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目的验证贵州省血液中心质量管理体系及其运行情况的符合性和有效性。方法通过回顾性分析2010-2013年内审发现的不合格项在各部门和各要素的分布情况,以及不合格项的性质和纠正措施完成情况,从而评价质量体系的运行情况。结果 2010-2013年内审发现的不合格项分别有42项、20项、18项和32项,不合格项的分布主要集中在供血科、体检采血科、检验科、质量管理科和后勤保障科等科室,主要涉及要素是组织和人员、设备、安全与卫生、记录和献血服务,一般不合格项107项(95.5%),严重不合格项5项(4.5%),不合格项的纠正预防措施基本得到落实。结论排除审核方式因素,不合格项逐年减少,说明贵州省血液中心的质量管理体系及其运行情况是符合和持续有效的。
Objective To verify the compliance and effectiveness of Guizhou Blood Center Quality Management System and its operation. Methods The situation of the quality system was evaluated by retrospectively analyzing the distribution of the non-conformities found in the internal audit in 2010-2013 in various departments and various factors, as well as the nature of the nonconforming items and the completion of corrective measures. Results There were 42, 20, 18 and 32 unqualified items found in the internal audit in 2010-2013. The distribution of unqualified items mainly focused on the blood supply department, physical examination blood collection department, laboratory department, quality management department and logistics support Departments and other departments, mainly related to the elements of organization and personnel, equipment, safety and health, records and blood donation services, 107 items (95.5%) were generally unqualified items, 5 items (4.5%) were serious unqualified items, Preventive measures have basically been implemented. Conclusion Excluding the factors of audit mode, the number of nonconforming items decreased year by year, indicating that the quality management system and operation status of Guizhou Blood Center are in line with and sustainable effective.