FCCA质量体系审核纲要
来源：中国验厂网 发布时间：2013-1-28
FCCA Quality System Audit Outline
FCCA质量体系审核纲要
(Quality System part质量体系部分)
Factory Quality System工厂的质量体系
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?足够的照明上：生产，返工，加工，检验，包装及装载的区域？
1.0.2 The facility maintains clean and organized production, finishing and packing areas.
工厂保持清洁和有组织的生产，加工和包装领域。
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工厂有单独的检验区与检验台并且适当的通风设备。
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工厂已记录害虫/霉菌和湿度的控制程序，其中包括经常巡查。(在公司内部或第三方)
1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit.没有打破窗户或屋顶漏水，可能导致产品污染的观察审核期间。
1.0.6 Factory has metal detecting unit. (Scoring will not apply (N/A) if factory does not need this machine.)工厂有金属检测单位。
1.0.7 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses and needles to be mixed with product.
(重要)工厂实行严格的尖锐工具控制程序，以防止剪刀、刀、刀片、碎玻璃和针头，以混合的产品。
1.0.8 Factory has back-up power supply available. “Generator”工厂有后备电力供应。“发电机”
1.1 Machine Calibration and Maintenance机器校准和维护
1.1.1 Factory machines and equipments are appropriate to produce Wal-Mart products.工厂的机器和设备是适合的生产沃尔玛的产品。
1.1.2 Factory has documented system and procedure for scheduled equipment cleaning and repairs.工厂有文件体系和程序，预定设备清洗和维修。
1.1.3 Factory machines and equipments appear to be clean and in good running condition.
工厂的机器和设备显示是清洁和良好的运行状态。
1.1.4 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule.机器、设备和工具有适当的标识最后维修/校准日期及进度表。
1.1.5 Machines, equipments and tools that needs to be repaired are properly labeled to avoid accidental use.机器、设备和工具需要维修时有标识以避免意外使用。
1.1.6 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves.工厂有适当的，清洁的和有组织的存储区域的关键模具(即注射模)与标识的货架上。
1.1.7 Factory has proper documentation and updated inventory of machines, tools, spare parts and equipments.工厂有适当的文件和更新库存机器、工具、零部件和设备。
1.1.8 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines.工厂维修团队与合适的技术水平和设备，以履行必要的维修和校准的机器上。
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.工厂建立适合产品和程序质量管理体系。
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.工人与主管所熟悉的这些质量的政策和目标。
2.0.3 Factory has documented customer complaint system and documented recall program.工厂已记录了顾客投诉体系，并记录召回计划。
2.0.4 (Critical)Factory QC team is independent from Production division. (重要)工厂QC团队是独立于生产部门。
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)生产管理和QC团队讨论和共同努力在解决质量问题/关注的问题。（记录）
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.工厂有制度和程序能控制物理、化学和生物污染风险，可能会损害产品和人员。
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments and tools.工厂进行风险评估，以识别危险化学品、原材料、工艺设备和工具。
3.0 Incoming Materials Control进料控制
3.0.1 Proper first in-first out (FIFO) system on materials are practiced.物料实施先进先出(FIFO)体系。
3.0.2 Factory has procedures for quality inspection on incoming raw materials, accessories and components.工厂有对进仓原物料、配件和部件质量检验的程序。
3.0.3 Incoming and outgoing material quantities are monitored and documented.进料和出货的物料的数量进行监测和记录。
3.2.4 Factory has specifications for purchased materials.工厂有采购物料规范。
3.2.5 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.工厂有文件程序和参考样品以确保进仓原料符合规格。
3.2.6 (Critical)Factory has proper system on material segregation to avoid accidental contamination from rejected items. (重要)工厂已适当的对物料隔离体系，不合格的项目隔离以避免意外污染，
3.2.7 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement.工厂适当隔离良品(不良品)，并确定不良品(拒绝)更换。
3.2.8 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding.厂房的存储区域周围有足够的照明、通风和清洁。
3.0.9 Materials, components and accessories are properly stacked and identified with tags / labels and off the floor.材料、部件和配件的妥善堆放并有标记/标签并与地板隔离。
3.0.10 (Critical)Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination. (重要)化学品和维修的物质妥善标识和储存，以防止污染的风险。
3.0.11 Color relevant materials such as fabrics, genuine leather and synthetic PU/ PVC, trims and accessories are sorted by lot numbers.颜色有关的材料如布料、真皮及合成聚氨酯/聚氯乙烯、装饰及配件按批号储存。
4.0 Process and Production Control过程和生产控制
4.0.1 Does factory have work area only for Product Development?工厂是否有产品开发工作区？
4.0.2 Does factory PD study and apply product safety features, evaluates patterns, moulds and samples during product design and development?在产品设计和开发工厂产品开发的研究与应用是否有产品安全功能、评估模式、模具和样品？
4.0.3 Does Product development includes packaging design and tests that conforms to industry standard (ISTA)产品开发包括包装设计和测试以确保符合行业标准(ISTA)。
