本帖最后由 beiwei5du 于 2017-9-7 16:00 编辑
各位蒲友：
先举一个例子，车间计划将“机械台秤”变更成“电子台秤”，那么变更初始风险评估出发点有两个角度：
1、从变更“机械台秤”的角度进行风险评估（不考虑变成什么）；
2、从“机械台秤”变更为“电子台秤”后的角度进行风险评估；
下面有投票，烦请投一票！希望将想法也说说！谢谢！
你们选择哪一种呢？？？
下文选自：<Current Chanllenges in Implementing Quality Risk Management>
http://blog.ispe.org/current-challenges-in-implementing-quality-risk-management
2. Risk assessment to justify a decision, not assess risk
The intent of QRM is to make data-driven and scientifically sound decisions proactively, not to justify an action or a decision that has already been taken. The outcome of a risk assessment may, of course, support an action, but there should be a logical, fact-grounded rationale to defend what is done. Considering risks should be a thoughtful inquiry instead of a biased vindication. Our experience shows that when risk assessments fall into this category, they sometimes lead to risk treatments that, when challenged by regulatory inspectors during inspections, do not withstand any level of scrutiny. In these cases, decisions are often not aligned with facts or the way that the risk question was explored. “Change control” is a quality system element used by some organizations in which QRM is used to justify the proposed plan asking “What could go wrong?” and then devising a control strategy for that possibility. Consider a case where QRM was performed in conjunction with a proposal at a drug product facility to revise (i.e., mainly reduce) calibration frequencies for instruments and other measuring devices at the site.
- In the risk assessment, the proposed reduced calibration frequencies identified two unacceptable risks. These were considered mitigated by three types of currently in-place detection-related controls: daily verification checks, in-process controls, and finished product testing.
- While to some the risk-reduction strategy may have seemed adequate, when the details were examined on inspection, it became evident that many types of instruments and equipment items at the site (including those deemed critical—e.g., pressure transmitters and in-line temperature probes) were not required by procedure to have any kind of daily verification checks performed, and the validity of this type of control for the risk in question was highly questionable.
- It was not clear how the two other types of documented risk-mitigating controls—in-process controls and finished product testing—could lead to the timely detection of process variation due to out-of-calibration instruments and other equipment items.
- Closer examination revealed that the risk-assessment part of the change control could actually assign the same 12-month default calibration frequency to both GMP-critical and GMP-noncritical instruments. There was no documented explanation to justify the practice, even though inspectors often want to know the basis or rationale for a decision.
Given the nature of the deficiencies seen with this application of QRM, it was clear that a true sense of inquiry and objectivity were lacking in the risk-assessment process to evaluate the proposed change; the emphasis seemed more on justifying the change control proposal. While Q9 does use the word “justify” in its guidance (though only twice in Annex II of the guideline), the emphasis of risk assessment in Q9 is more on “evaluate” or “determine,” terms that are used multiple times. This points to the importance of analysis over defending a particular position or proposal. | 
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发表于 2017-9-7 15:56:34
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