Six Sigma
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management…
We are one year away from the 100th anniversary of the creation of the control chart: Walter Shewhart created the control chart in 1924 as an aid to Western Electric’s manufacturing operations. Since it’s almost prehistoric, is it now time to leave the control chart technique—that started out…
Today’s manufacturing systems have become more automated, data-driven, and sophisticated than ever before. Visit any modern shop floor and you’ll find a plethora of IT systems, HMIs, PLC data streams, machine controllers, engineering support, and other digital initiatives, all vying to improve…
Corrective action and preventive action (CAPA) is probably the most important process in any quality management system because so much else depends on it. This includes not only its traditional role as a response to defects, nonconformances, customer complaints, and audit findings, but also…
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 reverse FMEA requirement reads: “Organizations are required to have a process in place that…
Within every organization, problems or incidents arise that can affect the quality of your operations. Take for example, food recalls due to improper food labeling that not only could cause sickness in humans, but also result in a hit to a company’s reputation. Or, automotive product recalls due…