Fluid Components International Quality Assurance Manual User Manual
Page 54
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
13
CURRENT
REVISION
L
e)
Resources to support the use and maintenance of the product during the
design phase.
Output from this planning is in a form suitable for FCI‟s method of
operations and may be (but is not limited to) the following:
Quality System Procedures and/or Documentation
MRP Data
Delivery Method Information
Quality Objectives
Organizational Infrastructure
Department Specific Documentation
Product Realization Documentation
7.1.1 PROJECT MANAGEMENT
As appropriate to FCI and the product, FCI shall plan and manage product
realization in a structured and controlled manner to meet requirements at
acceptable risk, within resource and schedule constraints.
7.1.2 RISK MANAGEMENT
FCI shall establish, implement and maintain a process for managing risk to the
achievement of applicable requirements, that includes as appropriate to the
organization and the product
a)
Assignment of responsibilities for risk management,
b)
Definition of risk criteria (e.g. , likelihood, consequences, risk
acceptance),
c)
Identification, assessment and communication of risks throughout product
realization,
d)
Identification, implementation and management of actions to mitigate
risks that exceed the defined risk acceptance criteria, and
e)
Acceptance of risks remaining after implementation of mitigating actions.
7.1.3 CONFIGURATION MANAGEMENT
The organization shall establish, implement and maintain a configuration
management process that includes, as appropriate to the product