Biomedical Engineering Reference
In-Depth Information
Water system corrective action flow chart
SOP No.:
Issued on:
Revision No.:
Initiator name:
Out of action limit or frequent alert excursions
Other deviations not related
to water system
Water system deviation
Perform lab
investigation
Inform QA & QC managers to assign “Risk”to products.
QA & water plant shall perform technical verifications to
determine the cause of error
Inform QA & production
managers to assign verifications
procedure to determine
the cause of error
Lab error
Within appropriate time
QA informs formally,
microb. lab with the applied
remedial action
Report and perform
technical verifications
Water plant staff shall repair the
source of error
Perform water plant sanitization
AQ informs formally, microb. lab
with the applied remedial action
3 times more
investigation at the
same site
3 times more
investigation at the
same site
3 times more
investigation at the
same site
Conform
Conform
Document
One test or more are
not conform
One test or more are
not conform
Document
One test or more
are not conform
Document
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