Quality Control Analysis Using the Failure Mode and Effect Analysis Method

Abstract

This study aimed to investigate critical factors contributing to defective Epodion® rh-Erythropoietin Alfa syringes, specifically focusing on reducing cracks during manufacturing. A Failure Mode and Effect Analysis (FMEA) approach was employed to identify the primary causes of failure, revealing cracking as the predominant issue affecting 43% of defective units. To mitigate this concern, we calculated a Risk Priority Number (RPN) of 162, highlighting the significance of addressing material-related issues. By recommending enhanced quality control measures for raw materials prior to their utilization within the production process, our findings suggest potential improvements in material strength, thereby minimizing product defects Highlight : The study aimed to investigate factors contributing to defective Epodion® rh-Erythropoietin Alfa syringes, with a focus on reducing cracks during manufacturing. A Failure Mode and Effect Analysis (FMEA) approach was used to identify the primary causes of failure, revealing cracking as the predominant issue affecting 43% of defective units. Enhanced quality control measures for raw materials prior to their utilization within the production process were recommended to minimize product defects. Keywords: Epodion, rh-Erythropoietin Alfa, syringes, FMEA, quality control.