Mind the gaps – safe steps to qualifying Additive Manufacturing (AM) processes and products

As more additive manufacturers look to move from prototypes and demonstrators to producing products that will be placed on the market and put into service, an understanding of regulatory requirements becomes essential. Responsibilities within the supply chain need to be understood by all parties, especially where fabrication of components is sub-contracted to facilities that specialize in additive manufacturing. Requirements and approaches for qualification and certification vary between industries so supply chains that include elements of additive manufacturing need to understand the differences and commonalities if they intend to supply to multiple industries. For example, since the additive manufacturer is also the material producer, understanding that they have the same legal responsibilities as producers of conventional material forms, such as forgings, castings, bar and plate. 

This talk will cover the following aspects, with a particular focus on powder-based AM: 

• Typical process for achieving certification of materials and components
• Pre-requisites within the supply chain, such as powder characterization
• Development of additive manufacturing standards and how these can be utilized to support the qualification and certification activities
• The typical approach taken to an additive manufacturing project, along with documentation requirements. 

By working to existing regulations and product standards, identifying the gaps within those requirements when considering additive manufacturing, and demonstrating an equivalent level of safety through quality control and assurance, we can remove the barriers to wider adoption of additive manufacturing technologies and promote greater acceptance of these products across industries.