A modified fuzzy PFMEA model for risk-centric Six Sigma assessment under the paradigm of Quality 4.0

Purpose The purpose of the study is to examine how risk factors contribute to the occurrence of defects in a process. By analyzing these risk factors in relation to process quality, the study aims to help organizations prioritize their resources and efforts toward addressing the most significant risks. These challenges, integrated with the emerging concept of Quality 4.0, necessitate a comprehensive risk assessment technique. Design/methodology/approach Fuzzy logic integrated with an analytic network process is used in the process failure mode and effects analysis for conducting risk identification and assessment under uncertainty. Through a mathematical model, the linkage of risk with Six Sigma is established and, finally, a value–risk matrix is developed for illustrating and analysing risk impact on process quality. Findings A case study on fused filament fabrication demonstrates the proposed methodology’s applicability. The results show its effectiveness in assessing risk factors’ impact on Six Sigma metrics: defects per million opportunities/sigma level. Practical implications By integrating qualitative assessments and leveraging available data, this approach enables a more comprehensive understanding of risks and their utilization for an organization’s quality improvement initiatives. Originality/value This approach establishes a risk-centric Six Sigma assessment method in accordance with the requirement of ISO 9001:2015 and in the context of Quality 4.0.