Quality Event Management and the CAPA System Part 2: Taking Effective Actions

February 6, 2018

In part two of this series, MasterControl Partner Ken Peterson talks about the action component of corrective and preventive action (CAPA). Once you’ve identified the root cause, you need to determine which action completely eliminates that cause. You also need to consider what’s required to carry out the action and the potential ripple effect on other processes.

With any corrective action, there’s a potential cost that needs to be identified beforehand so you can prepare for it. Part of preparing includes meeting the SMART criteria. Is your action specific, measurable, aligned, realistic and time bound? Asking the right questions now lets you anticipate possible problems and mitigate them by implementing preventive action.

The corrective action you’ve determined to pursue is useless unless you have a good implementation plan in place. Communicate with everyone involved, determine what resources you need, and get the necessary approvals. Once you have a plan in place that’s complete and realistic, the most important thing is to stick to it.

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