Study On Life Cycle Quality Management Of In Vitro Diagnostic Reagents

As populations age and the number of major chronic diseases increases,there are new challenges in diagnosing and treating diseases.Precision medical treatment for individualized treatment have a significant effect,genetic testing is a necessary means,the test used in vitro diagnostic reagent quality directly determine the precision and accuracy of the test results.Therefore,the quality management of the whole life cycle of in vitro diagnostic reagents is of vital importance.Any problems in any link will affect the diagnosis and treatment of diseases,or even lead to misdiagnosis and life-threatening cases.Based on G company as a case,this paper studies the whole life cycle of in vitro diagnostic reagent quality control.The present situation,organizational structure and product characteristics of G company were analyzed,the quality system of in vitro diagnostic reagents used in the whole life cycle was sorted out,and the existing quality problems of G Company were proposed.Based on the SIPOC model,the quality problems of G Company were analyzed,and solutions were proposed from the perspective of "human,machine,material,method and environment" total quality management.In order to provide help to the improvement of G company quality problem.Academic research on product life cycle quality management in the pharmaceutical industry only focuses on a certain stage of the product rather than the whole life cycle.In vitro diagnostic reagent quality management research is mostly in the production and research and development stage,and rarely involves end users.In this paper,the whole life cycle quality management of in vitro diagnostic reagents is studied,which is beneficial to break the information island in the upstream and downstream of the supply chain,optimize the work flow,reduce communication costs,improve work efficiency and create more benefits for enterprises.