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
$ m, t  l& R* f3 |* u7 c, s* r' g9 D
/ X0 q" \- P* Q/ G; Z2 G8 c1 Q4 i# rDocuments List for QMS Audit
1.  营业执照 (Business Licenses);
2.  质量体系认证证书 (QMS certificate);
# b9 m* Y, M, s, ^* O3.   组织架构图 (Organization Chart);
4.  质量手册 (Quality manual);
/ ?8 s7 n4 ~( o; K9 Z7 b- _5.  程序文件 (Quality procedure);
6.  质量体系内审计划 (QMS internal audit plan);
3 w1 c9 ?; N/ Y8 ]3 L! V  t7.  质量体系内审记录 (QMS internal audit records):
! y4 u9 J8 ^1 b1）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)
, H& [7 U5 ^3 J4 ~9.  质量体系管理评审记录 (QMS management review records):
# s- T- S( Q# J% O, S+ v1 ~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);
# N* G: n) F- k  ?# M" X11.设备保养计划 (Machinery maintenance schedule);
12. 设备保养记录 (Machinery maintenance records);
7 A3 k" S: ]/ r7 X13. 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 l' s1 N% T# N4 R: B, ?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);
2 E: u3 {6 [% `6 P4）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);
, o: R8 C0 M, q2 g7 O9 Y( t2）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);
2 H1 q( q  Z9 P: [& A: K19.  新产品设计开发资料 (New products design and development records):
1）产品规格书 (Product specification);
3 w4 E' K7 T/ [1 H$ e. V' ?2） BOM表 (BOM);
3）安规认证证书 (Safety certificate);
6 ~% m1 O* b8 D( \4）样品检测报告 (Design samples test and inspection reports)
2 ?9 R* s+ p' t4 A! n. k5）试产记录 (Pilot runs record);
6） 试产评估报告 (Pilot runs review records);
( B: t& A$ e! l0 x: X: ]7） 作业指导书 (Work instruction);
* ?+ E2 H7 K! G: q! P6 {6 E3 k. N$ b8）检验标准 (Inspection standard);
+ C; l' R& _6 S$ ]$ S9） FMEA分析资料 (FMEA analysis report);
, G! f7 N6 X$ x. Q: Q# ]# j( ]10）产品质量控制计划（QC工程图）-Product quality control plan/chart.
$ ?0 n6 ^" n: Q  ^% m9 _) k6 Z. v20.  订单评审记录 (Order review records);
21.  新供应商资格评定报告 (New suppliers evaluation reports)
8 Q7 v4 U* v0 i, [, O6 |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);
% I% N4 @+ G* V3 n24. 原材料规格承认书 (Materials specifications)
. o5 a) a( A' a. f9 B; M- _0 s25.  进料检验作业指导书 (incoming inspection procedure/instructions);
26.  进料检验标准 (Incoming inspection standards);
  u+ h4 G  J$ F5 O6 s, 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);
8 y5 d, P- X5 j/ j& B28.  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);
' @# U6 W# ?) f31. 原材料过期重检记录 (Materials periodic re-inspection records);
! x+ c0 }8 C  o, p32.  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);
/ k) A# ~+ F# L34.  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);
7 Z1 `7 R+ H) l, Y# \+ r. P38.   制程检验记录 (In-process inspection records):
/ r7 [% d) j- _. |& P% O5 `1）首件检验记录 (First article inspection reports);
2）巡检记录 (Production line tour inspection records);
; ^/ G, e- h; N) W0 y/ r& E, d0 \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);
; Q0 @7 I0 _' W; T: z8 T40.  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
! Q+ s+ c9 x; n9 K. X41. 停线管理规定及记录 (Production stop procedure and records);
- \$ m! a( s' J* k* e1 j42. 成品检验作业指导书 (Final inspection procedure/instruction);
' P4 v' q# s. |) N( k43. 成品检验标准 (Final inspection standards);
  g6 _  w) W7 _1 f8 \9 V- l; g44.  成品检验记录 (Final inspection records);
+ f3 r$ [& J" R; e0 |8 ^$ `45.   不合格成品处理记录 (Non-conforming products handling records):
% V2 A5 N  g, d! q1）返工、返修记录 (Rework, repair records);
2）重检记录 (Re-inspection records)
- ^7 |' B8 t4 j: @! M# o3） 纠正预防措施报告 (Corrective and preventive actions report
" }; G8 F8 Q, v5 H& M- ~5 e) v46.        成品入库单 (Finished products warehouse-in records);
+ T; W- _! _* f7 Z) N1 M47.        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);
( N7 x8 }3 [, O/ W& b52.   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~~~