Biomedical Engineering Reference
In-Depth Information
In conclusion, if procedures are correctly written, they will
need little streamlining in the future, and will facilitate
consolidation whenever new processes come on line and
need to be captured in a procedure. Of course, if procedures
have been poorly written, poorly chunked, or if there is a
great deal of redundancy, then they must be revised along the
lines sketched out above.
A fourth aspect of the fi t between training modules and the
larger curriculum is the relationship between training
modules and the various regulatory requirements. That
aspect will also be delineated in the Design phase.
5.2.3 How training modules relate to
regulatory requirements
There are a number of regulatory regimes that impact on the
training environment. These regimes include such agencies
as FDA, OSHA, EPA, DOT, DEA, and others, each with its
own set of regulations.
6
On the one hand, the number of regimes means that there
are simply more regulations to be taken into account.
However, the various regimes can present the problem of
regulatory overlap, where different agencies have differing
regulations covering the same situation.
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We will consider
how this impacts the design of the training module.
First, it overlooks the very abnormality of the abend. After
all, this is called an abend because, in important ways, it is
abnormal. Second, it overlooks the distinct division of labor
between operators who enact the routine steps of the
manufacturing cycle and the mechanics who address the
abnormal events. This has substantial training implications;
the procedures tend to be much longer, and both groups
must train on the whole GMP procedure. Third, it confounds
the “operational” level of detail in the routine situations
