Acrobat Stabilize System Product Quality Issue Casual Analysis And Management Decision Of MAQUET Medical Device Company

With the rapid development of China’s economy in recent years,the opening of intelligent life,the enhancement of people’s awareness of disease prevention,health care and the increase of the elderly population,the demand for medical devices is more and more vigorous.Medical devices are of great significance to improve the level of medical technology.Meanwhile,sterile medical devices,as an important part of medical devices,they are directly in contact with human blood or tissue.Due to their sterile characteristics,they can effectively reduce the cost and risk of treatment in clinical use,so they have been widely used in medical institutions in China.However,the safety of sterile medical devices continues to emerge in China.A notice on the website of the National Medical Products Administration shows that in 2020,the national Medical Device Adverse Events Surveillance system received about 530,000 suspicious medical device adverse events reports,an increase of around 35% over the previous year.It shows that the quality problems of medical devices need to be paid attention to,especially high-risk sterile medical devices,the quality problems of products have a more direct impact on patients.In this study,the stabilization system products of Maquet Medical Equipment Co.,LTD were taken as the research object,and the quality problems of the products were deeply analyzed with the complaint data of the products as the entry point.Through literature search and case study,the causes of product quality were analyzed by using fishbone chart analysis method,4M1 E analysis method and causal matrix analysis method,etc.The potential root causes were analyzed and summarized from human,machine,material,method,environment and other aspects based on the theory of total quality management and product quality control.Cause and effect analysis method was used to evaluate all the potential root causes and identify the key causes.The key causes were classified into different stages,and the corresponding decision analysis and quality improvement alternatives were designed for different key causes.Through the evaluation and sorting of quality improvement alternatives,the appropriate decision scheme was selected for the quality improvement of the final product.At the same time,in the final implementation process of quality improvement actions,this study also puts forward targeted implementation suggestions,from personnel training,incentive system,online inspection,system guarantee,human resources guarantee,cost guarantee and other aspects of the long-term effective implementation of the decision plan.The improvement alternatives proposed in this study provides a basis for the quality improvement of the cardiac stabilization system products of Maquet Medical Equipment Co.,LTD.,uses a variety of quality tools to analyze the root causes,effectively solves the root causes of the cardiac stabilization system product quality problems,effectively improves the brand image of the company and saves the cost waste caused by complaint handling.At the same time,this study also puts forward corresponding suggestions on how to effectively implement the quality improvement measures,and these implementation suggestions also provide guidance for other similar enterprises.This study focuses on improving the quality of class three of high-risk sterile medical devices,and the improvement program used has a significant improvement effect on product quality.In addition,this study carried out comprehensive quality improvement for different production stages,and the research results could provide reference for quality improvement and process control of other high-risk medical device enterprises.