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Processes, procedures and requirements

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Andrew Murray, Nov 22, 2022.

  1. tony s

    tony s Well-Known Member

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    The answer, most probably, is they already have an existing process that they can integrate the requirements of the standard pertaining to Management Review. These existing approaches can include operations meetings, management conference, strategic or business planning, staff/unit meetings, to simple discussion or submission of reports to management. Since most organizations may have already these approaches, this could be the reason why the standard itself mentioned the following:
    • "It is not the intent of this International Standard to imply the need for: the use of the specific terminology of this International Standard within the organization" (see 0.1 General, Introduction);
    • "There is no requirement for the terms used by an organization to be replaced by the terms used in this International Standard to specify quality management system requirements..." (see A.1 Structure and terminology).
    When an organization sets objectives that are relevant to satisfying its customers/applicable requirements and has processes and policies to achieve them, this organization already has a functioning QMS. The requirements in ISO 9001 standard did not cause to establish this organization's QMS, but can be employed as a valuable reference to ensure effectiveness of its QMS.

    Nice discussion Patricia.

    My warm regards,

    tony s
     
    Last edited: Jan 20, 2023
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In another forum (not the Cove) a discussion point was made that one of the challenges for the authors is that ISO 9001 isn't written for 'C Suite" people. It uses arcane, rather imprecise terminology - which from necessity - is reasonably translatable to many languages. Our friend Paul Simpson, who recently retired from TC 176 SC2, has attempted to author a more CEO-friendly version. https://lnkd.in/d8MxSQna
     
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Lots of good inputs so far.

    It is true that ISO uses language that most of us don't readily understand. Context is one, though if you think about it the information asked for really does provide context for the QMS.

    I have noticed, now more than ever, that the standard has a lot in common with every business plan template or software I have seen. Most of it is very sensible once one makes sense out of the language. The object is to establish a business plan that helps ensure your success - the shalls in the standard are not meant to govern our lives.

    ISO 9001:2015 In Plain English is a popular book for, well, putting the arcane language of ISO 9001 into plain English.

    Overall I can offer that one should not read too much into the requirements. Although lots of people ask for one, in no place does the standard require a documented process map. I actually find those things to be a waste of time because they have little practical value. We are instead asked to establish and implement a QMS, including the processes needed and their inputs, outputs, sequence and interactions. A map doesn't accomplish this.

    I hope this helps.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Last edited: Jan 20, 2023
  5. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hi Miner,
    Thanks for your response, but I disagree with you, too. ISO DOES tell Management HOW (at a bare minimum), they should ensure that they operate their business...Management can choose to embellish it with whatever bells and whistles and secret weapons they many choose, however, MINIMALLY, and as a standardized organization, they must operate HOW the standard dictates. That is...they MUST "PLAN, DO, CHECK, ACT", (in a nutshell), and that must be substantiated through audits.

    Anything beyond this "HOW" is left to their individual preference, whims, and/or creativity.

    Best regards,
    Patricia
     
  6. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hi Jennifer,
    You're absolutely right that most of the "key process maps" (outlining the key processes, their sequence and interface) in existence are of little practical value, and dare I say, inaccurate and insufficient, yet they almost universally pass the scrutiny of auditors. Even the auditors don't give them much thought...seems it's of no consequence.

    Giving the ISO-user universe the task of mapping out "visually" what the standard asks for "verbally", is a daunting task, and beyond the capability and/or understanding of most, and yet it is the key element and tool for facilitating the understanding and acceptance of the "management system", and ensuring that everyone (especially Management) has the same vision of how it operates. It's like having a schematic of a car and it's gasoline engine. It sure would help everyone if they had a common vision of how the beast they're driving actually operates, that is, how to make it go faster or slower, how to optimize resources used, enhance efficiency, how to plan to reach your destination, how to maintain it, how to ensure it's calibrated properly, so you don't get speeding tickets...etc. I'm sure you get the picture.

    You noted, "We are instead asked to establish and implement a QMS, including the processes needed and their inputs, outputs, sequence and interactions. A map doesn't accomplish this". If you look at my map, posted above, you'll see that it does exactly that, and at this level of detail, almost all ISO-compliant companies operate this same way (regardless of whether they're driving a GM, Ford...or whatever). It's a car...this is how it operates. It's an ISO-certified company...this is how it operates (at this level).

