FLASH VIVEN MACHINING TECHNOLOGIES PVT. LTD.

Process Name

Change Control

Document No
FVMT/Engg/QP/10

Amendment Record

Sr.No Issue Date Details of Change Page No. Rev.No

1 04.01.2018 Initial Release ---- 0

2 08.07.2020 Process revised for company logo change 1 To 11 1

Prepared By : Reviewed By : Approved By :

Engineer QMS Head Engineering Head
 QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
Document No :
Revision No. 01
FVMT/Engg/QP/10 Process Name
Revision Date 06.07.2020
Change Control Process
1. PURPOSE :- To describe the process to control & react to changes that impact product realization

2. SCOPE :- This process is applicable to Product/part design & process changes and supplier
initiated changes at ABC
Section: 1 - Product design change control
Section: 2 - Process change control
Section: 3 - Supplier change control
Section: 4 - Temporary change of process control

3. DOCUMENT REFERENCE :-
Sr. No. REFERENCE DOCUMENT NAME
1 NIL

4. ABBEREVATIONS :- DCR: Design Change Request

PCR: Process Change Request
SCR: Supplier Change Request
5. RECORDS :-

RECORD NAME FORMAT NO MAINTAINED BY DISPOSITION METHOD

ECR/PCR FVMT/Engg/F/37 Engineering Tear off

ECN FVMT/Engg/F/38 Engineering Tear off

Feasibility study FVMT/Engg/F/35 Engineering Tear off

SCR FVMT/MTRL/F/39 Engineering Tear off

DCR / PCR / SCR tracker FVMT/Engg/F/285 Engineering Tear off

PSW FVMT/Engg/F/22 Engineering Tear off

Control Plan FVMT/Engg/F/19 Engineering Tear off

Deviation Note FVMT/QMS/F/61 Engineering Tear off

3 Level Inspection Report FVMT/PRD/F/106 Engineering Tear off

6. KPI :-
MEASURABLE TARGET LEVEL REVIEW FREQUENCY RESPONSIBILITY

No of changes received Vs number of changes

As per KPI list As & When required Engg Head
reviewed

On time change(LOI) As per KPI list As & When required Engg Head

7. INTER-RELATED PROCESS :-
PROCESS NAME
RFQ

Production Control

Quality Management

Purchasing

Control of records

APQP

Control of documents
PAGE : 1 of 11
 QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
Document No :
Revision No. 01
FVMT/Engg/QP/10 Process Name Revision Date : 06.07.2020
Change Control
Document/Record Reference/
Input/ Trigger Responsibility Activity
Generated Instructions

Section: 1 - Product design change control

Input
*Customer 10
engg./spec.
changes Get the request for Engg change alongwith change related
10 10
*Errors / reports. for any one or more of the following reasons from
Engineering Engineering/Proc
Omissions External or Internal customer ess Change
identified after Head & -Errors identified after release of design
Concern Request
release of -Design changes due to manufacturing difficulties
Department ( ECR/PCR)
design -Changes required to improve the function or performance of the
*Supplier Head product
feedback / -Customer/ Internal Requests
requirements -Corrective action impact activities
*Corrective -Suggestions for continuous improvements
action impact
activity 20
*Continual 20 -220 20
improvements Engineering Acknoledge the Engineering/Process change ECN
*changes to Head
safety
/regulatory
requirements 30
*Request
from Is the change feasible considering
customer impact on form, fit, function, cost,
30
performance, durability, reliability,
Feasibility study
No manufacturability, serviceability?

40
Reject the change
inform customer Yes
50
40
Approve Engineering/Process change Request & update ECN for
60
60 Customer Mail
Sent Quatation to Cust. and get Approval ( if required)
70
Fill up the LOI within 10 working days. If Engg change triggers
process /supplier changes then follow PCR /SCR process parallel
80
80
Release drawings, marked-up prints for try-outs as applicable
Mark up
90 Drawing

Build sample as applicable

100

Conduct verification / validation tests as applicable

SPC report,
110 Set up
Approval,
Are verification / validation test
results satisfactory?
120 No
Yes Reject the change
inform customer
A

PAGE : 2 of 11
 QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
Document No :
Revision No. 01
FVMT/Engg/QP/10 Process Name Revision Date : 06.07.2020
Change Control Process
Document/Record Reference/
Input/ Trigger Responsibility Activity
Generated Instructions

130

Seek customer approval as applicable

140 110
Has customer approved the
changes? Customer Mail
No

130
Reject the change
Yes inform customer
150
140
Approve the changes (Engg)
Customer Mail
160
150
APQP
Identify PPAP requirements
Process
170
160
Update the relevant documents Updated
Document
180

Review the customer requirements on PPAP such as

-Trial production quantity
-Submission level

190
PPAP SWP
Submit and get the PPAP Approval

200
Conduct ECN meeting with all concerns.
Implement the Engg change. 200 ECN Format
ECR/PCR/SCR
210 Tracker

Inform customer for implementation if required

220

Maintain record of design changes implemented in ECN tracker

sheet

Output

PAGE : 3 of 11
 QUALITY SYSTEM PROCESS
Document No. FVMT/Engg/QP/10
(Turtle Diagram)
IATF 16949 Revision No. 01
7.5.3.2.28.2.4,8.3.6,8.3.6.1,8. Process : Change control (Turtle Diagram)
Revision Date 06.07.2020
5.6.1.1

With What ? With Who ?

