New Practice for Qualification principles — Enhanced installation, operation and performance (IQ/OQ/PQ) of PBF-LB/M equipment
1. Scope
The purpose of this Work Item is to further enhance the requirements of ISO/ASTM TS 52930:2021 Additive manufacturing — Qualification principles — Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment with specific terminology, Key Process Variables, Risk level requirements for air passenger and defense critical applications
Keywords
Installation Qualification; Operational Qualification; Material Qualification; Performance Qualification; Key Process Variables; Risk Weighted Qualification Events
Rationale
Although used in the Food and Drug industries as well as other applications such as automotive, construction, and aviation, ISO/ASTM TS 52930:2021 Additive manufacturing — Qualification principles — Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment does not meet some of the current and pervasive methodologies for some of the more critical PBF-LB/M applications. The intent is to build off of the current standard to further enhance the requirements on more of a risk based qualification with specific qualification minimum requirements and specimens.