现场审核怎么做

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1、文件控制

A、内部文件的审批、分发、更改：

1）工程图纸未经审批即已发行、使用；

2）作业指导书未能分发至具体作业岗位；

3）生产现场岗位悬挂的作业指导书未受控；

4）工艺文件存在直接在文件上更改的现象，未执行文件更改程序。

B、外来文件的识别、收集、分发：1）未能充分识别、收集到与产品有关的国家/国际、行业标准；

2）未能将外来文件分发至有关部门，如品管部、生产部

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1. Document control



A. Approval, distribution, and modification of internal documents:



1) The engineering drawings have been issued and used without approval;



2) The homework instructions were not distributed to specific job positions;



3) The work instructions hanging on the production site are not controlled;



4) The process file has the phenomenon of being directly modified on the file, and the file modification program has not been executed.





B. Identification, collection, and distribution of external documents: 1) Failure to fully identify and collect national/international, and industry standards related to the product;



2) Failure to distribute external documents to relevant departments such as Quality Control and Production

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2、质量记录的填写、管理、保存

1）质量记录存在涂改的现象；

2）质量记录未规定保存期限；

3）未按保存期限予以保存，到期销毁未能提供销毁记录

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2. Filling, management, and preservation of quality records



1) There is a phenomenon of alteration in quality records;



2) There is no specified retention period for quality records;



3) Failure to preserve according to the retention period, failure to provide destruction records upon expiration

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3、质量目标的统计、分析

1）质量目标的统计未能提供原始数据，无法掌握最终目标统计数值的真实性；

2）质量目标有统计，但未进行分析

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3. Statistics and analysis of quality objectives



1) The statistics of quality objectives failed to provide raw data, making it impossible to grasp the authenticity of the final target statistical values;



2) Quality objectives are statistically analyzed but not analyzed

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4、管理评审

1）管理评审输入信息不全，或未能提供输入资料；

2）管理评审主持人非最高管理者，且未能提供最高管理者对主持人（不是最高管理者自己时）的授权证明；

3）对管理评审决议事项无采取措施的相关证据，如纠正措施或预防措施；

4）对上次管理评审决议事项的跟踪结果无记录

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4. Management Review



1) Incomplete input information or failure to provide input materials for management review;



2) The management review host is not the top management and fails to provide proof of authorization from the top management to the host (when not the top management themselves);



3) There is no evidence of measures taken regarding management review resolutions, such as corrective or preventive measures;



4) There are no records of the tracking results of the last management review resolution matters

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三、内审方面：

15. 年度内审计划；

16. 内审计划及日程安排；

17. 内审小组长的任命书；

18. 内审成员资格证书复印件；

19. 首次会议记录；

20. 内审检查表（记录）；

21. 末次会议记录；

22. 内审报告；

23. 不符合报告及纠正措施验证记录；

24. 数据分析的有关记录

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3、 In terms of internal audit:



15. Annual internal audit plan;



16. Internal audit plan and schedule;



17. Appointment letter of the internal audit team leader;



18. Copy of qualification certificate for internal audit members;



19. Minutes of the first meeting;



20. Internal audit checklist (record);



21. Minutes of the last meeting;



22. Internal audit report;



23. Non conformance reports and verification records of corrective measures;



24. Records related to data analysis