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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.
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 header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
The FBI, United States Postal Inspection Service (USPIS), and state and local law enforcement partners are investigating multiple letters containing suspicious substances which have been mailed to ...
The second sentence of this article contradicts AS9102. The second sentence refers to the "testing of a pre-production sample", but AS9102 section 5.1 specifically states: "5.1 First Article Inspection (FAI) shall be performed for a new part representative of the first production run.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.
Adding margin is required due to the statistically small sample size and uncertainties in actual environmental levels. Since this is a destructive test, the UUT shall never be fielded in operational systems. Note: Must do Acceptance Testing including Pre-Conditioning first.
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