SEI SHRI RAM ENGINEERING INDUSTRY

Doc. No.:
SEI/DEV/PRO/41
Revision No.:01
Effective Date:10.05.2018
Page No.: 1 of 9
QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

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

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
C 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 &
Supplier change).
D That whenever there happens to be changed in production site

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.
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Revision No.:01
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QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

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

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

Responsibility/ Document No
Sl. No. Activity
Authority
Receive enquiry / Customer drawing / Customer provided
sample / any standards and specifications from --
4.1.1 Marketing
CUSTOMER, Sample submission time requirement (If
any).
Perform enquiry review and the details will be entered in Marketing SEI/DEV/F-16
Enquiry Register The details shall be reviewed for
4.1.2
adequacy if engineering drawing were provided by the
customer.
Top management shall constitute a Manufacturing Cross
Functional Team consisting of members from Marketing, SEI/DEV/F-01
4.1.3 Production, Maintenance, Quality, and Purchasing to Development
carry out the Advanced Product Quality Planning. List of
CFT Members
Team Feasibility /Drg.Review Drawing reviewed by SEI/DEV/F-02
CFT & For feasible products, a final Process details shall
4.1.4 be prepared. The final Process details, and then is
reviewed by MANAGER for preparation of cost data
sheet and facilitating submission of Quotation.
Evaluate feasibility through Product Data and Team
Feasibility Report. Marketing / Customer Representative SEI/DEV/F-02
shall interact with customer for any clarifications.
4.1.5 Development
Team feasibility Commitment Report shall be signed by
the CFT and the team now agrees to develop the new
product.
4.1.6 Additionally CFT Team shall collect information on Risk Quality
Assetment & Past History (KAKOTORA SHEET)
based on:
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QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

a) In house rejections / Rework SEI/DEV/F-20

b) Customer complaints
c) Process changes and their impact

Identify customer defined special characteristics, SEI/DEV/F-24

Check for Availability of published standards and record
4.1.7 Quality / Engg.
the details.

Preliminary Process flow Chart:

4.1.8 Tentative process flow chart (Block diagram) shall be Engg. SEI/DEV/F-07
prepared by the 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
4.1.9 and shall be closed when reasonable period of extension 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)

Marketing shall accept a Purchase Order / LOI from the --
4.2.1 Marketing
customer.
CFT develops New Product Development Plan (Master & SEI/DEV/F-04
Micro) as required by the organization, in-line with APQP
Matrix (SEI/DEV/F-19) SEI/DEV/F-19
Master plan is prepared for overall monitoring process & Developme
4.2.2
Micro Plan: Process were involve more time which are nt SEI/DEV/F-04A
monitor through Micro Level planning such as a tool / fixture
development & inspection testing establishment & process
validation.
4.2.3 New equipment/ Tooling / Gauges / Testing equipment / Engg. SEI/DEV/F-27
Facilities requirements:
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QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

Identify New Equipment, Tooling’s / Gauges / testing

equipment and Facilities Requirements to complete the
project.

PHASE –III (Process Design & Development)

Appropriate personnel of CFT shall ensure that the following
4.3.1 activities are carried out thru simultaneous Engineering Development
method
CFT shall prepare Packaging standards / specifications that SEI/DEV/F-11
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 prepare Process flow diagram as per the format to SEI/DEV/F-07
4.3.3 cover the incoming source of variation and expected Engg.
deliverables
CFT shall conduct Process Failure Mode and Effect analysis SEI/DEV/F-08
(PFMEA) for all value adding processes as per the PFMEA
4.3.4 Quality
Manual / methodology given in Customer Supplier
Development Manual.
Appropriate personnel of CFT shall prepare Pre-launch SEI/DEV/F-09
Control Plan for all processes as per the Process flow
4.3.5 Quality
diagram. Control Plan shall be prepared based on APQP
Manual / customer approved methodology.
Sample Trial : --
4.3.6 CFT team shall decide of sample planning of new Development
development part
CFT shall perform Job Verification setups. Produce samples SEI/QA/F-04
for initial product and process Establishment. Depending on
4.3.7 the model the actual quantity can be decided by the Quality
respective CFT / based on customer requirement.

