Process characterization is an essential element of process control. A process is a combination of people,
procedures, methods, machines, materials, measurement equipment, and/or environment for specific work activities to
produce a given product or service. When properly defined and controlled, it is a repeatable sequence of activities
with measurable inputs and outputs. The characterization of a process defines distinguishing features of a process
or its output on which variables or attributes data may be collected. Thus, through process characterization, a
manufacturer may define and measure the stability, repeatability, sensitivity, and robustness of a process.
Additionally, it supplies inputs for modeling which may be used to identify critical variables, optimize efficiency and
output, and provide avenues for continuous improvement. Furthermore, once process characterization has been
established, the process predictability may be used for self validation rather than auditing. Management support is
essential to the effective implementation and maintenance of a process characterization system.