Scribd Logo
Upload

Welcome to Scribd!

  • 85 views

    Fai 1

    Uploaded by

    Anbu
    The document provides guidance on conducting first article inspections (FAIs) according to SAE AS9102 standards. Key points include: FAIs should be performed on new products and when changes occur; all engineering, design, and specification requirements must be verified and documented; and inspection results for each characteristic must be traceable to design requirements. Templates are provided to document part numbers, processes, characteristics, and results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Fai 1

    Uploaded by

    Anbu
    85 views5 pages
    The document provides guidance on conducting first article inspections (FAIs) according to SAE AS9102 standards. Key points include: FAIs should be performed on new products and when changes occur; all engineering, design, and specification requirements must be verified and documented; and inspection results for each characteristic must be traceable to design requirements. Templates are provided to document part numbers, processes, characteristics, and results.

    Original Description:

    Europe Medical Device Harmonised Standards (MDD, AIMDD, IVDD), 2012

    Original Title

    FAI 1 Converted

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document provides guidance on conducting first article inspections (FAIs) according to SAE AS9102 standards. Key points include: FAIs should be performed on new products and when changes occur; all engineering, design, and specification requirements must be verified and documented; and inspection results for each characteristic must be traceable to design requirements. Templates are provided to document part numbers, processes, characteristics, and results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    85 views5 pages

    Fai 1

    Uploaded by

    Anbu
    The document provides guidance on conducting first article inspections (FAIs) according to SAE AS9102 standards. Key points include: FAIs should be performed on new products and when changes occur; all engineering, design, and specification requirements must be verified and documented; and inspection results for each characteristic must be traceable to design requirements. Templates are provided to document part numbers, processes, characteristics, and results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 5
    At a glance
    Powered by AI
    The key takeaways from the document are that an FAI is performed to verify that all engineering, design and specification requirements for a new product are met. It should be done on the first production run and in accordance with SAE AS9102. Various documents and processes are reviewed as part of the FAI.

    The purpose of carrying out an FAI is to give objective evidence that all engineering, design and specification requirements are correctly understood, accounted for, verified and recorded.

    A full or partial FAI shall be performed when there is a change in design, manufacturing source/process/location, computer program, or lapse in production of more than 2 years as specified by the customer.

    Quality – First Article Inspection

    FIRST ARTICLE INSPECTION (FAI)

    1.0 The purpose of carrying out an FAI is to give objective evidence that all engineering,
    design and specification requirements are correctly understood, accounted for, verified
    and recorded. The document is intended to guide how this is achieved.

    2.0 An FAI should be performed on all new products that are representative of the first
    production run. The FAIs should be performed in accordance with SAE AS9102.

    3.0 In support of the FAI, The Supplier should review:-

    a) Documentation for the manufacturing process, including ‘Route Cards’,


    ‘manufacturing/quality plans’, manufacturing ‘Work Instructions’ and any other
    document that may affect the final product.
    b) ‘Inspection data’, ‘test data’ ‘acceptance test procedures’.
    c) ‘Non-Conformance data’ for completeness and correct implementation.
    d) ‘Material certifications’ for compliance.
    e) That any special processes are documented and implemented correctly and that any
    manufacturing planning/routing documents correctly relate to relevant specifications.
    f) That key characteristics have been met.
    g) That specific gauges and tooling is qualified/calibrated and traceable as applicable.
    h) That every design characteristic requirement is accounted for, is uniquely identified
    and has inspection results traceable to each unique identifier.

    4.0 The FAI requirement, once invoked, should continue to apply even after initial
    compliance.

    5.0 When a partial FAI is performed, only the affected fields on the FAI form shall be
    completed. The remaining fields shall be completed when possible, or previous data
    may be referenced if it applies to identical characteristics of similar parts produced by
    identical means.

    6.0 A full or partial FAI shall be performed when there is:

    a) A change in design, affecting Fit, Form or function of the product.


    b) A change of manufacturing source(s), process(es), inspection method(s), location of
    manufacture, tooling or materials, that can affect fit, form or function.
    c) A change in a program (computer generated) that can affect fit, form or function.
    d) An event that can affect the manufacturing process (natural or man made)
    e) A lapse in production for a period of 2 years or as specified by the customer - SIRS.

    7.0 For components or assemblies regularly manufactured by the supplier, that have had
    an initial FAI but require a ‘set up’ prior to each manufacture – that may involve tool
    setting, sharpening, adjustment; a new FAI will be required.

