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

Abstract

Today, manufacturing operates as a global network, which has created more awareness of the quality of products and services. A systematic and rational way of managing quality assurance is currently lacking. This can cause serious problems in sectors such as the medical industry, as product failure may not only cause time delays, but also create risks for the health and safety of patients and users. This paper proposes a quality assurance approach that incorporates risk analysis (based on ISO14971) and failure analysis (based on FMEA) into the product design phase to assure product quality in the short term and facilitate global manufacturing practices in the long run. The proposed approach includes a Markov model to predict product failure from a customer perspective, which serves as a checkpoint for feedback to provide a basis for quality assurance. A medical equipment firm is used as a test-bed to illustrate how the proposed approach works and to verify its effectiveness.

Keywords:

• failure mode and effect analysis (FMEA)
• quality assurance
• supply chain
• product design
• ISO14971

Acknowledgements

The authors would like to express their sincere gratitude to the Hong Kong Polytechnic University for the financial support that made this study possible (Project number RPV2).