FCCA013 Quality System Audit Outline (Bilingual)updated(FCCA质量体系审核纲要).docVIP

FCCA Quality System Audit Outline FCCA质量体系审核纲要 ? (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，