解决质量问题标准化反应模式.pptVIP

防错装置确认ERROR PROOFING VERIFICATION 放错装置的主控文件应有识别号和位置Master Document of Error Proofing devices, with identification number and location 确认频率Verification frequency 确定标准样件（好的/坏的）已保证不合格品被检测出来Identify masters (Good/Bad) and defect being checked 明确定义反应计划如果防错装置失效Clearly defined reaction plan if device fails to detect 当防错装置不能检测出残次，什么时候停机？品When/if shut down when device fails to detect bad part? 遏制计划？Containment plan? (100% 检验Inspection, etc.) 通过防错装置的可疑品是否被返回？Are suspect parts rerun thru Error Proofing device? 怎样/什么时候防错装置被维修？“ How/when is Error Proofing device repaired? 在防错装置确认之间要生产的产品的批量大小 Lot size of parts run between Error Proofing verification 用程序的历史记录决定验证的频率 History of process to determine verification frequency 程序是否稳定 How robust is the process? 遏制可疑品的容易程度How easy is it to contain suspect product? Develop Log of Error Proof Verification failures with reaction plan to non-conformities Document as Lessons Learned Method for getting information to management Determine how information is to be displayed * * * * * * * (Example) 分层审核 领导层执行了分层审核了吗 分层审核提供了一套系统来：Layered Audits provide a system to: - 检验与备有证明文件的操作一致 - 灌输纪律instill discipline - 促进沟通improve communication - 改善总体质量improve overall quality 分层审核由制造者领导层掌握.质量和其他职能部门参与并支持分层审核系统Layered Audits must be owned by manufacturing leadership. Quality and other functions will participate and support the Layered Audit system. 制造和装配高风险的项目应该每班最少一次分层审核Layered Audits shall be conducted for manufacturing and assembly of high risk items at a minimum of once per shift. 分层审核的频率由生产量或者操作相关的风险水平决定Frequency of Layered Audits is based on production volume or level of risk associated with process. 分层审核补充了现行的控制计划和工作指导检查 分层审核 应建立分层审核时要检验的高风险项目核对表A check list of high risk items to be verified during Layered Audits shall be established. 在建立核对表时要考虑的因素Elements should be considered in developing the check list. 评论由内部审核产生（加工，安全，总务，常规管理等），包括在分层清单上可重复的不一致Re