( Material / Equipment ) ( Competency / Skilled / Training )

*Computer system
*Development engineers with
*Communication System
required skill & competence
*Human Resource

Inputs Process

*Customer engg./spec. changes Outputs

*Errors/Omissions identified after
release of design *Product with design changes meeting
*Supplier feedback/requirements customer requirements & feasible to
Product design change
*Corrective action impact activity manufacture
*Continual improvements control (Sec:1) *Updated drawing & process standards
*changes to safety/regulatory *Updated SOP if required
requirements
*Request from customer

How ? What Result ?

( Support processes & methods ) ( Performance indicators )

* No of changes received Vs number

*Change control process - sec:1 of changes reviewed
* On time change(LOI)

Inter Related Processes:

*RFQs, Purchasing,Production control process, APQP process, Control of records & Documents,Quality Managament

PAGE : 4 of 11
 QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
Document No :
FVMT/Engg/QP/10 Revision No. 01
Process Name
Revision Date : 06.07.2020
Change Control
Document/Record Reference/
Input/ Trigger Responsibility Activity
Generated Instructions
Section: 2 -Process change control
Input
*Customer 10
engg./spec.
changes 10
Get the request for Process change for any one or more of the
*POKAYOKE 10 Engineering/Proce
implementation
following reasons in ECR/PCR form
CFT, -POKAYOKE implementation ss Change
*Rearrangement Originator
of major -Changes required to improve the function or performance of Request
production the process ( ECR/PCR)
equipment -Customer/ Internal Requests
*Corrective -Rearrangement of major production equipment that change the
action impact sequence of process flow from that documented in the process
activity *New flow diagram
replacement -New replacement capital equipment installation
capital -Corrective/preventive action impact activities
equipment -Suggestions for continuous improvements
installation
*Continual
improvem-ents
20
*Request from
20
customer
Feasibility study
20-70
Is the change feasible considering
impact on form, fit, function, cost,
Engineering
performance, durability, reliability,
manufacturability, serviceability?

No Yes
30
Reject the Approve Engineering/Process Change Request
change

40

Build sample as applicable

50

Conduct verification / validation tests as applicable

60
Are verification / validation test
results satisfactory?

No
Yes 70

A Reject the change

PAGE : 5 of 11
 QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
Document No :
FVMT/Engg/QP/10 Revision No. 01
Process Name Revision Date : 06.07.2020
Change Control
Document/Record Reference/
Input/ Trigger Responsibility Activity
Generated Instructions

A
80

80 - 140 Seek customer approval as applicable.

Engineering

90

Has customer approved the

changes? Customer mail
No

100

Yes Reject the change

110

Identify PPAP requirements update the documents

PPAP

120

Submit & get the PPAP approval 120 PSW

130

Conduct ECN meeting with all concerns.

Implement the process change.
Implement the Process Changes & 130-140
relevent documents ECR/PCR/SCR
Tracker

140

Maintain record of process changes implemented in ECN tracker

sheet

Output

PAGE : 6 of 11
 QUALITY SYSTEM PROCESS
Document No. FVMT/Engg/QP/10
(Turtle Diagram)
IATF16949 Revision No. 01
7.5.3.2.28.2.4,8.3.6,8.3.6.1,8. Process : Change Control
Revision Date 06.07.2020
5.6.1.1

With What ? With Who ?

( Material / Equipment ) ( Competency / Skilled / Training )

*Computer system
*engineers with required skill &
*Communication System
competence
*Human Resource

Inputs Process

*Customer engg./spec. changes Outputs

*POKAYOKE implementation
*Rearrangement of major production
*Product with process changes meeting
equipment
Process change control customer requirements & feasible to
*Corrective action impact activity *New
replacement capital equipment (Sec:2) manufacture
*Updated process standards
installation
*Continual improvem-ents
*Request from customer

How ? What Result ?

