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ISO9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Yarnick de Jong, Nov 7, 2016.

  1. Yarnick de Jong

    Yarnick de Jong Member

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    Dear people,

    I made for 4.1 a SWOT analysis, confrontation matrix and for 4.2 a stakeholder analysis.

    What do I have to do for 6.1: "Actions to adress risks and opportunities?

    Make a risicomatrix/risico analysis for 4.1 and 4.2 or more?

    And if someone knows the answer, what to do for 14001? Just environment risks? Or am I completely wrong?

    Greetings,

    Yarnick de Jong
    Holland
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    6.1 Actions to address risks and opportunities refers us back to 4.1 and 4.2. Sometimes those early elements do not make sense. It may help to look at them out of order:

    There is an expectation to consider your organization's relevant interested parties (4.2), and identify the risks (6.1.1, defined as "effect of uncertainty") that could render your ability to satisfy the needs and requirements of the interested parties, given consideration of the external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system (from 4.1). Having identified the risks to achieving what has been determined as important, the organization is expected to make plan actions to address these risks and opportunities (6.1.2).

    In 9001 the subject is about quality, and in 14001 it is about environment. Although there is typically an FMEA-type approach to evaluating environmental risks and why they matter (called aspects and impacts) there is no specified format and there are many ways to address risks in quality. The SWOT can work for management level processes such as management review, and checklists can address some process-level risks. There are many additional ways to address risk. The organization can choose the methods that suit their needs best, and can "mix and match" for the processes.

    I hope this helps!
     
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  3. Yarnick de Jong

    Yarnick de Jong Member

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    Thanks for your comment! Is it better to do two SWOT analysis (1 for 9001 and also 1 for 14001) or combine in 1 analysis?

    Environment is for our company important. But the opportunities and threaths are more based on the quality.
     
  4. MCW8888

    MCW8888 Well-Known Member

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    If you are
    4.1 and 4.2 are inputs to 4.3 Scope. After identifying the scope, then comes the process interaction 4.4 addressing all of its requirements. 6.1 will address the risk and opportunities of the processes identified in 4.4. The weaknesses and threats are carried over to your risk and opportunities. For risk and opportunities, use a Risk-Based Planner which was previously shared by one of the moderators. The risk-based planner should contain a column which is applicable to regulatory requirement. It is here where you cover the environmental management system. Once developed this document is reviewed periodically during management review to determine its effectiveness.
     

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  5. Yarnick de Jong

    Yarnick de Jong Member

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    Thanks for your comment!

    I uploaded my Risk analysis and my confrontation matrix. Maybe you (or someone else) can have a look and tell me what I am doing wrong (or good)?
     

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    Last edited: Nov 8, 2016
  6. Yarnick de Jong

    Yarnick de Jong Member

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    Someone? Please help me! :)
     
  7. Yarnick de Jong

    Yarnick de Jong Member

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  8. MCW8888

    MCW8888 Well-Known Member

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    Thank you for sharing your risk-based thinking. You have put a lot of work into it. Annex A does not specify the use of any form. Since my company is IATF 16949 we are using the FMEA to address the QMS risk.
     
  9. tony s

    tony s Well-Known Member

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    I'm just using a simple matrix like the one below: Example: an analysis of a fastfood Order Handling process.

    upload_2016-11-20_9-59-32.png upload_2016-11-20_9-59-36.png
     
    Last edited: Nov 20, 2016

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