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How to Deal with Quality Objectives Not Met?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Evan Balcaen, Jan 12, 2016.

  1. Evan Balcaen

    Evan Balcaen New Member

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    Hello everyone,

    Currently we are projecting that two out of our six quality objectives will not be met by our year end (March).

    the 2015 standard states that when planning how to achieve its quality objectives, the organization shall determine how the results will be evaluated.

    So how does your organization deal with objectives that are not met? Do you use a corrective action or some other form.

    Let me know what you think.
    Thanks!

    Here's the two objectives if you are interested:

    Supply Chain

    A. Each branch that currently achieves 2.2 turns for a 97% fill rate on its high value high usage products will increase turns to 2.4. All other branches will achieve 2.2 turns and 97% fill rate. (By end 4th quarter)

    B. Each branch will lower the no-moving inventory by 10% (by end of 4th quarter)
     
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  2. MarkMeer

    MarkMeer Well-Known Member

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    Generally, we address these in management review reports.

    For each objective:
    - Was it achieved? (+ relevant data & analysis)
    - Does it need to be revised?
    (Note that one does not necessarily determine the other)

    If an objective is not met, this does not necessarily mean corrective action is required. The management review report discusses contributing factors, extenuating circumstances etc. ...and uses this to justify either leaving the objective as-is, or changing it.

    It could even be argued that NOT meeting objectives is a positive thing, if it drives improvement. Having a bunch of objectives that would be easily met...what's the point?

    Also, depending on how objectives are worded, it is often unrealistic to expect that targets are always met. If, for example, you say "will lower the no-moving inventory by 10%", how sustainable is this? ...there's got to be a point of diminishing returns.

    Bottom line: not meeting objectives is ok. Just document somewhere (e.g. management review) that you've considered the reasons, and re-examined the objective itself to see if it's still of value.

    MM
     
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  3. Golfman25

    Golfman25 Well-Known Member

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    100% agree. However, whenever you invite other parties to review you'll eventually get the simpleton who says "goal not met = corrective action" which begins a spiral into frustration. Thus, the desire to have "achievable" objectives. It avoids potential problems but doesn't make you any better.
     
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  4. drgnrider

    drgnrider Member

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    If leave as-is, use the aforementioned "contributing factors, extenuating circumstances etc" to decide if a CA is necessary.
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    I'm going to copy-and-paste my response from a similar thread, taking out some of the goal specifics...

    How were the goals/objectives determined? Logical analysis based on logical information and historical performance? Or more of a guesstimate?

    Was there an action plan developed that supported at the goal achievement? Was it possible to see with each step in the action plan, what the result would be on the process? Did the action plan include resources appropriate to achieving the goal?

    Who was involved in the goal and plan development? People familiar with the process?

    Was it possible to determine, before this point, that the goal would not be achieved? Reporting metrics on a regular basis is one thing...I also like to show "on pace" for those metrics where I can see a potential problem in the making.

    To be honest, not every goal is achieved by every organization. We can't predict the future and failure to achieve goal happens. But you're right in trying to figure out 'what now'. When an auditor came in, we wouldn't hide such "failures". Instead, we were honest about them, outlined how the results were presented, showed additional root cause analysis, demonstrated how we "re-spun" the PDCA cycle, and outlined the action plan for the immediate future.
     
  6. Leonid

    Leonid Active Member

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    If a quality objective is not met this is nonconformity to:
    ISO 9001:2008 cl. 4.2.3 b) - The objective in question was not reviewed, updated and reapproved.
    ISO 9001:2015 – cl. 6.2.1 g) - The objective in question was not updated as appropriate.
    It was nsessary to withdraw or review the objective as a controlled QMS document.
     
  7. tony s

    tony s Well-Known Member

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    When a quality objective wasn't met, I don't consider this a nonconformity but I would evaluate this against ISO 9001 clause 8.2.3 which specifies that "When planned results are not achieved, correction and corrective action shall be taken, as appropriate".
     
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  8. Leonid

    Leonid Active Member

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    Correction and corrective action are taken with regard to the nonconformity.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I agree, Tony. The idea that it's a non-conformity is a bit harsh. There are many factors at play and management shouldn't be forced into some kind of hand wringing to answer a corrective action. It may,after all, have been set on the high side and can be adjusted down. Management isn't simply about "compliance" to a standard.
     
