Course Content:
Complaints
•
Establish the process
o Who
is responsible
o When
to perform audit
o When
to use corrective action procedure
Corrective Action
•
Deviations from laboratory policies
•
Deviations from procedures
•
Deviations from quality control
•
Response to internal audits
•
Response to customer audits
•
Response to regulatory audits
Corrective Action Procedures
•
Identify the person(s) responsible for QC evaluation
•
Identify the person(s) responsible for initiation
of corrective action
•
Define how to treat a data set with unacceptable QC
measurements
•
Define how to handle out of control situations and
documentations
•
Define the person responsible for evaluation of the
corrective action process
Corrective Action Documentation
•
Document Control
o Controlled
forms
o Controlled
logs
•
Tracking of Corrective Actions
o Corrective
action numbers
o Due
dates
o Close
dates
o Customer
notification
Identify Events that Trigger Corrective
Action
•
Shifts
•
Trends
•
QC results out of control
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