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Documenting Change

Discussion in 'Documentation Control, Procedures, Templates,...' started by William Gray, Nov 13, 2015.

  1. William Gray

    William Gray New Member

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    Hi All

    I'm the QA change specialist at my company. I've recently taken over the role and have inherited a large amount of ongoing product changes, about 70 in total. Having reviewed them i would say a majority of these changes would not classify as significant change to the product and would not need to go through the offical product change system. With smaller changes documented somewhere else in our QMS like in revision histories.

    My manager does agree with me and has asked me to reduce the number of active product changes.
    I was wondering if anyone had any advice or tools they use on determining significant changes?
    Also how do others document smaller changes?

    Thanks
    Will
     
  2. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    By "Product change system", did you mean the activities leading to the release of Product changes, like re-verification, re-validation, review, approval?
    Or activities related to implementation of Product Changes released by your Design Department
    Or both
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hmmmm - product changes NOT going through a formal process? Alarm bells are ringing...

    Product changes which are not paid for by specific customer needs should be viewed as an indicator of a lack of effectiveness from the design process. One of the first steps is to determine what the changes relate to. Are they related to fit/form/function? An organization I am familiar with processed changes which cost a lot of money to do, for simple stuff like tolerances which are too tight for the actual use of the parts. As a result of looking into this is was found that they were wasting $$$$ for no good reason, other than Design Engineering not putting appropriate limits on parts because they didn't involve manufacturing engineering.

    I'd suggest you analyze the reasons for the changes, first, before you decide to "fast track" the things, so you can cost justify why they were created as being something to fix...
     
  4. William Gray

    William Gray New Member

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    I'm refering to changes to already released products and the processes that are used to manufacture these products therefore changes are raised by the manufacturing departments mainly.
    I think our actual formal product change system is robust and doesn't require a massive amount of change with regard to signing of the change as effective/complete and was looking for help with the fesability and determining if the change needed such a formulaic process or could be documented elsewere in the QMS.
     

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