Complaints Nonconformance Internal Audit External Audit Adverse Trend in

from Customer Report Finding Finding Manufacturing

Customer
Support
Escalatation
to QA

Continue to track D1: Initiate CAPA

and trend the No Initiate CAPA? Yes and Document in
issue Arena

D2: Identify Team

D3 :Containment
Actions

D4: Root Cause

No
Analysis
No

D7a:
Implementation of D5:
D7b: PA D6: CA
D8: CAPA Closed Yes Preventive Yes Implementation of
Effective? Effective?
Action(s) Corrective Action