4.0.4 Does factory PD perform assembly time-study on product and develop easy ways to use for consumer benefit?工厂产品开发在产品执行组装时间研究，产品开发和简便的方法使用的消费者受益呢？
4.0.5 Factory has documented Production procedures at each stage of operation.工厂有每一个阶段的运作生产程序文件。
4.0.6 Factory has documented Quality procedures at each stage of operation. 工厂有每一个阶段的运作质量程序文件。
4.0.7 Does factory conduct Pre-production meeting prior to start of production?工厂是否实施进行生产前的预产会议？
4.0.8 Are production and quality supervisors present during Pre-production meeting?目前在预产会议有生产和质量主管？
4.0.9 (Critical)Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting? (重要)是至关重要的质量和安全检查、审查，确定，并采取行动加以改进记录在预产会议？
4.0.10 Does factory conduct “pilot-run”, review product quality against specification sheet and document results with corrective actions prior to production?工厂是否进行“试运行”，检讨对产品质量的规格表和文件在纠正行动之前生产？
4.0.11 Is quality of item acceptable on current production? (Check 3 or 4 completed products from production floor).质量是可以接受的项目就目前的生产呢？(从生产区检查3或4个成品)。
4.0.12 Was in house lab-testing performed on current production? (Request for test copies)内部实验室测试是否实施当前生产测试？(要求测试的副本)
4.0.13 Does factory QC compare first piece samples with approval sample and specification sheet?工厂QC是否比较首件样品抽样检验和批准的规格表？
4.0.14 Are there adequate approved samples, first piece samples, reference samples and work instructions to provide workers with proper guidelines?是否有足够的核准样品、首件样品、参考样品和为工人提供适当的作业指导书？
4.0.15 Does factory use defective/ reject samples to demonstrate examples of common defects?
工厂使用有缺陷的/不合格样品是否普遍例子？
4.0.16 (Critical)Does Quality Control have authority to stop production if quality of products did not meet specification? (重要)如果产品质量不符合规格质量控制是否有权停止生产？
4.0.17 In-line inspections (IPQC) are performed by QC at every operation process.在巡检(IPQC)所执行品管在每一个操作过程。
4.0.18 Does factory use statistical process control (SPC for quality)?工厂使用统计过程控制?(质量统计分析)
4.0.19 Factory QC inspects per standard AQL or as per industry standards.工厂品管检验按照标准AQL或按照工业标准.
4.0.20 Factory performs 100% functionality check on final products?工厂最终产品实施100%功能性确认?
4.0.21 Does factory use corrective actions and root cause analysis methods? (Please provide examples)工厂是否使用的纠正措施和根本原因分析方法呢？(请提供例子)
4.0.22 Does factory have guidelines in place to ensure packaging is correct for product?工厂是否有指南以适当确保包装是正确的产品？
4.0.23 Does packing area have enough space to perform packing functions properly? Is it clean and organized?包装区是否有足够的空间用来履行包装职能？它是清洁和有组织的？
4.0.24 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather.包装纸箱都储存在封闭区域内没有暴露于阳光和潮湿天气。
4.0.25 Does factory track and document on-time ship performance?工厂是否有跟踪和文件准时出货职能？
4.1 Suppliers and Sub-contractors供应商和分包商
4.1.1 Does factory have a documented supplier selection and approval process?工厂是否有供应商选择和批准过程文件?
4.1.2 Does factory track, evaluate and document material’s supplier reliability (performance)?工厂是否跟踪、评价和文件物料供应商的可靠性(效能)？
4.1.3 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability?工厂是否有建立质量记录的程序和工厂评估、监测分包商的质量性能和可靠性呢？
5.0 In-House Lab-Testing内部实验室-测试
5.0.1 Does factory perform in-house lab testing and are facilities appropriately equipped?工厂是否执行内部实验室测试和配备适当设施？
5.0.2 All gauges and test equipments have valid calibrations.所有量规和测试设备有效校准。
5.0.3 Testing manuals of various industry standards are available as reference.各种行业标准测试手册是可作为参考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions.在内部实验室的技术人员受过适当训练的执行测试功能。
6.0 Final inspection最终检验
6.0.1 Does factory QC performs final inspection and documents it?工厂QC是否执行最终检验和文件？
6.0.2 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC.已核准的样品或参考样品与包装清单和唛头，可作为工厂品管参考的。
6.0.3 (Critical)Failed inspections are properly corrected prior to final inspection by customer.
(重要的)失效检验得到适当纠正在客户最终检验。
6.0.4 Factory does not ship goods unless subjected to release procedures from customer.
工厂不出货的货物除非从客户获得豁免的程序。
7.0 People Resources and Training人力资源和培训
7.0.1 (Critical)Factory conducts, documents, maintains on-job training for all personnel, or conducts pre-hire testing of skilled workers prior to hiring. (重要)工厂进行、文件、保持对在职培训的所有人员或进行岗前技能培训。
7.0.2 Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QA Auditor and Lab Test Technician.工厂进行和文件的技术培训计划电动/机械工程师，机械师，质量保证审计员和实验室测试技术员。
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.记录学员及所有工作人员定期与相应的业绩记录，保存和维修保养。
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