Designing and Evaluating Effective CAPA Systems
Situation:
Following the success of the initial CAPA training for senior leadership, it became evident that a deeper dive was needed to address CAPA creation quality at a granular level. Many CAPAs lacked specificity, measurable outcomes, or failed to address multiple contributing factors in a single issue.
Task:
I was tasked with creating a level-up training course that would teach teams how to:
- Design CAPAs that are auditor-ready,
- Distinguish between poor and effective CAPAs,
- Create multiple CAPAs for complex investigations,
- And apply the SMART framework for measurable results.
Action:
I built the course in Rise 360, combining interactive content with AI VoiceOver narration to enhance clarity and accessibility. The course included:
- A breakdown of what makes a CAPA effective (structure, evidence, ownership, timeline),
- Practical exercises in writing SMART CAPAs,
- Examples of strong vs. weak action statements,
- Guidance on evaluating CAPA effectiveness and implementation tracking,
- An application-based quiz to test learners’ ability to identify and design appropriate CAPAs.
Result:
The course led to a 75% reduction in CAPA creation errors across departments. It was widely praised by EVERSANA teams for being clear, actionable, and aligned with real-world audit expectations. The training is now a required follow-up for all leadership and QA professionals involved in CAPA processes.