Procedure (Process)

Control of Changes
Version 3
April 05, 2018

NOTICE: This document is confidential and may not be used without permission
from QMI.
Approved Version

4/5/2018
RAM BIR
Author Date

Version Version Date Change Description

Template for procedure updated as per global, All change
2 1/1/2018 related procedures linked in one procedure and reviewed
and updated as per IATF 16949 requirements
Abnormal changes (Section 7.4) linked with this
3 4/5/2018
procedure. Section 7.5 added.
 Number: QPINN-QA-8.5.6-
R03- Control of Change Control of Changes
Date: 18.02.2018

8.5.6 Control of Changes

Control of Changes
Procedure
Approved Version

Created by: Rambir

(signature/date) Dy. Manager – QA SMR North India

Approved by: Saurabh Tyagi

(signature/date) AGM – QA SMR North India

Owner of this document is SMR North India.

AVP’s approval is necessary to share this document out of company.

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 Number: QPINN-QA-8.5.6-
R03- Control of Change Control of Changes
Date: 18.02.2018

TABLE OF CONTENTS
1. TARGET OF THE PROCEDURE ............................................................................................3

2. APPLICATION’S AREA ........................................................................................................3

3. REFERENCES.......................................................................................................................3

4. RESPONSIBILITIES AND COMPETENCES............................................................................3

5. RELEVANT REGULATIONS..................................................................................................3
Approved Version

6. LIST OF ABBREVIATIONS ...................................................................................................3

7. PROCESS DESCRIPTION .....................................................................................................4

7.1 CONTROL OF ENGINEERING CHANGES ............................................................................................................................4

7.2 CONTROL OF PROCESS CHANGES..................................................................................................................6

7.3 CONTROL OF OTHER PLANNED / UNPLANNED CHANGES ...........................................................................7

7.4 CONTROL OF ABNORMAL CHANGES.............................................................................................................7

7.5 TIMELINES, TRACKING & MONITORING OF CHANGES .................................................................................7

8. RECORD RETENTION..........................................................................................................8

9. ANNEXES............................................................................................................................8

10. HISTORY OF THE REVISION ...............................................................................................8

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 Number: QPINN-QA-8.5.6-
R03- Control of Change Control of Changes
Date: 18.02.2018

1. Target of the procedure

The purpose of this process is to establish a system to control all the changes with respect to design
or specification during the new product development and mass production process; and all the
planned / unplanned and abnormal changes in manufacturing changes; man, machine, material &
method during the new product development and mass production process.

2. Application’s area
This procedure is applicable to all sites of SMR North India.

3. References
QWINN-MAN-8.5.6-001-Rxx-Change Point Control Matrix
QWINN-MAN-8.5.6-004-Rxx-Abnormal Situation flow chart
Approved Version

QWINN-MAN-8.5.6-005-Rxx-WI for handling abnormal Situation

QFINN-MAN-8.5.6-002-Rxx-List of alternate process controls
QFINN-QA-8.5.6-001-Rxx-Abnormal Record Sheet
QFINN-QA-8.5.6-002-Rxx-4M Change Tracking & Summary Sheet
QFINN-ENG-8.5.6-003-Rxx-ECN LOG BOOK.
F/ENG/07 – Feasibility study sheet
F/ENG/06 – Risk Analysis Sheet
F/ENG/11 – Engineering Change Note
F/ME/32 – Process Change Note
F/ENG/13 – Engineering Change Request
QFINN-ENG-8.5.6-001-Rxx-Affected documents list
F/ENG/14 – Before/After Changes
F/ME/29 – EJO
Customer approval records
Updated documents
Customer specific IPP tags
4M Cards (Mat. - Blue, Machine - White, Man - Red, Method - Yellow color)

4. Responsibilities and competences

HOD – QA is overall responsible for effective implementation of this procedure.

5. Relevant Regulations
NA

6. List of Abbreviations
AWR – As & When Required
ECN – Engineering Change Note

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PCN – Process Change Note

ECR – Engineering Change Request
PCR – Process Change Request
EJO – Experimental Job Order
IPP – Initial Production Parts
MSIL – Maruti Suzuki India Ltd.
M&M – Mahindra & Mahindra Ltd.
HCIL – Honda Cars India Ltd.
CARV – Change Approval Request for Vendors (MSIL Specific)
PSW – Part Submission Warrant

7. Process Description
In SMR, four types of changes will occurs:
1. Engineering changes – changes that will be done in drawing / specifications during NPD and mass
production. All the engineering changes will be implemented as described in section 7.1.
Approved Version

Engineering head is overall responsible for ECN implementation.

2. Process changes – changes that will be done in manufacturing process during mass production.
All the process changes will be implemented as described in section 7.2. Manufacturing
Engineering (ME) head is overall responsible for PCN implementation.
3. Other planned / unplanned changes – changes that will be done for any improvement activity
during mass production. All the planned / unplanned changes will be implemented as described
in section 7.3. QA head is overall responsible for implementation of these changes.
4. Abnormal changes – sudden changes that will be done after any abnormal situation (e.g.
breakdowns) happened in defined process during mass production. All the abnormal changes will
be implemented as described in section 7.4. QA head is overall responsible for monitoring &
implementation of these changes.

