Biomedical Engineering Reference
In-Depth Information
Coordinator failed to compare the employee's previous
training transcript with the training requirements.”
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Thereupon an organization might develop an even further
SOP that requires periodic checks by the quality unit of a
random sample of employees found in GMP areas at a given
time, to ascertain if they are in fact qualifi ed for their assigned
job functions. We will refer to such a controlled document as
an “Assignment Monitoring Procedure.” If discrepancies are
found, the Assignment Monitoring Procedure would require
the generation of a Notice of Event (NoE) to inform
management that a deviation has occurred. That NoE would
need to address both the impact on the batch, to the extent
the untrained employee had touched the regulated product,
and the supervisory error itself.
13.3.1 Problems with this approach
There are two major problems with this typical approach.
First, this approach presupposes that employees' training
curricula and ITPs, listed in the tracking system, correctly
and currently include the procedures that are relevant to the
tasks to which the employees may be assigned. On the one
hand, the curricula may not correctly refl ect the procedures.
How does a supervisor ensure that every single procedure
that relates to this task, or this process - regardless of who
the originator of the SOP may be - has been included in this
curriculum? However, the curriculum may not refl ect the
current procedures. How does the supervisor ensure that the
versioning up of each procedure has been the occasion for an
update of the employee's curriculum?
These are hardly trivial questions. Change control and
change management are substantial problems in a regulated
industry subject to pervasive and persistent technological
development. As if that were not enough, procedures are
