Integrated Incident Investigation, RCA, and CAPA Training by Tonex
In this interactive Integrated Incident Investigation, RCA, and CAPA workshop, participants will delve into the interconnected realms of Incident Investigation, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA). We’ll move beyond prescriptive approaches that can restrict analytical thinking and instead emphasize an adaptive, critical thinking-based methodology. This ensures that root causes are genuinely understood, and corrective actions are both relevant and sustainable.
Learning Objectives:
Upon completion of Incident Investigation and RCA training, participants will:
- Learn the nuances of Incident Investigation, RCA, and CAPA, and how they complement each other.
- Develop critical thinking skills to approach incidents without bias or preconceived notions.
- Learn to identify true root causes instead of forcing them into predetermined categories.
- Gain techniques to develop relevant and sustainable corrective and preventive actions.
- Engage in real-world scenarios and case studies to apply learnings in a practical context.
Target Audience:
- Quality Assurance and Quality Control professionals
- Health, Safety, and Environmental (HSE) professionals
- Process Engineers
- Operations and Production Managers
- Any professional involved in incident investigations, RCA, or CAPA processes
Workshop Outlines:
Introduction to root cause analysis (RCA)
- What is root cause analysis?
- Purpose of RCA (Root cause analysis)
- Value proposition and benefits of root cause analysis
- Different types of root cause analysis
- Corrective actions, preventive actions, and deviations
- The RCA process
- Corrective and preventive action plans
- Tools and techniques used in root cause analysis
- Five Whys
- Fishbone diagram
- Pareto chart
- Design and Process Failure Mode and Effects Analysis (FMEA)
- Fault tree analysis (FTA)
- Event Tree analysis (ETA)
- 8D method
Introduction to RCA and CAPA
- Overview of Incident Investigation, RCA, and CAPA
- Root Cause Analysis – Beyond the Bucket
- The value of open-ended analysis
- Techniques to foster unbiased analytical thinking
- Hands-on Exercise: Real-World Incident Analysis
- o Participants will work in groups to analyze a provided incident
- CAPA – Making it Relevant and Sustainable
- Principles of effective corrective and preventive actions
- Ensuring actions are genuinely responsive to the root cause
- Integrating RCA into CAPA
- Strategies to ensure root causes guide corrective actions
- Monitoring and feedback loops
- Deep Dive into Incident Investigation
- Best practices and common pitfalls
- Engaging critical thinking in investigations
Introduction to RCA, CAPA, and Incident Investigation
- Understanding the importance of an integrated approach
- Best practices, methodologies, and challenges
- Real-world case study discussion
- Techniques for deep analysis
- Common pitfalls and how to avoid them
- Group analysis of a provided incident
- CAPA: Designing Effective Solutions
- Principles and strategies
- Ensuring alignment with identified root causes
- Merging RCA and CAPA
- Case studies illustrating the integration
- Ensuring feedback mechanisms for continuous improvement
- Corrective and preventive action plans
- Modeling and analysis of incident investigation and RCA activities
Workshop 1: Working with root cause analysis (RCA) tools
- Different types of root cause analysis
- Steps involved in conducting a root cause analysis
- Tools and techniques used in root cause analysis
- Best practices to write a root cause analysis report
- Best practices to implement corrective actions
Workshop 2: Designing a CAPA for Yesterday’s Incident Analysis
- Using the previous day’s exercise, groups will develop CAPA plans
- Addressing challenges, sharing experiences, and clarifying doubts
Workshop 3: From Incident to Action
- Using the incident from Day 1, groups will identify root causes and design CAPA strategies
- Roundtable: Sharing and Learning
- Group presentations on CAPA strategies
- Peer feedback and expert critique
Closing Remarks and Certification Distribution
Note: This workshop can be further customized to align with the specific incidents or challenges the organization has faced, ensuring a more tailored and relevant experience for participants.