Biomedical Engineering Reference
In-Depth Information
Consider, as an illustrative example, the following scenario
and guided discussion, which can be incorporated into a NEO
session. It has three parts. The fi rst part is the presentation of
the scenario and an invitation to the new hires to share their
responses to it. The second part is a facilitated discussion of
the way SOPs provide guidance for most situations the new
hires will confront in the workplace. The third part presents
the principles that control the situation when procedures do
not suffi ce. This allows the NEO program to comfortably
introduce new hires to issues of regulatory complexity,
appropriate and inappropriate ways to respond to that
complexity, the role of SOPs in regulated industry, and the
necessity of problem escalation and change control when the
current procedures are clearly inadequate. Here is the scenario:
A couple of newly hired employees, call them Francine
and Frank, have been duly screened and certifi ed for
work with a controlled substance. During their fi rst
hour on the job, while processing the controlled
substance, the fi re alarm sounds in their area.
Ask the participants in the NEO session: How should Francine
and Frank respond? Points to raise include the following:
On the one hand, the chain of custody required by the
Drug Enforcement Agency stipulates that “manufacturing
activities with controlled substances shall be conducted
in an area or areas of clearly defi ned limited access which
is under surveillance by an employee or employees
designated in writing as responsible for the area.
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However, evacuation requirements of the OSHA call for
“procedures for emergency evacuation, including type of
evacuation and exit route assignments.”
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