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9.2 QA activities Outsourced Internal Audit to be conducted BEFORE or AFTER Management Review?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Micheal Lenka, Apr 3, 2019.

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  1. tony s

    tony s Well-Known Member

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    Yes I know.
     
    tony s, Apr 4, 2019
    #21
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sorry, Tony, I wasn't questioning you - I know better! It was meant for Micheal...
     
    Andy Nichols, Apr 4, 2019
    #22
  3. Richard Billings

    Richard Billings Active Member

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    We always do our Management Review after completion of the annual internal audits. If we did it before I'm pretty sure our Registrar would issue a nonconformance.
     
    Richard Billings, Apr 4, 2019
    #23
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Unlikely. They didn't write you up for only doing internal audits or management review once a year?
     
    Andy Nichols, Apr 4, 2019
    #24
  5. James Doherty

    James Doherty Member

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    Agreed!
     
    James Doherty, Apr 4, 2019
    #25
  6. James Doherty

    James Doherty Member

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    You can use weekly huddles, monthly / quarterly meetings, dashboards for metrics and KPIs, etc. as evidence of satisfy many -but not all - of the requirements for management review
     
    James Doherty, Apr 4, 2019
    #26
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And doing one honkin' internal audit a year is useless (except that, because that's what CB auditors do, it falls into the category of "imitation is the sincerest form of flattery"...and they don't get why it isn't effective)
     
    Andy Nichols, Apr 4, 2019
    #27
  8. Richard Billings

    Richard Billings Active Member

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    I don't want to get into debates regarding the freq
    They can't write us up for that. Our Top Management (VP of Operations) atttends the meeting because the standard requires it and we have determined that annual audits of our defined processes are all we need. There are numerous other meeting but Top Management doesn't attend them so they do not qualify as a Management Review.

    Our internal audit results are really good and we could probably change the frequency of some to once every 18 months but we don't want to get into any arguments with the external Registrar's auditor.

    We have an excellent business relationship with out auditor. He has been the audit team leader for about 5 years. We have had nomconformances both major and minor and in every instance arguing would be futile because the NC's were solid.
     
    Richard Billings, Apr 4, 2019
    #28
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Really? So all your process perform equally? They are all important and they never change? Your objectives for the processes are meeting and/or exceeding the objectives set? Your customer feedback is positive?

    This has nothing to do with your CB relationship, BTW. That simply fogs the issue, since rarely do CB auditors have a clue about internal audits.
     
    Last edited: Apr 4, 2019
    Andy Nichols, Apr 4, 2019
    #29
  10. Richard Billings

    Richard Billings Active Member

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    Andy,
    Our processes are primarily automated and they perform with amazing consistently. Process objectives fluctuate as they should but rarely if ever drift to an 'out of control' condition. Our Customer Satisfaction (CSAT) is measured on a transactional basis in that we send a survey www site with every invoice and urge the customers to provide us with their feedback. I think one reason why our CSAT is so good is because every survey is linked to the Account Manager responsible and he or she reacts immediately to customer feedback by contacting the client.

    Internal process audits are done at minimum once per year to ensure processes are functioning as we intend. We encourage all employees to report problems to the internal auditor. Our employees are all compensated above the industry average and a bonus system is in place.

    There are many, many meeting held throughout the year but only one requires that Top Management attend and that is what we call the year-end Management Review that is arrended to be the VP of Operations who is the Top Manager.

    We do like having a good relationship with our Registrar othewise we might get nicked with silly NCs that just create problems. Our system seems to work and we hope we can continue.
     
    Richard Billings, Apr 4, 2019
    #30
  11. Golfman25

    Golfman25 Well-Known Member

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    Then what to those guys do the 364 days? :)
     
    Golfman25, Apr 5, 2019
    #31
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  12. tony s

    tony s Well-Known Member

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    Ah okay.
     
    tony s, Apr 5, 2019
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  13. tony s

    tony s Well-Known Member

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    I hope your CB auditor find the other meetings as part of management review. Instead of expecting your organization to do it once a year and making the evidence easy for the auditor to evaluate against the standard requirements, your CB auditor can recommend to employ the other meetings as venue for reviewing the QMS. You can refer to this statement from ISO/TS 9002:2016 clause 9.3.1:

    "Management review should be conducted at planned intervals; this could be daily, weekly, monthly,
    quarterly, semi‐annually or annually. Some management review activities may be carried out by various
    levels of the organization, provided the results are made available to top management. 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..."    ​
     
    tony s, Apr 5, 2019
    #33
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not really their job, Tony. Based on experience over the past few years, I wouldn't want to hear any CB auditor "recommendations". It may not be the same in other countries, but here in the USA I'm not filled with confidence that there's a good understanding of the 2015 requirements. Admittedly it's one, but a large CB has one auditor who doesn't "get it" and worse, they don't know! So we can infer their "calibration" of auditors is ineffective, can't we?
     
    Andy Nichols, Apr 5, 2019
    #34
  15. tony s

    tony s Well-Known Member

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    Actually, I'm also not excited on CB auditors' "recommendations" but if they offer it, they need to be reminded that recommendations are not binding.
     
    tony s, Apr 5, 2019
    #35
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  16. Richard Billings

    Richard Billings Active Member

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    I was recently told that CB auditors should not be recording OFIs in their report because doing so is a form of consulting which CBS shouldn't be doing. I hope that isn't true because over the years we have had some really beneficial OFIs.
     
    Richard Billings, Apr 5, 2019
    #36
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Partly correct. The deal is that the contents of a non-conformity report often detailed a real non-conformity, however auditors were grading them "OFI". It's called "soft grading". So, "minors" became OFI, majors became minors. As a result, the Accreditation Bodies cracked down on the CBs for this practice. It all started when QS-9000 had such a grade "OFI" which opened the door for auditors to use opinion. In 30+ years of implementation experience, I've learned that, when someone (who isn't necessarily an expert) comes in and spends (only) 1 or 2 days with you, their "Improvement" simply becomes "Different". Improvement is measurable (cost saving), different is just change (which is costly)
     
    Andy Nichols, Apr 5, 2019
    #37
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  18. Richard Billings

    Richard Billings Active Member

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    We don't use external people to do our Internal audits. We use internal people that have a complete understaning of our processes. We have an internal audit tracing program and auditor's are told to use OFI category sparingly. Usually if the person is not certain about a finding they are trained to record it as an OFI. Individual process managers are required to review every OFI and respond in writing what they did and send it to our QA Manager.
     
    Richard Billings, Apr 5, 2019
    #38
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm always interested to know what's behind the "improvement"...
     
    Andy Nichols, Apr 5, 2019
    #39
  20. Golfman25

    Golfman25 Well-Known Member

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    Your internal auditors can call them anything they want. Just make sure you consider each one and act on those that are actual non-conformances.
     
    Golfman25, Apr 5, 2019
    #40
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