Root Cause Investigation for CAPA is a two-day training teaching 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), 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, the 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 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 investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.
Upon completion of the training, participants will able to immediately, effectively, and efficiently apply the methodology to identify root causes and restore performance, saving valuable time, resources, and reputation.
Who Should Attend
The training is appropriate for professionals who conduct or participate in root cause investigations from all industries, particularly those that are highly regulated (medical device, pharmaceutical, aerospace, defense, food, automotive, financial services, etc.), or organizations maintaining one of the various ISO certifications. Alumni of this program typically (though not exclusively) have a background in: quality, risk management, regulatory affairs, compliance, manufacturing, product development, CAPA, supply chain & purchasing, production, engineering, project management, R&D, fraud management, and more.