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Injection Molding Company Compliance Manager seeking help with prep for external cert audit

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by PeteWizkid, Jul 21, 2016.

  1. PeteWizkid

    PeteWizkid New Member

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    Hello all,

    Had a very multi-faceted question to ask everyone's' opinion. I am currently in charge of implementing a QMS for ISO 9001:2008 for an injection molding plant with faculty of about 44. I have basically been thrown under the bus as magically becoming the process owner of anything that people see as something "extra" to their workload as a result of striving for this QMS, and I do not know what to do to get them to see it is THEIR responsibility to do the things THEY stated when they created their quality manual/process flows/procedures before I was hired. I also fear that with the unwillingness to accept the change out on the floor by most of the operators/supervisors as they are blind to the actual benefits of implementing and maintaining an effective QMS, we may not be ready to undergo our initial cert audit. There is so much to do as far as keeping everyone on track to even get CAPAs implemented and actually enforced! I could go on and on with what we should do and what we are not doing, but to keep it brief, what should I do? the big fear for me is losing my job if we do not get the cert, but also, what will become of this company if we dont get this cert??? I am at a loss and seriously struggling...
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK, so let's go back through some of your issues and help you out. Firstly, you WILL get a certificate. It's not "Pass/Fail". You MIGHT get some non-conformities, but unless they are really big issues, then minors = certification.

    Secondly, the issues are never with the shop floor. As much as I detest the saying "Say what you do etc", but it's often the case that the auditor will see your processes and controls as currently practiced as effective. You may have some work to do on the less obvious stuff, like competencies etc. Don't forget that you can also do internal audits as a "CYA" action, to some extent. Management and supervision are always the problem - Deming said so!

    Can you get an outside consultant to come in (i.e do you have budget to spend?) It's sad but true that organizations rarely listen to their own. Pay someone and they listen.
     
  3. PeteWizkid

    PeteWizkid New Member

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    Andy, the sad part is, we have an outside advisor ON TOP of them bringing me in to implement everything.... This is possibly the most awkward and almost futile position I feel I have ever been in.
    For example, this is a QUALITY management system, but yet, they just took all 3 QA techs on all 3 shifts and made them regular operators, so there is no one doing daily quality audits on each shift. Also, the "Sales mgr/customer service rep" has not done a single customer satisfaction survey. (This is a family business and this individual "married" her way into the sales position and is married to the CEO, so she feels like she doesn't have to do this "ISO stuff"....) It's so weird. To me, it's like.... you were willing to pay an outside advisor PLUS hire me on as a salary person to tell you what needs done and assist in carrying out compliance, but you don't want to do what is necessary to ensure we are measuring our quality and customer satisfaction?!? It is weird. I wish you could've been a fly on the wall when I had my meeting with management to explain the need for a quality policy and quality objectives. They thought I was trying to replace their long-standing mission statement with a "new fan-dangled" quality policy. They simply could not grasp the concept that this is a separate entity. I explained there were some things that could be similar in their content, but the quality policy is different than the mission statement and must have certain info to be compliant with ISO. I think they thought I was coming in here and flipping everything upside down and that's totally not what I am doing. I just feel like they are so defensive to someone "outside" the family; but I want to do nothing but help. The outside advisor and myself are doing everything we can. I just really worry about the future of this company when the slack attitude and dumping of responsibilities on others is such a frequent thing in the office. Maybe I need a course in human relations so I can learn how to communicate better with these people.
    I appreciate the reinforcement to keep me positive. I keep telling myself everyday I am GOING TO succeed because I am crazy enough to think I can!!!
    Thanks again, Andy!
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I feel your pain. One option is to sell them on the idea of a "gap" or "pre-assessment" audit. Let someone else bring the bad news...
     
  5. ncwalker

    ncwalker Well-Known Member

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    Here's my advice on keeping your job: You need to have a conversation with the right person (owner/plant manager/whomever) and the start of that conversation needs to be you making a statement like:

    Boss, I am in a difficult position. The success and failure of this implementation of the QMS system depends on people and departments who are outside the scope of my control. I am going to rise to the challenge and do my best, but I want to also understand what YOU think success of my performance will be, regardless of the outcome. I want the plant to succeed, but I also want to succeed and need to know what that looks like separate from the plant's success.

    Get this in writing. Like via your employee review process. If the boss hasn't thought about that angle, he will at that point. You cannot be solely responsible for something unless you have sole authority. Though they will always try and make you a scapegoat - especially in the field of quality.
     
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  6. ncwalker

    ncwalker Well-Known Member

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    And here is my advice to you on how to get the system implemented. Another conversation with the appropriate boss goes like this:

    Boss, you hired me as a quality systems expert ...

    (aside - NEVER be afraid to say "I am an expert." Even if you don't FEEL like one sometimes. The people that hired you DO. Nobody says "Hey, look here folks, we just hired in PeteWizkid! He is sort of mediocre...." If they do, everyone will say "So what the hell did you hire him for?" No, they say "We hired in PeteWizkid - he's an EXPERT, the best we could find!" It's OK to remind them of this now and again. Don't parade around like a child with it, but don't be afraid to drop the sentence now and again.)

    ... you hired me as a quality systems expert, and here is how this system should work. The process owners need to be owning and enforcing their own standards. I am your expert on quality systems, this guy over here (whoever) is your injection molding process expert, and this other guy is your finishing expert (whatever). You don't want me writing and enforcing their processes, because that's not where my expertise lies. What you want me doing is ensuring they are following them. Not because they are lazy, but because they are busy and busy people can lose track of the big picture. You set the tone of where you want the company to go, they come up with a plan to get us there, and I monitor and report on how they are executing to this plan. A key way of doing this is with layered audits ....

    And then bring up that subject. They are great in a small company.

    But listen, you definitely don't need to be doing all the other guys work. But as a quality engineer, you also don't want to be just sitting there saying "This is wrong, and that is wrong." That's damn annoying. I've been a production guy with a QE like that and I hated him. Eventually, if you do this, the production folks (whom you very much need a good relationship with) will start working against you. So don't do their work, but BE INVOLVED, make their meeting the requirements as easy as possible.
     
  7. Golfman25

    Golfman25 Well-Known Member

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    My advice is to strip the word "quality" from everything. Most of ISO is not about old school quality -- checking parts. Rather you are just documenting good solid business practices. For example, knowing how your customers feel is an important thing for a business. It has nothing to do with "quality." Then the question is why do you need to do a formal survey. They are so last year. Find something less burdensome. My gut tells me if you strip quality out, you'll get further. Good luck.
     
  8. tony s

    tony s Well-Known Member

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    I agree with ncwalker. Talk to your boss.

    My take on the above statement: If after talking to your boss, they still don't do anything about your concerns and just retain the status quo, then that company does not deserve to be certified to ISO 9001 and they don't deserve your assistance.
     
  9. johnnymo77

    johnnymo77 Member

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    Use BOS (Business Operating System) instead of QMS where you can. It's about how the business is run and involves all departments & functions. Unless they are unnecessary.
     

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