Failure modes and effects analysis (FMEA) is used in the manufacturing industry to improve product quality and productivity. However, the traditional approach has many shortcomings that affect its effectiveness and limit its usefulness, especially in the early stages of design. Automating the FMEA report generation process seems to answer some of these problems, and there has been much past and...

Failure Mode and Effect Analysis (FMEA) is one of the well-known techniques of quality management that is used for continuous improvement in product or process design. One important issue of FMEA is the determination of the risk priorities of failure modes. The purpose of this paper is to compare three different methods for prioritizing failure modes in a process FMEA study. These methods are t...

Many processes are safety critical and therefore could benefit from proactive safety analysis techniques that attempt to identify weaknesses of such processes before they are put into use. In this paper, we propose an approach that automatically derives Failure Mode and Effect Analysis (FMEA) information from processes modeled in the Little-JIL process definition language. Typically FMEA inform...

The paper describes recent work to improve the safety process for aero-engine controllers. The role of FMEA is discussed in the context of the safety and certification processes, with reference to ARP 4754 and ARP 4761. Whilst the ARPs' emphasis on top-down hazard-driven approaches is valuable, it is concluded that the role of FMEA should not be down-played. Instead it should be recognized that...

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical device...

The paper presents work in progress aiming at extending Failure-modes-and-effects Analysis (FMEA) to include embedded software. It is based on the insight that requirements on Software FMEA in this context are only dependent on the required functionality of the physical system, which, in particular, allows the consideration of a finite set of qualitatively characterized software failures.

Failure modes and e€ects analysis (FMEA) is a quality improvement and risk assessment tool commonly used in industry. It is a living document used to capture design and process failure information. However, the traditional FMEA has its limitations in terms of knowledge capture and reuse. In order to increase its e€ectiveness, much research has been carried out to ®nd an e€ective way to provide ...

In any organization, the importance of failuremanagement cannot bementionedby a single word. However,most failure analysis is dominated by themanufacturing sector, despite the increasing importance of the service sector. In response, this paper proposes a systematic approach for identifying and evaluating potential failures using a service-specific failure mode and effect analysis (service-spec...

BACKGROUND Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. METHODS A multidisciplinary FMEA focus group ...