Biomedical Engineering Reference
In-Depth Information
manager may call for immediate action to address the event
that has been observed. Third, depending on the specifi cs of
the Management Notifi cation procedure, the manager may
acknowledge receipt of the employee's observation. The
employee may be required to submit the notifi cation to
management in writing; the manager may also be required to
acknowledge receipt of the notifi cation in writing. Fourth,
the manager may escalate the notifi cation further up the line.
Fifth, management may organize an investigative team
for the event, a team that is charged with discovering the
root cause.
11
The investigative team's report may lead to appointing a
person responsible for preparing a CAPA plan (Table 1.5). In
that case, management must also stipulate a due date for the
CAPA. Insofar as the CAPA requires the revision of an
operational SOP, the employee's observation initiates the
chain of events that lead to the revision.
Table 1.5
Elements of CAPA
1.
Analyze various sources of observations to identify existing and
potential causes of quality problems.
2.
Investigate the root cause of the quality problem.
3.
Identify remediations to correct and prevent recurrence of the
quality problem.
4.
Verify that the CAPA is effective and does not create further
problems.
5.
Implement and record changes in methods and SOPs required by
the CAPA.
6.
Ensure that information related to the quality problems is
disseminated to those directly responsible for assuring the quality
of such product or the prevention of such problems.
7.
Submit information on quality problems, as well as CAPAs, to
management.
8.
Document all activities under the CAPA.
