Biomedical Engineering Reference
In-Depth Information
of “re-training” as a solitary or even major remediation.
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For an example of such a fallacy, consider FDA Adverse
Determination Letter regarding the Baltimore manufacturing
facility of the American Red Cross, dated 27 July 2006. A
Red Cross employee had not been trained before touching
the whole blood product. When this problem was discovered
two months after the event, the Red Cross conducted a root
cause analysis (RCA) and concluded that this was a training
problem, “The corrective action was to fully re-train all
employees.”
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The FDA responded that “as a result of the
incomplete investigation, [the Red Cross] failed to determine
all root causes of the problem.” (ibid.) The Red Cross was
then fi ned more than $700 000.
A manufacturing unit is strongly inclined to release an
impounded batch by declaring that the catch-all category
“human error” was the root cause of the deviation or failure,
and suggest “re-training” of the employee(s) as the corrective
action. This is goal displacement;
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it places the unit's goal,
releasing the batch, above the organization's goal, which is
identifying the root cause and implementing a remediation
that will ensure the deviation will not recur. This goal
displacement results in a false alarm, where re-training is
the direct outcome of an investigation. The fallaciousness of
re-training is amply demonstrated - re-training, re-training,
re-training of the same employee(s),
ad infi nitum
. As Philip
Lindemann points out, “Not identifying the cause of failure
may lead to additional failures.”
The regulatory investigator
will recognize this - as will upper management if there are
metrics tracking CAPAs. The regulatory investigator, and
upper management, will thereupon question the adequacy of
the organization's investigations.
Moreover, if “human error” was proposed as the root
cause of the deviation requiring “re-training,” then the actual
root cause would be:
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