合格供应商年度稽查表.doc

合格供应商年度稽查表 A. Factory Contact Information(工厂的联络信息)A1. Holding company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:电话Fax:传真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:电话Fax: 传真E-mail:B. 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 policy, 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及权限?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?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及保留一份供应商的目录?1.10 Is there an effective procedure to define Identification and Traceability through raw materials to finished 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?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2.1.1 Is there a procedure to control the incoming materials and implemented effective? 是否有进料检验程序并有效执行?2.1.2 Is the storage area tidy, clean and sanitary? 仓库是否整洁、清洁、卫生?2.1.3 Is there a procedure to control the operation 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 waiting check area, confirming area and nonconforming area and they are marked clearly? 是否有待检区、合格区、不合格区且分区是否清楚？2.1.6Is the materials/products separated and marked clearly? Do the Materials or products store meet the requirement? 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?2.1.7Are 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 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 been marked and separated? Have actions been taken and records been maintained 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 conformity to the requirements 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 actions and preventive actions been taken for the nonconforming product or any reporting of nonconformities (Including customer complaints)? Have the records been maintained? 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？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?3.1.2 Have all main equipments used in inspection, measuring and testing been controlled and recorded effective? 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 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？3.1.4 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?3.1.5 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？3.1.6 Is suitable In-process quality control adopted in production? 生产中是否采取有效的质量控制?3.1.7 Is suitable quality control adopted to ensure the finished product complying with requirement? 是否采取恰当的质量控制来保证成品符合要求?3.1.8 Is there a Training procedure? Have the persons who affect the quality and work in special process been 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?3.2 Traceability and Identification 追踪及确认3.2.1 Are the raw materials, WIP and finished product in the workshop clearly identified? 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 and finished 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？Findings:调查的结果:4. Measurement测量Yes是No否Remark备注4.1 Is there a procedure to control the production process? Do the operators perform inspection and acceptance criteria comply with the procedure? 是否有制程检验程序?是否能按照程序规定检验?4.2 Have the measuring devices been controlled effective? Including calibration method/accepted criterion/calibration period and the relevant procedure and implementation. Have the measuring devices been controlled effective? Including calibration method/accepted criterion/calibration period and the relevant procedure and implementation.是否有对测量装置进行有效的控制?包括是否有校准方法/验收准则/校验周期及相应的程序及执行?4.3 Are the equipments/devices use for inspection under the scope of controlling? Is there a list of all equipments used in inspection, measuring and testing? 检验用的仪器/设备是否都在控制范围?是否有一览表包括了所有的检验仪器/设备?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 calibration 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 controls in place to assure that designs meet the input requirements, contain reference data, meet QSOPs such as 0006-3600 for Heavy 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 finished goods inspection program in place including the requirements of QSOP 3600 and QSOP 3610?完成品检查项目是否包含QSOP3600和QSOP 3610?4.8Does factory maintain legible testing reports for Incoming materials, semi-finished 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?Findings:调查的结果:5. Purchase and suppliers management采购和供应商管理Yes是No否Remark备注5.1 Is there a procedure to control the purchase process? Do the operators perform 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?5.2 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 requirements and the requirements for approval or qualification of product? And is it implemented 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?5.4Has the manufacturer evaluated its suppliers and established the procedure? What to do If the evaluation is non-conform? 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 signed any related DOC or Declaration? 工厂是否签署了相关DOC或声明书？5.6 Does factory maintain the effective MSDS? 工厂是否保持有效的MSDS？Findings:调查的结果6packing material suppliers management 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.Whats the Paint content on packing material? Is there packing 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,是否有对外发厂进行现场评审及评审频率？sub