化妆品功效评价项目即在化妆品上市之前，在保障安全性的前提下，对化妆品的 功效宣称进行证实评价工作。优质的项目质量不仅能有效地帮助客户更快且更准确地 将新品推向市场，还能助推化妆品行业的健康发展。由此，化妆品临床检测机构的责 任日益凸显，提升项目质量的重要性以及紧迫性尤为突出。 F 公司是一家第三方临床检测机构，据客户满意度调查结果显示，F 公司存在项 目无法同时兼顾效率和质量的问题。临床试验指导性文件《药物临床试验质量管理规 范》总则指出了临床试验的两大宗旨，即 “受试者的权益和安全”和“项目数据的 科学可靠”。本文以 F 公司化妆品功效评价项目中的人体试验为研究对象，从这两方 面查找项目质量问题。 首先，以《涉及人的生物医学研究伦理审查办法》规定的六大原则为标准，通过 受试者问卷调查来查找受试者的权益和安全方面的问题，结果显示，F 公司在保障知 情同意原则以及控制风险原则方面存在不足。通过对数据进行进一步分析，涉及质量 管理方面的问题包括研究人员服务意识不佳以及受试者安全预防措施欠佳两方面。 其次，以国际协调会议指南（ICH-GCP）提出的 ALCOA-CCEA 要素为标准，通过对 项目进行实地调研，来查找数据的科学可靠方面的问题，结果显示，及时性以及完整 性存在问题。通过对数据进行进一步分析，涉及质量管理方面的问题包括受试者等待 浪费集聚和仪器设备故障频发两方面。 最后，本文从客户角度定义价值，采用标准化作业来提升研究人员的服务意识， 采用防错法来加强安全预防措施，采用可视化管理来消除等待浪费，采用 5S 现场管 理法来降低设备故障。旨在通过优化最大限度地减少流程中的变异及浪费，在保证效 率的基础上追求项目质量水平提升的稳定性以及持续性。与此同时，提出预期效果及 后续实施计划，并通过企业文化、人员管理以及组织三方面对基于精益六西格玛的 F 公司化妆品功效评价项目质量管理优化方案得以稳定、持续实施保驾护航。 关键词：项目质量管理；精益六西格玛；化妆品功效评价III Abstract The efficacy assessment of cosmetics is the premarketing confirm assessment of the efficacy claims of cosmetics under the premise of ensuring safety. High-quality projects can not only help sponsors to bring new products to the market faster and more accurately, but also promote the healthy development of the cosmetics industry. Therefore, the responsibility for Contract Research Organizations of cosmetics has become increasingly prominent, and improving project quality has also become the focus of attention. F Company is a Contract Research Organization. According to the results of surveys on customer satisfaction, F company had a problem that the project could not balance efficiency and quality at the same time. The guidance document for clinical trials, GCP, clearly states the two main purposes of clinical trials, namely, Subjects' Rights and Safety and Scientific and Reliability of Project Data. Thus, this paper mainly discussed the human test quality problems of efficacy assessment of cosmetics of F Company based on these two aspects. Firstly, based on the six principles stipulated in the Ethical Review Methods for Biomedical Research Involving Humans, this paper used questionnaires to find problems of the subject's rights and safety. The results showed that F company had deficiencies in ensuring the principle of informed consent and the principle of controlling risks. Through further analysis of the data, issues related to quality management included two aspects: the researchers’poor service consciousness and the poor safety precautions for subjects. Secondly, based on the ALCOA-CCEA elements proposed in the ICH-GCP, the field investigation was conducted to find the problems of the scientific and reliability of project data. The results showed that there were problems with C(contemporaneous) of ALCOA and C(complete) of CCEA. Through further analysis of the data, issues related to quality management included two aspects: the subjects’ waiting waste and frequent equipment failures. Finally, defining conception of value in light of customers, this paper used Standard Operating Procedure to enhance researcher’s service consciousness, used Poka-Yoke to strengthen safety precautions for subjects, used Visible Management to eliminate subjects’ waiting waste, and used 5S to reduce equipment failures, in order to aim at furthest reducing variation and waste in the process and pursuing the sustainability and stability of project quality improvement on the basis of guaranteed effectiveness. Moreover, this paperIV also put forward the expected results and follow-up implementation plans, and set up the guaranteeing measures on corporate culture, personnel management, and organization, to ensure the stability and sustainability of the optimization scheme. Keywords ： Project Quality Management; Lean Six Sigma; Efficacy Assessment of Cosmetics目录 致谢.........................................................................................................................................I 摘要.......................................................................................................................................II Abstract................................................................................................................................ III 第 1 章 绪论..........................................................................................................................1 1.1 研究背景......................................................................................................................1 1.2 研究目的及意义..........................................................................................................2 1.3 研究现状......................................................................................................................3 1.3.1 国外研究现状....................................................................................................... 3 1.3.2 国内研究现状....................................................................................................... 6 1.3.3 研究现状评述....................................................................................................... 8 1.4 研究内容......................................................................................................................9 1.5 研究方法....................................................................................................................10 1.6 技术路线....................................................................................................................11 1.7 创新点........................................................................................................................11 第 2 章 相关概念和理论基础............................................................................................13 2.1 精益六西格玛管理理论概述....................................................................................13 2.1.1 六西格玛理论概述............................................................................................. 13 2.1.2 精益生产概述..................................................................................................... 14 2.1.3 精益与六西格玛的结合..................................................................................... 15 2.2 精益六西格玛管理理论改进工具............................................................................16 2.2.1 标准化操作......................................................................................................... 16 2.2.2 防错法................................................................................................................. 16 2.2.3 可视化管理......................................................................................................... 17 2.2.4 5S 现场管理法....................................................................................................18 2.3 化妆品功效评价项目质量概述................................................................................18 2.3.1 受试者的权益和安全......................................................................................... 19 2.3.2 数据的科学可靠................................................................................................. 21第 3 章 F 公司内外部环境分析...................