Abstract :

This study aims to enhance the quality of the Foley catheter assembly section at PT XYZ, an Indonesian medical device manufacturer, using Six Sigma methodology. PT XYZ currently faces an 8% defect rate in its Foley catheter assembly section, surpassing the acceptable 3% threshold. The current Sigma level of the Shrink process within the assembly section is 2.36, while the Balloon Vulcanizing and Assembly process stands at 2.68. The Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) framework was used to identify and address root causes of defects. Data collection methods included interviews, questionnaires, and field observations, revealing key issues such as incorrect tray loading, machine calibration errors, operator skill variability, and inadequate handling techniques. Proposed improvements include updating Standard Operating Procedures (SOPs), implementing SCAMPER for calibration, comprehensive training programs, and incentive schemes. Additional measures involve template overlays for precise cutting, vendor maintenance, and control charts for consistency. The Control phase ensures sustainability through documentation, training, and monitoring using control charts and Failure Modes and Effects Analysis (FMEA). Implementing these solutions is expected to reduce the defect rate and elevate the Sigma level of both processes to 3, enhancing process efficiency and product quality. This will improve operational efficiency and customer satisfaction, providing a robust framework for PT XYZ to elevate its quality control and contribute to better healthcare device manufacturing in Indonesia.

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Keywords :

DMAIC, Foley catheters, Medical Device, Quality Improvement, Six Sigma.

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