Small and medium-sized enterprise (SMEs) Mulya Mandiri is a SMEs that produces frozen meatballs in Batam.In facing the challenges of maintaining the quality of their products with The limitations of resources, technology, capital, and human resources often become obstacles in implementing an effective quality control system. In the study, it was found that the reject or defect rate of frozen meatball products was quite high. The most common product defects found are the wrinkled texture of the meatballs, followed by the shape of the meatballs not being perfectly round, being flat, and the meatballs clumping together. From the obtained data, it will be processed using the Statistical Quality Control method, which has tools such as check sheets, histograms, Pareto diagrams, control charts, and fishbone diagrams. Then it can be analyzed using the Fault Tree Analysis method, which is useful for identifying the root causes of defects in the product, as well as the Failure Mode and Effect Analysis, which is useful for determining potential failure modes, assessing the occurrence and severity of failures, calculating the Risk Priority Number (RPN), and proposing corrective actions to reduce the RPN value.