Study On Process Risk Evaluation And Control Of Angiography Control Cabinet Introduction

In recent years, the medical device industry is growing up rapidly, but the characteristics of many varieties, small batch, high requirement make most companies stopped in front of this field. The corporation mentioned in the following subject was cooperated with an international medical equipment manufacturing enterprises in 2011 to introduce the angiography machine control cabinet and manufacture domesticate. In a certain sense, it is a very first and great opportunity of the domestic factory to manufactory the angiography machine device. It means the international corporations start to trust that Chinese suppliers have the capability to manufacture such kind of high-end medical device. Consider of enterprise prospects and international influence, the corporation have to catch this opportunity and manufacture the fully comply the angiography machine device and make sure minimize the risk of medical accident.The following subject assessed all risks may happen and plotted the countermeasure according to the risk level to minimize the risks of domestic manufactory. The topic is focusing two points; risk of the quality of components and rick of the quality of the procedure. Researching the quality of components was majorly focusing the quality problem on the history defect from suppliers and the quality problem of the sample manufacture stage abroad. Analyzing the key components by the decision tree and adjusting the existing controlling method of the key components and normal components to fit the feature of angiography machine control cabinet. Researching the quality of the procedure was majorly focusing on ascertaining the risks of producing products by PFMEA system to evaluating all kinds of the risk factors in exploiting, manufacturing and testing and plotting the measure for improvement accordingly to minimize the risks during the manufacturing period.This project has already been successfully transferred domestically and confirmed that the research and methods are working appropriately and effectively as the quality are obviously better than the other medical products. It could be a significant reference for other industry peers.