Deviation to CAPA

Step by step

1. Exception entry QA Manager

   QA Manager opens a deviation on the affected batch and records its type, severity, description and due date.

   • Identifies the lot and issue
   • Updates Deviations, Batches

2. Investigation QA Manager

   QA Manager follows the deviation from Open to under investigation and records a root cause when identified.

   • Preserves root cause and equipment context
   • Updates Deviations, Equipment

3. Action assignment QA Manager

   QA Manager creates a linked corrective or preventive action, records its plan and owner name, and moves the deviation to capa assigned.

   • Connects plan and owner to investigation
   • Updates Capa actions, Deviations

4. Action completion QA Manager

   The action owner performs the plan; QA Manager records the completion date and checks what was done.

   • Records work and completion date
   • Updates Capa actions

5. Effectiveness review QA Manager

   QA Manager records the effectiveness check result and decides whether the CAPA is Effective or needs more work.

   • Records result and action status
   • Updates Capa actions
   ApprovalA person approves before the work moves on.

6. Batch review QA Manager

   QA Manager considers the deviation and CAPA state when deciding whether the lot may be approved.

   • Carries the evidence into the lot decision
   • Updates Batches, Deviations, Capa actions
   ApprovalA person approves before the work moves on.

QA Manager

Owns investigation and effectiveness review.

Production Manager

Supplies lot context.

Equipment Coordinator

Checks an affected asset.

Qualified Person

Considers the findings during release review.