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Standard Practice for Writing Quality Control Specifications for Standard Test Methods for Water Analysis 水分析标准试验方法质量控制规范的编写
发布日期: 2022-05-01
1.1 本规程规定了将质量控制(QC)程序纳入D19委员会管辖范围内的所有试验方法的具体强制性要求。 1.2 ASTM国际采用了以下内容: 执行D19水委员会制定的标准试验方法中质量控制部分要求的政策。 概述 -在1998年7月29日之前,或在下一次重新批准或修订时(以较晚者为准),每个D19标准试验方法应包含完全符合本规程要求的QC部分。 新的协作测试 -自1998年7月29日起,每个合作研究设计应包括QC部分,作为待测试方法的一部分。 在批准研究设计之前,结果顾问或同等人员应确定质量控制部分是否符合本规程和实施规程的要求 D2777 ,并应就满足这些实践要求所需的任何变更向研究设计者提出建议。在进行合作研究之前,应获得结果顾问或同等机构对研究设计的批准。 旧的验证方法 -使用实践验证的标准测试方法 D2777 – 77, D2777 –86,或 D2777 –94,当投票重新批准或修订时,应包含基于历史记录中最佳信息的QC部分。在适当情况下,应从合作研究记录中获得的信息应用于此目的。 在这些标准试验方法中引入质量控制部分不应被解释为新的合作研究的要求,尽管小组委员会可以选择这样的研究。有关QC或精度/偏差测试的任何可用信息应包含在已发布测试方法的适当章节中。 1.3 所有适用测试方法中所需的QC部分旨在实现两个目标。首先,委员会D19测试方法的用户将能够通过与协作研究数据进行比较来证明这些测试方法的最低性能。第二,测试方法的所有用户将被要求执行最低水平的QC,作为正确实施这些测试方法的一部分,以确保持续的能力。 1.4 本规程包含特定试验方法的质量控制的主要要求。在许多情况下,可能需要实施额外的质量控制要求,以确保所需的数据质量。 1.5 本规程中的具体要求可能不适用于所有试验方法。这些要求可能因所用试验方法的类型、所测定的分析物和所分析的样品基质而异。 1.5.1 如果本实施规程中列出的任何特定QC要求不适用于特定试验方法有令人信服的原因,则应在试验方法的QC部分记录这些原因。 1.5.2 经D19委员会根据D19结果顾问或同等人员的建议和执行小组委员会的技术操作科批准,一份声明将满足ASTM和本规程的要求,该声明给出了无法达到本规程所有或特定点的令人信服的原因。 1.6 本规程用于定量试验方法,可能不适用于定性试验方法。 1.7 目前,本规程主要适用于化学试验方法。其目的是,在未来的修订中,实践将扩展到包括其他测试方法,如微生物测试方法。 1.8 单位- 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 为了确保使用ASTM委员会D19测试方法获得的分析结果的最终用户能够确信这些值是通过测试方法的有效应用获得的,应证明分析系统的熟练程度。通过测试方法协作研究结果得出的性能标准,证明了适当的熟练程度。本规程中规定的质量控制措施应包括在每种ASTM试验方法中(如适用),以确保测量质量。 5.2 为了使D19试验方法的用户获得一致有效的结果,应进行最低水平的QC。 本规程和开发D19试验方法的任务组规定了最低质量控制水平。如果本规程中概述的具体要求不适用于试验方法,则应在试验方法中定义替代QC。
1.1 This practice provides specific, mandatory requirements for incorporating quality control (QC) procedures into all test methods under the jurisdiction of Committee D19. 1.2 ASTM International has adopted the following: Policy on implementation of requirements for a quality control section in standard test methods generated by Committee D19 on Water. GENERAL —By July 29, 1998, or at the next reapproval or revision, whichever is later, every D19 Standard Test Method shall contain a QC section that is in full compliance with the requirements of this practice. NEW COLLABORATIVE TESTING —As of July 29, 1998, each collaborative study design shall include a QC section as part of the method to be tested. Prior to approval of the study design, the Results Advisor or equivalent shall ascertain the appropriateness of the QC section in meeting the requirements of this practice and Practice D2777 , and shall advise the designer of the study of any changes needed to fulfill the requirements of these practices. Before a collaborative study may be conducted, approval of the study design by the Results Advisor or equivalent shall be obtained. OLDER VALIDATED METHODS —Standard test methods that were validated using Practices D2777 – 77, D2777 – 86, or D2777 – 94, when balloted for reapproval or revision, shall contain a QC section based upon the best information from the historical record. Where appropriate, information derived from the record of the collaborative study shall be utilized for this purpose. The introduction of the QC section into these standard test methods shall not be construed as a requirement for a new collaborative study, though the Subcommittee may opt for such a study. Any information available regarding QC or precision/bias testing shall be included in the appropriate sections of the published test method. 1.3 Required QC sections in all applicable test methods are intended to achieve two goals. First, users of Committee D19 test methods will be able to demonstrate a minimum competency in the performance of these test methods by comparison with collaborative study data. Second, all users of test methods will be required to perform a minimum level of QC as part of proper implementation of these test methods to ensure ongoing competency. 1.4 This practice contains the primary requirements for QC of a specific test method. In many cases, it may be desirable to implement additional QC requirements to assure the desired quality of data. 1.5 The specific requirements in this practice may not be applicable to all test methods. These requirements may vary depending on the type of test method used as well as the analyte being determined and the sample matrix being analyzed. 1.5.1 If there are compelling reasons why any of the specific QC requirements listed in this practice are not applicable to a specific test method, these reasons shall be documented in the QC section of the test method. 1.5.2 With the approval of Committee D19 on the recommendation of the D19 Results Advisor or equivalent and the Technical Operations section of the Executive Subcommittee, a statement giving the compelling reasons why compliance with all or specific points of this practice cannot be achieved will meet the requirements of both ASTM and this practice. 1.6 This practice is for use with quantitative test methods and may not be applicable to qualitative test methods. 1.7 Presently, this practice is applicable primarily to chemical test methods. It is intended that, in future revisions, the practice will be expanded to include other test methods such as microbiological test methods. 1.8 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 In order to be certain that the end user of analytical results obtained from using an ASTM Committee D19 test method can be confident that the values have been obtained through a competent application of the test method, a demonstration of the proficiency of the analytical system shall be performed. Appropriate proficiency is demonstrated by achievement of performance criteria derived from results of the test method collaborative study. The QC measures specified in this practice shall be included in each ASTM test method, as applicable, to ensure the quality of measurements. 5.2 In order for users of D19 test methods to achieve consistently valid results, a minimum level of QC shall be performed. This minimum level of QC is stipulated in this practice and by the task groups developing D19 test methods. If the specific requirements outlined in this practice are not applicable to the test method, alternative QC shall be defined in the test method.
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归口单位: D19.02
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