Potential Failure Mode and Effects Analysis—FMEA

Chrysler Corporation, Ford Motors, General Motors Corporation 1995 Potential Failure Mode and Effects Analysis (FMEA) - Reference Manual, 2nd Edition. 

Potential failure mode and effects analysis (FMEA) (GM, Ford, Chrysler)... 

Suppliers to those auto companies must meet the requirements set forth in a reference manual titled Potential Failure Mode and Effects Analysis—FMEA and must do what the title implies. They make failure mode and effects analyses of the equipment they supply. In that process, a risk priority number (RPN) is developed, giving consideration to occurrence likelihood, severity of effect, and detection ability. 

Potential Failure Mode and Effects Analysis—FMEA. Southfield, MI Automotive Industry Action Group, 1995. 

Automobile Industry FMEAs DaimlerChrysler, Ford, and General Motors are represented in the Automotive Industry Action Group (AIAG). FMEA teams in those companies, working under the auspices of the Automotive Division of the American Society for Quality (ASQC) and AIAG, developed a reference manual titled Potential Failure Mode and Effects Analysis FMEA, currently in its third edition. Excerpts from the manual are reprinted here with permission from the FMEA Manual (DaimlerChrysler, Ford, General Motors Supplier Quality Requirements Task Force). 

Failure Mode and Effects Analysis. The system design activity usually emphasizes the attainment of performance objectives in a timely and cost-efficient fashion. The failure mode and effects analysis (FMEA) procedure considers the system from a failure point of view to determine how the product might fail. The terms design failure mode and effects analysis (DFMEA) and failure mode effects and criticaUty analysis (EMECA) also are used. This EMEA technique is used to identify and eliminate potential failure modes early in the design cycle, and its success is well documented (3,4). 

There is one technique widely used in the automotive industry for detecting and analyzing potential nonconformities Failure Modes and Effects Analysis (FMEA). There are Design FMEAs and Process FMEAs. The technique is the same - it is only the focus that is different. As clause 4.14 addresses potential nonconformities, the subject of FMEAs is treated in Part 2 Chapter 14. 

Inductive methods, such as check lists, Failure Mode and Effect Analysis (FMEA), event trees, decision tables, Analysis of Potential Problems (APP). These methods proceed from an initial cause of the deviation and construct a scenario ending with the final event. They are based on questions of the type What if ... 

There are various types of analyses that are used for a process hazard analysis (PHA) of the equipment design and test procedures, including the effects of human error. Qualitative methods include checklists, What-If, and Hazard and Operability (HAZOP) studies. Quantitative methods include Event Trees, Fault Trees, and Failure Modes and Effect Analysis (FMEA). All of these methods require rigorous documentation and implementation to ensure that all potential safety problems are identified and the associated recommendations are addressed. The review should also consider what personal protective equipment (PPE) is needed to protect workers from injuries. 

Before we can define the mission for any particular test or inspection system we must be able to specify customer needs. While a detailed framework for designing inspection systems is given in Section 7, we must consider now how to define such needs. One way is to apply a failure modes and effects analysis (FMEA) to the product and design a test and evaluation system to cover each of the potential failure modes. But this technique does not make the customer an explicit part of the design process, whereas we have seen earlier (Section 1) that direct customer input is increasingly needed in more customized products. A preferable technique is to begin with customer function and quality requirements as the basis for a list of product attributes that form the basis of test and inspection. In attributes inspection (Section 2.1), this list is often a defect list or fault list defining the discrete defects that the inspection system must ensure the customer never experiences. 

It is critical to spend early development time using failure mode and effects analysis (FMEA) and establishing a design plan that minimizes or eliminates the potential failure modes identified as part of the design FMEA. Using multiple tests to evaluate failure modes is also a key component to success. 

Potential Failure Mode and Effects Analysis in Design (Design FMEA) and Potential Failure Mode and Effects Analysis in Manufacturing and assembly Processes (Process FMEA) Reference Manual. Society of Automotive Engineers, 2000. 

A formal hazard analysis of the anticipated operations was conducted using Preliminary Hazard Assessment (PHA) and Failure Modes and Effects Analysis (FMEA) techniques to evaluate potential hazards associated with processing operations, waste handling and storage, quality control activities, and maintenance. This process included the identification of various features to control or mitigate the identified hazards. Based on the hazard analysis, a more limited set of accident scenarios was selected for quantitative evaiuation, which bound the risks to the public. These scenarios included radioactive material spills and fires and considered the effects of equipment failure, human error, and the potential effects of natural phenomena and other external events. The hazard analysis process led to the selection of eight design basis accidents (DBA s), which are summarized in Table E.4-1. 

Assesses the likelihood of occurrence of potential misuse modes and their effect on safety before and after corrective actions. See also Failure Mode and Effects Analysis (FMEA/FMECA). 

The hardware safety of medical devices is important because many of their parts, such as electronic parts, are vulnerable to factors such as electrical interferences and environmental stresses. This calls for analysis of each part of a medical device with respect to safety and potential failmes. There are several methods that can be used to perform such analysis, two of which are failure modes and effect analysis (FMEA) and fault tree analysis (FTA). 

The failure mode and effect analysis (FMEA) is one of the more familiar of the system safety analysis techniques in use. It has remarkable utility in its capacity to determine the reliability of a given system. The FMEA will specifically evaluate a system or subsystem to identify possible failures of each individual component in that system, and, of greater importance to the overall system safety effort, it attempts to forecast the effects of any such failure(s). Because of the FMEA s ability to examine systems at the component level, potential single-point failures can be more readily identified and evaluated (Stephenson 1991). Also, although the FMEA should be performed as early in the product life cycle design phase as possible (see Figure 3.4), based on the availability of accurate data, the system safety analyst can also use this tool, as necessary, throughout the life of the product or system to identify additional failure elements as the system matures. 

Failure Mode and Effect Analysis (FMEA) - mostly used in the design stage of products, this checklist procedure not only identifies potential problems, but also assess their likelihood and the consequences of failure... 

A Failure Mode and Effects Analysis (FMEA) is a sequential analysis and evaluation of the kinds of failures that could happen and their likely effects, expressed in terms of maximum potential loss. The technique is used as a predictive model and forms part of an overall risk assessment study. This analysis is described completely in the MIL-STD-1629A. The FMEA is most useful in system hazard analysis for highlighting critical components (Ridley, 1994). 

SAE J1739 Potential failure mode and effects analysis in design (design FMEA) and potential failure mode and effects analysis in manufacturing and assembly processes (process FMEA) and effects analysis for machinery (machinery FMEA) ... 

The conventional method for the reliability analysis of electronic systems is a component level failure mode and effect analysis (FMEA) which involves assessing the potential effects on the system of each mode of failure of each component. Because of the large numbers of components involved, the internal complexity of the integrated circuit components themselves and the time-dependence of internal states in a programmable system, this approach is impractical for the fuelling machine control system. 

Failure mode and effects analysis (FMEA) process by which each potential failure mode in a system is analyzed to determine the results, or effects thereof, on the system and to classify each potential failure mode according to its severity Fallout (nuclear) minute particles of radioactive debris that descend slowly from the atmosphere after a nuclear explosion... 

The Failure Mode and Effect Analysis (FMEA) is a structured technique which investigates failure modes and their effects. The aim is to identify potential weaknesses and improve reliability, availability or safety. A system or process is hierarchically decomposed into its basic elements and then the failure modes of the elements are examined for causes and effects [3]. FMEA was developed in the 1950s... 

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