Document Title

Product Design and Development Procedure

3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 1 of 8

Revision History
Rev No DCN # Changes Effective Date Approved
01 Initial release 08/06/04
02 0005 Modification of procedure, footer change 10/12/04 CA
03 0024 Modification of procedure 01/08/06 CL
04 0718 Change process owner & format 07/28/09 YZ
05 1009 Document # and format changed. 06/29/11 A. Qin
06 1149 Yearly review, Change doc owner 05/03/13 D. Yu
07 1202 Yearly review, rewording 06/02/14 D. Yu

Product Design and Development Procedure

Process Owner: Danny Yu Date: 06/03/2014

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 2 of 8

1.0 Purpose

This procedure defines the process flow to control new product designs and development
process.

2.0 Scope
This procedure applies to all new product design/development activities.

3.0 Authorities and Responsibilities

 Marketing/ Sales  Identify customer/market needs for new product.

 Participate in design/review/PDC meeting when needed.
 Engineering  Identify new product concept based on technical
innovation.
 Design/develop new product.
 Create all technical documents.
 Production  Support Engineering during new product development.
 Conduct process pilot run to verify and qualify new process.
 Participate in design/review/PDC meeting when needed.
 Customer Service  Communicate with customer during product development
process.
 Purchasing  Support Engineering during new product development.
 Communicate with supplier when needed during new
product development process.
 Work with QA on qualification of new supplier for new
material required for new product.
 Participate in design/review/PDC when needed.
 Quality  Support Engineer on product DVT/qualification.
Assurance  Participate in design/review/PDC meeting.

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 3 of 8

4.0 Definitions and Acronyms

PDC Product Development Committee

A review panel comprised of representatives from Marketing and
Sales, Engineering, Manufacturing, and Quality Assurance. A PDC
meeting is convened to review the progress of new product design
and development status and to approve allocation of resources for
next design and development stage.
EVT Engineering Verification Test
Testing and measurement performed on small set of prototypes to
verify that the design concept is feasible and capable of performing
its intended function at normal operating condition.
DVT Design Verification Test
Testing and measurement performed on small set of prototypes to
verify that the product built with current design/process is capable of
performing its intended function at normal operating condition.
ECN Engineering Change Notice
BOM Bill of Material
FMEA Failure Mode Effect Analysis
An analytical technique used to consider and address potential
failure modes and their causes and mechanism.
DFMEA Design FMEA
PFMEA Process FMEA
UPH Unit per Hour

SPC Statistic Process Control

Cpk An index used to measure the capability of a manufacturing process

against target specification.
Mfg Manufacturing

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 4 of 8

5.0 Flow Chart of Procedure

Flow Chart Responsible Notes Record

Any Employee New product Needs “New Product Design &

Identify New may be based on Development Record”
Product Needs customer requirements,
advances in technology,
and new market
applications, etc.

Establish New Engineering Propose product

Product Concept concept against
customer needs &
applications
Identify all requirements
as design input

PDC: Review customer/ “Design Review Report

Conduct Critical Marketing/Sales market requirements (Gate 0)”
Design Review Engineering Assess the strategic “New Product Design &
(Gate Review: G0) Management and technical fit of the Development Record”
product to company and
Engineering company’s engineering
capability
Product Concept
Determine the
Approved?
preliminary timeline
No (Time-to-Market)

Yes
Revise for
Engineering
Resubmission or
Terminate
Against Design Input “New Product Design &
Engineering Concept Includes Development Record”
Propose Design technology to be used,
Customer Service
Concept potential manufacturing
processes (method), and
preliminary schematics &
drawings
Communicate w/
customer when needed
Engineering Use theoretical analysis “New Product Design &
Verify Design and/or simulation Development Record”
Concept (EVT) Perform bench-top test “EVT Report”

Feasibility & risk “Feasibility & Risk

Analyze Feasibility Engineering Assessment Report”
assessment includes:
and Risk technical feasibility,
material supply risk
manufacturing risk,
reliability risk.

