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Thread: Equipment that is out of contract.

  1. #1
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    Equipment that is out of contract.

    In my lab we have a piece of equipment that is out of contract at the end of the year. The supplier can't provide maintenance after the 31st December but we may not get a replacement until March. If we get the equipment serviced before it goes out of contract it would not be due service/ calibration for 6 months. Although not ideal we were looking at keeping the equipment in use until the new kit arrives, hopefully by March. Yes, if it malfunctions we won't be able to get it repaired which is far from ideal. However, if it does not break down and we keep it maintained in the validated state, we were hoping it could stay in use until the new kit is in place.
    Has anyone had to use this type of approach before? Anyone any views on how this would sit from an inspection perspective? We realise this is far from ideal but we are weighing up all possible solutions and would be keen to get an independent point of view.

  2. #2
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    Hi Matt

    The GPG states:

    4. Equipment and materials

    4.1. General requirements

    4.1.1. All equipment must be qualified, calibrated and maintained to suit its intended purpose.
    Operating instructions must be available and appropriate records kept
    (Directive/2005/62/EC/Annex 4.1).

    4.1.3. All validated processes must use qualified equipment. Qualification results must be
    documented. Regular maintenance and calibration must be carried out and documented
    according to established procedures. The maintenance status of each item of equipment must
    be available.

    4.1.4. All critical equipment must have regular, planned maintenance to detect or prevent avoidable
    errors and keep the equipment in its optimum functional state. The maintenance intervals and
    actions must be determined for each item of equipment.

    Taking the above into account, as long as the piece of equipment is


    1. Validated for use up until the equipment is replaced in March
    2. It is working as expected and the maintenance certificate is in date i.e. the suggestion is that the certificate runs out in June so an alternative supplier , with appropriate qualifications/certificates, for the maintenance of the piece of equipment will need to provide an in date certificate so you can carry on using it or it is replaced with a alternative technology.
    3. You have adequately protected your business continuity process i.e. have a validated process to replace the function the current equipment performs if it malfunctions before you have replaced it.
    4. The site would have to have a way to assure themselves that the equipment was performing satisfactorily up to its last use. Depending on the equipment then maintenance may also detect issues that have occurred since the last maintenance session. Where this is the case then the impact of such issues on results etc could be assessed.


    The fact that the supplier maintenance contract has expired would not necessarily be an issue.

    Please ensure that the appropriate change control processes are in place to manage the management of the equipment after the expiry of the maintenance contract and the introduction of the new piece of equipment.

    I hope this helps you.

    Regards

    Mike

  3. #3
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    Hi Mike
    thanks for the detailed reply, it is much appreciated. I'm glad to hear youthink this could be an option provided we put the measures above in placeto mitigate the risk. We are really only discussing this as a fallbackposition and will hopefully be able to get new kit in place before the old oneruns out of contract. This is however dependent on moving the procurementprocess quicker than it has been, so we thought it best to identify a few options incase this doesn't pan out in time.

    Many Thanks
    Matt



  4. #4
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    Glad i could help please dont hesitate to contact me via the details below if you need any further help.

    Kind regards

    Mike Dawe
    Haemovigilance Team Manager
    E Mail: Michael.Dawe@mhra.gov.uk
    Mob: 07709428989
    Tel: 0203 0806239

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