DEFECT REDUCTION IN MEDICAL CATHETER LINE USING LEAN SIX SIGMA

—This study applies the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology to reduce defects in the production of medical catheters. In the Define phase, the scope of the project was established, identifying critical defects (such as bubbles, irregular diameters, and contamination) that impact product quality. In the Measure phase, historical data were collected, and key metrics (DPU, DPMO, and initial Sigma level) were calculated. During the Analysis, tools such as Pareto diagrams (to prioritize defects), Ishikawa (to identify root causes), and ANOVA (to validate significant factors) were used. The main problems detected were variability in extrusion parameters, lack of process standardization, and environmental pollution. In the Improve phase, solutions were implemented, such as adjustments in molding temperatures, training in good manufacturing practices, and cleanliness controls in the clean room. Finally, in Control, procedures were standardized, control charts were established (SPC), and an audit plan was designed to ensure sustainability. The results showed a 60% reduction in defects and an increase in the Sigma level from 3.2 to 4.5, demonstrating the effectiveness of Six Sigma in optimizing critical medical processes.