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Do you have instructions for your design inputs?

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  • Опубліковано 20 лип 2023
  • Your design inputs need to be much more than just a few words in a cell of your Input-Output-Verification-Validation (IOVV) Matrix. An Excel spreadsheet just doesn't have enough information to ensure that your testing plan is detailed and will be done correctly. Creating a work instruction for each design input might be overkill, but what does need to be documents for a design input?
    Here are ten things you could consider:
    1. Is there more than one applicable standard or version of the standard (i.e., ISO 14937:2009 ed. 2.0 and ISO 22441:2022 ed. 1.0)?
    2. Does the standard(s) include testing methods and acceptance criteria?
    3. Which vendors on your Approved Supplier List can perform the testing?
    4. What is the anticipated timeline for testing?
    5. What is the estimated cost for testing?
    6. Do you have a documented rationale for the worst-case samples for testing?
    7. Do you have a statistical rationale for the sample size?
    8. How will you make sure the final testing report is acceptable?
    9. What guidance documents are applicable to your design input?
    10. Which protocol is applicable to this input?

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