8D Process Application On Medical CT Control Board Quality Improvement

CT is the abbreviation of computer tomography scanning technique.It can help doctors to quickly and accurately get the image of the human body fault without damaging the patient's condition,and provide the basis for doctors to provide the diagnosis of the disease.Since the birth of the 1971 world first CT,due to its excellent lesion detestability,CT imaging equipment is widely used in medical diagnosis.In order to get share of the market and trust from country authority department,the quality is the basis.The improvement activities are follow 8D method and combined requirements of the medical equipment industry.At first,use Plato chart identify the main failure modes.An expert discussion meeting is conducted to analyze and find the root causes of process problem of the CT control board by using tools such as brainstorming,cause and effect diagrams and 5whys for Detector noise fake failed alarm,DOM firmware load failed and control board failure misjudgment.To the DOM function self-check test failed problems,the first step is to determine circuit output Vo as a key indicator of whether the control board is working normally.Then measure the existing sample to find the current Vo distribution,then optimize design and verify the new parameter.Define improvement measures according to the root cause.Through short term validation and long-term follow-up,the effectiveness of the measures is fully evaluated.The probability of the occurrence of four major unqualified medical CT control board is reduced from 4% before the improvement to 0.33% after improvement.The unqualified rate of the CT control board is obviously reduced.This paper improved the traditional 8D process so as to suitable the application in medical device industry.It played a guide line in X company's quality improvement activities of medical CT control board improvement.During the improvement,the practice of mathematical statistics was applied.It will be the golden example and reference in future quality improvement activities.