FMEA stands for Failure Mode Effects Analysis
FRACAS stands for Failure Reporting and Corrective Action System
Definitions – FMEA is a process to reduce the risk of undesirable events. FRACAS is a process to reduce the rate of undesirable events. Hence FMEA failures haven’t happened while FRACAS failures have. FMEA failures are often much more severe than FRACAS failures.
Not a FMEA – When someone says they have reduced the rate of failures for a process, they have performed FRACAS not FMEA.
Lack of management support – Companies make money by selling products and services and also by reducing costs. FMEA does neither. It consumes resources while reducing the risk of costs (caused when failures occur). A nonprofit has to worry about the same issues. If they lose money, they will have to reduce services.
The following is not a compelling appeal to management for resources – “There are some catastrophic failures that have never happened. We can spend some money to make these events even less likely”.
I participated in a company FMEA that was always held during lunch. The reason given by management was that they have more important tasks to do during regular working hours.
Lack of a facilitator – The purpose of a FMEA is to question the design of a product or process. Often, the designer is present. A facilitator can prevent an adversarial confrontation.
Lack of interest – People who design medical instruments like to design. It’s a challenge to motivate them to perform tasks other than design.
Insufficient detail – FMEA is a bottoms up approach and requires listing all process steps. (Fault trees are a top down approach). Mapping out a process requires inclusion of all relevant events. Providing insufficient detail is a problem. Example, a technician examines a clinical sample before it is analyzed. An additional branch could be how is this person hired, trained, etc.
Stopping at the status quo – As one conducts a FMEA, one lists the possible failure modes for each step, the effect of each failure, and the mitigation for each failure. Example: a process step is to test whether a sample is hemolyzed, the effect (of a failure) is potassium is artificially elevated, and the existing mitigation is to rely on the instrument’s automatic flagging of hemolyzed samples. One might conclude that’s it – no need to do anything further. But all that’s been done is to describe the existing process. This is not FMEA. One must ask questions such as how can the instrument’s flagging system fail.
Acceptable risk is hard to quantify – One can never have a zero failure risk. For example, for blood gas, which is an emergent assay, one remedy to mitigate against an instrument failure is to use two instruments. One can estimate the probability of both instruments failing at the same time. One can add a third machine and so on, always lowering the risk, but it is never zero. Mitigations cost money so one must make a tradeoff between cost and risk.