Quality Control of Infusion RL 500 Ml Single Port Flip-off Product Packaging Using the Six Sigma Approach

Abstract

The purpose of this study is to calculate the Defects Per Million Opportunities (DPMO) and sigma level values for defective tubing packaging, identify the root causes of defective tubing packaging, and provide suggestions for improving the quality of defective tubing packaging for the Infusion RL 500 ml Single Port Flip-off product at PT Sanbe Farma Unit III. Based on data processing using the Six Sigma method, the DPMO value obtained was 34,703.93 defects per million and the sigma level value was 3.33. The analysis using the 5 Why's Analysis identified factors causing defects, including machine factors such as dull blades and shifting gripper stoppers, human factors such as careless operators, and material factors such as clumps of silica particles inside the tubing. In the improvement phase using the 5W 1H analysis method, proposed improvements include: scheduling blade orders, periodic blade replacements on machines, routine machine inspections before use, resetting production schedules, supervisor oversight during each shift, creating detailed production standard operating procedures, and updating tubing packaging material inspection standards.