Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study ...

In this paper, a new fuzzy group decision making (FGDM) model based on  -level sets, is proposed to generate, more accurate fuzzy using, risk priority numbers (RPNs) and ensure to be robust against the uncertainty. This model allows decision makers (DMs) to evaluate FMEA risk factors using linguistic terms rather than precise numerical values, allows them to express their opinions independentl...

BACKGROUND Failure Mode and Effect Analysis (FMEA) is a method used to assess the risk of failures and harms to patients during the medical process and to identify the associated clinical issues. The aim of this study was to conduct an assessment of blood transfusion process in a teaching general hospital, using FMEA as the method. METHODS A structured FMEA was recruited in our study performe...

Failure mode and effects analysis (FMEA) has been extensively used for examining potential failures in products, processes, designs and services. An important issue of FMEA is the determination of risk priorities of the failure modes that have been identified. The traditional FMEA determines the risk priorities of failure modes using the so-called risk priority numbers (RPNs), which require the...

Failure mode and effects analysis (FMEA) is a widely used, powerful tool to identify assess potential failure modes in products make more reliable. Due the complexity of lack knowledge, FMEA involves many uncertainties practice. In previous studies, numerous modified methods based on fuzzy logic Dempster-Shafer (D-S) evidence theory have been employed address these uncertainties. These studies ...

Fault diagnosis and prognosis methods are the most useful tools for risk reliability analysis in food processing systems. Proactive techniques such as failure mode effect (FMEA) important detecting all probable failures facilitating process. However, significant uncertainties exist classical-FMEA when it comes to ranking priority numbers (RPNs) of modes. Such may have an impact on sector’s oper...

BACKGROUND The aim of blood transfusion risk management is to improve the quality of blood products and to assure patient safety. We utilize failure mode and effect analysis (FMEA), a tool employed for evaluating risks and identifying preventive measures to reduce the risks in blood transfusion. STUDY DESIGN AND METHODS The failure modes and effects occurring throughout the whole process of b...

Failure mode and effects analysis (FMEA) is a widely used engineering technique for designing, identifying and eliminating known and/or potential failures, problems, errors and so on from system, design, process, and/or service before they reach the customer (Stamatis, 1995). In a typical FMEA, for each failure modes, three risk factors; severity (S), occurrence (O), and detectability (D) are e...

There are varieties of QFD combination forms available that can help management to choose the right model for his/her types of problem. The proposed MOCC-QFD-FMEA model is a right model to include variety of objectives as well as the risk factors into the model of the problem. Due to the fact that the model also takes into consideration the concept of Fuzzy set, it further allows management...