摘要
目的通过风险管理,以复验标本检测过程为例,建立关键控制点识别和管理体系,保证检测质量。方法根据血液筛查实验室质量管理特点,制定血液筛查实验室检测过程风险等级表;使用等级表对关键控制点进行识别和评分,根据风险等级评分制定关键控制点管理措施。结果根据关键控制点的影响程度,风险等级分为4级,针对每个级别制定管理措施。复验标本检测过程较为复杂,风险等级高,有7个关键控制点,其中5个为风险等级危重,中度和重度各1个。根据风险等级,制定相应的管理措施,保证了关键控制点识别和管理措施的充分有效可行。结论应用风险管理,能够充分有效的对关键控制点进行识别,根据风险等级制定管理措施,能够对关键控制点进行充分有效可行的管理,保证质量管理体系能够建立和持续改进的充分有效性,保障血液安全。
Objective To applicate the risk management in re-inspection process as an example to establish identification and management of critical control point and ensure the quality of testing. Mediods According to the characteristics of blood screening laboratory quality management, the risk level table of the blood screening laboratory test process was developed. The critical control point was identified and scored according to the grade table, and the identification and management of critical control point were developed according to the risk grade score. Results According to the degree of impact of critical control point, the risk level was divided into four levels, for each level to develop management measures. The re-inspection process was more complex and the risk level was high. There were 7 critical control point, of which 5 for the risk level critical, moderate and severe each 1. According to the risk level, to develop appropriate management measures to ensure that critical control point identification and management measures were fully effective and feasible. Conclusion Application of risk management can be effective identificate of critical control points. According to the risk level to develop management measures, the critical control point can be fully effective and feasible to protect the blood safety and ensure that the quality management system can be established and continuous improvement fully effective.
出处
《云南医药》
CAS
2017年第4期386-389,共4页
Medicine and Pharmacy of Yunnan
关键词
风险管理
关键控制点
复验标本检测
质量体系
Risk management
Critical control point
Re-inspection process
Quality management
