Biomedical Engineering Reference
In-Depth Information
versioning up the relevant SOPs, as well as associated changes
in support of the laboratory procedure changes. Table 3.3
outlines the CAPA plan approved by management.
This section discussed the development and
implementation of a CAPA plan to respond to the results of
the investigation. All the changes to the weighing facility and
equipment described in the plan were completed. These
included relocation of the weighing of the analytical standard
Table 3.3
CAPA plan for the illustrative problem
1.
The fi rst step would include changes to the weighing facility and
equipment:
■
The weighing area for the analytical standard would be
relocated. The new area would provide virtual isolation
from personnel traffi c during the weighing process.
■
The balance would be retrofi tted with a protective shield to
further protect the weighing pan from air drafts during the
weighing procedure.
■
The balance would be relocated to a stand-alone vibration-
free table.
2.
The calibration procedure for lab balances would be critically
reviewed. Changes to the SOP would be proposed as
appropriate.
3.
The weighing procedure for samples would be critically
reviewed. Changes to that SOP would be proposed as
appropriate.
4.
Both procedures would be revised as necessary. In light of the
criticality and complexity of the problem, it was decided to use
the step-by-step real-world challenge for both SOPs.
5.
Once all recommended changes and revisions were made, an
experiment to evaluate changes would be conducted. Test
results would be compared to the previous experimental data
that characterized current balance performance.
6.
Training on the revised SOPs would be conducted as
necessary.
7.
A fi nal report summarizing the above would be appended to
change management documentation as necessary.
