SEI

DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

1. PURPOSE

This Procedure is to be defining new product development and Changes in existing Parts and to
define the process needed for the Product Quality planning process to ensure that:
1. Resources are directed to satisfy the customer.
2. To promote early identification of problems / changes to avoid late changes
3. To provide a quality product on time at the lowest cost.
4. Use of CFT approach & Simultaneous engineering during design and development of
the process.
5. To Ensure flaw less launch

2. SCOPE

Applicable to all new development parts and Changes in existing Parts

IATF 16949:2016 Clause: 8.3

CATEGORY DETAILS
AA Absolutely new component : no Experience of Production so far
That the part happens to be similar to what had been produced so far but there happens to be
A large scale difference in raw material, Machining Methodology, In the structure or in the function.
B That whenever there happens to be a minor deviation in the component produce so far (To
implement only for inspection of initial product) ECN & DCN parts
That whenever there happens to be extremely Process change in details related to the
component ,so much so that even the inspection becomes non mandatory(It becomes more of
checks in regard to monitoring of the points of variation in regard to 4M(M/c Procurements &
C
Supplier change).
D That whenever there happens to be changed in production site

3. RESPONSIBILITY

It is the responsibility of the MR to ensure that this procedure is latest, implemented and
understood by all appropriate personnel across the organization.

It is the responsibility of the CFT & relevant functional heads to ensure that this procedure is
implemented in their respective departments.
4. PROCEDURE

Phase – I (Plan and Define the program / Pre contract review)

Responsibility/ Document No
Sl. No. Activity
Authority
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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

Receive enquiry / Customer drawing / Customer provided sample /

4.1.1 any standards and specifications from CUSTOMER, Sample Marketing --
submission time requirement (If any).
Perform enquiry review and the details will be entered in Enquiry Marketing F/PD
4.1.2 Register The details shall be reviewed for adequacy if engineering
drawing were provided by the customer.
Identify the Customer drawing, standards, if given by putting
`MASTER COPY’ on the rear side of the drawing and standard.
Mark the date of receipt suitably handwritten on the rear side and
4.1.3 update the master list of customer drawing immediately. In case if any Quality
drawings received for reference purpose as design input, it can be
considered only for reference by putting `Reference only’ on the rear --
side of the drawing.
4.1.4 Photocopies of the customer drawing affixed with CONTROLLED --
Quality
COPY stamp can be used for reference purpose.
Top management shall constitute a Manufacturing Cross Functional
Team consisting of members from Marketing, Production, FPD
4.1.5 Development
Maintenance, Quality, and Purchasing to carry out the Advanced
Product Quality Planning. List of CFT Members
Drawing Review: The drawing shall be reviewed by Manager. --
In case of samples received from the customer, it can be used for
Development
Comparative purpose only and does not absolve the CFT to comply
with customer requirement as stated in the assembly drawing.
4.1.6
Clarification from customer, If required:
During drawing review if any incomplete information found, the
marketing person shall interact with customer to get the relevant
Development --
required information.
Additionally CFT Team shall collect information on Internal voices /
Past History based on:
a) In house rejections / Rework
b) Customer complaints
4.1.7 c) Process changes and their impact Quality
F/PD/
d) SPC results
e) TGR / TGW reports

Pre – Feasibility Study:

Conduct Pre-feasibility study to understand the manufacture ability of Development F/PD/
new product.
For feasible products, a final Process details shall be prepared. The
4.1.8 final Process details, and then is reviewed by MANAGER for Development / --
preparation of cost data sheet and facilitating submission of CFT
Quotation.
If found not feasible, CFT shall send regret letter intimating the --
Development
customer the inability to service this enquiry.
Reliability and Quality, Goals: (If required)
CFT Team shall identify goals in the form of: F/PD/
4.1.9 1.Product cycle time Development
2.In-Process Rejection PPM
3. Process capability requirement
4.1.10 Bill of materials : Engg. --
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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

CFT shall prepare a tentative material parts list if required based on

parts list, purpose shall prepare an early subcontractor list.
Preliminary Process flow Chart:
4.1.11 Tentative process flow chart (Block diagram) shall be prepared by the Engg. F/PD/
CFT.
Marketing shall provide a Quotation to the customer with lead-time --
and validity of quote. Marketing shall resolve any difference with the
customer in regard to the quotation. Marketing to monitor the status
of the quote and shall be closed when reasonable period of extension
4.1.12 MARKETING
based on the interactions with the customer is over.
If at a later stage, the customer revises the same enquiry, it shall be
the prerogative / discretion of the Marketing / Top Management to
consider the enquiry at the earlier quote.

