Biomedical Engineering Reference
In-Depth Information
to critical review of procedures that is selected will be part of
a more general CAPA project.
This section has discussed how revisions to SOPs
should be critically reviewed in the same manner as
changes to processes such as manufacturing processes,
cleaning processes, analytical methods, etc. As mentioned
previously, risk assessment should be included in the
weighing of costs and benefi ts.
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An SOP that is associated
with a process or component of greater complexity and
criticality will have more stringent requirements, and will
require a more critical approach to the review of the
procedure.
3.3 Risk assessment and
critical review
The critical review of a new or revised procedure should be
guided by the following three fundamental questions, all
elements of risk assessment:
1. What might go wrong with the associated process?
Answering this question involves
risk identifi cation
.
2. What is the likelihood that this will go wrong? A
risk
analysis
addresses this second question.
3. What are the consequences? How severe are they if
this goes wrong?
Risk evaluation
provides an answer
to this question.
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The fi rst of these three questions raises the issue of the
complexity
of the associated process. Defi nitions of
complexity include the following:
■
Interconnectedness
: the organization and interaction of
system components;
