Biomedical Engineering Reference
In-Depth Information
versioned up to change a single word. Procedures are
versioned up and then found to be misaligned with higher
corporate policies and standards; then they are versioned up
still further to restore the
status quo
ante
and alignment.
Procedures are versioned up, omitting key paragraphs; they
are subsequently versioned up to re-insert the omitted
paragraphs. Multiple procedures co-exist for similar
functions, for example, gowning; these procedures are
versioned up, one by one, by their disparate business owners
independent of each other.
The remedy for the constant revision of procedures is a
combination of making better business cases for proposed
changes, and having more peer review of the documents in
process. But that remedy will not resolve the supervisor's
dilemma of task assignment.
If the curriculum is either incorrect or not current, the
supervisor cannot ensure the employee is adequately trained,
no matter how diligently the training record is checked, no
matter how carefully the Task Assignment Procedure is
executed. The only way to ensure compliance in this case is
by over-training, that is, by providing training to employees
for whom the SOP may not be relevant. Of course, that is
not cost-effective training.
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Moreover, over-training may result in employee resistance
to training. Many times this occurs among high-performing
individuals, say in a research institute, and presents special
problems for organizational morale and productivity.
Second, assuming for just a moment that the curriculum is
correct and current, this approach presupposes that recourse
to a NoE is an adequate procedural response for supervisory
error. Regulators typically fi nd this unacceptable, because
recourse to a NoE also requires a list of immediate and
specifi c corrective actions that will be taken. As an example
of the failure to meet this requirement, consider the FDA
