Biomedical Engineering Reference
In-Depth Information
Severity of harm
Negligible
Moderate
Serious
Critical
Probable
Low
Medium
High
High
Occasional
Low
Medium
Medium
High
Remote
Low
Low
Medium
High
Figure 2.3 Example risk matrix.
6. Identify current controls.
7. Rank and prioritize (using a criticality analysis (matrix or RPN method)).
8. Recommend mitigations.
9. Implement recommendations and update the analysis.
Figure 2.4 shows how the process fits into the risk management program.
Initiate
quality risk management process
FMEA/FMECA
1. Define boundaries
Risk assessment
2. Identify potential failure modes
Hazard identification
U
n
a
c
c
e
p
t
a
b
l
e
3. Identify failure causes and effects
Risk analysis
4. Determine severity of effects
Risk evaluation
5. Estimate likelihood of occurrence
Risk control
6. Identify current control
Risk reduction
Risk acceptance
7. Rank and prioritize
8. Recommend mitigations
Output/report and implementation
Risk review
9. Implement and update
Risk event
Figure 2.4 FMEA/FMECA quality risk management process.
Search WWH ::




Custom Search