Live eLearning - PDA 576.2 Root Cause Investigation for CAPA

Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify:

• Technical root causes: the change(s) that occurred resulting in performance decline
• Systemic root causes: failures that allowed the change(s) to occur
• Corrective and preventive actions: restore performance to previous levels or requirements
• Control plan: monitor and prevent recurrence

This training is designed to engage the participants the entire time. In addition to the instructor case study, lecture, polls, quizzes, and conversations, participants will apply the methodology during the training on a real-life case study. Participants are provided a training manual, an Investigation Roadmap, and a set of electronic templates that guide them through the methodology, recommend tools, and establish the basis for documentation.

1. Apply a 7-step investigation methodology to determine the root cause of a technical problem
2. Identify the technical root cause (the change) and any systemic root causes
3. Implement effective corrective/preventive actions
4. Develop and implement a control plan to prevent issues from reoccurring