Upon completion of this course, participants will be able to:

• Explain the importance of systematic RCA and the difference between symptoms and root causes.
• Identify the appropriate RCA tool for different types of problems (incident, quality, process failure).
• Effectively use the 5 Whys and Fishbone (Ishikawa) Diagram to map potential causes.
• Conduct data collection and verification to confirm the identified root cause(s).
• Apply process mapping techniques to understand the failure point in context.
• Develop and evaluate effective corrective and preventive actions (CAPA).
• Document the RCA process clearly for management review and audit purposes.
• Contribute to a proactive, problem-solving culture within the organization.

• Quality, Safety, and Environmental Managers.
• Internal and Supplier Auditors responsible for CAPA review.
• Process Engineers and Manufacturing Supervisors.
• Personnel responsible for nonconformity and incident investigation.
• Project Managers and Continuous Improvement Specialists.
• Anyone involved in solving recurring operational problems.

• Case Studies (e.g., complex equipment failure or systemic process error).
• Individual Exercises (5 Whys application to a personal or work problem).
• Group Activities (Constructing and challenging a Fishbone Diagram).
• Practical Application: Developing and testing a verified root cause hypothesis.
• Discussions on human factors and corrective action effectiveness.

Unit 1: Foundations of Root Cause Analysis

• Defining Root Cause Analysis (RCA) and its systematic process.
• The difference between symptoms, direct causes, and root causes.
• The importance of evidence-based investigation and data integrity.
• Understanding the Human Error component in RCA.

Unit 2: Problem Definition and Data Collection

• Techniques for clearly defining the problem (e.g., Is/Is Not analysis).
• Developing a structured investigation team and plan.
• Gathering factual evidence and data related to the failure.
• Creating a timeline of events leading up to the failure.

Unit 3: Simple to Intermediate RCA Tools

• Practical application of the 5 Whys technique and its limitations.
• Constructing and utilizing the Fishbone (Ishikawa) Diagram (Man, Machine, Material, etc.).
• Using Pareto charts to prioritize causes for further investigation.
• Introduction to Cause and Effect Matrix and scatter diagrams.

Unit 4: Advanced RCA Tools and Verification

• Introduction to Fault Tree Analysis (FTA) and Event Tree Analysis (ETA).
• Techniques for process mapping to identify system failures (e.g., flowcharts).
• Statistical methods for verifying the hypothesized root cause.
• The importance of independence in the RCA investigation team.

Unit 5: Corrective Action and Sustained Improvement

• Developing effective, systemic corrective actions (CAPA) that address the root cause.
• Applying Poka-Yoke (Error-Proofing) principles to solutions.
• Verifying the implementation and long-term effectiveness of CAPA.
• Integrating RCA findings into risk management and continuous improvement processes.