Root Cause Investigation for CAPA is a two-day training on a proven methodology ideal for investigating any performance change. Based upon 40+ years’ experience, this science-based methodology integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), as well as other techniques to identify:
- Technical root cause(s): the change(s) that occurred
- Systemic root cause(s): system failures that allowed the change(s) to occur
- Corrective and/or preventive actions: restore performance to previous levels
- Control plan: prevent recurrence
On day one, participants are introduced to the seven-step root cause investigation methodology. An Investigation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging a trainer case study, the participants will immediately apply their learning on their own case study (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.
Upon completion of the training, participants will be able to immediately, effectively, and efficiently apply the methodology to identify root causes and restore performance, saving valuable time, resources, and reputation. Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.