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  • #43519

    Saherngu
    Participant

    Hi All,
    I was hoping to introduce new SPC software to our medical device company. I have heard WinSPC is excellent. Has anyone any other ideas of what is possibly the best to use in a medical device industry. Thanks,
    James

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    #138090

    Karl Krogmann
    Participant

    We evaluated 6 packages (including WinSPC) and selected these guys instead:
    http://www.infinityqs.com/
    I do NOT work for them or otherwise represent them.  I’m just telling you what we did.  Their program seemed to allow the greatest versatility in setup and we’ve been up and running for more than 5 years without issue.

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    #138101

    Mike Carnell
    Participant

    James,
    Before you invest in SPC software I would evaluate if automated SPC was as effective as manual SPC or if it just makes prettier wall paper (charts that are hung on the wall in spc profelactics and are not used to control anything).
    You get a different level of commitment when someone picks up a pencil and places a dot on a chart. They did it not a computer and that gets ownership. What is ownwership worth? When was the last time you washed a rental car or checked the oil?
    The other question you need to ask is do I really need SPC?
    Just my opinion.
    Good luck

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    #138108

    Lance Miboyle
    Participant

    So…Mike…….this must mean you build all your own furniture from sticks and rocks so you appreciate it more when you sit on it(?).
    Yes, James, I agree with Mike……I think you should make SPC as difficult as possible for the user so he/she hates it.  It’s hatred and being saddled with meniality that makes an average operation a belligerent, average operation.
    Also, the FDA loves to see record-keeping done by an operator using pen and paper when there are a dozen electronic solutions available.
    Has anyone heard when IBM will be releasing the AT?  I can hardly wait!

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    #138116

    Mike Carnell
    Participant

    Lance,
    You need to get together with julio on the cause and effect thing. Lets see because there is a software solution available it must be better? Take a look at what makes SPC work. It isn’t automation it is how the people use the system. Without ownership it sucks.
    If you want to automate something automate the process so you don’t need SPC.
    The extrapolation from automated SPC to my furniture (assuming you are using the correct name – you have never been in my home) is about as ignorant an anology (where you compare things) as julio having SS drive Ford to bankruptcy. Furniture is functional and I spend next to no time “appreciating” it. On a cost benefit anylysis – what I earn versus what I could save – I buy. Lets take that point for the sake of appearing very twentyfirst century I will automate my SPC – because I can not because it will function better? I am glad there are people like you in industry – SS will always have something to work on.

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    #138121

    Lance Miboyle
    Participant

    See, the FDA has this thing about…..accuracy (of less concern to the consulting industry).  I would LOVE to see you attempt to make the case that an operator sweating over a control chart with a pen and ruler is more dependably accurate than a validated electronic system. 
    Actually, comparison is “when you” compare things;  analogy is “when you” describe a simpler, familiar, more understandible example in an effort to grasp a more complex concept. 
    I’m also going to take a wild guess here and suggest that your furniture doesn’t appreciate you much either. 

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    #138129

    Mike Carnell
    Participant

    Lance,
    We can take a look at the FDA’s record of having a good method of qualifying products and god knows with all the products the FDA produces they should be able to determine a good manufacturing process from another.
    As far as accuracy. I will take the mistake rate of an operator (by the way they don’t all sweat) to get ownership. Having the most accurrate system in the world that nobody pays any attention to is definately something I would not recomend to my customers.
    As far as data. I inherited a factory with 1200 control charts – the automotive SQE’s loved it. Most were not controlling anything that was relevant to controlling the process but since they had no effect on operators time – they proliferated. about 400 out of control points per day and not one shut down. Actually nobody really knew they were out of control since it wasn’t their problem. It was QA’s problem because it was their system.
    Gotta love that automation. Good, bad, or indifferent if it is available put it in or someone may think you aren’t doing the best thing possible for the process.
    Justify it with something beyond what the FDA thinks. When they become a customer or own a customers stock they I will worry about what they think. How about some original thought on your own.

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    #138136

    Lance Miboyle
    Participant

    Wow…you’ve never had the opportunity to bill an FDA-regulated company, have you?  Where you have “FDA” in your message, replace with “FBI” or “State Patrol” and re-read. 
    I am somewhat confused by your proud display of the “ownership” badge, enthusiastic protestation of “automation” of SPC, and simultaneous suggestion to “automate the process.”  Yeah, that process automation really gives the operator that sense of ownership you so value (oh, wait, come to think of it, it really does the opposite….it really, actually releases them completely of any responsibility for the process).
    So which is it?  What is your actual position?  Do you have an actual position?  Or do you know what to think only when the guy writing the check this week tells you what he’s looking for from your visit, Mr. Original Thought?
    I hear the AT will be a lot faster. 

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    #138149

    Mike Carnell
    Participant

    Lance,
    When they are a FDA regulated company they become one of the customers – pretty basic concept.
    “oh, wait, come to think of it, it really does the opposite….it really, actually releases them completely of any responsibility for the process).” Lets see you believe it relieves the operator of any ownership in the process except the SPC process. I think you get my position and my point.
    Automation has always been an alternative to SPC in some situations. By your logic you would prefer to automate the SPC to control the process (leaving the operator involved in the system and consequently some of that people induced variation you are so worried about) rather than automate the process where you know how the process operates and where it needs to run. Lets see if we can make this really complex and add SPC to it.
    This isn’t about toys. It is about business and running it effectively.

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    #138183

    Lance Miboyle
    Participant

    “Justify it with something beyond what the FDA thinks. When they become a customer or own a customers stock they I will worry about what they think.  How about some original thought on your own.”
    “When they are a FDA regulated company they become one of the customers”
    Wow!! Would you like some whipped cream and perhaps a cherry with that waffle, Mr. Carnell? 
    The operator always owns (or should always own) the process (unless someone convinces them that they don’t have to worry about it because the PLC and vision system will take care of everything – that’s a bad, bad, really bad move). 
    SPC is the best tool available for operator’s use to monitor and control all significant process parameters.  It allows them to know that what they are making is good — that they aren’t wasting their time building (s)crap — that they won’t have to come in on Saturday to rerun the batch.  Automated data collection and evaluation using one of them confounded 21st century ‘puter SPC programs with all the pretty colored charts and such affords the responsible operator the greatest possible assurance of the acceptability of the process for which he/she is already responsible.  Confidence in such a system allows him/her to feel good about what’s coming off their line, the freedom to spend more time running the equipment and less time writing down numbers, and a sense that they are doing a good job.
    And isn’t that what we’re all after:  “It is about business and running it effectively.”
    It’s like if you were to go into business selling your furniture made from sticks and rocks.  You could either set up a website to sell it online or take the position that the furniture will mean more to people who are willing to fill out an order with a pencil and paper and then mail it in.  I’m thinking you would be better off going with the computer approach (if for no other reason, simply because there would be fewer order-processing errors). 
    (btw, that was an analogy)

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    #138208

    Mike Carnell
    Participant

    Lance,
    You have yourself in a circular argument. You are willing to duck automation and dump a more operator dependant process on an operator for the sake of buying SPC software. Keep up the good work. As long as I have guys like you out there, there will be lots of business. Just keep blindly following the rules you’ll be just fine.

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    #138214

    Lance Miboyle
    Participant

    So…if I’m reading your nonsense correctly, you are in the process automation business.  I thought all this time you were a six sigma consultant trying to help companies understand what parameters need to be controlled in a process in order to minimize defective output.  Now I understand that the service you actually sell is to go into a company and automate everything (it’s all so simple that way, isn’t it?).  No responsibility, no accountability — it’s perfect! (i.e., for the consultant).
    Removing operator/human responsibility for process is NOT the path to improvement — “I thought it looked a little strange, but I knew if it was a problem the vision system would catch it.”
    My wife wants to know if you offer a dining room set (w/8 chairs) in that rustic rock/stick crap you do.  Hey, any chance you do computer workstations?  I’m gonna buy one’a them IBM AT’s! when they come out.

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    #138221

    Mike Carnell
    Participant

    Lance,
    Your lack of understanding of the Six Sigma process is amazing. Lets do the basics. It starts with Y=f(x). We sort out the x’s and get the leverage x’s. Now this may be the tough part for you. SPC is not the only solution available to you in the Control phase. Let me give you an example since the abstract doesn’t seem to register with you. If in a soldering operation I find that the solder pot temperature is critical and needs to be run at 500 degrees +/- 25 degrees I can apply a temperature controller and then I do not need to worry about the x. You view would be to put a control chart on it so I have to take the temperature, log it on the chart and adjust it. Get it – that is a dumb solution.
    SPC was a great solution in the 30’s when it was developed. That technology you claim to be such an advocate of has changed processes tremendously and SPC is not the best solution to many control situations. Currently we have a process with more than 1,000 control loops lets do your solution and take out that automation on the process and automate 1,000 SPC charts.
    You always seem to see the automation as relieving the operator of responsibility for the process but in your automated SPC they miraculously stay responsible? Keep up the good work. As long as we have people like you consultants will always have work.
    As far as your chairs – maybe if you didn’t have you head located somewhere it shouldn’t be you could earn enough to buy your own chairs.

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    #138223

    Craig
    Participant

    James,
    I have used a package called StatGraphics in the past with some positive results. I am sure there are many available today, so just make sure you do a broad search. Keep in mind that it is the overall system that will bring success. Develop a stable and capable process, and then use SPC. Make sure your OCAPS are well understood and effective. Mike Carnell makes a good point about KPIVs (Solder pot temperature in his example). If you run some well designed experiments, you probably can determine the best control methodology. (KPIVs, KPOVs, or both) Also keep in mind that data extraction is a great feature that you will get with automated SPC. A quick multi-vari analysis or Cpk analysis is quite useful! 
    Good luck!

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    #138253

    Lance Miboyle
    Participant

    Congratulations on your discovery of temp controllers;  they’ve been around since……what……the ’40’s? – good work!!  “We’ve completed our six sigma project, Mr. Plant Manager, and we recommend you put a temp controller on your solder pot.”  “That’s some good work, there, Mr. Carnell;  I’ll get someone who does actual work on that and here’s your check.”
    …and when the heating element begins to fail (see that would show up as a “trend” — see glossary — IF you are tracking for it)….or when the thermocouple begins to fail and reports incorrect values to the controller?  …….500 +/- 25 degrees?….That sounds like a spec; is your controller/pot system “capable” — see glossary — within that spec? “Don’t you worry Sally, we got us a temp controller on here and it’ll take care’a everything.  You just run them parts and don’t worry ’bout nothing.”
    You clearly advocate disempowering/demoralizing employees because you feel they must be incompetant rather than fully utilizing their full potential.  It’s people who make things work.  It’s people who understand processes.  It’s people who make improvements. 
    As long as there are consultants like you, there will be people like me (with actual jobs) making things actually work after you’ve finally graced our factories with your absence. 
    just my opinion

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    #138258

    Jered Horn
    Participant

    Lance,
    First of all, the modern form of temperature controllers is a tiny bit different than any controller that may have been around back in the 40’s.  You do realize PC’s didn’t show up until the early 80’s?
    You know how Six Sigma works, right?  In this solder pot analogy, you don’t just end the project and say, “Hey, just add a temperature controller and all your problems will be solved”.  You’re actually able to prove, with data, that if you control this temperature to +/- whatever, you will not produce a bad part.  Of course, there will probably be other key process input variables (KPIVs) that need to be controlled as well.  In the Control phase of the project, you implement/install the best type of control, that’s practicle, then show its effectiveness with verification data.  If it’s an uncontrolled temperature, a digital temperature controller is pretty much a no-brainer.  It would be silly to try to control a temperature manually, with an operator and SPC (by hand, or “automated”).
    Mr. Carnell’s comments show no evidence of him being an advocate of disempowering/demoralizing employees.  Do you really have such an issue with manual SPC?  Or is it something personal against Mike or consultants in general?
    I like gadgets, and automated SPC is a pretty cool gadget.  And, in some cases, it CAN be the best control solution.  Not always, though.  And SPC is useless if you don’t know what it’s telling you.  If you’ve measured the samples, recorded the results, ran the calculations, and plotted the points on a manual chart, you are FAR more likely to be able to interpret what that chart is telling you than if it was all done automatically.
    I really don’t think operators would have a problem with manual SPC, as long as it’s only for true KPIVs where a better control mechanism is not available, they were trained properly, and it works to the point of allowing them to produce superior quality product.
    Just my two cents.
     

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    #138271

    Craig
    Participant

    I’d have to say that I disagree about a manual chart being easier to interpret. They can be effective, but there are opportunities for error in how the statistics are calculated, how the various rules are evaluated, and even where the points are plotted.  Xbar/sigma charts are kind of out of the question. If you set up the overall system well, the operators will get a great sense of empowerment as they resolve many of the issues on their own. This holds true for manual or automatic SPC.
    It is true that control systems are more sophisticated these days, but product requirements have become more stringent, and SPC is just as valuable.
     

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    #138491

    BurghGuy68
    Participant

    We also researched a bunch of companies and found that InfinityQS was the best product out there on the market.  I’m in the food industry, but not under the stricter FDA regulations that you’re in…and I know they conform to the FDA’s CFR 21 (or whatever it’s called).
    The thing you want to be cognizant of is that it’s a databased system, not a file-based system.  Before I got to this company, we were using a file-based product, and you couldn’t compare line-to-line, day-to-day, product-to-product, etc. because everything was stored into separate files.  It sucked!  The Infinity product allowed us to do comparisons across lines, products, days, shifts, etc. and had all kinds of great analytical tools beyond just control charts, such as box and whisker plots, pareto charts, regressions, etc.
    So far we’re pleased with what we’ve got – we’re about a year into it in one plant and just starting out in the other plant.  The best part is the Assignable Cause Codes and Corrective Action Codes that force to get at the root causes and make the permanent corrective actions.  And you can pareto those as well.

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    #145803

    Ang
    Participant

    Hi, im working at a medical company producing dental products and we have all the medical restrections to work under. Before we was working with manual spc metods. But by the time it get harder and more complicated. After look on the software market we finaly deasided to use the swedish company rektrons produkt called Rektron SQC. Been working with the program for 1 year almost and its working great its based on a database and its really oprator near. And we can now get all sorts of reports out of the program by a simple button click. they have a bounch of other products to at there website http://www.rektron.se .

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    #146732

    QAEngr
    Participant

    Why did you decide on InfinityQS vs winspc? I am trying to decide on a software package for our company and dont know whether to choose winspc or InfinityQS

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    #169936

    SPCRules
    Member

    We evaluated both InfinityQS and WinSPC via several webexes.  We liked WinSPC better because  it seems more configurable (i.e. easier to “link” to external db, easier overall setup) than InfinityQS while maintaining good audit trail and traditional SPC functionality.  I also played with Infinity’s setup and it seemed more complicated.  I work with someone who had hands-on experience with InfinityQS and feels that WinSPC provides more capability and it’s easier to setup.  We wanted to choose a software that we could setup on our own with as little customization/training as possible.  We’re proceeding with a more in depth evaluation of WinSPC now.  How did your evaluation go?

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