    Almost any company could use the map above (with company-specific nomenclature) to meet the mandate to map out their key processes, sequence and interface.

    I appreciate your input and the opportunity to share my perspective (albeit, controversial)!

    Best regards,
    Patricia
     
  7. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hi Andy,
    With regard to preventive action...I agree, it is not a separate process, and I don't map it out separately (on the map, it's just one of the "interfaces" between "Management Review" and the other respective Procedures). The actual procedure in my documentation is called "Corrective and Preventive Action and Continual Improvement". They're all inextricably intertwined.

    The attached procedure should substantiate how I see this working.

    Thanks,
    Patricia
     

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  8. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hi Tony,
    I couldn't agree with you more.

    That is why, in my model (rather that attempting to detail all the iterations of Management Review), as an aside, I have included samples of what Management Review might entail (similar to your noted "operations meetings, management conference, staff meetings, etc.)
    upload_2023-1-20_14-6-36.png

    Again, at this level, all the levels of Management Review may not be evident. What's important is that somewhere in the Management System, they are identified and implemented.


    Best regards,
    Patricia
     
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  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I have to disagree with this. I do find your map to be a splendid visual display, but I don't see the sequence and interaction of processes in a manner that would help your managers understand what is going on in the QMS.

    Let us remember that managers don't have time for fluff. Managers need to know what is required, by whom, to whom and when. A map doesn't show that. I have seen hundreds of process maps and have only been impressed by those that were not visuals but were instead arranged in a table, showing inputs on the left, process in the middle and outputs & to whom on the right. Those tables were actually informative. I am not saying you must develop a table, but please make your plan for identifying, determining sequence and determining interaction of processes actually usable.
     
    Last edited: Jan 20, 2023
  10. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hello Jennifer,
    Thanks for taking the time to respond to my posting regarding the Universal Management System Model. I was reluctant to post it, since I never introduce it to an audience this way. It was created as an animated, Powerpoint presentation, that builds the system in a methodical, concise manner and which is very easy to understand. I usually personally narrate the presentation. I never introduce the static model to an audience without doing a narration first. I can understand and appreciate the genesis of your comments.

    I've tried to load it here, but the file is too large to upload (compressed version was too large too), so I can only forward it to you at an e-mail address. It is part of a multi-page Powerpoint presentation, but I've abbreviated it to 2 pages to clarify this discussion and so that it's manageable for electronic transfer.

    If you want to text your e-mail address to my cell phone, I will e-mail a copy to you. Text to: 519-252-nine-00-nine.

    This offer is open to anyone who would like to see the animated model.

    Thanks again for your comments.

    Patricia
     
  11. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hello Jennifer,
    Further to the above, I was able to post the animated model to YouTube, where it can be viewed. Again, there is no narration, but it is fairly self-explanatory (see take the time to read the notes posted on YouTube).
    Some of the animation is fast, so if you need to slow it down, just use the video stop/start feature to control the pace. Also, keep in mind that the "processes" that are in "arrow shapes" are what constitute the "interaction" between the procedures.

    Ravanello Management System Model - Animated:

    Hope this helps.

    Patricia

    P.S. If you have difficulty seeing the text in the video, print a copy of the Model posted earlier, and use it as a reference as you view the video.
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    That's a very detailed map, please let me caution you that a lot of viewers will have trouble focusing on the message with all that shape shifting text.

    Let us take it to the next level and ask ourselves: What does this do to help users understand what is going on with the processes? Imagine you are a new manager. What actionable knowledge is gained from this mapping method?
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    From my perspective, anything which leads with "Corrective Action" is going to raise eyebrows with Leadership, because it means we fundamentally miss the premise of "Plan for Success". I don't believe they are "intertwined", because one foreshadows the other. If we did a good job preventing, why would correction be necessary? They might be sequential, but not intertwined. Yes, customers/regulatory bodies require corrective action to be applied to other areas in a preventive measure, but that's simply corrective action because the prevention wasn't effective and they want people to take note...
     
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  14. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hi Andy,
    You noted: "anything which leads with "Corrective Action" is going to raise eyebrows with Leadership, because it means we fundamentally miss the premise of "Plan for Success".".

