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traceability using labels with no document control?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Mar 10, 2022.

  1. Qualmx

    Qualmx Well-Known Member

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    Hello everybody

    For the traceability of raw and products into de company, in some products we use a label, which has 6 type of data, PN, quantity, material, etc.
    It is a small form with name and revision in order to control it, when changes are needed.
    In the last times we have the need to have traceability on some materials and just need a label
    with two type of data.
    we want to use a label (small paper) with no control (no identification nor revision)
    Im I under compliance in ISO 9001?

    Thanks
     
    Qualmx, Mar 10, 2022
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  2. John C. Abnet

    John C. Abnet Well-Known Member

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    In ISO 9001 the "organization" is left to determine if/type of traceability (assuming no specific requirements by customer). Be selfish and protect the organization from undue exposure. Your organization determines.

    Hope this helps.
    Be well.
     
    John C. Abnet, Mar 10, 2022
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  3. russell nugent

    russell nugent Active Member

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    The large box label can have all the required information such as lot , batch ,rev and inspector/packer . This should cover as long as you have faith that your system is able have correct information for traceability .
     
    russell nugent, Mar 11, 2022
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why does anyone feel the need to do this? A label isn't a form. What compliance aspect with ISO 9001 are you concerned with? Is it really an issue of being written an NC by an auditor?
     
    Andy Nichols, Mar 11, 2022
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  5. Qualmx

    Qualmx Well-Known Member

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    In my case is not a printed label, is a small form and data on it, is written down by hand and added to the product.
    but in order for this form be controlled against a change (avoid other people to use a different form) because it has 10 blank fields.
    The idea is to have control of this document under 7.5.3.
    To have the control like any other document into the sustem.
    Please advice.
     
    Qualmx, Mar 11, 2022
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It seems to me someone created a monster. Remove the monster. Automate the creation and printing of the label. It's a label, not a form.
     
    Andy Nichols, Mar 11, 2022
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  7. Qualmx

    Qualmx Well-Known Member

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    Thanks Andy for your advice.
    Yes, is a monster, now I dont see the need to have a control of that.
     
    Qualmx, Mar 11, 2022
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  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Hello Qualmx,

    Document control for forms is usually about format. Part number, revision number, date, etc. for a label as you describe. The label's contents are as per your system and customer requirements.

    The justifications for controlling a form include, for example (there may be more depending on your industry, your standard and your customer requirements)
    • Changing information content
    • Changing the layout in a way that would conflict with customer requirements, e.g. position of data or barcodes
    • Changing the layout in a way that would confuse users
    Forms like this should only be controlled for reasons involving customer requirements and our QMS. The data on the forms are NOT controlled. They are information.

    I hope this helps.
     
    Jennifer Kirley, Mar 12, 2022
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