( Support processes & methods ) ( Performance indicators )

* No of changes received Vs number

*Change control process - sec:2 of changes reviewed
* On time change(LOI)

Inter Related Processes:

*RFQs, Purchasing,Production control process, APQP process, Control of records & Documents,Quality Managament

PAGE : 7 of 11
 Document No : QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
FVMT/Engg/QP/10 Revision No. 01
Process Name Revision Date : 06.07.2020
Change Control
Document/Reco Reference/
Input/ Trigger Responsibility Activity
rd Generated Instructions

Section: 3 -Supplier change control

Input
*Supplier or 10
material source
change proposed Get the request for change for any one or more of the following reasons
by purchasing 10-10A -Supplier or material source change proposed by purchasing,
*Tooling transfer, CFT, -Tooling transfer, replacement, or additional.
replacement, or Originator -Supplier requests on Product or Process changes
additional -Corrective action impact activities. 10
*Customer -Suggestions for continuous improvements. SCR
requests
*Corrective action 10A
impact actives
Inform to Engg. department through Supplier Change Request
*Suggestions for
continuous
improvement
20 Supplier
20 Feasibility management
20-160 Is the change feasible considering study process
Engg. Head impact on form, fit, function, cost,
performance, durability, reliability,
manufacturability, serviceability?
No

Reject the
change Yes
30

Approved SCR

40

Build sample as applicable

50

Conduct verification / validation tests as applicable

60
Are verification / validation test
results satisfactory?

No
Yes 70

Reject the change

A

PAGE : 8 of 11
 Document No : QUALITY MANAGEMENT SYSTEM Issue Date 08.07.2020
FVMT/Engg/QP/10
Revision No. 01
Process Name
Revision Date : 06.07.2020
Change Control
Document/Reco Reference/
Input/ Trigger Responsibility Activity
rd Generated Instructions

A
80

Seek customer approval as applicable

90
Has customer approved the
changes?
No

100

Yes Reject the change

110

Identify PPAP requirements and update the

110
documents PPAP

120

Submit & get the PPAP approval

130
130, 140
ECR/PCR &
Implement the Process Change and ensure the SCR
PPAP compliance as applicable

140

Inform customer & re- submit PPAP documents if required

150

Conduct ECN meeting with all concerns.

Implement the process change.
Implement the Process Changes &
relevent documents

160
160 160 Record
Maintain record of changes implemented on ECR/PCR & SCR ECR/PCR/S control
tracker & LOP
CR Tracker process

Output

NOTE: For Supplier/Source change - Follow the supplier selection process

PAGE : 9 of 11
 QUALITY SYSTEM PROCESS
Document No. FVMT/Engg/QP/10
(Turtle Diagram)

IATF16949 Revision No. 01

Process : Change control
8.2.4,8.3.6,8.3.6.1,8.5.6.1.1 Revision Date 06.07.2020

With What ? With Who ?

( Material / Equipment ) ( Competency / Skilled / Training )

*Computer system
*engineers with required skill &
*Communication System
competence
*Human Resource

Inputs Process

*Supplier or material source change Outputs

proposed by purchasing
*Product with changes meeting
*Tooling transfer, replacement, or
customer requirements & feasible to
additional Supplier change
manufacture
*Customer requests control *New approved supplier / part meeting
*Corrective action impact actives
customer requirements
*Suggestions for continuous
improvement

How ? What Result ?

( Support processes & methods ) ( Performance indicators )

* No of changes received Vs number

*Change control process - sec:3 of changes reviewed
* On time change(LOI)

Inter Related Processes:

*RFQs, Purchasing,Production control process, APQP process, Control of records & Documents,Quality Managament

PAGE : 10 of 11
 08.07.2020
QUALITY MANAGEMENT SYSTEM Issue Date
Document No :
FVMT/Engg/QP/10 Revision No. 01
Process Name Revision Date : 06.07.2020
Change Control
Document/Record Reference/
Input/ Trigger Responsibility Activity
Generated Instructions

Section: 4 - Temporary change of process control

Input
*Control plan with 10
temporary change of
process controls Identify and list down the process controls (Primary process
details 10 -20 10 Control plan
controls and approved back up or alternate control) including
*Corrective action Engineering /Annexture
inspection, measuring, test and error proofing devices in control
impact actives Head plan or annexture

20
Based on severity and risk,take internal approval prior
implementation of the alternate process control method and notify 20 Deviation Note
customer. Update deviation form with temporary control usage
duration and obtain internal approval
30
30 to 80 QA Review the operation of alternate process control method on daily
Engineer basis (at a minimum) Example- Layer audit /Poyoke verification
sheet

40
Periodically review the approved alternate process controls
referenced in control Plan/ annexture

50
Perform and document restart verification ( to confirm that error
proofing devices / processes are effectively restore to original
controls)

60
Trace all products produced while any alternate process control 60
devises or processes are being used.(e.g.- verify and retain first 3 Level Inspection
piece from every shift) Report

70

If required, obtain approval from customer before shipping product

that was inspected / tested by alternate process control method

80

Retain all relevent documents

Output

PAGE : 11 of 11