PURPOSE Failure mode and effects analysis (FMEA) was used to evaluate a smart i.v. pump as it was implemented into a redesigned medication-use process. SUMMARY A multidisciplinary team conducted a FMEA to guide the implementation of a smart i.v. pump that was designed to prevent pump programming errors. The smart i.v. pump was equipped with a dose-error reduction system that included a pre-de...

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...

FMEA is a useful tool that helps to find possible flaws in a system or element, mainly in the design phase. But it is a mere document that has no further ''direct'' use than the observation. Mapping all this knowledge into a Bayesian Network would make it possible to use the information in further ways, like software applications for maintenance. A good FMEA has the necessary features to build ...

FMEA was formally introduced in the late 1940s for military usage by the US Armed Forces. Later, it was used for aerospace/rocket development to avoid errors in small sample sizes of costly rocket technology. FMEA enables the team to design those failures out of the system with the minimum of effort and resource expenditure, thereby reducing development time and costs. It is widely used in manu...

Whereas the verification of non-safety-related, embedded software typically focuses on demonstrating that the implementation fulfills its functional requirements, this is not sufficient for safety-relevant systems. In this case, the control software must also meet application-specific safety requirements. Safety requirements typically arise from the application of hazard and/or safety analysis ...

FMEA(Failure Mode and Effects Analysis) is a systematic method of identifying and preventing system, product and process problems. As a standard document, FMEA is produced during the design of products or systems. However, FMEA documentation is rarely validated or updated in practice after it was generated. FMEA validation remains a challenge. In this technical report, we propose to validate FM...

Critical aircraft systems are becoming more dependent on software. This brings with it the need to establish that the software will perform safely and reliably through all flight regimes, including emergencies. Verification and validation (V&V) is a key process for meeting that need for both military and civil procurements. For software developed with the UML (Unified Modeling Language), we are...

Quality and reliability of product and manufacturing process are the critical factors to the product development. However, to ensure good quality and reliability of the product and to predict any inadequacies of the product, an efficient quality system must be established at the earliest stage of the product development process. Failure Mode and Effect Analysis (FMEA) is a popular quality tool ...

Quality function deployment (QFD) is a customer-driven approach in processing new product developments in order to maximize customer satisfaction. Determining the fulfillment levels of design requirements (DRs) and parts characteristics (PCs) is an important decision problem during QFD activity processes for new product development. Unlike the existing literature, which mainly focuses on the de...

The main research intent of this paper is to introduce the use of fault tree analysis (FTA) and failure mode and effects analysis (FMEA) in conjunction to analyse the risk and reliability of a complex mechatronic system in both qualitative and quantitative manner. The major focus is on handling imprecise and vague information with the help of fuzzy synthesis of information. A complex mechatroni...