Target 验厂自检表格(FE Form With Chinese 2009 5 14)
最新的GMP审核验厂检查表完整版
0
0
Are there adequate environmental controls for the building?If the product under assessment requires environmental controls, ensure that the supplier has controlled and verified temperature at critical areas. If environmental control is inadequate, the answer is NO. If environmental control is not applicable to the production, the answer is N/A.
虫害控制程序是否合适？确保有外发的定期虫害控制合约，合约至少包括a)服务内容和所有材料b)鼠笼的安放位置图c)虫害防治公司的营业执照，检查12个月的虫害控制记录，鼠笼等设备有编号，可以追溯。鼠笼等设备合适安装并定期检查证据
3
0
0
Are the washrooms and toilets clean and in good working order?Clean, stocked with Antibacterial Soap and single use napkin/towel, running hot water.
工厂是否干净（评估的整个过程都要观察工厂清洁情况，工厂应该有定义清洁的环境要素并持续改善清洁状况）
2
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Are there written procedures addressing the maintenance of the facility?Preventive Maintenance policies and schedules should be documented. Records should be available for review and should contain information regarding daily pre-operation equipment inspection, daily monitoring of equipment function, daily housekeeping activities, sanitation activities and any other necessary activities to maintain the safety and quality of product.有没有书面的厂房/设施维护程序？预防性维护的政策和程序。每日开机检查记录，每日设备功能检查记录，每日打扫卫生记录，以及其他所需的工作来保证产品的安全和质量……
Target质量体系验厂清单中英文
Target质量体系验厂清单中英文Target质量体系验厂清单Document (s)文件 SL SH HGISO CertificationISO 证书 x x xFormal documented system to control document revision, distribution and maintenance 控制文件的修订、分发及维护的正式文件系统， x x xDocumented system to define storage, protection and retention of quality records规定质检记录的存放、保护及归档的文件 x x xDocumented Production procedures/instructions for all processes各步骤的生产流程及操作指南 x x xDocumented Inspection procedures/instructions for all stages of production各生产步骤的检验流程及操作指南 x x xDocumented pre-production meeting process产前会议的文件 x x xPre-production meeting records产前会议记录 x x xDocumented Pilot/Test Run process试产流程 x x xDocumented Pilot/Test Run results试产结果 x x xDocumented factory delivery performance records工厂出货的绩效记录 x x xDocumented preventative maintenance process for allfactory equipment工厂所有设备的预防维护流程 x x xTraining培训Documented training program for QC Inspectors on QC ProcessesQC验货流程的培训计划 x x xDocumented training program for Maintenance Workers维修工人的培训计划 x x xDocumented training program for Production Workers生产工人的培训计划 x x xFactory Organizational Chart工厂组织架构图 x x xFactory QC Shift schedule工厂QC员轮班表 x x xDaily/Weekly quality goals and results每日或每周的质量目标及结果 x x xFactory Defect Classification List产品瑕疵分类清单 x x xQuality Control Meeting schedule质量控制会议安排 x x xQuality Control Meeting results质量控制会议记录 x x xMaintenance Workers personnel files维修工人个人档案 x x xQC Inspectors personnel filesQC员个人档案 x x xProduction workers personnel files生产工人个人档案 x x xMaterial/Supplier Management材料与供应商管理Documented inventory process for monitoring/documenting incoming/outgoing material 监控或记录进出材料的库存清单 x x xDocumented process for reviewing all incoming raw material, components, sub-assemblies conform to Specifications, Quality Standards and US safety requirements检查所有进厂原材料、零部件及半成品是否符合说明书、质量标准及美国的安全要求的程序 x x xDocumented process for reviewing all incoming raw material, components, sub-assemblies conform to Specifications, Quality Standards and US regulatory requirements检查所有进厂原材料、零部件及半成品是否符合说明书、质量标准及美国的法规要求的程序 x x xDocumented process for reviewing all incoming packaging material under lightbox (UL3500 lightsource)在灯箱下（UL3500 光源）对所有进厂包装材料的检查程序 x x x Records of non-conforming packaging status and disposition不合格包装的状态及处理记录 x x xSupplier performance and reliability documentation供应商绩效和可靠性记录 x x xNon-conforming/rejected raw material, in process product, finished product disposition records不合格或拒绝的原材料、半成品及成品的处理记录 x x xDocumented process for fabric inspection面料的检验流程 x xIncoming fabric inspection results进厂面料的检验结果 x xIncoming fabric count, construction, weight records进厂面料的经纬密度、结构、及重量的记录 x xDocumented process for proper storage and handling of hazardous chemicals有害化学品的正确储存及使用流程 x x xDocumented process for proper storage and handling of dyes/inks染料或油墨的正确储存及使用流程 x x xDocumented process for proper packaging/handling of product going to a Sub-contractor 外加工产品的正确包装、处理流程 x x xDocumented process for inventorying, reconciling and inspecting product received from sub-contractor外加工产品回厂的库存、核对及检验流程 x x x。
Target 供应商自评表Vendor Factory Evaluation (VFE)
5001
ቤተ መጻሕፍቲ ባይዱ
Document Control
Is there a procedure in place that defines how documentation is controlled?
