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Record Management (paper-based document system)

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by laden, Apr 21, 2020.

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  1. laden

    laden Member

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    Dear All;

    I've a question regarding record management on forms in paper based system?


    For instance; when the form template document number and revision is changed; how do we create the new record ? How can we describe it on the record revision history ?

    I'd appreciate if you share with me your ideas?

    Thanks
     
    laden, Apr 21, 2020
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome laden:

    The answer is somewhat dependent upon what was created as your document control system. For example, some folks seem to think that putting a revision history in the affected document is a "good thing" and a requirement of document control. Not at all. It's a burden and creates a bureaucracy.

    I'm not exactly sure of your question regarding a "new record". What do you mean?

    Can you clarify? Do you have, for example, a mechanism to request, authorize and track changes to documents?
     
    Andy Nichols, Apr 21, 2020
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  3. laden

    laden Member

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    Hi Andy;
    thank you so much for warm-welcoming and your reply.

    Ok. I understood your explanations.
    Yes, we 're trying to add also revision history for the content.But as you say that it is hard to manage!

    I'll tray to explain via creating a story:

    I have a "form" which document code is QMS-F-001 (version 02) and I create my records via this form.

    When I'd like to update the filled form (I meant the record; not form's template, I'm also adding revision history for follow up for the record.)

    But it is a little bit confusing since the form itself has a version number. these both can mix with each other. I'd like to prevent this.. but I can not find a better way:(

    Do you understand what I mean?

    and secondly if I change the template document number, the new record (revision number) should be started as revision01, right?

    I hope I managed to explain:)

    thank you so much!
    Laden
     
    laden, Apr 21, 2020
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think I understand...:confused:

    Let me see if I can explain what could/should happen. Firstly, records (retained documented information) are historical. Those records shouldn't change. Never. Ever. If the form used to record data/information changes, then the new form will mark a point in time and from that point on, the revised data/information will be recorded. No need to go back, before that point and do anything. It's gone, into the mists of time.

    As for the actual form, I'd suggest that what you do is use a document change form and use that to initiate changes to all types of documentation, including forms, such that it becomes the place to record EVERYTHING to do with the change - instead of recording that ON the actual document. That way, anyone who needs the information can research the change note (they should receive a copy when the change is made, to inform them. After that, all which is required is the rev # on the document (or a date, if you like). The numbering system is yours to decide - K.I.S.S is best

    Does this help?
     
    Last edited: Apr 22, 2020
    Andy Nichols, Apr 21, 2020
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  5. laden

    laden Member

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    Hi Andy again;
    Thanks for your valuable input.Yes, it helps a lot..
    Actually we're processing the document change request form for changes as you mentioned above.But this change process is applicable only for Quality management system documents like work instructions, sops and forms..

    we're not perform this for the records...as I understand you suggested that kind of change process for the records, right?

    Thanks
    Laden
     
    laden, Apr 22, 2020
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Laden:

    Records shouldn't be changed and I certainly was NOT suggesting you do this. Since you posted this in the Medical Device forum (unless that was an error) your organization could get into serious problems if records are changed.

    Can you clarify, by explaining WHAT and WHY records are being changed?
     
    Andy Nichols, Apr 22, 2020
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  7. laden

    laden Member

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    Hi Andy;
    actually I think I could not express myself clearly. I'm not mentioning the change of the records.
    Of course I know there you can not change what you created.

    What am I saying is when you start to fill a form and in meanwhile the form template is change; how can you establish linkage between the previous record?
     
    laden, Apr 22, 2020
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You don't need to establish a linkage. It's all historic. If you change a form the new form should have a date/time when you wish it to be implemented and that becomes a "line in the sand" after which, the records are created using that new form. No linkage to the past is necessary - except that the change control form you used to request and approve the form tells you when the (new) form was implemented.
     
    Andy Nichols, Apr 22, 2020
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  9. laden

    laden Member

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    Okey..It is understandable for me now:) Thank you very much for the clarification...
    Otherwise it can be a chaos to managing...
     
    laden, Apr 22, 2020
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  10. Mike S.

    Mike S. Member

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    One minor point: I agree that records should not be changed, but they may be corrected.
     
    Mike S., Apr 29, 2020
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