Fluid Components International Quality Assurance Manual - Manual (Page 36)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
Date
10-8-2012
SECTION
1
PAGE
14
CURRENT
REVISION
L
b) The availability of work instructions, as necessary,
c) The use of suitable equipment,
d) The availability and use of measuring and monitoring devices,
e) The implementation of monitoring and measurement,
f) The implementation of product release, delivery, and post-delivery
activities.
7.5.2 VALIDATION OF PROCESSES
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 (aka 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) Revalidation.
7.5.3 IDENTIFICATION AND TRACEABILTY
Where appropriate, FCI identifies the product by part number throughout product
realization.
FCI identifies the status of the product with respect to measurements and
monitoring requirements on the associated Operation Sheet or in the Business
System.
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.
7.5.4 CUSTOMER PROPERTY
FCI exercises care with customer property (including intellectual property and
personal data) while it is under the organization‟s control or being used by the