Engineering Use project “New Product Design &

Propose Design & Customer Service management approach Development Record”
Development Plan Team organization and
responsibilities,
milestones schedules,
product testing plan,
resource requirements
and budget are
identified
Interface w/ customer &
A supplier when needed

(To be continued on next page)

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 5 of 8

(Continued from previous page)

(To be continued on next page)

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 6 of 8

(Continued from previous page)

Ye
Flow Chart Responsible
s
Notes Record

PDC: Review product design, “Design Review Report

Conduct Critical Marketing/Sales DFMEA results and (Gate 2)”
Design review Engineering effectiveness of actions, “New Product Design &
Production DVT & Design Development Record”
(Gate Review: G2)
Purchasing Validation test results,
Quality Assurance customer feedback &
Management supplier development
progress
Approve product design
Design & Plans
Review and approve
Approved? No proposed manufacturing
process & pilot run plan
Yes
Propose Engineering Follow “Engineering “Engineering Change
Engineering Production Change Control Order Request”
Change or Procedure” for any
Terminate design change
Verify/validate design
accordingly
Engineering “Process FMEA”
Production
Conduct Process Quality Assurance
FMEA

Engineering Collect process “Pilot Run Report”

Production statistical data “Engineering Change
Perform Pilot Run (Distribution, yield & Order Request”
Cpk etc)
Calculate production
cycle time, UPH etc
Build samples for
process validation and
qualification
Communicate w/
customer & supplier
when needed
Follow “Engineering
Change Control
Procedure” for any
design & process
change
Engineering Per pre-approved plan “Qualification Test &
Conduct Quality Assurance Estimate product Reliability Assessment
Qualification Test (Reliability) reliability using proper Report”
statistic tools “Failure Analysis Report”
Perform failure analysis “Engineering Change
if failure identified Order Request”
Follow “Engineering
Change Control
Procedure” for any
design & process
change
Start production ramp-
up or process transfer
after products are
passing provisionally
qualified
C

(To be continued on next page)

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 7 of 8

(Continued from previous page)

Ye
Flow Chart Responsible
s
Notes Record

PDC: Review mfg process, “Design Review Report

Conduct Critical Marketing/Sales PFMEA results and (Gate 3)”
Design Review Engineering effectiveness of actions, “New Product Design &
(Gate Review: G3) Production Pilot Run Test Report, Development Record”
Purchasing customer feedback &
Quality Assurance supplier development
Management progress
Approve mfg process
Review qualification &
reliability assessment
results
Review customer/
supplier feedback
Review & approve “New Product Design &
Pilot Run &
Qualification production ramp-up Development Record”
Pass? plan (including off-site “Product Release
No Binder”
process transfer plan if
applicable)
Yes

Engineering Follow “Engineering

Propose Change Control
Production
Engineering Procedure” for any
Change design/process change
Perform necessary
verification test

Engineering Product Release “New Product Release

Prepare New Production Document includes: Checklist”
Product Release manufacturing process
Documents map (flow chart w/ key
control point identified),
work instructions,
testing/inspection
instructions & criteria,
BOM, material
specifications/drawing,
approved supplier list,
updated DFMEA/
PFMEA

Ramp-up
Production
Quality Assurance
Production or
Transfer Process

Production Set goal/objectives to

Monitor Process & Quality Assurance drive continual
Field Performance (Reliability) improvement activities
Fine-tune product
design & mfg process
for better quality/
reliability
Follow “Engineering
Change Control
Customer Service Procedure” for changes
Plan for End-of-Life Engineering
of Product Production
Quality Assurance

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 Document Title
Product Design and Development Procedure
3390 Gateway Boulevard
Document No: QP 73001 Revision Number 07
Fremont, CA 94538
USA Effective Date 06/03/2014 Page Number Page 8 of 8

6.0 General Requirements

N/A

7.0 Reference Documents

QM 001 Quality Manual

QP 73003 Engineering Change Control Procedure

QP 73002 Reliability Program Procedure

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