Failure Modes and Effect analysis (FMEA) is a widely used technique for inductive safety analysis. FMEA provides engineers with valuable information about failure modes of system components as well as procedures for error detection and recovery. In this paper we propose an approach that facilitates representation of FMEA results in formal Event-B specifications of control systems. We define a n...

This article discusses the risk assessment of a health information system. A case study was conducted at the South Western Sydney Area Health Service to examine the potential risks of the Maternal and Infant Network (MINET) health information system using Failure Mode Effect Analysis (FMEA). FMEA was conducted by utilising safety attributes identified by the authors. Potential failure modes of ...

Despite of the popularity of the fuzzy Failure Mode and Effects Analysis (FMEA) methodology, there are several limitations in combining the Fuzzy Inference System (FIS) and the Risk Priority Number (RPN) model. Two main limitations are: (1) it is difficult and impractical to form a complete fuzzy rule base when the number of required rules is large; and (2) fulfillment of the monotonicity prope...

Failure mode and effect analysis (FMEA) is a useful tool to define, identify, and eliminate potential failures or errors so as to improve the reliability of systems, designs, and products. Risk evaluation is an important issue in FMEA to determine the risk priorities of failure modes. There are some shortcomings in the traditional risk priority number (RPN) approach for risk evaluation in FMEA,...

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.