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作废 ASTM E1329-10
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Standard Practice for Verification and Use of Control Charts in Spectrochemical Analysis (Withdrawn 2019) 光谱化学分析中控制图的验证和使用的标准实践
发布日期: 2010-10-01
废止日期: 2019-01-16
1.1本规程涵盖了确定光谱化学分析是否处于统计控制下的程序。 1.2提出了确定何时需要采取纠正措施的标准。 1.3使用验证器测试仪器响应将影响控制。尽管不是必需的,但建议同时绘制控制图。 1.4描述了控制图的编制。 1.5 局限性 — 所述程序不适用于每次运行一组分析时都需要校准的分析。具体参考了原子发射光谱法,但实践具有更广泛的应用。 1.6本规程不适用于监测校准正确性的验证程序。 ====意义和用途====== 分析的一致性取决于意识到仪器响应的显著变化,例如由漂移或分析精度变化或两者引起的变化,并采取纠正措施。 漂移的通常纠正措施是标准化。然而,当没有实际需要时,标准化只能扩大后续分析的范围。这种做法的一个目的是制定准则,避免 “ 不必要的标准化。 ” 为了控制制造过程,必须确信正在生产一致的材料,并且对材料的分析是可靠的。为确保材料符合规范,买方可要求提供控制图的支持记录,以评估是否保持了适当的分析控制。 理想情况下,分析结果的变化可能是偶然原因。控制图上置信区间或极限的概念是基于在执行所有正常预防措施时可以预期的情况。当结果似乎失控时,分析员应考虑并纠正可能是可分配原因的原因。然而,随着经验的积累,随着光学性能的下降、探测器响应的变化或激发条件的变化,例如,当沉积在对电极上时(一个可纠正的可指定原因),或当X- 射线管变质。
1.1 This practice covers procedures for determining if a spectrochemical analysis is under statistical control. 1.2 Criteria are presented for determining when corrective action is required. 1.3 Control will be effected by using verifiers to test instrument response. It is recommended, although not required, that this be accompanied by the plotting of control charts. 1.4 The preparation of control charts is described. 1.5 Limitations — The procedures that are described do not apply to analyses that require a calibration each time a set of analyses is run. Reference is made specifically to atomic emission spectrometry, but the practice has a more general application. 1.6 This practice does not apply to validation procedures that monitor the correctness of calibration. ====== Significance And Use ====== Consistency in analysis depends on being aware of a significant change in instrumental response, such as that caused by drift or changes in analytical precision, or both, and taking corrective action. The usual corrective action for drift is standardization. Standardization, however, when there is no real need, can only broaden the spread of subsequent analyses. One purpose of this practice is to set guidelines that will avoid “ unnecessary standardization. ” To control manufacturing processes, there must be confidence that a consistent material is being produced and that the analysis of the material is reliable. For assurance that the material meets specification, a purchaser may require the supporting record of control charts to assess that proper analytical control has been maintained. Ideally, variations in analytical results may be held to chance causes. The concept of a confidence interval or limits on a control chart is based on what can be expected when all normal precautions are exercised. When results appear to go out of control, the analyst should consider and correct what might be an assignable cause. As experience is accumulated, however, it may not seem unusual for readings to drift with time as optics degrade, detector response changes, or excitations conditions change, for example, when deposits build up on a counter electrode (a correctable assignable cause), or the longer range effects as an X-ray tube deteriorates.
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归口单位: E01.22
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