September 2015
Intermediate to advanced
652 pages
18h 20m
English
Content preview from Quality Assurance
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483Appendix IV
Required Criteria of Requirements Verication Possibilities
2. Procedure developed that
includes method dening
sediment collection and system to
measure cleanliness.
3. Cleanliness results are
documented and plotted on
control chart.
4. Control limits are utilized to
trigger reaction plans. Do not
confuse specication limits with
control limits. They are not the
same. Control limits are
calculated based on the voice of the
process. Specications are given by
the customer.
Check if the cleanliness controls
are being done according to
frequency established at PCP.
Frequencies are reasonable.
Check sediment measurement in
lab (instruction ...
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