Biomedical Engineering Reference
In-Depth Information
the associated Target Audience List. Fourth, we will discuss
the use of the Target Audience List as the alternative approach
to ensuring the requisite training occurs.
13.4.1 The purpose of a SOP
As already pointed out, a procedure lists the necessary steps
(tasks) that, taken together, are suffi cient to produce the
desired process result. It can address several kinds of process
- a person to machine process, a person to paper process, or
a person to person process, or some combination of the three
types. An SOP, typically in documentary form, indicates the
sequence of tasks, the personnel or positions that are
responsible for the tasks, and the standards that defi ne the
satisfactory completion of the tasks. 21
13.4.2 The purpose of training to
a procedure
Training is a person to person process that prepares each
employee (the trainee) to successfully execute the steps
(tasks) in a procedure, in the appropriate setting, stipulated
order, mandated workgroup, and specifi ed timeframe.
Training is the combination of trainee(s), training materials,
virtual or actual trainer, and the interaction of these elements.
Thus procedures and training are different. The procedure
is a document, a controlled document subject to the quality
unit's approval. Training is an interactive process. Of course,
a procedure can be the object of training, and training can be
proceduralized. But the two are distinct; reading a procedure
is not the same as being trained on that procedure; 22 being
trained on a procedure is not the same as being a subject
matter expert on that process.
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