
Introduce the course agenda for medical device test method validation, covering measurement system analysis, accuracy and precision, calibration, validation types, and visual inspection and conventional methods.
Master measurement system analysis, a technique to determine the measurement component of total variation from instruments, equipment, standards, and methods, including production variation in regulated manufacturing like medical devices.
Explore four measurement system analysis examples, including variable measurements with a calibrated ruler and a multimeter, and attribute measurements using visual inspection and go/no-go criteria.
Explore measurement system analysis accuracy errors, focusing on bias, linearity, and stability, with practical examples across operating ranges and time to illustrate bias shifts.
Explore measurement system analysis by defining precision, repeatability, and reproducibility, and compare single-operator repeatability with multi-operator reproducibility using standard deviation and variance.
Compute the mean by summing data and dividing by samples, and determine the median by sorting data and averaging the middle values to show central tendency and skew.
Quantify data spread using range, variance, and standard deviation with a plastic bottle production example, comparing two production lines and calculating deviations from the mean.
Learn calibration techniques that compare devices with a standard to quantify accuracy and precision, and use validation methods to assess repeatability and reproducibility with statistical techniques.
Identify four prerequisites for test method validation: quantify equipment and fixtures, calibrate gauges, ensure tenfold resolution beyond tolerance, and fix consistent setup to reduce operator variation.
Determine type of test method for medical device validation by answering two questions about requirements; explore inspection, industry recognized standard test methods, and conventional testing methods, including go/no go measurements.
Identify prerequisites for inspection test methods, including no gauge required and operator-based good/bad part differentiation with minimal interpretation. Explain minimal validation of measurement risk in practice.
Identify the criteria for visual inspection: discrete test units with a clear conformance boundary, no measurement or gauge, and pass/fail or count-based acceptance; examples include particulate matter checks.
Examine the design analysis test method with CAD-based engineering analysis and basic calculations, and compare worst-case with group sum squared tolerance stack-up analyses for assembly tolerances.
Identify the four criteria of functional verification: design outputs conform to design inputs, no physical measurement, no gauges, no sampling, with a car key unlock example.
Explore conventional test methods as industry standards, including destructive and non-destructive approaches, with examples like caliper and multimeter measurements, validated by regulators.
Explore how in-house developed test methods differ from industry standard and conventional methods, highlighting validation, custom fixtures and settings, and regulatory requirements in healthcare and automotive industries.
Explore elements of test method validation, including categorizing methods as attribute or variable, defining quality characteristics, specifications, measurement ranges, and reducing variation with defined protocols and statistics.
Discover the seven-step approach to attribute test method validation, from protocol drafting and sample size to data collection. Assess repeatability and reproducibility with kappa statistics and measurement system analysis.
Explore a comprehensive test method validation template covering revision history, approvals, scope, responsibilities, data analysis techniques (attribute agreement, gauge repeatability and reproducibility), and data collection for repeatable measurements.
Offers an example of a method validation protocol for inspecting foreign material on product packaging using dirt estimation charts, detailing scope, responsibilities, data collection, and acceptance criteria.
Create and evaluate an attribute test method validation report using attribute agreement analysis, data collection templates, and consensus acceptance criteria to assess measurement accuracy.
Learn the seven-step approach to variable test method validation, from defining requirements to drafting validation reports, using data templates, measurement system analysis, and repeatability and reproducibility concepts.
Explore variable test method validation through a practical example: measuring plastic tube length with a calibrated ruler in centimeters to assess repeatability and reproducibility.
illustrates preparing a variable test method validation report for length measurement with a calibrated ruler, detailing data collection, anova analysis, and evidence of repeatability and reproducibility.
Hello students, in this course you will learn about what a Test Method Validation is.
In this course we have 10 different sections.
In Section 1 we have introduction where we will look at Agenda of course.
Next In section 2 we have measurement system analysis, In this section we will look at what a measurement system is and what a measurement system analysis is and we will look at some of the examples of measurement system analysis and what kind of errors that typically are present in a measurement system and we will also look at accuracy and precision errors and how calibration and test method validation play role in reducing these errors.
Next in In Section 3 we have test method validation introduction, In this section we will look at an introduction to test method validation and prerequisites to authoring a test method validation and also types of test method validation.
Next in section 4, we have visual inspection test methods, in the section we will look at prerequisites for a test method-to-be visual inspection test method and we will also look at what a visual inspection test method is and what a design analysis test method is and what a functional verification test method is and also finally what an industry recognized standard test method is
Next in section 5, we have conventional test methods, in this section we will look at theory of what a conventional test method is and some of the examples.
Next in section 6, we have in-house developed test methods in the section we will also look at theory of what an in-house developed test method is and will also look at some of the examples of this in-house develop test method.
Next in section 7 we have Test method validation, in this section review look at elements of test method validation and we will also look at a general test method validation template that can be used for any type of test method validation development.
Next in Section 8, we have attribute test method validation, in the section we will look at what an attribute test method validation with Theory and also we will look at an example with an attribute test method validation protocol and an attribute test method validation report.
Next in Section 9, we have variable test method validation, in the section we will look at what variable test method validation with Theory and also we will look at an example with a variable test method validation protocol and an attribute test method validation report.
Finally in section 10, we will look at a the conclusion of this test method validation course.
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