Capability and Performance Indices

<Under construction.>

The following links are to a 'sister' website to this site, and address common questions about the use and validity of Process Performance and Process Capability Indices.

Process Stability and Cpk

• When studying a process, is a stable process a prerequisite for Cpk?

• The information on this page explains why the calculation and reporting of Cpk is valid only when the process is shown to be stable (statistically in-control).

• https://sites.google.com/a/crlstatistics.net/qms/home/role-of-statistics-in-qms/process-stability-and-cpk

Process Stability and SPC Charts

• When studying a process, are SPC charts necessary to demonstrate that a process is stable?

• https://sites.google.com/a/crlstatistics.net/qms/home/role-of-statistics-in-qms/process-stability-and-spc-charts

Process Validation and Process Stability

• For a process to be considered "validated", is it a prerequisite to show that the process is stable (statistically in-control)?

• https://sites.google.com/a/crlstatistics.net/qms/home/role-of-statistics-in-qms/process-validation-and-process-stability

Process Verification and Statistical Sampling

• Are we required to use a statistical sampling system during process verification and for determining conformance of product when manufacturing lots/batches?

• https://sites.google.com/a/crlstatistics.net/qms/home/role-of-statistics-in-qms/process-verification-and-statistical-sampling

Process "Worst Case" (aka "Challenge") Conditions and DOE

• Is the use of DOE required to determine “worst case” conditions?

• https://sites.google.com/a/crlstatistics.net/qms/home/role-of-statistics-in-qms/process-worst-case-conditions-and-doe

Statistical Methods and Regulatory Compliance (in the Medical Device Industry)

• Do medical device industry regulations and standards really require the use of appropriate statistical methods?

• https://sites.google.com/a/crlstatistics.net/qms/home/role-of-statistics-in-qms/statistical-methods-and-regulatory-compliance