Fluid Components International Quality Assurance Manual - Manual (Page 78)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
3
PAGE
5
CURRENT
REVISION
L
3.3 New Designs
New product requiring qualification to specific requirements shall have a
Qualification Test Procedure developed to accomplish the testing. When required
this document shall be submitted to the customer for approval.
The results of completed qualification testing shall be documented in the
Qualification Test Report.
3.4 Qualification Design Verification
Design applications based on previously qualified designs and requiring traceability
to an existing qualification test report shall be reviewed against the original design to
ascertain any possible design changes or deviations made necessary by the customer's
application and/or qualification envelope. Written documentation of the verification
shall be required for all domestic Nuclear customers, and if imposed by the customer,
for all other industries and regions.
Qualified personnel not responsible for initiating the original design for all nuclear
applications shall perform this design verification and analysis.
This verification shall incorporate as appropriate, suitable testing programs, alternate
or simplified calculations, design reviews, similarity analysis, or other approved
methods. The verification shall be documented in accordance with Quality Assurance
Procedure 06QA020013, Qualification Verification Analysis”.
3.5 Design Changes
Changes to or deviations from existing engineering design documents (i.e., revisions,
temporary “Deviations” and "Use As Is" or "Repair" dispositions of nonconforming
items) shall be properly documented and controlled. Design changes or deviations to
engineering documents shall be reviewed, approved, and recorded in accordance with
Engineering Procedure 01DM000064/01DM000025 and the nonconforming material
procedure 04QA704004.
Any of the above-described design changes that affect the customer‟s specifications
or the Company‟s documents approved by the Customer, shall require customer
participation in the formal approval cycle. Customer approval shall be documented.