Biomedical Engineering Reference
In-Depth Information
education and background for the relevant SOP. If the
SOP lists several prerequisites, documented evidence must
indicate that the prospective trainee has completed training
on each of these.
14
■
Personnel OQ may be likened to providing objective
evidence that the trainee can function in the training
situation (event) in an appropriate fashion. In a SOJT
event, for example, this means the trainee performance is
within the “control limits” set by the SOP. In the last
analysis, this means that the trainee can perform the task
correctly and independently.
15
■
Personnel PQ may be likened to the demonstration of
acceptable performance during representative operational
conditions. The trainee's activities (e.g., on the shop fl oor
or at the lab bench at the close of training) consistently
produce a product that meets the standards set by the SOP
or manufacturing order. In the GMP framework, the
performances are directly related to the quality attributes
(i.e., the SISPQ) of the regulated product.
16
Once the process of employee qualifi cation is successfully
completed, employees are qualifi ed, and remain so unless
and until they become disqualifi ed.
8.4.2 Qualifi cation status
Qualification as status, sometimes called certifi cation,
characteristically applies to persons. For instance, employees
are sometimes designated SME because they are the originator
of a new SOP. The reasoning for this practice is the following.
An SME on a given SOP, who is a qualifi ed trainer,
17
can
train another employee on that SOP. But who will provide
the training to a new SOP? Who is to be the fi rst mover? For
a new SOP, there must be at least one SME, or compliant
