Improving the Packaging Quality of Surgical Suture Products at PT. XYZ with the Application of the Six Sigma Method and Failure Mode Effect Analysis (FMEA)

Abstract

The medical industry today upholds strict quality standards for medical products, including surgical sutures. PT XYZ, a leading manufacturer in this sector, faces challenges in mitigating surgical suture product defects. This research focuses on the packaging of surgical suture products produced by PT XYZ, with a focus on the production period from January to March. During this time period, there was a significant level of packaging production defects. The aim of future research is to improve the quality of packaging for surgical suture products. Specifically, it aims to identify the causes of defects in PT The Six Sigma method, using DMAIC, will be used in this research. The Define stage combines tools such as the Supplier, Input, Process, Output, and Customer (SIPOC) diagram, along with Critical to Quality (CTQ) identification. The Measure stage involves calculations using the P control chart, C control chart, DPMO, and sigma level. During the Analysis phase, a thorough analysis of the causes of failure is carried out using tools such as Pareto diagrams, fishbone diagrams, and Failure Mode Effects Analysis (FMEA). Moving to the Improve stage, FMEA identifies high-risk defects, including torn cartons, inconsistent colors, and damp cartons. Therefore, the proposed defect repair involves analysis of 5W 1H cartons. The results of the analysis provide alternative solutions such as increasing the frequency of replacing cutting tools on mold cutting machines, using cleaning aids on molding machines, and improving environmental monitoring SOPs in factories. An additional suggestion is to include antiseptic wet wipes in each carton of surgical suture products. After making improvements in the Improve stage, the final Control stage is carried out to assess the impact of the proposed changes on the company. The results show a positive impact, with an increase in the sigma value to 3.670.