Quality control is one of the important things to maintain the company’s reputation in the eyes of consumers. PT. Kimia Farma Tbk is a pharmaceutical company engaged in medicine. At present the product defects that occur in the company still exist beyond the company boundary provisions, which are above the percentage number set by the company, which is equal to 1%. So that the company immediately makes repairs so that there is no waste that harms the company.
With good and correct quality control, products will be obtained that can meet consumer desires. One of the tools used to help control quality is to use the Failure Modes and Effects Analysis method (FMEA).
The purpose of this study is to analyze the failure modes that cause product defects by using the FMEA method, getting the risk of the biggest production process failure in the value of the RPN (Risk Priority Number), providing proposed improvements for subsequent production. Based on processing with the FMEA method can identify modes of failure that occur in the process making drugs. The mode of potential failure in the process of making drugs consists of 6 types of failures.
Keywords : Quality; Failure Mode and Effect Analysis; Risk Priority Number.