Failure Mode and Effects Analysis (FMEA) – Managing Risk

Course Overview:

This course focuses on Failure Mode and Effects Analysis (FMEA) as a systematic method for identifying potential failure points in products, processes, or systems and evaluating their impact on operations, safety, and customer satisfaction. Participants will learn how to perform both Design FMEA (DFMEA) and Process FMEA (PFMEA), calculate Risk Priority Numbers (RPN), and develop mitigation strategies to reduce or eliminate high-risk failure modes.

Designed for quality, engineering, and risk professionals, this course integrates real-world applications of FMEA in manufacturing, services, and project management, supporting improved reliability, compliance, and continuous improvement initiatives.

Course Objectives:

By the end of this course, participants will be able to:

1. Understand the purpose, methodology, and types of FMEA (DFMEA, PFMEA, and others).
2. Identify failure modes, their causes and effects, and assess their risk levels.
3. Calculate and interpret Risk Priority Numbers (RPN) for prioritizing risks.
4. Use FMEA as a proactive tool for improving design and process reliability.
5. Integrate FMEA with quality and risk management systems (e.g., ISO 9001, IATF 16949).
6. Apply FMEA in cross-functional teams to support risk-based thinking and continuous improvement.

Who Should Attend:

This course is ideal for:

• Quality Engineers and Managers
• Process and Design Engineers
• Project Managers and Product Developers
• Manufacturing and Operations Personnel
• Risk Management Professionals
• Compliance Officers and Auditors
• Professionals in automotive, aerospace, medical device, and high-reliability industries

Course Outline:

Module 1: Introduction to FMEA

• History and evolution of FMEA
• Importance in risk management and quality assurance
• Types of FMEA: Design (DFMEA), Process (PFMEA), System (SFMEA), Functional FMEA

Module 2: FMEA Methodology

• Step-by-step breakdown of the FMEA process
• Identifying functions, potential failure modes, causes, and effects
• Severity, occurrence, and detection ratings
• Calculating the Risk Priority Number (RPN)

Module 3: Design FMEA (DFMEA)

• Applying FMEA in product design and development
• Linking DFMEA to design validation and reliability analysis
• Common design failures and mitigation strategies

Module 4: Process FMEA (PFMEA)

• Applying FMEA in manufacturing and service processes
• Identifying and prioritizing process risks
• Integrating PFMEA into production planning and control

Module 5: Advanced FMEA Concepts

• Action prioritization beyond RPN (e.g., AIAG-VDA approach)
• Linking FMEA to control plans and corrective action systems
• FMEA in new product introduction (NPI) and Six Sigma

Module 6: FMEA in Standards and Frameworks

• Role of FMEA in ISO 9001, IATF 16949, AS9100, and ISO 13485
• FMEA and risk-based thinking in compliance and audit
• Documentation and audit-readiness

Module 7: FMEA Software and Tools

• Introduction to FMEA tools and templates (Excel, APIS IQ, etc.)
• Collaborative tools for cross-functional teams
• Integrating FMEA into PLM or QMS systems

Module 8: Case Studies and Practical Exercises

• Real-world examples of FMEA in design and process environments
• Hands-on group FMEA workshops
• Reviewing completed FMEAs and critiquing effectiveness

Module 9: Review and Action Planning

• Summary of key concepts and tools
• Creating a customized FMEA framework for your organization
• Final Q&A and course evaluation