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Understanding of the changes to the QMS

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by judegu, Sep 21, 2018.

  1. judegu

    judegu Well-Known Member

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    It may be a quite silly question. Still, I want to figure it out. ;)

    In the Sub Cl. 6.3 Planning of changes
    "When the organization determines the need for changes to the quality management system, the changes
    shall be carried out in a planned manner (see 4.4)."

    Which kinds of changes can be considered as “changes to the quality management system”

    In my theory, it is safe to say that changes to the organizational structure, the COPs, SPs, MPs can be classified into this category. However, what about the changes to the manafacturing processes, such as the changes in 5M1E? They are just engineering changes? Has nothing to do with the changes to the quality management system? And is there other examples of changes to the QMS?

    PS: The answer may be just lying in the context of the Standards. Sadly, I didn`t get lucky to find it.
     
    Last edited: Sep 21, 2018
  2. Qualmx

    Qualmx Well-Known Member

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    Take a look to TS 9002
    Here is an extract as a sample

    upload_2018-9-21_10-25-11.png
     
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  3. judegu

    judegu Well-Known Member

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    TS 9002, It seems to be a good direction to follow up. Thanks, man.
    I also do some readings, some say that even change in the Enginneeing can be a change to QMS.
    Maybe "changes to QMS" is generic.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Engineering (product design) changes affecting the QMS? I'd like to get some concrete examples. Whatever the change (category) is, the organization should understand it must be done in a planned manner and to avoid unintended consequences.
     
  5. judegu

    judegu Well-Known Member

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    @Andy Nichols
    Maybe I am not correct, however it may be worth some discussion.
    A simple change in product design will not affect the QMS as a whole. But, to me, the engineering is more a generic term.
    In my opinion, the processing method is also part of the engineering. The change to the processing method can be considered as a change to the QMS, right?
    To be honest, I am not quite sure what I am talking about. What is QMS, exactly? Sometimes it is so huge, sometimes it can be so tiny. Where is the boundary lying?
    Indeed, we need to take the change seriously because we don`t know when it will bite.
     
  6. Golfman25

    Golfman25 Well-Known Member

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    Enginenering and process changes are probably the most important changes. If you change the way a product is made without covering all the bases problems usually arise.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's why there's a separate clause for design changes
     
  8. tony s

    tony s Well-Known Member

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    6.3 - Planning of changes is within the main clause of Planning. It should mean that whenever there are changes (e.g. planned changes in 8.1, design change in 8.3.6, production and service provision changes in 8.5.6, need for changes in 9.3.3, necessary change in 10.2.1) these should be in alignment with the intention of 6.3 that is "ensure that any proposed changes are planned, introduced and implemented in a controlled manner" (see 6.3 of ISO/TS 9002:2016).
     
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  9. John C. Abnet

    John C. Abnet Well-Known Member

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    Interesting conversation. As you all know, control of "changes" appears in numerous locations throughout the standard (6.3; 7.5.3.2; 8.2.4; 8.3.6; 8.5.6) , however, many organizations have a singular "change point control" system. I am an advocate of a single change point control system, however, it is not uncommon for individuals/groups/processes within the organization to be or feel as if they should be, excluded. Particularly in instances where organizations title their one and only change point control system as "Engineering Change" or some other pigeon-holed term.

    I offer the following that I use to teach teams regarding the application of change control....
    "If it is wrong, or gone, can it cause a nonconformance?"

    If the answer is YES, then "it" should be controlled, including the control of any changes to "it".

    Hope this helps.
    Be well.
     
  10. judegu

    judegu Well-Known Member

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    @John C. Abnet
    I know that in order to ensure ISO 9001 to be generic, applicable to all the industries, the terms and requirements in the standard can be quite vague. To be exaggerating, they may be, to some degree, regarded as the words from the prophecy. :rolleyes: Everyone has his/her own understanding. Most of them can not be simply considered as being right or wrong.
    In my company, I am just familiar with the Engineering Change System. We control the changes to 5M1E in the manafacturing via a computer-aided system(BTW, quite a powerful system, we can retain the relevant documentation and do the on-line approval via this system). Other changes to the QMS, such as organization structure changes, appointment of staff (I believe they are 100% changes to the QMS), are just out of my reach. All I know, it is that Top management has approve these changes. I don`t know whether this kind of change approval even conforms to the 6.3 (Usually it has many other things involved). However, in my personal perspective, the Auditors from CB always tends to "neglect" this kind of change. They pay much more attention on the so-called Engineering changes which are all about the product provision. It may another latent rule, I suppose.
     

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