如何进行根本原因分析并采取纠正预防措施
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”
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”
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yangzi2001778 (威望:2) (浙江 杭州) 生物医药 经理
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下面是看的根本原因和纠正措施
Nonconformance: Nonconformance material was not identified.
不符合项：不合格品没有进行标识
Root Cause: 根本原因分析
why? Inspector rejected the material but did not fill out reject tag
为什么？检验员拒收了材料但是没有填写拒收单
why? Inspector was waiting for supervisor to approve reject status before hanging tag
为什么？检验员在等待主管批准拒收的状态而没有填写单据
why? Work instruction says supervisor will make final rejection disposition
为什么？作业指导书说主管将对拒收进行最后的判断
Corrective Action: (1) （方法）Work instruction was modified to place a reject tag on all suspect material without waiting for supervisor’s approval. The supervisor is required to sign the reject tag if he/she concurs with the reject status. If material is to be reworked, the supervisor will place a “to be re-worked” tag on the material. (2) （培训）All inspectors and supervisors have been trained on the new work instruction (3) （监控系统）Audit of area shows that the change was effective.
纠正措施：1. 修改作业指导书，无论是否等待最后判断，针对任何可疑品进行拒收的标识, 主管在拒收状态的同时签署拒收单,如果材料进行返工, 主管更换”进行返工”的标识; 2. 对所有的检验员和主管进行新的作业指导书的培训. 3. 对所有相关的区域进行审核以证明变更是有效的