On the issue of resolving disputes about the compliance of the research object with regulatory requirements

Yurij A. Rahmanin, Oleg M. Rozental
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Abstract

Conclusions on the fulfillment or violation of regulatory requirements ensuring the hygienic safety of the research object of the supervised object are carried out by state sanitary and epidemiological supervision bodies based on the results of laboratory studies of controlled indicators. These are, in particular, conclusions on the safety of drinking water sources for the population. The composition and properties of this water, on the instructions of sanitary and epidemiological supervision bodies and water supply institutions, can be examined equally by accredited laboratories that comply with the accreditation criteria in carrying out their activities. At the same time, unfortunately, it is impossible to guarantee the same results of laboratory testing of controlled microbiological, chemical, and other indicators, due to their variability and measurement errors. As a result, the conclusions about the quality and safety of water obtained by the supervisory authority and the supplier (user), primarily in cases concerning the boundary values of hygiene standards, may differ. For constructive resolution of controversial situations arising in this case, this paper proposes a method of tolerance control, the result of which is a logical judgment on the compliance or non-compliance of controlled quantities with established standards. It is shown how this reduces the risk of erroneous recognition of non-compliance of the composition or properties of water with hygienic requirements and guarantees safe water supply to the population. Authors suggested equations of admission control to assess compliance with the requirements of sanitary, epidemiological, and hygienic safety of controlled facilities. A method convenient for practical use is proposed, and using a specific example of monitoring the water quality of wells in the Talitsky district of the Sverdlovsk region, it is shown how it is possible to establish the water safety of almost half of the initially rejected water sources. The use of tolerance control is recommended if it is necessary to increase the reliability of hygienic conclusions on the safety of a wide range of supervised facilities, for which convenient mathematical expressions are given.
关于解决研究对象是否符合监管要求的争议问题
国家卫生和流行病学监督机构根据对受控指标的实验室研究结果,就受监督对象的 研究对象是否符合或违反确保卫生安全的法规要求做出结论。这些尤其是关于居民饮用水源安全的结论。根据卫生和流行病学监督机构和供水机构的指示,这些水的成分和性质同样可以由在开展活动时遵守认证标准的认证实验室进行检验。同时,遗憾的是,由于微生物、化学和其他受控指标的可变性和测量误差,无法保证实验室检测结果的一致性。因此,监管机构和供应方(用户)获得的水质安全结论可能会有所不同,主要是在涉及卫生标准边界值的情况下。为了建设性地解决这种情况下出现的争议,本文提出了一种容差控制方法,其结果是对控制量是否符合既定标准做出逻辑判断。本文说明了这种方法如何降低错误识别水的成分或特性不符合卫生要求的风险,并保证向居民安全供水。作者提出了评估受控设施是否符合卫生、流行病学和卫生安全要求的准入控制方程。作者提出了一种便于实际使用的方法,并以斯维尔德洛夫斯克地区塔利茨基区的水井水质监测为例,说明了如何确定近一半最初被拒绝的水源的水质安全。如果有必要提高关于各种受监督设施安全的卫生结论的可靠性,建议使用容差控制,并给出了方便的数学表达式。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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