Department : CORP QA

Document No : SOP/CQA/01

ADVIK Standard Operating Procedure for Change Point Control Revision No : 00

Revision Date : 17.08.2015
Origin Date: 17.08.2015
ISO /TS -Clause No : 6.3.2 ,7.1.4

PURPOSE :-
This Procedure Provide guidelines to Control all Change Points wrt Part Drawing Specification, Labour, Manufacturing Process, Manufacturing Method or Process Condition etc at
Inhouse as well as Supplier End.

SCOPE:

This Procedure is applicable for Overall Chage Management of Product Eg : Specification Change, 4M Condition Change, Quality Improvement Change, Self Controlled Changes etc.

All changes must be recorded in 4M Change Record Register and Maintain the tracebility of all Change Points.

RESPONSIBILITY :-
HOD ME, HOD QA, HOD PROD ,HOD R&D from Corporate Plant and QA of Respective Plant is responsible for Compliance of the System.

Flowchart:-
4M CONDITION CHANGES ,CHANGES DUE TO QUALITY PROBLEMS(
SPECIFICATION CHANGE FIELD OR WARRANTY COMPLAINTS). SELF CONTROLLED
CHANGES.ETC

Change in 4M Conditions or Quality Improvements or Self

Need for Changes in Design /Drawing
Need for Change in Design /Drawing
Specification/Material (Inhouse or Supplier Suggested
Specifications/Material (Customer Trigered Changes )
Changes)
Controlled Changes Such as1) New Supplier or Supplier
Change ,Inhouse Processes Outsourced or Vise Versa.2)
Process Condition or Method Change (Changes in Process
Parameters)3) Jig/Tool/Fixture Modification or Change.3) Die
or Mould Modification Or Change 4) Inspection Method
Change 5) Any changes due to Quality Problem 6) Operator
Change 7) Change in Delivery Method or Delivery Packaging.

Generate the Engineering Change Note (ECN) /DCAR and
Circulate to all Concern Department
RESPONSIBILITY : DESIGN Engineer / Manager
Change Proposal needs to discuss in NPD Meeting by all
CFT Members including Design,ME,QA,CD etc.
RESPONSIBILITY : HOD R&D.
Change Proposal approved by
ADVIK CFT Team?
Yes
Implement the Changes
Generate the Change Management Note regarding Changes
Submit the Change approval request or IPP Tag or ECN
and Circulate to Concern Dept for Verification and
etc to Customer for approval with Product Samples. (If
Implementation. If required Send to Customer for approval
Customer decide to Evaluate the Samples in one or Two
through IPP tag , Countermeasure request form ,Change
Stages) approval request ,DCAR or any other Valid format.
RESPONSIBILITY : HOD R&D,HOD QA. Responsibility :- HOD QA
Proposed changes is internally approved by Concern
Change Proposal approved by Customer? HOD'S or CFT Members in NPD Review Meeting or
No
approved by Customer ??
No
Yes
Continue with Existing Yes
Process and inform to
Customer Implement the Changes as Per Change Management
Implement the Changes and accordingly revise all
Note and Record in 4M Change sheet.
Necessary Documents such as Drawing,PFD,Process
Control Plan, PFMEA,DFMEA,Inspection Standard etc.
Responsibility: HOD ME/HOD QA

Revise the all Necessary documents for the Changes such as

Revise the all necessary Documents for the Changes
Drawings ,PFD,Control Plan,PFMEA, Inspection
Such as PFD,Process Control Plan, PFMEA,DFMEA,Process
Standards,Work Instructions etc.
RESPONSIBILITY : HOD ME /HOD QA. Capability Studies, Inspection Standards etc.
Responsibility : HOD ME/HOD QA

If Decision by Customer to Evaluate the Samples in one or two

stages, Submit the Samples with all supporting(PPAP)
Documents Such as PFD,PEMEA,PCP,Inspection
reports,Testing Reports etc to Customer for approval.
RESP : Design Engineer/Manager , QA Engineer/ Manager

Customer approval Transition to Mass Production

Prepared By Checked By Approved By

Name Mr Rajesh Kulkarni Mr S.Udayabhanu Mr Prem Gajpal
Designation Manager CQA Sr VPP COO

Signature