Methods in validating tests

09 Apr

Solving a problem, especially when two different parties are involved, can be stressful. As it turns out, there were three factors involved: But it is even more difficult to step back and see the bigger picture. In other words, this was no longer simple part-to-part shot-to-shot variation. Test method validation isn’t just about performing Gage R&Rs. In fact, it will be one of the case studies I plan to present during the MD&M East conference.When the mold cavity itself was dimensionally modified, this resulted in a different part as far as the gage was concerned. It is about knowing the requirements, applying design controls, verifying the requirements, and validating that the test method actually performs as intended. One must truly understand the process, the nature and origin of the materials, the environment, and also the design itself. This blog is not intended to provide a tutorial in multivariate linear regression, but for those that are interested, follow With those points in mind, let’s ask ourselves, why we should treat developing, validating and controlling a measurement system differently than we would a process? We should build our Test Method Validation components and programs the same way we build our process validation programs.Process Validation programs understand that before equipment is qualified or processes can be validated, a data driven understanding of the process parameters, the potential control points, and their effect on the critical quality attributes of the process must be developed.

They repeated the same Gage R&R study, on the same fixtures, and they failed. Yet the test failed in the United Kingdom—and passed again in the United States!

If this paradigm exists in your workplace, and you find yourself in a position to challenge it, the first step could be as simple as changing language.

Let’s try be as precise with our language as we are with our gauges.

The difficulty in providing a convincing defense for the use of the Gauge R&R is not due to a lack of experience in the field, this is not a new or innovative tool.

Gauge R&R methods have been on the engineering scene for decades, the method’s structure, objectives, and faults are well understood.