7.1 Control of Engineering Changes

S. No. Activity Resp.

1 Identify the need for the changes in existing specifications or drawing (Part / Assembly) All Concerned

2 Fill all the details in "ECR" format and provide the same to Engineering department All Concerned
Receiving the Change request from concerned department or customer and enter the details
3 Engg.
in QFINN-ENG-8.5.6-003-Rxx-ECN LOG BOOK.
4 Inform the CFT about the same and call the ECN Meeting Engg.
Conduct the feasibility review (Review changes and drawing thoroughly). If request is from CFT
customer then review application timing, compensation for tooling & part and cost impact
5
and inform customer about the review result.
If not feasible, close the request and inform the customer or requester about the same Engg.
6 If feasible, conduct risk analysis including product homologation CFT
If High Risk or any cost impact, Inform mgmt. (For internal request) or customer (For
7 customer initiated request) for approval before proceed further. Engg.
If not approved, close the request and inform the customer or requester about the same

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For Internal request, Raise change request* in customer specified format*** to customer**
8 and get approval. Engg.
If rejected by customer, close the request and inform the requester about the same
9 If approved, decide the disposition of current stock and ECN implementation date. CFT
Make a time plan for all the required activities and release the ECN along with initial drawing
10 ECN Team
and affected document list
Prepare sample parts and trial out the parts
11 (In case of special requirement of samples from customer before ECN approval, sample can ECN Team
be submitted on deviation)
12 Inspect, test and review the result (before / after) and process capability (if applicable) QA

13 If Fail, Define & Implement corrective action & submit fresh samples ECN Team
If Pass, update the drawing and release accordingly. Drawing & ECN register to be updated
14 Engg.
for revision.
Approved Version

Interim update affected documents, submit PPAP package for internal validation by QA HOD
15 ECN Team
with relevant documents
16 Approve internal PSW with supporting document QA Head

17 Sample submission to customer with Customer specific IPP tag# for approval ECN Team

18 Receive and review the received customer report ECN Team

If rejected by customer reject the remaining parts, review the observed issues, take actions
19 ECN Team
and submit the fresh samples to customer for approval.

20 If approved by customer, Get PSW approval from customer if applicable ECN Team

21 Updated the affected documents as per the affected documents list ECN Team
Implement the ECN as per decided date, ensuring that the current stock disposition has been
22 ECN Team
done. Start mass production and send parts to customer with IPP tag and record lot details
Start of "Initial Supply Control" phase. Monitor the effectiveness↗.
23 ECN Team
Follow QPINN-QA-8.6.1-Rxx-Initial Supply Control.
24 Update the ECN LOG BOOK ECN Leader

*For MSIL and M&M – 01 Month; For HCIL – 03 Months prior to implement the change
**For MSIL – Inform Engineering, For HCIL – Inform Purchasing, MPD and MPQ and For M&M –
Inform Engineering Department
***For MSIL – Use CARV, For HCIL – Use Countermeasure request form (CRF) and For M&M – Use
ECN format
↗For MSIL and M&M – 15 Days, For HCIL – 30 Days

# For Honda - HCQF CM 0053 /APR'17 IPP Tag

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 Number: QPINN-QA-8.5.6-
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Date: 18.02.2018

7.2 Control of Process Changes

S. No. Activity Resp.

1 Identify the need for the changes in defined process as per "Change Point Control Matrix" All concerned

2 Fill all the details in "PCR" format and provide the same to ME department All concerned
Receiving the change request from concerned department and enter the details in change
3 ME
tracking register
4 Inform the CFT about the same and call the PCN meeting ME
Conduct the feasibility review and risk analysis of requested change. Make action plan for
5 CFT
high risk items and take approval from management.
If required (as per QWINN-MAN-8.5.6-003-Rxx-Change Point Control Matrix), inform
6 customer## in customer specific format*** about the change. If rejected, close the request QA
Approved Version

and inform requester.

If approved, prepare time plan along with the affected document list. Take consensus of
7 concerned dep. for related declaration like stock disposal, tool/mold modification, trial & ME
validation after modification, cost impact, etc.
8 Raise PCN with Initial data like change details, time plan and affected documents list ME

10 Prepare sample parts as per proposed changes and trial out the parts ME
Conduct EJO or process / product validation (as per requirement) for proposed change. ME / QA /
9
Release report accordingly. Prod.
Evaluate the results with before & after comparison / dimension results / cpk study (for
10 QA
critical dim.) and validate the product for Fit, form and function
If Not OK, scrap all the sample parts, take suitable action against observations and conduct ME / QA /
11
EJO again. Prod.
12 If OK, update the affected documents as per affected document list ME

13 Approve internal PSW with supporting document QA Head

Go ahead for change implementation in mass production. Start of "Initial Supply Control"
14 phase. Monitor the change effectiveness↗. ME
Follow QPINN-QA-8.6.1-Rxx-Initial Supply Control.
15 Update the details in PCN tracking sheet PCN Leader

***For MSIL – Use CARV, For HCIL – Use Advance IPP form
↗For MSIL and M&M – 15 Days, For HCIL – 30 Days

##For
MSIL, send monthly 4M change report for the changes which are not required to
communicate to customer before implementation.

