Risk Analysis for Quality Control Part 3: Practical Application of the Precision Quality Control Model

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Quality Management

Background:

• A theoretical framework, Precision Quality Control (PQC), was developed to minimize the cost of quality.
• The practical applicability of the PQC framework for determining optimal control limits was previously unknown.

Purpose of the Study:

• To evaluate the practical application of the PQC framework in establishing optimal laboratory control limits.
• To assess different visualization methods for interpreting PQC results.

Main Methods:

• Applied the PQC framework using data for two analytes: cadmium and carbohydrate-deficient transferrin (CDT).
• Explored three visualization approaches: risk trade-off, cost-risk trade-off, and cost minimization.
• Analyzed analytes with differing sigma values to determine their impact on control limits.

Main Results:

• The PQC framework successfully generated three distinct visualizations for suggesting control limits.
• Risk-based analysis was simple to apply but challenging to interpret.
• Cost-risk and cost minimization methods offered varying degrees of interpretability and ease of application.

Conclusions:

• The Precision Quality Control (PQC) method is a viable approach for determining laboratory control limits.
• PQC effectively minimizes the overall cost of quality in laboratory settings.