First Article Inspection Procedure

Plan and document a medical device component first article inspection against approved drawings, dimensions, tolerances and acceptance criteria. This editable First Article Inspection Procedure includes a data sheet and report form to record inspection results, equipment, exceptions and disposition before routine acceptance proceeds.

The First Article Inspection (FAI) Procedure provides instruction on conducting first article inspections and the method of documenting a first article inspection. The First Article Inspection (FAI) Procedure includes a first article inspection data sheet and a first article inspection report form as a guide.

The procedure establishes when a first article inspection is required, how engineering defines the test or inspection method, and how trained quality personnel evaluate results against approved drawings or specifications. It also addresses recording exceptions, corrective action and repeat inspection when a change affects the product. A completed first-article record provides a documented check before routine acceptance proceeds.

Supplied as an editable Microsoft Word document as a digital download.