1. Scope

Keywords

Rationale

Additive manufacturing increasingly represents an attractive alternative to conventional manufacturing methods for companies. The trend towards complex parts, decentralised manufacturing and customised products allows economically viable application for a wider area. This applies to an increasing number of serial applications, which pose new requirements and risks to the processes’ performance. High quality, safety and risk mitigation requirements need to be fulfilled for components used industrially, especially in regulated industries (e.g., automotive, railway, aerospace, energy, medical). The present lack of standards means that processes and corresponding risk management for the additive manufacturing of parts need to be defined from scratch for each individual case, which entails a high degree of expense, and which permits little transparency and hence little trust amongst stakeholders in the process. Where industrial parts are produced using additive manufacturing techniques, the manufacturer needs to verify how the applicable requirements are satisfied and that the corresponding risks are eliminated or reduced as low as reasonably practicable. To this end, the process chain and environment are designed and evaluated in a way that the process quality and resultant part quality remain consistent and reproducible, and simultaneously suppress new risks and hazards emerging in or after the process. The document outlines the relevant areas to establish an additive manufacturing process conforms to risk management principles. This document aims to outline the risk relevant areas as an integral whole (not product specific), which are necessary as a basis for designing processes for high-quality and risk-minimized additively manufactured parts. In regulated industries, such as the automotive industry, mechanical engineering, the rail sector, aerospace, process and industrial systems, energy sector or medical technology, consideration of the criteria defined within the framework of this document will establish a basis for fulfilling the requirements for specific products risk management.