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82 Safety Risk Management for Medical Devices

12.4.1 Facilitation of FMEAs
Successful execution of FMEAs requires skillful facilitation of the FMEA sessions. The
facilitator takes responsibility to:

• Convene the FMEA work sessions
• Ensure persons with appropriate competences are present
• Ensure proper resources, materials, and support elements are present at the
working sessions
• Ensure the purpose of the FMEA, the ground rules, and context of operation
are understood at the start of each working session
• Assist in the discernment of Causes, Failure Modes, effects, and mitigations
• Limit lengthy discussions and guide the team to useful conclusions
• Help the team maintain focus, and remain within the scope of analysis
• Manage the working sessions and terminate when productivity of the team
declines due to fatigue, or other factors.

12.4.2 Hierarchical multilevel FMEA
Hierarchical multilevel FMEAs is a strategy that you can adopt to enable efficiencies
of parallel processing, and modular reusable analysis. This technique requires a system
decomposition based on the system architecture as explained in Section 10.1.
The System, referred to as Level 1, or L1 in Fig. 12.5, is decomposed into two
Level 2 (L2) components. Each L2 component is further decomposed into multiple
L3 components and so on. You can perform DFMEAs and PFMEAs on the lower
level components. And just as the system itself is progressively integrated from lower
levels up to the top level, so too can the lower level FMEAs be progressively inte-
grated until the top-level System DFMEA is generated.

Figure 12.5 Multilevel hierarchy.