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外审老师开的不合格项

不合格项:
审核制造现场的时候发现:;油管零件D26-115-31的定型工艺记录中显示的实际的保温时间和作业指导书的不一致。


Immediate action taken to contain situation临时措施
1)立即进行作业指导书的评审,确保现场的控制和作业指导书一致。
2)评估温度不一致造成的风险,对已以往5批零件进行重新确认,是否有类似问题发生,并确保性能试验合格。
1)review the work instruction and ensure the control method was consistent with that of work instruction
2) review the risk and trace back the previous 5 lots of part and ensure the functional test is OK


Root cause analysis. For example supply copies of a completed 5 why or similar problem solving methodology原因分析
1)根本原因是因为原来的类似零件温度控制在1350度,该批零件为新零件,作业指导书进行了更改,而员工获得的是旧的版本。
2)作业指导书审批和发放程序问题
1) root cause is new part ,the parameter has been changed , the previous 1350 temperature was changed ,and the work instruction was he old verision.

Systemic corrective action. Process/system creation and/or enhancements to prevent recurrence 纠正措施
1) 作业指导书文件发放程序重新更新,
2) 更新控制计划,
3) 更新PFMEA。
1) the new procedure of document distribution should be updated.
2) Update the control plan
3) Update the PFMEA.


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shiny888 (威望:96) (上海 闵行区) 电子制造 VP of Quality

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Horizontal Deployment Action:
Review all working instruction to ensure its suitable and effectiveness.

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