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性别保密
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发表于 2017-8-26 10:01:13
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关联一下：
Management Review – what is it for?
https://www.inspiredpharma.com/2012/09/10/management-review-what-is-it-for/
在FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
5. Review the System
System review is a key component in any robust quality system to ensure its continuing suitability, adequacy, and effectiveness. Under a quality system , senior managers should conduct reviews of the quality system’s performa nce according to a planned schedule. Such a review typically includes assessments of the pr ocess, product, and customer needs (in this section, customer is defined as the reci pient of the produc t and the product is the goods or services provided). Under a quality systems approach, a review should consider at least the following:
1、The appropriateness of the quality policy and objectives
2、The results of audits and other assessments
3、Customer feedback, including complaints
4、The analysis of data trending results
T5、he status of actions to prevent a potential problem or a recurrence
6、Any follow-up actions from previous management reviews
7、Any changes in business practices or environment that may affect the quality system (such as the volume or type of operations)
8、Product characteristics meeting the customer’s needs
When developing and implementing new quality systems, reviews should take place more frequently than when the system has matured. Outside of scheduled reviews, the quality system
should typically be included as a standing agenda item in general m anagement meetings. In addition, a periodic review performed by a qualif ied source, external to the organization, may also be useful in assessing the suitab ility and effectiveness of the system.
Review outcomes typically include:
1、Improvements to the quality system and related quality processes
2、Improvements to manufacturing processes and products
3、Realignment of resources
Under a quality system, the results of a management review would typically be recorded. Planned actions should be implemented using effective corrective and preventive action and
change control procedures.
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