4.3.8 Sample Submission : Quality

After trial run completion, QA person will evaluate the
Prepared By: Reviewed and Approved By:
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Revision No.:01
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QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

sample and then make the layout report

CFT Team shall review the all customer requirements and all
required documents submit to customer with sample.
Feed Back & Corrective Action :
Review the customer evaluation report and take necessary Development
action based on customer feedback
Appropriate personnel of CFT shall prepare MSA plan as per SEI/QA/F-35
the requirement for which MSA to be conducted.
4.3.9 Quality
Develope MSA Plan indicating the process, product and
process tolerance and the appraiser and the time.
Appropriate personnel of CFT shall prepare Preliminary SEI/QA/F-05
process capability study plan
Prepare plan indicating the process, Equipment and the
4.3.10 qualified appraiser and tolerances Quality
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 Development
plan prepare for pilot lot.
4.4.2 Production Trial Run : Production --
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 SEI/DEV/F-05
customers identified depending on the model the actual
quantity can be decided by the respective CFT / Customer.
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 SEI/DEV/F-30
appropriate actions to solve the issue, same shall be
recorded in the PDCA
Whenever there is an issue observed in form, fit & function
Prepared By: Reviewed and Approved By:
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Doc. No.:
SEI/DEV/PRO/41
Revision No.:01
Effective Date:10.05.2018
Page No.: 6 of 9
QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

during trail, it should be analyzed & 8D to be prepared for

the issue reported.
CFT shall perform Job Verification setups. Produce SEI/QA/F-04
samples for initial product and process Establishment.
4.4.3 Quality
Depending on the model the actual quantity can be decided
by the respective CFT / based on customer requirement.
During the Production Trial Run, CFT shall ensure that : SEI/QA/F-35A
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
4.4.4 the drawing shared by customer and prepare a report. Quality
Process Validation: Conduct test that validate that products
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
4.4.5 Pilot Lot Submission with PPAP : Quality
After pilot lot completion, QA person will evaluate the SEI/DEV/F-05
sample and make the layout report.
CFT Team shall review the all customer requirements and

Prepared By: Reviewed and Approved By:

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Revision No.:01
Effective Date:10.05.2018
Page No.: 7 of 9
QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

PPAP submit to customer with pilot lot.

CFT shall prepare
Production Control Plan
Production Process control standard
Other documents as required
Development
4.4.6 Develop production Process control standard which is a
/ Quality
logical extension of pre-launch control plan and catering to
all the requirements 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 SEI/DEV/F-14
team to assure that the new product developed has met the
4.4.7 customer requirements and that all tools, equipment’s, Quality
facilities, testing requirements are in line with customer
expectations

PHASE V (Feedback Assessment and Corrective Action)

Track customer feedback after pilot lot (PPAP), Feedback SEI/QA/F-06
and
Corrective action. The overall objective of this process shall
4.5.1 be: Quality
Reduced variation
Incorporate ongoing process performance meeting
Cpk>1.67 for all special characteristics.
Customer Satisfaction SEI/MKT/F-01
Evaluate customer satisfaction
4.5.2 Quality
Delivery
Monitor 100% delivery performance
CFT shall prepare Things Gone Right (TGR) and Things SEI/DEV/F-38
4.5.3 Gone Wrong (TGW) TGR/TGW Report and also define Development
corrective actions that are required.

Review Time:

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Revision No.:01
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QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

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.
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.

REFERENCES - DOCUMENTS:

Procedure for Marketing

Procedure for Production & Maintenance

REFERENCES – RECORDS & RETENTION PERIOD :-

1 APQP Activities Matrix SEI/DEV/F-04 Till Next Status

2 List of CFT Members SEI/DEV/F-01 Till Next Status
3 Enquiry Register SEI/DEV/F-16 Till the product is alive
4 Team-Feasibility SEI/DEV/F-02 Till the product is alive
5 New Product Development Master Plan SEI/DEV/F-04 Till the product is alive

6 New Product Development Micro Plan SEI/DEV/F-04A Till the product is alive
7 Management support & Review Meeting SEI/MGT/F-15 5 yrs
8 Quotation Free format Till further revision
9 Purchase Order Free format Till further revision
10 List of new equipment’s / Tooling / SEI/DEV/F-27 Till Next Status
Gauges / Facilities
11 Packaging standards / specifications SEI/DEV/F-11 Till further revision
12 Process flow diagram SEI/DEV/F-07 Till further revision
13 List of Special Characteristics Matrix SEI/DEV/F-24 Till further revision
14 Potential Process FMEA SEI/DEV/F-08 Till further revision
15 Control Plan- Prelaunch SEI/DEV/F09 Till further revision

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 SEI SHRI RAM ENGINEERING INDUSTRY
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Revision No.:01
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QUALITY SYSTEM PROCEDURE

(Manufacturing Process Designing)

New Product Development

16 MSA Reports SEI/QA/F-35A Till further revision

17 SPC Reports SEI/QA/F-06 Till further revision
18 PPAP SEI/DEV/F-05 Till further revision
19 Quality Planning Sign Off SEI/DEV/F-14 Till Next Status
20 PDCA( Trial Report) SEI/DEV/F-30 Till Next Status

• - Customer Representative shall maintain copies of the above records in the APQP file for each
part.

AMENDMENT SHEET

Re
v Date Change Description Reason for Change Remarks
No.
00 New Release

01 10.05.2018 Aligned with APQP Matrix Not Aligned with APQP

Matrix

Prepared By: Reviewed and Approved By: