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1 & 6. Procedure For New Product Development

1) This document outlines the procedure for new product development (APQP) at JJ Plastalloy. 2) It establishes responsibilities and requirements for planning new products to minimize quality risks and ensure timely completion. 3) Key phases include planning and defining requirements, product and process design/development, validation, feedback analysis, and mass production.

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Rahul Yadav
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89% found this document useful (9 votes)
2K views

1 & 6. Procedure For New Product Development

1) This document outlines the procedure for new product development (APQP) at JJ Plastalloy. 2) It establishes responsibilities and requirements for planning new products to minimize quality risks and ensure timely completion. 3) Key phases include planning and defining requirements, product and process design/development, validation, feedback analysis, and mass production.

Uploaded by

Rahul Yadav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 15

QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 1 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
1.0 Purpose:
The purpose of this procedure is to plan in order to minimize the product launch quality risk and
to ensure timely completion of all required steps through effective communication with
everyone involved within the organization.

2.0 Scope:
This procedure is applicable to the development of new product/process and major changes in
existing products/ processes i.e. master batches at JJ Plastalloy
Major changes – Any material change (known or unknown to customer); any dimensional
change affecting fit and function of the product; process sequence change; any machine change.

3.0 Definitions / Acronyms :


3.1 SC : Steering Committee 3.8 PFD : Process Flow Diagram
3.2 APQP : Advance Product Quality 3.9 PQSR : Product Quality Signoff
planning Report
3.3 NPD : New Product Development 3.10 NPDCRC: New product
3.4 MDT: Multi-Disciplinary Team Developments completeness review
3.5 APQP Time Line checklist
3.6 3.11 SCM : Supply Chain Management
3.7 ITME : Inspection & Test Measuring 3.12 TR: Tool Room
Equipment 3.13 QA : Quality Assurance

A Detailed time line is prepared indicating the various phases.


There are phases as per APQP manual,
Phase - I Plan and define,
II Product Design and development,
III process Design and development,
IV Product & Process Validation
V Feedback analysis and
VI Mass Production

4.0 Responsibility & Authority:


Overall Responsible is Program Manager (Program Leader) under the guidance of SC and
support of CFT. Program manager are appointed based on market segment/product
range.

SC consists of:
A. VP – Operation
B. Head (R&D and QA)
Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 2 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

Cross Functional Team members from:


ME / Design / Production / QA / SCM / Tool Room/Maintenance / Marketing/Sales /PPC

5.0 Process Description: (Turtle Chart)

Who (Resp.) Process KPI’s #


Who (Resp.) Process KPI’s #
Program Manager Effectiveness:
Program Manager Effectiveness:
(Program Leader) % of instance of PPAP Right
(Program Leader) % of instance of PPAP Right
NPD steering committee first time approved
NPD steering committee first time approved
CFT Head of ME / Design Efficiency:
CFT Head of ME / Design Efficiency:
/ Production / QA / Adherence to time line -
/ Production / QA / Adherence to time line -
Delay
SCM / Tool Room Delay
SCM / Tool Room

Input
Input
Process
Process Output
Output
Supplier Customer
Supplier Customer specific Production control plan Customer
Customer Customer specific Receive Requirement of new Production
Purchase control
RM / plan
packing Production In
Customer Requirements Receive Requirement of new Purchase RM / packing Production In
Top mgmt Requirements product specification charge
Top mgmt New product product specification
Validated Quality Product charge
New product Prepare NPD(APQP) timeline Validated Quality QA in charge
requirement Prepare NPD(APQP) timeline Validated SOP Product
Approved QA in charge
requirement Implement the phase wise Validated SOP Approved Customer
Implement the phase wise PPAP Documents Customer
Purchase
Business Plan product/process development PPAP Documents
Controlled Operation Purchase
Business Plan product/process development Controlled Operation Tool Incharge
(Format Monitor the progress Environment
Tool Incharge
(Format Monitor the progress Environment
required) Validate and launch the product
required) Validate and launch the product
Update the documents
Update the documents

Key Resource
Key Resource Method
Method
Computer
Computer Procedure for NPD (APQP)
Software (PLM etc) Procedure for NPD (APQP)
Software (PLM etc) AIAG manuals
Test Facility AIAG manuals
Test Facility
Tool makers
Tool makers
Supplier
Supplier
Human Resource
Human Resource

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 3 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
6.0 Deploymentflow:

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 4 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
Top Management Head Marketing

