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  • Design Controls - Current: - If Radically New Design, List Under Recommended Action Column

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    ವಿಕಾಸ ಏಕನಾಥಭಟ್ಟ
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    The document provides guidance on design controls for current projects. It instructs to list current design validation, verification, and prevention activities that will ensure designs are adequate. Additionally, it asks to describe current controls used for similar past designs, as initial risk rankings will be based on these existing controls, assuming prototypes represent the overall design intent. For new innovative designs with no past examples, it recommends noting them separately for additional review.

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    The document provides guidance on design controls for current projects. It instructs to list current design validation, verification, and prevention activities that will ensure designs are adequate. Additionally, it asks to describe current controls used for similar past designs, as initial risk rankings will be based on these existing controls, assuming prototypes represent the overall design intent. For new innovative designs with no past examples, it recommends noting them separately for additional review.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    19 views1 page

    Design Controls - Current: - If Radically New Design, List Under Recommended Action Column

    Uploaded by

    ವಿಕಾಸ ಏಕನಾಥಭಟ್ಟ
    The document provides guidance on design controls for current projects. It instructs to list current design validation, verification, and prevention activities that will ensure designs are adequate. Additionally, it asks to describe current controls used for similar past designs, as initial risk rankings will be based on these existing controls, assuming prototypes represent the overall design intent. For new innovative designs with no past examples, it recommends noting them separately for additional review.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Design

    Controls - Current
    • List Design Validation / Verification (DV), Prevention
    or other activities which will assure design adequacy
    for failure mode and / or cause / mechanism under
    consideration
    • Current controls - those that have been or being used
    with the same or similar designs
    • Initial occurrence and detection rankings will be based
    on these current controls, provided prototypes / models
    represent design intent
    • If radically new design, list under Recommended Action column.
    15

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