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FCCA验厂清单
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           FCCA审核文件清单  
 
  1.0 工厂自我评估表 Wal-Mart Factory Pre-Audit Questionnaire

  1.1工厂简介 Brief introduction of factory

  1.2营业执照 Business license

  1.3公司组织架构图 Organization chart

  1.4(公司)厂区/厂房平面图 Factory’s plane figure-factory floor plans

  1.5生产工序流程图 Production process chart

  1.6管理系统证书 (质量/环保/社会责任等) Certificate of various management systems ISO9001/ ISO14001/ ICTI/ GSCP, etc.

  2.1虫鼠控制/防潮防霉控制程序(制度)及记录 Documented pests/mildew and moisture control program

  2.2利器 (刀片,断针等) 收发控制/断针控制/验针记录 Procedure and records of sharp tools control/broken needle control/metal detection

  3.1仪器设备校验程序/记录和报告 Procedure and records of equipment calibration

  3.2设备(生产机器检验设备/工具/备件)清单 List of machines, tools, spare parts and equipments

  3.3设备维修保养记录Maintenance and repairing records for machine/equipment.

  4.1质量手册 (质量方针/目标)/ 程序文件 Quality manual/ procedures

  4.2客户投诉处理程序及记录 Procedure and records of customer complaint

  4.3产品紧急事故处理程序(包括召回程序)及记录 Recall program including procedure and records when applicable

  4.4品管组织架构图 Organization chart of QMS/QC

  4.5质量管理体系/控制关键人员职责 Role and Responsibility of QC personnel

  4.6定期不定期质量管理体系/控制会议的机制及记录 Mechanism and records of regular/ irregular review/meeting on QMS/QC

  4.7潜在危害风险评估(物理异物如金属, 玻璃等/化学/微生物方面的危害) Risk assessment to identify hazards from chemicals/ raw materials/ process/ equipment and tools

  4.8控制(生产及产品受物理异物/化学/微生物等)污染风险的控制程序及记录(可能对产品或人造成伤害) Procedures and records about control risk of physical/chemical/biological contamination (which may damage the product and personnel)

  5.1来料检验控制程序 Procedure of quality control on incoming materials

  5.2各种来料检验标准及缺陷分类 Inspection criteria (e.g. sampling plan/ AQL/ defective classification)

  5.3IQC来料检验报告/ 不良品处理(退货,挑选及让步接收等)记录 Inspection/test reports of incoming materials including rejected items and concession when applicable.

  5.4来料中免检产品的符合性证书或测试报告Certificate of compliance or test report of incoming materials when applicable.

  5.5物料库存/周转控制的程序或规定 Procedure/rules of materials rotation control and inventory management warehouse (e.g. FIFO)

  5.6供应商评审程序及记录 (包括初次供应商挑选批准评估及后续定期的供应商表现评估) Supplier Assessment System (including initial evaluation and regular assessment)

  5.7供应商来料状况统计 KPI of ongoing performance

  6.1产品设计程序及记录 (适合时) Procedure and records of product design when applicable

  6.2(量产前进行)试产的制度记录及相应的纠正改善措施(有需要时 Mechanism of pilot-run and the corresponding CAP when applicable)

  6.3产前会议制度及记录 Procedure/records of pre-production meeting

  6.4制造各工序包括包装的作业指导书/规格要求, 参考样板, 批准板, Working instruction/ specification/ approval and reference sample for manufacturing and packing

  6.5过程质量控制的程序/标准/记录 (首件检验,在线检验,巡检,抽检, 全检,批次检验) Procedure/criteria/ records of IPQC (First piece inspection, on-line inspection, routine inspection, random inspection, full inspection, ,lot inspection, etc.)

  6.6过程不良处理机制及记录 Procedure of non-conformance control during manufacturing

  6.7过程不良的纠正预防 CAP in case of rejected products/lots of semi-products

  7.1终检验程序(可能多种形式, 叫法也可能不同)包括FQC或OQC或QAProcedure of final inspection (e.g. FQC/OQC/QA)

  7.2终检验标准(可能多种形式, 叫法也可能不同)包括FQC或OQC或QA Inspection criteria/ specification and reference sample/ records of final inspection

  7.3成品不良处理机制及记录 Procedure of non-conformance control of finished products

  7.4成品不良的纠正预防 CAP in case of rejected products/lots

  7.5成品出货放行机制 Procedure of shipment release

  7.6标识及可追溯性:批次标识/日期标 Identification and traceability (batch code/date code, etc when applicable)

  8.1内部测试清单/ 测试手册(操作指引)/ 测试记录 List of in-house testing/ testing manual / testing records

  8.2仪器校验记录 Calibration of testing equipment

  8.3测试人员资质培训记录 Training records of testing technician

  9.1培训的机制及记录 (包括入职前, 岗前培训, 定期培训, 包括普通操作员/检验员/工程技术人员) Training procedure and records (pre-work training, on-job training and regular training) for workers/ QC members/ technician/ engineers

  9.2对熟练工技术人员的招聘前的考核Pre-hire test for skilled personnel
 
 

 


 


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