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1、合格供应商年度稽查表A. Factory Contact InformationA1. Holding pany控股公司Name: 名称公司印章：Address:地址Primary contact person name:主要联系人名称Title: 职级Telephone: Fax: E-mail:A2. Factory工厂English Name:英文名Chinese Name中文名English Address:英文地址Chinese Address中文地址Primary contact person name:主要联系人名Title:职级Telephone: Fax: E-mail:B.
2、 Checklist审核清单1. Quality Management 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 system in a documentation of quality polic
3、y, quality objective and quality manual?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 manufacturer been defined and established a procedure?是否有文件规定管理人员的职责与权
4、限?1.5 Has a member of management been appointed as a Management Representative with responsibilities 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 Internal Quality Audit Procedure? Does the manufacturer conduct the internal audit？是否有内部质量审核程序并按程序执行
5、?1.8 Is there a procedure of Management Review and implemented?是否有管理评审程序并执行?1.9 Does the factory evaluate its vendors periodically and keep a vendor list?工厂是否定期地评估供应商与保留一份供应商的目录?1.10Is there an effective procedure to define Identification and Traceability through raw materials to finished product?从来
6、料到最终产品的追溯是否有一项有效的程序来确认?Findings:稽查的结果:2. Warehouse仓库2.1 Warehouse management仓库管理Yes是No否Remark备注 Is there a procedure to control the ining materials and implemented effective?是否有进料检验程序并有效执行? Is the storage area tidy, clean and sanitary?仓库是否整洁、清洁、卫生? Is there a procedure to control the operation in wa
7、rehouse?货仓是否有控制程序? Does factory apply the FIFO ?工厂是否有实施物料发放先入先出?2.1.5 Are there waiting check area, confirming area and nonconforming area andthey are marked clearly?是否有待检区、合格区、不合格区且分区是否清楚？Is the materials/products separated and marked clearly? Do the Materials or products store meet the requirement
8、? Is there a record for entering or issuing 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?Are the materials/products identified clearly, in order to avoiding misuse?物料/成品是否标识清楚,以防止误用？Findings:稽查的结果:2.2 Nonconforming products不合格品2.2.1 Is there a procedure to control of nonconforming
9、products and implemented ? Have the controls and related responsibilities and authorities for dealing with nonconforming product been defined clearly?是否有不合格品控制程序并执行? 不合格控制与处置的有关职责和权利是否有明确的规定?2.2.2Have the nonconforming products been marked and separated? Have actions been taken and records been main
10、tained for the nonconforming product? Are the physical character nonconforming products and environmental substance nonconforming products 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是否分开放置？2.2.3 Have the nonconforming product been subject to re-verification to demonstrate conformi
11、ty to the requirements after reworked?是否有不合格品的处置的相关措施与记录?不合格品若返工后有无得到再次验证?2.2.4 Have actions and preventive actions been taken for the nonconforming product or any reporting of nonconformities ? Have the records been maintained?是否有对不合格品或不合格报告进行纠正和预防改进?是否有相关的记录? Is there any failure of hazardous subs
12、tance requirement in the past year ?过去一年内有无有害物质不合格发生？Findings:调查的结果:3. Manufacturing processes 制造过程Yes是No否Remark备注3.1 Manufacturing management 制造管理3.1.1 Are the workfloors clean and tidy?工作地面是否干净整洁? Have all main equipments used in inspection, measuring and testing been controlled and recorded effec
13、tive? Including maintain effective.Are the records of daily maintained? And termly maintenance kept?在用的主要设备是否有控制与记录?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？ Is the quality ensured by the clear manufacture control procedure? Can the control information and process abnormity disposing records be provided?是否有明确的生产控
14、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？ Is the main and special process controlled 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? Is the SOP in the work locale? Is the regulation clear? Do the operators do 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？ Is suitable In-process quality control adopted in production?生产中是否采取有效的质量控制? Is suitable quality control adopted to ensure the finished product plying with requirement?是否采取恰当的质量控制来保证成品符合要求? Is there a Training procedure? Have the persons who a
