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  1. KP1SP

    Revision Levels and Traceability Of Specifications and Controlled Documents

    KENAT, That is what the QA manager and myself are pushing for as the new protocol; to use a letter or number for draft and opposite for official release. Others are pushing for us to have an internal release and new revision for every little change along the R&D path. I don't think they...
  2. KP1SP

    Revision Levels and Traceability Of Specifications and Controlled Documents

    Also, When a customer places a PO we need the most current part number and revision listed for both companies. So I do need to have a revision level on the part number. But I was hoping there might be a standard for this so that I may just shut down the opinionated suggestions going back and...
  3. KP1SP

    Revision Levels and Traceability Of Specifications and Controlled Documents

    swertel/KENAT, We are an ISO13485 certified company so we need to have very detailed SCN. Every change that affects form, fit or function needs to be documented. There has been debate here whether or not we need a revision level when the product specification is still going back and forth to...
  4. KP1SP

    Revision Levels and Traceability Of Specifications and Controlled Documents

    Hello All, Wondering if anyone know if there is a standard for controlling revision levels for specifications and documents? We have to many personal opinions flying back and forth at work and I need something concrete as evidence for a change, simply to just get something standardized here...
  5. KP1SP

    Radii Verification

    All, I have spoken with some people around here and we have decided to have a film proof(clear plastic material with print) made for each lid. Just to verify our standard tolerance can be held, I was mainly trying to avoid any non conformancies with prior customers and also not to have to...
  6. KP1SP

    Radii Verification

    MikeHalloran, I have, they are just operators. They don't validate the radii, just width x length. I have measured leftovers from past production. All I can measure are print location markers and width x length dimensions. Other than printing a 1:1 of the spec and placing samples on top...
  7. KP1SP

    Radii Verification

    Hello, I'm designing a spec for a tyvek(CR27 1073B Coated) lid for a thermo formed plastic tray, nto at liberty to say material for that. What is the best way to verify that the radii on the lid are within tolerance? Raidus 1 is 0.38" ± 0.06", the other 3 radii are 0.86" ± 0.06". I have a...

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