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Not all inputs covered in Management Review - NC?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Jun 23, 2019.

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Do you agree or disagree with the audit finding? And why?

  1. Agree

    4 vote(s)
    66.7%
  2. Disagree

    2 vote(s)
    33.3%
  1. tony s

    tony s Well-Known Member

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    An organization just recently audited and was slapped with an NC against 9.3.2. In verbatim, here's the finding:

    "The standard requires that the organization shall consider all the inputs required in the management review. However, the following inputs were not discussed during the management review conducted last Feb. 6, 2019: a) changes of issues, b) effectiveness of actions on risks and opportunities, c) performance of the external providers"

    I'm posting it here to get the members opinion. The question is: Do you agree or disagree with the audit finding? And why?
     
  2. Qualmx

    Qualmx Well-Known Member

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    Tony's could you give input regarding the post " controlling autocad drawings, and po from an erp system?
     
  3. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    I think it depends on frequency of the management review. e.g. if over the course of one year there isn't evidence to support all the inputs being addressed, then yes it is an NC.

    It is also dependent on the plans for Management reviews, if at the time of the audit there was no evidence to support all inputs being addressed but there is a plan for it to be addresses them within the financial year of the company (and its documented din a procedure or meeting minutes), then it is not an NC.

    I've worked at a company where we had monthly management reviews, the agenda would vary each month, but within a year we would ensure all inputs are covered.
     
  4. tony s

    tony s Well-Known Member

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    The statement in Clause 9.3.2 mentioned "taking into consideration". There is no requirement that all inputs are to be discussed. In ISO 14001:2015 clarification of concepts and ISO 45001:18001 terms and definitions the word "consider" means it is necessary to think about but can be excluded, whereas "take into account" means it is necessary to think about but cannot be excluded. So, the statement mentioning the inputs to be "taken into consideration" is not mandatory.
    There is also no mention in the standard that requires retaining documented information as evidence of what inputs were discussed. The only statement in the entire Clause of 9.3 that requires documented information to be retained is under the management review outputs where it specifies "The organization shall retain documented information as evidence of the results of management reviews".
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If, for example, there are no changes, why discuss them? If the auditor determined there was evidence of a change which would have been relevant but NOT discussed at MR, then fair enough...
     
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  6. Golfman25

    Golfman25 Well-Known Member

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    So I think it depends on how you read the "shall." Does shall modify both "planned" (shall be planned) and "take into consideration" (shall take into consideration)? If it modifies consideration, then you need to consider all the listed inputs. I think that is where most auditors fall.

    Now, there is no requirement that the inputs be considered at every meeting. And coming up with evidence of something that didn't happen (ie; changes) is difficult. We use a simple checklist, where if something is NA, we make that notation. We can review the list each year to makes sure we have captured everything required in our meetings.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And not even a meeting!

    Experience shows that, if the inputs support it ("green" on scorecard types of things), the only need is to deal with the exceptions ("yellow" or "red")
     
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Rick, is this regardless of if anything needs covering? For example, let's say management review the QMS quarterly, but there's been a period of great stability, no (significant) changes, nothing strange about process performance and/or supplier performance. Would it be an expectation that each review go through "nothing to report" for the vast majority, or could the review be only any "spike" of performance, customer feedback, internal audit etc. and be addressed at the time as "management by exception"?
     
  9. Golfman25

    Golfman25 Well-Known Member

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    Agreed, but knowing what is green, yellow, red is part of the review. Someone has to look and say it's "green," lets move on.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Exactly so, Tony and well pointed out! Clearly, the auditor is reading more into the standard than is actually there. Of course, this is not an unusual scenario, that auditors put their "spin" on things and, when it's pointed out, become aggressively defensive. No wonder clients don't enjoy pushing back, when they are harangued with arguments.
     
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  11. tony s

    tony s Well-Known Member

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    If the standard says "shall take into consideration", it's just saying "shall think about it but can it can be excluded". When the standard says "shall take into account", it's saying "shall think about it and don't exclude it" (e.g. 6.2.1c: "The quality objectives shall take into account applicable requirements").

