Limitations
Since FMEA is effectively dependent on the members of the committee which examines product failures, it is limited by their experience of previous failures. If a failure mode cannot be identified, then external help is needed from consultants who are aware of the many different types of product failure.
FMEA is thus part of a larger system of quality control, where documentation is vital to implementation. General texts and detailed publications are available in forensic engineering and failure analysis. It is a general requirement of many specific national and international standards that FMEA is used in evaluating product integrity.
If used as a top-down tool, FMEA may only identify major failure modes in a system. Fault tree analysis (FTA) is better suited for "top-down" analysis. When used as a "bottom-up" tool FMEA can augment or complement FTA and identify many more causes and failure modes resulting in top-level symptoms. It is not able to discover complex failure modes involving multiple failures within a subsystem, or to report expected failure intervals of particular failure modes up to the upper level subsystem or system.
Additionally, the multiplication of the severity, occurrence and detection rankings may result in rank reversals, where a less serious failure mode receives a higher RPN than a more serious failure mode. The reason for this is that the rankings are ordinal scale numbers, and multiplication is not defined for ordinal numbers. The ordinal rankings only say that one ranking is better or worse than another, but not by how much. For instance, a ranking of "2" may not be twice as severe as a ranking of "1," or an "8" may not be twice as severe as a "4," but multiplication treats them as though they are. See Level of measurement for further discussion.
Read more about this topic: Failure Mode And Effects Analysis
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