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
) Z' S& i9 ^+ s
Documents List for QMS Audit
' G8 ?8 M# s% E; j' j! c1.  营业执照 (Business Licenses);
2.  质量体系认证证书 (QMS certificate);
# `  f$ I, U$ J/ n5 ?# x3.   组织架构图 (Organization Chart);
4.  质量手册 (Quality manual);
+ I3 c" W3 Z! |" a/ p2 q: c5.  程序文件 (Quality procedure);
6.  质量体系内审计划 (QMS internal audit plan);
! {3 ]8 A8 B/ e( U" B5 _( j7.  质量体系内审记录 (QMS internal audit records):
1）内审员资格证书 (Internal auditor qualification certificate);
- ^9 q. k+ t4 w8 i. A  I2）首末次会议 (Opening meeting and close meeting records);
' l0 s1 W" D5 i5 Y- i3）检查表 (QMS internal audit checklist);
, ?" a) U5 v3 a7 o4）不符合项报告 (QMS internal audit NC reports);
5）内审报告 (QMS internal audit report)
, r! `: l+ v" w# z3 l, @/ t. U' v8.  质量体系管理评审计划 (QMS management review plan)
1 d$ T$ i# U# u6 F) O* Y: [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);
' x7 R' [( w# m1 g9 T9 Q2）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)
7 r8 d& R) L3 w! P1 ^10. 主要生产设备清单 (Major production machinery list);
9 {6 {/ \% F) S11.设备保养计划 (Machinery maintenance schedule);
1 w' T6 o1 I8 E; B: Y2 O12. 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);
8 g. J) @' L# Z* @, B  b15. 仪器校准记录 (Test and measure equipment calibration records):
; g, @2 c& S' k! `9 F/ s- @1）外校报告 (External calibration reports);
2）内校人员资格证书 (Internal calibration personnel qualification)
) F8 _; v( F7 b$ r7 r$ g3）内校规程 (Internal calibration instruction);
4）内校报告 (Internal calibration reports
5 T' w/ m8 g# p6 \* Y- M1 L. ?, y9 `( i16. 年度培训计划 (Annual training plan)
17.  培训记录 (Training records):
& [* v$ \7 X. @& r1） 签到表 (Training attendee signature);
2）测试卷 (Training effectiveness verification records
% A, f2 X+ T, D' O9 s! N/ O/ a$ F18.   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);
1 s/ H! P, E! u: ~7 X, L19.  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);
; `4 g7 j# d) ^5 {% \6 Z3）安规认证证书 (Safety certificate);
8 ~& |- [* m1 F( @( |. j4）样品检测报告 (Design samples test and inspection reports)
1 R5 z& h$ [( S! k* }& o5）试产记录 (Pilot runs record);
6） 试产评估报告 (Pilot runs review records);
- C5 M9 t& O! M; s7） 作业指导书 (Work instruction);
8）检验标准 (Inspection standard);
9） FMEA分析资料 (FMEA analysis report);
3 c5 e" Z7 [! F) J10）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);
" s/ i6 S1 ^' n' B% s6 ]/ x( U21.  新供应商资格评定报告 (New suppliers evaluation reports)
8 W' h3 A" a. U! J22.  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);
* B/ T) j# z$ O$ @7 X23.  原材料采购订单 (Materials purchasing order);
, y9 r4 T. k/ L) S  n24. 原材料规格承认书 (Materials specifications)
25.  进料检验作业指导书 (incoming inspection procedure/instructions);
& M- p. s! Y  Z/ x9 w' |! }. C26.  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);
3 F0 K% j9 H; O8 M30. 原材料保存周期规定 (Materials storage period instruction);
0 \8 _3 ~; e; j31. 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);
! i- I3 r3 [: {33.  CPK应用指引 (CPK usage guideline);
% ]1 K) A- M0 `& V4 S34.  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);
; M, @; g0 W4 ?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)
2 ^' I* L+ h5 c+ ~- `, h6 i# I- X39.        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
" j" r/ ~; G, |, S* o$ g& T2 ?41. 停线管理规定及记录 (Production stop procedure and records);
4 X# J( f: M) @8 E9 l( X% G42. 成品检验作业指导书 (Final inspection procedure/instruction);
43. 成品检验标准 (Final inspection standards);
0 |: w( |( `8 ]7 u44.  成品检验记录 (Final inspection records);
$ T: o; y3 g5 M6 ^+ o45.   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)
) n' M% H( a( ^* j7 `3） 纠正预防措施报告 (Corrective and preventive actions report
* P6 D* ?& \( a+ {4 G4 w46.        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);
7 j$ _7 G3 P7 P! Y, e7 z8 a: v+ M48.  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
3 V( o0 V) w+ g. e# \! o) b50.  客户沟通资料 (Customer communication records);
51.   客户投诉处理程序 (Customer complaints procedure);
' @( e. e2 {5 F, Y9 z* x5 {52.   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~~~