With the introduction of QS-9000 requirement, the automotive industry has reemphasized one more time the importance of the Failure Mode and Effect Analysis (FMEA). In fact, the FMEA now has become one of the most basic requirements in both the QS-90000 and the Production Part Approval Process (PPAP).The importance of the FMEA is to evaluate the extend of risk as a prerequisite to risk reduction. On this basis, our everlasting desire to minimize “all” risks, practical measures for reduction can be planned and implemented. It is precisely this reason why the QS-9000 and the PPAP have recognized the FMEA as a leading practical measure to minimize risk(s) and failure(s).Failure Mode and Effect Analysis (FMEA) is a methodology that helps identify the activities that are potential risks in the introduction of a new product, process or service. In addition, it helps eliminate problems from current designs, processes and or services.In this paper we will discuss the methodology of the FMEA and we will discuss its relationship with the QS-9000.