Fluid Components International Quality Assurance Manual - Manual (Page 34)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
Date
10-8-2012
SECTION
1
PAGE
12
CURRENT
REVISION
L
d) Specifies the characteristics of the product that are essential to its safe and
proper use.
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 development to meet
requirements, and
b) Identify problems and propose necessary actions.
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 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.
7.3.7 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.
Records of the results of the review of changes and any necessary actions are
maintained.