    Not really...It just means that no one person and no company is perfect, and because we accept that as a realistic premise, Management, in its wisdom, has defined a process and strategy to deal with performance/product/process failure. Corrective Action keeps the ship on course and focused on its targets and "destination".

    Pity the Leadership that is derailed by the threat of the term "corrective action"...it's like not telling the pee-wee baseball team that they "lost" the baseball game, because you don't want to hurt their feelings, or to traumatize them. Life and business is full of failures and challenges. Teaching kids to fail and bounce back makes them stronger and more ready to face life’s challenges. Similarly, in the business setting, it's critical that Management have a mechanism to deal with failures and not pretend they don't exist or to sugar-coat the terminology.

    Perhaps viewing "Corrective Action" from the perspective of the attached procedure would diminish it's association with "failure", as you point out. Perhaps you could post a procedure that delineates a "gentler way of breaking the news to management"?

    ...or perhaps you would just like to offer alternate nomenclature for "Corrective Action"?

    Patricia
     

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  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe that mariners all across our sees would vehemently disagree! Planning and measurement with "correction", keeps the ship on course, NOT corrective action.

    It seems that we have a fundamentally different perspective about these 2 activities. My experience is of planning for success with the outcome being that NO corrective action was necessary. It's not about people being perfect or any other type of hyperbole regarding the human condition and a need for corrective action. We do a poor job of planning and, as a result, we have been forced to "intertwine" preventive actions, as I pointed out previously. It's wrong. Preventive is planning and corrective action is when it's clear performance requires it. Entirely the "other end" of a process...
     
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  16. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I'm with Andy. Corrective action is fixing something that went wrong. Would it have saved the Titanic or the Navy ships that collided with each other or piers? No.

    I would suggest you use a different metaphor, but the same concept goes with all of them: it is far better to plan away as much error as is practical. To be sure, the need for corrective action should not be considered a point of weakness, but rather an opportunity to learn - most importantly, learn what planning might have avoided the nonconformity.
     
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  17. BradM

    BradM Moderator Staff Member

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    Hey Patricia!! I just wanted to pop in and say hello. Good to have you hear.

    Ok... back to the arguing. Ha!!! LOL!!!
     
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  18. PatriciaCRavanello

    PatriciaCRavanello Member

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    Hi Jennifer:

    If you look at my model, you'll see that the procedure, Corrective/Preventive Action and Continual improvement is always preceded by the procedure of "Monitoring, Measurement and Analysis". The logical output of Monitoring/Measurement and Analysis are four possibilities:
    1) to do nothing, if nothing is warranted, and all metrics are being met, or
    2) to initiate corrective action in response to metrics failing or trending negatively, in order to ensure safe conditions are maintained, speed and direction are adjusted to ensure customer satisfaction (i.e. safe, timely, comfortable arrival at destination), or
    3) to assess the utility of the identified corrective action to determine if there is an opportunity to implement it in another area, as a preventive action, as it is applicable and/or
    4) to determine if there are opportunities for continual improvement and implement them.
    It is said that the Titanic sank because the captain had ignored ice warnings from other ships and failed to reduce the ship's speed to fit the conditions at hand.

    Seems to me, if the captain had "checked" and then "acted" (i.e. correcting his strategy, course and speed, etc.) appropriately, the Titanic's fate might have been different. So yes, IMHO, the Titanic "might" have been saved.


    To Andy:
    Yes, Plan-Do-Check-Act... That I agree with, however, how do you distinguish between "Correction" and "Corrective action"?

    Thanks,
    Patricia
     
  19. PatriciaCRavanello

    PatriciaCRavanello Member

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  20. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    At the risk of diving headlong down a rabbit hole, the Titanic's issue was about a lot more than the iceberg. It was also about the lack of compartmentalization (design), and a documentary I watched also pointed out there was a good deal of slag in the rivets used to hold the hull plates together (production processes). Yes, the force of the hit allowed water to enter the ship, but the damage may have been contained if more robust ship design and process design had been accomplished.

    Ships running into each other and into piers also often have more than one cause. That's why it's so important to do robust risk analysis and plan the risks away.
     
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