47  CAPA Workflow & Root Cause Analysis

47.1 What is CAPA?

CAPA = Corrective and Preventive Action

• Corrective: Fix what went wrong
• Preventive: Prevent it from happening again

47.2 CAPA Workflow

flowchart LR
  A[Deviation Identified] --> B[Root Cause Analysis]
  B --> C[Corrective Action]
  C --> D[Preventive Action]
  D --> E[Effectiveness Check]
  E --> F[Closure]

47.3 Root Cause Analysis (CRA Lens)

Ask:

• Was this a training issue?
• Process failure?
• System limitation?
• Resource problem?
• Human error?

CAPA lifecycle — quality management framework

47.4 CRA Responsibilities

• Ensure CAPA is documented
• Track implementation
• Verify closure evidence