为何很多工厂都不能顺利通过COSTCO GMP质量审核呢？深圳创思维验厂总结众多顾问老师的经验及教训，审核员现场解读现综合分析如下：

1. 员工不了解工厂的质量和产品安全方针;

 Employees are not familiar with factory quality and products safety policy.

2. 只有个别部门有设定质量可测量的目标；未定期考核目标的执行情况。当目标未达到时，无相应的原因分析和改善方案。

Only several departments have established measurable quality objectives. No regular monitoring of the achievement of Quality objectives. There is no root causes or improvement actions when objectives are not achieved.

3. 内审和管理评审未包括GMP方面；

Internal audit and management review do not include the content related GMP.

4. 工厂的外来文件清单不完整，比如缺客户标准、产品销售地相关法规标准，产品标准等， 且未按受控要求发放。

The external documents lists are not complete, such as Client‘s requirements, Laws and Regulations of products sale markets, product related standard, etc are not listed and under controlled distribution.

5. 风险评估不完整，比如：缺程序，记录不完整（生产，包装或存储过程中物理，化学，生物方面对产品的污染），控制措施，人员的职责等。

Risk assessment is not complete, such as no documented risk assessment procedure, risk assessment records do not include physical(sharp tool, glass)，chemical (heavy metal) or biological(pest, mould) contamination during the production, packaging or storage processes, no control method, no responsible person, etc

6. 工厂没有对供应商/分包商的初选评估或定期评估记录。

No pre- assessment assessment or regular assessment records for suppliers/subcontractors.

7.仓库物料，半成品，成品无日期或批号标识，不能确认工厂先进先出是否有 效实施，不能实施追溯。

No receiving date or batch number for materials, semi-products, final products to make sure FIFO policy or traceability is implemented in audited factory.

8. 无模拟召回记录，或者没有保存召回中追溯的记录。

No simulation recall drill records, or the simulation recall drill records are not complete, such as the tracing records are missed

9. 文件备份无周期要求；无应急计划

 No back up period requirement on data or server. No emergency contingency plan

10. 物料/产品未离地离墙靠窗存储

 Materials or products are stored on the floor directly， closed to the outside wall and window.

11. 墙皮脱落发霉、地面脏、有蜘蛛网, 屋顶破导致地面积水等

 Wall surface are peel off or have significant mould sign, dirty floor, spider web observed， broken roof result in wet ground；

12. 车间和仓库无自动关闭门/门帘。窗户打开,没有安装纱窗。生产和存储区域的灯无屏蔽罩。

No self-closing door or curtain for production and storage area. Open window without screen. Lights are not shielded or shatterproof in all production and storage areas including receiving, docks and storage areas.

13. 工厂无清洁计划和实施记录。

No Master Sanitation Schedule (MSS) and implementation records

14. 工厂无预操作检验程序验证设备已有效清洁且状态良好

No pre-operative inspection program to verify that cleaning methods are effective and that equipment is in good repair

15. 木栈板存储不合适、破损、无程序、清洁检查记录。

Wood pallets are not properly stored. They are broken. No Wood pallets control procedure. No sanitary checking records for being used Wood pallets.

16. 无虫害控制人员培训记录/第三方虫害公司的资质证明。无虫害控制记录。无捕鼠装置、灭蝇灯装置、无分布图、位置安装不合适。

Internal pest control operator has not training records. No copy of the licenses for the pest control company and current license for inspectors. No pest control records kept. No rodent traps and no fly-killer lamps or not properly installed. No map indicating the locations of all rodent traps and fly-killer lamps which should be cleaned regularly.

17. 员工不懂AQL, 内审员无内审培训记录或不熟悉内审要求，年度培训计划无GMP相关的培训课题；或者无考核记录。

Employees are not familiar with AQL. Internal auditors are not trained or not familiar with internal audit requirement. Annual training plan do not including the topic on GMP. No validation records for each training.

18. 部分测试设备校准已过期。

Some of test equipments are out of calibration date.

19.机器设备的生产参数未按规定的要求控制。

Required production control parameters are defined but not controlled well during the production process.

20. 食物或饮料带入生产和存储区域

 Food or beverage are found in production and storage area.

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