Fundamentals of Root Cause Evaluation for CAPA and Deviation

Root Cause Evaluation for CAPA (Corrective and Preventive Action) and Deviation is a crucial process in quality management systems to identify the underlying reasons for issues and implement effective corrective and preventive actions. 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

Why should you attend?

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). 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.

Learning Objectives

• Understand the importance of problem-solving and how Root Cause Analysis can be used to identify and address the underlying issues in a process or system.
• Develop a clear and compelling problem statement and learn how to create a SIPOC diagram to provide a view of the situation.
• Utilize process mapping tools to visualize the steps of a process and identify areas for improvement, including Spaghetti Diagrams for physical activities and Communications Circle for virtual/interaction activities.
• Use quantitative root cause identification tools, such as Is/Is Not, Fishbone and 5-whys, and Inter-relationship diagram, to identify potential causes of a problem.
• Collect and present data to support the analysis, using tools such as Data Collection Planning, Pareto charts, and Histogram graphics.
• Identify and prioritize solutions using brainstorming techniques and four prioritization tools, including Failure Modes and Effects Analysis and Mistake Proofing.
• Understand how to use Visual Management to assist in the deployment, assessment, and management of solutions and other controls in the operating environment.
• Be equipped with a complete framework that considers the context and situation the analysis is being applied to, supporting successful execution and being able to maintain any actions that have taken place as a result.
• Be able to effectively analyse problems and develop solutions that achieve process improvements, leading to increased efficiency, productivity, and customer satisfaction.
• Enhance their problem-solving skills and apply the principles and tools of Root Cause Analysis to a variety of business scenarios, leading to better decision-making and problem resolution.

Cours Content

• The Root Cause Problem: difference between content and critical thinking
• Root Cause Elimination 
• Root Cause Process and Analysis Steps
• The logistic of Root Cause Analysis
• Understand the process
• Sept (7)-step investigation methodology
• Event and Problem Definition
• Find and Idendify the the possible causes
• Data collection and Analysis
• Human Error Consideration 
• Enterprise and Organizatinal assets affecting RCA project
• Consideration of Statistical Tools and Six Sigma

Who should attend

• This training course is intended for professionals who conduct or participate in root cause investigations for all medical devices and pharmaceuticals.
• Departments Manufacturing, Quality Assurance, Quality Control, Facilities, Engineering, Project Management, Supply Chain
• Roles Manager, Supervisor, Specialist, Analyst

Education approach

• Lecture sessions are illustrated with examples based on case studies
• Practical exercises include examples and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer