ISO9001-10.2

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10.2不合格和纠正措施

10.2.1当出现不合格时，包括来自投诉的不合格，组织应：

a）对不合格做出应对，并在适用时：

1）采取措施以控制和纠正不合格；

2）处置后果。

b）通过下列活动，评价是否需要采取措施，以消除产生不合格的原因，以避免其再次发生或在其他场合发生：

1）评审和分析不合格；

2）确定不合格的原因；

3）确定是否存在可能发生类似的不合格。

c）实施所需的措施；

d）评审所采取纠正措施的有效性；

e）需要时，更新在策划期间确定的风险和机遇；

f）需要时，变更质量管理体系。

纠正措施应与不合格所产生的影响相适应。

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10.2 Non conformities and corrective measures



When non conformities occur, including those from complaints, the organization should:



a) Respond to non conformities and, where applicable:



1) Take measures to control and correct non conformities;



2) Consequences of disposal.



b) Evaluate whether measures need to be taken to eliminate the causes of non conformities and avoid their recurrence or occurrence in other situations through the following activities:



1) Review and analyze non conformities;



2) Determine the cause of nonconformity;



3) Determine if there is a possibility of similar non conformities occurring.



c) Implement the necessary measures;



d) Review the effectiveness of corrective measures taken;



e) When necessary, update the risks and opportunities identified during the planning period;



f) Change the quality management system when necessary.



Corrective measures should be adapted to the impact of non conformities.

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——根本原因分析（Root Cause Analysis，RCA），一种结构化的问题处理法，用以逐步找出问题的根本原因并加以解决， 而不是仅仅关注问题的表征。所谓根本原因，就是导致我们所关注的问题发生的最基本的原因，引起问题的原因通常有很多，物理条件、人为因素、系统行为或者过程中流程因素等，通过科学分析，有可能发现不止一个根源性原因。

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——Root Cause Analysis (RCA) is a structured problem-solving method used to gradually identify and solve the root cause of a problem, rather than just focusing on the characterization of the problem.
The so-called root cause is the most fundamental cause of the problem we are concerned about.

There are usually many reasons that cause the problem, such as physical conditions, human factors, system behavior, or process factors.

Through scientific analysis, it is possible to discover more than one root cause.

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——8D问题解决法（8D ProblemSolving，又称为“Team Oriented Problem Solving”即团队导向的问题解决法），美国福特公司处理问题的一种方法,亦适用于工程能力指数低于其应有值时相关问题的解决,它提供了一套符合逻辑的解决问题的方法，适用于诸如汽车及其零部件生产领域质量问题的解决。

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——8D Problem Solving (also known as "Team Oriented Problem Solving" or "Team Oriented Problem Solving") is a method used by Ford in the United States to solve problems.
It is also suitable for solving related problems when the engineering capability index is below its expected value.

It provides a logical set of problem-solving methods, suitable for solving quality problems in fields such as automotive and its component production.

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——5问法（5Why），即对一个问题连问5个为什么（可以少于或多于5次），直到找出能够实施可执行性与效果保证的措施为止。

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——The 5 Why method refers to asking 5 consecutive Why questions (which can be less than or more than 5 times) to a question until a measure that can ensure enforceability and effectiveness is found.

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——失效模式和效果分析（FMEA），适用于针对潜在问题，即问题虽未发生，但苗头已经很明显了，快要发生了，这种问题也可以判断为不符合或潜在不符合，而要求实施以前称为“预防措施”现在可划归纠正措施的措施。FMEA也适用于设计和开发过程中的确认

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——Failure Mode and Effects Analysis (FMEA) is applicable to potential problems, where although the problem has not occurred, the symptoms are already obvious and are about to occur. This type of problem can also be judged as non compliant or potential non compliant, and requires the implementation of measures previously known as "preventive measures" that can now be classified as corrective measures.
FMEA is also applicable to confirmation during the design and development process.