4.1 Control charts are the primary process monitoring tool in SPC for radiation processing. The general objectives of implementing a SPC program with control charts are to:

4.1.1 Increase knowledge of the process,

4.1.2 Control the process to provide a targeted or required process output,

4.1.3 Reduce variation of the process output or in other ways improve the performance of a process, and

4.1.4 Identify single process run results that are outside of established control limits but may be within the USL and LSL limits.

4.2 These objectives when achieved:

4.2.1 Reduce costs through reduction of losses due to scrap, rework, and investigation time,

4.2.2 Improve consistency of the process output,

4.2.3 Facilitate preventive process adjustments, and

4.2.4 Provide evidence of accurate process targeting and process performance; state of statistical control.

1.1 This document provides guidance for the statistical analysis of the irradiation process from dosimetric data.

1.2 This document is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628 and ISO/ASTM 52303.

1.3 This document employs a set of standard statistical methods and is intended to be read in conjunction with Practice E2586, Practice E2281, Practice E2587, and ASTM Manual MNL72.

1.4 This guide is applicable to high-energy electron beam, X-ray and gamma-ray irradiation processes.

1.5 This document assumes user knowledge of statistics, radiation processing, and radiation dosimetry. (See Annex A6)

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.