Phase –II – (Product Design & Development, Team Feasibility Commitment)

4.2.1 Marketing shall accept a Purchase Order / LOI from the customer. Marketing --
4.2.2 CFT shall also conduct Contract Review If required. Development --
The CFT shall be specific to the product and if required representatives
from other functions may be inducted
4.2.3
Development --

CFT develops New Product Development Plan (Master & Micro) as F/PD/ &
required by the organization, in-line with APQP Matrix (F/PD/).
Master plan is prepared for overall monitoring process & Micro Plan: F/PD/ &
4.2.4 Development
Process were involve more time which are monitor through Micro Level
planning such as a tool / fixture development & inspection testing F/PD/
establishment & process validation.
Identify customer defined special characteristics, Check for Availability F/PD/
of published standards and record the details.
Appropriate personnel of CFT shall prepare Process instructions (Work
Instructions) for all processes as the PFD.
Quality /
4.2.5  Develop Process Instructions based on the output of the above
Engg.
steps.
 Ensure Process Instruction referred in the Control Plan.
Identify Special Characteristics Symbol in process Instructions.

Product error proofing, as appropriate:

4.2.6 CFT shall review for any Poke Yoke requirements to ensure the error Development
proofing / mistake proofing.
Engineering Drawings / Specifications / Material Specifications:
CFT shall prepare process drawings and material specifications based on
Customer Drawing input if required. In addition to the above, wherever Engg. / F/PD/
4.2.7 applicable all engineering changes shall be as per Process Manual for Quality
Document Control Process. Purchase shall insist through P.O the
traceability requirements like date and month code to be followed
wherever feasible on the Brought out.

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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

New equipment/ Tooling / Gauges / Testing equipment / Facilities F/PD/

4.2.8 requirements: Engg.
Identify New Equipment, Tooling’s / Gauges / testing equipment and
Facilities Requirements to complete the project.
CFT shall review for other facilities, equipment’s and other resources that --
4.2.9 are required for the New product that is to be developed CFT

Evaluate feasibility through Product Data and Team Feasibility Report.

Marketing / Customer Representative shall interact with customer for any
4.2.10 clarifications. Development
F/PD/
Team feasibility Commitment Report shall be signed by the CFT and the
team now agrees to develop the new product.

PHASE –III (Process Design & Development)

Appropriate personnel of CFT shall ensure that the following activities are --
4.3.1 Development
carried out thru simultaneous Engineering method
CFT shall prepare Packaging standards / specifications that are required --
for the new product that is being developed
 Decide Packaging Specifications
4.3.2 Quality
 Reflect Packaging Specifications in Work Instruction
 If Customer provided the packaging specification, the same shall be
used.
CFT shall review the entire Quality System Documentation thru Product / --
4.3.3 Process quality system review to ensure that the existing quality system is Quality
adequate to meet the requirements of new product.
CFT shall prepare Process flow diagram as per the format to cover the --
4.3.4 Engg.
incoming source of variation and expected deliverables
CFT shall conduct Process Failure Mode and Effect analysis (PFMEA) --
4.3.5 for all value adding processes as per the PFMEA Manual / methodology Quality
given in Customer Supplier Development Manual.
Appropriate personnel of CFT shall prepare Pre-launch Control Plan for --
all processes as per the Process flow diagram. Control Plan shall be
4.3.6 prepared based on APQP Manual / customer approved methodology. Quality

Sample Trial : --
4.3.7 Development
CFT team shall decide of sample planning of new development part
CFT shall perform Job Verification setups. Produce samples for initial
product and process Establishment. Depending on the model the actual
4.3.8 quantity can be decided by the respective CFT / based on customer Quality
requirement.

Sample Submission :
 After trial run completion, QA person will evaluate the sample and
4.3.9 then make the layout report Quality
 CFT Team shall review the all customer requirements and all
required documents submit to customer with sample.
Feed Back & Corrective Action : Development
Review the customer evaluation report and take necessary action based on
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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

customer feedback
Appropriate personnel of CFT shall prepare MSA plan as per the
requirement for which MSA to be conducted.
4.3.10 Quality
Develop MSA Plan indicating the process, type of MME, product and
process tolerance and the appraiser and the time.
Appropriate personnel of CFT shall prepare Preliminary process
capability study plan
Prepare plan indicating the process, Equipment and the qualified appraiser
4.3.11 Quality
and tolerances
SPC Plan shall be for processes where there are special characteristics as
define by the customer and as define by the CFT.

