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4.4.1 ..."...shall determine the processes needed..."

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by John C. Abnet, Nov 16, 2020.

  1. John C. Abnet

    John C. Abnet Well-Known Member

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    Hey all-
    Let us kick a sleeping dog and burrow into this subject...shall we?

    We have all seen organizations go to great length (complex turtles, matrices, etc..etc...), attempting to satisfy the certification body registrar in an attempt to fulfill this requirement. Sadly, most of the efforts I have seen add no benefit to the organization. I have seen simple organizations have up to 30 listed processes. While this is not "wrong", it begs the question, ...
    * what is expected by the CB?
    ...More importantly,...
    * what is beneficial to the organization?

    What all needs listed as a "process needed" ?
    Most companies invoice customers. Does "invoicing" need listed ? Most companies have a purchasing agent and pay suppliers. Does "accounts payable" need listed? "accounts receivable" ? What about maintenance ? ...The list goes on and on.

    Example:
    A pizza shop opens and wishes to become ISO 9001:2015 registered. They make a simple one page flow diagram, which sequentially lists the following processes.....

    - Build
    - Bake
    - Cut
    - Package
    - Deliver

    The process owners are identified via osmosis and corollary documentation.

    Sufficient?

    What say all of you ???
     
  2. Eric Twiname

    Eric Twiname Well-Known Member

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    A list of if's...

    - If building needs no other description, or if said description is covered in "corollary documentation"
    - If baking needs no other description, or if said description is covered in "corollary documentation"
    - If cutting needs no other description, or if said description is covered in "corollary documentation"
    - If packaging needs no other description, or if said description is covered in "corollary documentation"
    - If deliver needs no other description, or if said description is covered in "corollary documentation"
    "Needs" being defined by the Pizza shop management

    And if there are no other products other than Pizza.

    Then I say "Yes"...the simple flow chart satisfies more than just 4.4.1 (which only requires determining), but also documents this determination for the auditor.

    What is expected by the CB? I've honestly stopped caring.
    What is beneficial to the organization? A bit more specifics than the flowchart...perhaps in the corollary documentation... this lets you hire cheaper folks who don't have decades of Pizza making in their background.
    Ref: Pizza Hut or Costco...they just have a machine do the build, bake and cut.

    Not sure if that's what you're looking for.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Thanks for the feedback @Eric Twiname (of course now I know your alter ego from the Cove ;)

    I'm not really looking for anything...simply trying to prompt some dialogue. Specifically hoping to hear some real world experiences anyone may have had with a certification body on this topic. In all the scenarios I have been a part of/encountered, I have not known of any CB "push back" regardless of the approach used.

    My professional opinion (based on experience and the text of the standard) is that since the "organization shall determine", any reasonable approach should be acceptable. No actions and/or controls need to meet the requirements of the standard are contingent upon how this is approached....i.e. regardless of the approach, it is certainly possible to meet the requirements of the standard in the form of a well functioning and sustainable management system.

    This action ("...shall determine the processes needed...") CAN (should), however, be done in a way that is very beneficial to an organization, assuming it is approached that way.

    Be well.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    From my perspective - and a little late to the game - since ISO 9001:2015 was drafted to address the needs of "Freds-in-Sheds" businesses, where there's only a few in the leadership role, there's a clear message that documentation isn't "all that". So, we mustn't confuse the need for determining something with the other "d" word "documenting". There's value in determining and less value (in small businesses, unless they determine otherwise - see Context etc) in documenting some of these things from ISO 9001. To mis-apply "document" for "determine" is to undo the work of TC 176 and the years of experience of countless customers...
     
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  5. RoxaneB

    RoxaneB Moderator Staff Member

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    To the point made by @Andy Nichols , "determine" does not necessarily correlate into "document," although this is the route most organizations have taken. To use your pizza shop example, why are some of the processes documented and others not? How did the pizza shop determine which processes became worth of being on a document? That determination exercise is what I'm more interested in.

    Coming from a larger organization, we identified processes and indicated if they were directly linked to the business management system or a supporting process. Both direct and support processes were documented in the same manner to facilitate a common organizational culture and language, however, only those processes with a direct link were within scope for external audits. Internal audits could delve into the support processes to ensure consistency to the business requirements and to validate their input/output relationship to the direct processes.

    Maintenance processes had, for us in the steel-making work, a direct link as they had a strong impact on our ability to consistently meet stakeholder expectations.

    Information Systems processes were a split...server maintenance impacted record control, but the issuance of new tech was a support function.

