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Observations vs. Opportunities for improvement

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Mike_P, Jul 11, 2019 at 6:47 PM.

  1. Mike_P

    Mike_P New Member

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    Regarding an external audit report, am I required to take action on findings categorized as "observations"? How about those categorized as "Opportunities for Improvement?"

    Our transition audit to the 2015 standard left me with a pile of OFI's. Some I agree with and addressed accordingly, a few I don't agree with, and a few are simply financially prohibitive. Would like some advice on how to best address these open items...

    Thanks in advance!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Mike:

    This is a confusion a lot of Certification Bodies and their auditors leave behind them, after the audit is done, without their understanding of the grief it causes... Let me help clear the air:

    If it's not reported as a non-conformity, you don't have to do anything about any other type of report, whatever it's called. In SOME situations, a CB auditor might leave a report which indicates that, when they were auditing they detected a situation which if left alone, might be the cause of a non-conformity. Those kinds of things might be worthy of a second look and some action. Of course, if the contents of the report indicate - and you can agree - something needs work, then have at it (don't worry what it's labelled as)

    Having said that, from your comments:

    It looks to me as if your auditor isn't at all good at their job. CB auditors have, in passed years, been warned about "soft-grading" non-conformities such that a "minor" NC became an "OFI" etc. If it reads like a good NC should, it shouldn't be graded as something else.

    Secondly, if you don't agree with anything they wrote, there's a problem with the way they handled it. End of story.

    To be honest, the fact that this happened and you've had to seek help means a distraction from doing something useful which indicates the audit was more cost than cost-benefit. I'd take anything you disagree with, send it back to your CB's Operations Management and tell them you paid for an independent, objective audit, not a loosey-goosey consulting visit.
     
    yodon likes this.
  3. Qualmx

    Qualmx Well-Known Member

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    Easy, You only have to solve the NC's, for the ofi's , you are not obligated to do something, but take a look at them,and if something is found useful, do it .
    Hope this helps
     
  4. tony s

    tony s Well-Known Member

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    Observation is an old concept of an audit finding. Certifying Bodies, even Accreditation Bodies, regard the term as "Not a violation of the criteria, an observation is typically an identification that there may be a better way to monitor a process or document a procedure. It's not a problem, just a potential for improvement - a way to avoid future problems" (from https://www.anab.org/about-anab/faq).

    In the old ways, they treat observations as a "precursor to something more serious" (see this link). But, obsolete versions of ISO standards like ISO 8402:1994 (vocabulary section 4.10) and ISO 10011:1994 (guidelines for auditing section 3.6) defined observation as "a statement of fact made during an audit and substantiated by objective evidence". Therefore, observations can relate to both negative and positive audit findings.

    In the current ISO/IEC 17021-1:2015 an observation is not an audit finding. It is just one of the methods to obtain information during an audit (See its section 9.4.4.2). ISO 19011:2018 has the same treatment of the word observation (See its section 6.4.7).

    Unlike with the nonconformity findings, recording of opportunities for improvement is optional as per ISO/IEC 17021 section 9.4.5.2 (i.e. "Opportunities for improvement may be identified and recorded... Audit findings, however, which are nonconformities, shall not be recorded as opportunities for improvement"). In ISO 19011 section 6.4.10, organizations are not required to take actions on opportunities for improvement (i.e. "If specified by the audit objectives, opportunities for improvement recommendations may be presented. It should be emphasized that recommendations are not binding").
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And, along those lines, I'd like to see the person who can spend less than a day (in many cases) and find an "improvement", which isn't just a "change"...:D
     
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