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Building a new QMS and/or Calibration system from scratch.

Wes Cisco
Hello Everyone,

I get to help bootstrap an ISO 9001:2015 compliant, (with an eye towards possibly certified), QMS. We currently have only some ad hoc procedures in place that our many individuals with major automotive manufacturing backgrounds have brought with them. We do not at this time have a Quality Manual. I would greatly appreciate any templates, tips, tricks, words of wisdom or derision you care to share.

We are going to purcahse the official ISO 9001:2015 document. Are there any accompanying ISO docs that we will also need?

Where does one begin to create a Quality Manual? (Why recreate the wheel?)

In addition to helping create a Quality Manual, I am going to be overseeing the creation/implementation of a Gauge Tracking/Calibration/Certification system. We currently do not have anything in place. Aside from our main metrology tools, only a few 'hand tools' recently purchased are still covered by the certification they shipped with, but the vast majority are out of calibration.

Can we designate most of that stuff as 'ref only' under ISO 9001:2015?

Or should we plan to get rid of anything we can not calibrate/certify?

What Gauge Tracking software do you like or dislike and why?

Is anyone just using Excel and storing associated documents in folders by Gauge number? Any problems from auditors about doing it this way.

We as a company are also looking into software to track and plan maintenance needs. It has been suggested here we could make such a platform do double duty by treating each Gauge as an Asset. If anyone is using a single software for both Gauges and Maint, please tell me about it.

From an economic and logistical stand point it seems our best option would be to get/keep our main metrology tools certified/calibrated (CMM, Surface Plate, Optical Comparator, CTS Leak Tester, Torque Wrenches/guns, Hardness Tester, etc.), and some 'master' artifacts like gauge blocks and rings, then do all the small stuff in house, (gauge pins, calipers, micrometers, etc.)

What do you do?

Do you think a Super Micrometer or the like is necessary?

I could use some resources for planning a system, advice on calibration stickers, pitfalls to avoid before an auditor finds them, etc.
One of our engineers has suggested we consider hiring a contractor for calibration/NIST traceable. (Trescal)

We have several devices and fixtures we have custom designed for our manufacturing line. We will need to develop work instructions and pass/fail criterial for all of those.

Thanks in advance for sharing your lessons learned.

tl;dr - If you had the opportunity to build a new ISO 9001:2015 quality or calibration system/department what would your bullet points be?
  • Thanks to everyone for the replies. I have purchased a copy of ISO 9001:2015 and am in the process of digesting it.


    There will probably be more targeted questions in the future.

    Alien
  • in reply to JEFMAN
    I'd buy one too. If personally signed by JEFMAN... and the cert reads:
    Designed by JEFMAN. Built by JEFbots. Inspected by JEFMAN.
    It would be beyond reproach. Sunglasses

  • What Gauge Tracking software do you like or dislike and why? gagetrak is pretty sweet We use GAGEpack, I have looked at gagetrak and they both are similar however gagepack has a few extra features that we as a company liked. Both do a trial version I believe so you can check it out.

    Is anyone just using Excel and storing associated documents in folders by Gauge number? Any problems from auditors about doing it this way.     I've done it in the past. It works. As long as the system you set up is established, documented, implemented, and maintained... and can be explained to the auditor... then there will be no issue. I find this method of gage control to be cumbersome. There are relatively inexpensive softwares available that do a better job then excel but to each their own I suppose. We used excel for many years at various sites across the UK, it was OK but you really have to work at it and I wouldt recommend if you have a lot of gauges as you will miss something. With gagepack we can have a central database that everyone can access, we can then share gauges and everything is compliant and traceable wherever it goes. You can also set up an automatic email system to email the relevant department, say a month before calibration is due. You can add whatever you want into gagepack, including maintenance tasks (see your question below) which are then separate to the calibration tasks. You can also add things like does the outside company (Like Trescal) still have a UKAS certificate, a reminder is set every year to check this.

    We as a company are also looking into software to track and plan maintenance needs. It has been suggested here we could make such a platform do double duty by treating each Gauge as an Asset. If anyone is using a single software for both Gauges and Maint, please tell me about it.     Start looking into getting a proper ERP. Excel is the cheap and at first comfortable way to go..but as you grow you need something that will grow with you and not hold the company back.

    From an economic and logistical stand point it seems our best option would be to get/keep our main metrology tools certified/calibrated (CMM, Surface Plate, Optical Comparator, CTS Leak Tester, Torque Wrenches/guns, Hardness Tester, etc.), and some 'master' artifacts like gauge blocks and rings, then do all the small stuff in house, (gauge pins, calipers, micrometers, etc.)     Yes. Do this. We have an expensive set of blocks that we send out to calibration and then use those for all calipers, mics, layout equipment, etc...

    What do you do?     See above

    I could use some resources for planning a system, advice on calibration stickers, pitfalls to avoid before an auditor finds them, etc.
    One of our engineers has suggested we consider hiring a contractor for calibration/NIST traceable. (Trescal)     I am not sure what your engineer is talking about. NIST is an organization that writes standards that are then used to calibrate things in our industry. Every calibration house I use will utilize NIST traceable standards and those will be listed on our cal certs.... We don't put calibration stickers on anything really, as long as the database is upto date the auditors have been happy about this. This also means you dent get caught leaving an out of date sticker on something that is ok.

