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Effect of article "the"

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Leonid, Dec 12, 2019.

  1. Leonid

    Leonid Well-Known Member

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    According to 6.1.1 “… the organization shall … determine the risks and opportunities that need to be addressed to…” Does it mean that all risks and opportunities that were determined need to be addressed? I think not all but only THOSE (the meaning of article “the”) that NEED to be addressed. The organization will have to analyze and assess the risks and opportunities prior to making decision which ones to address. There is no need to address minor risks and opportunities.
     
  2. Eric Twiname

    Eric Twiname Well-Known Member

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    FWIW, in the wordplay of life...

    It seems to direct that the company ONLY needs to determine the risks and opportunities that the organization judges as "needs addressing".
    I don't see a requirement to determine, or even identify, risks or opportunities that you don't need to address, though as you suggest...it is fairly unavoidable.

    Worded pretty well, all in all, IMO.
     
  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Leonid ;
    If you are looking for affirmation, then consider yourself affirmed. You are indeed correct in regards to the fact that it is left to the organization to determine which risks an opportunities "need" to be addressed.

    My only word of caution would be in regards to your comment..."There is no need to address minor risks and opportunities."

    The use of subjective terms (i.e. "minor") is not sustainable as many instances of my experiences have proven, since if individual members of staff and leadership in an organization are asked, rarely will they agree on which are "minor" and which are "major" risks.

    Hope this helps.
    Be well.
     
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  4. Leonid

    Leonid Well-Known Member

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  5. Leonid

    Leonid Well-Known Member

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    Thanks John. Anyway some risks are always left without addressing. And there are risks which are
    unanimously assessed by sight as minor.
     
  6. tony s

    tony s Well-Known Member

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    Let's say I have "determined" the risks and listed them all in a table. Should I need further "determination" to demonstrate I really "determined" the risks that need to be addressed? Or I can just say "all those that are listed are the ones that need to be addressed"?
     
  7. Leonid

    Leonid Well-Known Member

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    Of course you can say it and then the auditor may ask you to provide evidence that the risks are addressed by the planned actions. By the way information about addressing risks needs to be documented as a part of processes according to 4.4.1(f), 4.4.2 and 8.1(e).
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No, because it doesn't use the word "all".
     
  9. Leonid

    Leonid Well-Known Member

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    Without "all" the meaning of the statement in the standard is the same. Organization determines risks that need to be addressed. What was determined should be addressed.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is it?
     
  11. tony s

    tony s Well-Known Member

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    Not sure about this when Annex A.4 specifies:
    • Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process.
    • Under the requirements of 6.1, the organization is responsible for its application of risk-based thinking and the actions it takes to address risk, including whether or not to retain documented information as evidence of its determination of risks.
     
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  12. Leonid

    Leonid Well-Known Member

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    Tony, let's consider the situation (sort of happened in my life). I am an 3rd party auditor. You are the auditee. I am asking you to provide documented information about actions planned (6.1.2) and implemented (8.1 e.1) to address risks and opportunities. You give me the above answer. I agree with you because 6.1 does not actually require to document information. The requirements to document information about the processes are stated in 4.1.2 and 8.1. Actions to address risks and opportunities are carried out in processes as per 4.4.1 f. Eventually I issue a NC report.
     
  13. tony s

    tony s Well-Known Member

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    If the issue here is about documented information about addressing risks/opportunities (based on your post #7), auditors should understand that not all evidences rely on documented information. The International Accreditation Forum's Auditing Practices Group Guidance on Evidence Collection clarified this, as specified below:

    "Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001".

    Clause 8.1e.1 mentioned "to the extent necessary". If my organization has actions in place to address risks/opportunities and an auditor will slap us an NC report because we failed to document the plan, I will definitely challenge his/her finding.
     
  14. Leonid

    Leonid Well-Known Member

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    I addressed the actions which were both planned and implemented. If you say there is a documented evidence that actions were implemented then evidence of decisions about how to address the risks will be available and shown to the auditor.
     
  15. tony s

    tony s Well-Known Member

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    Why would an auditor look for the documented evidence of decision if I'm already showing him/her the actual action that addresses the risk/opportunity?
     
  16. Leonid

    Leonid Well-Known Member

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    How to show the actual action?
     
  17. tony s

    tony s Well-Known Member

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    Actual actions can include:
    • physical controls installed by the organization (e.g. stand by generator in case of power outages);
    • newly introduced tools, policy, procedures, checklist;
    • acquisition of alternate production site;
    • additional supplier for a specific material; etc.
    The above examples are actual actions that an organization may have established to address risks and opportunities. Planned actions may be in a form of documents but it's up to the organization. There's no requirement in the standard that plans to address risks/opportunities are to be reflected in a document. The IAF APG on Evidence Collection further says:

    "It is the organization’s responsibility to provide objective evidence of conformity. Organizations may be able to demonstrate conformity without the need for extensive documented information".
     

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