    8.0 The FAI shall not be considered complete until all relating non-conformances are closed
    and corrective actions - implemented.

    9.0 The documents attached can be used as templates to complete the FAI.

    10.0 Record of Results: the results from inspection of design characteristics should be
    expressed in quantative terms (variables data) when a design characteristic is

    Page 1 of 2

    Iss 1 Rev 0 June 11


    Quality – First Article Inspection
    expressed by numerical limits.

    11.0 The recorded results shall be expressed in the same units as those specified on the
    drawing or within the specification.

    12.0 Control of FAI Records: The FAI records should be considered as ‘Quality Records’
    and controlled for retention for at least 7 years.

    13.0 Instructions to complete the FAI forms are detailed within AS9120 – available from the
    ISO website. SIRS will provide assistance if required

    14.0 For Assemblies, the assembly level FAI shall be performed on those characteristics
    specified on the assembly drawing.

    15.0 The documentation used by the supplier to record the data shall be based upon
    attached :-

    Form 1: ‘Part Number Accountability’ shall be used to summarise associated part


    numbers and associated FAIs for Assemblies.

    Form 2: ‘Product Accountability’ shall be used for raw materials, specifications,


    processes and functional tests.

    Form 3: ‘Characteristic Accountability’ shall be used to summarise actual specific


    design characteristics. Each characteristic shall have its own unique characteristic
    number and this number shall be marked on the relevant drawing/specification
    document. Characteristics not measurable in the final product shall be verified in the
    manufacturing process.

    16.0 The FAI policy should be ‘flowed down’ to all SIRS’ suppliers and sub-tier suppliers.
    FAIs will be required for products that fall within the requirements detailed in Para 6.0
    above. The FAI procedure used by all Suppliers, shall be based upon AS9100.

    Page 2 of 2

    Iss 1 Rev 0 June 11


    FIRST ARTICLE INSPECTION Company:

    FORM 1 – PART NUMBER ACCOUNTABILITY Sheet 1 of


    1. Part Number 2. Part Name 3. Serial Number 4. FAI Report

    5. Part Revision Level 6. Drawing Number 7. Drawing Revision Level 8. Additional Changes

    9. Manufacturing Processes 10. Organisation Name 11. Supplier Code 12. P.O. Number

    13. Detail FAI 14. Full FAI Baseline Part Number Including Revision Level
    Partial FAI

    Assembly FAI Reason for Partial FAI:

    a) if above part number is a detail only, go to field 19


    b) if above part number is an assembly, go to the “INDEX “ section below.
    Index of part numbers or sub-assembly numbers required to make the assembly noted above

    15.Part Number 16. Part Name 17. Part Serial Number 18. FAI Report Number

    1) Signature indicates that all characteristics are accounted for; meet drawing requirements or are properly documented for disposition

    2) Indicate if the FAI is complete: FAI Complete FAI Not Complete

    19. Signature 20. Date

    21. Reviewed By 22. Date

    23. Customer Approval 24. Date


    FIRST ARTICLE INSPECTION Company:
    FORM 2 – Product Accountability – Raw Material, Specifications and Special Process(es), Function Testing.
    Sheet 1 of
    1. Part Number 2. Part Name 3. Serial Number 4. FAI Report Number

    5. Material or Process Name 6. Specification 7. Code 8. Special Process 9. Customer 10.Certificate of Conformance
    Number Supplier Code Approval Number
    Verification
    (Yes/No/NA)

    11. Functional Test Procedure 12. Acceptance Report Number, if applicable


    Number

    13. Comments

    14. Prepared By 15. Date


    FIRST ARTICLE INSPECTION Company:
    FORM 3 Sheet 1 of
    1. PART NUMBER 2. PART NAME 3. SERIAL NUMBER: 4. FAI REPORT #
    W/O #: FAI/
    Characteristic Accountability Inspection / Test Results
    5. Characteristic 6. 7. 8. Requirement 9. Results 10. 11. 14.
    Number Reference Characteristic (Dimension + Tolerances, (Actual results identified) Designed Non-Conformance Comments
    (1,2,3 etc) Location (if Designator (e.g. Performance requirement, Tooling Number
    req’d) Critical, Key etc) colour etc) (Tool (if Applicable)
    References etc)

    The signature indicates that all characteristics are accounted for; meet drawing requirements or are properly documented for disposition.

    Date Comments

    12.
    Prepared by:
    12.
    Approved by Production Manager or Chief
    Engineer:

    You might also like