Biomedical Engineering Reference
In-Depth Information
can observe various problems - an out-of-spec lab result or a
manufacturing deviation, say - and report those problems to
management. The responsible manager can initiate an
investigation into the root cause of the probelem. Once the
investigation report is complete, the manager can than
implement an appropriate remediation.
Candidates for the root cause of the problem include such
process elements as equipment, facilities, procedures, raw
materials, utilities, employee performance, etc. Consider the
Ishikawa diagram displayed in Figure 8.7. The investigation
proceeds along the same lines as we have discussed in Section
2.2, “The process of investigation.” Candidate elements are
considered and eliminated from consideration, until only
one remains. That remaining element is labeled the “root
cause.” An element is removed from consideration once it is
determined that it could not have been the root cause of the
deviation. That is where the process of qualifi cation becomes
important. An excellent way to eliminate an element from
further consideration as a root cause of a problem is by
qualifying that element in advance.
Take equipment, for example. Installation qualifi cation
ensures that a piece of equipment, say an autoclave, has
been installed within design specifi cations. Operational
Figure 8.7
Main elements
