雅诗兰黛验厂之管理层职责及培训要求
2018-03-02
B、MANAGEMENT RESPONSIBILITY 雅诗兰黛验厂之管理层职责
1. Is there a periodic Management review conducted of the Quality system to assure its continuing adequacy, suitability and effectiveness?
是否对质量体系有定期的管理评审以确保其持续的充分性，适宜性和有效性？
2. Does this management review include:管理检查包括：
(1) training effectiveness培训效果
(2) internal & external audits内部和外部审查
(3) quality problems质量问题
(4) complaints investigation意见调查
(5) corrective and preventative actions (CAPA)纠正和预防措施
3. Is there sufficient Engineering, Production, Quality Assurance and Customer Service support to meet customer requirements/needs?
有足够的工程，生产，质量保证和客户服务来满足客户的需求？
4. Are GMP, regulatory and customer requirements communicated, as appropriate to each level of the organization?
每一级组织是否有适当的GMP，法规和顾客的要求传达？
5. Is top management notified of quality critical situations in a timely manner?
最高管理层及时通知质量重要情况？
C、TRAINING 雅诗兰黛验厂之培训要求
1. Is there a documented training program in GMP's, QA procedures and policies, equipment operation and safety?
是否有GMP的质量保证程序和政策，设备运行和安全的书面培训计划？
2. Is there a training program for new employees? 是否有新员工培训计划？
3. Are training records up to date? 培训记录是最新的吗？
4. Is the effectiveness of training assessed? 评估培训的效果如何？
5. Is refresher training conducted at defined intervals? 进修培训是否在规定的时间间隔内进行？
6. Are temporary personnel trained or under supervision of a trained person? 临时人员培训或训练是否在受过训练的人监督下？