    We tailor each situation to each site. For example where I work we have 4-5 "master" gauges which are sent out for external UKAS(or American equivalent) calibration. These are only used for calibrating other gauges and nothing else. We do this is it is cost effective to have master gauges as we have hundreds of pin gauges and DTI's on site and each one is around £10-15 to get calibrated externally. Or £3-400 a day for someone to come on site. One of our other sites only has a few gauges so they get an external company (actually Trescal in this case) to come on site and calibrate everything. They have them in 2-3 times a year which covers everything for them, but does offer much flexibility as the gauges have to be available on that day for calibration.



    Just added a few things to Dan's post. Sorry about some of the text being small, I couldn't increase its size.

    I would also recommend getting an external auditor in before you do all this to do an inspection off of the books. We did this for the recent change to IATF16949, it isn't cheap but having someone find all the things you have missed is a good idea (you will miss something).
  • Here I'm currently in charge of programming and running the cmm, but I'm also responsible for keeping up with calibration of calipers, micrometers, tape measures etc. basically all of the hand tools, but for torque wrenches, gage blocks and any other special tools are sent out for calibration.

    We have Gage Track and I would strongly recommend you stay away from it, half the battle is getting it started-because it will crash. And the labeling on items calibrated usually include a 1-Gauge ID 2-date of calibration and 3- due date of cal.

    We recently had and audit in Feb. the biggest thing when it came to calibration was making sure any item out on the floor had a calibration sticker and was not due for calibration, this includes quick check templates or check fixtures.

    And if the first time you have an audit performed the auditor will be somewhat lenient and wont be digging in to deep.
  • I have little input, but I mise'well share.

    We use Microsoft Access to keep track of gages, calibration dates, emailing notifications, etc.
    I'm not sure who, but somebody I've never met programmed a custom Access database that stores all of the relevant information, such as the gage, type, location, relevant calibration dates, contact info, etc.
    It's kind of cool, because it can be easily (relatively speaking) customized to fit any application, add/remove items and queries, set up visual representations of whatever crap, blah blah.
    It's quite unprofessional,and as clunky as the guy made it.
    BUT
    If you happen to know a guy, maybe they can get a better set up programmed. It's all VBA, AFAIK, and not intrinsically difficult to add new items and queries, if you have the time.

    I would probably recommend something more professional, but it does work, it's cloud based so anyone can access it from wherever, you can set up custom dashboards and the like.. There are pros and cons to every situation, obviously.

    We also happen to use Access for our rejection database, so anyone with access can go in, fill out a form, save & email it to the relevant departments with a button click.
    Our particular set up is quite inefficient, but that's us; I guarantee this idea taken with a grain of salt can be implemented successfully.

    I don't know much about ISO, but AFAIK they don't necessarily set a standard; they look to you to set a standard for yourself that both you and they can understand and implement, and they just make sure it's implemented and it works for your company.
    As long as you can set something up, it doesn't necessarily matter about professionalism or how much $$$ you spent on the latest and greatest software no one can understand.
    .02
  • in reply to kingsld1
    You beat me to it! I use to comb 'The Elsmar Cove' back when QMS stuff was of interest to me. I lost interest once I found out that the thicker you make your QMS the more likely you'll pass an audit. I was told that the auditor will weigh your QMS book and if it's 20lbs or more you'll pass! I thought to myself what a monkey you are you'll never pass an audit! The buffoon passed and he is still doing contract work for small shops around here. I'm still convinced there are good QMs out there. I've gone into other things and haven't thought about perusing QM stuff again, maybe one day you never know.
  • in reply to Wes Cisco
    Feel free to reach out any time.

    I haven taken AS9100 Lead Auditor Training
  • I suggest a file cabinet with a folder for each gage or type of gage, a gage management software program that will spit out reports of gages due for calibration and such, a Brother P-touch type label maker, and a 'gage cloud' of some sort off-site to store electronic copies of certs. Usually ISO 17025 labs also store electronic versions of their certs that can be accessed, as well, I believe.

    Each gage should be labeled with the S/N or whatever naming convention you devise, the cal date and due date, and location. We use Engage software. Doesn't crash, but it's pretty antiquated.

    "Reference Only" gages at my place of work are for those things 'not used for quality decisions', like a bubble level used to check if something is in the correct position to be assembled or something like that.

    Nothing is complicated, it's simply an exercise in organization.

    The QMS I am subject to is that of a giant global corporation, but I'm sure it's very similar to ISO 9001.

    If you calibrate in-house using gage blocks and such, those need to be ISO 17025 certified/calibrated, and you probably need a lab scope with uncertainties, a temperature budget, work instructions and all kinds of other stuff.

  • Wes, so your company is not ISO 9001 certified. ISO 9001:2015 is the easiest of all certifications to get and you can implement it yourself or bootstrap it but I would not advise it. Hire a firm to set it up for the whole company. ISO is not a quality function alone, its a management system.
    I hate that people refer to it as a Quality Manual like it is only part of Quality Control but it is not. It is in actuality a Quality Management Manual which encompasses the whole company from upper Business Management, purchasing, shipping and receiving, maintenance, HR, every department including Quality.

    We are right now stepping from ISO 9001 ( which is the easiest accreditation you can get) up to ISO/TS 16949:2009 which allows us to do aerospace and international and its a pain in the *** and it really is at least 1 person job to keep it going let alone to set it up. Sure you can do the quality department side but not the whole thing.

    ​

    The ISO 9001:2015 standard requires your organization address seven key areas to achieve continual improvement:
    • Context of the organization.
    • Leadership.
    • Planning.
    • Support.
    • Operation.
    • Performance evaluation.
    • Improvement.
    ​As for gage calibration system I use excel for tracking. No one really needs a complicated system to let you know what is due today and tomorrow.
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