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.

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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.

Component drawing checks and first-article records

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.

For routine delivery receipt, material identification and lot records, see the separately sold Receiving and Identification of Materials Procedure. First-article approval and routine receiving serve different stages of material control.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Receiving Inspection, First Article Inspection and Lot Acceptance for workflow guidance, a checklist and common mistakes.