Unlocking the Power of FMEA: A Guide to Risk-Based Decision Making

by Ray Harkins and Dianna Deeney

As engineering, quality, and product design professionals, we constantly strive to ensure that our products and processes meet the highest standards of reliability and quality. In our pursuit of excellence, one indispensable tool in our arsenal is Failure Mode and Effects Analysis (FMEA). FMEA offers a structured approach to risk management, enabling us to proactively anticipate potential failures, assess their impact, and prioritize mitigation efforts accordingly. However, the practical implementation of FMEA can sometimes prove challenging. How do we navigate its complexities to derive actionable insights and make informed decisions? Let's explore some of the key components and best practices of FMEA.

Foundations of FMEA

FMEA is rooted in the principle of proactive risk management. It aims to identify and mitigate potential failure modes before they occur, thereby reducing the likelihood of defects, delays, and customer dissatisfaction. At its core, FMEA involves systematically analyzing failure modes, their causes, and their effects on product performance or process functionality. By understanding the relationships between failure modes, causes, and effects, we can develop targeted mitigation strategies to minimize risks and improve overall reliability.

FMEA Methodology

The FMEA process typically involves several key steps, beginning with defining the scope and objectives of the analysis. Next, a cross-functional team is assembled to bring diverse perspectives and expertise to the table. The team then identifies potential failure modes and their associated causes and effects, using tools such as brainstorming, process flow diagrams, and historical data analysis. Risks are analyzed based on severity, occurrence, and detection criteria, allowing for prioritization of mitigation efforts. Finally, risks are evaluated and action plans are developed to address high-priority risks, and the effectiveness of these plans is monitored and evaluated over time.

Risk Assessment Techniques

FMEA employs both qualitative and quantitative techniques to assess risks effectively. Qualitative assessments involve assigning severity, occurrence, and detection ratings to each failure mode based on expert judgment and collective experience. Quantitative techniques, such as fault tree analysis and probability calculations and assignments, provide a more rigorous evaluation of risk likelihood and impact. By combining these approaches, teams can gain a comprehensive understanding of potential risks and their implications for product or process performance.

Cross-Functional Collaboration

Successful FMEA requires collaboration across different departments and disciplines within an organization. The FMEA process involves people making decisions about risk based on the information known at a given time. By involving stakeholders from design, manufacturing, quality assurance, and other relevant areas, teams can leverage diverse perspectives and insights to identify and mitigate risks more effectively. Cross-functional collaboration fosters buy-in, ensures comprehensive risk coverage, and promotes alignment with organizational objectives.

Inputs into Design and Test Requirements

FMEA can be an input into the design and test of products, services, and manufacturing processes. For example, characteristics that are critical to quality, safety, and functionality can be identified and prioritized from FMEA. Design engineers may use critical characteristics for layout, component interaction, and reliability requirements. Manufacturing engineers may use them to define the process output requirements and quality engineers to define what to monitor for quality and its sampling needs. Verification and validation test engineers may use these characteristics to help define test methods and criteria. Auditors may use FMEA to identify which processes or suppliers to add to their audit schedule to help ensure quality of products and services. By the team using FMEA as an input into design and test, they can focus and coordinate their efforts on what is critical to manage risk.

Integration with Other Quality Tools

FMEA can be integrated seamlessly with other quality tools and methodologies to enhance overall effectiveness. For example, Six Sigma principles can be applied to reduce variation and improve process stability, complementing FMEA's focus on risk identification and mitigation. Similarly, Lean Manufacturing techniques can help streamline processes and eliminate waste, reducing the likelihood of failure modes occurring in the first place. By integrating FMEA with complementary approaches, organizations can achieve synergistic benefits and drive continuous improvement across the board.

Information Sharing

FMEA can be used to share risk information with people that create other products and services. Information within FMEA may be used to help design troubleshooting guides, instructions for use with warnings and cautions, or other customer communications. FMEA may help engineers develop routine maintenance schedules and instructions or respond to field failures. By communicating the information from an FMEA, the broader team is better informed to make decisions to mitigate risks from multiple aspects.

Continuous Improvement

FMEA is not a one-time exercise but rather an ongoing process of continuous improvement. As new information becomes available and product or process conditions change, it is essential to revisit and update FMEA assessments accordingly. By maintaining a proactive approach to risk management and staying vigilant for emerging threats, organizations can adapt quickly to evolving circumstances and maintain their competitive edge in the marketplace.

Case Studies and Best Practices

Learning from real-world examples and best practices is key to mastering FMEA. Case studies offer valuable insights into how organizations in various industries have successfully applied FMEA to improve product reliability, enhance quality, and mitigate risks. By studying both successes and failures, we can extract valuable lessons learned and apply them to our own FMEA initiatives, ensuring greater effectiveness and efficiency.

FMEA is a powerful tool for proactively managing risks and driving continuous improvement in product reliability and quality. By understanding its key principles, methodologies, and best practices, reliability engineers, quality professionals, and product designers can unlock new opportunities for innovation and success. If you're interested in diving deeper into FMEA and enhancing your risk-based decision-making skills, consider exploring further resources, including our online course titled “FMEA in Practice: From Plan to Risk-Based Decision Making”.

Ray Harkins is the General Manager of Lexington Technologies in Lexington, North Carolina. He earned his Master of Science from Rochester Institute of Technology and his Master of Business Administration from Youngstown State University. He also teaches manufacturing and business-related skills such as Reliability Engineering Statistics, Quality Engineering Statistics, Failure Modes and Effects Analysis (FMEA), and Root Cause Analysis and the 8D Corrective Action Process through the online learning platform, Udemy. He can be reached via LinkedIn at linkedin.com/in/ray-harkins or by email at [email protected].

Dianna Deeney is president of Deeney Enterprises, LLC. She is an IEEE senior member and a senior quality professional as an ASQ certified CQE, CRE, CQA, and CMQ/OE. She founded Quality during Design as an online resource about awareness and use of quality and reliability methods during the design development process. She also co-hosts the Speaking of Reliability podcast and is a contributing author to Quality Disrupted (Working It?- Future of Work Series) published by CERM Academy. Dianna can be reached at [email protected].