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Test Method Validation of Continuous Non-Destructive Measurements

Also known as Gage Repeatability and Reproducibility! In the previous blog post about test method validation, we already discussed...

Test Method Validation

You may be thinking, "OMG, what more do we need to validate? Is this still not enough?" Well, no, it isn't. Fortunately, we really need...

Performance Qualification - Run 3 batches and ready, right?

Great, you finished the OQ, found your process window, and now must show the consistency of your process. The performance qualification...

Cultural differences… And how to not let them become an issue!

When working with people from different cultural backgrounds, we sometimes think we can work together just like we do with people from...

Operational Qualification

The fun part of process validation! Great, you finished the IQ and now want to start with the fun part? The operational qualification...

Installation Qualification

Ticking-off as a necessary evil or to build a strong foundation? Do you think IQ is the least important part of process validation? Do...

Do you know Process Validation?

Yeah, sure, it's IQ, OQ, and PQ! What's really behind these acronyms that everyone believes to know! Does your customer suddenly want you...

Cpk of 1,33 is not enough!

A deep dive into sample sizes for process validation Are you questioning why a Cpk of 1,33 should not be enough, although it means only...

Statistical Tolerance Intervals - Explained simply and practically based on ISO 16269-6

Statistical tolerance intervals are frequently used during process validation and design verification, maybe because the approach is...