Functional safety standards (ISO 26262, IEC 61508) require a safety life cycle which demands additional design and engineering tasks to be managed. This paper addresses how the existing FMEAs have to be extended and refocused to address and overview signal paths throughout the system. The safety standards require to classify signals with a SIL (Safety Integrity Level) and the higher the SIL the...

Failure Mode and Effects Analysis (FMEA) is a technique used in the manufacturing industry to improve production quality and productivity. It is a method that evaluates possible failures in the system, design, process or service. It aims to continuously improve and decrease these kinds of failure modes. Adaptive Resonance Theory (ART) is one of the learning algorithms without consultants, which...

Technical systems are prevalent in many areas of our society. Nowadays they often include a considerable amount of software. Identification and avoidance of technical risks is of major importance in the development of these softwareintensive technical systems. A powerful analysis technique in the development process for technical systems is the Failure Mode and Effects Analysis (FMEA). This tec...

OBJECTIVE This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. METHODS The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failur...

PURPOSE/OBJECTIVES To assess and improve the safety of hospital-based adult chemotherapy administration. DESIGN Prospective, systems-focused clinical risk assessment. SETTING An adult inpatient and outpatient oncology unit in a large urban hospital in the United Kingdom. SAMPLE 8-person nurse-led multidisciplinary team, which included managerial staff and patient safety researchers. MET...

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...

Increasingly complex systems lead to an interweaving of security, safety, availability and reliability concerns. Most dependability analysis techniques do not include security aspects. In order to include security, a holistic risk model for systems is needed. In our novel approach, the basic failure cause, failure mode and failure effect model known from FMEA is used as a template for a vulnera...

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 ...

Failure mode and effect analysis (FMEA) is a widely used reliability analysis and risk assessment tool in various industries. It is one of the most established project management techniques to identify and eliminate failures before actual manufacturing starts. In traditional FMEA, Risk Priority Number (RPN) ranking system is used to evaluate; the risk level of failures, to rank failures, and to...