Biomedical Engineering Reference
In-Depth Information
qualifi cation ensures that the autoclave operates as designed
and as required by the user. Performance qualifi cation
ensures that the autoclave displays continued suitability for
its intended use. The IQ, OQ, and PQ of elements are critical
for pharmaceutical, biotech, and medical device
manufacturing and lab systems. Pharmaceutical, biotech,
and medical device companies all must install, operate, and
maintain equipment to be used in the manufacturing and
laboratory system within design specifi cations, ensuring their
operations are reliable and the quality of the output or
product is consistent. In this case, the output of the autoclave
is sterilized instruments.
When an autoclave is qualifi ed, it is ensured that it has
been installed according to design specifi cations, it operates
in a reliable fashion, and that its output or product has a
uniform (and high) quality. Thus the autoclave will not vary
from design specifi cations upon installation. The autoclave
will not vary from its specifi ed range during the operation of
the system. And its output, sterilized instruments, will not
vary from the desired level of quality. Because there has been
no variation of the autoclave that has been qualifi ed,
it cannot be the cause of the manufacturing deviation or
out-of-specifi cation lab result. Through the qualifi cation
process, that element can be eliminated from consideration
in an investigation.
As the various elements are eliminated, the set of candidates
for “root cause” decreases. Suppose the only elements
remaining are raw materials and employee performance
(Figure 8.8). The same approach can be applied to the
performance element (i.e., employee performance). At some
point the employees working on the process that generated
the deviation had been trained on the relevant SOPs (or not).
The constituents of the performance element include
employees (who were the trainees), their trainer(s), the
