合格供应商年度稽查表备课讲稿

1、合格供应商年度稽查表A. Factory Con tact In formatio n（工厂的联络信息）A1. Holdi ng compa ny 控股公司Name:名称公 司 印早：Address 地址Primary con tact pers on n ame: 主要联系人名称Title:职级Teleph one 电话Fax:传真E-mail:A2. Factory 工厂En glish Name:英文名Chin ese Name中文名En glish Address: 英文地址Chin ese Address中文地址Primary con tact pers on n ame: 主要联系

2、人名Title:职级Teleph one电话Fax:传真E-mail:B. Checklist审核清单1. Quality Ma nageme nt System 质量管理系统Yes是No否Remark备注 1.1 Does the factory have any certified quality/environment management system such as ISO 9001/ ISO 14001?工厂是否建立类似ISO 9001/ ISO 14001公认的质量/环境管理系统？1.2 Has the manufacturer documented its quality sy

3、stem in a documentation of quality policy, quality objective and quality manu al?有无形成文件的质量方针，质量手册，质量目标？是否有贯彻执行？ 1.3 Does the factory well define the responsibilities of Quality staff? 工厂是否确定质量人员的职责？1.4 Have the responsibilities and authorities of the management within the manu facturer bee n defi ne

4、d and established a procedure?是否有文件规定管理人员的职责及权限？1.5 Has a member of man ageme nt bee n appo in ted as a Man ageme nt Represe ntative with resp on sibilities and authorities?是否有指定管理者代表并明确其职责和权限？ 1.6 Is there an Organizational Chart? 是否有组织结构流程图？1.7 Is there a In ternal Quality Audit Procedure? Does th

5、e manu facturer con duct the internal audi?是否有内部质量审核程序并按程序执行?1.8 Is there a procedure of Man ageme nt Review and impleme nted? 是否有管理评审程序并执行 ？ 1.9 Does the factory evaluate its ven dors periodically and keep a ven dor list? 工厂是否定期地评估供应商及保留一份供应商的目录？ 1.10 Is there an effective procedure to define Ident

6、ification and Traceability through raw materials to fini shed product?从来料到最终产品的追溯是否有一项有效的程序来确认？Findin gs: 稽查的结果：2. Warehouse仓库2.1 Warehouse man ageme 仓库管理Yes是No否Remark备注2.1.1 Is there a procedure to con trol the incoming materials and impleme nted effective?是否有进料检验程序并有效执行？2.1.2 Is the storage area t

7、idy, clean and sanitary? 仓库是否整洁、清洁、卫生？2.1.3 Is there a procedure to con trol the operati on in warehouse? 货仓是否有控制程序？2.1.4 Does factory apply the FIFO (First- In-Fist-Out)? 工厂是否有实施物料发放先入先出？2.1.5 Are there wait ing check area, confirming area and nonconforming area and they are marked clearly?是否有待检区、合

8、格区、不合格区且分区是否清楚？2.1.61s the materials/products separated and marked clearly? Do the Materials or products store meet the requireme nt? Is there a record for en teri ng or issu ing any materials /products?物料/成品分区是否明确？货品的摆放是否符合要求？进出物料等是否有效 的记录控制？2.1.7Are the materials/products identified clearly, in or

9、der to avoiding misuse? 物料/成品是否标识清楚，以防止误用？Findin gs: 稽查的结果：2.2 Nonconforming products不 合格品2.2.1 Is there a procedure to con trol of nonconforming products and impleme nted Have the controls and related responsibilities and authorities for dealing with noncon form ing product bee n defi ned clearly?是

10、否有不合格品控制程序并执行？不合格控制及处置的有关职责和权利是否有明确的规定？?2.2.2Have the nonconforming products bee n marked and separated? Have actior bee n take n and records bee n mai ntai ned for the noncon form ing product? Are th physical character nonconforming products and en vir onmen tal substa nee noncon form ing products

11、separated and marked clearly?不合格产品是否有得到标识，隔离？物理性质不合格与环境有害物质不合格is是否分开放置？2.2.3 Have the nonconforming product bee n subject to re-verificati on to dem on strate con formity to the requireme nts after reworked?是否有不合格品的处置的相关措施及记录？不合格品若返工后有无得到再次验证？2.2.4 Have acti ons and preve ntive actions bee n take n

12、for the nonconforming product or any report ing of noncon formities (In cludi ng customer compla in ts)? Ha the records bee n maintain ed?是否有对不合格品或不合格报告(包括客户投诉)进行纠正和预防改进?是 否有相关的记录？ 2.2.5 Is there any failure of hazardous substance requirement in the past year (such as heavy metals and phthalates)?过去

13、一年内有无有害物质不合格(如重金属及邻苯二甲酸盐)发生？Findin gs: 调查的结果：3. Manu facturi ng processes制造过程Yes是No否Remark备注3.1 Manu facturi ng man ageme nt 制造管理3.1.1 Are the workfloors clean and tidy? 工作地面是否干净整洁？3.1.2 Have all main equipme nts used in in specti on, measur ing and test ing been con trolled and recorded effective?

