Biomedical Engineering Reference
In-Depth Information
8 lives and sickened some 19 000 people in more than 40
states.
37
This section has sketched an historical account of the FDA
that can be presented in the NEO program. The sketch limits
itself to four or fi ve critical episodes. Several threads were
drawn from these illustrative episodes. One thread provided
an opportunity to summarize the history of the FDA for the
new employees. Another thread treated each of the episodes
as representing the logic of investigation and remediation.
That thread was intended to familiarize the new employees
with regulated industry's approach to continuous
improvement and risk management. The following section
will touch on aspects of the organization of the NEO
program, including the need for coordination.
6.6 Organizational issues
The breadth of topics that must be covered in a NEO program
means that there must be close coordination and buy-in of
each department that is involved. This usually includes HR,
EHS, and the GMP training unit, as well as other units. A
representative of each of these units should be a member of a
coordinating committee for the whole program. This
committee should work closely with the business owner of the
NEO program, whether that business owner is located in HR
or some other department. In addition, if senior management
is to be involved in welcoming new hires, that activity must
also be closely coordinated. It may also require coaching the
offi cer in this role, as some are good at it and others are not.
The high visibility of the NEO program means that all
facilitators must be fully engaged in their assignments. None
of the facilitators can behave as though they feel that their
time would be better spent elsewhere. Nor can the facilitators
