Corrective and preventive action 纠正与预防措施Prepared by Julian WuCorrective and preventive action1Problem Statement 不符合项项的描述2Correction/Containment 更正/遏制措施3Root Cause Analysis 根本原因分析4Corrective action 纠纠正措施5Preventive action 预预防措施6Implement and Verification 实实施和验证验证Corrective and preventive actionWhen should you use CAPA You do not know the cause of the problem 不清楚问题的原因 For repeat problems 重复发生的问题 For very serious problems 非常严重的问题 When it is a hard to define the problem 难以定义的问题 When you have disagreements about the problem or potential solutions 对问题和潜在解决方案存在不同意见 Customer complaint 客户投诉 Internal audits findings 内部审核发现 Significant product nonconformance 重要的产品不合格或过程 As a results of deviation requests 偏差引起的结果 Other nonconformance warranting corrective action 其他需要纠正措施的不符合Corrective and preventive action1. Problem statement 问题描述 -Completely describe the problem. 完整地描述问题 Create a well formed problem description. 建立一个良好的问题描述的模式 Make sure it: Describes the problem in terms of : Who What Where When Why How much How manyHow much How muchWherewhenWhatwhoWhyCorrective and preventive action1.Problem statement Questions to ask before moving on to the next step in the process Has the problem been described using who, what , when , why, how much and how many?是否有使用“何时何地何人，为什么，发生多少”去 描述一个问题 Have failed parts or other samples of the problem been reviewed and analyzed to confirm the problem description?是否有发生问题的样板来确认问题的描述？ Has a complete operational definition of the problem been developed and agreed upon by the team?是否对问题有完整的定义并得到团队的认可？Corrective and preventive action2. Correction / Containment Action 更正/遏止措施. Take actions to protect the customer from further impacts采取措施保护客户以避免进一步的影响 Consider all affected inventories at the customer，考虑到在客户处受影响的库存 Re-inspection , rework, and recalls may be necessary必要时， 重新检查、返工、召回 Put short-term corrective actions in place until root cause is determined在根本原因确定前，制定短期的纠正措施 Additional monitoring of the process增加过程的监视 Increased inspection增加检查 100% sorting 100% 翻拣 Collect data and verify effectiveness of containment actions收集数据和验证遏制措施的有效性Corrective and preventive action2. Correction / Containment Action 更正/遏止措施. Questions to ask before moving on to the next step in the process:在进入一个步骤前，提出如下几个问题 Have all alternative containment actions been evaluated?是否评估有可替换的遏制措施？ Will the interim containment actions chosen truly protect the customer是否有临时遏制措施以保护客户 Will the interim containment actions stop the problem at each potential escape point in the process?临时遏制措施是否可以阻止问题仍有可能在整个过程中发生 Are action plans defined, including responsibilities and target completion dates?是否明确行动计划， 包括责任人以及预计完成日期 Can containment actions be maintained until permanent corrective actions are in place?遏制措施是否一直保持有效直至永久纠正措施的产生 Will containment actions create other problems in the process遏制措施是否会产生其他的问题 Can the effectiveness of containment action be measures?是否评价遏制措施的有效性Corrective and preventive action3. Root cause analysis Determine the root causes Typically most time consuming and difficult step of the process Identify possible causes识别可能的原因 Consider looking for the root causes explain why the problem escape寻找发生问题的根本原因 More importantly, look for the root cause explaining why the problem occurred更重要的是，寻找根本原因以解释为什么会出现这个问题 Data analysis starts with the indicator of the problem form D2 and D3 steps 从D2 和D3 显示的文件进行数据分析 Start by asking”what changed”开始问“发生了什么变化”Corrective and preventive action3. Root cause analysis Determine the root causes Use appropriate analyses tools:使用合适的分析工具 A flow diagram of the process过程流程图 A cause and effect diagram(fishbone diagram)因果图（鱼骨图） Control charts of the process过程的控制图 Collecting physical evidences(samples)收集实物证据（样板） Using the “5why” 运用5个为什么 The “ is and is not” tools运用“是和不是”工具 Performing screening experiments运用筛选法Corrective and preventive action3. Root cause analysis Questions to ask before moving on to the next step in the process: Have all sources of variation been identified 是否识别到发生偏差的所有源头 Have all sources of information been used to identify possible causes for the problem?是否有利用所有信息资源来识别问题发生的可能的原因 Do you have physical evidence of the problem?是否问题的实物证据 Can a relationship be established between the process and the problem?过程与问题之间是否建立联系 Have you continually challenged root caused with the question “why” followed by “Because” to see if the potential cause ties to the problem description and data是否利用因果法持续挑战根本原因，看是否有更深入的原因。 Does the root cause chosen fit the IS versus IS NOT model?根本原因是否有选择适用“是与不是”模型Corrective and preventive action4. corrective action Based on root cause, consider alternative corrective actions基于根本原因， 考虑可替代的纠正措施 Identify and implement measures of the effectiveness the chosen corrective actions识别和实施所采取的纠正措施的有效性的方法 Take measures before and after implementation of corrective actions采取措施以评价纠正措施实施前后的比较 Consider pilot testing the corrective action before full implementation 在纠正措施完全实施前， 可考虑初步试验性的验证纠正措施Corrective and pre