Biomedical Engineering Reference
In-Depth Information
reviewing service or maintenance instructions that are
specifi c to the equipment, implementing a set of corrective
and preventive actions, conducting follow-up monitoring, as
well as addressing safety or other relevant regulatory
concerns (Figure 5.7).
At the point of an abnormal event, the GMP requirements
of the manufacturing cycle are suspended, temporarily, by an
OSHA-mandated Lockout/Tagout (LOTO).
8
That is where
the mechanics or engineers (in OSHA terms, the “LOTO
Authorized employees”) intervene with their Troubleshooting
SOP and associated ESI to troubleshoot and maintain/repair
the equipment.
These troubleshooting procedures and ESI protocols make
up the horizontal process map. Its training modules would
Figure 5.7
Manufacturing cycle with abend
