Corrective and preventive action - upload.pptxVIP

Corrective and preventive action纠正与预防措施 Prepared by Julian Wu Corrective and preventive action Corrective and preventive action When 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 action 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 many How much How much Where when Corrective and preventive action 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 action 2. 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 action 2. Correction / Containment