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Procedure

Procedure for Design &


Development

1. PURPOSE & SCOPE: The purpose of this procedure to describe the detail activities for design & development
process. The scope of this procedure is limited to design and/or development of new product or modification of
existing products.
2. REFERENCE: ISO 9001: 2008, Clauses – 7.3
3. RESPONSIBILITIES: In charge Design & Development is responsible for implementation of this procedure
5. PROCEDURE:
No. Activity responsibility Record ref.
5.1 Design & Development
planning
5.1.1 Planning shall be done with In charge Design & Development Design &
the concerned
Dev.Plan
departments/personnel.
Area concerned for
planning :
 Identification of qualified
personnel
 Identification of adequate
resources
 The design and
development stages
 The review, verification
standards that are
appropriate to each design
& development stage

5.2 Design and/or Development Inputs


Design inputs relating to Do
product requirements are
determined.
No. Activity responsibility Record ref.
These inputs shall include : Design &
 Functional & performance Dev
requirements
.Input Data
 Applicable statutory and
regulatory requirements Sheet
 Information derived from
previous similar design, and
 Other requirements
essential for design and
development.
Design inputs shall be
reviewed for adequacy.
Requirements shall be
complete, unambiguous
and not in conflict with
each other.
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Records shall be
maintained.

5.3 Design and development


Outputs
Design output information In charge Design & Development Design &
relating to the confirmation
Dev
of the product to the
specification/requirements/ Out Put Data
inputs and its performance
Sheet
is recorded in various
documents. Design output
shall be documented (D&D
file), so that it can be
verified and validated
against requirements.
While verifying the design
output, it is ensured that,
 Design output needs with
input.
 The design outputs provide
appropriate information for
purchasing, production and
for service provision.
 Product acceptation criteria
shall be define

5.4 Design and development


review
After getting data from In charge Design & Development Design &
design input and output,
Dev
documented design shall be
reviewed for feasibility of Plan
the design to meet the
requirements of the
products and to identify any
problem and propose
necessary actions.
Members of design Review
meeting are VP(O)/MR,GM
(M&S,QA) COO, & D&D I/c
and other persons require
for the project.
Record of design review
shall be maintained
5.5 Design and development
verification
Verification of output In charge Design & Development Design &
performance shall be done in Dev
accordance with planned
Verification
arrangements to ensure that
the design outputs have met Sheet

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the input requirements.

Records of the results of the


verification and any
necessary actions shall be
maintained.
5.6 Design and development
validation
Design validation is carried GM ( M&S,QA) Design &
out on final production in Dev
accordance with planned Validation
arrangements to ensure
Sheet
that the product conforms
to defined user
needs/requirements.
Whenever practicable,
validation is completed
before the delivery or
implementation of the
product.
Records of the validation
results and necessary action
shall be maintained

5.7 Control of design and


development changes
If any, Design and GM ( M&S,QA) Design &
development changes are Dev
identified shall be reviewed, Validation
verified and validated, as Sheet
appropriate, and approved
before implementation. The
review of design and
development changes
include evaluation of the
effect of the changes on
constituent parts and
product already delivered.
Records of the results of the
review of changes and any
necessary actions are
maintained.

Design & Development Process Flow Chart

Input from Marketing Business Environment


based on market &
customer requirement
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Evaluation of the Inputs to
determine its technological,
commercial & environment
suitability

Yes No Shelve the idea

Design & Development


Process

Output of Design/ Development

Review of Design/ No
Development with plan Re planning

Yes

Prototype Manufacturing/
Modification/

Verification / Prototype
Re planning
Testing

Successful

Validation as per plan

Review of Validation
Re planning
Report

OK
Integration with
manufacturing process

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