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Field Failure Actions

Discussion in 'Other Quality and Business Related Topics' started by Scott, Feb 6, 2017.

  1. Scott

    Scott Member

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    Hello,

    i am currently working on something and although i have some thoughts as to how to go about this, i was wondering if you could give me some guidance on where to start - methods to use etc.

    The scenario is:
    There is an intermittent fault on a component. the component at fault is known. It is an externally supplied part and there are outstanding orders on the system for this part.
    Internal testing shows a 10% reject rate.
    There are thousands of units out in the field and some at various stages in production - with orders placed.
    The product has been a source of high order volumes for many months and has various approvals such as CE marking etc

    In terms of tackling this issue and managing it - what would be the best way to go about it?

    The thoughts i have so far are
    Component traceability (to try and work out, how many of the "sold" units would potentially be affected) Analysing test results to see trends (this may help determine when the issue initially occurred)
    High sample frequency inspection on the internal WIP units
    Report fault to supplier to try and get a better understanding of the issue

    I', unsure as to how to go about informing the market place (if this is required) whilst keeping the risk to the business as low as possible.

    any help would be appreciated
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi Scott

    One area you are missing is a Risk Analysis.

    Is this a regulated product, such as a Medical Device?

    Chris
     
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  3. Scott

    Scott Member

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    Hi Chris,

    yes this is a regulated device, in terms of risk analysis - what steps would i need to consider?

    Thanks
    Scott
     
  4. Vintage Goose

    Vintage Goose Active Member

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    Hi (assuming its a medical device....)

    At the end of the day its the risk to the patient, the risk to the user and the commercial risk to the company (and if applicable, distributors). In addition, you probably need to consult ISO 14971 and MEDDEV 2.12-1 Rev 8 for Vigilance. The MHRA also has information on their website.

    Chris
     
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  5. Scott

    Scott Member

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    Hi Chris,

    thanks for the input - so if i was to put together a standard process - a basically "what to do if" guide / standard process for what to do in the event of failures being detected when products have already launched onto the market place:

    1 - Risk analysis (Covering commercial, customer and end user)
    2 - Consult standards / relevant legislation on mandatory requirements
    3 - Implement anything results from action 2 above
    4 - Component traceability to determine the potential impact (what supplied parts are effected)
    5 - Serial traceability to narrow down on the impact (which units have the supplied parts being installed into)
    6 - Relevant communication to the customers (if required)
    7 - Recall / replace faulted product
    8 - Higher sample inspection on WIP
    9 - Countermeasures (request the supplier to implement prevention methods into their process)
    10 - Countermeasures 2 (implement detection methods into our goods in and sample inspection process)

    do you think that would cover the business with regards to - helping maintain reputation / reduce impact - or am i being blind and missing something that is blatantly obvious?

    Thanks again
     

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