导　　师： 杨雷;郑捷

学科专业： 1201

授予学位： 硕士

作　　者： ;

机构地区： 华南理工大学

摘　　要： 质量改进是质量管理的一部分，增强满足质量要求的能力。众所周知，一个产品质量的好坏，直接影响用户的满意度和一个企业的利益，而要提高产品的质量就要进行质量改进，在质量改进的过程中，采取措施纠正现存质量问题，使产品的质量在现有水平的基础上进一步得到提高。 本文以质量改进理论为基础，PDCA质量改进方法为主线，以A公司的D药片为研究对象。针对D产品生产过程中存在的质量问题，利用质量改进工具，找出主要影响因素，并制定质量改进措施，最终改善D产品的质量来提高产品的合格率，提高生产效率，降低生产成本。 首先根据D产品生产情况及存在的质量问题，收集生产相关数据，运用帕累托图分析确定D产品存在的主要质量缺陷，即皱裂质量缺陷，并用因果图分析影响皱裂质量缺陷可能的影响因素。在因果图分析的基础上用PFMEA（潜在失效模式及后果分析）确定主要影响因素并进行分析，针对各主要影响因素分别提出相应的改善措施，并对相关测量系统进行分析。 然后利用试验设计方法，找出主要影响因素制粒物料配比及包衣工艺参数最优组合，并实施改善措施。最后，对改善措施实施效果进行验证，并进行有效控制，更新生产工艺及生产操作等相关文件，针对A公司在人员管理及企业质量文化建设方面存在的问题提出了相关建议，并对其改善效果进行了经济性分析。改善结果和经济分析结果证明，此次D产品质量改进活动，提高了压片、包衣工序D产品合格率，尤其是包衣工序产品合格率，且每年可节约约1.8万元的人工成本和7.5万元的生产成本，提高了生产效率，缩短了产品生产周期，降低了生产成本。 QI/(Quality Improvement/), as a part of QC/(Quality Control/),aims to strengthen the abilityof meeting the QR/(quality requirements/). It is known to all that the level of product quality isvital to the satisfaction of clients as well as the profit of a company. In a bid to improve thequality of products, it is necessary to take measures to solve the quality problems so that theproduct quality can be improved to a higher level. This essay will take D film-coated tabletof A company as a study target based on thetheory of QI and a method of PDCA. With the help of QI tools，working out the Qualityimprovement measures in order to improve its Production Pass Rate as well as to lower theproduction cost. First, to identify the main quality defects: cracks, by pareto diagram analysis of thecollected manufacturing data and production status and the existing quality problems, find outthe possible factors that may contribute to the quality defects by cause-and-effectdiagram.Then, propose the improvement measures of the main factors respectively on thebasis of PFMEA and to analyze the related measuring system. After that, find out the optimal combination of granulating ratio and coating parameterby the method of experiment design，and implement improvement measures.Finally, to verifythe results of the improvement measures and update the production process and the relevantdocuments of production operations, and a series of suggestions were made on the personnelmanagement and quality control system of company A，and carried out economic analysis onits improvement measures.The improvement outcomes and economic analysis results showedthat the D product quality improvement activity has improved the qualification rate of Dproduct in the tablet compressing and coating processes,especially the qualification rate of thecoating process.Besides,about1.8million yuan of labor costs and7.5million yuan ofproduction costs could be saved annually,and production efficiency was increased. Moreover,it shortened product production cycle and decreased production cost.

关 键 词： 药片 皱裂 质量改进 试验设计

分 类 号： [F273.2 F426.72]

领　　域： [经济管理] [经济管理] [经济管理]