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Uncertainty-based internal quality control. Harmonization considerations.

E Bonet-Domingo1, L Escuder-Gilabert, M J Medina-Hernandez

  • 1Departamento de Química Analítica, Universitat de València, C/ Vicente Andrés Estellés s/n, E-46100 Burjassot, Valencia, Spain.

Analytical Chemistry
|December 1, 2006
PubMed
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A novel u-approach for internal quality control (IQC) in analytical laboratories improves reliability. This method harmonizes method validation, quality control, and uncertainty estimation for more accurate chemical assays.

Area of Science:

  • Analytical Chemistry
  • Laboratory Quality Management

Background:

  • Analytical laboratories face challenges in harmonizing quality aspects: internal method validation, internal quality control (IQC), and sample result uncertainty.
  • Existing criteria for setting IQC mean chart limits often fail to reflect the true nature of analytical results.
  • This non-harmonized approach can lead to inconsistencies in laboratory quality assessment.

Purpose of the Study:

  • To introduce a new, harmonized approach (the u-approach) for setting control limits in IQC mean charts.
  • To enhance the reliability of IQC by integrating method validation and uncertainty estimation.
  • To align the validation-control-uncertainty process within analytical laboratories.

Main Methods:

  • Developed the u-approach, utilizing combined uncertainty (u) derived from method validation data.

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  • Applied the u-approach to fix control limits for IQC mean charts.
  • Conducted a comparative study using simulated, bibliographic, and real laboratory data.

    • Main Results:

    • The u-approach demonstrated superior reliability compared to established criteria for fixing control limits.
    • The u-approach mean chart was identified as a consistent IQC tool for chemical assays.
    • This method effectively harmonizes the previously disparate processes of validation, control, and uncertainty estimation.

    Conclusions:

    • The u-approach offers a more reliable and harmonized method for IQC in analytical laboratories.
    • Integrating combined uncertainty into IQC enhances the accuracy and consistency of laboratory results.
    • This approach provides a unified framework for quality management in analytical chemistry.