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820.40 document controls

Discussion in 'Medical Devices (21 CFR Part 820)' started by dosumi, Aug 7, 2015.

  1. dosumi

    dosumi New Member

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    Would like opinions on current ECO process, Have been assigned task of streamlining the document control process especially drawing approvals, revisions and review process. I have attached a copy of the current ECO procedure , I can't see how to improve on this much other than possibly making the approval process electronic by pdf.
    To me the time involved is in creating or revising the actual drawings, the ECO is basically a cover page that is signed off by the reviewers in different departments QA, fabrication etc..

    Any opinions or advice would be realty appreciated.

    Regards

    Will miss Elsmar Cove enormously
     

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  2. QAengineer13

    QAengineer13 Member

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    Hi dosumi,

    I glanced through the document very quickly and I would like to add few comments:
    1) The Definition should be in the beginning of the document and also the definition is not clear its vague and open for interpretation for Form , fit and Function definition. Ex. Form – the shape, size, dimensions, mass, weight and other visual parameters that uniquely distinguish a part.
    Fit – the ability of a part to physically interface with, connect to, or become an integral part of another part.
    Function – the action or actions that a part is designed to perform.

    2) There is no mechanism described for communication of approved changes and the training of appropriate personnel in a timely manner and details of the Change Record. (GAP in complying with 820.40(b) Document Change)
    3) I am not a great fan of Redline change but if its inevitable add more clarity in your document for the method of training and communication of redline changes

    Hope this helps.

    Regards.
     
  3. dosumi

    dosumi New Member

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    Thanks for the input.
    Unfortunately the new Non-Eng. Manager is trying to limit what they have to do when it comes to document control especially the ECO process, so any additions at the moment wouldn't be received well.
    I personally don't see any major time issue with the current procedure, I believe the issue is within the Engineering dept. with the most time consuming aspect is creating or change the actual drawing in the system and not the approval process. I have suggested that if the approval process takes to long we should move to an electronic systems where all approving departments receive the document at the same time, currently they use a hard copy and it goes from one department to the next until completed.

    Regards
     
  4. QAengineer13

    QAengineer13 Member

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    Yes, I agree. Document Management database is a good way going forward, I am sure you're aware just ensure the database is Validated and Part 11 compliant (for electronic signature and Records).

    Good luck with your management,to get the database purchase approved.

    Cheers.
     
  5. Ronen E

    Ronen E Well-Known Member

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    Sorry to say but I've been through this, and electronic systems don't seem to be the solution. Do a bottleneck analysis to find your culprits, then work with them on minimizing approval delays.

    Cheers,
    Ronen.
     
  6. Gert Sørensen

    Gert Sørensen Member

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    I beg to differ :)

    Using a well designed and compliant database can improve the handling time quite significantly - I have seen reduction in case handling times of up to 85%. As long as one remembers that the database is only as good as its design and implementation (and of course the people using it). It also helps you to identify bottlenecks, and gives you a good opportunity to work with them to e.g. reduce their workload or provide more training to them to better equip them to fulfill their tasks.
     
    Ronen E and Somashekar like this.

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