| The competition in the medical device industry is becoming more and more fierce,and the quality of medical device products largely determines the success or failure of the competition.The quality of medical device products first needs to be guaranteed by product technical specifications and standards,and secondly,more importantly,it needs to be realized through the comprehensive quality management of medical device manufacturers.For enterprises,the key factors to remain invincible in the fierce competition are always the quality control of products and the continuous optimization ability of enterprise total quality management.The medical device industry is a key nationally regulated industry.Compared with traditional industries,product quality problems are more likely to cause harm to users,that is,the quality risk is greater.Therefore,how to continuously provide high-quality products,continuously provide customers with satisfactory products,and continuously improve the status quo of the enterprise’s total quality management are issues that enterprises must face.Strict implementation of total quality management and continuous optimization and improvement are effective means to ensure product quality and improve enterprise market competitiveness.This study focuses on G Medical Technology Company.By reviewing domestic and foreign literature,we study cases of comprehensive quality management of medical devices at home and abroad,and learn the theory and scientific management methods of comprehensive quality management.Through interviews and questionnaires,a survey was conducted on G Medical Technology Company from three aspects: overall quality management,overall process quality management,and overall scope quality management.It was found that there are two problems in overall quality management: a lack of internal quality management activities and insufficient quality management training for employees;In terms of overall quality management,there are three problems: poor management of the design and development process,lax control of design and development changes,and lax quality control of the manufacturing process;In terms of comprehensive quality management,there are three problems: insufficient applicability and comprehensiveness of the comprehensive quality management system,lack of quality management responsibility system,and insufficient attention from leaders to product quality.In response to the above issues,using the theory of total quality management and the theoretical framework of PDCA cycle for process improvement,using the 5W2 H analysis method and QC group activities,two optimization measures have been developed in terms of overall quality management,namely,carrying out necessary quality management activities and strengthening employee quality management training.In terms of quality management throughout the entire process,standardized design and development processes and optimized project management methods have been developed to optimize design and development process management measures;Standardize the design and development change process and optimize the design and development change management optimization measures to change the process management mode;And the manufacturing process optimization measures developed from six aspects of "human machine material method environmental testing".In terms of comprehensive quality management,three optimization measures have been formulated to optimize the applicability and comprehensiveness of the comprehensive quality management system,establish a quality management responsibility system,and increase the attention of leaders to product quality.In terms of overall quality management,two optimization measures have been formulated to improve employee quality awareness and establish quality team spirit;In terms of overall process quality management,a comprehensive quality management system has been established to continuously optimize the quality management process;In terms of comprehensive quality management,two optimization measures have been formulated to fully leverage leadership and develop a corporate quality culture.By formulating these optimization measures,we provide guarantees for the continuous optimization of the comprehensive quality management of G Medical Technology Company.I hope to provide reference for enterprises in the same industry by optimizing the overall quality management of the enterprise.The main innovation of this paper is that,from the point of view of medical device manufacturing enterprises,using the theory of total quality management,with the help of the theoretical framework of process improvement of PDCA cycle to optimize the total quality management of enterprises.Using 5W2 H analysis,5Why analysis,QC group activities and other quality management analysis methods and quality improvement methods,combined with the practical problems of quality management of medical device manufacturing enterprises to solve the problems faced by enterprises. |
