Design and application of process control charting methodologies to gamma irradiation practices

The relationship between the contract irradiation facility and the customer has historically been based upon a “PASS/FAIL” approach with little or no quality metrics used to gage the control of the irradiation process. Application of process control charts, designed in coordination with mathematical simulation of routine radiation processing, can provide a basis for understanding irradiation events. By using tools that simulate the physical rules associated with the irradiation process, end-users can explore process-related boundaries and the effects of process changes. Consequently, the relationship between contractor and customer can evolve based on the derived knowledge. The resulting level of mutual understanding of the irradiation process and its resultant control benefits both the customer and contract operation, and provides necessary assurances to regulators.

In this article we examine the complementary nature of theoretical (point kernel) and experimental (dosimetric) process evaluation, and the resulting by-product of improved understanding, communication and control generated through the implementation of effective process control charting strategies.