Biomedical Engineering Reference
In-Depth Information
address business performance issues, and “justify their
existence” by pointing to the improved performance of the
workforce. Otherwise the training department will be viewed
as overhead and not active contributors. In this sense, trainers
are indeed an audience for training record-keeping. However,
we see that this is a distinctly secondary audience, behind the
two major audiences.
Good training record-keeping may well contribute to a
corporate climate that supports widespread and disciplined
use of organizational metrics. Such metrics allow benchmarking
and trending to enhance organizational control.
11.6 Conclusion
There are two main audiences for training records, operational
staff and auditors. In addition, there are other audiences such
as the training unit itself. To serve these audiences, training
record-keeping must possess characteristics of good document
management. At each level of the organization, document
management must be appropriate so that training record-
keeping will be “audit proof,” and will, moreover, have
business value to operational staff.
Regulatory compliance, as it relates to training record-
keeping, requires that personnel touching the product be
trained. FDA regulations, with few exceptions, do not
address training records. It is important to review carefully
the several cases where the regulations do apply and ensure
compliance. It is equally important to ensure that the
organization is not wasting time and resources overbuilding
the training record-keeping process.
The fi elds that are necessary for training records, as well as
necessary roles and responsibilities, need to describe the fall-
back process in case there are access or other system problems
