This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning. Pharmaceutical development ...

Fuzzy Process Capability Analysis represents an advanced statistical framework that extends traditional process capability indices (PCIs) by incorporating fuzzy set theory. This approach allows ...

In a highly competitive market, a plastic parts company leveraged Lean Six Sigma methodologies, particularly Process Capability Analysis (C pk and P pk), to analyze supplier performance and ...

Manufacturing quality evaluation is a critical discipline that focuses on assessing a process’s ability to produce outputs within pre‐defined tolerance limits. Recent advances combine traditional ...

When holes produced satisfactorily on lathes suddenly have to meet a process capability of 1.67 or 2.0 Cpk, turning operations may fall short. That capability requires a process that makes it easy to ...

If you do not specify both LSL and USL, the variable _CP_ is assigned a missing value. The process capability index C pk is computed as If you specify only USL, the index C pk is computed as You can ...

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 ...

COBIT 5 uses the Process Assessment Model (PAM) based on ISO 15504, whereas COBIT 2019 supports a Capability Maturity Model Integration, CMMI-based process-capability scheme, ranging from zero to five ...

In Figure 1.2, the table labeled Specification Limits lists the specification limits and target value, together with the percents of observations outside and between the limits. The table labeled ...