Practical Guide for Root Cause Investigations - Methodology & Tool Kit - Training / Workshop von PDA Europe gGmbH


This engaging two-day workshop teaches a step by step, proven process ideal for researching any change/decline in the performance of a product or work process/system, whether it be physical or virtual. It is appropriate for individuals new to this discipline, as well as those who are seasoned veterans looking to improve/refresh their skills, regardless of industry or function within the organization. Simply put, this is one of the most practical and applicable trainings available!

On day one, the participants are introduced to the seven step methodology. A Roadmap is provided to guide the participants through the steps and suggest appropriate tools to ensure the right questions are being asked, the right data is being collected, and the right documentation is being made. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strengthening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.

Participants will be emailed a set of electronic templates. These templates, plus the Roadmap, guide the investigator through the methodology and provide the basis for documentation.


  • Identify the technical root cause(s), that is, the change(s) that occurred.
  • Identify systemic root cause(s), that is, any underlining breakdown in the organizations broader systems that allowed the change(s) to occur.
  • Implement a comprehensive corrective and/or preventive action plan to restore performance.
  • Implement a control plan to minimize and/or prevent recurrence.


  • Quality
  • Risk management
  • Regulatory affairs
  • Compliance
  • Manufacturing
  • Product development
  • CAPA
  • Supply chain & purchasing
  • Production
  • Engineering
  • Project management
  • R&D
  • Fraud management and more

SG-Seminar-Nr.: 1804294

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