SOP-CAPA-001 CAPA Procedure

Purpose

Establish process for corrective and preventive actions based on quality data.

Inputs

• Nonconformance reports
• Complaints
• Audit findings
• Trend analysis

CAPA Flow

1. Open CAPA with problem statement.
2. Perform root cause analysis.
3. Define corrective and preventive actions.
4. Implement actions with owners and due dates.
5. Verify effectiveness and close.

Metrics

• Open CAPA aging
• Overdue actions
• Effectiveness check pass rate