Analysis of dose distribution changes in radiation processing using a continuous variable F-test and p-value

A process monitoring practice is established from the evaluation of dose distribution within simulant or phantom materials. As a part of change control, an evaluation of potential changes to dose distribution is conducted when change activities occur to the irradiator. (AAMI/AAMI/ISO 11137-1, 2006) The dose distribution evaluation is conducted to verify either the continued validity of an established process monitoring practice or demonstrate that the monitoring practice is no longer valid. Historically, change control evaluation of a process monitoring practice has been based on a non-statistical evaluation of dose distribution data for potential change. A statistical method has been developed using a continuous variable F-test and p-value, which tests a null hypothesis of no change in dose distribution, and provides a means of either substantiating or refuting the continued validity of a process monitoring practice.