Biomedical Engineering Reference
In-Depth Information
training will never occur. Those SMEs must be designated by
management (in this case, the business owner), not because
they have been through a qualifi cation process, there is not
any, but because they are the originator of the SOP, which is
a status.
Occasionally an organization will develop a procedure
that indicates employees are qualifi ed when they have
successfully executed the procedure three times. To be
distinguished from various certifi ed fellow employee (CFE)
approaches to training, this approach requires neither a SME
nor a qualifi ed trainer. However, it appears to violate the
predicate rule, personnel qualifi cations, which stipulate that
“Each person engaged in the manufacture, processing,
packing, or holding of a drug product shall have the
education, training, and experience, or any combination
thereof, to enable that person to perform the assigned
functions.”
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This means that employees must be capable of
performing assigned tasks prior to touching the regulated
product. They already have the educational, training, and
experiential status - they are not “learning as they go.”
8.4.3 Qualifi cation measures
Qualifi cation measures consist of SDAs. A training procedure
for employee qualifi cation stipulates how, when, and where
the trainee can independently perform the task on relevant
equipment.
The training procedure will also stipulate that the trainer
use a controlled form that is the SDA checklist. The SDA
checklist has fi elds for entering the number and version of
the relevant operational SOP. The checklist also includes a
number of items that describe the identifi ed critical or
representative tasks to be assessed on the SDA. These are the
items assessing the trainee's performance (Figure 8.6). The
