scope:

This document addresses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence on the consolidation of material. The first three elements of process validation, process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine qualification, however, they are outside the scope of this document.

This document covers issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal.

Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.