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Must all Documented Information be controlled?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by QualityNoob, Feb 4, 2017.

  1. Venson

    Venson New Member

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    What will be more worrying is the tendency to over-control documents. Positions and departments have been created just to cope with document and data control activities.
     
  2. Venson

    Venson New Member

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    The active register can be treated as a "record" rather than a "document". Controlling it as a record is slightly different than controlling it as a document---more focused on identification, access, maintenance, storage, retention and disposal.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    True, however, that's not what worries me...
     
  4. Pancho

    Pancho Active Member

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    This worries me too, in these ways:
    1. Redundant information where one instance is controlled and another is not, will result, sooner or later, in documents being out of sync, or in most documents being uncontrolled. Both will soon produce major product non-conformities.
    2. Having a policy that allows discretion in which documents are controlled and which are not will justify having most documents be uncontrolled, as the "minimal" system achieves certification.
    3. "Minimal" quality systems are the opposite of what the new standard intends, despite having no mandatory documented procedures. Such systems are usually not worth the paper they are printed on.

    The purpose of document control is quality, in the documents, in the processes and in the product. When done right, such control is far from a burden. It actually makes things easier and helps achieve quality.
     
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  5. RoxaneB

    RoxaneB Moderator Staff Member

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    As Jennifer has indicated, the template is the controlled document. The process for controlling the information/content gets into records control. To add to Jennifer's items on authorization to update and preventing loss of data, you may also wish to consider information retention (if the template completely changes and you want to copy information over) and an acknowledgement that some fields may be blank for historical data if additional columns/fields are added at a certain point. This could help address any questions regarding seemingly missing data.

    As for Andy and Normzone, can you hear my eye roll from all the way over here? *lol*
     
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  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Call it what you like, but let's consider a record is usually thought of describing something that has happened, while a document describes something that is to happen. It is important not to overthink it; protect it from loss, unintended change and unauthorized access, and the risk-based-thinking aspect has been met. But like Roxanne said, changing format enough to alter content could warrant a typical sort of controlled document change.

    It's supposed to be about risk, like it always has been (just didn't say so before).