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如何进行根本原因分析并采取纠正预防措施
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ACCEPTABLE CLIENT CORRECTIVE ACTION RESPONSES MUST INCLUDE:可接受的客户纠正措施必须包括

1. The results of an investigation to determine the root cause or most basic cause(s) of the nonconformance.
基于多种可能原因上的导致问题产生的根本原因(建议用鱼刺图进行分析/考虑方法的更改/监控措施)
If the root cause is not determined, it is unlikely the corrective actions will prevent recurrence of the nonconformance. In fact, a good test to determine if you have properly identified the root cause, is to ask, “if we eliminate this cause, will the nonconformance happen again?” If the answer is no, then the root cause is properly identified. If the answer is yes or maybe, then the root cause needs to be further analyzed. It often takes asking “why did the potential root cause occur” several times to reach a root cause upon which corrective actions can be based to prevent recurrence
如果根本原因没有找到,而提出预防不符合再次发生的纠正措施是不可能的。实践中,一个好的方法去识别根本原因是问自己:如果我们消除了这个原因,不符合还会再发生吗?如果回答是:不,那么根本原因要再深入分析,我们问这样的问题“为什么潜在的根本原因还会发生呢”多几次的话,我们可能会找到根本原因所在(也就是我们常说的“五步法”“FIVE WHY”)

Below are some root causes that are usually inadequate and should be rarely used :下面是部分通常被认为不足够的根本原因分析:
• “Operator error” or “Oversight on the part of the operator”,
• “操作工失误”或“对操作工监督不够”
• “Poor training” or “Training not effective ”,
• “缺乏培训”或“培训不够”
• “Didn’t understand the requirement” or “Not aware of the requirement”
• “不理解要求”或“不知道要求”
• “Isolated occurrence”
• “孤立事件”
9 回答 9570 浏览 2009-03-22
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Use of these root causes may result in customers asking for further clarification or investigation because they are not specific and lend themselves to narrow corrective actions that may not prevent recurrence of the nonconformance. When these are encountered, “why” should be asked at least once more to determine an underlying or more basic cause. For example, if asked why an operator error occurred, it may be determined to have been caused by the operator inadvertently selecting the wrong switch that looked similar and was close to the correct switch. This root cause would lend itself to mistake proofing that would separate or distinguish the switches to prevent recurrence.
用以上的根本原因将不可能完全避免不符合的再次发生。例如,如果问为什么操作工失误呢,可能的原因是错误的开关看起来很象正确的按钮,而操作工在选择时出错了,那根本原因应该是采用防错的方法去消除按错键的事件发生
Root causes must also be sought over which management has control. A root cause of “severe weather” does not support preventing recurrence of the nonconformance where-as root causes of inadequate contingency planning or leaking trucks do support preventing recurrence of the nonconformance.
根本原因必须是被管理层控制的,根本原因如“气候影响”不是防止问题再发生的根本原因,而根本原因应该是应急措施不够
2. Corrective actions including both: 纠正措施包括
• Corrective actions taken to determine the extent of, contain and correct (i.e fix) the specific nonconformance
• 采取纠正以消除特定的不符合
• Corrective actions taken in response to the root cause(s) to eliminate recurrence of the nonconformance. These corrective actions focus on changing a process to eliminate the root cause and thus eliminate recurrence of the
2009-03-22 17:29
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