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International Journal of Production Research Volume 50, 2012 - Issue 8
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Original Articles

Integrating failure analysis and risk analysis with quality assurance in the design phase of medical product development

S.L. Chan Department of Industrial and Systems Engineering, Hong Kong Polytechnic University, Hong KongCorrespondence[email protected]
,
W.H. Ip Department of Industrial and Systems Engineering, Hong Kong Polytechnic University, Hong Kong
&
W.J. Zhang Department of Mechanical Engineering, University of Saskatchewan, Saskatoon, Canada
Pages 2190-2203 | Received 14 Jul 2010, Accepted 08 Feb 2011, Published online: 04 Aug 2011

Citations (16)

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Yao Liu, Cuiqing Jiang, Yong Ding, Zhao Wang, Xiaozhong Lv & Junhua Wang. (2019) Identifying helpful quality-related reviews from social media based on attractive quality theory. Total Quality Management & Business Excellence 30:15-16, pages 1596-1615.
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Tsu-Ming Yeh & Long-Yi Chen. (2014) Fuzzy-based risk priority number in FMEA for semiconductor wafer processes. International Journal of Production Research 52:2, pages 539-549.
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Articles from other publishers (14)

Harvey José Santos Ribeiro Cosenza, Nilra do Amaral Mendes Silva, Ana Carolina Sanches Zeferino, Teresa de Lourdes da Rosa Dos Santos, Maria Helena Teixeira Da Silva, Luis Enrique Valdiviezo Viera, Marcos Alexandre Teixeira & Robisom Damasceno Calado. (2024) HFMEA-fuzzy model: an evaluation of the main risk factors occurring in 47 emergency care units (ECU). Revista de Gestão e Secretariado 15:3, pages e3576.
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Lin Wang, Jianying Xiong & Chenglu Ruan. (2024) Research on product design of FAHP bone marrow aspiration needle. Heliyon 10:5, pages e27389.
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Mansoor Alruqi, Martin Baumers, David T. Branson & Sourafel Girma. (2022) The Challenge of Deploying Failure Modes and Effects Analysis in Complex System Applications—Quantification and Analysis. Sustainability 14:3, pages 1397.
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Neven Hadžić, Viktor Ložar, Tihomir Opetuk & Jerolim Andrić. (2021) A finite state method in improvement and design of lean Bernoulli serial production lines. Computers & Industrial Engineering 159, pages 107449.
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Bo Sun, Zhaojun Yang, Narayanaswamy Balakrishnan, Chuanhai Chen, Hailong Tian & Wei Luo. (2020) An Adaptive Bayesian Melding Method for Reliability Evaluation Via Limited Failure Data: An Application to the Servo Turret. Applied Sciences 10:21, pages 7591.
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Petra Marešová, Blanka Klímová, Jan Honegr, Kamil Kuča, Wan Nur Hidayah Ibrahim & Ali Selamat. (2020) Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review. Frontiers in Public Health 8.
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Daniel Martinez‐Marquez, Klemens Terhaer, Peter Scheinemann, Ali Mirnajafizadeh, Christopher P. Carty & Rodney A. Stewart. (2020) Quality by Design for industry translation: Three‐dimensional risk assessment failure mode, effects, and criticality analysis for additively manufactured patient‐specific implants. Engineering Reports 2:1.
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Hongzhan Ma, Xuening Chu, Weizhong Wang, Xinwang Liu & Deyi Xue. (2019) A directed failure causality network (DFCN) based method for function components risk prioritization under interval type-2 fuzzy environment. Advanced Engineering Informatics 41, pages 100920.
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Chrissoleon T. Papadopoulos, Jingshan Li & Michael E.J. O'Kelly. (2019) A classification and review of timed Markov models of manufacturing systems. Computers & Industrial Engineering 128, pages 219-244.
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Milind Shrikant Kirkire, Santosh B. Rane & Surya Prakash Singh. (2018) Integrated SEM-FTOPSIS framework for modeling and prioritization of risk sources in medical device development process. Benchmarking: An International Journal 25:1, pages 178-200.
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Raof Ahmad Khan, Ankush Anand & Mohd Farooq Wani. (2018) A holistic framework for environment conscious based product risk modeling and assessment using multi criteria decision making. Journal of Cleaner Production 174, pages 954-965.
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Manoj Kumar Paras & Rudrajeet Pal. (2017) Application of Markov chain for LCA: a study on the clothes ‘reuse’ in Nordic countries. The International Journal of Advanced Manufacturing Technology 94:1-4, pages 191-201.
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Santosh B. Rane & Milind Shrikant Kirkire. (2015) Interpretive structural modelling of risk sources in medical device development process. International Journal of System Assurance Engineering and Management 8:S1, pages 451-464.
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Milind Shrikant Kirkire, Santosh B. Rane & Jagdish Rajaram Jadhav. (2015) Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study. Journal of Industrial Engineering International 11:4, pages 595-611.
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