First Article Inspection (FAI)

First Article Inspection (FAI) is the formal verification that the first produced part or assembly meets all design specifications before full production begins. 
 
In regulated manufacturing, FAI supports design and process control expectations under FDA 21 CFR 820.30 and 820.70 for medical devices, and aligns with ISO 13485 and ISO 9001 requirements for production validation and conformity to requirements. 
 
Why it matters: skipping or weak FAI leads to repeat defects, batch scrap, supplier issues, and audit findings.