fulfillment
  • Report Integration: Combined reporting capabilities

Document Control

  • Procedure Updates: Automated document revision triggers
  • Training Requirements: CAPA-related training assignments
  • Version Control: Document change management

📞 Support

For questions about CAPA management, contact info@masetra.com or call +256-760-927180.

Last updated: July 30, 2025