Analysis of Product Defects Using Statistical Process Control (SPC) and Failure Mode and Effects Analysis (FMEA) Methods

PT. XYZ faced significant product defects attributed to inadequate quality control. This research aimed to identify defect causes and propose improvements. Statistical Process Control (SPC) was used to analyze, control, and enhance production processes, while Failure Mode and Effects Analysis (FMEA) identified potential failures to boost reliability and safety. Defect data showed the highest rate in December (1,771 out of 127,800 bags) and the lowest in August (1,300 out of 147,600 bags). Defect types included imperfect sealing (2,475 bags), loose stitching (4,641 bags), and bulging bags (1,549 bags). Recommendations include enhancing production processes, improving worker skills, maintaining machines, revising SOPs, and optimizing working conditions. FMEA should prioritize improvements based on the highest Risk Priority Number (RPN) to address the most critical failure modes first.