Hierarchically-Performed Hazard Origin and Propagation Studies

Hierarchically-Performed Hazard Origin and Propagation Studies (HiP-HOPS) is a model-based safety analysis technique developed at the University of York for complex, safety-critical systems. Its core methodology involves creating a hierarchical model of the system and annotating base components with their failure modes. The technique then uses automated tools to deduce how these low-level failures propagate through the system architecture to cause top-level hazards, automatically synthesizing outputs like Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA). Within an ERM framework, it serves as a sophisticated operational risk assessment tool. It directly supports compliance with the rigorous hazard analysis requirements of standards such as ISO 14971 for medical devices and ISO 26262 for automotive functional safety, offering greater consistency and completeness than traditional manual methods.

Practical application involves three key steps. Step 1: System Modeling, where a hierarchical model of the product or process is built, defining its components and their interconnections. Step 2: Failure Annotation, where domain experts define potential failure modes for each component. Step 3: Automated Analysis, where the HiP-HOPS tool synthesizes FTA and FMEA reports from the model, identifying critical failure propagation paths. For example, a medical device manufacturer applied HiP-HOPS to an infusion pump's software. The analysis revealed a critical failure path in the dose calculation module that was missed by manual reviews. By implementing a specific software patch to address this, they reduced the predicted probability of a critical overdose event by over 95%, ensuring compliance with ISO 14971 and achieving a higher Safety Integrity Level (SIL) as defined in IEC 61508.

Taiwan enterprises face three primary challenges. 1) High Technical Barrier: The method requires a rare combination of skills in systems engineering, formal methods, and safety standards. Solution: Partner with specialized consultants and launch pilot projects to train an internal core team. 2) Significant Initial Investment: The cost of software tools and the intensive effort required for initial system modeling can be prohibitive. Solution: Begin with a high-risk, high-impact pilot project to demonstrate a clear return on investment, such as quantifiable reductions in potential warranty claims or liability costs. 3) Cultural and Process Integration: Engineering teams may resist moving from familiar spreadsheet-based FMEA to a more abstract, model-based approach. Solution: Secure strong executive sponsorship and demonstrate how automation reduces manual documentation effort and improves the accuracy of safety assessments, positioning it as an efficiency-enhancing tool.

Winners Consulting specializes in Hierarchically-Performed Hazard Origin and Propagation Studies for Taiwan enterprises, delivering compliant management systems within 90 days. Free consultation: https://winners.com.tw/contact