Study On Raw Material Quality Management Process Optimization Of Z Medical Technology Company Based On FMEA

With the increase of Chinese residents’ income and the increasing demand of personal disease prevention and treatment as well as healthcare,both urban and rural residents’ expenditure on health care shows a steady growth trend,which also expands the proportion of China’s medical device industry in the national economy gradually.In China,however,the medical device industry started much later than its foreign counterparts,resulting in relatively backward technological innovation and low level of quality management;this is especially evident in those small-and medium-sized medical device manufacturing companies as they have lagged behind dramatically on both aspects.On top of that,many of them have seen a significant decline in profits as a result of energy costs,soaring raw material prices,rising labor and financing costs,and increasing competition in the market.In the face of this complicated dilemma,how to survive and seek opportunities for development is the top priority for every small-and medium-sized one struggling in current economic environment.Due to the particularity of this industry,it is surely a feasible way to streamline the process under the premise of complying with relevant laws and regulations so as to reasonably reduce the cost.Therefore,under the current situation,optimizing the quality management process would be the preferred strategy for every single medical device firm as this process is dedicated to ensuring compliance.Z Medical Technology Company(Company Z),a typical small-and medium-sized medical device manufacturer,has devoted itself to producing medical sodium hyaluronate gel beyond 20 years,and it is widely recognized within its industry holding an upward momentum.Nevertheless,the cost of raw materials,labor,energy,etc.has continued to rise during the past five years,among which the cost of raw materials is the most prominent conundrum.Facing the predicament of the surge of the expenses pertinent to raw materials year by year,its future might be unpromising if Company Z opts to increase the price of products instead of seeking for effective means to resolve this issue by the roots.Aiming at the raw material quality management process of Company Z,this essay starts from the theoretical research,exploring the theory of the quality risk management,the quality management,and the FMEA method.Based on the literature research and the status quo of Company Z,this paper will materialize the issues looming in the current process via fishbone diagram.Then these problems could be subdivided according to the composition of the main raw materials in order to employ 5why tool for further analysis to learn the root cause of each one.Thus,the corresponding optimization protocols could be developed and then the FMEA method will be used to identify the possible risks upon the implementation of these protocols under the guidance of the quality risk management theory.On this basis,measures for further reducing the risks will be raised so as to understand the availability of these protocols by assessing their residual risks.Eventually,those optimization protocols will be implemented only when their residual risks assessed as acceptable,and then the data before and after the implementation of optimization protocols can be collected for comparison.Consequently,a conclusion could be safely reached that the optimization protocol can harvest both direct and indirect benefits,which strongly proves that the purpose of cost reduction and efficiency increase in quality management process can be achieved by careful employment of FMEA.