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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.
This document specifies guidelines and recommendations to be followed prior to carrying out dimensional measurements on three-dimensional (3D) volumetric X-ray Computed Tomographic (XCT) images of additive manufacturing (AM) series production parts. It is applicable to cone beam XCT systems. However, these guidelines and recommendations can easily be transposed to fan beam XCT systems. The process to be followed prior to performing dimensional measurement on 3D volumetric XCT images of AM series production parts, in this standard, is divided into two steps: Step 1: Quantification of an XCT system performance, in terms of image quality and basic dimensional measurement accuracy, with a reference object and eventually a Representative Quality Indicators (RQI), with the specific part (part chosen from the AM series production parts) XCT setting under certain environmental conditions. This step leads to the determination of the image quality, the voxel size and the basic dimensional measurement accuracy of an XCT system; Step 2: Validation of the XCT system compliance, in terms of dimensional measurement accuracy, with the specific part, with the chosen XCT setting under the specific environmental conditions. This step leads to a simplified determination of the dimensional measurement uncertainty of each measurand of the specific part. If step 1 does not comply with the set requirements, the XCT system cannot be used for step 2. This document does not claim to provide a definitive method to determine XCT dimensional measurement accuracy, which, given the complexity of an XCT process, is not yet established. For the same reason, it is addressed to qualified XCT operators with the support of metrology experts. This document is dedicated to AM series production parts and its aim is to provide a methodology for controlling the geometric specificities associated with AM (internal shapes, lattice structures). It is applicable on parts that are fabricated by any type of AM categories of processes and material provided the X-ray penetration lengths are sufficient to scan the test part. These prior quantification and validation processes, which allow dimensional measurements to be carry out on 3D volumetric XCT images of AM series production parts, are valid for a specific part geometry in a given material associated with a chosen XCT setting (magnification & XCT acquisition and reconstruction parameters of the specific part) under specific environmental conditions for the measurands specified. The quantification and validation processes are reconsidered when different geometry of the part or material or XCT setting or environmental conditions or measurands are taken into account.