Fluid Components International Quality Assurance Manual - Manual (Page 57)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
16
CURRENT
REVISION
L
managed to ensure effective communication and clear assignment of
responsibility.
Planning output is updated, as appropriate, as the design and/or development
progresses.
7.3.2 DESIGN AND/OR DEVELOPMENT INPUTS
Inputs relating to product requirements are determined and records maintained.
These include:
a) Functional and performance requirements,
b) Applicable regulatory and legal requirements,
c) Applicable information derived from previous similar designs, and
d) Any other requirements essential for design and/or development.
These inputs are reviewed for adequacy. Incomplete, ambiguous, or conflicting
requirements are resolved.
7.3.3 DESIGN AND/OR DEVELOPMENT OUTPUTS
The outputs of design and/or development shall be in a form suitable for
verification against the design and development input and shall be approved prior
to release.
Design and/or development output:
a) Meets the design and/or development input requirements,
b) Provides appropriate information for purchasing, production, and service
provisions,
c) Contains or references product acceptance criteria,
d) Specifies the characteristics of the product that are essential to its safe and
proper use, and
e) Specify, as applicable, any critical items, including any key characteristics,
and specific actions to be taken for these items.
FCI shall define the data required to allow the product to be identified,
manufactured, inspected, used and maintained.
Examples may be:

Drawings, parts lists and specifications necessary to define the
configuration and the design features of the product, and