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
