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How different will be CB audits against ISO 9001:2015?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Sidney Vianna, Aug 26, 2015.

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  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can I ask how you plan and prepare for your audits? Do you make them align with managements' objectives or anything they might find a risk to attaining those objectives? Sitting down with your process owners and asking them what they are concerned about, then auditing the process to see if those objectives are at risk? Or do you put a calendar together and satisfy the CB auditor by covering all the requirements a year etc? Please be honest...
     
    Andy Nichols, Aug 31, 2015
    #21
  2. MCW8888

    MCW8888 Well-Known Member

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    Andy, generally the audit planning is based on a process checklist (inputs, outputs). I reference the Company's policies and procedure manuals and the Control Plans. Compliance to these documents are quite varied sometimes and that's when I see findings. The findings are classified as High, Medium or low Risk. High risk have direct impact to achievement of the objectives (which is Customer Satisfaction), medium have inderect impact to the objectives and low as continuous improvement. A calendar is put toether as proposed schedule but it changes. This is not an issue with the CB. If an audit is not completed according to the schedule, a justification is documented in that schedule. The weakness I find in our process audit is associated with verifying whether or not the process being audited is effective in meeting the target objectives. The audit is simply focused on compliance to work instructions. thank you.
     
    MCW8888, Aug 31, 2015
    #22
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    But you ARE schedule driven. Do you sit down with you management and plan their audits?
     
    Andy Nichols, Aug 31, 2015
    #23
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Sigh. I was very fortunate to have a strong manager at my back, and a Director who backed me to, because I did write a fair number of Majors for repeat NCs. I upset some engineering managers...
     
    Jennifer Kirley, Aug 31, 2015
    #24
  5. MCW8888

    MCW8888 Well-Known Member

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    Once the schedule is out I review them and whatever is assigned to me, as a member of Corporate, I plan with the Management representative at the facility. The facility plan the internal audit based on schedule. Once the audit is complete, I visit the site and conduct Management process audit and audit the Internal Audit process. Your comment is highly appreciated, I remain grateful.
     
    MCW8888, Aug 31, 2015
    #25
  6. MCW8888

    MCW8888 Well-Known Member

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    Andy,
    I have upset a lot of people by writing nonconformance.
     
    MCW8888, Aug 31, 2015
    #26
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I understand, however, I'm left wondering why that would happen. In my experience, if the internal audit is focused and planned to address something they are interested in, why are they upset? You see, when (the vast majority of) internal audits are done based on external audit techniques, there is almost zero of this type of planning and preparation. As a result, all kinds of defensive responses happen...
     
    Andy Nichols, Aug 31, 2015
    #27
  8. RoxaneB

    RoxaneB Moderator Staff Member

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    I look at the role of the lead internal auditor as the person who has the say in "grading" an internal audit finding. In fact, as part of the training provided to the internal auditors within our organization, they are instructed to never classify a finding as a major or minor or opportunity...simply that there is a potential finding that will be discussed with the team during the team caucus. Why this approach? Because the internal auditor is only seeing one snapshot of the moment in time. Let's say they found a documented procedure that did not reflect the actual process. It's a one time situation. But if there is another audit team who also finds one...another team who finds yet another a little later in the audit...well, now we're looking at a systematic issue, not an "isolated within one department" finding.

    During these team caucus meetings, led by the lead internal auditor, observations/findings/discrepancies are raised...discussed...sometimes debated...and ultimately classified by the lead internal auditor, who has attained that position through experience and demonstrated skills. (and, no, it's not always me!)

    The lead internal auditor is to be cognizant of the fact that audits need to add value. Multiple findings of "procedure did not reflect reality" mean very little next to the identification of a systematic breakdown within the document control and production processes.

    I have said - and will continue to say - that I expect more value from my internal audits than the external ones. Internal audits should catch all dirty laundry before it's aired before an external party.

