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8D in iso 9001?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Nov 2, 2020.

  1. Qualmx

    Qualmx Well-Known Member

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    Hello everyone.

    I come with some questions regarding 8D.
    I have ISO 9001 2015, and some customers are requiring us to use 8D method for the analysis
    of some non conformances.

    We only use 5W and ishikawa for the analysis of Corrective actions.
    Questions:
    What form, (where is the source) of 8D form so that we start to evaluate
    if this requirement fits into our system?

    As I understand, into this method, is considered the FMEA, which really we don´t
    know about it.

    Could we deliver to customer a 8D, without including the FMEA section?

    Please provide some help.

    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    8D is 8D, nothing to do with FMEA. Google 8D there will be plenty of forms to use.
     
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  3. Miner

    Miner Moderator Staff Member

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    There is an expectation in D7 that the Process FMEA be updated to help prevent future occurrences. However, the actual FMEA is not part of the 8D.
     
  4. Qualmx

    Qualmx Well-Known Member

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    Thanks Andy and Miner.
    Where can I see this statement "be updated to help prevent future occurrences"
    What is the source of 8D form? is there an official form that has to be based on?
    Thanks
     
  5. Miner

    Miner Moderator Staff Member

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    There is no "official" 8D template, only the required content. There are numerous versions on the Internet that you can use.

    Regarding the requirement for the updated FMEA, the origin goes back to the original Ford training on 8D.
     
  6. Qualmx

    Qualmx Well-Known Member

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    Very helpful your support, thanks again
     
  7. Golfman25

    Golfman25 Well-Known Member

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    8D are just the steps to be used. It's just step by step process to add some discipline into your problem solving. Depending on your customer's expectations, you can uses as many of the Ds that you want. We may only do "5D" in a lot of cases. As others have said, google is your friend.
     
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  8. tony s

    tony s Well-Known Member

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    Here's an 8D form that I used before.
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Don't forget! Doing an 8D is NOT FILLING OUT A FORM! It's a structured way to have a team, using effective tools, identify an issue and then work through to root cause. Anyone who believes anything else is not going to have an effective process. Too many of these types of quality-related tools are debased by thinking it's a form to be completed...
     
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  10. Qualmx

    Qualmx Well-Known Member

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    Thanks Tony s

    Three question about this form.

    D5

    Determine the Corrective Action – Propose to the management a list of corrective actions which are concrete in nature and verifiable. The CA must be approved by the management prior to their implementation.
    I understand is to define actions to eliminate root causes and to prevent recurrence.

    D6

    Verify the Corrective Action – Evaluate effects of the actions taken. Check whether all recommended changes have been completed including communication and documentation of CA.
    In this D, I suppose it is to verify the effectiveness of all the actions taken? the whole D analysis.

    To verify this 8D was effective? of course evaluated after action were running for some time, is it this way?
    and in which D it is to verify that actions have been implemented?
    They are different concepts.

    D7

    Prevent Problem Recurrence – Review other existing products, processes, including documentation with the potential for the same problem and extend the CA to prevent recurrence.

    In this point, it is like make it extensive? to observe if this happens in other process, our neighbors, so that to apply
    same actions?, sometimes will not apply?
    Is it the same approach, currently stated in Iso 9001 2015?
    In 10.2.1, b (3) Determining if similar nonconformities exist, or could potentially occur.

    Or it means something different?, in the past , I was supposing same actions defined in D5, in order to prevent recurrence.
    But Now I see, I was wrong, because the prevention already was addressed in D5.
    Another two points.
    I´ve seen somewhere the Escape term, what that is mean? something like "what was weak in the system which allowed this to happen?
    When root causes have been found, I also have seen what % of contribution they have.

    Please share comments about this.
    Thanks
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The focus of the 8D as you work through is 1) to work on the identified problem and take action to eliminate recurrence (step 5) and at the end to take a look at other products/processes etc to see if it can be prevented.

    The term "escape" refers to the occurrence when, despite all the required controls (the flavour of escape comes from the auto-industry) stated in the Control Plan (derived from the PFMEA) a defective product gets through, undetected, to the customer.
     
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