How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the corrective and preventive

Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach.

Electronic temperature compensation in gaging has become a valuable tool in improving the accuracy and gage repeatability and reproducibility (GR&R) of gages in harsh manufacturing environments.

Last year, the corporate world adopted a new term: flattening. This refers to how tech companies, which rapidly hired droves of middle managers during the pandemic boom, are now eliminating this layer through widespread job cuts.

In a world where change is the only constant, organizations can no longer afford to be complacent. Keeping up with the pace of technological change is tough, and all business leaders must learn to adapt. It’s no longer enough to react to disruption.

The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals.

Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model.

Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.

When conflicts in a team, no matter how minor, are left unresolved, they can eventually breed resentment. If unaddressed, this could lead to cynicism and distrust, as well as harm to individual and team performance. How should leaders deal with this?

Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.