Fluid Components International Quality Assurance Manual - Manual (Page 53)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
12
CURRENT
REVISION
L
activities and how they contribute to the achievement of the quality
objectives, and
e) Maintain appropriate records of education, training, skills and experience.
6.3 INFRASTRUCTURE
FCI determines, provides, and maintains the infrastructure needed to achieve
conformity to product requirements. Infrastructure includes, as applicable:
a) Buildings, workspace and associated facilities;
b) Process equipment (both hardware and software), and
c) Supporting services (such as transport or communication).
6.4 WORK ENVIRONMENT
It is each departmental manager/supervisor‟s responsibility to determine and
manage the work environment needed to achieve conformity to product
requirements.
7.0 PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
FCI plans and develops the processes needed for product realization. Planning of
product realization is consistent with the requirements of the other processes of
the quality management system.
Upon the identification of the need to make a product available to our customers,
the planning of the processes for realization occurs to determine the following as
appropriate:
a) Quality objectives and requirements for the product during the Design and
Planning Phase;
b) The need to establish processes, *documents, and provide resources specific
to the product during the Design and Planning Phase;
c) Required verification, validation, monitoring, inspection and test activities
specific to the product and the criteria for product acceptance during the
Design and/or Planning Phase;
d) Records needed to provide evidence that the realization processes and
resulting product meet requirements;
e) Configuration management appropriate to the product; at the design phase