Research On Production Quality Control Of The Troponin Test Kit

With in vitro diagnostic reagents to increasingly fierce competition in the industry, it is very important for the diagnostics company to continue to strengthen quality control and improve product quality in the market. L company is a new diagnostic company that produces troponin test kit,this company has been received a great number of customer complaints since the sales, the company leaders attach great importance to this matter. So plan to make production process quality control of troponin test kit, to improve product quality.After consulting literature and investigating, this thesis thorough researches on the production process quality control of troponin test kit in the L company. The main work has been done as follows:1.Find out the current production quality control of the test kit in detail.To collect customer complaint records in February 2014 to June 2014, find the current product quality problems in the 253 records.2. Analyze the harmfulness and hazard rating of the quality problems through investigation, and analyze the occurring frequency of the quality problems through statistical data.3. Work out the risk rating of quality problems according the hazard rating and the occurring frequency; analyze the level of risk through using Pareto diagram, and according to Pareto principle to seek out the main quality problems of products.4.Analze the causes of the main quality problems, through Causality diagram and Control charts.5. According to the causes of the main quality problems, develop quality control measures, and predict the quality control effect.6.Introduce the implementation situation of quality control measures.At the end of this thesis, through the Control chart of the test data in the intermediate product and finished product testing of the 16 batches, it is proved that the production process is stable and controlled. And the failure rate of the product is greatly reduced after the implementation of the quality control measures by the customer complaint data comparison. At the same time, the quality awareness of the staff has been improved. All the above faces prove that the quality control is very effective.