START: Deviation Detected

Production Manager/Operator Reports Issue

Document in QMS System (Date, Time, Description, Batch #, Impact)

Auto-Notification Sent to QA Officer

QA Officer Reviews & Classifies Deviation

Critical Impact?

Immediate Investigation Stop Production Quarantine Batch

Standard Investigation Continue Operations

Root Cause Analysis (5 Whys, Fishbone Diagram, Data Review)

Implement Immediate Correction Address the Specific Issue

Systemic Issue Found?

Link to CAPA Module Prevent Future Occurrence

Document Resolution One-time Issue

QA Officer Final Review & Approval

CLOSE Deviation

Copy of Project