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Opportunities in context of ISO 9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Leonid, Jan 4, 2016.

  1. MCW8888

    MCW8888 Well-Known Member

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    I have already pushed the auditor during our transition audit. But we have TS certified plants that are going through upgrades. The standard specifies the use of FMEA.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Does it?
     
  3. MCW8888

    MCW8888 Well-Known Member

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    The IATF16949 does specifies the use of FMEA.
     
  4. tony s

    tony s Well-Known Member

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    Ah, so for consistency with IATF 16949, the CB recommended to use the same tool for your other areas. Would you use FMEA for non-manufacturing processes?
     
  5. MCW8888

    MCW8888 Well-Known Member

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    For consistency, I would be very creative and use it. The risk I could face is nonconformance to what? Our CB auditors audit to ISO and TS15949, it is hard to please everyone.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    But the non auto parts manufacturing sites don't have to use an FMEA (unless it's product design) so why force the use of the FMEA. It's only one tool. Once again, I fear that the auditor isn't thinking this through and, IMHO, doesn't qualify their comments when the make such a suggestion. WHAT, exactly, needs improvement through the use of an FMEA? Did the auditor show you where an FMEA would help to address something your current methods? Let's not forget - as PSRiordan states quite correctly - ISO 9001:2015 doesn't mention anything but risk and opportunity - risk based thinking. I would start force fitting an FMEA into non-product areas just because some individual - who spends just a few hours in your location and may be well intentioned - suggests it. Let's not forget that it is not they who have to live with the consequences. MCW8888 - are you prepared to do what it takes to prepare the FMEA with a team and then ensure it's kept up to date? Because no-one else will and there will be no ownership and when it fails guess whose name is going to be on it?
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Wrong perspective MCW! The auditor isn't the one who needs to be pleased - other than by your organization demonstrating a kick-butt QMS...
     
  8. tony s

    tony s Well-Known Member

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    I'm reminded of a quote that says, "Give a small boy a hammer, and he will find that everything he encounters needs pounding." FMEA maybe a good tool for manufacturing processes, but organizations should not be forced to use one tool for all QMS processes.
     
    Jennifer Kirley and Andy Nichols like this.
  9. MCW8888

    MCW8888 Well-Known Member

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    Thank you for that feedback Andy. 9I DO NOT UNDERTSTAND WHAT KICK-BUTT QMS MEANS). At the moment the ISO certified facilities are not implementing the FMEA. When they are audited by the customer to VDA 6.3 they are really struggling when the customer ask about this tool. As for QMS and the risk, these are presented together with our SIPOC and the auditor thinks it's not very formal.
     
  10. MCW8888

    MCW8888 Well-Known Member

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    I agree with you wholeheartedly. But the customers conducting their audits in Europe are asking us about FMEA. If we have to satisfy our customer, then we need to learn these things and it's my job to simplify it for the non-automotive facilities. Tony asks how about the QMS processes. Well we put that item in the end as QMS processes and itemize the requirement of ISO. Potential failure mode of Leadership commitment for example is: ineffective processes due to poorly or rigidly defined roles, responsibility and accountability. How do you control Leadership? to assign focal point to be in charge of preserving the integrity of QMS during revisions. If the RPN comes out to be too high, increase the frequency of internal audits and conduct a follow-up after an agreed time to lower the RPN.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK, so I have to ask... Another auditor or is it in CONTRACTUAL language? Customer auditors often pull out the same biases in their comments. Unless they put it in the contract (and pay you to do it) you don't have to satisfy them!
     
  12. MCW8888

    MCW8888 Well-Known Member

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    I know, if I want to cause trouble I could do that. Anyway the following is an excerpt from TS9200 (?) which is suppose to be the guideline for implementing ISO9001:2015 section 6.1:

    "In determining risks and opportunities, the organization can consider using the outputs of techniques


    such as SWOT or PESTLE. Other approaches can include techniques such as Failure Mode and Effects

    Analysis (FMEA); Failure Mode, Effects and Criticality Analysis (FMECA); or Hazard Analysis and

    Critical Control Points (HACCP). It is for the organization to decide which methods or tools it should use.

    Simpler approaches include techniques such as brainstorming, structured what if technique (SWIFT)

    and consequences/probability matrices."

    During the coaching session I gave all these suggestions which resulted in confusion. Everyone wants to have a standardized method. I manage to pilot one plant without using any of the above, except the SWOT (for Context). I used the SIPOC (satisfied all the elements of (4.4) and extended the columns to include Risk and Opportunities and it was traceable. But as I mentioned before, the auditor made comment that the RBT needs to improve. The moral of my story is not to use a TS auditor to audit an ISO9001 QMS.
     
  13. tony s

    tony s Well-Known Member

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    I empathize with you MCW.

    I've been in an organization where they produce auto and non-auto parts. They use FMEA for the manufacturing processes for both parts, including for non-manufacturing processes. Since they have a well developed documentation of their control plans, procedures and instructions for all types of processes, they use FMEA whenever changes occur to these documents. If a process owner would like to introduce a new procedure or just a modification - it triggers the accomplishment or updating of the associated FMEA. However, there is a separate descriptions of the rating criteria for Severity, Occurrence and Detection to suit the needs of the non-manufacturing processes.
     
  14. MCW8888

    MCW8888 Well-Known Member

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    That is why the quality manual for IATF 16949 will explain how the ratings of the ratings are describe. No empathy needed. Thank you anyway.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maria:

    A "kick butt Quality Management System" is one which Management owns and uses to plan and control the process of the organization, using the competencies of a motivated workforce who produce products which the customer wants and (when applicable) comes back for more. One where the planned results, including objectives, are met through careful planning and implementation of the necessary steps. Where the tools of the ISO 9001 toolbox are used harmoniously, where an external auditor has no reason to suggest an "improvement" because management KNOW already what needs improvement, why and how it'll be measured following said improvement.
     
  16. hogheavenfarm

    hogheavenfarm Well-Known Member

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    Ok, all this is known, but the original question that started all this still stands, how are opportunities addressed with a FMEA? If we address risks at various points in the process, where and how to address opportunities? (Management Review?) Very little is said on this while much time is spent discussing risk. The standard treats them equally, so I would think that auditors would be looking at both.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    We always end up getting side tracked when auditors decide that they want to see the use of a specific tool...

    To answer Leonid's original question (where IS he, btw?) the opportunities mentioned with "risk" are not the same as opportunities for improvement. As someone stated here (or in another forum) an organization may find an opportunity to do work with a new supplier- but it might not come from the need to improve. There's risk associated with that. New customer? Risks become apparent.
     
  18. littlefish

    littlefish New Member

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    My comments to Leonid 's initial questions. It seems to me the item 1 is to proactively identify the potential opportunities through SWOT analysis and develop the organization's business strategic plan. The item 2 and 3 are to focus on the opportunities ( both positive and negative) derived from QMS review.
     
  19. MCW8888

    MCW8888 Well-Known Member

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    FMEA-six sigma is a tool for improvement in a non-manufacturing process.
     
  20. tony s

    tony s Well-Known Member

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    FMEA for training, document control, internal audit, sales, accounting and other non-manufacturing processes? I'd like to see IATF or AIAG to release an FMEA manual with sample on these processes.