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Corrective and preventive action - upload
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
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