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

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%.