质量保证是一个总体术语,用来描述为确保系统正常运行而采取的活动。这些活动可分为三类:质量控制、质量评估和内部纠正措施。通常,这些活动是循环进行的:质量控制在分析开始之前和分析期间进行,而质量评估在调查期间和调查结束之后进行。内部纠正措施是根据分析后的质量评估结果或在开始新的分析之前实施的。
质量保证过程从为分析制定清晰简洁的使用目标开始,最后制定预期结果的规范。这一详尽的过程包括取样、空白测试、校准检查、质量控制检查、准确度、精密度、检测限、选择性、灵敏度、稳健性和错误结果率。最后,质量保证过程需要审查结果是否符合分析的规范和使用目标。
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