基于PDCA循环的连锁药店冰箱验证方案设计与实施  

Design and Implementation for Verification Scheme of Refrigerator Operation Quality in Chain Drugstores Based on PDCA Mode

作　　者：吴杰[1,2] 樊世清[2] 赵志静 

机构地区：[1]江苏省徐州医药高等职业学校,江苏徐州221116 [2]中国矿业大学管理学院,江苏徐州221116 [3]徐州医药股份有限公司,江苏徐州221000

出　　处：《中国药业》2017年第8期73-76,共4页China Pharmaceuticals

摘　　要：目的通过对冷藏药品保存过程中冰箱验证方法的设计与分析,探讨药品在冰箱中的最佳存放位置及存放条件,保证药品质量及用药安全。方法联合运用PDCA循环与鱼骨图,测定冰箱正常装载情况下48 h内不同部位温度变化曲线,同时对保存的药品进行抽检,检查药品质量。结果所设计的方案符合冷藏药品温度管理的基本要求,方法稳定可靠,可实现零售药店冷藏药品全程冷链的保存要求,可保证药品质量。结论冰箱验证是一项系统工程,需要通过不断循环,形成有效的验证方案,对药店岗位操作进行指导,最终达到保障药品质量的目的。Objective To discuss the best storage position and storage condition of the medicine in the refrigerator by design and analy-sis of refrigerator verification method in the refrigerated drugs preservation process,in order to ensure the quality and safety of drugs. Methods The temperature change curve in different parts of refrigerator within 48 h was determined under normal loading according to the PDCA cycle and fishbone chart. At the same time,the drug quality was checked by sampling the preserved drugs. Results The verification scheme was in accordance with the basic requirements of the temperature management of cold medicine,and it was stable and reliable,which could realize the preservation requirements of whole cold chain of refrigerated pharmacy in retail pharmacy and ensure the drugs quality. Conclusion Refrigerator verification is a systematic project,which needs to form an effective verification scheme by continue cycle and to guide the operation of pharmacy post,and ultimately achieve the purpose of en-suring the quality of drugs.

关 键 词：PDCA循环 鱼骨图 冷链 冰箱 运转质量 验证 

分 类 号：R952[医药卫生—药学]