Biomedical Engineering Reference
In-Depth Information
it can be further analyzed into supervisory factors and
business case. If the employees (who were the trainees)
remain, they can be further analyzed in terms of skill set(s)
and disposition(s). Was their morale low? If the category
training facilities remains, it can be further analyzed into
allocated space, allotted time, and utilities. Were the location
and time adequate and appropriate? If the constituent
element Auxiliary Materials remains, it can be analyzed into
instruments and equipment, raw and in-process materials,
etc.
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These further analyses would make up a more fi ne-
grained version of the Ishikawa diagram.
This discussion has considered the rationale for
qualifi cation, highlighting the role the qualifi cation process
plays in deviation investigations and RCA. Employee
qualifi cation proves to be a relatively expensive kind of
training, when compared to training
per se
. The one-on-one
character of this kind of training, the adding of a qualifi cation
event to the training process, and other factors contribute to
this expense. How does an organization determine which
procedures require employee qualifi cation, and which require
only training
per se
? This raises the issue of the criticality of
a procedure.
8.5.1 Critical procedures require
employee qualifi cation
An important consideration in determining whether the
training will consist of training
per se
or employee
qualifi cation is the criticality of the procedure and the
process it represents. A procedure is considered to be
critical, if:
■
The procedure requires a complex or highly skilled activity
or a job for which a high skill level must be demonstrated
