Statistical Techniques for Test Method Validation (1 day)
Covers STAT-08, Statistical Techniques for Test Method Validation, from the book Statistical Procedures for the Medical Device Industry
Teaches how to evaluate measurement systems including how to perform Gage R&R studies, and how to handle destruction and attribute test methods. It includes acceptance criteria and their justifications. Also covered is the effect of rounding and the number of reported digits.
It covers the contents of STAT-08, Statistical Techniques for Test Method Validation, of the book Statistical Procedures for the Medical Device Industry. Further information can be found in the book Optimization & Variation Reduction in Quality in Part II: Measurement.
What You Will Learn
- Components of measurement error such as accuracy, precision, trueness, repeatability, and reproducibility.
- How to Perform a Gage R&R Study.
- Variations of the traditional Gage R&R study.
- Selecting acceptance criteria and justifications.
- How to handle destructive tests including an Operator Reproducibility Study.
- How to handle attribute inspections.
- Covers many special topics like rounding rules, calibration, etc.
Scientist, engineers and other technical staff.
- Metrology Terminology
- Gage R&R Study – Multiple Parts
- Acceptance Criteria
- Rounding Error
- Destructive Test
- Attribute Tests