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,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 labeled, stored, and traceable?

所有的原物料是否有合适的标识, 储存及可溯性？

3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.

工厂是否有文件程序和参考样品以确保来料符合规格.

3.0.7 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items.

(严重) 工厂是否建立起适当的物料控制体系, 以隔离不合格的原材料及避免意外污染?

3.0.8 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement.

工厂是否分离良品与不良材料,并标识所需更换的不良材料.

3.0.9 Facility's storage areas have sufficient lighting, well ventilated and clean surrounding. 厂房的存储区域是否有足够的照明、通风和清洁.

3.0.10 Materials, components, and accessories are properly stacked and identified with tags / labels and off the floor.

材料、部件和配件是否妥善堆放并有标牌/标签,且与地板隔离.

3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.

(严重) 化学品和保养的物质是否妥善标识和储存,以防止污染的风险.

3.0.12 Does factory have a documented supplier selection and approval process?

工厂是否有书面的供应商的的选用和认可流程?

3.0.13 Does factory track, evaluate and document material's supplier reliability (performance)?

工厂是否跟踪及评估物料供应商的可信度(表现)并记录在案?

3.0.14 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability?

工厂是否建立起书面的对分包商的品质控制流程文件? 是否有评估及监督分包商的品质表现及信赖度?

4.0 Process and Production Control过程和生产控制

4.0.1 Does factory PD study and apply product safety features, evaluates patterns, moulds, and samples during product design and development?

产品设计和开发部门是否在产品设计及开发过程中研究与应用产品安全特性,评估样式、模具和样品？

4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.

工厂是否在每一个生产操作阶段都有质量程序文件.

4.0.3 Does factory conduct Pre-production meeting prior to start of production?

工厂在生产前是否进行产前会议？

4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?

(严重) 在产前会议中有没有审查及确认严重的质量问题和安全问题并记录采取的改进行动？

4.0.5 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"试生产",根据产品规格明细检讨产品质量, 并记录在生产前的纠正行动？

4.0.6 Was in house lab-testing performed on current production? (Request for test copies)

当前生产有没有实施内部实验室测试？(要求测试记录副本)

4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?

工厂QC是否根据客户签样和产品规格表来制定首件样品？

4.0.8 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、参考样品和作业指导书提供给工人做适当的指引？

4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?

(严重) QC是否被授权当产品质量不符合规格时是否有权停止生产？

4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.

在每一个操作过程是否由QC 执行巡检(IPQC).

4.0.11 Is quality of item acceptable on current production? (Check 8 finished products taken from factory final inspected goods and check for major defects on the item.)

现行生产的产品质量是否可以接受? (检查8个已检验的完成品是否有主要缺陷)

4.0.12 Factory QC inspects per standard AQL or as per industry standards.

工厂QC检验是否按照AQL抽样检验标准或按照工业标准.

4.0.13 Factory performs 100% functionality check on final products?

工厂对最终产品有没有实施100%功能性检查?

4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)

工厂是否使用纠正措施和根本原因分析方法？(请提供例子)

4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?

工厂是否有工作指引以确保产品包装是正确的？

4.0.16 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？是否清洁和有秩序？

4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包装纸箱是否储存在封闭区域内, 没有暴露于阳光和潮湿天气.

4.0.18 Does factory track and document on-time ship performance?

工厂是否有跟踪和记录准时出货的表现？

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? (Please refer to the FCCA attachment for in-house lab testing requirements.)

工厂是否执行内部实验室测试和配备适当设施(请参考FCCA 内部实验室测试要求的附页)？

5.0.2 All gauges and test equipments have valid calibrations.

所有量规和测试设备是否有效校准.

5.0.3 Testing manuals of various industry standards are available as reference.

是否有各种行业标准测试手册作为参考.

5.0.4 In-house Lab Technicians are properly trained to perform testing functions.

内部实验室的技术人员有没有受过适当训练来执行测试工作.

6.0 Final inspection最终检验

6.0.1 Does factory have procedure and working instruction for final QC?

工厂有没有最终检验程序, 最终检验QC有没有工作指导书？

6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.

工厂QC 有没有根据AQL抽样检验标准或行业标准来实施最终检验.

6.0.3 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC.

最终检验QC有没有客户签样或参考样品, 包装清单以及出货唛头作参考.

6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?

有没有正式的最终检验报告? 这些报告是否归档及可追踪产品质量?

6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?

工厂最终检验QC有没有做一些机械测试以确保产品的安全性?

6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?

检验及测试的仪器设备是否使用良好且有校正?

6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.

(严重) 退货的产品在客户最终检验前有没有得到适当纠正.

6.0.8 Factory does not ship goods unless subjected to release procedures from customer.

工厂有没有程序控制只有当客户同意的情况下才能出货.

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) 工厂有没有实施、记录、保持对所有人员进行岗位培训, 对技术工人在聘用前进行测试.

7.0.2 2. Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QC and Lab Test Technician.

工厂有没有对电气/机械工程师、技师、检验员和实验室测试技术员实施技术培训,并保持记录.

7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.

是否有保存所有人员的培训记录和个人表现记录？