In industry, the failure mode and effect analysis (FMEA) methodology is one of the main tools used for reliability management in product design and development. However, the academic literature highlights several shortcomings of the FMEA methodology. Therefore, the main purposes of this paper are the analysis of the weaknesses of FMEA, the improvement of the method, and the implementation of a new methodology able to support quality and reliability management in a more efficient way. Motivated by these objectives, a formal new methodology is proposed by extending the classic FMEA methodology through C-K design theory. To test the effectiveness of the proposed approach and analyze the acceptance of this method by users, a case study is conducted in STMicroelectronics, one of the European leaders in the semiconductor industry.