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Support Process Definition Document

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by lukeb, Apr 11, 2017.

  1. lukeb

    lukeb New Member

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    Hi all,

    I am relatively new to a business and the standard and they are wanting to implement ISO 9001:2015. We are a small manufacturing cnc company with around 30 employees and 4 managers. Now our understanding is that Processes have to be defined and we have set on Business development, purchasing, production and inspection and shipping as our 4 core processes. In our review we have identified support processes such as internal audits, management review etc...do each of these have to be documented with their own process definition with inputs and outputs and related risks etc?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome to the new and exciting world of Quality Management Systems.

    To be very open, in response to you question, it's up to you - the management team - to decide what needs to be documented. If you consider the section 4 requirements, including customers (interested party) and internal (employee) needs, you might conclude that they would like things to be written down. Practically speaking, you might also conclude that some things are very well understood by the people who do the work that it's not necessary to document somethings, but others - like the process for internal audits - should be, because you don't have the knowledge to do them (unless you hire someone who has 35 years experience of doing them!)

    It can't help to document most things as a set of interacting processes - because everyone will see them for what they are - very ugly. I did this with a company just recently and it became apparent they waste a ton of time keep on checking and double checking things for no good reason...
     
  3. lukeb

    lukeb New Member

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    Thank you for the reply, does this mean that we can document a process definition for each of our core processes with risk analysed and a KPI assigned and support processes, as long as they are shown as such on the IOP, could be documented with a procedure only?
     
  4. tony s

    tony s Well-Known Member

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    Clause 4.4 has given a list of what are expected for the QMS processes. As per clause 4.4, QMS processes must:
    • have the required inputs and expected outputs;
    • have applied criteria and methods;
    • have monitoring, measurement and related performance indicators;
    • have the needed resources (e.g. people, infrastructure, environment);
    • have assigned responsibilities and authorities;
    • have actions to address the identified risks and opportunities;
    • be evaluated and implement any changes needed to achieve the intended results;
    • be improved;
    • to the extent necessary, maintain and/or retain documented information to support its effective operation;
    • be in accordance with the requirements of ISO 9001.
     
  5. carey Dunnagan

    carey Dunnagan New Member

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    Does anyone have any thoughts on a swim lane diagram for each one of our core processes?
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Swim lanes can be used with good effect. However, you might want to check with your CB as I've heard that one will NOT accept them (oddly, since it's nothing to do with them)
     
  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I would like to see your swim lanes diagrams.
     
  8. carey Dunnagan

    carey Dunnagan New Member

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    I have started this one as a high level flow for our Quality Manual. I was also creating one for each one of our core processes? Please HELP... any ideas?
     

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  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    What occurred to me is how you will show the interaction with strategic management, which resources and is responsible for everything, and support processes like IT that support everything, and Maintenance that supports all production processes. I see people dealing with that by "nesting," that is boxes inside of boxes with all inside a big box Strategic Management.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A key aspect you may be missing is that your leadership need to be able to be comfortable with talking to what ever process sequence and interaction you may come up with, and there in lies the real issue. If you do this, they won't. They need to own this description. I'd strongly suggest you start with them working on a real map of what happens, warts and all. Your example looks to me as if you're attempting to map ISO requirements (which has already been done in the front of the standard). Before you go too far and create a monster and get no support from anyone else for feeding it, I'd go back to basics...
     
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  11. lukeb

    lukeb New Member

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    All thanks for the responses, this has certainly posed more questions than it has answered but I guess that is a good thing. We have split our Processes as per the Swim lane diagram attached Core, Management and Support. We have created process definition documents for the CORE processes, including owners, KPIs and risks etc. Does the same have to be done for the management and support processes, as this will be a lot of KPI's for only a small management team to monitor? If not, what is the best way to document the support and management processes?
     
  12. carey Dunnagan

    carey Dunnagan New Member

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    Hi Luke,

    Do you have an example of what you have created?
     
  13. MCW8888

    MCW8888 Well-Known Member

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    IMO Swim lanes process flow are good. I would like to see this converted into a SIPOC diagram to clarify the process interaction.
     

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