Biomedical Engineering Reference
In-Depth Information
Key words:
elixir sulfanilamide, Employment Life-cycle,
FDA (history of), management notifi cation, new employee
orientation (NEO), regulatory overlap,
Salmonella
contamination, Upton Sinclair's
The Jungle
, thalidomide,
tylenol poisoning.
6.1 Introduction
The new employee orientation (NEO) program can
importantly contribute to both GXP compliance and
organizational productivity. NEO can contribute to GXP
compliance by indicating to the new hire or transfer that the
organization (and the regulatory agency) has a series of
expectations for employee performance in the workplace.
These expectations:
■
are covered by the GXP regulations, corporate policies,
and local procedures;
■
are written and readily available to employees; and
■
are mandatory.
The new hire or transferred employee may not have
experienced such regulation in his or her previous position.
The NEO program can contribute to organizational
productivity by presenting new hires with the organization's
process for assessing workplace performance, such as
employee productivity. The organization's expectations are
summarized in the specifi cs and criteria of the periodic
performance review process. Again, new hires or transfers
may not have experience with such processes, and can adjust
their performance to meet the expectations.
However, both sets of expectations for workplace
performance - compliance and productivity - are operative