Business Plan Receive program Receive new product Voice of


initiated through Requirements from Customer
Business Plan Customer
Phase I: Plan Program Product design and
Manger development input
and Review Production Design and Development.
Input Data Sheet and prepared project sheet data sheet
Define Inputs /
Warranty trend having: Preliminary BOM
Preliminary PFD
Outputs
Warranty summary a. Design Goals, b. cost targets
List of Preliminary
sheet CTQs
SC Appoint CFT
Design Goals
Quality Quality goals
rejection/rework data Sale / Service Project sheet for mg.
Collect product sample / Production
Market feedback Head approval
design and development input data
sheet from customer / Market
feedback/Warranty/ Quality data
Design Team
Consider nearest
matching product, if any Review of suitability of existing
product/Minimal
development/complete Pre - BOM
development

Program Manger Phase II:


Move ahead for project if approved Product Design
by Top Mgmt output to be added. And
SC Development
Prepare NPD Time plan
(Output)
NPD Time Plan

Program Manger /
CFT DFMEA
Similar past DFMEA s Conduct DFMEA for final design DFM
and consider past similar DFMEA DFA
for DFM aspects

Design Head BOM


Prepare BOM & Drawings (Child Drawings
parts, Sub Assembly & assembly) DVP
& DVP
Design
Head
Design Team Review the Drawing & BOM with X
special reference to DFM aspect

No Yes
Revise Drg. & Is it OK? A
BOM
Program Manger /
CFT Conduct detailed feasibility study Team feasibility report

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 5 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

Design Team

Share the preliminary Drawings to customer. If Customer approved drawing


required & take approvals on drawings / DVP. DVP

No Is proto sample
B
req. to be Drawings
developed? Proto control plan
Yes Preliminary PFD
Design Team
List of proto sample.
Release drawing to ME, Tool room, QA & SCM
for Proto Sample development

Tool room SCM QA

Development of tools/ Plan Gauge development and


Procurement of the material, procurement / Plan
Development of BOP / Plan

Procedure for Purchasing


Procedure for Assessment, Procedure for Calibration and
Procedure for New Tool ME/QA
Development Selection and approval of Procurement of new gauges /
Part development and inspection, Assemble supplier instruments
Sample &conduct the inspection, Submit the
inspection reports with sample to Design team
Inspection Reports of ME
Design Team part, assembly
Conduct Performance test / Endurance Test as Jigs/fixtures development, capacity
applicable planning, Process design &
Performance test establishment
Endurance test
Design HOD
Review the Result
Phase 2NPDCRC

X No Is it ok?

Yes
Program Manager
Packaging standards
Send proto Sample to sales for
developing Packaging Standards.
Design Calculation
DFMEA
D & D Head List of SCC / CTQ’s
Material Specification
Work instruction for Release drawing to ME, Tool room & SCM Packaging standards/ spec.
drawing control for pilot production Prototype Control Plan
DVP
Component Drawing
List of ITME

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 6 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

Y NPDCRC PHASE II

Program Manager / SC / MDT


Conduct toll gate review / & PFD
NPDCRC Phase II
update timeline sheet Process validation/acceptance
Phase II review criteria
Phase III: Process Design and Development (Output) Check sheet for process
parameters review against
Drawings SCC/CTQ
DFMEA Prepare process flow diagram &
Process validation plan
TGW/TGR prepare process validation plan
Preliminary PFD CFT
.
Review prototype PFD & DO
PFMEA as per procedure
PFMEA
ME/QA
Characteristic matrix
Input Drg. Prepare MSA/SPC Plan
CSR
MSA Plan
List of product CFT
SPC plan
SCC/CTQ
Prepare prelaunch control plan SPC Plan
Procedure for PFMEA
DFMEA Prelaunch control plan
ME/QA/Tool
room
Prepare list of machine/
fixtures/ equipments /gauges / E/IMT/Too requirement list
tools.
Selection criteria for CFT/ME Capacity planning
machines Trigger procurement
Make Development/
Machine process (P.O. etc)
Procurement Plan
Specifications
Maintenance M
requirements E
Prepare floor layout as Floor Layout
applicable Check sheet

Prepare packaging standard & Packaging specification


ME/SCM/Sales
specification

Process facility
ME Follow up for facility readiness readiness check
list

Prepare theoretical line


ME balancing chart / productivity Trigger HR for skill
index & Skill requirement of required
man

NPDCRC
ME Review the product & Process
Update NPD timeline
out puts

B
Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 7 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

ME/Program manager Inform purchase for material


procurement for pilot production

ME Set up manufacturing line on shop


floor as per floor layout

Trial Production report


Phase IV: Product Process Validation MSA study report
ME / QA Produce / Conduct pilot run &
Conduct MSA & Review the results
Process Validation SPC study report
Conduct preliminary process capability
ME / QA / Production during pilot run

Log record the process parameter & Inspection Report


carry out inspection such as time, Production trial report / logs
temperature, RPM, etc

Review the inspection results/ process


parameter.

No Is the process
validating result as
per process approval
criteria?

