Abstract
The research focuses on a pharmaceutical company operating in the pharmaceutical and health-related products industry. The filling process for injection medicines has experienced a higher average rate of rejects, reaching 3.2% between September 2022 and February 2023, which exceeds the company's set limit of 2.0%. This study aims to identify the factors contributing to the problem and provide recommendations for reducing rejects using the DMAIC method. During the Define stage, SIPOC diagrams and CTQ identification are utilized. Three CTQ categories are identified: volume defects, imperfect sealing defects, and empty defects. The Measure phase, employing a Pareto diagram, highlights volume defects as the most prevalent. DPMO calculation using the rejected injection medicinepreparation data results in a value of 10630, with a sigma level of 3.80. The Analyze stage involves identifying the factors causing the problem through the use of a Fishbone Diagram. Furthermore, the highest RPN value of 112, indicating potential failure, is determined to be due to insufficient supervision during the production process according to FMEA. In the Improve stage, the 5W+1H tools are employed to generate appropriate improvement proposals. These proposals are documented, disseminated, and adopted as standard work guidelines.
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