Biomedical Engineering Reference
In-Depth Information
Table 3.2
Complexity and criticality of process
Criticality
Low
Med
High
Low
A
Complexity
Med
B
High
C
review must take into account the dimensions of complexity
and criticality of the associated process.
Table 3.2 displays the dimensions of complexity and
criticality.
When the Complexity × Criticality is Low/Low (Scenario
A in Table 3.2), the fi rst approach (the management review
of the new or revised procedure) may be appropriate. A
procedure for weight checks of cartons might be an
illustration of Scenario A. When the Complexity × Criticality
is Med/Med (Scenario B in Table 3.2), the second approach
to the critical review of the new or revised procedure, expert
inputs, may be appropriate. The acquisition of a new model
of a lab balance, and the issue of the revisions to the procedure
for weighing this purchase requires, might be an illustration
requiring more than management review. Finally, when the
Complexity × Criticality is High/High (Scenario C in
Table 3.2), the critical review of the revised procedure may
necessitate a step-by-step challenge. The planning of a new
central weigh facility, and the procedures that will be
necessary in that facility, might be an illustration requiring
more than SME inputs.
This section has discussed how risk assessment is an
important component of the management of change. The
level of critical review and appropriate work supporting
implementation of the change is directly related to the