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  10. V S Ramesh Rao

    V S Ramesh Rao Member

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    Goals not met - CAPA required =NC is not the purpose of the standard. Unfortunately it is interpreted thus by both internal as well as external auditors. For any goal that has not been met on the due date
    1. but one that has shown intended improvement, provide an improvement road-map to the auditor to show how you could meet the goal 3 or 4 months down. This always helps.....with me 100% of the time.
    2. and one that has shown no improvement, provide a new work plan if you have one.

    In all cases where the goals are results of improvement projects, it helps to have a risk/constraints register to convince the auditor why goals could not be met.

    Ramesh
     
  11. Leonid

    Leonid Active Member

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    Sorry, colleagues.
    ISO terms and definitions are not the matter for agreement or concession.
    Nonconformity, by definition, is non-fulfilment of a requirement (ISO 9000:2015 cl. 3.6.9).
    Requirement, by definition, is need or expectation that is stated, generally implied or obligatory (ISO 9000:2015 cl. 3.6.4).

    Objective, by definition, is result to be achieved (ISO 9000:2015 cl. 3.7.1.).
    Auditors reasonably treat objectives as the need that is stated.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe you are looking at it from a CB auditor's perspective in which case, some CB auditors might report it as such. However, since ISO compliance is mutually exclusive of Certification rules, it doesn't HAVE to be treated - by internal auditors for example - as an NC. PLUS, if management perform a review of their objectives - during their "ISO" management review, would you expect them to write an NC against themselves? I sincerely hope not...
     
  13. RoxaneB

    RoxaneB Moderator Staff Member

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    With all due respect, I disagree with this very black-and-white interpretation of the standard and its application.

    Was there a failure to achieve the objective? Yes.

    However:
    (a) There was a defined objective in place - requirement met.
    (b) If there was a process in place that reviewed, updated and re-approved the objective - requirement met

    Slapping the organization with a nonconformance adds very little value to the process and simply creates an exercise in paperwork.

    I am going to stress the IF in (b) above. If there was no process in place to review, update and re-approve the objective THAT is the really nonconformity, not the failure to achieve the goal.
     
  14. Candi1024

    Candi1024 Well-Known Member

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    I would contest that a goal and a requirement are two different things.

    Such as a control limit and a spec limit are two different things.
     
  15. Leonid

    Leonid Active Member

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    If the internal auditor decided not to record the evident nonconformity for whatever reason, this will be nonfulfillment of 9.2.1.
     
  16. MCW8888

    MCW8888 Well-Known Member

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    The objectives that are not met are to be taken up during the management review for action plan with dates of follow-up for checking. Top management must decide whether or not to change the target goal to make it more achievable and implement improvement in the process. The auditor must recognize that the action is being taken and document it in his audit report.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, IF an internal auditor found it, maybe - but the OP didn't mention ANYTHING about an internal auditor...
     
  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Let us all consider this thing from the various high altitude perspectives.

    1) The standard requires the setting of objectives and defining the means to evaluate - that is, how we know we are meeting the objectives.
    2) Reasons for not meeting objectives can include many factors, among them setting unreasonable objectives and failure to meet based on a range of issues.
    3) Having set its objectives, management is expected to pursue but a nonconformity is less about achievement than the issues causing the shortcoming.
    - in 2015, top management is expected to consider wide-ranging forces that can impact (constrain) achieving objectives. That does not mean we can correctly predict all things, for example global economic recessions.
    - if objectives are not achieved, nothing in the standard explicitly requires a nonconformity. Management recognizes, issues responding plans as appropriate, and we move on.

    Given these perspectives, I would want to exercise a great deal of caution in issuing a nonconformance to elements involving objectives. A NC statement had better explicitly state top management's failure to conform to the elements' exact wording. I do not see "failure to achieve objective" as a valid writeup.
    ...2 cents...
     
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  19. Leonid

    Leonid Active Member

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    Objectives are subject to monitoring. Monitoring defines the status of the objectives. If monitoring shows an objective cannot be achieved in time, it can be revised as any document. If not revised, this is a nonconformity to 6.2.1g or 7.5.2c.
    By the way, a nonconformity is a trigger for corectivre avtion and, hence, the opporunity for improvement (10.1). It is not easy to detect a nonconformity, but if it is found, this will have an advantage for QMS.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed, Jennifer. Management don't run their businesses because ISO clauses say "do this" or "do that". To suggest that everyone will live and operate by ISO requirements is to misjudge the purpose of ISO 9001 implementation and also how leadership functions.
     

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