FMEA, shortcomings and adaptationsFailure Mode and Effect Analysis (FMEA) is a qualitymethod that identifies, prioritizes, and mitigates potentialproblems in a given product. FMEA begins withidentification of functions or requirements of a system,subsystem or component, ways that they can fail and itspotential causes of failure. A small, but representative,group with members of the design team and otherdisciplines familiar with the product life cycle performs theanalysis in one or more meetings. For each failure modeand cause, the team identifies the probability that they canoccur and scores them on a scale from 0 to 10. Afteridentifying the effects, the analysis scores the severity ofeach end effect on a similar scale. The team documentswhich actions have already been taken, and which actionshave still to be performed in order to avoid or to detect thefailure mode. Finally, the detection rating scored refers tothe likeliness of catching the failure modes before theyhappen. The product of these terms is the risk prioritynumber (RPN) which gives a relative magnitude for eachfailure mode.If an FMEA is done properly, the resulting documentscontain a lot of knowledge about the product design.Thus, it is a valuable source of know-how for thecompany. Furthermore, since it supports the earlydetection of weaknesses in a design, a reduction ofdevelopment costs and fewer changes during seriesproduction are expected [20].However, there are numerous shortcomings within thefailure analysis of FMEA, its implementation and utility.Some of these shortcomings include a lack of welldefinedterms [21], problems with the terminology [22],problems with identifying key failures [23] and it is treatedas a stand-alone technique [20], which is neitherintegrated with the design process, nor with othermethods of quality management. Other commoncomplaints of the FMEA method is that it is tedious andtime consuming [13] [24] [25], its analyses are subjective(based on the users experience) [26], it is considered bythe engineers to be laborious [20], the analysis is oftendone to check rather than to predict [22].When concerned with product design, it is important thatfailure analysis is carried out early in the design processin order to reduce the necessary amount of redesigns. Itis important to perform failure analysis in conceptualdesign, but it has been reported that FMEA is commonlyperformed too late in the NPD cycle and has very littleeffect on the overall product design [27].To overcome the FMEA shortcomings, many adaptationsand improvements have been made to its process,application and target. Previous papers [25] [26] havedescribed concepts for automated FMEA employingqualitative simulators and reasoning process to produce areport that is more timely, complete and consistent in thedesign cycle. Other authors [28] take automated FMEA astep further, developing a concept for analysis of theeffects of significant multiple failures as well as singlefailures. A software that uses quantitative simulator hasbeen developed [29], to produce results that are not onlymore accurate for designers, but are also more useful totest and diagnostics engineers. Bayes belief networkshas been employed [21] to provide a language for designteams to articulate, with greater precision andconsistency and less ambiguity, a physical system failurecause-effect relationship, and the uncertainty about theirimpact on customers. It has been shown [30] thatfunction to structure mapping can be used in the earlystages of design to assess diagnosability; i.e., a measureof the ease of isolating the cause of a malfunction.DRBFMDRBFM is a method of discovering problems anddeveloping countermeasures by taking notice of anddiscussion intentional changes (design modifications) andincidental changes (changes in part environment) [31]. Itis carried out, throughout the NPD process, to guide thedesign engineer during the engineering change process,to integrate design, production, quality and supplierpersonnel into this process, and to achieve a robustdesign [32].DRBFM was developed by Tatsuhiko Yoshimura, whohas worked at Toyota Motor Corporation for 32 years. Inthe Japanese automobile manufacturer, Yoshimura wasone of the responsible engineers to assure the qualityand the reliability of the products, dedicating hisprofessional life to avoid problems before they occur.However, the other employees acting astroubleshooters, namely, solving problems just whenthey appeared, were apparently the heroes of thecompany [33]. It has been reported [33] that the summaryfor Yoshimura of this experience is similar than thefindings of the study conducted by MIT: Nobody EverGets Credit for Fixing Problems that Never Happened[34].