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
* @% U2 ^/ Y+ @
Documents List for QMS Audit
; y. G/ f% a( K) d4 f+ C! g1 ?$ X1 g" `1.  营业执照 (Business Licenses);
" k# Z, w: }7 k1 O2.  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);
/ f" T4 Q# K1 M: K5.  程序文件 (Quality procedure);
6.  质量体系内审计划 (QMS internal audit plan);
2 Y  W+ U* x% d7.  质量体系内审记录 (QMS internal audit records):
1）内审员资格证书 (Internal auditor qualification certificate);
, [% ~: {" b# C+ t, ^2）首末次会议 (Opening meeting and close meeting records);
6 O  w1 \' H+ Y# m& m/ H3）检查表 (QMS internal audit checklist);
, m  E; f: p' w: J% k4 p* g- O4）不符合项报告 (QMS internal audit NC reports);
: a6 l' S& o; _, {, W5）内审报告 (QMS internal audit report)
# ^$ Z$ z% h4 y5 S0 C* C8 x& {8.  质量体系管理评审计划 (QMS management review plan)
& {3 W& V' q5 J5 ?5 y. k4 v: |9.  质量体系管理评审记录 (QMS management review records):
: _* O6 Y9 b' A2 z" G1）管理评审会议记录 (QMS management review meeting record);
; X  m! T& m( K5 r2）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);
11.设备保养计划 (Machinery maintenance schedule);
4 b) I7 H# }! v# O$ Z+ s12. 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);
& M  F. `. l% N15. 仪器校准记录 (Test and measure equipment calibration records):
1）外校报告 (External calibration reports);
2）内校人员资格证书 (Internal calibration personnel qualification)
' x1 z' G  a+ Y1 q. q3）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)
17.  培训记录 (Training records):
1） 签到表 (Training attendee signature);
+ c# M0 S7 V( Q) [# m0 V2）测试卷 (Training effectiveness verification records
( V7 s6 N1 {2 \9 X  a18.   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);
/ P/ o" l* R! x2 B. w8 O8 x- o19.  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);
/ \- K# X/ g% I9 {1 Y  Y5 u/ R4）样品检测报告 (Design samples test and inspection reports)
5）试产记录 (Pilot runs record);
6） 试产评估报告 (Pilot runs review records);
" }! o+ {/ r. O" D/ V" _; d7） 作业指导书 (Work instruction);
$ S0 L1 f0 c! ^6 P2 N- n8）检验标准 (Inspection standard);
& h0 H$ e) V1 g, |/ r9） FMEA分析资料 (FMEA analysis report);
: n1 R. x6 Z& ]* J3 m! h10）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);
6 I: L5 `3 N' B/ `! Y! l21.  新供应商资格评定报告 (New suppliers evaluation reports)
+ W! r. ?! \: N( q) M: D22.  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);
' W9 j/ ]' ~3 L( D9 a, c0 ?' ?23.  原材料采购订单 (Materials purchasing order);
+ l0 p9 ^: H* N9 b3 ~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);
' I1 |$ f* K" l/ K# F27.  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);
; H$ Z0 E& z' C4 H* H: K30. 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);
: e( n* M2 G6 A) i* e2 O2 j/ D32.  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);
' ]. _+ Q$ \  Y# i9 @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);
/ s+ r  M9 `- E/ V35.  生产作业指导书 (Work instruction);
( \" G5 V/ d$ z" Y! w36.  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);
" q2 q) b/ q; s, B( r38.   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)
% z( h# h1 }& {) e1 F  s39.        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);
43. 成品检验标准 (Final inspection standards);
: Y& x, U+ W* b8 H2 d: ^' d2 Q6 t44.  成品检验记录 (Final inspection records);
+ ?; F8 j5 w+ w+ b8 D- G% u) S5 d45.   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)
5 J# T4 x- X. J: l3 c3） 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);
. [, q  n+ }# b/ i6 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
50.  客户沟通资料 (Customer communication records);
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)

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~~~