Biomedical Engineering Reference
In-Depth Information
procedure can be referred to and summarized at this point in
the NEO session:
Moreover, organizations have another workplace
expectation: Employees shall deal with unexpected
situations in an orderly fashion - situations for which
currently implemented SOPs do not provide guidance,
or SOPs that are clearly inappropriate.
This expectation that change will be controlled is captured
in the organization's “Change Control” procedure. This
procedure also can be referenced and summarized at this
point.
Overall, discussion of this scenario in the NEO session
should give new hires the following takeaway:
The web of regulations is complex, but distinct processes
and procedures are operative even in the most complex
situation.
At this point, having presented the scenario and discussed
topics of the complexity of regulations, appropriate and
inappropriate responses to that complexity, the role of
procedures, and the necessity of problem escalation and
change control when the current procedures are clearly
inappropriate, the agenda can move to broader areas of
organizational history and culture.
6.5 Presenting the history of the FDA
In regulated industry, the history of the FDA is usually
presented in a NEO program as part of organizational
culture and history. The historical account might be
