ISO22716变更控制与内审管理

15 Change control 变更控制

Changes that could affect the quality of product should be approved and performed by authorized personnel on the basis of sufficient data.

任何会影响到产品质量的变更均应当经过批准，并需要有足够的数据作为变更的依据。

16 Internal audit 内审

16.1 Principle 条例

An internal audit is a tool which is designed to monitor the implementation and the status of these cosmetic Good Manufacturing Practices and, if necessary, to propose corrective actions.

内审是用于评价化妆品公司是否具有良好生产规范并不断改进的管理活动，

16.2 Approach 方法

16.2.1 Specially designated competent personnel should conduct internal audits in an independent and detailed manner, regularly or on demand.

专业人员通过独立的或者详细的，定期或者按规定要求的方式进行内审

16.2.2 All observations made during the internal audit should be evaluated and shared with appropriate management.

审核中所观察发现到的问题要与部门经理确认并和部门人员分享。

16.3 Follow-up 追踪

Internal audit follow-up should confirm the satisfactory completion or implementation of corrective action.

内审追踪应验证结果是否满意或采取的措施是否正确。