PHASE – IV (Product and Process Validation)

Production Sample Preparation : --
4.4.1 CFT Team shall review the feedback of sample parts and plan prepare Development
for pilot lot.
Production Trial Run : --
 Produce samples as per pre-launch control plan for initial
sample submission to the customer with PPAP Documentation
for Customer requirements.
 Ensure significant production run quantity for PPAP run for
F/PD/
customers identified depending on the model the actual
quantity can be decided by the respective CFT / Customer.
4.4.2 Production
 Follow up results: Collect the all issues found at
internal/customer end problem during trial run. CFT shall
conduct the analysis on the issues identified & take appropriate
actions to solve the issue, same shall be recorded in the PDCA
 Whenever there is an issue observed in form, fit & function
during trail, it should be analyzed & 8D to be prepared for the
issue reported.
CFT shall perform Job Verification setups. Produce samples for initial
product and process Establishment. Depending on the model the actual
Quality
quantity can be decided by the respective CFT / based on customer
requirement.
4.4.3 During the Production Trial Run, CFT shall ensure that : Quality --
 MSA study is conducted with follow-up action for
marginal/non capable system.
 Preliminary Process capability study is conducted and action
plan is established where Cpk Values do not meet customer /
Default requirements.
 Process/Product audit do for validate the process and that
product made from production tools and process meet Engg.
requirements
 Production Part Approval Process (PPAP) as per customer
requirement Production Validation testing
 Layout Inspection: Conduct layout inspection in line with the
drawing shared by customer and prepare a report.
 Process Validation: Conduct test that validate that products

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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

made from production tools and processes meets Engineering

requirement.
 Results follow up during production preparation, all internal
issue capture and record in PDCA sheet
 Packaging Evaluation is carried out
 Conduct trials and assess results,
 Carry out corrective actions,
 Freeze packaging standards and specifications.
 Logistics: Marketing shall discuss with customer on the
logistics front. Adopt the suitable & Mutual Agreed logistics
modem
Pilot Lot Submission with PPAP :
After pilot lot completion, QA person will evaluate the sample and Quality --
make the layout report.
CFT Team shall review the all customer requirements and PPAP submit
to customer with pilot lot.
CFT shall prepare
Production Control Plan
Production Process control standard
Other documents as required Development /
4.4.4 Develop production Process control standard which is a logical
extension of pre-launch control plan and catering to all the requirements Quality
of Production control plan
CFT shall ensure relevant statuary & regulatory, Health & safety,
Environmental requirements are met if required.
CFT shall sign Quality planning sign off with production team to
assure that the new product developed has met the customer
4.4.5 Quality
requirements and that all tools, equipment’s, facilities, testing
requirements are in line with customer expectations

PHASE V (Feedback Assessment and Corrective Action)

Track customer feedback after pilot lot (PPAP), Feedback and --
Corrective action. The overall objective of this process shall be:
4.5.1 Reduced variation Quality
 Incorporate ongoing process performance meeting
Cpk>1.67 for all special characteristics.
Customer Satisfaction --
Evaluate customer satisfaction
4.5.2 Quality
Delivery
Monitor 100% delivery performance
CFT shall prepare Things Gone Right (TGR) and Things Gone Wrong F/PD/
4.5.3 (TGW) TGR/TGW Report and also define corrective actions that are Development
required.

5. Review Time:

CFT Review: CFT Members will review the project status every 10 days & the same will be recorded in MOM. If
any delay found it will be reviewed & corrective action planned. Timing plan also updated accordingly if required.
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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

After Sample Submission CFT Team shall be review the project month wise instant of date.

CFT Members shall appraise the Top Management about the status and analysis for any variance to provide further
appropriate supports (Interims of Resource Requirements) and the same are mounted in Management Support &
Review Meeting Report for Long duration project shall be reviewed month wise instead of phase wise.

6. REFERENCES - DOCUMENTS:

Procedure for Marketing

Procedure for Production & Maintenance

7. REFERENCES – RECORDS:

1 APQP Activities Matrix F/PD/

2 List of CFT Members F/PD/
3 Enquiry Register F/PD/
5 Pre-Feasibility F/PD/
6 New Product Development Master Plan F/PD/
7 New Product Development Micro Plan F/PD/
8 Management support & Review Meeting F/PD/
10 Quotation Free format

11 Purchase Order Free format

12 Contract Review Free format

13 List of new equipment’s / Tooling / Gauges / Facilities F/PD/
14 Team Feasibility Commitment F/PD/
15 Packaging standards / specifications Free format
16 Product / Process quality system review Free format
17 Process flow diagram Free format
18 List of Special Characteristics Matrix F/PD/
19 Potential Process FMEA Free format
20 Target For Productivity, Process Capability & Cost F/PD/
22 Product/Process Quality System Review Checklist F/PD/

8. REFERENCES – RECORDS

a. 5M Change Sheet - SEI/QA/F-34

b. 5M Change & Abnormal Situation Register - SEI/QA/F-41
c. Change Control Management Matrix - SEI/QA/F-42
d. 5M Change / Abnormality Tag (Blue) - SEI/QA/F-43
e. Information required for 5M Change Control - SEI/QA/F-44
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DOC.No.: SEI/QA/PRO/27
PROCEDURE FOR 5 M CHANGE Revision No.: 01
Rev. Date: 10.05.2018

f. Frequency of 5M Change - 2 Working Days

AMENDMENT SHEET

Rev Date Reason for Change

Change Description Remarks
No.

00 01.04.2017 New Release

01 10.05.2018 4M Change into 5M Change Customer Audit NC

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