    CB auditors do need to relearn how to audit. They rely too heavily on the existence of documentation and pay little attention to the consistent application of activities within a process or even across processes. However, part of this could be the amount of time. In order to observe consistency, one much have time to observe and with only 1-4 days (depending on the nature of the audit), it is easier to fall back to documentation and a one-time observation of the documented process.
     
    RoxaneB, Aug 31, 2015
    #28
    Jennifer Kirley and Sidney Vianna like this.
  9. Sidney Vianna

    Sidney Vianna Well-Known Member

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    Training is, many times, a component for developing competence, especially when delivered by competent instructors.

    I am surprised you don't know what softgrading is. It includes the practice of reporting a finding in a way the organization does not feel necessary to avoid it's recurrence. For example, reporting a clear failure in complying with a contractual requirement as an "observation", "comment", "oops", instead of clearly identifying it as a nonconformity, which would require root cause analysis and corrective action.
     
    Sidney Vianna, Aug 31, 2015
    #29
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Of course I know what they are, Sidney! Where ever did you get that notion? You know I've been in the CB industry since 1990!

    My comment was made in the context of internal audits, where no oversight exists to discuss such matters or set criteria for grading. And please don't tell me it's the same for all audits...
     
    Last edited: Aug 31, 2015
    Andy Nichols, Aug 31, 2015
    #30
  11. Sidney Vianna

    Sidney Vianna Well-Known Member

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    If an internal auditor is categorizing something as an observation, when it clearly represents a nonconformity (per ISO 9000 definition) s/he is soft grading a finding, impacting negatively on the effectiveness of the audit. So, soft grading CLEARLY applies to internal audits, as well.

    As for my previous comment, you used the words "whatever that is", referring to soft findings, what led me to believe you did not know;
     
    Sidney Vianna, Aug 31, 2015
    #31
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    But the content of the nc hasn't been discussed. Only a "grade". So how can we comment (other than grades have no place in internal audits)
     
    Andy Nichols, Aug 31, 2015
    #32
  13. Sidney Vianna

    Sidney Vianna Well-Known Member

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    I hope you realize that "grading" of a finding goes beyond categorizing a nonconformity as critical, major, minor, etc....

    If something is MIS-categorized as an "observation", that is still grading.
     
    Sidney Vianna, Aug 31, 2015
    #33
  14. MCW8888

    MCW8888 Well-Known Member

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    This is interesting. How might I improve the internal audit planning so that it is not mimicking the external audit and there are no defensive responses? Thank you.
     
    MCW8888, Aug 31, 2015
    #34
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What do you do currently, to schedule and plan internal audits? It helps to know the 'as is" state.
     
    Andy Nichols, Sep 2, 2015
    #35
  16. Karen Rawson

    Karen Rawson New Member

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    Andy, my concern is that the person responsible for managing internal audits is also responsible for selecting the CB. The CB auditor is disinclined to find any fault whatsoever with the person who has the authority to have him replaced. Errors in Internal Audits would have to be egregious for most CBs to document a nonconformance. I expect most would make a comment, at most.
     
    Karen Rawson, Sep 2, 2015
    #36
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I agreed Karen. In fact, your well-made point adds fuel to the fire that internal audits and external audits should be taught differently. I'd suggest that the days of the "lead auditor" course are run. In my 16+ years of teaching it, few students were actually destined to become a CB auditor. Some were going to do supplier audits and after that, most were internal auditors and many of those were "pirating" the course to teach their own people (to "save money" no doubt)...

    So, why would the CB auditor expect anything different to what they'd been taught in class? They got the same training as the internal auditors! What's more, there's no accredited training for audit programme management - the CB figures that as a business and it's quite different from the needs of the internal auditor process owner.

    Fro my perspective, this whole auditor training industry is a trainwreck in slow motion and no-one seems to see it. Management, almost totally, see no benefit to internal audits other than "we do them because it's a requirement..."
     
    Andy Nichols, Sep 2, 2015
    #37
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