• Design DOCuments and Manufacturing DOCuments

    These are the basic design and manufacturing documents, which include, but are not limited to:

    Electrical:
    • Theory of Operation
    • Schematics, state charts, flow diagrams
    • Spice and other simulation analyses
    • Power budget
    • EMC and safety maps & critical component lists
    • Bills of materials, AVL
    • Performance Specific electronic Parts requirements
    • Fabrication drawings
    • Assembly & Test drawings and instructions
    • COTS and MOTS components, requirements & tests
    • Cable drawings
    • Manufacturing test fixtures

    Mechanical:
    • Theory of Operation
    • Bills of materials, AVL
    • Finite element analysis
    • Mold flow analysis
    • CAD and Fabrication drawings
    • Sheet Metal parts: 3D drawings, wireframe drawings
    • Machined Parts: 3D drawings, wireframe drawings
    • Assembly drawings and instructions
    • COTS Components, MOTS components requirements & tests
    • Manufacturing test fixtures

    Software:
    • Theory of Operation
    • Flow charts, state diagrams
    • Source code
    • Object and compiled code
    • Manufactured Components processes (programmable parts)
    • COTS and MOTS components, requirements & tests
    • Manufacturing test software source &/or executable code

    Manuals masters
    Packaging & Labels masters
    Process oriented documentation (Manufacturer specific)
    Schedules
    Q/A procedures
    Design Review reports
    Recycling design and instructions

    Regulatory plans
    • FDA 510(k), PMA
    • EMC, Safety
    • Quality Manual
    • Environmental Safety plan
    • Agency submittals

    System metrics
    • Financial, such as Net Present value
    • Project
    • Product
    • Software11 and hardware
    • Process
    • MTBF & MTTR

 
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©1999, 2005, Richard M. (Dick) Haney
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