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Lighter documented information ISO9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Somashekar, Aug 25, 2015.

  1. Somashekar

    Somashekar Moderator Staff Member

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    Going into the ISO9001:2015 from the ISO9001:2008., meaning that your quality management system is fairly mature..... would you seriously consider getting rid of some FAT in your documented information and become lighter slimmer and more purposeful in your documentations ... ?
     
  2. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    Yes, but IMHO every revision and/or review should have that as a goal. The 2015 update is a perfect time to rethink how things have been done in the past and work on improving them. A lot depends on your organization, some will just want to get past the re-cert by the time it's required. Not much you can do with those since they really don't get it, but others won't complain as long as their involvement is minimal.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's going to depend on the "context of the organization". It's not a case of "trimming fat", it's going to be a case of what's needed, given competencies and so on. To make it sound like a simple editorial task is to depict the activity wrongly, IMHO. It's going to be up to management to determine what level of documentation (contents that is) and verify that with the internal audits. In fact, I'd ask what the internal auditors have been doing all along, if it takes a revision to stimulate the discussions...
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    One piece of documentation I am happy to see jettisoned is the Preventive Action procedure. The element allowed too much confusion in how to implement preventive actions - led to too much pointless effort just to leave evidence for an auditor while failing to credit things like error proofing projects.
     
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  5. Pancho

    Pancho Active Member

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    Imo, no procedue should exist in a QMS only to satisfy a standard. Any such procedure is fat indeed and should be trimmed or modified regardless of the version of the standard in vogue.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's true but only in theory, Pancho. Why, otherwise, would anyone have certain procedures, unless required by the standard? In my 40 years of being in industry - and a significant number of organizations along the way - no-one ever woke up one morning and decided to do internal audits, for example. It took the requirements of ISO 9001 to tell them to a) write a procedure and b) do them...
     
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  7. Pancho

    Pancho Active Member

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    Ok, maybe in a new qms the purpose of some procedures is indeed to meet the standard. But if the qms doesn't evolve rapidly beyond that, then something is wrong.

    Internal audits clearly add value to any qms, even at the beginning, don't they? They do to us, or they'd be gone.

    Where I've seen some folks go wrong is in reading requirements that don't really exist and creating cumbersome procedures to meet such requirements. I'd insist that if a standard-dictated requirement is not adding value (beyond the cert), then it's wrongly implemented.
     
  8. Sidney Vianna

    Sidney Vianna Well-Known Member

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    In my view, organizations should assess the need for a command media (whatever form that might take) to support a process and/or activity, using the so called RBT. How complex, critical, etc. is the process? what level of competence will people performing these duties have? how much variation is acceptable in the process? how much automation is involved? how easy/difficult will be to train/qualify people for this process in the absence of documentation?

    I think questions such as these should be the litmus test for the need (or not) of documentation. Not because a standard mandates it.
     
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  9. Pancho

    Pancho Active Member

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    Agree, Sidney. Also, in a mature qms the number of documents that exist because they were originally created to meet the standard is small, and even those few are very different than what they started as.

    In a functioning, mature system, docs are the evolved result of improvement actions and they are a platform for further improvement.

    "Command media"? I had never heard that term for documentation, although reading Claes-recommended Gemba Kaizen, I came across "standards". Maybe it should be called "organizational DNA".
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In reading your comments, Sidney, I'm struck by the idea that - based on a lack of top management involvement in the development of many management systems - will anyone go through something like your set of criteria when considering documentation and the need for it. (FWIW - I don't like the term "command media", as documentation is for process control and "command" brings the wrong "aura" IMHO).

    In the past, when there was an implied structure to documentation, the old "Pyramid" of documentation "levels", it was easier and more convenient to dismiss the task to "gotta have" levels 1, 2 3 and so on. Without that, what's the "model" going to be?
     
  11. RoxaneB

    RoxaneB Moderator Staff Member

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    This boils down to an organization understanding WHY they do what they do...even down to the documentation of standards, or the mere act of standardization. I've become a big proponent of Simon Sinek's "Start with Why" (the TED Talk video on it is excellent!) Saying WHAT we do is one thing, but to truly make any process (documented or otherwise) add value, people should understand WHY we do it.

