Clinical CAPA Management Performance Metrics Working Group

MCC Releases CAPA Process Performance Metrics Set v1.0

In 2015, Metrics Champion Consortium (MCC) member organizations requested that the MCC facilitate the development of a standard set of Corrective Action, Preventive Action (CAPA) performance metrics.  While many organizations follow a CAPA process, few actually measure how well it’s executed, and of those organizations that did measure their performance, they lacked confidence in the measures they had defined.  They felt it was time for this sector of the industry to collaborate on a set of measures that could be used to help manage and improve their CAPA processes. MCC responded by launching the CAPA Performance Metrics Initiative to define a standardized set of CAPA performance metrics that would be used by clinical trial sponsors and CROs to assess the timeliness, quality and effectiveness of their CAPA process.  The metrics will help organizations raise the quality of their CAPA process, which in turn can contribute to higher quality trials. In the initial phase of developing the metric set, MCC worked exclusively with a CAPA Leadership Team that established the direction for building the metrics. Specifically, they used the MCC Metrics Development Process to develop a CAPA Process Map, Define CAPA Critical Success Factors (CSFs) and draft Key Performance Questions (KPQs). In the second phase, the Leadership Team’s output became the input for an MCC CAPA Working Group.  This group of members vetted and refined the work of the Leadership Team to define a basic set of CAPA metrics that they believe any organization can and should use to oversee the performance of their CAPA process.  The complete set of CAPA performance assets that are available for downloading by MCC members includes:
  • Recorded Presentation of the CAPA Process Metrics
  • PowerPoint Slides of the Presentation
  • CAPA Process Map
  • Detailed MCC CAPA Performance Metric Definitions
(Wiki Terms are included with the metrics definitions) MCC members are invited to visit the Existing Metric Sets section of the MCC Member Portal to view all of the CAPA Metrics Initiative materials. Please contact Keith Morgenstern for additional information To learn more about membership options or to register to become a member of the MCC please CLICK HERE or contact MCC Membership Director, Teresa. Return to Work Group List