产品持续稳定性管理 Continuous stability management of products

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产品持续稳定性管理（Product Continuous Stability Management）是确保产品在整个生命周期内（从设计、生产到市场使用）始终保持一致的质量水平和性能表现的关键管理活动。
它不仅仅是“不出问题”，更是通过系统性的监控、分析和改进，主动预防变异，实现质量的长期受控与持续提升.



Product Continuous Stability Management is a key management activity that ensures consistent quality levels and performance throughout the entire lifecycle of a product, from design, production to market use. It is not just about 'no problems', but also about actively preventing variation through systematic monitoring, analysis, and improvement, achieving long-term controlled and continuous improvement of quality

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监控维度方法与工具
过程数据SPC控制图、OEE（设备综合效率）、一次合格率（FTY）
产品数据成品抽检不良率、客户退货率（PPM）、市场故障率
测量系统定期执行MSA（Gage R&R），确保检测数据可靠
供应商质量来料不良率、供应商绩效评分
客户反馈客诉趋势分析、NPS（净推荐值）




Monitoring Dimension Methods and Tools
Process data SPC control chart, OEE (overall equipment efficiency), first pass rate (FTY)
Product data: Finished product inspection defect rate, customer return rate (PPM), market failure rate
The measurement system regularly performs MSA (Gage R&R) to ensure reliable detection data
Supplier quality incoming material defect rate, supplier performance rating
Customer feedback and complaint trend analysis, NPS (Net Promoter Score)

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• 质量趋势会议（Monthly Quality Review）

  • 分析关键指标趋势（如PPM、客诉数、返工率）
  • 识别潜在风险点（如某工序不良率缓慢上升）
    

• 使用质量工具进行分析

  • 帕累托图（Pareto Chart）：识别“关键的少数”问题
  • 趋势图（Run Chart）：观察指标随时间变化
  • 鱼骨图/5Why：对异常波动进行根本原因分析
    
  
  

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4. 变更管理（Change Management）

任何变更都可能破坏稳定性，必须严格管控：

变更类型管控要求
工程变更（ECN）设计、材料、规格变更 → 评估影响、试产验证、客户批准
工艺变更设备、参数、方法变更 → 更新SOP、重新做PPAP/MSA
供应商变更新供应商导入 → 打样、小批量验证、质量协议
人员变更新员工上岗 → 培训+考核+上岗证管理




Monthly Quality Review
Analyze key indicator trends (such as PPM, number of customer complaints, rework rate)
Identify potential risk points (such as a slow increase in the defect rate of a certain process)
Use quality tools for analysis
Pareto Chart: Identifying 'Key Minority' Problems
Run Chart: Observing the Changes of Indicators over Time
Fishbone Diagram/Why: Root Cause Analysis of Abnormal Fluctuations
4. Change Management
Any changes may disrupt stability and must be strictly controlled:

Change type control requirements
Engineering Change (ECN): Design, Material, and Specification Changes → Impact Assessment, Trial Production Verification, Customer Approval
Process change equipment, parameters, method changes → Update SOP, redo PPAP/MSA
Supplier Change New Supplier Import → Sample Making, Small Batch Verification, Quality Agreement
Personnel Change: New Employee Onboarding → Training+Assessment+Certificate Management

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持续改进机制

• CAPA（纠正与预防措施）

  • 对异常问题实施闭环管理，防止复发。
    

• FMEA 动态更新

  • 根据实际失效数据更新DFMEA/PFMEA，优化风险控制。
    

• 精益生产与六西格玛

  
  
  • 通过DMAIC项目减少过程变异，提升稳定性。
    
• Continuous improvement mechanism
• CAPA (Corrective and Preventive Action)
• Implement closed-loop management for abnormal issues to prevent recurrence.
• FMEA dynamic update
• Update DFMEA/PFMEA based on actual failure data to optimize risk control.
• Lean Production and Six Sigma
• Reduce process variability and improve stability through the DMAIC project.
  

whping

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whping

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