Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

نویسندگان

  • Jagdish Rajaram Jadhav Department of Mechanical Engineering, K. J. Somaiya Polytechnic, Vidyavihar, Mumbai, India
  • Milind Shrikant Kirkire Department of Mechanical Engineering, Sardar Patel College of Engineering, Andheri, Mumbai, India
  • Santosh B. Rane Department of Mechanical Engineering, Sardar Patel College of Engineering, Andheri, Mumbai, India
چکیده مقاله:

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 approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

برای دانلود باید عضویت طلایی داشته باشید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Using fuzzy FMEA and fuzzy logic in project risk management

Risk management is one of the most important phases of project management and isthe most recently used by many researchers. In this paper, a fuzzy based method wasproposed which identifies different kinds of risks through the project life cycle.Then, the project risk magnitude can be obtained in regards to five factors, namely“severity”, “occurrence”, and “not detection” which form fuzzy FMEA a...

متن کامل

using fuzzy fmea and fuzzy logic in project risk management

risk management is one of the most important phases of project management and isthe most recently used by many researchers. in this paper, a fuzzy based method wasproposed which identifies different kinds of risks through the project life cycle.then, the project risk magnitude can be obtained in regards to five factors, namely“severity”, “occurrence”, and “not detection” which form fuzzy fmea a...

متن کامل

eplicitation in interlingual and intralingual translations of shahnameh ferdowsi: a text linguistic approach

بررسی و مقایسه تفاوتها و شباهت های ترجمه ی درون زبانی و برون زبانی با تمرکز بر زبانشناسی متن. برای امر مقایسه میزان بسامد تصریح به کار رفته در ترجمه ی درون زبانی و نیز برون زبانی شاهنامه ی فردوسی مورد بررسی قرار گرفت.

A multidimensional approach to information security risk management using FMEA and fuzzy theory

Because of the evolution and widespread use of the Internet, organisations are becoming more susceptible to attacks on Information Technology Systems. These attacks result in data losses and alterations, and impact services and business operations. Therefore, to minimise these potential failures, this paper presents an approach to information security risk management, encompassing Failure Mode ...

متن کامل

from linguistics to literature: a linguistic approach to the study of linguistic deviations in the turkish divan of shahriar

chapter i provides an overview of structural linguistics and touches upon the saussurean dichotomies with the final goal of exploring their relevance to the stylistic studies of literature. to provide evidence for the singificance of the study, chapter ii deals with the controversial issue of linguistics and literature, and presents opposing views which, at the same time, have been central to t...

15 صفحه اول

A dynamic risk analysis on new product development process

Abstract In the dynamic and competitive market, managers seek to find effective strategies for new products development. Since There has not been a thorough research in this field, this study is based on a review on the risks exist in the NPD process and an analysis of risks through FMEA approach to prioritize the existent risks and a modeling behavior of the NPD process and main risks using s...

متن کامل

منابع من

با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

ذخیره در منابع من قبلا به منابع من ذحیره شده

{@ msg_add @}


عنوان ژورنال

دوره 11  شماره 4

صفحات  -

تاریخ انتشار 2015-12-01

با دنبال کردن یک ژورنال هنگامی که شماره جدید این ژورنال منتشر می شود به شما از طریق ایمیل اطلاع داده می شود.

میزبانی شده توسط پلتفرم ابری doprax.com

copyright © 2015-2023