MARS验厂咨询-全面评估工厂质量保障之从设备校准到外包实验室审批

"Is there a defined maintenance program that includes all assets required to manufacture product?
是否有维修保养的程序，包括制造产品需要的设备？"
"Are all measuring devices essential to quality production calibrated by recognised methods, labelled and records maintained?
是否所有的必备的测量设备通过认可的方法、标签以及维保记录来校准生产质量？"
"Are adjustments made to equipment in a timely manor when found to be out of calibration?
当发现设备失准，是否及时对设备进行校准？"
"Are all chemicals in use controlled to prevent contamination of the product?
是否所有在使用中的化学品已被控制, 以防止产品被污染？"
"Is there a pest control program in place being managed by competent operators?
是否有称职的人员管理虫害控制程序？"
"Does the program ensure that data is recorded, written reports with corrective actions are issued and trends reviewed?
程序是否确保数据已被记录，并有书面报告包括纠正措施及有效性评估？"
"Is there a RISK-BASED supplier qualification procedure?
是否有对供应商资格有风险上的审查程序?"
"Are Specifications agreed with suppliers with clear delivery performance criteria?
是否有和供应商就交货程序上制定清晰的标准?"
"Is there an ongoing inbound quality program?  
是否有对外部购买的材料进厂时有质量管理程序?"
"Is a mock recall performed?  
如果有问题是否有召回程序？"
"Is there an effective traceability system that is capable of tracing finished products including batches of materials used to make those finished items? 
是否有一个有效的追溯系统，能够追溯到成品的批次信息以及用于直接生产成品的材料的批次信息？"
"Is there a documented procedure for handling rework with full traceability?
是否有文件化程序处理返工及可以全程追溯"
"Is there on-site lab? Is there a laboratory manual?  Are Laboratories designed, equipped and operated in an effective manor? 
有沒有实验室在现场？是否有实验室手册？实验室的设计、装备和操作是否有效的进行？"
"Is there an approval process for outsourced laboratory analysis?
是否有审批流程去评判外包的实验室？"