Research On The Quality Management Model Of Pharmaceutical Cold Chain Logistics

With the rapid development of cold chain logistics, the concept of quality security has been firmly established in people's lives. Because series of medical accidents have happened in China these years, the quality of cold chain logistics attracted great concern in the whole society. In recent years, the market of cold chain pharmaceutical products, including vaccines, blood, biological agents, has been expanding. The requirements of pharmaceutical cold chain logistics has gradually increased, which makes Pharmaceutical Cold Chain Logistics Quality management facing unprecedented opportunities and challenges. Because of poor cold chain logistics infrastructure and lack of industry standards and regulatory, few pharmaceutical cold chain logistics companies can provide qualified services in China, often caused painful events, which exposes the hidden quality dangers in the pharmaceutical cold-chain logistics system. How to establish and improve pharmaceutical cold chain logistics system, and explore the Quality Management Model which is suitable for the development of the cold chain logistics in China has become the direction of the joint efforts.Making pharmaceutical cold chain logistics as a subject, firstly, this paper described the related theories about quality engineering and cold chain logistics, and analyzed the status and trends of quality management of pharmaceutical cold chain logistics in China. Then, based on the clear understanding of content, features and principles of pharmaceutical cold chain logistics quality management, a pharmaceutical cold chain logistics quality management system which was composed of "a platform", "two interface", "three elements", "four process" had been constructed; system framework had been analyzed in detail, and the key elements——man, machine, material, method, environment, measurement, which affected the quality of pharmaceutical cold chain logistics, had been analyzed one by one. Thirdly, based on the Eclipse development platform, using Java language, a pharmaceutical cold chain logistics quality management information system framework had been build. At last, this paper innovatively integrated Total Quality Management and Six Sigma Quality Management, and proposed strategic concepts based on the collaborative management of two methods; Using the PDCA cycle, the key quality factor analysis, DMAIC quality improvement model, SIPOC flow analysis and other quality management tools and methods, this paper focused on analyzing the pharmaceutical cold chain logistics quality improvement case on the basis of collaborative management approach.