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New fish in a big pond

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Chemist Bob, Nov 5, 2019.

  1. Chemist Bob

    Chemist Bob Member

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    Hello all, my name is Bob, real name actually, and I'm a new fish to the big pond called quality assurance. In all honesty I'm a little over my head and I'm hoping this forum will help guide me to what I need to figure out.

    So some background I'm a chemist at a small manufacturing company which is part of a larger life sciences company. A job opening appeared for a Quality Assurance Manager and I applied for the job thinking it was a long shot. I had limited QA experience but big ideas of what needed fixed in the company so they took a shot on me.

    So I didn't know the can of worms that I had opened, as this position had been created and we didn't have anyone doing it before. We are ISO 9001:2015 but a lot of our stuff is everywhere being handled by 5+ different people all doing things there own way. My duties so far have been 1st to find a QMS that can handle complaints, CAPA's, document control, equipment maintenance, supplier systems, and much more. 2nd my direct supervisor wants me to get a better understanding of iso audits and what auditors will be looking for and thus wants me to take a Lead Auditor Course. 3rd is to get one of our other sites ready to change over from 9001:2008 to 9001:2015 as they never did the change over when they were required to. Many more to follow but those are my 6 month goals.

    So as you can see I have my work cut out for me and any advice you could give to help point me in the right direction would be greatly appreciated.

    Chemist Bob
     
    Chemist Bob, Nov 5, 2019
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Bob! You're in safe hands here!

    Don't waste your time or money. Lead Auditor courses don't help with this. No-one knows what a specific audit will ask. What you and your supervisor should focus on is what are the ways to demonstrate how your system works. Good auditors will understand, bad auditors should be shown the door.

    May I ask where you are located?
     
    Andy Nichols, Nov 5, 2019
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  3. Chemist Bob

    Chemist Bob Member

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    We are international, our headquarters location is Ohio, US based but we also have sister sites in other states as well as in the UK and a BU in Germany.
     
    Chemist Bob, Nov 5, 2019
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  4. Miner

    Miner Moderator Staff Member

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    Bob,

    We also have a sister forum that you should check out. Similar questions to yours are frequently asked and answered in both forums, so I recommend taking advantage of the search function in both forums. Here is an interesting article by Craig Cochran, a respected poster that highlights some of the important changes that are often overlooked.
     
    Miner, Nov 5, 2019
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  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome Bob, congratulations (I think!) on your new role.

    Miner gave good advice to find Craig Cochran's works. His book ISO 9001 In Plain English gets a lot of good reviews.

    You could take a lead auditor course, but they are not intended to inform about the standard's requirements, and are not necessary to understand the audit process. Your registrar should provide enough explanation about the registration process and its various activities.

    As for the functions associated with being a Quality Manager and the Quality Department's functions, I find ASQ's handbook for Certified Manager of Quality/Organizational Excellence to be a good desk reference.
     
    Jennifer Kirley, Nov 5, 2019
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  6. Chemist Bob

    Chemist Bob Member

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    Is there any other training that might be more useful? I don't think it will go over well if I get to my boss and say that I don't need any kind of training because people online say it's a waste of time, lol
     
    Chemist Bob, Nov 11, 2019
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  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    You could certainly use some training. The American Society for Quality has courses, maybe you would like to get the one for Quality Manager. They have other training too, of course. They have the handbook for certification too, which makes a decent desk reference. You don't yet have the prerequisites to take the CMQ/OE exam, but studying for one can build knowledge that you need.

    If you prefer self study, I find it helpful to look up answers to questions. I find I absorb more of the reading material that way. If that is the same with you, ASQ also has test question banks that can help.

    Affiliation note: I am an ASQ member.
     
    Jennifer Kirley, Nov 11, 2019
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well, yes, but we said "Lead Auditor" training wasn't helpful. There's other types of training available. Try an implementation course, for example
     
    Andy Nichols, Nov 12, 2019
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