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 ?

  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?

  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?