Product Validation
Yes

ME / QA Conduct product performance Test & Performance test


Endurance test, inspection as per DVP, Endurance test
as applicable
ME / Production
Phase V: Feedback/ Corrective Actions
No Conduct pilot production based on
Is it ok?
changes

Yes

Program manager /CFT Freeze document process


instructions CP. QMS, etc

X
Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 8 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

Program Manager / SC / MDT

Conduct toll gate review / Phase NPDCRC P-V


NPDCRC Phase V
review

Program Manager / QA
Submit PPAP PPAP documents

Program Manager / QA Head / Marketing


Head

Seek PPAP approval from


customer

ME/QA Head / Program Manager


Product Quality Signoff
Prepare signoff documents for
PQSR check list Report (PQSR)
regular production

MR / Program Manager
Review the QMS and Update the
documents as per procedure for
document and data control

Program Manager
Review check list
Warranty policy Conduct toll gate review / NPD review
Service guidelines Phase V review

Production team

Use control plan for mass production


(Improve Cp / Cpk process capability ongoing
basis)

Production team

Conduct SPC, MSA and Process Re-validation SPC Study report


as per plan MSA study report
Re-validation report

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 9 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

7.0 Details :
Sr. Details of activity Resp.

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 10 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
In DFM review meetings it is mandatory that the functional head shall
1. remain present so that timely effectively decisions are taken. Program Functional head
manager shall record the minutes of the meeting for the same.
While reviewing, the ME head along with NPD shall ensure that projects /
actions planned in the previous FMEA version are effectively taken. The
optimization of incoming inspection / process inspection / final
2. inspection is done in terms of optimizing frequency / sampling plans ME head
meaning thereby where ever high RPNs are the improvements / error
proof action are planned and mean while 100% inspection are done, as
appropriate.
Respective program manager maintaining updated summary of ongoing
Program
3. projects along with stand date & completion date along with the time
manager
plan for each project.
4. The product characteristics shall be identified appropriately. Head-Design
Program
5. The review meetings are done on daily/weekly basis as appropriate.
manager
Program manager shall review the status at each phase completion in Program
6.
respective NPDCRC check sheet and present it to mgmt. manager
Packing/packaging specifications are finalized and developed in ME, Production
7.
consultation with Mktg/sales . & QA
Past data shall be collected and reviewed,(preferred data of last 12
8. months) while product and process design.i.e. Warranty / supplier CFT
performance etc.
The status of the product development activities in relation to the
customer commitment and feedback with respect to APQP process is
9. reviewed during Executive Committee Meeting(ECM). The support from SC
the Management and their commitment to assist in any open issue is
obtained.
The delay/changes in the programme time plan is referred to SC or Program
10.
Management Manager/SC
11.  Signoff and clearance for Mass production Head Design
 All the bought out parts are approved based on the PPAP approval. Sourcing & QA
The Ppk record is generated for proto batch/pilot (pre-production) Batch.
 The parts which are produced in-house are also approved as per the ME, Tool room,
PPAP approval. The tools are manufactured outside. The Ppk study is Production & QA
carried out by the internal team as a part of approval process.

 The machined parts are approved as per PPAP approval process. Ppk ME, Production &,
Study is carried out. QA

Controlled copies are available on the web only.


QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 11 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
 The heat treatment process is established. The process shall be ME, Production &
validated prior to pilot batch production. QA
 The heat treatment/special process at supplier end are established
ME, SCM& QA
and validated before start of pilot batch.
 The sub-assemblies are manufactured and approved. The final ME, Tool room,
assembly is manufactured and approved. Ppk study is carried out. Production & QA
 The material handling systems are reviewed and designed as per ME, Production
requirement ensuring defect free part movement.
QA /Production
 The MSA studies are carried out for variable and attribute and applicable
characteristics. Dept.

 The packing and packaging shall be finalized and released. Logistic, Mktg &
QA.
 The latest drawings shall be released. ME/R&D.
 The above activities are completed during pre-production run with all
12.
facilities which are to be used during production. Generate All QA
Documents and File.

Concerned custodian (master copy of documents as defined in document and data control
procedure ) in consultation with MR shall distribute and control the documents as mentioned
below table.
Program manager shall ensure that all updated documents are distributed

Typical Document distribution list


Record/ Document D&D ME PRD QA SCM SERVICE SALES

Drawing / Component drawing - Y Y Y Y N N

Design FMEA - Y Y Y Y N N
Process flow diagram Y - Y Y Y N N
Process FMEA Y - Y Y N N N
Control plan /Quality Plan Y Y Y - Y N N
Work instructions N - Y Y N N N
Process plan N - Y Y N N N
Packing specification / standards Y - Y Y Y N Y
Note: This will be modified by program manger (if required).

