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Richard Harpster
On Dec. 7, 2021, Ford Motor Co. updated its IATF 16949—“Customer specific requirements” (CSR), which require the use of reverse FMEAs (RFMEA) on new equipment (“tooling”). The first sentence of the...
    Many different approaches to process improvement are on offer today. An appreciation of the way each approach works is crucial to selecting one that will be effective. Here we look at the problem of production and consider how the different improvement approaches deal with this problem. The...
    Big data is a relatively new phenomenon. Its use is increasing in many organizations. But, as with many new processes, its use cuts both ways. It has positive benefits to both the organization and customers. It also has its potential downside. This piece looks at both with respect to the quality...
    Students are told that they need to check their data for normality before doing virtually any data analysis. And today’s software encourages this by automatically providing normal probability plots and lack-of-fit statistics as part of the output. So it’s not surprising that many think this is the...
    inspecting plant roots
    At some point, every medical device company will encounter an issue that requires an internal investigation. Whether it’s due to a nonconformance, complaint, CAPA, or an audit issue, you’ll have to conduct a failure or root cause investigation to pinpoint why the issue occurred in order to resolve...

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