Root Cause Investigation for CAPA teaches a proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc.
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), 8D, 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
The participants learn the seven-step root cause investigation methodology through hands-on application. After each step is presented leveraging a trainer case study, the participants immediately apply the concepts on their own case study (which is based upon a real-life investigation).
Participants receive an Investigation Roadmap that details the methodology and suggests appropriate tools. They will also be emailed a set of electronic templates. These tools guide the investigator through the methodology and provide the basis for documentation.
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.