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 12 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
8.0 Cross reference
Sr. Types Of Documents Document No.
1. Procedure for New tooling development QP/TR/02
2. Procedure for SPC QP/QA/10
3. Procedure for MSA QP/QA/08
4. Procedure for Customer PPAP QP/QA/07
5. Procedure for Supplier PPAP QP/PUR/04
6. Procedure for DFMEA QP/D&D/02
7. Procedure for PFMEA QP/ME/03
8. Procedure for Control of documents QP/MR/01
9. Procedure for Purchasing QP/PUR/03
10. Procedure for Management Review QP/MR/04
Procedure for Systematic Problem Solving (Product ,System, Process
11. QP/MR/03
and New projects)
12. Procedure for Manufacturing Process Validation and Revalidation QP/ME/04
13. Procedure for escalation QP/D&D/03
14. Procedure for Assessment, Selection and approval of supplier QP/PUR/01
Procedure for Calibration and Procurement of new gauges &
15. QP/QA/04
instruments

9.0 Document
Sr. Types Of Documents Document No.
Phase 1

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 13 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
1. Preliminary BOM ML/D&D/01
2. Master List of DFMEA APQP STD FORMAT
3. Design Validation Plan ML/D&D/02
Phase 2
4. Preliminary drawings --
5. List of proto sample ML/D&D/03
6. Preliminary PFD APQP STD FORMAT
7. Proto control plan APQP STD FORMAT
8. Bill Of Material ML/D&D/01
Phase 3 & Phase 4
9. Process Flow Diagram APQP STD FORMAT
10. List of Required Test & Inspection equipment ML/QA/03
11. List of required work instruction ML/MR/04
12. List of Packing standards /Specifics ML/ME/02
13. PFMEA APQP STD FORMAT
14. MSA Plan As per QP/QA/08
15. SPC Plan As per QP/AS/03
16. Pre Launch Control Plan APQP STD FORMAT
17. List of PFMEA ML/ME/02
18. Floor Layout ML/ME/04
19. Product/Process validation plan QF/ME/20
20. List of Jigs/Fixtures ML/ME/03
21. List of Machines ML/ME/04
22. List of material handling/storage requirement ML/ME/05
23. Process Validation Criteria As per QP/ME/04
Phase 5
24. Control Plan APQP STD FORMAT
25. Diagnostic Guidelines APQP STD FORMAT
26. Process revalidation plan QF/ME/16

10.0 Records:
Sr.
Name of the Record / register Document No.
No.
Phase 1
1. Production design and development input data sheet QF/NPD/01
2. Design Calculations QF/NPD/02
3. Management approval feasibility report QF/NPD/03
4. NPD Time Plan QF/NPD/04
5. Team feasibility report QF/NPD/05

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 14 of 15 Rev. No.: 00 Rev. Date: 09.04.2017
6. NPD Completeness Review Checklist Phase 1 QF/NPD/06
Phase 2
7. Proto Inspection Reports of Part & Assembly QF/QA/07
8. Performance test QF/QA/10
9. Endurance test QF/NPD/09
10. Packaging standards/ Specification QF/NPD/11
11. NPD Completeness Review Checklist Phase 2 QF/NPD/06
Phase 3
12. Check sheet for process feature review against SCC/CTQ QF/NPD/12
13. Process facility readiness check list QF/NPD/13
14. NPD Completeness Review Checklist Phase 3 QF/NPD/06
Phase 4
15. Trial Production report
16. MSA study report As per QP/QA/07
17. Process capability study report As per QP/AS/03
18. Inspection Report (HT) QF/HT/04
19. Inspection Report (Press shop) QF/PP/08
20. Inspection Report - Machine shop QF/MS/14
21. Inspection Report - Assembly QF/QA/07
Production trial report / logs ( BO / Press shop/ Machine shop / HT /
22. QF/MS/01
Assembly )
23. Part Submission Warrant - Internal QF/ME/22
Phase 5
24. Design Check list / Review meeting Phase-5 QF/NPD/06
Part Submission Warrant
25. QF/NPD/14
(Submission of Proposal Drawings to Customer for Approval)
26. Project sign off and handover sheet QF/ME/21

11.0 Amendment Summary:


Pages
Rev No Rev Date Amendment Summary Reason for Change
Affected

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.
QUALITY SYSTEM PROCEDURE

Doc. No.: QP/ DD/001

Title: Procedure for New Product Development (APQP)


TS 16949:2009 Clause No: 7.1 / 7.3 Page 15 of 15 Rev. No.: 00 Rev. Date: 09.04.2017

Prepared By Approved By Issued By

Head - ME VP (Operation) and Head (Design and Management Representative


QA)
Controlled copies are available on the web only.

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