    Here are the collection of statements in the standard that mention the word "consider"
    • 4.3 - When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization;
    • 6.1.1 - When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed...
    • 6.3 - The organization shall consider: a) the purpose of the changes and their potential consequences; b) the integrity of the quality management system; c) the availability of resources; d) the allocation or reallocation of responsibilities and authorities;
    • 7.1.1 - The organization shall consider: a) the capabilities of, and constraints on, existing internal resources; b) what needs to be obtained from external providers;
    • 7.1.6 - the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates;
    • 8.3.2 - the organization shall consider: a) the nature, duration and complexity of the design and development activities; b) the required process stages, including applicable design and development reviews...
    • 8.3.3 - The organization shall consider: a) functional and performance requirements; b) information derived from previous similar design and development activities...
    • 8.4.2 - The organization shall take into consideration: 1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements...
    • 8.5.5 - the organization shall consider: a) statutory and regulatory requirements; b) the potential undesired consequences associated with its products and services...
    • 9.2.2 - shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;
    • 9.3.2 - taking into consideration: a) the status of actions from previous management reviews; b) changes in external and internal issues that are relevant to the quality management system...
    Although all of them has a "shall" before the word "consider", the standard is still saying "shall think about it but can it can be excluded".
     
  12. tony s

    tony s Well-Known Member

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    The statement in 9.3.2 mentioned the word "consider". So, it's not mandatory. The statement in 9.3.3 mentioned "shall include decisions and actions related to:" This is mandatory. If the standard intends to be prescriptive in 9.3.2, then it should mention "The management review shall be planned and shall include a) to f)" instead.
    You have to complete the statement which is, categorically, "The organization shall retain documented information as evidence of the results of management reviews". The standard requires retaining of documented information as "evidence of the results" and not "evidence of inputs covered" or "evidence of management reviews".
     
  13. Golfman25

    Golfman25 Well-Known Member

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    Is that even possible? How can you "think about" something if it's excluded? You have to think about it and then decide it's not relevant or not applicable at the time and move on to the next item. In other words, if it's not applicable you need to show that you thought about it and determined that it's not applicable. That's where the "NA" next to the checklist becomes handy, because you can't prove a negative.
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not really. If part of a review is to look at a dashboard of process performance, supplier performance, feedback etc and, for the most part, the performance is "green" then why put it on the agenda? It can be handled as a "management by exception" very nicely.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What do you think of my earlier, post, Rick? If a dashboard is used, why record that a "green" item was reviewed, when in fact it clearly didn't need to be reviewed. If the record of review mentioned the dashboard and stated Process X, Y and Z were all "green" and then went on to review the "yellow" and "red" status issues, wouldn't that work?
     
  16. RoxaneB

    RoxaneB Moderator Staff Member

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    In a previous life, we put all measures, regardless of their colour on our agenda, however, our documented process was to, as a minimum, focus our conversations on reds and yellows. That being said, time permitting (and political drivers being present), some people wished to discuss the greens - sometimes to call out the efforts need to keep things green, or to celebrate/recognize key efforts, etc.

    As well, you don't know what you don't know, so at least having some visibility to the green results, at least there is some "review" even if it's only a quick scan by the participants.

    I recognize that "management by exception" can by used to help move management review along, but depending on how frequent their reviews are (and the method by which they occur), excluding information could be excluding some insightful and meaningful conversations.

    As for the poll, I'm choosing to not answer. There isn't enough information to give the situation context nor allow for a proper perspective on an opinion.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    One of the most common comments I hear, regarding Management Review, is that it takes too long, especially when ALL the items in the ISO 9001 standard are on the agenda. This is often attributed to the fact that performance is "green" - and when small/medium sized organizations are reviewing "green" status items, they are generally well-aware of this fact. Management don't need to wait for 3 months to know this. In larger corporations, the amount of stuff to be gone through can also be overwhelming, even if done quarterly, so, once again, addressing ONLY the "yellow" and "red" statuses is far more efficient.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you mean at every review?
     
  19. tony s

    tony s Well-Known Member

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    Can you point to me the statement in the standard that requires this.
     
  20. tony s

    tony s Well-Known Member

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    What if the organization opted to have more frequent conduct of management reviews (e.g. monthly, quarterly) and will cover the other inputs on the subsequent reviews? ISO/TS 9002:2016 mentioned this: "It is not required that all the inputs to management review be addressed at one time, but instead they may be addressed during sequenced management reviews".
     

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