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Approval of Form Templates

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jamescrockford, Oct 22, 2019.

  1. jamescrockford

    jamescrockford Active Member

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    Hi all,

    Quick question...I understand how to capture the review and approval of procedures (typically through signature of the document) but when it comes to form templates e.g. Corrective Action Form, Corrective Action Log, I am a little stumped.

    Can I ask how you guys do this?

    Many thanks,

    James
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @jamescrockford ;
    My council is always change point control vs "document control". In other words, for whatever controlled documentation or processes (i.e. anything where "wrong or gone" can lead to a non-conformance) your organization has, utilize the method(s) instituted to manage and track the the change.

    If you have a template that needs controlled, then I'm not sure why them method would be any different for a template than for a procedure.

    Hope this helps.

    Be well.
     
  3. jamescrockford

    jamescrockford Active Member

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    Thank you John...my question is...it is straight forward to capture review and approval of a procedure (through a signature) but I'm not certain of the best way to capture the same on a master form template?
     
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Awww...I understand your question better now @jamescrockford ;
    The method that has worked best in my experiences, is a log or data base, which identifies (among other things) the "level" at time of change for each document. The method I prefer is one where every change point receives a discrete identifier (i.e. "serial number").

    For example, the log or data base may look like this...
    cpc# 0001 (item, who approved, what changed, etc..etc..etc...)
    cpc# 0002
    cpc# 0003
    cpc# 0004

    etc...etc..etc...

    The CPC# would then be the "revision" listed in the footer or prescribed field which is established on every document type. This way, the details /approvals, etc.... of the change don't need to be on the document itself. You simply reference the CPC# on the document and then look in the log/data base to see the approval history.
    NOTE: A traditional revision level (i.e. Rev 1.0, Rev. 2.0 etc..etc...) also works for this, but the log/data base will need to track by document ID and not by CPC#.

    Hope this helps.
    Be well.
     
  5. jamescrockford

    jamescrockford Active Member

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    Understood...but how do you evidence that approval? Simply typing a name surely cannot be enough and hence why a signature (wet or electronic) would provide the integrity. This is easily done on a procedure/policy/manual but not so easy on a form template
     
  6. John C. Abnet

    John C. Abnet Well-Known Member

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    Whatever works best for your organization.

    Typing is certainly "enough" if it works for your organization. Don't over complicate it.

    You can type, or establish digital signature, or you can have traceability back to the IP address.
    Simplest would be to have limited access to the "log"/data base to only approved signatories.
    If you simply typed, is there really a culture that would intentionally misrepresent/"forge" someone else's name? Generally not.

    Having a separate physical signature on every approved document seems very antiquated and difficult to scale/manage.

    How have you done it in the past? What is prompting a change to how it has been done in the past?
     
  7. Golfman25

    Golfman25 Well-Known Member

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    In our company, the forms are referenced in a procedure. So the "signature" on the procedure includes the referred to forms. As John points out, don't over complicate it.
     
  8. jamescrockford

    jamescrockford Active Member

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    A
    Absolutely agree...thanks John. I think that is how I am muddying the waters i.e. around the need for an actual signature.

    I will just use our Master Document Index which contains all relevant details including approver etc.
     
  9. jamescrockford

    jamescrockford Active Member

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    This is how I did it in my last company. Tends to make sense and always tends to be associated with a procedure.
     
  10. jamescrockford

    jamescrockford Active Member

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    Having said that; if I needed to revise a form, say the corrective action form, but no changes to the corrective action procedure were required; how would the approval work then or would you need to up issue the procedure also?
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I use a "DCN" - a form which is the whole 9 yards of document control, like an ECN. Simples!
     
    tony s likes this.
  12. jamescrockford

    jamescrockford Active Member

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    I had thought of that but I think it might be one for further down the line...
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    it's a basic tool, James.
     

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