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.