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

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?
Parents

  • 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).
Reply

  • 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).
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