基于HACCP体系浅析食品微生物定性检测中的风险管理

Risk management in microbiological qualitative testing of food based on hazard analysis critical control point system

食品微生物中致病菌的检测多为定性检测,定性检测的结果可能受到检测过程中人、机、料、环、法关键因素影响导致检测结果偏离,出现假阳性或假阴性结果,造成检测结果不可信、实验室数据准确性下降。根据中国合格评定国家认可委员会(China National Accreditation Service for Conformity Assessment, CNAS)及中国计量认证(China Metrology Accreditation, CMA)对检测实验室的相关要求,实验室应考虑与检测活动相关的风险,预防和减少风险带来的可能不利影响及可能的失败,并策划应对这些风险的措施。为了确保检测结果准确性,微生物实验室应对实验室和食品微生物定性检测流程中存在的风险进行风险管理。本文将实验室质量管理中的风险管理与危害分析和关键控制点(hazard analysis critical control point, HACCP)体系相结合,对微生物定性检测流程进行梳理并应用HACCP原理对各流程中存在的关键控制点进行分析及评估,建立监控系统,提出预防措施,最终形成HACCP计划表,降低或者避免风险的产生,提高检测结果准确度和可靠性。

There are a large number of qualitative tests in the detection of pathogenic bacteria of food microbiological testing. Qualitative test results may be affected by key factors such as human, machine, material, environment and method in the process of testing, resulting in deviation of test results to unreliable test results such as false positive or false negative results. As a result, the test results are not credible and the accuracy of laboratory data decreases. According to the requirements of China National Accreditation Service for Conformity Assessment(CNAS) and China Metrology Accreditation(CMA) for food testing laboratories, laboratories are required to consider the risks associated with testing activities, prevent and reduce the possible adverse effects of risks and possible failures, and the laboratory should plan measures to deal with these risks. In order to ensure the accuracy of the results, the microbiological laboratory should carry out risk management for the risks existing in the laboratory and food microbiological qualitative testing process. This paper analyzed the critical control points in microbial qualitative tests by combining the risk management in quality management with hazard analysis critical control point(HACCP) system, proposed monitoring system and preventive measures, though all above way formed the HACCP schedule. This schedule can help reducing or avoiding the risks in the lab, and improve the accuracy and reliability of test results.