关键词: 品管圈, 彩色超声诊断仪, 质量控制

Abstract: Against the backdrop of national fertility policy adjustments, Shanghai First Maternity and Infant Hospital ranks among the top in annual delivery volumes nationwide. As a core device for prenatal screening, the quality control of color ultrasonic diagnostic equipment directly impacts fetal anomaly detection rates and clinical safety. To address this, we established the "Pregnancy Eye Circle" quality control circle （QCC）, integrating 9 multidisciplinary members including biomedical engineers, quality controllers, and clinicians （circle competence score： 80%）. Focusing on "improving the pass rate of color ultrasonic diagnostic equipment quality control inspections", we defined 5 critical performance indicators （e.g., maximum depth and resolution） as mandatory compliance standards. Utilizing the PDCA-SDCA dual-loop model and seven QCC tools, we systematically addressed the pass rate deficiency （baseline 41%）. Through image quality factor analysis, standardized training programs, and process optimization implementation, we conducted full-cycle quality monitoring on 34 ultrasound systems, achieving an upgraded pass rate of 81.8% （target attainment ratio： 104.1%; improvement rate： 99.5%）. This project demonstrated significant enhancements in equipment quality control efficiency, established an integrated medical-engineering-clinical quality management framework, and strengthened multidisciplinary collaboration capabilities. Future initiatives will focus on refining preventive maintenance protocols and advancing lifecycle management for medical devices.

Key words: Quality control circle, Color ultrasonic diagnostic equipment, Quality control