• 中国科学论文统计源期刊
  • 中国科技核心期刊
  • 美国化学文摘(CA)来源期刊
  • 日本科学技术振兴机构数据库(JST)

临床输血与检验 ›› 2020, Vol. 22 ›› Issue (4): 405-407.DOI: 10.3969/j.issn.1671-2587.2020.04.017

• 临床检验 • 上一篇    下一篇

溯源性审核在采供血机构质量内部审核中的运用

王锦, 邱艳, 崔爽, 石丽萍, 徐华   

  1. 710000 西安, 陕西省血液中心(王锦, 徐华);
    北京市红十字血液中心(邱艳, 崔爽, 石丽萍)
  • 收稿日期:2019-02-19 出版日期:2020-08-20 发布日期:2020-08-12
  • 通讯作者: 邱艳, 女, 主任技师, 研究员, 理学博士, 主要从事输血技术与输血医学研究和管理, (E-mail)13681201834@163.com。
  • 作者简介:王锦(1990-), 女 , 陕西西安人, 主管技师, 硕士, 主要从事质量管理工作, (E-mail)411872565@qq.com。

Application of Traceability Audit in Internal Audit Quality of Blood Collection and Supply Organization

WANG Jin, QIU Yan, CUI Shuang, et al.   

  1. Shaanxi Blood Center, Xi'an 710000
  • Received:2019-02-19 Online:2020-08-20 Published:2020-08-12

摘要: 目的 建立采供血机构溯源性审核模式, 提升质量管理体系审核水平。方法 在集中式质量管理体系审核中增加对血液产品、设施设备、关键物料、人员的溯源性审核, 审查各环节实际操作、质量体系文件与法律法规三者之间的符合性、充分性与可追溯性。结果 通过溯源性审核对各质量要素进行风险管控, 确保国家法律法规、行业标准、产品质量要求的贯彻执行, 减少安全隐患。结论 溯源性审核提升了质量管理体系内部审核的深度, 补充了采供血机构内部审核的内容。

关键词: 采供血机构, 质量管理体系, 审核, 内审, 溯源性

Abstract: Objective To establish a traceability audit mode of blood collection and supply organization, and to improve the level of quality management system audit. Methods Under the centralized quality management audit, increase the traceability audit of blood products, facilities and equipment, key materials and personnel, and review the three links of compliance, adequacy and traceability between actual operations, quality system documentation and regulations. Results Through traceability audits, the risk management and control of each quality element is carried out to ensure the implementation of national laws and regulations, industrial standards and product quality requirements, and reduce potential safety hazards. Conclusion The traceability audit enhances the depth of internal audit of the quality management system, and supplements the content of internal audit of blood supply and blood supply organization.

Key words: Blood, collection, and, supply, organization, Quality, management, system, Audit, Internal, audit, Traceability

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