Dynamic Analysis Of The Audit Non-conformance Terms From Hefei CDC Quality Management System

Objective:This article analyzes the audit non-conformance terms found in CDC quality management system and summarizes the underlying reasons and rules. In order to ensure that CDC laboratory quality management system effectively operated and continuously improved, the development trend is forecasted and the improvement measures are put forward through the dynamic analysis.Methods:Using the data of all non-conformance terms from CDC Quality Management Audit in 2005-2013, the distribution of non-conformance terms among the elements, the years, the sections and the categories are investigated and analyzed, to compare and analyze the non-conformance terms on internal audits and external(CNAS) audits by Chi square. Speeds of the increase(fixed base relative, link relative) are used to analyze dynamically the non-conformance terms found in CDC quality management system. With Year Sequence as independent variables, the year non-conformance terms after converted by the natural logarithm as dependent variables, stepwise linear regression analysis was made to forecast the development trend line.Results:There were 106 non-conformance terms discovered during the last 9 years, which was distributed in 18 elements. The first three most non-conformance terms are: 4.3 document control,4.13 records control and 5.5 equipment, which take 15.09%, 12.26% and 11.32% respectively; Among all the non-conformance terms years, there are 11.8 non-conformance terms in average of all the past years, the top three were 2008, 2006 and 2005, with a proportion of 30.19%,18.87% and 13.21% respectively. The non-conformance terms were distributed in all 10 departments related to CDC quality management system. Laboratory, Quality Control Department and clinics had 38,15 and 11 non-conformance terms respectively and make most among them, accounting for 35.85%,14.15% and 10.38% of the total respectively. There are 94 implementation items with an proportion of 88.68% of the total, far more than other two kinds, which are System Items of 7.55% and Effect Items of 3.77%. Non-conformance terms were discovered more in internal audits than in external(CNAS) audits during the last 9 years. The comparison between the management elements and technical elements in internal and external audits,the difference has no statistically significance (Table 3, x2=3.06, P =0.08). The dynamic analysis shows that the number of non-conformance terms had been steadily declined yearly at the rate of 50%-78.12%. It is forecasted that there will be 120 non-conformance terms in 2018. The results show that central laboratory quality management system is running well and the management level is improving.Conclusion:The Laboratory Quality Management System of Hefei CDC is running well, but there are still weaknesses. The key points of the improvement are strengthening the file management, records control, confirmation of standard methods and personnel training, perfecting the supervision and assessment system.