Biomedical Engineering Reference
In-Depth Information
Under these conditions, SMEs become qualifi ed when they
have successfully qualifi ed on a number of SOPs that address
the competences of their subject matter. The business owner
usually identifi es the particular SOPs that characterize the
subject matter. The ensuing employee qualifi cation process
has two elements: overview training and skills training.
Overview training (i.e., training
per se
that provides an
overview of the subject matter), tends to be more conceptually
focused, while skills training tends to be more performance
oriented. Concepts tell what a thing is; tasks describe how to
do something. Concepts provide the “science” for task
performance. For example, the process of sanitizing
equipment might be conceptualized as “reducing the levels
of microorganisms and particulates to acceptable limits,”
thereby minimizing the risk of product contamination from
the equipment.
Overview training may be delivered by a qualifi ed trainer
in a classroom. There will be a SOP that will be the basis of
this overview training, as well as a KTA. The event is
documented in a training record where the facilitator and
trainee concur that the trainee has successfully concluded the
training (or not). Should the trainee be unsuccessful in the
overview training, by procedure the trainee will have options
such as repeating the training event at a later date, etc.
Once the overview training is successfully concluded, the
trainee goes on to the SOJT events. The qualifi cation event
will usually be conducted one-on-one by a SME who is also
a qualifi ed trainer, as a SOJT event. There will be a SOP for
each of the SOJTs in the module, as well as a SDA for each.
The completed SDA form is then entered into the training
tracking system.
Consider the typical SME qualifi cation process for the use
of vaporized hydrogen peroxide (HPV) for sterilizing
controlled areas.
10
That SME individual training plan (i.e.,
