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
* p- [9 I" ~+ P# w1 N$ q
; k/ P; S2 a% `$ _; P/ z- PDocuments List for QMS Audit
% O! J( [0 ^, U) X1.  营业执照 (Business Licenses);
# ~. o1 u' ?( F2 t2.  质量体系认证证书 (QMS certificate);
% V% L4 X3 t' Q8 p* r3.   组织架构图 (Organization Chart);
% }9 z+ p9 @3 |% y) m& ^- S! q$ v$ g7 M4.  质量手册 (Quality manual);
6 A( }6 h( z. B' w5.  程序文件 (Quality procedure);
6.  质量体系内审计划 (QMS internal audit plan);
- Z* e% L) R( g9 |. V, T2 b7.  质量体系内审记录 (QMS internal audit records):
. {( e" C- g. ~6 Y% ?  W6 ^1）内审员资格证书 (Internal auditor qualification certificate);
2）首末次会议 (Opening meeting and close meeting records);
% K7 F, S5 J# p3）检查表 (QMS internal audit checklist);
4）不符合项报告 (QMS internal audit NC reports);
4 u. @! y9 ~$ I) ?$ b( J5）内审报告 (QMS internal audit report)
8.  质量体系管理评审计划 (QMS management review plan)
! b2 T( h- L9 l8 _' E3 k3 n9 p( g' |9.  质量体系管理评审记录 (QMS management review records):
0 |  ]& ]# E0 U" {7 t. s1）管理评审会议记录 (QMS management review meeting record);
2）管理评审报告 (QMS management review report);
9 g8 _4 W  e1 C- A* U3）决议事项的跟进记录 (QMS management review decisions follow-up records)
2 j, t  r6 j- E2 ?0 v1 x10. 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);
8 w- w" D( A% `& R  \# K4 O6 e14. 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):
0 H# p/ l& y2 Z& @9 P5 \" a1）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)
2 d2 y" J/ S; M" Q* p1 D  O17.  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);
% J, C* ^  r* ?* I, Q4）样品检测报告 (Design samples test and inspection reports)
5）试产记录 (Pilot runs record);
; V6 U. p. R9 C6） 试产评估报告 (Pilot runs review records);
* d" y' h0 k4 I. P* Y7） 作业指导书 (Work instruction);
* t1 ~& K2 h7 d( \3 B( ~) `8）检验标准 (Inspection standard);
- P0 g. e& a* p  Q9） FMEA分析资料 (FMEA analysis report);
& u6 W! s4 V4 r; g3 R6 x) A7 p+ I* w10）产品质量控制计划（QC工程图）-Product quality control plan/chart.
& B6 h3 b6 w+ p; Y1 C9 o: {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)
( h# _" C) N  ?! r22.  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);
  d9 o6 b( G  d8 b* Q4 ~3 S0 z. k* ~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);
- a4 E3 _) P9 ^: q26.  进料检验标准 (Incoming inspection standards);
- p$ {4 c! i5 n8 Z27.  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);
$ d1 w& h' H% c- K% v+ a29.  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);
) y4 Y+ i* g: Q7 @30. 原材料保存周期规定 (Materials storage period instruction);
1 I1 K4 {0 l8 g5 D4 |( L31. 原材料过期重检记录 (Materials periodic re-inspection records);
4 E3 |" E* R& {  @( U* k32.  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);
4 ?2 ?6 @' Y% Q) _- F35.  生产作业指导书 (Work instruction);
36.  制程检验作业指导书 (In-process inspection procedure/instruction);
. {$ X" n0 _5 A/ l: b37.   制程检验标准 (In-process inspection standards);
# f7 z- o& Z( v8 }+ p8 H38.   制程检验记录 (In-process inspection records):
1）首件检验记录 (First article inspection reports);
1 k/ {# E8 C, d2）巡检记录 (Production line tour inspection records);
& E8 M6 A' U( e2 q& `3）抽检记录 (Sampling inspection records)
: p# @& P% ]0 ?# n, T39.        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);
! `! f. }7 G$ _/ ]. E43. 成品检验标准 (Final inspection standards);
44.  成品检验记录 (Final inspection records);
; ?6 F: O, P; O45.   不合格成品处理记录 (Non-conforming products handling records):
: `( o! Q2 q0 Q! X( V" W1）返工、返修记录 (Rework, repair records);
1 f+ N; q5 J: G) V/ Z# ?8 l4 c; n7 v. c2）重检记录 (Re-inspection records)
7 k! m6 j9 z7 s! h; r3 i( F3） 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);
6 H7 R; ?& Q) a52.   客户投诉处理记录 (Customer complaints handling reports)

tiger_hwa

很好啊!

ediqi

学习一下，我们最近要某个公证行验厂。

babyliss

很好，春节后我司就要CCC审厂了

johnmark

这东西实在是太好了，谢谢这位大哥。

wwnw_007

是中英文对照的质量管理术语啦

fjwbf

这东西实在是太好了

DFQYTCOM

我们正要审厂，要用到啊。谢谢了。

jqheart

  [s:8] 谢谢分享~~~