EMCO ELECTRONICS Appr.

By :

Page No. 1 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

1.0 PURPOSE

To ensure that the design and development of products including design

changes, is controlled through planning, implementation, review,
verification and validation.

2.0 SCOPE

All products developed by EMCO ELECTRONICS for manufacturing

3.0 REFERENCES

DD00 - 401 Format -"Design Plan"

DD00 - 402 Format -"Design Change Record"
DD00 - 403 Format -"Design Review Redord"
DD00 - 404 Format -"Summary of Design Measures"
DD00 - 501 Format -"Check list for Design Input Adequacy"
DD00 - 502 Format -"List of Design Outputs"
DC00 - 403 Format -"Masterlist of Documents (Internal)"
ITXX - 402 Format -"Test Reports"
PD00 - 201 Procedure -"Procedure for Production"
MK00 - 201 Procedure -"Procedure for Contract Review"
DC00 - 201 Procedure -"Procedure for Document and Data Control"

4.0 ANNEXURES :
Annexure A - Process Maps & Flow-Charts
Annexure B - Records Table
 EMCO ELECTRONICS Appr. By :

Page No. 2 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

Annexure A - PROCESS MAPS & FLOW-CHARTS

Process Owner : Process Controls : Process Performance Targets :

Ÿ Head Design --- Ÿ Completion as per plan
Ÿ Actual cost not exceeding 5% of
planned cost

Process Inputs : Process Name : Process Outputs :

Ÿ Specific Customer requirement Design and Development Ÿ Design Plan
Ÿ Customer Feedback Ÿ Design Verification Records
Ÿ Design Validation Records
Ÿ Design Review Records
Ÿ Design Change Records

Process Verification : Process Resources (Means): Process Measures (Metrics) :

Ÿ Through Auditing and Ÿ Availability of softwares Ÿ % Delay in implementation.
Process Performance Measures (DD00-404)
Ÿ % Actual cost : Planned cost
(DD00-404)
 EMCO ELECTRONICS Appr. By :

Page No. 3 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

Design and Development Process:

New product / Non-standard product /

Design change requirement from Marketing
through Design Input Specification

Design change Non-standard

D
Design input E
specification
Design Input
Specification New
product

Review of Design Input

Des. Hd.

specification for adequacy as

A1.1

Check list for

Design Input per Check list for Design input
Adequacy Adequacy

DD00-501
Obtain necessary

Sales Engr.
Information No information through
A1.2

Customer
Drawings / adequate? marketing
Samples

Yes
Preparation of Design &
Development Plan, indicating
the following :
Design Input Ÿ Design & development stages
Des. Hd.

Design Plan
A1.3

Specification Ÿ Review, verification &

validation as appropriate to
each stage DD00-401
Ÿ Defined responsibilities
Ÿ Review & updation of plan
List of Design
Outputs

DD00-502

Design Input Preparation of appropriate

Design
Des. Hd.

Specification Design & Development Outputs

A1.4

Outputs
as per list of Design outputs

Customer A
Drawings /
Samples
 EMCO ELECTRONICS Appr. By :

Page No. 4 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

Design Input
Specification
A

Verification of Design Outputs at

Design Plan the stages defined in the Design Design

Des. Hd.
& Development plan for Verification
A1.5

confirming that the same have Record

DD00-401 met the Design Input specification.
Results of Design Verification are
Customer Recorded.
Drawings /
Samples

Correction of the design

outputs, as required to

Des. Hd.
Design Output No

A1.6
OK? ensure that the same
Design
meet the Design Input
Outputs
Specifications
Yes
Review of Design & Development
Outputs with concerned functions,
Design Plan (namely marketing, purchase,
production, QA, service as
applicable), at the stages defined Design
Des. Hd.

DD00-401 in the Design & development plan, Review

A1.7

for confirming that there are no Record

concerns, issues relating to :
Design DD00-403
Ÿ 'marketability'
Outputs
Ÿ 'procurability '
Ÿ 'manufacturability'
Ÿ 'testability'
Ÿ 'servicaability'

Any comments Yes

/ changes
required?
Correction of the
Des. Hd.

Design outputs as per

A1.8

No the comments /
B changes required by
the concerned functions
 EMCO ELECTRONICS Appr. By :

Page No. 5 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

Customer Yes
approval
required ?
Forwarding of required

Des. Hd.
drawings / documents

A1.9
to marketing for
No obtaining customer's
approval

Manufacturing of
Des. Hd.
A2.2

prototype
Yes Drawings /
Documents
approved ?

No
F

Functional
Testing of prototype Test Report
Des. Hd.

Verification
A2.3

(Product)
Checklist
ITxx-402

Necessary Modification of
Functional No No
changes/ drawings / documents
Des. Hd.

Verification
modifications as per customer's
A2.1

OK
cariied out comments and
re-submission to
Yes customer for approval
F

Prototype send to
Des. Hd.
A2.4

customer where agreed

for field test and feedback

Master List of
Updating of Master-list
Des. Hd.

Documents
A2.5

for the final drawings / (Internal)

documents
DC00-403

C
 EMCO ELECTRONICS Appr. By :

Page No. 6 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

Manufacturing of Pilot

Prod. sup
Batch where
A2.6

necessary, as per
manufacturing process

Procedure for
Production Final Inspection and

Prod. sup
testing of Pilot Batch as Test Report
A2.7

PD00-201 per procedure for

production, as
validation of design ITxx-402

Test Results No
OK?

Yes
Procedure for Necessary
Release of drawings / modifications / changes

Des. Hd.
Document
A2.8

Documents to production /
Des. Hd.

and Data carried out and

A2.9

Control QA / Stores as per procedure drawings updated for

for Document and Data the same
DC00-201 Control

Design
Design Changes are
Des. Hd.

Change
A3.0

Specification implemented as per

requirement

Ÿ Design Changes are

verified, revieved &
validated as Design
Des. Hd.

appropriate including Change

A3.1

effect of changes on Record

existing design
Ÿ Results are recorded DD00-402
in Design Change
Record

Related Documents are Design

Des. Hd.

revised & Design Change

A3.2

Change Record is Record

updated DD00-402
 EMCO ELECTRONICS Appr. By :

Page No. 7 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

Design Changes related to Non-standard

requirement from customer which has been
reviewed & accepted as reffered in procedure Memo for Non-
for contract review are carried out as under : Std
Ÿ Design Changes are worked out & where Requirement
required, the same are verified and
Procedure for reviewed to ensure that they meet the
Contract changed requirements and to identify any

Des. Hd.
Review problems in implementing the changes.
A3.4

Ÿ Necessary instructions for implementing

MK00-201 such changes is given to various
Departments through Memo for Non-
standard requirements including any
changes required in the inspection and
testing of the product wherever necessary. Test Report
Ÿ The changes are validated through in-
process final testing and recorded in the ITXX-402
test report wherever practicable and
applicable.
 EMCO ELECTRONICS Appr. By :

Page No. 8 of 8
Doc No. DD00-201
DOC. TITLE : Procedure for Design and Development Issue No. 3
Issue Dt. 01-04-10

RECORDS TABLE

Sr. FILE FILE LOCATION MAINTAINED RETENTION

No. REFERENCE DESCRIPTION BY PERIOD

1. DD 00 - 801 "Design Record File" . R&D R&D 3Years

(Product) -Design Plan Department Head
(DD00 - 401)
-Design Review Record
(DD00 - 403)
-Design Verification /
Validation Record

2. DD 00 - 802 "Design Change File" .

-Design Changes R&D R&D 3 Years
-Design Change Record Department Head
(DD00 - 402)
-Design Change Verification /
Validation Record