Research On CT Project Quality Improvement In FLP Healthcare Company

With the rapid development in medical treatment,modern medical devices are gaining more and more attention by the medical area,and its importance is indeed extraordinary,however,the quality of medical devices are so closely related directly to the safety of patients,as well as impacting to the development of social people’s livelihood.Therefore,how to strengthen the quality management in medical devices becomes currently a key focus in medical working area.Following actively the China government requirements to strengthen the quality management to medical devices manufacturing,and in accordance with the The Provision Supervision of Medical Devices Manufacturing and the Good Manufacturing Practice for Medical Devices,China Food and Drug Administration organized the Guidance on Quality Control and Final Devices Release in Medical Devices manufacturers,to help guide and supervise the quality management in medical devices manufacturers,and strengthen the quality control during the production process,strictly control the final release of medical devices,to best limit the potential quality risks of medical devices,to improve product quality control capability of medical devices manufacturers in China.Author of this article is based on the research in the quality management of Computed Tomography(CT)in company FLP,an international corporation,who is one of the leading companies of medical devices industry.The article starts with the current status of CT project,supported by the basic quality management theories,makes a deep-dive research on the whole quality management process in CT project in FLP.After making a comprehensive analysis on the quality figures,investigating on it together with the root cause digging-out,defines the quality improvement countermeasures,and tracks the effectiveness of the defined countermeasures,to finally standardize and sustain these effective preventions.This research includes following contents:1.Introduced the subject background,research value,research process and content,as well as the methodology.2.Systematically listed the quality management related theories and problem solving tools,and introduced current status of quality management systems and regulatory requirement on medical devices both in other main developed countries and China domestic.3.Deep analyzed current status and summarized several main quality management issues in CT project in FLP.4.Defined the improvement countermeasures for every quality management issue,and made the comprehensive effectiveness evaluation after implementing all countermeasures.5.Further standardize the quality improvement countermeasures in CT project,in order to strengthen the improvement achievements,sustain the long-term effectiveness of the improvements.In the end,it is a summary of the complete research and prospect of the future.This successful quality improvement project in CT project in FLP,did challenge the traditional manufacturing quality management mode in current domestic and international medical devices companies,it helped find out an innovative control method for big medical image system in cross-countries manufacturing.The author expects this research can be a good reference in quality management improvement for other image medical products in FLP Company and even for other companies from the medical devices industry.