Fcca Quality System Audit Outline

Topics: Quality management system, Quality assurance, ISO 9000 Pages: 5 (1374 words) Published: January 20, 2013
FCCA Quality System Audit Outline
  (Hardline 杂货) (Quality System part质量体系部分)
Factory Quality System工厂质量体系
1.0 Factory Facilities and Environment工厂设施和环境
1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas? 在生产,修理,加工,检验,包装及装载的区域是否有足够的照明? 1.0.2 The facility maintains clean and organized production, finishing and packing areas. 工厂是否保持清洁,在生产,加工和包装区域是否有秩序? 1.0.3 Facility has separate inspection area with inspection table and proper ventilation. 工厂是否有单独的检验区与检验台并且通风良好? 1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party) 工厂是否有害虫/霉菌和湿度的控制程序文件? 是否有经常巡查(公司内部或第三方检查)? 1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit. 在审核其间有没有发现窗户破损及房顶漏水可能导致产品污染。 1.0.6 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses, and needles to be mixed with product. (严重) 工厂是否实行严格的利器控制程序,以防止剪刀、小刀、刀片、碎玻璃及针等混入产品中。  

1.1 Machine Calibration and Maintenance机器校准和维护 1.1.1 Factory has documented system and procedure for scheduled equipment cleaning and repairs. 工厂是否有书面的文件系统和程序计划安排设备的清洁及维修。 1.1.2 Factory machines and equipments appear to be clean and in good running condition. 工厂的机器和设备是否清洁及运行良好。

1.1.3 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule. 机器、设备和工具是否有最近的维护/校准日期及计划日期的标识。 1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use. 需要维修机器、设备和工具是否有维修标识以避免意外使用。 1.1.5 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves. 工厂是否有适当,整洁的存储区域储存关键模具(比如:注射模具), 并且放在有标识的架子上。 1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments. 工厂有适当的机器、工具、零部件和设备的库存文件,并保持更新。 1.1.7 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines. 工厂是否拥有一定技术水平的保养团队和设备可以执行必要的机器维修和校准的工作。  

2.0 Quality Management System质量管理体系
2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures. 工厂是否建立起符合他们产品和生产流程的质量管理体系。 2.0.2 Workers & Supervisors are familiar to these quality policies and objectives. 工人与主管是否熟悉这些品质政策和目标。

2.0.3 Factory has documented customer complaint system and documented recall program. 工厂是否建立了顾客投诉体系及产品召回程序。 2.0.4 (Critical) Factory QC team is independent from Production division. (严重) 工厂QC团队是否独立于生产部门。

2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented) 是否有书面记录显示生产管理和QC团队共同讨论、解决质量问题及其他相关的问题. 2.0.6 Factory has systems and procedures in place to control the risk of physical, chemical, and biological contamination that may damage the product and personnel as well. 工厂是否有系统和程序去控制那些可能会影响产品或对人造成伤害的物理、化学和微生物污染风险。 2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools. 工厂是否进行风险评估,以识别化学品、原材料、工艺设备和工具中带来的危害。 2.0.8 Is factory accredited with any international, national or customer quality standards association (e.g. ISO 9001, etc.)? 工厂是否取得了国际的, 国家的或客户的质量标准组织认证证书(例如: ISO 9001证书, 等.)?  

3.0 Incoming Materials Control来料控制
3.0.1 Has the factory taken adequate measures to assure raw materials conformance to required specifications before use? 工厂是否检测原物料以确认是否与要求的明细规格一致? 3.0.2 Proper first in-first out (FIFO) system on materials are practiced. 工厂是否实施物料先进先出(FIFO)体系。

3.0.3 Factory has procedures (instructions, guidelines, and documented records) for quality inspection on incoming raw materials, accessories, and components. 工厂是否有进仓原物料、配件和部件的质量检验程序, 作业指导书, 及记录文件。 3.0.4 Is needed testing equipment available, and maintained in good condition? 所需的来料测试仪器是否配备及保持在一个良好的状态? 3.0.5 Are raw materials properly...
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