5002
Document Control
Is there a "Master List" of controlled documents?
5003
Document Control
Are documents in use the current version and are they authorized and dated?
5004 5005
Document Control Document Control
Is there a procedure in place to ensure obsolete documentation is removed from use? Is the documentation readily accessible by all relevant staff at all times?
5006
Document Control
Review documented procedure on how the factory maintains quality records. The Procedure must Is there a written procedure that defines how quality records are stored, indicate the retention period is at minimum 5 years after production has ended. Record review must protected, and disposed of as well as a defined retention period? validate records have been maintained for a minimum of 5 years after production has ended; or maintained since the creation of the Document Retention Procedure. Does the QA (Quality Assurance) or QC (Quality Control) department operate separately from the Production department? Does the quality department have coverage during all shifts? Review an Organizational Chart to see where the QA or QC Department reports. If they report to General Manager, President, etc. score a YES. If they report to anybody in the Production Department, score is a NO. If organizational chart is not available, interview factory QA/QC leadership. Review random documentation of shift schedules. If shift schedule is not available, interview factory QA/QC leadership. For every production shift, there must be QC coverage.
TARGET质量验厂最新的要求及详细解释
核对工厂的原材料和零部件是否有清晰的标识,以确保产品的可追溯性。包括：包装材料，生产助剂，中间产品/半成品，产品部件原料，成品，待检原料。这些物料包括从不同原料供货商采购的产品。
举例：根据清晰的标识追溯钮扣的供应商，螺丝钉的供应商
5044
生产管理
5011
质量管理
工厂的持续质量会议记录，是否显示工厂的产品质量水平是可
以衡量的、并且得到了持续性的改进？
核对工厂的质量会议记录，相关数据，同管理层面谈。核实质量方面是否有可衡量的持续改
进。
5012
质量管理
每天或每周质量目标和实际质量执行结果是否张贴在生产现场
？
在车间巡视的时候，核实工厂的质量目标和实际质检结果是否在生产车间明示。
5013
供货商管理
工厂是否有库存管理系统来控制和记录进出物料（存放地点， 数量，）
核对工厂的库存管理文件和记录，核实所有进出物料是否被库存管理系统有效监控。核对存放地，物料类型和数量与库存记录是否匹配。
5014
供货商管理
工厂是否有供应商审核程序，包括被核可的供货商清单，被认可的产品、物料和服务类别，被核可的供货商所提供产品，应符合安全、法律法规及质量的要求？
工厂的可追溯性系统是否贯穿从原材料和零部件的采购到成品出运？
在工厂随机抽取一个正在生产的产品,请工厂对其内部的追溯系统加以解释，证明根据原材料/ 零部件的标识，生产批次，可以追溯到成品的完成时间，出运批次等。
5045
生产管理
工厂是否有内部测试,以鉴别自己的追溯系统的有效性？
核对工厂的定期测试追溯系统的记录。工厂要提供报告或会议记录来证明工厂的追溯系统工作正常。
验厂准备工作检查记录表
工伤处理记录
12、法定证件
13、其他资料
验厂准备工作检查记录表
仓库（注塑/原料/成品） 完善事项 检查人员/日期： 检查内容 确认人员/日期： 检查结果 相关表格 不符合内容描述
1、确保所有通道畅通，物料不压黄线；消防栓 及灭火器不被阻挡，并有醒目的标识。 2、所有楼梯间及紧急出口出需要安装应急灯、 疏散方向箭头标识和安全出口标识； 3、安全出口需张贴《应急走火疏散图》并标明 看图者所在位置。
3、安全出口需张贴《应急走火疏散图》并 标明看图者所在位置。 1、消防安全
4、灭火器定期点检；每月检查1次；检查日期： 灭火器检查记录 必须避开周日及国家法定假期日。 表
5、消防栓定期点检；每月检查1次；检查日期： 消防栓检查记录 必须避开周日及国家法定假期日。 表
6、所有电气开关盒旁不允许放置杂物，所 有电器开关必须有面板保护，有警告标识；
材料领用单/存卡/ 退补料单/库存报表
2、危险品/化学品管理
退补料单
3、物料、资料及看板管 理
库存报表
出货凭证
1、急救箱需配备充足及完善的药物，包括 烫伤药膏和剪刀，药瓶盖好盖子以保证药 效；急救箱不能上锁； 4、 生产安全及劳动保护 2、急救箱旁应张贴： 1）公司急救员联系电话，医院联系电话； 2）急救流程及急救常识等宣传文字或图 片；
