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  • 1.  Equipment IQ-OQ

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jun-2023 08:10
    This message was posted by a user wishing to remain anonymous

    Hello everyone, 

    I work in a small start-up IVD manufacturer that has ISO-13485. I have a question about equipment qualification that I would appreciate your input on. 

    Do we need to perform IQ-OQ on every piece of equipment we have such as centrifuge, pipette? is there any guidance to know what type of equipment we should/should not qualify? 

    Kind Regards. 



  • 2.  RE: Equipment IQ-OQ

    Posted 23-Jun-2023 08:24

    Hello

    I think any piece of equipment that has an effect on product specification should be qualified. According to Clause 7.5.1 in ISO 13485

    "Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specifications"

    Sub-clause 7.5.1(b) requires qualification of infrastructure

    You could look at each piece of equipment and clearly define how it affects the final product. You could then rank each equipment on a criticality scale based on its impact on specs. This should be done as part of your planning process.

    Best regards



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    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
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    Original Message


  • 3.  RE: Equipment IQ-OQ

    Posted 23-Jun-2023 10:02

    I infer that your QMS is both FDA QSR and ISO 13485:2016.

    The requirements for process validation traditionally use the IQ, OQ, PQ paradigm. However, there are no regulatory requirements to use this paradigm.

    IQ (installation qualification) ensures the equipment is placed and installed properly. Typically, this applies to fixed equipment. For example, a multimeter would not require IQ.

    OQ (operation qualification) ensures the validated process input parameters are set so that the process produces only conforming material. In process validation, one doesn't check the output, so the control is on the process inputs.

    PQ (performance qualification) checks that the validated process is stable.

    If you are doing equipment qualification outside a validated process, then you only need IQ. The best description of what to include in IQ is found in 820.70(g) – appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use. For each piece of equipment develop a checklist that covers these elements. The QSR section also includes maintenance. This includes inventory management of consumables such as grease and oil. I recommend adding the OSHA requirements for Lock out/Tag out as well as for machine guarding to the IQ checklist.

    You don't need OQ and PQ unless you have a process that requires process validation.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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