14、In cludi ng maintain effectivAre the records of daily maintain ed? And termly maintenance kept?在用的主要设备是否有控制及记录？包括有效的保养？日常维护和定期维护的记录是否得到保存？3.1.3 Is the quality en sured by the clear manufacture con trol procedure? Can th control information and process abnormity disposing records be provided? 是否有明确的生

15、产控制程序来确保质量？是否能提供控制数据和制程异 常处理记录？e3.1.4 Is the main and special process con trolled effective? Any Records can be reviewed?对关键和特殊过程是否得到有效控制，并有记录可查？3.1.5 Is the SOP in the work locale? Is the regulati on clear? Do the operators d( as the SOP?作业指导书是否悬挂在作业现场？规定是否清楚明了？操作员是否按照 作业指导书的规定作业？3.1.6 Is suitable

16、In-process quality con trol adopted in product ion? 生产中是否采取有效的质量控制？3.1.7 Is suitable quality con trol adopted to en sure the fini shed product compl yin with requireme nt?是否采取恰当的质量控制来保证成品符合要求？g3.1.8 Is there a Training procedure? Have the pers ons who affect the quality an work in special process be

17、en trained?是否有培训程序？是否对所有从事质量有影响和特殊工作的人员进行了 培训？d3.2 Traceability and Identification追踪及确认3.2.1 Are the raw materials, WIP and finished product in the workshop clearly ide ntified?在车间原材料，半成品和最终产品是否清楚地区分？3.2.2 Does factory maintain clear records on traceability? 工厂是否保留清楚的追踪记录？3.2.3 Are all in-process an

18、d fini shed goods activities records traceable to a specific lot?所有的半成品和成品是否都具有可追溯性？Findin gs: 调查的结果：4. Measureme n测量Yes是No否Remark备注4.1 Is there a procedure to con trol the producti on process? Do the operators perform in specti on and accepta nee criteria comply with the procedure? 是否有制程检验程序？是否能按照程

19、序规定检验?4.2 Have the measuri ng devices bee n con trolled effective? In cludi ng calibrati on method/accepted criteri on /calibrati on period and the releva nt procedure and impleme ntati on. Have the measuri ng devices bee n con trolled effective? In cludir calibrati on method/accepted criteri on/cal

20、ibrati on period and the releva nt proced and impleme ntati on.疋否有对测量装置进行有效的控制？包括疋否有校准方法/验收准则/校验周期及相应的程序及执行？gjre4.3 Are the equipments/devices use for inspection under the scope of controllin( Is there a list of all equipme nts used in in specti on, measuri ng and test ing? 检验用的仪器/设备是否都在控制范围？是否有一览表包

21、括了所有的检验 仪器/设备？J?4.4Is there a Calibration Plan for the testing equipment? 是否有测试仪器的校准计划？4.5Are all measuring devices under use identified with available label and calibrati on record?在用的仪器/设备是否有有效的校正状态标志和校准记录？4.6 Are there process con trols in place to assure that desig ns meet the in put requireme n

22、ts, contain reference data, meet QSOPs such as 0006-3600 for Hea Elements and 0006-3610 for Plasticizers, and fulfill customer requirements?是否有客户设计开发控制程序，客户要求是否都在控制范围内，包含0006- 3600 HE 与 0006-3610 PH要求。4.7 Is there a fini shed goods in spect ion program in place in cludi ng the requireme nts of QSOP

23、3600 and QSOP 3610?完成品检查项目是否包含 QS0P3600和QSOP 3610?4.8Does factory main tai n legible testi ng reports for I ncomi ng materials, semifinished goods and finished product?工厂是否保留清楚的来料，半成品及最终产品的测试报告？Findin gs: 调查的结果：5. Purchase and suppliers man agemenft 购和供应商管理Yes是No否Remark备注5.1 Is there a procedure to

24、con trol the purchase process? Do the operators perf purchase comply with the procedure?是否有采购控制程序？是否能按照程序规定进行采购？orm5.2 Has the conforming suppliers list? 是否有合格供应商清单？5.3 Has the purchasing information described the specified purchase requireme and the requirements for approval or qualification of pro

25、duct? And is it impleme nted effective?采购数据是否有订购产品的技术要求及放行要求及得到有效的执行？nts5.4Has the manufacturer evaluated its suppliers and established the procedure? What to do If the evaluati on is non-con form?是否有对供应商进行评定及相关程序？当供应商评审不合格时如何处理？ 5.5 Does the factory sig ned any related DOC or Declarati on? 工厂是否签署了相

26、关 DOC或声明书？5.6 Does factory mai ntai n the effective MSDS? 工厂是否保持有效的 MSDS?Findin gs: 调查的结果6. packing material suppliers managemer包装材料供应商管理Yes是No否Remark备注6.1包装材料上有些什么涂层 ？检查项目是否包括 QSOP0006-3600与 QSOP0006-3610.What s the Paint content opacking materia? Is therepacking material inspection program in place including the requirements of QSOP 3600 and 3610?6.2包装材料的喷涂工序 是否外发？如外发，是