IEC 61025 - NUREG 0492 - SAE 4761 - MIL-HDBK 338b

Fault Tree Analysis (FTA)

The International Electrochemical Commission (IEC) has developed a standard that describes fault tree analysis (FTA) and provides guidance on its application. Providing both a definition of the basic principles, and a description of the steps involved in a fault tree analysis, IEC 61025 ensures accurate studies are completed for efficient risk assessment, and helps maintain safety and reliability in products and processes. Industries focusing on quality, including automotive, medical device and general manufacturing, as well as aerospace and defense, can benefit from using fault tree analysis to analyze failures.

This standard is also closely linked to similar guidelines discussing fault tree analysis. NUREG-0492 is a Fault Tree Handbook published by the United States Nuclear Regulatory Commission (NRC) and focuses specifically on fault-tree analysis for the nuclear energy industry. SAE ARP 4761 ‘Guidelines and Methods for Conducting the Safety Assessment Process on Civil Airborne Systems and Equipment’ is published by the Society of Automotive Engineers and focuses on civil aircraft. MIL-HDBK 338b is a design handbook, published by the United States Military and covering all aspects of electronic systems reliability as they relate to Department of Defense equipment and systems.

Impact

Fault Tree Analysis is a top-down approach for analyzing pre-event failures with systems in development, beginning with the top event (the potential failure), then determining all the ways it can occur. Similarly, post-event failures can be analyzed to find the root cause of the failure. The FTA methodology can be used to determine the reliability of production equipment and can predict when and where a failure will occur. FTAs facilitate compliance with safety and regulatory requirements, allowing companies to reduce design defects, product recalls and production downtime. The result is an increased ability to produce safe, reliable, high quality products. FTAs can serve as early warning systems that allow a company to make proactive decisions when failures are predicted. This is an essential function for many companies where part replacement or process re-designs can take several months.

Challenge

Many companies are managing quality assessment documents in disparate systems or even paper-based systems making it difficult to leverage data across divisions and teams. It is necessary to have a seamless integration as changes in requirements are made, or errors are detected. Faults must be accurately traced to the design to ensure that compliance with regulations can be verified. Assessing quality studies throughout the lifecycle can be difficult without a standardized view of FTAs and an integrated approach to risk management to see how FTAs relate to other quality studies. With integrated workflows and a standardized quality culture, effective and accurate fault tree analysis and compliance with IEC 61025 is easier and more efficient.

The Dyadem Solution

Dyadem provides comprehensive Enterprise Risk Management solutions that enable global manufacturing companies to reduce risk management effort by 50%-80%. In addition to improved quality and reduction in compliance risks, Dyadem also offers an integrated lifecycle model linking all parts of design and production risk analysis. This provides full traceability for IEC 61025-compliance and the identification of critical quality attributes to align design with manufacturing, and prevent recalls and work stoppages before they occur. Dyadem enterprise software, Stature, is an innovative, integrated and intelligent quality management platform, providing real-time risk visibility and minimizing potential undesirable events, allowing manufacturers to drive a consistent quality culture within their organization and efficiently comply with governing regulations.

The Stature enterprise risk management solution is built on the principles of continuous improvement, providing seamless communication from the operator up to the executives and customized dashboards and reporting for every level of the company.  Its modules support multiple workflows that can be configured to any corporate standards and provide a global risk register of all hazards across the organization. Gaining this critical risk visibility, in real-time, is crucial for ensuring that all fault tree analyses are conducted properly, and in compliance with the IEC 61025 standard.