Fluid Components International Quality Assurance Manual - Manual (Page 69)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
28
CURRENT
REVISION
L
8.2.4 MEASUREMENT AND MONITORING OF PRODUCT
FCI measures and monitors the characteristics of the product to verify that
product requirements have been met. This is carried out at appropriate stages of
the product realization process in accordance with planned arrangements.
Evidence of conformity with the acceptance criteria shall be maintained, through
the use of Lot Packages, Discrepancy Reports, Operation Sheets and Final
Acceptance Test Data Sheets.
Measurement requirements for product acceptance shall be documented and shall
include:
a) Criteria for acceptance and/or rejection,
b) Where in the sequence measurement and testing operations are to be
performed,
c) Required records of the measurement results (at minimum, indication of
acceptance or rejection), and
d) Any specific measurement instrument required and any specific instructions
associated with their use.
When critical items, including key characteristics, have been identified the
organization shall ensure they are controlled and monitored in accordance with
the established processes.
When FCI uses sampling inspection as a means of product acceptance, the plan
shall be justified on the basis of recognized statistical principles and appropriate
for use (i.e., matching the sampling plan to the criticality of the product and to the
process capability).
Where product is released for production use pending completion of all required
measurement and monitoring activities, it shall be identified and recorded to allow
recall and replacement if it is subsequently found that the product does not meet
requirements.
Records shall indicate the person(s) authorizing release of product for delivery to
the customer.
Where required to demonstrate product qualification, the organization shall ensure
that records provide evidence that the product meets the defined requirements.
The release of product and delivery of service to the customer shall not proceed
until the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, where applicable, by the
customer.
FCI shall ensure that all documents required to accompany the product are present
at delivery.