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The Failure Mode and Effect Analysis (FMEA) is the gateway to the Quality Management System (QMS), and its correct application should imply that projects reach the start of production (SOP) with zero issues, which frequently is not being achieved. The cost of poor quality (COPQ) in industrial companies represents a disproportionately high percentage of the revenue volume. This cost can be avoided with a proper application of risk analysis using FMEA. In this work, we address a more effective way to identify failure modes in FMEA through “the physic of the process”. The expected final result is a reduction in COPQ, because failures are detected earlier and better, so they do not reach SOP.

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Beyond Formal FMEA Requisites in Process Risk Management

  • 会议论文

  • 发表日期：

    2025年

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  • Rafael Pastor,
  • José Costas,
  • Isabel Fernández,
  • Raúl Pino

摘要

The Failure Mode and Effect Analysis (FMEA) is the gateway to the Quality Management System (QMS), and its correct application should imply that projects reach the start of production (SOP) with zero issues, which frequently is not being achieved. The cost of poor quality (COPQ) in industrial companies represents a disproportionately high percentage of the revenue volume. This cost can be avoided with a proper application of risk analysis using FMEA. In this work, we address a more effective way to identify failure modes in FMEA through “the physic of the process”. The expected final result is a reduction in COPQ, because failures are detected earlier and better, so they do not reach SOP.