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Unmet objective - is it a nonconformity?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Nov 23, 2018.

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Would you raise a nonconformity if an objective/target was not achieved?

  1. Yes

    5.9%
  2. No

    94.1%
  1. tony s

    tony s Well-Known Member

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    From people with solid background of process behavior, stability, control of outliers - I couldn't agree more.
     
  2. lebhugz

    lebhugz Member

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    Btw we have atleast 2 OTPs per area in our institution in total of 92 area total and having a total of 200 OTP.

    I am tasked to validate a quarterly audit along with my QA Team if they are monitoring their OTP,
    if then I can assume that even though they did not met their OTP it is possible not to sanction a NC,
    but if there were no monitoring and activity done in their objective now we can issue an NC?

    Sorry I'm being curious and slow about this because I didn't receive a proper training as a TQM Staff and I am the one starting the system inside the hospital especially on Monitoring of OTP and Implementation of Kaizen.
    Self Study and crowdsourcing is my strategy thanks
     
  3. tony s

    tony s Well-Known Member

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    In raising an NC, you have to be clear first of the requirement. No requirement, no NC. Requirements can come from your organization's own requirements (e.g. policies, procedures, process/product parameters, etc.), customer, regulatory bodies, national and international standards, and other interested parties. So if clause 6.2.1e says "The quality objectives shall... be monitored" and clause 6.2.2a says "When planning how to achieve its quality objectives, the organization shall determine... what will be done", I believe, you have now a definite answer to your question.
     
  4. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    my two cents on the topic....

    Internally: I have kept the Quality Manual and included under Clause 6 that my company issues Non-conformance if KPIs are not met for 3 consecutive months (this is really to trigger a structured corrective action process). When they are reported monthly and they are not met the process owner will indicate why and if needed a plan to correct the issue. This works for me.

    External Audits: In my opinion if the company can show corrective actions for kpis not met, or some sort of plan a non-conformance should not be issued.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How often do you perform Management Review? Waiting for an auditor to write a non-conformity because a process isn't meeting a target is management by abdication.
     
  6. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    We don't wait for management reviews to issue non conformances... I dont follow your response...
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And you shouldn't wait for internal audits to detect this, either. Management should be overseeing the performance of their respective e processes. Waiting on anyone else to detect not meeting objectives is an abdication of management's responsibility.
     
  8. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    We don't wait for internal audits either... it is monitored monthly and NCs are automatically issued when the KPI is not met for 3 consecutive months...
     
  9. RoxaneB

    RoxaneB Moderator Staff Member

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    If this approach works for your organization and its culture...great. Personally, I think raising an NC for a KPI not met for 3 consecutive months is a bit non-value-added, but that's from my own experience with such an approach. I also think KPIs are at a different level of Objectives (and their targets), and so the approach taken with either must be suitable to their audience.

    In my previous job, we developed an in-house software for monitoring our KPIs. Any red KPI required a documented (in the software) FCA - Fact Cause Action. A little bit more indepth than a correction, but not so hardcore like a nonconformance. These approach was taken with our routine KPIs - the ones associated with processes with defined control limits and no improvement initiatives planned for them.

    Improvement metrics were linked in with objectives and projects. If they went red, it was still documented in the software but more in the approach of a 5W1H approach, similar to the format of the project plan.
     

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