ENHANCEMENT OF FOLEY CATHETER ASSEMBLY SECTION QUALITY USING SIX SIGMA (A CASE STUDY OF AN INDONESIAN MEDICAL DEVICE COMPANY)

• Main Author: Patricia Ulina, Catherine
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/82915
• Institution: Institut Teknologi Bandung

Indonesia, with over 270 million people, faces significant challenges in its healthcare infrastructure. Foley catheters, essential for urine drainage during surgeries and for patients with urinary issues, are critical components of this system. The growing demand for these devices highlights the need for strict quality assurance methods. PT XYZ, an Indonesian medical device manufacturer, struggles with an 8% defect rate in its Foley catheter assembly, exceeding the acceptable 3% threshold. The high rate of defects has a negative effect on the quality of the product and the satisfaction of customers, which requires a thorough examination and a plan for improvement. Using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology, this research identifies and addresses the root causes of defects in PT XYZ’s assembly process. Data collected through interviews, questionnaires, and field observations revealed four main root causes in Shrink process: (1) incorrect tray loading practices, (2) machine temperature calibration errors, (3) variability in operator skill and technique, and (4) inadequate handling techniques during the shrink insertion process. Additionally, issues in the Balloon Vulcanizing and Assembly process, such as (1) worker misalignment during cutting and (2) inconsistent mold configurations, were identified. The Improve phase proposes several solutions: updating Standard Operating Procedures (SOPs), implementing the SCAMPER technique for calibration, developing comprehensive training programs, using visual aids, and creating incentive programs. Template overlays for precise cutting and vendor maintenance and control charts for mold consistency are also recommended to address issue in Balloon Vulcanizing and Assembly. The Control phase ensures these improvements are maintained through a detailed documentation plan, comprehensive training, and a monitoring plan that includes control charts and FMEA. Implementing these solutions is expected to reduce the defect rate to the acceptable 3% threshold, enhancing process efficiency and product quality. This will improve operational efficiency and customer satisfaction, providing a robust framework for PT XYZ to enhance its quality control measures and contribute to the improvement of healthcare device manufacturing in Indonesia.