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D6299-23 – Standard Test Method Technical Guide
📐 Scope and Application
This practice covers the design and operation of a program to monitor and control ongoing stability, precision, and bias performance of analytical measurement systems using statistical quality control (SQC) procedures. It is applicable to stable systems that produce results on a continuous numerical scale, including laboratory test methods (1.3) and validated process stream analyzers (1.4). Additionally, it can be applied to monitor differences between two systems that purport to measure the same property, provided both are assessed per Practice D6708.
Selection of measurement systems for this practice should consider factors such as frequency of use, criticality of the parameter, system stability and precision based on historical data, business economics, and regulatory or contractual requirements (Note 1). The practice assumes the normal (Gaussian) model is adequate for describing system behavior when in statistical control (1.6).
| 🔍 Factor | 📌 Description |
|---|---|
| Frequency of Use | How often the analytical system operates |
| Criticality | Importance of the measured parameter |
| Historical Performance | Stability and precision based on past data |
| Business Economics | Cost-benefit considerations |
| Regulatory Requirements | Contractual or test method obligations |
⚙️ Statistical Quality Control Procedures
This practice utilizes generally accepted SQC tools and emphasizes the importance of a state of statistical control. For non-Gaussian processes, transformations of test results may permit proper application of the tools (Note 4). Key referenced documents provide specific guidance for validation and quality management activities.
⚠️ Note: If the process is non-Gaussian, consult a statistician for appropriate data transformations before applying these control charting techniques.
| 📘 Standard | 📖 Application |
|---|---|
| D3764 | Validation of process stream analyzer systems |
| D6708 | Assessing agreement between two test methods |
| D6792 | Quality management in testing laboratories |
| D6300 | Determination of precision and bias data |
💡 Tip: Use control charts with limits derived from historical precision data to monitor system stability. Practice D6617 provides additional guidance for bias detection using single test results.
❓ Frequently Asked Questions
🔍 What is the primary purpose of D6299?
To provide a standard practice for applying statistical quality assurance and control charting techniques to evaluate the ongoing stability, precision, and bias performance of analytical measurement systems.
💡 Is this practice applicable to non-Gaussian processes?
Yes, but with modifications. The practice assumes a normal model, but for non-Gaussian processes, transformations of test results may allow proper use of the tools as noted in the scope.
⚡ What types of systems are covered?
Stable analytical measurement systems that produce results on a continuous numerical scale, including laboratory test methods (1.3) and validated process stream analyzers (1.4).
📌 How are measurement systems selected for monitoring?
Selection should consider factors such as frequency of use, criticality of the parameter, historical performance, business economics, and regulatory or contractual requirements as outlined in Note 1 of the standard.