Quality Improvement Research On New Product Phase Of Pre-filled Syringe In Chinese Company Of M Medical Group

Pre-filled glass syringe is a new packaging form of Pharmacy.Pre-filled glass syringes have been on the market for decades and are very mature in both the European and American markets.Prefilled syringes are in the early stage of development in China.With people's increasing attention to health and safety,China's huge population base will promote the formation of a huge market for prefilled syringes.M medical group decided to build a new production line of pre-filling syringes in China to achieve localized production of products,seize the Chinese market,and reduce operating costs at the same time.Pre-filled syringes product line is the first line of this kind of product for M medical companies in China,The Chinese company of M medical group is currently in the trial production stage between the development and mass production of new products.the M medical company set up the new product team,but product related processes,documents,automatic production line maintenance,personnel experience is not enough,etc.,The project encountered quality related issues in the manufacturing process of new product,project team need to take more time and more people to solve those issues,it will delay the market schedule of new product,to impact the company's goal.Through the guidance of quality management theory and the local use of appropriate quality tools,this paper reduces the proportion of defective silicone on needle,reduce the number of workshop environment exceeding standard,reduce the QTY of batch record mistake.In this Article,the case of M medical group China co.,ltd.was used to study the trial production quality improvement of new prefilled syringe products.This article explain the product structure,function and process of the pre-filling syringe,and selects the problems of poor silicone oil,excessive production environment and wrong production records in the trial production stage of the new product of M medical group in China as the improvement research object.This paper adopts quantitative analysis method,attribution analysis method and case analysis method to study the quality of the product in the trial production stage,and scientifically take the analysis methods of questionnaire,FMEA,4M1 E and 5Why to find out the main causes of various problems.In this paper,according to the various problems of the main causes of design improvement plan and assign to improve the execution of continuous implement improvement plan,perfect continuous monitoring plan implementation effect and eventually formed beforehand potting syringe problem effective improvement plan,new product production as well as to explore a series of Chinese companies meet M medical group of new product trial production quality management problem.In this paper,through the implementation of the improvement document,the shortage of silicone on needle,the number of exceeded standards in the workshop environment and the number of production record errors in the trial production stage of pre-filling syringe products have been significantly improved.In this paper,the product quality improvement research,through the combination of actual cases and quality management theory,the use of quality management theory to guide the actual product quality problem improvement.The practice of improving the product problems of pre-filling and sealing syringes proves that the improvement of product quality not only solves the problem of product trial production,but also accumulates valuable experience of product quality improvement for the future daily production and improves the quality management level of the company.Quality improvement is the only way for every company to improve the quality of its products,and is also the premise to establish a good reputation for the company's products.