Title: An FMEA-based integrated framework to quantify and improve operational performance in advanced manufacturing environments: a case study

Authors: Chen Fung Liew; Joshua Prakash; Kok Seng Ong

Addresses: Faculty of Engineering and Green Technology, Universiti Tunku Abdul Rahman, Jalan Universiti Bandar Barat, 31900 Kampar, Perak, Malaysia ' Faculty of Engineering and Green Technology, Universiti Tunku Abdul Rahman, Jalan Universiti Bandar Barat, 31900 Kampar, Perak, Malaysia ' Faculty of Engineering and Green Technology, Universiti Tunku Abdul Rahman, Jalan Universiti Bandar Barat, 31900 Kampar, Perak, Malaysia

Abstract: The failure mode and effect analysis (FMEA) aims to improve the operational performance in manufacturing processes of a product. Current FMEA practice does not define a specific method for quantifying achievement in operational performances. Risk priority number (RPN) is independent of operational performance. The capability of current FMEA to improve operational performance cannot be validated unless a quantifiable operational performance improvement is demonstrated. This study offered guidelines to quantify the operational performance within the FMEA methodology. Different from traditional FMEA, the new FMEA-based integrated framework ascertains the priority set by RPN with operational performance indicators (OPI) for ensuring the priority is relevant to operational performance. Design for manufacturing and assembly (DFMA) and poka-yoke provide systematic guidelines for optimising design and developing a highly robust error-proofing system. Application of the new FMEA-based integrated framework in a medical device manufacturer in Malaysia demonstrated that the overall defect rate was reduced by 87.2%.

Keywords: failure mode effect and analysis; FMEA; risk priority number; RPN; operational performance indicator; OPI; design for manufacturing and assembly; DFMA; poka-yoke.

DOI: 10.1504/IJPQM.2019.103527

International Journal of Productivity and Quality Management, 2019 Vol.28 No.3, pp.318 - 339

Received: 26 Jun 2018
Accepted: 22 Sep 2018

Published online: 05 Nov 2019 *

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