工廠是否擁有一定技術水平的保養團隊和設備可以執行必要的機器維修和校準的工作。

2.0 Quality Management System質量管理體系

2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures.

工廠是否建立起符合他們產品和生產流程的質量管理體系。

2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.

工人與主管是否熟悉這些品質政策和目標。

2.0.3 Factory has documented customer complaint system and documented recall program. 工廠是否建立了顧客投訴體系及產品召回程序。

2.0.4 (Critical) Factory QC team is independent from Production division.

(嚴重) 工廠QC團隊是否獨立于生產部門

2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)

是否有書面記錄顯示生產管理和QC團隊共同討論、解決質量問題及其他相關的問題.

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.

工廠是否有系統和程序去控制那些可能會影響產品或對人造成傷害的物理、化學和微生物污染風險。

2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools.