Company Name
Division or Address
Division or Address
Design Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 1 of x
ISO Procedure
Design Control
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
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Company Name
Division or Address
Division or Address
1.
2.
Design Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 2 of x
Purpose
•
To control the design and development of new products.
•
To define the checks and balances applied to the design and development
activity.
•
To control and verify the design of the products, assign design function
responsibilities, define technical interfaces, ensure that the product meets
the specified requirements, and verify that the design output meets the
design input requirements.
•
To expose the product design to persons with viewpoints and opinions
other than those of product design and development engineers.
•
To re-evaluate distributed products.
•
To maximize protection against oversight that might adversely affect
product quality, safety, and efficacy.
Scope
This procedure applies to the development of all new products from the initial
design to the release for manufacturing.
3.
Responsibilities
<Job title> approves the product specification for major new products, product
revisions, and accessories.
<Department> evaluates performance, durability, safety, reliability, and
maintainability of the design under expected storage and operational conditions;
verifies that all design features are as intended and that all authorized design
changes have been accomplished and recorded; validates computer systems and
software.
<Department> provides initial product requirements, performance target values,
and market utility assessments.
<Department> ensures the availability of products and services required for the
manufacturing and testing of the product.
<Department> advises and reviews necessary testing and inspection
requirements.
<Department> ensures that sufficient personnel are available and suitable for the
production of the product, and that an appropriate training program is instituted.
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Division or Address
Design Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 3 of x
<Department> ensures that the facilities, instrumentation, machinery, equipment,
and services are available for the efficient production of the product.
<Department> tracks revision levels and changes to preliminary drawings. <Job
title> approves revisions to preliminary drawings.
<Job title> coordinates:
•
•
•
•
the design and production of sketches, drawings, and layouts
the building and testing of models, prototypes, and pilots,
including the acquisition of materials
the collection and recording of test data
any modifications to the product specification, if necessary
At all stages of development, <team> representing <departments> may determine
whether to modify the product specification or change the design of the product
based on test results.
4.
Procedure
4.1
Review Team
See Contract Review xxx.
<Job title> translates the customer’s needs into technical specifications.
<Team> composed of <job titles> reviews the specification and ensures it
is producible, verifiable, and controllable.
<Team> generates a design plan identifying activities and assigning
responsibility to the activities. Those assigned to perform design
activities meet company qualifications. <Records of qualification> are
stored as Quality Records at <location>.
<Team> meets <activities>.
<Records> of <team> meetings are maintained as Quality Records. <Job
title> maintains the records for <length of time> in <location>.
4.2
Market Review
<Job title> can initiate a concept for a new product. Features of a new
product are based upon <information>.
4.3
Product Definition
See Document and Data Control xxx.
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Division or Address
Design Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 4 of x
<Job title> develops preliminary drawings. <Job title> approves the
preliminary drawings.
Customer requirements are incorporated into the design. <Department>
communicates the requirements to the design team through <activity>.
Design of product includes the applicable statutory and regulatory
requirements to which <Company> adheres.
<Job title> generates <document> to support the design. The documents
are controlled and maintained by <department>.
4.4
Qualify and Verify
See Quality Records xxx.
<Job title> is responsible for testing the new design and records test
results on <name of form>. The <name of form> is maintained by
<department> for <length of time>.
<Job title> reviews the test results and if required the preliminary design
drawings are revised.
The preliminary drawings are released for a pilot run. <Job title>
evaluates the pilot run.
The test procedures specify the following <criteria> and include: <types
of analysis>.
<Job title> records the test results onto <name of form>. The <name of
form> is maintained by <department> for <length of time>.
4.5
Final Review
A final review to determine if the product meets the requirements of the
product specification is held by <team>.
<Job title> qualifies the pilot run determining if the product meets the
requirements of the product specification.
Subcontracted, suitably qualified facilities are used for specialized
testing.
The review includes <criteria>.
The <name of form> releases the design to production. <Job title>
approves the <name of form>. The <name of form> is maintained by
<department> for <length of time>.
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Company Name
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Division or Address
4.6
Design Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 5 of x
Requalification
Periodically the product is re-evaluated to ensure that the design is still
valid with respect to all specified requirements. The review includes:
<criteria>.
Records of the re qualification are maintained on the <name of form>.
<Job title> approves the <name of form>. The <name of form> is
maintained by <department> for <length of time>.
4.7
Revision Control
Design changes are given the same review as the initial design. <Job
title> reviews changes and modifications to the design of the product.
<Job title> revises the documentation.
5.
Related Documentation
<record of meetings>
<design plan>
<form for qualification>
<test procedure>
<training records>
Contract Review
Document and Data Control
Corrective and Preventive Action
Quality Records
Training
<list of work instructions>
Controlled Copy, Do Not Duplicate
For Internal Use Only