论文总字数：20543字

摘 要

近年来，随着疫苗接种率的上升和群众对于疾病预防的重视程度提高，我国可预防疾病的发病率有了明显的下降，与此同时，疫苗的接种事故率却一直居高不下，疫苗的安全性逐渐成为了一个必须直视的问题，而除了把好生产源头这一关，保证疫苗冷链物流的健康发展绝对是提高疫苗安全性与可靠性的最佳手段。那么，研究如何对现有的疫苗冷链物流体系进行质量评价，从中总结经验，提出改进措施，以达到优化整个疫苗冷链物流体系的目标，不仅能够帮助提高疫苗的安全性，于我国医药产业和物流产业的协同发展也至关重要。

本文主要内容为研究分析靖江市疾控系统的疫苗冷链物流质量，并针对存在问题设计靖江市疾控系统的疫苗冷链物流质量评价体系。首先对疫苗的相关知识进行简单的介绍和了解，然后对靖江市疾病与预防控制系统进行数据采集和项目分析，得出系统现状并研究目前所存在的问题及问题形成的原因；再结合现行的法律法规和国内外疫苗冷链物流的发展趋势，做好质量评价体系设计的先导工作；接着大致阐述六西格玛法的主要内容和运用该方法的优势，最后制定质量评价体系。在制定过程中主要采用六西格玛法中的DMADV设计方法，通过定义、衡量、分析、设计及验证五个步骤，对影响疫苗冷链物流的关键因素进行总结和量化，得出品质关键点并对其进行正确分析和评估，从而进一步得出改进措施，设计出质量评价体系。

关键词：冷链物流；疫苗安全；六西格玛法；质量评价

Study on the Evaluation of Vaccine Cold-chain Logistics Quality：Taking the Disease Control System of Jingjiang City as an Example

Abstract

In recent years, as the vaccination rate has increased and people’s emphasis on disease prevention has increased, the incidence of preventable diseases in China has dropped significantly. At the same time, the vaccination inoculation rate has remained high. Security has gradually become a problem that must be looked at directly, and in addition to putting a good source of production at this level, ensuring the healthy development of vaccine cold-chain logistics is absolutely the best means to improve the safety and reliability of vaccines. Then, study how to evaluate the quality of existing vaccine cold chain logistics system, sum up experience, and propose improvement measures to achieve the goal of optimizing the entire cold chain logistics system of vaccines. This will not only help improve the safety of vaccines in China"s pharmaceutical industry. Collaborative development with the logistics industry is also crucial.

The main content of this article is to study and analyze the vaccine cold chain logistics quality of the disease control system in Jingjiang City, and to design a vaccine cold chain logistics quality evaluation system for the disease control system in Jingjiang City. Firstly, we briefly introduce and understand the relevant knowledge of vaccines, and then conduct data collection and project analysis on the disease and prevention and control systems of Jingjiang City, obtain the current status of the system, and study the current problems and the causes of the problems; The laws and regulations and the development trend of vaccine cold chain logistics at home and abroad, and do a good job in the design of the quality evaluation system, followed by a general description of the main content of the Six Sigma law and the advantages of using this method, and finally develop a quality evaluation system. In the formulation process, the DMADV design method in the Six Sigma method is mainly adopted. Through defining, measuring, analyzing, designing, and verifying five steps, the key factors affecting the cold chain logistics of vaccines are summarized and quantified, and the key quality points are obtained and their quality is determined. Correct analysis and evaluation are conducted to further develop improvement measures and design a quality evaluation system.

Keywords: Cold chain logistics; Vaccine safety; Six sigma method; Quality evaluation

目 录

第一章 绪论 1

1.1 选题背景及其意义 1

1.1.1 选题背景 1

1.1.2 研究意义 2

1.2 研究内容及目的 2

1.3 研究方法和思路 3

1.4 主要概念的界定 3

第二章 文献综述 4

2.1 疫苗质量管理相关文献综述 4

2.2 医药冷链物流质量管理文献综述 4

2.3 疫苗冷链物流质量管理文献综述 5

第三章 靖江市疾控系统的疫苗冷链物流现状 7

3.1靖江市疾控系统疫苗冷链物流现状 7

3.2 靖江市疾控系统疫苗冷链中存在的问题及产生原因 8

3.2.1 疫苗冷链的具体要求 8

3.2.2 靖江市疫苗冷链系统中的具体问题及原因 9

第四章 使用六西格玛法制订疫苗冷链物流质量评价体系 11

4.1 六西格玛法概述 11

4.2 使用六西格玛法制订质量评价体系 12

4.3 六西格玛设计结论 19

第五章 结论 20

参考文献（References） 21

第一章 绪论

1.1 选题背景及其意义

1.1.1 选题背景

近年来,疫苗、基因工程试剂等生物制品的种类和数量不断增加，消费市场扩大,对该类产品全程冷链物流的要求也逐步提高, 生物制品质量安全作为该类产品冷链物流的基本要求，其冷链物流质量管理面临着前所未有的机遇与挑战。

由于疫苗的成分和作用方式都较为特殊，因此事故率远大于其他医药用品。我国就发生过多次由疫苗引起的接种事故，例如2002年，成都市营门口社区医院误将结核疫苗当作脑膜炎疫苗接种给17名儿童，造成这些儿童发生严重的结核病扩散；2007年，我国山西发生多起儿童注射疫苗后致伤致死事件；以及2013年，我国南方数名婴儿在接种乙肝疫苗后死亡事件；和2016年我国爆发的涉及十八个省市的问题疫苗事件等。

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