    Often, I see the Purpose/Objective within a documented process that is just an extended version of the title. Big deal. I still don't know why it's important for me to understand processes such as making a grilled cheese sandwich or responding to a customer complaint or calibrating some measuring device.

    We can probably align this notion with Risk Based Thinking, but I prefer putting it more simple terms...Understand the WHY. Why do we do this? Why is this important. Why should anyone care?
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Great points, Roxane! (I got it right!) And therein, lies the rub. Where's the guidance? Where's this type of critical thinking going to be part of the ISO training curriculum? Where's the Accredited Implementation Training course?
     
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  13. RoxaneB

    RoxaneB Moderator Staff Member

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    In my opinion, Risk Based Thinking is an attempt to bring in such "guidance", however, RBT still focuses heavily on the WHAT. WHAT would happen if we didn't do this? ... or ... WHAT would happen if we did do that? It doesn't get to the heart of the matter, however...the WHY do we care if this does or does not happen?

    I always smile at the Apple example that Simon Sinek uses, but perhaps the easier way to explain why the WHY is a better starting point than the WHAT is Martin Luther King's speech...He said "I have a dream.", not "I have a plan." Do you think the latter would have resonated more with people? Start with the dream, the belief, the WHY first. The WHAT will then naturally follow.

    At a glance, it may seem that we're off-topic from the original post, but I think we're looking at a prime way to get rid of any excess within a management system. WHY do we document certain activities? WHY is it important?

    It's amusing. When I first started down the road of management systems years ago, I tried to explain my role to non-ISO folks as simply "I'm paid to be a five year old and ask why a lot." Maybe I was ahead of my time with this approach. ;-)
     
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  14. Sidney Vianna

    Sidney Vianna Well-Known Member

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    I am sure many people would, after seeing product being wasted, repeated mistakes leading to frustration and financial losses, it is very easy for people responsible for a process to realize that they need to do more to bring such process under control. Defining how the process is supposed to flow (via a document or otherwise) is a natural step.

    The term command media is commonly used in aerospace. It serves the purpose to expand the type of mechanisms that provide parameters for a process. It can be a written procedure, a visual aid, a video clip, a checklist, a manual, a leaflet, a photograph, etc... As for the command connotation, isn't that what part of process control is all about? Providing direction? Beyond that we need monitoring and measurement as well as feedback loops.

    Ask any process owner how s/he controls the process(es) they are responsible for and they will allude to some type of instructions (i.e. command).

    The "model" should be what is appropriate for the context of the organization. Imagine you trying to convince a college drop out CEO working on his start-up, which could be valued at billions of dollars in a year's time, that they need a manual, 20 procedures, 326 work instructions and 76 forms....
     
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  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It appears that "command media" is unique to a specific aerospace prime - not what I'd call "common".

    I've spent 40 years in businesses where those things happened daily - it didn't drive them to take a greater interest in process control. Many shrug their shoulders and mutter that "sh*t happens", or try to justify why it can't be fixed! It's endemic in industry...
     
  16. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    Critical thinking? I thought it is a *general* sense to know as to why we write A particular procedure or document.
     
  17. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    If given a privilege to have my own way, I would prefer to have all my Procedures converted into Presentations. I believe it is simple, easy-to-digest and effective to have a Procedure explained in the form of Presentation. We, in my current Organization, always prepare a Presentation to start with, which gets discussed, debated and finalized before getting converted into a conventional Word file as a 'Documented' procedure. Also, Presentations carry huge benefits of easy-to-refer and easy-to-grasp for Users, Clients or Newbies who generally hate reading bunch of papers to understand how things work. I think, this presentation structure if controlled is well within the realm of even 2008 version of standard, albeit it does not go down well with some stereotype Auditors. But will it be accepted unanimously as a Documented information? will have to wait and see.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I wouldn't hold my breath waiting for people to "get" that. You see examples, all around, of the lack of that "general sense"...
     
  19. Pancho

    Pancho Active Member

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    Yes, both 2008 (4.2.1) and 2015 DIS (3.11) versions of the standard allow your organization to have documented information in presentation format. No need for "unanimity". If coloring book format would work, that's what we'd use, and we'd invite any stereotype auditor to flush their NCs on it.
     
  20. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    You wouldn't get any complaint out of me! :)
     
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