By William Porter
Published in: Research
Published on: October 1, 2022
The role of sampling and measurement uncertainty in assessing production process capability is examined, using content uniformity testing as an example. An expanded components of variance model is proposed for consideration during risk assessment and mitigation studies, with emphasis that either empirical (“top-down”) or model-based (“bottom-up”) approaches to estimation of uncertainty can be equally valuable in completing an expanded production process characterization (PPC) study.