FMEA goals in healthcare

November 17, 2007

FMEA is now a common risk management tool used in healthcare. Here’s a quick test. If the words “minimal cut set” and “Petri net” don’t mean anything to you, then you probably don’t have a quantitative FMEA goal. The rest of this entry explains some things to know about goals.

A quantitative goal must also be measureable and realistic. For example, a goal for imprecision (reproducibility) for a clinical laboratory sodium assay, might be 4% CV. One can measure this goal using a variety of experiments including those defined by standards such as the CLSI standard EP5A2.

FMEA deals with risk. Some common pitfalls about risk goals are:

·         A goal that an event should never happen. For example, the NQF (National Quality Forum) implies such by talking about “never events.” Risk is probabilistic and can never be zero. It is possible that an estimated risk is so low that in lay terms, it may be said to never be possible to occur but this lay usage is different from a formal quantitative assessment.

·         Too many goals. The NQF has a list of 28 “never events.” Virtually all of these cause serious patient harm. A goal could be restated in terms of patient harm, as the combination of risk from any of the 28 events.

·         The institute of Healthcare Improvement (IHI) implies goals in terms of evaluating the RPN (risk priority number) before and after implementing control measures. Some problems here are:

o   One may improve this metric by reducing the risk of less severe events (without reducing risk of severe events)

o   A severe risk with the lowest (categorical) probability of occurrence may be ignored as a candidate for improvement, since its RPN won’t change, but there still may be a way to lower risk (and still have the same (categorical) probability of occurrence rank.

Quantitative FMEA goals are possible and are used in the nuclear power industry although fault trees are used instead of FMEAs. Quantitative fault trees are evaluated among other ways using “minimal cut sets” and “Petri nets.”

A reasonable non quantitative goal for FMEA is to learn more about potential failure modes. However, one should realize that it is difficult to assess how much is learned.

It is easy to have a quantitative FRACAS goal because it is easy to measure failure rates from observed failures, before and after implementing control measures.