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现行 ASTM D6689-01(2019)e1
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Standard Guide for Optimizing, Controlling, and Reporting Test Method Uncertainties from Multiple Workstations in the Same Laboratory Organization 相同实验室组织中多个工作站的优化 控制和报告测试方法不确定性的标准指南
发布日期: 2019-03-15
1.1 本指南描述了一种协议,用于优化、控制和报告同一实验室组织中多个工作站的测试方法不确定性。当不同的测试方法、不同的仪器或同一实验室组织的不同部分独立运行以验证或验证特定分析测量的准确性时,本标准不适用。 1.2 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.3 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====== 4.1 许多分析实验室符合公认的质量体系要求,如NELAC第5章、, 5. (参见 注释2 )和ISO/IEC 17025。当使用标准试验方法时,其在相同样品上的试验结果应与标准中公布的再现性估计值(R2)内的其他类似实验室的结果一致。作为实验室间研究(ILS)的一部分,在标准化过程中生成再现性估计。许多实验室参与能力测试,以确认它们随着时间的推移表现一致。在ILS和能力验证协议中,通常假设只有一个工作站用于生成数据(参见 6.5.1 ). 注2: NELAC第5章允许使用一个工作单元,其中多个仪器/操作员被视为一个单元:跟踪工作单元的性能,而不是独立于每个工作站。 本指南旨在超越工作单元,实现独立监控工作站的好处。 4.2 许多实验室有工作量或后勤要求,或两者都有,这决定了多个工作站的使用。有些在同一地区有多个工作站(中央实验室格式)。其他站点分散在整个设施中(以线路实验室形式)。通常,分析报告不会识别用于测试的工作站,即使工作站的测试不确定性不同。如果客户端错误地将报告值的变化归因于进程,而不是工作站的变化,则可能会出现问题。如果实验室组织自始至终设定、遵守并报告一套统一的测量质量目标,这些问题可以最小化。 4.3 本指南可用于协调所有工作站的校准和控制协议,从而提供相同级别的测量跟踪和控制。 它简化了文件和培训要求,从而促进了人员分配的灵活性。最后,它提供了一个机会,可以声称能力测试测量可追溯到所有包含的工作站,无论在哪个工作站上测试了能力测试样本。使用该协议的潜在好处随着实验室组织中包含的工作站数量的增加而增加。 4.4 本指南可用于识别和量化与性能不佳的工作站相关的纠正措施带来的益处。它还提供了在改进后跟踪改进性能的方法。 4.5 本指南的所有用户都必须遵守ISO/IEC 17025,尤其是使用文件化程序、应用测量过程的统计控制以及参与能力验证。 4.6 该协议的一般原则可适用于其他类型的测量,如机械测试和在线过程控制测量,如温度和厚度测量。在这些领域,用户可能需要建立自己的模型来定义测量质量目标。能力验证可能不可用或不适用。 4.7 特别重要的是,本指南的用户应负责确保根据本协议操作的工作站所做测量的准确性。除上述检查外 6.2.3 ,鼓励实验室使用其他技术,包括但不限于在同一实验室内或与其他同等能力的实验室合作,通过独立方法分析某些材料。从仔细协调但未正确校准的多个工作站生成大量数据的风险显而易见,必须避免。
1.1 This guide describes a protocol for optimizing, controlling, and reporting test method uncertainties from multiple workstations in the same laboratory organization. It does not apply when different test methods, dissimilar instruments, or different parts of the same laboratory organization function independently to validate or verify the accuracy of a specific analytical measurement. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.3 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 ====== 4.1 Many analytical laboratories comply with accepted quality system requirements such as NELAC, Chapter 5, 5 (see Note 2 ) and ISO/IEC 17025. When using standard test methods, their test results on the same sample should agree with those from other similar laboratories within the reproducibility estimates (R2) published in the standard. Reproducibility estimates are generated during the standardization process as part of the interlaboratory studies (ILS). Many laboratories participate in proficiency tests to confirm that they perform consistently over time. In both ILS and proficiency testing protocols, it is generally assumed that only one workstation is used to generate the data (see 6.5.1 ). Note 2: NELAC, Chapter 5, allows the use of a Work Cell where multiple instruments/operators are treated as one unit: the performance of the Work Cell is tracked rather than each workstation independently. This guide is intended to go beyond the Work Cell to achieve the benefits of monitoring workstations independently. 4.2 Many laboratories have workloads or logistical requirements, or both, that dictate the use of multiple workstations. Some have multiple stations in the same area (central laboratory format). Others’ stations are scattered throughout a facility (at-line laboratory format). Often, analysis reports do not identify the workstation used for the testing, even if workstations differ in their testing uncertainties. Problems can arise if clients mistakenly attribute variation in report values to process rather then workstation variability. These problems can be minimized if the laboratory organization sets, complies with, and reports a unified set of measurement quality objectives throughout. 4.3 This guide can be used to harmonize calibration and control protocols for all workstations, thereby providing the same level of measurement traceability and control. It streamlines documentation and training requirements, thereby facilitating flexibility in personnel assignments. Finally, it offers an opportunity to claim traceability of proficiency test measurements to all included workstations, regardless on which workstation the proficiency test sample was tested. The potential benefits of utilizing this protocol increase with the number of workstations included in the laboratory organization. 4.4 This guide can be used to identify and quantify benefits derived from corrective actions relating to under-performing workstations. It also provides means to track improved performance after improvements have been made. 4.5 It is a prerequisite that all users of this guide comply with ISO/IEC 17025, especially including the use of documented procedures, the application of statistical control of measurement processes, and participation in proficiency testing. 4.6 The general principles of this protocol can be adapted to other types of measurements, such as mechanical testing and on-line process control measurements such as temperature and thickness gauging. In these areas, users will likely need to establish their own models for defining measurement quality objectives. Proficiency testing may not be available or applicable. 4.7 It is especially important that users of this guide take responsibility for ensuring the accuracy of the measurements made by the workstations to be operated under this protocol. In addition to the checks mentioned in 6.2.3 , laboratories are encouraged to use other techniques, including, but not limited to, analyzing some materials by independent methods, either within the same laboratory or in collaboration with other equally competent laboratories. The risks associated with generating large volumes of data from carefully harmonized, but incorrectly calibrated multiple workstations are obvious and must be avoided.
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