Quality Metrics相关问题求助

larffier

各位大侠：
    我公司在过澳大利亚GMP认证，其中一条缺陷是：“there is no formal system for regularly capturing and reporting quality metrics in order to fulfil the requirements of “Management Responsibilities” as defined in ICH Q10 Sections 3.2.4 and 4.1.”
    目前已查阅ICHQ10相关条款，但仍对quality metrics 不是很理解该怎么做。
    请问大家针对这条缺陷，该如何整改呢？

道路漫长黑暗

What Are Quality Metrics?

When evaluating whether a project or business is successful, companies measure performance against quality standards to determine whether they’re meeting expectations. Quality standards vary from company to company, but they should be tied to the business mission and organizational goals. Tracking quality metrics can reveal weaknesses in a process or product, which notifies a business of the necessity to correct areas of deficiency quickly.

道路漫长黑暗

Determining Quality Metrics
Before deciding on the quality metrics to track, company management needs to define its organizational goals and desired outcomes. That helps them ask the right questions about the processes needed to be put in place and how to measure success. For a company that produces products, quality metrics can include defects per unit or per batch. Quality metrics also may include data that measures supply chain performance, customer service or financial targets.

Setting Standards
Quality metrics don’t tell much in a vacuum. They should be judged against a baseline, whether that takes the form of industry standards or a business’s own track record. Companies should insert quality metrics into each phase of their processes to ensure there aren’t any gaps. By tracking the performance of these metrics over time, company leaders can quickly measure how well the processes are working and what areas need improvement.

幻影

全是拼音，怎么理解。

476258417

看到一沙一叶老师写的：
       在回答听众提问时，余煊强博士强调了质量量度(Quality Metrics)[/b]的概念。质量量度适用于产品、工厂和质量体系。

质量量度仅是整个图景的一部分，旨在加强FDA的分析能力,而非取代现有测量方法。质量量度提供了产品质量、工厂和质量体系的当前状态。FDA正在征求公众意见以发展最佳的质量量度体系。

玻璃杯

476258417 发表于 2014-7-22 22:32
看到一沙一叶老师写的：
       在回答听众提问时，余煊强博士强调了质量量度(Quality Metrics)的概念 ...

FDA的质量办公室主任，观念很新的，FDA确实是想办实事的，和我朝的CFDA光想着如何改名是完全不一样的

玻璃杯

想改好，改成完全符合审核人员的心意，怕是难于上青天了
建议咨询教授，最后祝圆满解决。

yuansoul

老外的意思是：你们阴阳五行学说太浓厚，评价事物不是拍脑袋就是拍屁股。酱紫是不行的。

tsingsea

来学习了{:soso_e163:}