A systematic, proactive method to identify potential failure modes in a design or process, assess their potential effects, and prioritize actions to mitigate or eliminate them.
- 方法: 工程, 产品设计, 项目管理
FMEA(故障模式与影响分析)

- 持续改进, 面向制造设计 (DfM), 六西格玛设计(DfSS), 故障模式和影响分析(FMEA), 流程改进, 质量保证, 质量控制, 风险分析, 风险管理
FMEA(故障模式与影响分析)
- 持续改进, 面向制造设计 (DfM), 六西格玛设计(DfSS), 故障模式和影响分析(FMEA), 流程改进, 质量保证, 质量控制, 风险分析, 风险管理
目标
如何使用
- A cross-functional team identifies potential ways a product or process can fail (failure modes), the potential consequences of those failures (effects), and the likelihood of occurrence, severity, and detectability to calculate a Risk Priority Number (RPN). Actions are then planned for high-RPN items.
优点
- Proactive approach to identify and mitigate risks; Improves product reliability and safety; Prioritizes actions based on risk; Facilitates cross-functional communication and knowledge sharing.
缺点
- Can be time-consuming and resource-intensive; Effectiveness depends on the thoroughness and experience of the team; RPN calculation can be subjective and sometimes misleading if not used carefully; Requires ongoing updates as designs or processes change.
类别
- 精益西格玛, 制造业, 产品设计, 质量, 风险管理
最适合:
FMEA finds extensive application across various industries including automotive, aerospace, healthcare, and manufacturing, where it is implemented during the design phase (DFMEA) or in the manufacturing and assembly stages (PFMEA) to enhance product quality and process efficiency. In contexts such as product development and process optimization, cross-functional teams typically involve members from engineering, quality assurance, manufacturing, and product management, ensuring diverse perspectives are considered when evaluating potential failure modes. The methodology is particularly beneficial during early stages of project development, allowing teams to assess risk before products are launched or processes are finalized. This proactive approach enables organizations to identify weak points in designs or workflows and implement corrective actions or design improvements, thereby reducing potential recalls, customer dissatisfaction, and associated costs. Industries employing FMEA can demonstrate a commitment to safety and reliability, often meeting regulatory standards that require thorough risk assessments, which in turn can enhance brand reputation and market competitiveness. The systematic calculation of the Risk Priority Number (RPN) offers a quantifiable method to prioritize risks, enabling teams to focus their resources and efforts on the most significant issues that could impact performance or safety. In practice, organizations may integrate FMEA with other methodologies such as Six Sigma or Lean, further enhancing efficiency and fostering a culture of continuous improvement across processes and products.
该方法的关键步骤
- Identify potential failure modes for each component or process step.
- Determine the effects of each failure mode on the overall system or process.
- Assess the severity of each effect on a predefined scale.
- Estimate the likelihood of occurrence for each failure mode.
- Evaluate the detectability of each failure mode before effects occur.
- Calculate the Risk Priority Number (RPN) using the formula RPN = Severity × Occurrence × Detectability.
- Prioritize failure modes based on their RPN values.
- Develop and document actions to mitigate high-RPN items.
- Implement and track the effectiveness of the mitigation actions.
专业提示
- Utilize software tools for FMEA documentation and analysis, enhancing data integration and real-time collaboration across teams.
- Incorporate historical failure data and benchmarks from similar products for more accurate risk assessments and RPN calculations.
- Implement regular review sessions post-design or production phases to reassess and update FMEA findings based on new data or failure occurrences.
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