质量管理整改Quality management rectification

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质量体系审核：

A 符合性：对质量体系文件（质量手册、程序文件）是否符合标准要求。

B 有效性：质量体系活动与文件要求是否一致，即文件要求是否有效实施。

C 适宜性：质量体系的实施结果是否适合达到质量目标的要求。

D 系统性：审核工作本身要求正规化，有程序可以遵循。

E 独立性：审核应由与被审对象无直接责任关系的人员进行

                               
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Quality system audit:

Compliance: Whether the quality system documents (quality manual, procedure documents) meet the standard requirements.

B Validity: Whether the quality system activities are consistent with the document requirements, that is, whether the document requirements are effectively implemented.

C Suitability: Whether the implementation results of the quality system are suitable for meeting the requirements of quality objectives.

Systematic: The audit work itself requires standardization and procedures to be followed.

E Independence: The audit should be conducted by personnel who have no direct responsibility relationship with the audited object

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1）原因分析

找出问题产生的原由，

可能的原因有：资源配备问题；

职责不清；

管理方法不当；

工艺技术问题；

文件规定有问题；

操作出现问题；

培训效果不佳，

2）纠正

为消除已发现的不合格所采取的措施，

3）纠正措施/预防措施

根据分析的不合格原因，确定并实施纠正措施

                               
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1) Cause analysis

Identify the root cause of the problem,



Possible reasons include: resource allocation issues;

Unclear responsibilities;

Improper management methods;

Process technology issues;

There are issues with the document regulations;

Problem with operation;

The training effect is not satisfactory,

2) Correction

The measures taken to eliminate identified nonconformities,

3) Corrective/preventive measures

Determine and implement corrective measures based on the analyzed reasons for non conformities