Biomedical Engineering Reference
In-Depth Information
Management review provides the lowest degree of
assurance of the resulting evidence among the several
approaches. This is in good part due to the organizational
role of management review in the document change process.
The manager of each department, or the designee, looks for
the potential impact of the revision on that department. The
manager also looks for departmental responsibilities and
responsible persons. Beyond those issues, there is little
interest in the critical review of the procedure.
In the case of
expert review
, the SMEs will review the draft
for both positive and negative elements. On the positive side,
they will look for best practices, value-adding steps, fl exibility
in light of changing demands, scalability in light of changing
output targets, etc. On the negative side, they will look for
bottlenecks in the process, duplication of effort, unnecessary
tasks, non-value-adding steps, role ambiguities (i.e., several
positions responsible for a task, or no one responsible for a
task), etc. It is important to document all the points raised by
the experts in their review.
Expert review provides a higher degree of assurance than
management review, because it is a compilation of expert
opinion, and it is focused on the technical content of the
procedure. The International Organization for Standardization
(ISO) has stipulated that validation evidence should be
“objective.”
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The same is the case for the critical review of
procedures. The opinions of SMEs, while clearly not the simple
prejudices of lay persons, are also not clearly “objective.”
The
real-world challenge
tests the procedure's applicability
by challenging it step-by-step on the fl oor or lab bench. This
involves selecting one (or more) seasoned employee(s) within
the scope of the draft procedure - not necessarily a SME -
and comparing the steps as drafted in the procedure with the
employee's activities. It is important to ascertain if they align.
It is equally important to consider evidence of resistance,
