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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

by AAAAAA

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