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Quality control review: implementing a scientifically based quality control system.

James O Westgard1, Sten A Westgard2

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Summary
This summary is machine-generated.

This review details statistical quality control (SQC) strategies for quality management systems. It introduces tools like Westgard Sigma Rules and Sigma Quality Assessment Charts for enhanced performance monitoring and error detection in laboratory testing.

Keywords:
Quality controlSix Sigmaquality management

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Area of Science:

  • Laboratory Medicine
  • Quality Management
  • Statistical Process Control

Background:

  • Effective quality management systems are crucial for reliable laboratory testing.
  • Statistical quality control (SQC) is integral to monitoring and ensuring the performance of examination procedures.
  • Method performance validation is a prerequisite for implementing robust SQC procedures.

Purpose of the Study:

  • To review the application of statistical quality control within a quality management system.
  • To introduce novel tools for validating method performance, selecting control strategies, and monitoring ongoing quality.
  • To provide guidance on establishing and maintaining high standards in laboratory analytics.

Main Methods:

  • Utilizing the Sigma-metric for validating new examination procedures.
  • Employing Westgard Sigma Rules for selecting appropriate control rules and sample sizes.
  • Applying risk-based individualized quality control plans.
  • Determining measurement uncertainty and bias from collected SQC and proficiency testing data.

Main Results:

  • The Sigma-metric offers a validated approach to assessing examination procedure performance.
  • Westgard Sigma Rules simplify the selection of control strategies for detecting medically significant errors.
  • The Sigma Quality Assessment Chart provides a graphical method for monitoring ongoing analytic performance on the sigma scale.

Conclusions:

  • Statistical quality control is essential for monitoring laboratory performance and detecting instability.
  • New tools enhance the ability to design, implement, and monitor effective quality control plans.
  • Continuous monitoring using tools like the Sigma Quality Assessment Chart ensures sustained test quality and reliability.