Advances in Failure Mode and Effects Analysis for Reliability Engineering in Complex Hardware-Software Systems

Abstract

Failure Mode and Effects Analysis (FMEA) has been a foundation of reliability engineering for more than six decades, yet its classical form was designed for systems dominated by mechanical and electrical components with well-characterized physical failure modes. Modern products such as automotive electronic control units, avionics, medical devices and industrial controllers are hardware-software systems in which a large share of failures originate in requirements, logic, timing and component interaction rather than in wear-out of parts. This paper reviews the advances in FMEA for such systems that emerged to date. Using an integrative review methodology, it screened standards, peer-reviewed literature, practitioner sources and a consolidated seed list, retaining sources published to date. The literature synthesis covers seven themes: the limitations of classical FMEA; the third edition of IEC 60812, the AIAG-VDA harmonized handbook review draft with Action Priority and FMEA for Monitoring and System Response, the second edition of ISO 26262 and the STPA Handbook; model-based FMEA from SysML; software FMEA taxonomies; fuzzy, multi-criteria and severity-led prioritization; hybridization with system-theoretic and security analyses; and related literature on maintenance, inspection, process safety, power systems and information security. Building on the synthesis, the paper proposes the Integrated Hardware-Software FMEA (IHS-FMEA) conceptual model with eight elements and five testable propositions, and illustrates it with a brake-by-wire controller. The discussion shows that the advances to date are complementary and that their value depends on a shared architecture model and evidence-grounded ratings. Theoretical, practical and standards-related implications are drawn, limitations are stated and directions for future research are proposed.