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Flow Chart Change Control

This flowchart outlines the change control process for a quality management system. It involves 5 main steps: 1) change initiation proposed by a department head, 2) assessment of the change by the QMS coordinator, 3) assignment of action items by the QMS coordinator, 4) implementation of the change and review for closure, and 5) effective verification and final closure of the change control by management. Key parties involved include the initiator, affected departments, QMS coordinator, and senior management for approval of major changes.

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JAGADISH PHARMACEUTICALS
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© © All Rights Reserved
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191 views

Flow Chart Change Control

This flowchart outlines the change control process for a quality management system. It involves 5 main steps: 1) change initiation proposed by a department head, 2) assessment of the change by the QMS coordinator, 3) assignment of action items by the QMS coordinator, 4) implementation of the change and review for closure, and 5) effective verification and final closure of the change control by management. Key parties involved include the initiator, affected departments, QMS coordinator, and senior management for approval of major changes.

Uploaded by

JAGADISH PHARMACEUTICALS
Copyright
© © All Rights Reserved
Available Formats
Download as ODT, PDF, TXT or read online on Scribd
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Format No.: QA010-F04.

04
ANNEXURE – IV Effective Date
Page No. 1 of 2
TITLE FLOWCHART FOR CHANGE CONTROL

A : Change Initiation

Initiator

If any
HOD of initiating department
corrections/addition
al information
required
B : Assessment of Change
Evaluation by QMS Coordinator

Comments from Change


control Committee who
are effected by the change QMS ( Not accepted )
control. Coordinator

Cross Functional Review & impact


Assessment
Senoir
(If applicable) (If Major Change Controls)
Customer Comments Management
Review
QMS Cordinator Review

Approval/Reject by
Head/Designee - QA

Prepared By Reviewed By Approved By


Sign&Date
Format No.: QA001-F10.01
Format No.: QA010-F04.04
ANNEXURE – IV Effective Date
Page No. 2 of 2
TITLE FLOWCHART FOR CHANGE CONTROL

C. Action Item Assignment Change Control & Closure

Assignment of Action items By


QMS Coordinator

Reviewed by Respective
Department Head

QMS Coordinator Comments


(If Required)

Extension 1 Extension 2 Extension 3

QMS Coordinator Review

Head/Designee - QA Comments

Senior Management Comments

D. Change Implementation and Review for Closure

QMS Coordinator Review


(If Required)

E. Effective Verification & Final Closure

Closure of Change Control


by Head/Designee - QA

Prepared By Reviewed By Approved By


Sign&Date
Format No.: QA001-F10.01

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