Fluid Components International Quality Assurance Manual - Manual (Page 33)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
Date
10-8-2012
SECTION
1
PAGE
11
CURRENT
REVISION
L
7.3 DESIGN AND/OR DEVELOPMENT
7.3.1 DESIGN AND/OR DEVELOPMENT PLANNING
FCI plans and controls design and/or development of the product.
Design and/or development planning determines:
a) Stages of design and/or development,
b) Review, verification and validation activities appropriate to each design
and/or development stage, and
c) Responsibilities and authorities for design and/or development.
Interfaces between different groups involved in design and/or development are
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 the design and/or development shall be in a form that is suitable
for verification against the design and/or development inputs 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,