Additive manufacturing - Qualification principles - Part 1: Common failure modes used for risk mapping
Abstract
This document identifies common failure modes, which can occur within operations across additive manufacturing (AM) process categories defined in ISO/ASTM 52900. It lists state-of-the-art failure modes, which can lead to risks within AM parts and equipment, as well as providing informative examples of corresponding failure effects and mitigation actions. This document can be used to aid manufacturers in their risk management. While doing so it supports the implementation of AM as a production method within critical applications and regulated industries. This document helps to address the requirements for risk management set by regulated industries for part and production method compliance. Technology specific failure modes will be addressed in separate standards, including but not limited to PBF-LB/M, PBF-LB/P, MEX, MJT, BJT, and DED. This document aims to close the existing gap between general risk management standards, such as ISO 31000 or ISO 14971 (medical), and the know-how gap of existing failure modes of the AM process category and their integrated workflow. The standard maps risks according to AM processes defined within ISO/ASTM 52920. This document does not cover environment, health and safety risks and will not measure, assess, or evaluate the risk impact on the AM part to be produced. It does not list the part specific input and output parameters, during the respective process steps. This task is dedicated to the risk management evaluation teams, which usually comprise quality managers and product domain specific experts. The document enables all part owners and manufacturers to use it for the risk mapping activities, to support subsequent risk assessments, continuous improvement, validation planning, estimation of manufacturing efforts, and conformity audits. For risk examples that are relevant only to specific AM machinery brands, manufacturers might consider use of the informative annex.
Begin
2024-10-18
WI
00438083
Planned document number
DIN EN ISO/ASTM 52954-1
Project number
14500250
Responsible national committee
NA 145-04-01 AA - Additive Manufacturing - Interdisciplinary topics/Digitalization
Responsible european committee
CEN/TC 438 - Additive Manufacturing
