安规网

标题: 多年验厂辅导经验总结之验厂资料提纲概括 [打印本页]

作者: hdzgwlc 时间: 2009-12-12 09:59
标题: 多年验厂辅导经验总结之验厂资料提纲概括
质量体系审核文件资料清单

Documents List for QMS Audit
1.  营业执照 (Business Licenses);
2.  质量体系认证证书 (QMS certificate);
3. 组织架构图 (Organization Chart);
4.  质量手册 (Quality manual);
5.  程序文件 (Quality procedure);
6.  质量体系内审计划 (QMS internal audit plan);
7.  质量体系内审记录 (QMS internal audit records):
1）内审员资格证书 (Internal auditor qualification certificate);
2）首末次会议 (Opening meeting and close meeting records);
3）检查表 (QMS internal audit checklist);
4）不符合项报告 (QMS internal audit NC reports);
5）内审报告 (QMS internal audit report)
8.  质量体系管理评审计划 (QMS management review plan)
9.  质量体系管理评审记录 (QMS management review records):
1）管理评审会议记录 (QMS management review meeting record);
2）管理评审报告 (QMS management review report);
3）决议事项的跟进记录 (QMS management review decisions follow-up records)
10. 主要生产设备清单 (Major production machinery list);
11.设备保养计划 (Machinery maintenance schedule);
12. 设备保养记录 (Machinery maintenance records);
13. 仪器清单 (Test and measure equipment list);
14. 仪器校准计划 (Test and measure equipment calibration schedule);
15. 仪器校准记录 (Test and measure equipment calibration records):
1）外校报告 (External calibration reports);
2）内校人员资格证书 (Internal calibration personnel qualification)
3）内校规程 (Internal calibration instruction);
4）内校报告 (Internal calibration reports
16. 年度培训计划 (Annual training plan)
17.  培训记录 (Training records):
1）签到表 (Training attendee signature);
2）测试卷 (Training effectiveness verification records
18. 品管人员岗前资质认定资料（培训及测试记录）-Quality personnel certification records (including training and examination records);
19.  新产品设计开发资料 (New products design and development records):
1）产品规格书 (Product specification);
2） BOM表 (BOM);
3）安规认证证书 (Safety certificate);
4）样品检测报告 (Design samples test and inspection reports)
5）试产记录 (Pilot runs record);
6）试产评估报告 (Pilot runs review records);
7）作业指导书 (Work instruction);
8）检验标准 (Inspection standard);
9） FMEA分析资料 (FMEA analysis report);
10）产品质量控制计划（QC工程图）-Product quality control plan/chart.
20.  订单评审记录 (Order review records);
21.  新供应商资格评定报告 (New suppliers evaluation reports)
22.  现有供应商质量、交期、价格及服务定期评分表 (Suppliers performance rating score in quality, delivery, price and services);
23.  原材料采购订单 (Materials purchasing order);
24. 原材料规格承认书 (Materials specifications)
25.  进料检验作业指导书 (incoming inspection procedure/instructions);
26.  进料检验标准 (Incoming inspection standards);
27.  进料检验样板清单及定期评估记录 (Incoming inspection samples list and its periodic review records);
28.  进料检验记录 (Incoming inspection records);
29.  不合格来料处理记录（含供应商纠正预防措施报告）-Non-conforming materials handling records (including supplier corrective and preventive reports);
30. 原材料保存周期规定 (Materials storage period instruction);
31. 原材料过期重检记录 (Materials periodic re-inspection records);
32.  控制图表及超限处理记录 (Control charts and corrective and preventive records for the process/products out of control limit);
33.  CPK应用指引 (CPK usage guideline);
34.  CPK测量记录及制程能力不足时的改进记录 (The improvement actions for the incapable process);
35.  生产作业指导书 (Work instruction);
36.  制程检验作业指导书 (In-process inspection procedure/instruction);
37. 制程检验标准 (In-process inspection standards);
38. 制程检验记录 (In-process inspection records):
1）首件检验记录 (First article inspection reports);
2）巡检记录 (Production line tour inspection records);
3）抽检记录 (Sampling inspection records)
39.       制程不合格品的处理记录（含纠正预防措施报告）-In-process non-conforming products handling records (including corrective and preventive actions report);
40.  制程检验不良统计报表（周报/月报，柏拉图）-In-process inspection defects analysis report (weekly/monthly report, Plato figure
41. 停线管理规定及记录 (Production stop procedure and records);
42. 成品检验作业指导书 (Final inspection procedure/instruction);
43. 成品检验标准 (Final inspection standards);
44.  成品检验记录 (Final inspection records);
45. 不合格成品处理记录 (Non-conforming products handling records):
1）返工、返修记录 (Rework, repair records);
2）重检记录 (Re-inspection records)
3）纠正预防措施报告 (Corrective and preventive actions report
46.       成品入库单 (Finished products warehouse-in records);
47.       产品可靠性及环境测试计划及记录 (Products reliability and environmental test plan/schedule and records);
48.  数据分析程序 (Data analysis procedure);
49.  质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records
50.  客户沟通资料 (Customer communication records);
51. 客户投诉处理程序 (Customer complaints procedure);
52. 客户投诉处理记录 (Customer complaints handling reports)

作者: BT_XP 时间: 2009-12-12 10:38
提示: 作者被禁止或删除内容自动屏蔽

作者: tiger_hwa 时间: 2009-12-12 11:54
很好啊!

作者: ediqi 时间: 2009-12-12 12:41
学习一下，我们最近要某个公证行验厂。

作者: babyliss 时间: 2010-2-4 09:20
很好，春节后我司就要CCC审厂了

作者: johnmark 时间: 2010-3-5 14:53
这东西实在是太好了，谢谢这位大哥。

作者: wwnw_007 时间: 2010-3-5 15:03
是中英文对照的质量管理术语啦

作者: fjwbf 时间: 2010-3-5 15:20
这东西实在是太好了

作者: DFQYTCOM 时间: 2010-5-1 11:10
我们正要审厂，要用到啊。谢谢了。

作者: jqheart 时间: 2010-5-3 15:04

[s:8] 谢谢分享~~~

作者: violet1278 时间: 2010-5-3 15:11
很好，谢谢，好多都是通用的

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