Biomedical Engineering Reference
In-Depth Information
Initiate
quality risk management process
Risk assessment
Risk identification
Risk analysis
Risk evaluation
unacceptable
Risk control
Risk reduction
Risk acceptance
Output/result of the
quality risk management process
Risk review
Review events
Figure 5.2 Showing a typical quality risk management process [2].
ICH Q9 also suggests a list of the key risk assessment and statistical tools,
including, for example:
• failure mode effects analysis (FMEA);
• failure mode, effects, and criticality analysis (FMECA);
• fault tree analysis (FTA);
• HAZOP;
• preliminary hazard analysis (PHA);
• risk ranking and filtering;
• design of experiments (DOE); and
• process capability analysis.
A typical diagrammatic example of the output of an initial risk assessment is
shown in Figure 5.3. This output uses risk ranking to categorize potential impact
on a patient (normally based on severity) into high (red), medium (yellow), and
low (green).
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