1、物料不超高堆放，物料须有效防护，不 超框堆放；
2、所有原料、半制成品及成品不能直接落 地；不合格物料区分放置并标识；
2、物料、看板及现场管 3、工作环境必须整洁，按5S标准实施； 理 4、物料标识卡填写日期适逢当月错峰用电 休息日、国家法定假期日时，填写日期顺延 一天。 5、逢错峰用电休息日、国家法定假期日的 相关记录表格单独列册，在验厂当天锁藏。 1、急救箱需配备充足及完善的药物，包括 烫伤药膏和剪刀，药瓶盖好盖子以保证药 效；急救箱不能上锁；
Target质量验厂Questionnaire(第8部分)问卷调查-中文2020.(20210420
8问卷调查制造控制计划1级1工厂是否有确定适当质量控制点的生产流程图？工厂的生产工作流程图必须涵盖产品的所有关键制造步骤，并有明确的范围。
每个产品类别必须有一个详细的生产流程图，包括对所有确定的关键流程的检查和确认。
工厂生产流程图必须是最新的，并由工厂的生产和质量团队使用。
工厂生产流程图必须与工厂关键质量控制相关必须有有效/明确要求和记录的点。
符合2工厂是否执行适当的制造控制计划，包括所有产品类别的过程监控、质量控制和内部测试？观察在工厂执行的制造控制计划。
制造控制计划必须针对产品，包括过程输入和输出（如适用）。
制造控制计划必须包括但不限于以下关键要素：工艺步骤、控制对象、规格限制、测量方法、控制方法、样本量、频率、谁测量、记录在哪里、决策规则或纠正措施、SOP编号（指定）。
工厂生产和质量团队必须拥有并使用制造控制计划来监督他们在所有检查点的生产。
高风险产品的附加要求：对于外包过程，分供应商/承包商必须对外包制造过程制定有效的制造控制计划。
符合3是否有文件和记录支持正在执行的制造控制计划？通过检查记录、测试报告和过程监控记录，验证生产流程图和生产控制计划的执行。
符合产品开发Level 11工厂是否有效地为其产品类别执行预生产流程？1•验证工厂是否有有效的预生产流程，以确保批量商品满足或超过客户对质量和安全的要求，并且可能不限于预生产会议（基于制造和产品类型），但有效的预生产流程必须结构化，以审查以下要素合适的团队：a、产品详细信息/规格b、批准的样品（如有意见，请提供意见）c、工艺流程图，包括确定的关键质量参数的控制计划d、生产前风险评估（原材料、部件、结构、批量再现性和其他增值工艺）e、试验要求及其结果f、批量生产和行动计划中可能的制造变量（MVs）,基于初始/试运行g•识别缺陷和批量执行问题的类似产品的历史性能。
h、包装和标签i、审查生产计划，包括分包工艺j、阴影带（如适用）2•基于生产前评估的产品制造控制计划修订。
3C_工厂检查调查表（英文版）
3C_工厂检查调查表（英文版）Questionnaire for Factory InspectionName of Applicant:Name of Manufacturer:Name of Factory:Certification CenterQuality CertificationChina QualityChina1.1Factory’s registered name:Factory’s registered address:Note: Factory’s address should be filled in according to the fact, which may be different with the registered address. Factory’s address is the location of final assembling, implementing routine test and verification test, packing and bearing product nameplate and certification mark. If those working procedures mentioned above could not be completed in one location, a compared integrated location should be filled out here in which at least routine test and verification test, packing, product nameplate and certification mark bearing are implemented, moreover other locations should be indicated with geographical places.Tel: Fax: Postcode:E-mail:Directions of the best way of reaching the factory (nearest railway station, airport; attach one photocopy of local map if possible)1.2Manufacturer’s registered name:Manufacturer’s registered address:Tel: Fax: Postcode:E-mail:2.Applicant’s registered name:Applicant’s registered address:Tel: Fax: Postcode:E-mail:Contact person of certification: Department & position: Tel:3. The name, department and position held and telephone number of the factory quality assurance manager Name of the QA manager: Department & Position: Tel:4. Total number of employees in the factory (If products applied for the certification are only one part of the whole production, please indicate the total number