Fluid Components International Quality Assurance Manual - Manual (Page 66)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
RELEASE DATE
10-8-2012
SECTION
2
PAGE
25
CURRENT
REVISION
L
a) Cleaning;
b) Prevention, detection and removal of foreign objects;
c) Special handling for sensitive products, such as caps on connectors;
d) Marking and labeling including safety warnings;
e) Shelf life control and stock rotation;
f) Special handling for hazardous materials.
7.6 CONTROL OF MEASURING AND MONITORING DEVICES
FCI determines the monitoring and measurements to be undertaken and the
measuring and monitoring equipment needed to provide evidence of conformity
of product to determined requirements.
FCI maintains a register of these monitoring and measuring equipment, and
defines the process employed for their calibration/verification including details of
equipment type, unique identification, location, frequency of checks, check
method and acceptance criteria.
The organization establishes processes to ensure the monitoring and measurement
can be carried out and are carried out in a manner that is consistent with the
monitoring and measurement requirements.
FCI ensures that environmental conditions are suitable for the calibrations,
inspections, measurements, and tests being carried out.
Where necessary to ensure valid results, measuring equipment is:
a) Calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to international or national standards;
where no such standards exist, the basis used for calibration or verification
is recorded,
b) Be adjusted or re-adjusted as necessary,
c) Be identified in order that the calibration status is determined,
d) Be safeguarded from adjustments that would invalidate the measurement
result,
e) Be protected from damage and deterioration during handling, maintenance
and storage,
FCI shall establish, implement and maintain a process for the recall of monitoring
and measuring equipment requiring calibration or verification.
In addition, the organization assesses and records the validity of the previous
measuring results when the equipment is found not to conform to requirements.