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 Number: QPINN-QA-8.5.6-
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Date: 18.02.2018

7.3 Control of other planned / unplanned changes

S. No. Activity Resp.

Identify the need for the changes in defined process / product and any improvement activity
1 as per QWINN-MAN-8.5.6-003-Rxx-change point control matrix and QWINN-MAN-8.5.6-005- All concerned
Rxx-
Inform QA with all relevant documents as described in "QWINN-MAN-8.5.6-003-Rxx-change
2 All concerned
point control matrix"
QA / Plant
3 Review the request for changes. If rejected, close the request and inform requester
Head
If approved by QA / Plant head, Prior* information to customer** for advance approval.
QA / Plant
4 Furthermore, in urgent cases, contact customer first and follow their instructions. If request
Head
rejected by customer then close the request and inform requester.
If approved by customer, make a trial lot and check process qualification and follow approval
5 QA / Prod.
Approved Version

condition (As written in approved change request)

6 Send parts to customer with customer specific IPP Tag QA / Prod.
7 Parts decision from customer (OK or Rejects) Customer
If parts rejected by customer, reject the remaining material, prepare new proposal or
8 QA
continue with existing process / part
If OK by customer, update the relevant documents as described in "Change Point Control
9 QA / Prod.
Matrix" and if required, submit the documents to customer for approval
Mass production by following approval conditions and start of "Initial Supply Control"
10 QA / Prod.
phase↗
Track all the planned / unplanned changes in QFINN-QA-8.5.6-002-Rxx-4M change tracking
11 QA
and summary sheet
12 Start supply of changed parts. Record the lot details with change point details Production

*For MSIL and M&M – 01 Month; For HCIL – 03 Months prior to implement the change
**For MSIL – Inform Engineering, For HCIL – Inform Purchasing, MPD and MPQ and For M&M –
Inform Engineering Department
↗For MSIL and M&M – 15 Days, For HCIL – 30 Days

7.4 Control of abnormal changes

For Abnormal changes, all changes will be managed as per “QWINN-MAN-8.5.6-004-Rxx-Abnormal
Situation flow chart” and “QWINN-MAN-8.5.6-005-Rxx-WI for handling Abnormal Situation”.
For temp. changes, controls to be implemented as per the controls defined in the list “QFINN-MAN-
8.5.6-002-Rxx-List of alternate process controls”.

All the abnormal changes trcked in QFINN-QA-8.5.6-002-Rxx-4M change tracking and summary sheet.

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 Number: QPINN-QA-8.5.6-
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Date: 18.02.2018

7.5 Timelines, tracking & monitoring of Changes

 For customer / Supplier raised requests related to engineering specifications, Change request
will be reviewed by Engg. within 02 working days, Feasibility review will be completed by 07
working days. Customer / Supplier will be informed about the review result within max. 10
working days after receiving of request.
 For Internal raised requests related to ECN and PCN, feasibility study and risk analysis will be
completed within 07 working days. Timeplan and raising of ECN/PCN with initial data will be
done within 07 working days after implementation decision.
 Change management meeting to be conducted every week to review the status of changes
w.r.t. defined timeplan and current status. All the issues in open changes and effectiveness of
implemented changes will be reviewed in this meeting. Change management meeting will be
headed by Unit Head / Operations Head and all concerned persons from Engg., ME, QA,
Production, Purchase / STA (If required), and any change specific required person.
 All the change requests will be entered in change tracking register and status will be updated
on weekly basis as an output of change management meeting.
Approved Version

 It is the responsibility of QA Head to ensure that the proper tracking of changes through weekly
meeting will be done.
 All the open issues related to changes, open change requests and change effectiveness data
will be then reviewed in MRM by top management.

8. Record retention
Supervision of this procedure is at the QA / Engg. / ME department and/or an authorized QMS
Coordinator / Quality Head in the SMR North India. This and the referred documents must be
handled as per QWINN-QA-7.5.3-001-R02-Record Retention and according to the general
Documentation procedure in the QM-System (CEBOS).

9. Annexes
NA

10. History of the revision

Rev. No. Cause of modification Date Issued By
1 Customer information departments updated 20.09.2017 Rambir
Template for procedure updated as per global, All change related procedures
2 linked in one procedure and reviewed and updated as per IATF 16949 01.01.2018 Rambir
requirements
3 Abnormal changes (Section 7.4) linked with this procedure. Section 7.5 added. 18.02.2018 Rambir
4
5
6

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