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! \8 ~" y% V+ X; ~4 b  }
2 ~- ~1 U& n/ S2 `, HDocuments List for QMS Audit
1.  营业执照 (Business Licenses);
( S4 v' E' q& Q. u- r2.  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);
  W1 C2 K9 _  U1 w4 W5.  程序文件 (Quality procedure);
6.  质量体系内审计划 (QMS internal audit plan);
) {$ B8 M: z! `- k7.  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)
# Y! ^/ A8 m) b/ p& ?; q% T8.  质量体系管理评审计划 (QMS management review plan)
) ]* `' M7 o" m3 A9.  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);
2 i3 z" e( C* p/ u- y% V3 Z+ K3）决议事项的跟进记录 (QMS management review decisions follow-up records)
  {, j" v0 {; ^. P10. 主要生产设备清单 (Major production machinery list);
11.设备保养计划 (Machinery maintenance schedule);
" S: X( h0 \7 U& I) c12. 设备保养记录 (Machinery maintenance records);
* x/ F7 D3 f! o* I$ o13. 仪器清单 (Test and measure equipment list);
14. 仪器校准计划 (Test and measure equipment calibration schedule);
+ P4 B8 d8 ~& j4 C2 y, h" w. O15. 仪器校准记录 (Test and measure equipment calibration records):
; h/ O$ c3 m+ _& ?1）外校报告 (External calibration reports);
2）内校人员资格证书 (Internal calibration personnel qualification)
5 V/ Y8 G  Z! R! ?% o3）内校规程 (Internal calibration instruction);
4）内校报告 (Internal calibration reports
$ P; [$ i: E% C16. 年度培训计划 (Annual training plan)
5 l3 K9 R8 m8 Y( Z17.  培训记录 (Training records):
3 `6 @% g- U9 E) B1） 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):
$ z5 y7 n, O2 r9 I1）产品规格书 (Product specification);
+ S( q( m: f7 I6 b0 K0 d4 Z2） BOM表 (BOM);
3 M  b" W4 x( ]4 e# o3）安规认证证书 (Safety certificate);
, u" d6 z, D2 t& R  t6 h4）样品检测报告 (Design samples test and inspection reports)
5 Q) R! m2 ?; w, s5）试产记录 (Pilot runs record);
1 B) R! x' O! I: s( p3 c6） 试产评估报告 (Pilot runs review records);
7） 作业指导书 (Work instruction);
1 t' k  K) i- s! b( A8）检验标准 (Inspection standard);
9） FMEA分析资料 (FMEA analysis report);
5 ^' Q' u1 s9 L6 g6 R! v) ?10）产品质量控制计划（QC工程图）-Product quality control plan/chart.
6 d' T) q, P& f20.  订单评审记录 (Order review records);
8 p2 j" F, G! \3 u/ M2 b21.  新供应商资格评定报告 (New suppliers evaluation reports)
, e- b- y6 ~& Q) Z$ k; u: b22.  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);
- v: H# K* Y- |& h$ u23.  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);
! M# C' V. Q& p! M* w27.  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);
4 y/ i+ b0 y! d( W29.  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);
- f+ H2 n" h+ c- G! |: L( F+ Q30. 原材料保存周期规定 (Materials storage period instruction);
% F8 n+ \% v9 _8 E; I1 G/ |9 [/ m31. 原材料过期重检记录 (Materials periodic re-inspection records);
$ O* h' g8 k0 ?) O2 ^( f9 |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);
! t# c1 q  ^/ L33.  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);
( X8 a- k; x" c* F5 w35.  生产作业指导书 (Work instruction);
! I3 H: i1 p+ M9 T& |36.  制程检验作业指导书 (In-process inspection procedure/instruction);
( L$ }; Q6 `6 S37.   制程检验标准 (In-process inspection standards);
6 Q  Z' ]$ G1 p$ W, r5 d7 `38.   制程检验记录 (In-process inspection records):
, J: Z: ]6 n0 }0 s6 i+ X/ R1）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)
, W5 v% l+ |& q4 H) D5 M7 L39.        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);
% U* Y! v+ \$ i5 r( u40.  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
' L# Y# }! D. k/ B3 n41. 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);
8 F: P/ g9 [& J/ N43. 成品检验标准 (Final inspection standards);
, G* J6 U' @6 O5 D44.  成品检验记录 (Final inspection records);
45.   不合格成品处理记录 (Non-conforming products handling records):
9 ^( m: Y- t. n( h' s- r1）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
5 Y+ {- N% p, Y9 C* a  _0 J46.        成品入库单 (Finished products warehouse-in records);
% s7 [& P1 C& q" N- c47.        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
  J* A) @/ t/ v6 ?' Q0 }50.  客户沟通资料 (Customer communication records);
% A; w5 `4 ~  e) V% a) h* w% |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)

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!