The Research Of Six Sigma Application In Small And Medium-sized Pharmaceutical Enterprises Of Shanxi Province

The pharmaceutical industry has a profound historical background and technical support in Shanxi Province, however, in recent years the development is relatively slow, since the relatively weak ability in quality management, and a serious loss in the producing process.In order to promote the development of pharmaceutical industry in the "12th Five-Year" period, the Shanxi Provincial Party Committee and the provincial government put forward the "Jin drug strategy", at the same time promote the2010edition of pharmaceutical production and quality management practices (GMP) approach to promote the management level of the pharmaceutical industry enterprises, in order to enhance their core competitiveness and encourage progress of the pharmaceutical industry as a whole. This will bring new opportunities and challenges to pharmaceutical industry enterprises in Shanxi, especially small and medium-sized pharmaceutical companies. In the pharmaceutical industry enterprises in Shanxi Province, The small and medium-sized pharmaceutical companies account for97.2%of the total number of enterprises in Shanxi Province, so the level of quality management, and core competitiveness of them, not only related to the overall competitiveness of the pharmaceutical industry in Shanxi Province, but also the sustained and rapid development of the province’s economic.This study researched the current situation of quality management in small and medium-sized pharmaceutical enterprises in Shanxi, aimed at upgrading the capability of quality management and offering the scientific guidance for enterprises to pass GMP certification of the2010edition. The significance of introducing the Six Sigma management to small and medium-sized pharmaceutical enterprises in Shanxi was discussed. To solve the problem of quality management in small and medium-sized pharmaceutical enterprises in Shanxi, on the basis of the partial improvement of the Six Sigma Improvement Model-DMAIC, a more applicable and relevanted model-PDAIC was suggested. the model not only specified Shanxi SMEs in the implementation of Six Sigma steps, as well as the work need to do and use of tools in each stage, but also suggested the improved failure mode analysis, resulting in better connection between enhancing the level of quality management and the implementation of the2010version of the GMP standard. Finally, carried out the Six Sigma Improvement with the proposed PDAIC model in a pharmaceutical company of Shanxi, helped the enterprise solve the problem of fosfomycin calcium Glycols excessive practically, and summarize the experience of the application of Six Sigma Management in enterprise.The innovation of this paper is to:1. Built the Six Sigma improvement model for small and medium-sized pharmaceutical enterprises in Shanxi, and analyze the implementation steps and the tools each stage required.2. Build failure mode analysis method based on the2010version of the GMP. Help the enterprised to implement the2010version of the GMP standard better by looking for the gap of quality management methods and the2010version of the GMP, and raise the level of quality management.