Four Generations of Quality: key Quality Indicators and their impact on the associated environments

Abstract

Introduction Having now established two of the principal tracks with respect to the quality systems in use, this article, the sixth in the series, focuses on some of the specific Quality “tools” in use in both the ISO and GxP environments; how these are defined, applied and used; and how these have evolved with time. In addition, the crossover, with respect to these specific concepts, is investigated by the use of the adoption/exchange in each environment, e.g. Qualification from GxP being implemented in ISO labs, and vice versa, the use of Expanded Uncertainty Budgets from ISO being used in updates to pharmaceutical standards etc. As we shall see, this process began in earnest at the end of the last millennium and continues, evolves and accelerates to this day. The key quality “tools”: Traceability, Va l ida t ion Qua l i f i ca t ion and Calibration (VQC) and Uncertainty of Measurement.