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A copy of the AAI (Appearance Approval Inspection) form signed by the customer. Applicable for components affecting appearance only. Sample Production Parts A sample from the same lot of initial production run. The PPAP package usually shows a picture of the sample and where it is kept (customer or supplier). Master Sample
First article inspection. A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.
Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483, [2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Pre-shipment inspection (also preshipment inspection or PSI) is a part of supply chain management and an important quality control method for checking the quality of goods clients buy from suppliers. PSI helps ensure that production complies with the governing specification, contract, or purchase order. A final random inspection (FRI) checks ...
The warning letter includes the inspection dates and a description of the violating condition, practice, or product in brief but sufficient detail to provide the respondent the opportunity to correct the matter. It cites the section of the law and, where applicable, the regulation violated. Unlike the Form FDA 483, the warning letter cites ...
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the ...
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