Ask the Experts- MCC Answers Your Metric Questions

With more organizations focusing on metrics, the MCC has received an increase of questions ranging from how to use metrics, why some metrics are better than others, which type of metrics is best to use, as well as questions about specific MCC Metrics. This column provides a forum for us to share these questions and answers with you.

MCC Members at the Gold or Platinum benefit level, can access the “MCC Ask the Experts – Questions and Answers Archive” by logging into the MCC member website. Interested in becoming a member or have questions about your membership? Contact membership director, Terry Holland.

May 2019

A: You’re right – ICH E6(R2) 5.20.1 states “[for a significant noncompliance] the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.” This is an important addition to ICH E6(R2) but it doesn’t help clarify the terms corrective action and preventive action. It is immediate actions (sometimes called containment actions or corrections) that are aimed at trying to contain an issue. These are the actions that you can implement without knowing the root cause(s). For example, in a car accident they are the actions such as getting passengers safe and turning off the engine.

Corrective actions, meanwhile are the ones where ideally, you have a good understanding of root cause(s). They are actions designed to act on those root causes or to stop the cause-and-effect chain of events so that a similar issue doesn’t recur. In a car accident, you might discover it was caused by a tire failure and that an inferior re-tread brand was used. A corrective action would be to use better quality tires in future.

ICH E6(R2) does not link preventive actions and reducing risk by risk-based quality management (section 5.0) but the international quality standard ISO9001:2015 does make that important link between preventive actions and risk reduction. Preventive actions are really risk reductions or risk controls. They are aimed at reducing the risk of the issue from occurring in the first place. In the car accident example, a preventive action may involve a regulatory agency taking action to ensure only a certain quality of tire can be purchased and fitted.

MCC staff will be presenting on this topic at events in May and MCC will be issuing a white paper on this topic shortly.

Meet the Experts

Keith Dorricott, MCC Ambassador and Director,
Dorricott Metrics and Process Improvement, LTD

Linda B. Sullivan, Co-Founder & President,
Metrics Champion Consortium

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