    Accounting processes had a support link to the quality side of things but was fairly relevant when it came to Sarbanes-Oxley.

    As you suggested @John C. Abnet , it's about what adds value to the organization. The CB, while not a moot point, should be a secondary consideration. What we realized was a "Lord of the Rings" approach was going to add the most value to the organization - one system regardless of the standard, one system regardless if there was a direct or supporting link:

    One System to control them all, one System to find them
    One System to audit them all, and to the bottom line bind them.
     
    Last edited: Nov 24, 2020
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As ever, a most worthy post from Roxane...:) (nice to see you "back")
     
  7. John C. Abnet

    John C. Abnet Well-Known Member

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    There is some good feedback over on "the cove" as well, for anyone interested in hopping over there to take a look. I am extremely pleased with and thankful for the feedback I received in regard to my OP. I was able to glean exactly the type of multi-front ; multi-position, and frank feedback I was hoping to receive.

    Thanks all.


    https://elsmar.com/elsmarqualityfor...the-processes-needed.80371/page-2#post-657244
     
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You had Frank feedback? I didn't see anyone called Frank make a post...:D
     
  9. Eric Twiname

    Eric Twiname Well-Known Member

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    Now that's a keeper...nicely done. Frame it.
     
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  10. RoxaneB

    RoxaneB Moderator Staff Member

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    I know that I have a tendency to complicate and over-think matters and I continually need to remind myself to simplify matters...sometimes these types of sayings are how I manage that. Right up there with OTIS (On-Time, In-Spec) that @Andy Nichols has borrowed from time to time...although, OTIS is courtesy of my father. Let the "so the apple doesn't fall far from the tree" comments begin. *lol*
     
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  11. Eric Twiname

    Eric Twiname Well-Known Member

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    Close but different...one of the primary metrics I use is OTIF ... (In-spec is assumed, since shipping the wrong thing is not "on time" in my book).

    OTIF = On-time, In-full. I've seen too many folks claim on-time shipment when only a partial was shipped and the rest backordered.
     
  12. RoxaneB

    RoxaneB Moderator Staff Member

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    If there is a way to capture that the customer agrees to a partial shipment, that might be a way to maintain a positive client experience. Amazon, for example, gives me the choice to select a one-delivery option if I'm purchasing multiple items that are not all available for shipment on the same day.

    As for OTIS, folks wore shirts and coveralls with the name tag reading as OTIS...it was a way of helping to establish accountability of their actions - that each person, regardless of their role, was OTIS and a key player in meeting customer expectations.
     
  13. Eric Twiname

    Eric Twiname Well-Known Member

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    Agreed...for customer satisfaction.
    The business benefits more, however, from in full shipments the first time...so that is the goal. Partials (with agreement) are 'good enough'...OTIF is better. Lower cost (rehandling orders) and faster revenue generation.
    As with anything like this...OTIF is better...to a point. If 100% OTIF requires higher inventory levels and cost, the benefit starts to diminish, and can even turn negative if taken too far.

    Did they build elevators?
    I guess I wouldn't care much for constant reminder that "In Spec" was important...it's a sine qua non, so it would make me wonder why folks needed the reminder. But that's just preference...
     
  14. RoxaneB

    RoxaneB Moderator Staff Member

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    No, they were not the elevator company - their primary line of business was blades for wind turbines.

    To them, "in-spec" meant ALL customer requirements, including shipping, not just the design specs.
     
  15. tony s

    tony s Well-Known Member

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    I will definitely agree that "what is beneficial to the organization" is way more important than "what is expected by the CB".

    Most, if not all, even me, would prefer to have some form of documentation of the processes covered within the scope of the QMS. Similar with organizational charts, family-trees, or even a map of the islands of a country within its territory, these can provide easy references for people. For the processes necessary for the QMS, I would prefer to have a high level process map to describe their sequence and interaction. However, this is not a requirement by ISO 9001 standard.

    The statements in section 4.4.1b of ISO/TS 9002:2016 - Guidelines for the application of ISO 9001:2015 even clarified that:

    "when determining the sequence and interaction of these processes, the links with the inputs and
    outputs of the previous and subsequent processes should be considered; the methods for providing
    details of the sequence and interaction of the processes depends on the nature of the organization;
    different methods can be used, such as retaining or maintaining documented information (e.g.
    process maps or flow diagrams), or a more simple approach, such as a verbal explanation of the
    sequence and interaction of the processes"