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Quality Criteria

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Gypsyjo, Jan 25, 2022.

  1. Gypsyjo

    Gypsyjo Member

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    Hi everyone,

    I am working for a small synthetic biology company. We are preparing our quality management system as in the future we would like to become ISO9001 accredited.
    A colleague has produced a process asset diagram, this has every step from client onboarding to final sales and how they interact. He asked me to provide a quality criteria for each step. I’m not sure what he means, can anyone help?
     
  2. pkfraser

    pkfraser Active Member

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    No, I have no idea(!) Why not ask him for an example. I would suggest that you define the process from the point of view of i) what do we need to define and communicate to staff to ensure consistent performance, ii) how much detail do we need to show to make sure that a new start can fit in seamlessly, and iii) what risks might arise at each step and how do we manage them. Think of what the business needs, not an external assessor. If you get it right then you should comply OK.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "Quality criteria" in my book means what it looks like when the job is done properly. Maybe that's what it means?

    I'd be worried if someone has created a diagram and then is coming to you to ask you to finish it! Sounds like the diagram has no real purpose and/or was poorly conceived...(sorry). If the person creating the diagram doesn't know what should be achieved, why are they doing it?

    (BTW it's ISO 9001 certified, not accredited)
     
  4. BradM

    BradM Moderator Staff Member

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    Hello there!!

    I guess... one could step back and look at this asset diagram, and say, where there is a process there is a deliverable. Then, if there is a deliverable, there is a measure of quality.
    Ok... let's assume for a moment that is reasonable and what your colleague was envisioning. If this diagram is fairly detailed, there could evolve a hundred different processes; thus, 100 measures of quality! Gad!

    Could you consider biting off this diagram in chunks. So have the client onboarding in one, requisition and raw material quality in another, work in process in one, then final inspection/ finished goods in the last? Then, maybe get with management and identify the critical quality parameters from each of those, and focus on them.
     
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  5. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Gypsyjo ;
    I believe @pkfraser and @Andy Nichols have raised some good points.

    May I ask..
    - what is the impetus for your organization wanting to "...become ISO 9001 (certified) ?
    - Is your organization familiar with ISO 9001 and how to implement so that it serves your organization ? (and not simply to serve an auditor?)
    - Is your organization familiar with aspects to avoid to ensure ISO 9001 certification is not a cumbersome burden i.e. "'full time job" ?
    - Does the "diagram" you mentioned serve a purpose and benefit the organization or is it simply an exercise to appease an auditor?

    These are some topics I am hoping your organizations TOP MANAGMENT is considering?

    Please continue to reach out to us here as/if we can assist.

    Be well.
     
  6. Gypsyjo

    Gypsyjo Member

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    The company was a research organisation, they have just made a marketable product. We do not have any customers yet. The diagram was made last year by the informatics team, before I joined the company, to focus on the processes the company would need to carry out to produce a produce.
    As yet the company is no where near ready for ISO9001
    BradM I think this is what he means but it’s not something you can just add to the diagram. It currently looks like a dish of spaghetti :D. We have another meeting this afternoon so I will discuss further
     
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  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Hello Gypsyjo,

    I don't know what your role is in this company, but asking you to come up with "quality criteria" is, in my view trying to take the easy way out - who would know what success is better than the people within the processes? I suspect they don't realize how much they already know, but people in "young" systems tend to lack confidence in their own knowledge. They want to lean on QA and get on to their "real work."

    Times like these call for a meeting of the minds; get together over lunch or coffee and start brainstorming what success looks like in these processes, and how one would notice when success or failure takes place. It is okay to use the simple language: "What does winning look like? What does failure look like? How would we notice it? How could we keep track of it? Don't make it difficult. It doesn't need to be.

    There may be more than one type of success, because some processes serve internal people while others more clearly affect end users. Recognizing both can help the organization understand why doing things right the first time is so important to everyone involved.

    Stay away from "Profit!" because there are 50 ways to affect profit and very few are direct. Most are chain reactions that eventually lead to lost customers. Internal waste, as in forced rework of products, services and even process steps is a killer of fledgling organizations. It sucks the energy from within and fosters unhealthy interpersonal dynamics.

    The answer lies within.
     
    Last edited: Jan 28, 2022
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Further to Jennifer's well-made points, I'd also suggest that in such a small organization that you get together and map your "core" business processes on the wall - buy some spray low tack adhesive and stick paper to the wall. Then, have someone facilitate the mapping of the processes from lead generation, through quoting, sales, order entry and so on. At each hand off define the inputs/outputs and what the "success" criteria are (what is a good quote?), process controls, measures (as applic) and so on, through to delivery. Experience shows (my son did this in his business with excellent results) that everyone buys in, understands how it all fits together, can see where problems may become apparent and so on. You'll need a good facilitator, however, because you may have some personalities who need to be "controlled"...
     
    Last edited: Jan 28, 2022