Biomedical Engineering Reference
In-Depth Information
look much the same as the template given above, where the
Troubleshooting SOP would be delivered by an instructor in
a classroom, or electronically; the ESI protocols would be
SOJTs. These would appear on the curriculum of the
mechanics, as shown in Figure 5.8.
After the abnormal event is under control, the LOTO is
removed and the LOTO-affected employees (the operators)
resume the manufacturing process again, under the guidance
of the GMP procedures.
Back in the GMP realm again, and depending on the
specifi cs of the abnormal event - for instance, the impact on
the product - a Management Notifi cation is prepared (a
Notifi cation of Event, NoE) that could lead to an investigation,
corrective action and preventive action, and follow-up
monitoring.
9
By keeping these processes separated (vertical and
horizontal), the operators would have training on the GMP
procedures on their curricula, and would qualify on these
modules. The mechanics would have training on the
troubleshooting SOPs on their curricula, and would qualify
on these modules. Thus the operators would not need to
train on the troubleshooting modules and the mechanics
Figure 5.8
Training module for mechanics