of employees involved in the production and management of the products applied for certification)5.1The application number(s), name(s), model(s) /specifications and trade mark(s) of the product(s) applied for certification5.2Specify the standard(s) according to which the certification is made on the products6.1Has the factory established a documented quality system according to the requirement of the IMPLEMNENTATION RULES FOR COMPULSORY CERTIFICATION? Please provide:①organizational chart②list of the quality manual③ procedural documentation6.2Indicate the production processes of the products appliedfor certification performed in the factory. (Please provide the production flow chart, and fill in the Appendix 1 -- List of Key Production Equipments.)6.3Indicate which critical parts and materials are provided by the subcontractors.(Please indicate which have been already awarded the CCC or other equivalent certificates.)6.4 Please specify which inspection the factory is able to conduct during receiving inspection, process inspection and final inspection in order to ensure that the final products conform to corresponding standards. (Please provide a list of inspection documents and fill in Appendix 2 -- List of Main Test Instruments and Equipments).7.Please indicate the Certificates and the Marks already granted by other certification body/bodies for the products applied for certification.8.Has the manufacturer’s quality system been assessed and certified? If yes, please provide a copy of the certificate(s). Please specify the date and the conclusion of the last inspection.9.Date of factory inspection expected:Off day of factory: On duty time of factory:Could the inspection be done on off day:yes discussible no10.Are the inspectors of Certification Body allowed to access all locations concerning production and management processes of products applied for certification during normal working hours, after having contacted the quality assurance manager?Signature and stamp of the representative of the factory:Date:Note: On behalf of the manufacturer, the signatory to thisform is required to verify the accuracy of the information provided.Appendix 1List of Key Production EquipmentsName of factory: page of/doc/674072517.htmlof equipment Manufacturer ofequipmentMain technicaldataQuantity LocationAppendix 2List of Main Test Instruments and Equipments Name of factory: page of/doc/674072517.htmlof instruments& equipmentsManufacturer ofinstruments &equipmentRange of theMeasurementPrecision Quantity Location。
Target质量体系验厂清单
