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