Fluid Components International Quality Assurance Manual - Manual (Page 64)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
23
CURRENT
REVISION
L
and
e) Controls required for off-site work (e.g., organization‟s work undertaken at
the customer‟s facilities).
7.5.2 VALIDATION OF PROCESSES, PRODUCTION AND SERVICE
PROVISION
FCI validates any processes for production and service where the resulting output
cannot be verified by subsequent measurement or monitoring, and as a
consequence, deficiencies become apparent only after the product is in use or the
service has been delivered (a.k.a.; Special Processes).
Validation demonstrates the ability of the processes to achieve planned results.
FCI establishes arrangements for these processes including, as applicable:
a) Defined criteria for review and approval of the processes,
b) Approval of equipment and qualification of personnel,
c) Use of specific methods and procedures,
d) Requirements for records, and
e) Re-validation.
7.5.3 IDENTIFICATION AND TRACEABILITY
Where appropriate, FCI identifies the product by part number throughout product
realization.
FCI maintains the identification of the configuration of the product in order to
identify any differences between the actual configuration and the agreed
configuration.
FCI identifies the status of the product with respect to measurements and
monitoring requirements on the associated Operation Sheet or in the Business
System.
When acceptance authority media are used (e.g.; stamps, electronic signatures,
passwords), FCI establishes and documents controls for the media.
Where traceability is a requirement, FCI controls and records the unique
identification of the product via the Receiving Inspection, In Process Inspection,
Job Order, and Final Inspection procedures.
Traceability requirements can include: