Statistical tolerance limits and prediction intervals provide two complementary frameworks for quantifying uncertainty in statistical inference. A tolerance interval is constructed from sample data to ...

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements. Unused, misused, or misunderstood, ...

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...

Medical device customers often say, “The design is close to lockdown.” This means that the list of requirements has been met and that the project is nearing handoff to manufacturing. The next steps ...

Suppose that a manufacturer must demonstrate that a high percentage of units (say, 100p percent) meet a particular specification with some level of confidence—say, 100(1 - α) percent. Since every unit ...

The discipline of tolerance analysis and variation simulation focuses on quantifying and predicting how dimensional and geometrical deviations of individual parts affect the performance and ...