Fluid Components International Quality Assurance Manual User Manual

Page 59

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DOCUMENT NUMBER

07QA070003

SUBJECT

Quality Manual

CAGE CODE

64818

RELEASE DATE

10-8-2012

SECTION

2

PAGE

18

CURRENT
REVISION

L

b)

Test procedures describe the method of operation, the performance of the
test, and the recording of the results;

c)

The correct configuration standard of the product is submitted for the test;

d)

The requirements of the test plan and the test procedures are observed;

e)

The acceptance criteria are met.

7.3.6.2 DOCUMENTATION OF DESIGN AND/OR DEVELOPMENT

At the completion of design and/or development, FCI ensures that reports,
calculations, test results, etc., demonstrate that the product definition meets the
specification requirements for all identified operational conditions.

7.3.7 CONTROL OF DESIGN AND/OR DEVELOPMENT CHANGES

Design and/or development changes are identified and records maintained. The
changes are reviewed, verified and validated, as appropriate, and approved before
implementation. The review of design and development changes includes
evaluation of the effect of the changes on constituent parts and product already
delivered.

Objective evidence that design changes necessary to ensure only current, correct
and approved changes are used. Records of the results of the review of changes
and any necessary actions are maintained.

Design and/or development changes shall be controlled in accordance with the
configuration management process (see 7.1.3)

7.4

PURCHASING

7.4.1 PURCHASING PROCESS

FCI ensures that purchased product conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the purchased product is
dependent upon the effect of the purchased product on subsequent product
realization or the final product.

FCI shall be responsible for the conformity of all products purchased from
suppliers, including product from sources defined by the customer.

FCI evaluates and selects suppliers based on their ability to supply product in
accordance with the organization‟s requirements. Criteria for selection,
evaluation, and re-evaluation are established. Records of the results of
evaluations and any necessary actions arising from the evaluation are maintained.

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