Failure Modes and Effects Summary

There are a number of sources of data for failure rates, including Failure Modes and Effects Analysis (FMEA)/Failure Modes and Effects Summary (FMES), product data sheets, failure tests data and accelerated life tests. However, these sources ultimately stem from the following data types ... 

Failure Modes and Effects Summary (FMES) Number Revision Date ... 

The total failure rate for each failure effect category may be detailed in a summary sheet or is summarised in the Failure Modes and Effects Summary (FMES, see Section 5.2.5). 

The results of an FMEA may be used to generate the Failure Modes and Effects Summary (FMES). This is especially useful for very large FMEAs or to consolidate individual piece-part FMEAs. 

This concept of this process of amalgamating and consolidation is illustrated in Fig. 11.2, and an example of this process is demonstrated in the generation of the Failure Modes and Effects Summary discussed in Step 4 in Chapter 5. The ultimate aim is to summarise and consolidate the data, so that it can be presented in a format which is compatible with the SMS of those organisations (see Section 11.2.2) who are exposed to the hazards inherent in the design. ... 

Component designers (i.e. System Level 2 in Fig. 1.1) may be required by the system integrator to develop a piece-part FTA with a top-level event for particular failure modes of a unit. The piece-part FTA would then develop through layers of logic gates until individual component failures (resistors, capacitors, etc.) are identified. This is often supported by a Failure Modes and Effects Analysis (FMEA) from which a Eailure Modes and Effects Summary (FMES) (see Chapter 5) can be generated for the individual next or end effects. 

BOX 8.6 Healthcare failure modes and effects analysis a summary of the Veterans Administration process... 

This paper is organised as follows. Section II describes the transceiver architecture of the BTM, on the one hand the functional blocks and on the other one the BIST topology. Section III includes a summary of a Fault Tree Analysis (FTA) and a Failure Mode and Effect Analysis (FMEA) of the design. The components reliabihty data and the results of the analysis are shown in section IV Finally, conclusions are drawn in section V... 

For the apphcation of Failure Modes and Effects Analysis was used the Table 3 that consists of four columns component (identifying each component belonging to the system), function (summary description and precise task that must carry out by the component), potential failure mode (description of how the loss of function is observed by operating staff) and cause of failure (simple and concise description of the causes that generate the occurrence of the failure mode) (BRITISH STANDARD, 2007). 

I would read my section and consider all the questions about failure modes and testing that we discussed earlier in this chapter. Then, most importantly, I would summarize my conclusions in a written review. I had to be able to describe any safety or effectiveness issues clearly and succinctly. If my summary was too long or confusing, the other team members might have to ignore my work completely and go read the original submission themselves, which would be a waste of everyone s time. It was also not sufficient for me to just critique a device. I had to think proactively and describe what actions needed to be taken by the manufacturer to resolve each issue. Otherwise, I would put everyone (the FDA and the company) in an awkward state of limbo with no idea of what to do next. My recommendations would be included in a letter to the company, and I might be asked... 

The second analysis is the FMEA, this is the bottom-up analysis. First, the failure modes of all the transmitter blocks are defined. Each of these modes is related to one or more effects on the transmitter functionality. Once the modes and effects are listed, the last step is the definition of the solution to mitigate the effect of the possible failures. These conclusions can result in changes in the transceiver design or changes in other components of the system, as DPU. Table 1 shows the summary of the results of the process where the most significant cases are presented. 

The literature includes additional information regarding the factors siffecting corrosion [1-3]. Also, several corrosion data summaries are avculable to assist in material selection [4-9]. Many of these include consideration of several modes of corrosion and the effects of impimties. All of the above issues must be considered when evaluating a material for service. Testing of an unstressed-annealed material when the material in service will be bent, welded, or stress-relieved may result in a service failure regardless of satisfactory test results. 

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