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
% `1 _' b2 m# f: Q
8 r/ N8 M' r) M6 TDocuments List for QMS Audit
! s" X# w, O" O+ E# R9 w1.  营业执照 (Business Licenses);
2.  质量体系认证证书 (QMS certificate);
( e. j8 p% A* g0 E) t" M! }/ x3.   组织架构图 (Organization Chart);
" y2 X/ i! L/ p/ \4 N4.  质量手册 (Quality manual);
5 @2 @5 ]# x$ G5.  程序文件 (Quality procedure);
% c6 R' {7 A) D9 ^+ g# S8 n$ M. W6.  质量体系内审计划 (QMS internal audit plan);
7.  质量体系内审记录 (QMS internal audit records):
1）内审员资格证书 (Internal auditor qualification certificate);
, f! \% T2 G( A1 K  Q2 j2）首末次会议 (Opening meeting and close meeting records);
3）检查表 (QMS internal audit checklist);
0 q6 x. x( }( h4）不符合项报告 (QMS internal audit NC reports);
) k3 S" d0 i, p! i' a; W5）内审报告 (QMS internal audit report)
8.  质量体系管理评审计划 (QMS management review plan)
% l, B+ \; u* ]  t/ ?9.  质量体系管理评审记录 (QMS management review records):
9 H* G& {% W/ m% S( V2 o! S1）管理评审会议记录 (QMS management review meeting record);
! C# p" B# n8 a$ g' D$ K2）管理评审报告 (QMS management review report);
8 c- d( O& ]/ O( `) z5 e3）决议事项的跟进记录 (QMS management review decisions follow-up records)
. V; w9 D( x" J! q0 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);
0 a3 Q+ [* `  ~% G+ j4 a) C14. 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):
- S. P3 J& {8 ?) Z% _) k9 R1）外校报告 (External calibration reports);
2 M  u$ U$ F+ d2）内校人员资格证书 (Internal calibration personnel qualification)
  t* U& H4 z/ b3）内校规程 (Internal calibration instruction);
4）内校报告 (Internal calibration reports
9 \+ j, M1 s0 }% S% N0 w16. 年度培训计划 (Annual training plan)
17.  培训记录 (Training records):
$ Z: a& w' e0 P/ @2 c5 R1） 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);
* m0 i. e: L& u  v- p( [  I3 G8 b$ \2） BOM表 (BOM);
3）安规认证证书 (Safety certificate);
' E6 b. u8 e! q$ W) S/ ?9 r3 E4）样品检测报告 (Design samples test and inspection reports)
3 N8 m/ M& N7 I8 ~  N; A6 t5）试产记录 (Pilot runs record);
. Y! z2 G8 n7 d" u/ o4 m6） 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);
  c) f$ u7 M( R9 i, L# c3 S( C; l9） FMEA分析资料 (FMEA analysis report);
7 o3 s; W( U$ c" I8 h, C10）产品质量控制计划（QC工程图）-Product quality control plan/chart.
3 N) d& d1 `/ o8 L20.  订单评审记录 (Order review records);
& P8 C2 s. k( m# _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);
8 q5 t! h/ Y# g5 @' R24. 原材料规格承认书 (Materials specifications)
, c5 E- o9 I* c! g. ?9 }5 L/ C25.  进料检验作业指导书 (incoming inspection procedure/instructions);
0 D8 f% }6 Q* y. i# U( @9 s/ x26.  进料检验标准 (Incoming inspection standards);
% f  s  i6 a( K- U  p6 @, a27.  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);
* B+ D# A3 k$ z* E& r30. 原材料保存周期规定 (Materials storage period instruction);
31. 原材料过期重检记录 (Materials periodic re-inspection records);
2 T: [! M" X/ G. t% B& H1 S6 M5 ?3 g32.  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);
1 c: }' E/ S4 L( o3 C' B# r33.  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);
) I  q2 A" M( M- ^2 j35.  生产作业指导书 (Work instruction);
36.  制程检验作业指导书 (In-process inspection procedure/instruction);
$ N+ m" L5 l" s& s. F0 O37.   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);
4 h5 M/ ~0 `( w0 B6 T: D, O' [" ?" p2）巡检记录 (Production line tour inspection records);
3）抽检记录 (Sampling inspection records)
- y4 B+ u9 T/ K. t5 {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);
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);
7 Z& j9 t7 Z9 i( V42. 成品检验作业指导书 (Final inspection procedure/instruction);
43. 成品检验标准 (Final inspection standards);
44.  成品检验记录 (Final inspection records);
/ V1 w2 |% ?& ^9 C% b45.   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)
3） 纠正预防措施报告 (Corrective and preventive actions report
3 M1 j$ E9 o4 r/ p46.        成品入库单 (Finished products warehouse-in records);
: ?) U- @& M6 l- R47.        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
- V- J# i: H; C  `% D50.  客户沟通资料 (Customer communication records);
51.   客户投诉处理程序 (Customer complaints procedure);
' _% \7 y% F/ w52.   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~~~