多年验厂辅导经验总结之验厂资料提纲概括

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质量体系审核文件资料清单
( D! P, T" o! t: t; [6 T6 W
Documents List for QMS Audit
9 \% U; D/ G! P( i: B1.  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);
4 j! t- b. P5 U4 O5 z6.  质量体系内审计划 (QMS internal audit plan);
& B( x/ f* t' f( t7.  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 \5 P% }9 h- e/ o2）管理评审报告 (QMS management review report);
' [* s* Y- r% j% S3）决议事项的跟进记录 (QMS management review decisions follow-up records)
! |( w+ Y+ s4 \8 Z7 y10. 主要生产设备清单 (Major production machinery list);
; ?/ @+ l6 `0 Q3 g4 b% p$ c, m11.设备保养计划 (Machinery maintenance schedule);
12. 设备保养记录 (Machinery maintenance records);
, b: l) z# S- z* K# M5 b13. 仪器清单 (Test and measure equipment list);
7 k# h) z6 [$ M6 A" M$ f3 T+ B14. 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);
6 X" A5 o- U7 n; b# i2）内校人员资格证书 (Internal calibration personnel qualification)
( g5 ^" c( p. K$ l5 E" j: i, v3）内校规程 (Internal calibration instruction);
4 G5 }. p: e, m; S4）内校报告 (Internal calibration reports
16. 年度培训计划 (Annual training plan)
8 B: l/ D. a+ A' q7 L  @17.  培训记录 (Training records):
1） 签到表 (Training attendee signature);
8 ]5 b$ T  z0 W' |& s5 E* `! F! u2）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):
. X  y# M2 i/ P' l1）产品规格书 (Product specification);
( |) d( l' n: c, l9 Q2） 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);
4 A8 S3 t% i9 m8 e7 ~% x+ H9） 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)
# J2 P. H2 |0 z$ R2 P25.  进料检验作业指导书 (incoming inspection procedure/instructions);
26.  进料检验标准 (Incoming inspection standards);
+ S3 i3 ?6 h; O' t9 d27.  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);
/ h4 K2 \) n1 z6 j% n31. 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);
7 t" |! `; }& J33.  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);
# [; |+ w! Y8 l36.  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);
5 w( w% \3 S0 U- k6 h+ `0 c( [- u38.   制程检验记录 (In-process inspection records):
& [: t5 x) Q2 J' E2 `" N3 M0 z2 g1）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);
, o7 u8 A0 N; A& |$ I/ L1 M40.  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);
" u6 P6 b4 L, Q9 S- L7 Q) J44.  成品检验记录 (Final inspection records);
2 N5 Q8 t1 G0 n; O+ G! _6 n7 r+ D45.   不合格成品处理记录 (Non-conforming products handling records):
1）返工、返修记录 (Rework, repair records);
9 ?% e) O- ~; ]8 \' C! r2）重检记录 (Re-inspection records)
8 ?7 t+ c! y2 J/ L3） 纠正预防措施报告 (Corrective and preventive actions report
$ D9 h* F9 z% P0 ?. y9 q& \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);
$ z1 m5 y" |1 Z# b2 N7 t48.  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
8 S, G% t" Q( L+ Z, W* b( \2 G50.  客户沟通资料 (Customer communication records);
51.   客户投诉处理程序 (Customer complaints procedure);
% i8 d, R0 q% J1 K* c. N0 A52.   客户投诉处理记录 (Customer complaints handling reports)

violet1278

很好，谢谢，好多都是通用的

jqheart

  [s:8] 谢谢分享~~~

DFQYTCOM

我们正要审厂，要用到啊。谢谢了。

fjwbf

这东西实在是太好了

wwnw_007

是中英文对照的质量管理术语啦

johnmark

这东西实在是太好了，谢谢这位大哥。

babyliss

很好，春节后我司就要CCC审厂了

ediqi

学习一下，我们最近要某个公证行验厂。

tiger_hwa

很好啊!