Target质量体系验厂清单文件SL SH HG ISO 证书x x x控制文件的修订、分发及维护的正式文件系统，x x x规定质检记录的存放、保护及归档的文件x x x各步骤的生产流程及操作指南x x x各生产步骤的检验流程及操作指南x x x产前会议的文件x x x产前会议记录x x x试产流程x x x试产结果x x x工厂出货的绩效记录x x x工厂所有设备的预防维护流程x x x培训QC验货流程的培训计划x x x 维修工人的培训计划x x x生产工人的培训计划x x x工厂组织架构图x x x工厂QC员轮班表x x x 每日或每周的质量目标及结果x x x产品瑕疵分类清单x x x质量控制会议安排x x x质量控制会议记录x x x维修工人个人档案x x x QC员个人档案x x x 生产工人个人档案x x x材料与供应商管理监控或记录进出材料的库存清单x x x检查所有进厂原材料、零部件及半成品是否符合说明书、质量标准及美国的安全要求的程序x x x检查所有进厂原材料、零部件及半成品是否符合说明书、质量标准及美国的法规要求的程序x x x在灯箱下（UL3500 光源）对所有进厂包装材料的检查程序x x x 不合格包装的状态及处理记录x x x 供应商绩效和可靠性记录x x x 不合格或拒绝的原材料、半成品及成品的处理记录x x x 面料的检验流程x x进厂面料的检验结果x x进厂面料的经纬密度、结构、及重量的记录x x有害化学品的正确储存及使用流程x x x 染料或油墨的正确储存及使用流程x x x外加工产品的正确包装、处理流程x x x 外加工产品回厂的库存、核对及检验流程x x x 外加工产品回厂的库存及检验记录x x x 外加工厂的质量控制及绩效结果，等等x x x 辅料、配件、吊牌的检验流程，等等x x x 辅料、配件、吊牌的检验结果x x x 辅料、配件、吊牌的库房出库记录x x x实验室灯箱的维护、校验记录x x x 实验室技术员的培训文件或证书x x x 实验室所有负责颜色评估人员的色觉测试记录x x x 第三方实验室或工厂内部的测试结果x x x车缝/生产车间次品的核对流程x x x 现场线检流程x x x 现场线检结果x x x 成品生产中的检验流程x x x 成品生产中的检验结果x x x 成品包括包装和纸箱的抽检流程x x x 成品的终期抽检结果x x x 断针控制流程x x x 断针控制每日记录x x x金属探测器对适用产品的过针测试流程x x x 所有需要过针测试产品的过针测试记录x x x 金属探测器的校验结果x x x验布/裁剪用料记录x x x 丝印/绣花丝印材料的库存和发放记录x x x 丝印网版的清洁流程x x x水洗测量适当水洗量的记录x x x 污水处理文件x x x九段人权验厂系统是一套完整的验厂管理工具，包括人事、考勤、工资等的管理，已有数千家企业成功通过验厂，包括玩具、服装、家具、礼品、印刷、家居、五金等行业，也是众多顾问咨询公司的推荐产品。
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2.Training and Quality Systems 培训和品质系统
Question/问题 Training /培训 培训 2.01 Is there a formal, documented training or certification program for QC INSPECTORS on QC processes?/ 是否有给在产线、工作岗位、机械上工作的工人提供一个正规、书 面的培训/交叉培训或证明程序？ 2.02 Are defect samples used during training to indicate what they should be looking for?/ 在培训中是否用到暇疵品来指出他们应该找什么的问题？ 2.03 If hiring maintenance workers without a formal technical education, is there a formal, documented training or certification program for MAINTENANCE OR EQUIPMENT TECHNICIANS?/ 假如雇佣没有受过正规维修教育的工人，是否有提供一个正规的、 书面的维修机器工人培训或证明程序？ 2.04 Are training requirements AND records maintained?/ 培训的要求和记录是否有保留？ 2.05 Is training performed off of the production line?/ 是否有进行现场培训？ 2.06 Is there a formal, documented training/cross-training or certification program for PRODUCTION WORKERS on process, work station, equipment that they perform/use?/是否有给在产线、工作岗位、机 械上工作的工人提供一个正规、书面的培训/交叉培训或证明程序？ Quality Systems/品质系统 品质系统 2.07 Does the QA (Quality Assurance) or QC (Quality Control) department operate separately from the Production department?/QA（品质保证）或QC（品质控制）部门与生产部门 是否是独立操作的？ 2.08 Does the quality department have adequate coverage during all shifts? /品质部是每一班次是否有足够人手？ 2.09 Are daily or weekly quality goals developed and actual performance results collected?/品质目标与实际执行结果是否被保 存？ 2.10 Are DCL's (Defect Classification List) or similar being used?/有无 DCL(缺陷分类目录)或其他类似的？ 2.11 Are defects identified and recorded by operation, operator and machine?/操作人员，管理者以及机器是否有标记以及记录产品缺 陷? 2.12 Are weekly documented, ongoing Quality Control (QC) meetings held at the factory during production?/生产过程中，工厂有无召开 每周有纪录的，生产中品质管理会议？ 2.13 Are quality records reviewed at the weekly QC meetings? /品质纪 录是否在QC每周例会上评论？ 2.14 Are corrective action plans developed and documented based on the results of the weekly QC meetings?/有无根据每周QC例会的结 果来制定改善计划并存档？ YES NO N/A Comments
