The present study analyzes the evolution and applications of Process Failure Mode and Effects Analysis (PFMEA) within the context of Production Engineering and Industry 4.0 through a bibliometric review and qualitative analysis of 15 articles published between 2010 and 2025. The objective is to understand how PFMEA has been applied and enhanced, highlighting methodological advances and its contribution to structuring, standardizing, and improving production processes. The results indicate a significant increase in publications after 2016, particularly in the manufacturing and automotive sectors, driven by the need for greater reliability and technological integration. Notable methodological advances include integrating PFMEA with multicriteria decision-making tools, fuzzy logic, Monte Carlo simulation, computational intelligence, and data mining techniques to reduce the subjectivity of the traditional method and improve risk prioritization. Furthermore, PFMEA applications have expanded to areas such as healthcare, material recycling, and academic laboratories, although its use remains predominantly industrial. The analyzed studies report benefits, including reduced failures, improved operational robustness, enhanced decision-making support, and increased process safety. It is concluded that PFMEA remains an essential tool for Production Engineering in the digital era, contributing to the development of more efficient, reliable, and Industry 4.0-oriented processes. This study consolidates current trends and research opportunities, reinforcing the importance of integrating PFMEA with emerging technologies.
