Quality in Additive Manufacturing by standards
Additive Manufacturing is entering industrial serial production. Especially in regulated industries such as aviation and medical, the need for internationally accepted standards and proven practices for machine qualification is continuously growing. To meet this demand, Ampower Insights Vol. 4 presents a comprehensive approach and best practices to establish a qualified production environment and gives an overview on standardization efforts and published standards.
A thorough machine qualification is the essential foundation for a successful implementation of manufacturing systems in regulated industries. Due to the pioneering role of medical applications, the methodologies from the Global Harmonization Task Force for machine qualification including Installation, Operational and Performance Qualification (IQ, OQ, PQ) have been widely adapted in the AM industry. Ampower Insights presents the requirements as well as documentation and testing efforts for each of the qualification steps and highlights best practices for a successful implementation of Additive Manufacturing.