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Trend is significantly improving but NC raised

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by VRamkumar@coimbatore, Oct 21, 2020.

  1. VRamkumar@coimbatore

    VRamkumar@coimbatore New Member

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    Hi,,

    Performance indicator:
    Rejection PPM shall not exceed 75 PPM

    Month. --- Rejection(Qty). ---Cumulative Rejection (PPM)

    April. - 0. - 0
    May. - 0. - 0
    Jun. - 5. - 30
    Jul. - 100. -500
    Aug. - 1. - 400
    Sep. - 2. - 300


    My doubt:
    1.Whether cumalative PPM can be used to measure performance indicator on month basis, or else it suits only yearly basis?
    2.The above tabulation is whether significantly improving or not?
    3.Whether NC can be raised as mentioning "there is no evidence of significant improvement at this performance indicator"

    Note:Internal Audit done on october.
    1.Rootcause analysis available,
    2.monitoring activity carried out and its results evaluated(evidence available)
     
  2. Miner

    Miner Moderator Staff Member

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    Cumulative PPM is a YTD (Year to date) measure. It also provides a smoothing function, so it is slow to respond (both to real problems as well as corrective actions). Monthly or weekly measures should be used to determine whether the process is improving or worsening. Also, PPM is a lagging indicator, so using a leading indicator would be even better.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As with all audit findings, the auditor must consider:

    What is the requirement which the NC is going to be written against to give it credibility and applicability? Or, said another way, "Where does it say that it needs to have "significant improvement"?
    An internal audit especially should carefully consider "what am I going to cause to happen that management would recognize as necessary to have corrected"?
     
  4. qmr1976

    qmr1976 Well-Known Member

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    I think as long as you have evidence of a plan to improve upon your objective there wouldn't be a need to issue a nonconformance. ISO 9001:2015 states that you just need a plan on how to achieve your objectives, which your company determines. If they are not feasible/attainable objectives, they need to be re-evaluated to be a little more realistic.
     
  5. Eric Twiname

    Eric Twiname Well-Known Member

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    From the limited data, it sure looks like there was a problem in July...perhaps it started the last days of June...it was recognized and addressed (Aug = 1, Sep = 2), but may need more work to get back the the initial zero/month.

    "In my parlance...there was an issue, we saw it, we fixed it, and we are seeing if the fix is complete or there is still more work to do."
    That's pretty much what the QMS should be doing...why bother writing a NC on it?
    We had a bucket for "Quality Improvement" to handle stuff like that...things where we called foul before the auditor ever showed up. Never had a NC written on one of those since we were already on top of it.

    HTH
     
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  6. qmr1976

    qmr1976 Well-Known Member

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    Right! It's always been our experience that if you write yourself up for it internally or have addressed the issue prior to the auditor getting here, it shows you have acknowledged the issue and are working on it. However, this can come back and bite you have you not done your due diligence to ensure your efforts to improve have been effective. (i.e. minor NC for an issue, no improvement, write yourself up, still no improvement can very well lead to a major NC)
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's an internal audit...
     
  8. qmr1976

    qmr1976 Well-Known Member

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    Ooops. Sorry! I guess I read that wrong. I interpreted that as them doing an internal audit and wondering if a NC could be raised during an external audit.
     
  9. Eric Twiname

    Eric Twiname Well-Known Member

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    I guess I mentioned the "call your own fouls" option since we had it in place already... if there was no easy place to start a CA (for the point of systematizing follow up), writing an NC could be just as functional.
    Either way, both (with the open or closed CA) should 'protect from the external audit'.
    (Yeah, I know that isn't the point...but having the QMS work properly is good protection all the same)
     
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