Comments(总评)
1.Document and Process Control /文件与程序控制 文件与程序控制
Question/问题 1.01 Is the Factory ISO certified?/工厂有无ISO认证？ 1.02 Is there a formal, documented system to control documents and ensure that they are legible, identified, reviewed, authorized, up-todate and distributed?/有无正规的文档管理系统用于文档管理，从而 确保文档是否清晰，易于识别、翻阅，是否授权的,并确保更新和分 类？ 1.03 Is there a documented process to ensure product specific documents such as specifications (both internal and customer's), purchase orders, etc. are controlled and updated regularly to reflect changes? /有无文件制程确保产品详细文件受管理，如：规格(内部 及客户要求)、销售订单等，并时常更新反映变化？ 1.04 Is there a documented process to identify obsolete documents and protect them from use? /有无文件程序用于文件的区分，从而确保 文件的正常使用？ 1.05 Are quality records such as test reports, laboratory results, inspection results, certificates, lot control documents, etc. kept and controlled?/品质纪录，如：测试报告，实验结果，验货结果，认证 证书，抽货控制文件等，是否被保存管理？ 1.06 Is there a written procedure that defines how quality records are stored, protected and disposed of as well as a defined retention period?/有无书面程序来规定如何保存，保护，处理品质纪录和保留 时间？ 1.07 Do documented PRODUCTION procedures or instructions exist? / 有无生产手册或说明书？ 1.08 Do documented INSPECTION procedures or instructions exist? / 有无检验手册或说明书？ 1.09 Are they present at each inspection operation? / 是否每个生产车间都有？ 1.10 Does the factory have an internal documented pre-production process?/ 工厂是否具有生产前内部文件？ 1.11 Do documented Pre-Production meeting records exist?/ 有无生产前的会议记录 1.12 Does the factory hold a pre-production meeting prior to start of production?/ 生产前，工厂有无举行产品生产前会议？ 1.13 Are both production and factory QC represented at the preproduction meeting? / 是否生产人员与工厂QC都出席生产前会议？ 1.14 Are product specifications and approval samples reviewed prior to production or at the pre-production meeting and is this documented in the meeting notes? / 产品的规格与签版是否于生产前讨论，或 在生产前会议讨论？这些有无纪录于会议纪录？ 1.15 Are product test requirements and results reviewed prior to production or at the pre-production meeting and is this documented in the meeting notes?/ 产品测试要求和测试结果是否于生产前讨 论，或在生产前会议讨论？这些有无纪录于会议纪录？ 1.16 Are critical quality or inspection checks reviewed, identified and documented prior to production or at the pre-production meeting? / 在生产前，或生产讨论会议中，重要品质问题和检验核对是否被讨 论、鉴别并存档？ 1.17 Are Pre-production meeting notes/issues communicated to the line supervisors? / 生产间会议纪录是否传达到生产线主管？ 1.18 Does the factory perform a pilot/test run before production start with documentation?/ 生产前，工厂是否对产品执行测试运行从而 确保产品符合各项要求且备有文件？ YES NO N/A Comments