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ISO 9001:2015 & Machine Validation

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by nwall1985, Jun 22, 2023.

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  1. nwall1985

    nwall1985 New Member

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    Our company has purchased a new Lathe to machine existing parts. The machine was purchased with a certificate of compliance. A random sampling of the finished parts will also be inspected against the drawing prior to shipment to the customer. Is validation of the Lathe still needed?

    If not, do I need a policy to state that post production inspection is sufficient to bypass validation?
     
    nwall1985, Jun 22, 2023
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  2. MonsterEnergy22

    MonsterEnergy22 Member

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    Key word "Appropriate stages", ISO 9001 doesn't mention "Inspection", anywhere I believe? It's based on risk, is this the only part that goes from Lathe to Storage? What would you do if your Pre-dispatch failed? Could you have caught it earlier? Why/can't/won't you randomly sample inspect coming off the lathe? What if a new member of staff operates the machine, are you just going to let the parts through?

    Whilst I don't think it's necessary to inspect coming off the lathe as you say if the risk is minimal however I'd want to catch any potentional problems earlier, but at the end of the day it's up to you to determine the controls you think are necessary.

    You could monitor the product from the Lathe for a while, and phase out inspections, is the Lathe part of a preventative maintenance program to support this decision?
     
    MonsterEnergy22, Jun 22, 2023
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    RonR Quality Pro likes this.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    nwall: I'm not sure about your question. ISO 9001 only requires what might be termed process validation where product cannot be subsequently inspected. As a lathe operator (in the dim and very distant past) all the parts produced can be gauged in some fashion. Now, it's possible that some form of capability study should be performed - a run of 50 parts to determine how capable a feature/tolerance can be repeated (using the classic "SPC" study).

    Don't over look that ISO 9001 doesn't require any sophistication - 177 nations use the requirements, many of them 3rd World countries.
     
    Last edited: Jun 23, 2023
    Andy Nichols, Jun 22, 2023
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    John C. Abnet and RonR Quality Pro like this.
  4. tony s

    tony s Well-Known Member

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    If you're concern is about the requirement in clause 8.5.1f, the answer is "not needed". The resulting output of lathe machining process can always be verified by measurement activities.
    No need for a policy. The statement in the standard is already a policy in itself.
     
    tony s, Jun 25, 2023
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  5. John C. Abnet

    John C. Abnet Well-Known Member

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    What @tony s said.

    Be well.
     
    John C. Abnet, Jun 26, 2023
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