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  2. First article inspection - Wikipedia

    en.wikipedia.org/wiki/First_article_inspection

    First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.

  3. Form FDA 483 - Wikipedia

    en.wikipedia.org/wiki/Form_FDA_483

    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 ...

  4. Production part approval process - Wikipedia

    en.wikipedia.org/wiki/Production_part_approval...

    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

  5. Check sheet - Wikipedia

    en.wikipedia.org/wiki/Check_sheet

    A check sheet is a form (document) used to collect data in real time at the location where the data is generated. The data it captures can be quantitative or qualitative.When the information is quantitative, the check sheet is sometimes called a tally sheet.

  6. FDA warning letter - Wikipedia

    en.wikipedia.org/wiki/FDA_Warning_Letter

    If the firm markets other FDA-regulated products and the issue(s) affect marketed products—or the inspection extended to marketed products included on the FDA 483, then they may issue a Warning Letter These include the following statement: "Due to the deficiencies listed on the attached FDA 483 we are recommending to the center that approval ...

  7. Mill test report (metals industry) - Wikipedia

    en.wikipedia.org/wiki/Mill_test_report_(metals...

    A mill test report (MTR) and often also called a certified mill test report, certified material test report, mill test certificate (MTC), inspection certificate, certificate of test, or a host of other names, is a quality assurance document used in the metals industry that certifies a material's chemical and physical properties and states a product made of metal (steel, aluminum, brass or ...

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