Fluid Components International Quality Assurance Manual User Manual
Page 58
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
17
CURRENT
REVISION
L
Information on the material, process, manufacturing and assembly of the
product needed to ensure conformity of the product.
7.3.4
DESIGN AND/OR DEVELOPMENT REVIEW
At suitable stages, systematic reviews of design and/or development is performed
in accordance with planned arrangements to:
a)
Evaluate the ability of the results of design and/or development to meet
requirements,
b)
Identify problems and propose necessary actions, and
c)
Authorize progression to the next stage.
Participants in such reviews include representatives of functions concerned with
the design and/or development stage(s) being reviewed. The results of the
reviews and any necessary actions are maintained.
7.3.5 DESIGN AND/OR DEVELOPMENT VERIFICATION
Verification is performed in accordance with planned arrangements to ensure the
design and/or development outputs have met the design and/or development input
requirements. The results of the verification and any necessary actions are
maintained.
7.3.6 DESIGN AND/OR DEVELOPMENT VALIDATION
Design and/or development validation is performed in accordance with planned
arrangements to ensure that resulting product is capable of meeting the
requirements for the specified application or intended use, where known.
Wherever practicable, validation is completed prior to the delivery or
implementation of the product. Records of the results of the validation and any
necessary actions are maintained.
7.3.6.1 DESIGN AND/OR DEVELOPMENT VERIFICATION OR VALIDATION
TESTING
Where tests are necessary for verification and validation, these tests are planned,
controlled, reviewed, and documented to ensure and prove the following:
a)
Test plans or specification identify the product being tested and the
resources being used, define test objectives and conditions, parameters to
be recorded, and relevant acceptance criteria;