Page 172 - Safety Risk Management for Medical Devices

CHAPTER 16

Integration of Risk Analysis

Abstract
Once the System is decomposed, it is possible to perform a hierarchical multilevel Failure Modes
and Effects Analysis (FMEA) on the System components. Lower level components’ FMEAs, as well as
input from supplier FMEAs roll up into higher level FMEAs. This process continues until the System
Design Failure Modes and Effects Analysis from which System hazards can be derived.

Keywords: Integration; multi-level FMEA; supplier risk management

16.1 HIERARCHICAL MULTILEVEL FAILURE
MODES AND EFFECTS ANALYSIS

Once the System is decomposed, it is possible to perform a hierarchical multilevel
Failure Modes and effects analysis (FMEA) on the System components. Lower level
components’ FMEAs roll up into higher level FMEAs. This process continues until
the L1, System Design Failure Modes and Effects Analysis (DFMEA) (Reference—
Fig. 12.5).
Fig. 16.1 illustrates the connectivity between consecutive decomposition levels.
The rationale for this construct is that lower level components can fail due to design
issues or manufacturing issues. From the perspective of an upper level DFMEA, what
matters is that the lower level component has failed. Whether it was due to a design
or a manufacturing issue is only relevant when the Cause of that failure is
documented.

Figure 16.1 Failure Modes and Effects Analysis integration.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00016-7 All rights reserved. 151