Research On Quality Improvement Of Medical Instruments In R Company

With the gradual improvement of national health awareness and the acceleration of social aging,the demand for medical upgrades will continue to rise,and the demand for high-quality products and services abroad will continue to grow.From 2014 to 2018,China’s medical device market rapid growth,but the domestic production ratio was low.At the same time,labor costs in China have increased year by year,demographic dividends in India and other regions have gradually become prominent,and Southeast Asian countries have obvious advantages in raw material costs and labor costs.Therefore,many multinational companies have relocated from China to Southeast Asia to establish new production bases.R Company is a professional medical device manufacturer.The German headquarters has a history of 184 years,and its production center in China has been in operation more than 15 years.Existing quality management systems such as GMP and ISO 13485 only reflect the minimum legal requirements.As the surgical instrument business continues to grow,it will reduce the cost of rework and the waste of bad quality costs,and improve the efficiency and productivity of the entire process.Competitiveness in sister plants has become even more important.This article analyzes the top three major quality rework issues of R company’s medical device products during the production process,such as:Handling,Belt Marking,Form Issue.After focus analysis deeply,we find out the main processes wash and polish process affect a lot,and key factors affecting quality rework as below:long-term transport,dry way in wash process,stack display,rough grinding too much,no clear specification for form and so on.Then identifies and controls them through quality control plans.Meanwhile,from the viewpoint of management,deeply analyze the reasons for the high rate of rework problems.From the existing organization chart,it can be seen that QM department’s main responsibility is to ensure system meet compliance,and release the customer’s and Government audit,but not to solve and improve the quality problems of daily operations.This part of the responsibility is missing.The QM manpower allocation is insufficient,and it reported to other plant CEO,not directly to the R company’s CEO.Through the analysis of R company’s quality management mechanism,we found that the four quality gates belong to the production department,that are relatively independent and cannot be effectively linked.The latter three quality gate inspection items are highly overlapping and there is a loss of work efficiency.The QC department only has the responsibility of final quality inspection after production operators’inspection,and often the judgment standards and opinions are inconsistent with the production department.Product quality relies heavily on the last quality gate,and the timing of control is too late.By re-optimizing the organizational responsibilities of QC,the inspectors originally attached to production are assigned to QC,and the inspection tasks and personnel allocation of QC in the process are increased.The inspection plan that can be adjusted with the final inspection is designed to optimize the quality management mechanism.Through six-sigma tools such as QVSM,fishbone diagram,MSA measurement system analysis,Process Mapping,etc.,in-depth analysis and verification of the three major rework issues,optimize the quality control process and quality gate settings,and improve the original KPI evaluation index accordingly,making afterwards control in quality control advancedly,it promotes in-process quality management and add in continuous improvement process in the daily operations of the R company.Through a series of improvement activities,the DMAIC methodology was implemented in the organization,and the "10-steps method" of continuous improvement methods suitable for the R company management system was summarized,which has a certain reference role for the medium-sized manufacturing enterprises in the medical industry.