Biomedical Engineering Reference
In-Depth Information
SOPs. SOPs that cover such situations typically indicate that
line personnel such as Francine and Frank should comply
with the emergency evacuation plan for the area. But the
procedures go on to say that their supervisor is responsible
for maintaining the chain of custody for the controlled
substance. This seems to accord with the stipulation in
∫1301.73(b) that an employee, “specifi cally authorized in
writing,” shall be responsible for the area.
Of course this does not resolve the question initially posed:
How should Francine and Frank respond to the scenario? It
simply shifts the question from all employees certifi ed for
work with controlled substances to their supervisors. The
employees, including Francine and Frank, can evacuate - but
what about the supervisors? Do they remain and maintain
the chain of custody for the controlled substance, complying
with DEA regulations, or do they too evacuate the area,
complying with OSHA regulations?
If the relevant SOPs do not provide guidance for the fate of
the supervisors, this helps to further focus the discussion on
the topics of problem escalation and change control in
regulated industry. Once it is evident that there is no SOP
that covers the supervisors in the scenario, and once the
inadequate answers “Ask Joe,” “Use good sense,” have been
dispensed with, the participants can be introduced to the
principles that control the situation. Two important principles
are Management Notifi cation and Change Control:
Most organizations have the following workplace
expectation: Employees shall escalate any problem
that they do not know how to deal with, to their
supervisor.
This escalation process can be proceduralized; call the SOP
“Alert Management, Notifi cation, and Escalation.” This
