警报线示例:
质量目标:产品一次合格率要求为80%,统计频率为每 月。1月至6月的的数据分别为90%、87%、85%、83% 、82%、81%,虽然总体都为合格,但已有趋势表明7 月份的一次合格率将有可能不达标,这时就要开启 CAPA.
举例 工程部程序文件中的要求没有被执行,该 未被执行的文件包含了对镀铬不同供应商的变 更的要求。要求在研究报告中要记录供应商的 名称和供应商的编号
情况C
Scenario C 情况C Correction and escalation to further investigation under the improvement phase. 纠正并上升到改进阶段,作进一步调查。
The decision is made to perform an initial correction. However, there is a need for escalation to Phase III (see 6.0) to further investigate as a result of the analysis performed in order to determine the appropriate corrective action. 所做的决定是,进行初始纠正。然而,作为已进行分析的结果,需要上升到阶段3进行进一步调查以决 定合适的纠正措施。 Nonconformity The supplier name and number was not included in the research report. 不合格 供应商的名称和编号没有包括在研究报告中。 Key Results of Analysis indicates that the procedure may not be adequate and it is not well know to the users of the research Measurement and procedure. The issue has been identified in multiple reports. Analysis 分析表明该程序是不充分的,并且不为研究程序的用户所知晓,该问题已经在多个报告中被识别。 测量和分析的关键 In some cases, traceability to the supplier could be established via other means, and in other cases it could not. 结果 有些案例,供应商的追溯性可通过其他方法来建立,但是其他的案例则不能。 Conclusion 结论 Take an initial correction to update the research report with the supplier name and number (in the cases where the supplier could be identified). Escalate to Phase III for corrective action. 采取初始的纠正,将供应商的名称和编号更新的研究报告中(对供应商和已确定的案例) 上升到阶段3采取纠正措施。