本文件涉及与添加剂制造系统直接相关的安装鉴定（IQ）、操作鉴定（OQ）和性能鉴定（PQ）问题，这些问题对材料的整合有直接影响。工艺验证的前三个要素、工艺映射、风险评估和验证计划是机器鉴定的必要先决条件，但它们不在本文件的范围内。 本文件涵盖与AM设备直接相关的问题，不包括除粉以外的原料鉴定或后处理。 物理设施、人员、工艺和材料问题仅包括在支持机器鉴定所需的范围内。

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.