Verification of Gages Before Use

J

jenboy

#1
I took over as QM a year ago in a mold shop that employs 23 toolmakers, CNC operators and machinists. When the company had a calibration finding for uncalibrated devices, the previous QM went through and slapped For Reference Only labels on every gage pin set, gage block set, angle block set and milling machine depth indicator. Coming from a TS environment, I get a real bellyache over FRO gages in the manufacturing process. After gage pins were inspected (we have hundreds of them) we knew we needed a tighter control, but, of course, I'm limited by cost. It is 2 bucks a pin to calibrate, a Z mic is out of my budget allowance and doing it on CMM just isn't cost effective. After talking with some colleagues in the biz, I decided to introduce a verification before use with a calibrated device policy for these types of gages, which, technically, is what the guys have been doing all along. Only this time, we've established criteria in their work instructions and the SOP for visual acceptance and defined actions to take for these gages that fail dimensional or visual verification. Here's my fear, the records that we decided to go with is the documentation of any failures and subsequent disposition by the QM after the piece is turned in, and, recording verification results on the Job Order Paperwork (the closest thing we have to a control plan) along with the ID of the calibrated gage used if the results of the measurement were used to dimensionally verify conformance to requirements. This is also outlined in the training document and the work instructions. My question is, is this compliant to ISO9000? I've gone through it word for word, tore apart the work instructions and SOP and couldn't find an audit trap, but I still have an uneasy feeling about going this way. Maybe it's because it's just not something I'm used to having come from a production environment where control plans ruled and EVERYTHING is documented somewhere; but I'm in a quandry. The guys here are stone solid when it comes to making sure their tools are in good shape and what they're using is measuring accurately - we've never had a defect reported due to a gage failure or measuring issue. Any thoughts?
 
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J
#2
Well I'm a bit rusty on this....But I like what you are doing. I don't really see a problem with ISO.....but like I say, I'm pretty rusty....
 

John Broomfield

Staff member
Super Moderator
#3
I took over as QM a year ago in a mold shop that employs 23 toolmakers, CNC operators and machinists. When the company had a calibration finding for uncalibrated devices, the previous QM went through and slapped For Reference Only labels on every gage pin set, gage block set, angle block set and milling machine depth indicator. Coming from a TS environment, I get a real bellyache over FRO gages in the manufacturing process. After gage pins were inspected (we have hundreds of them) we knew we needed a tighter control, but, of course, I'm limited by cost. It is 2 bucks a pin to calibrate, a Z mic is out of my budget allowance and doing it on CMM just isn't cost effective. After talking with some colleagues in the biz, I decided to introduce a verification before use with a calibrated device policy for these types of gages, which, technically, is what the guys have been doing all along. Only this time, we've established criteria in their work instructions and the SOP for visual acceptance and defined actions to take for these gages that fail dimensional or visual verification. Here's my fear, the records that we decided to go with is the documentation of any failures and subsequent disposition by the QM after the piece is turned in, and, recording verification results on the Job Order Paperwork (the closest thing we have to a control plan) along with the ID of the calibrated gage used if the results of the measurement were used to dimensionally verify conformance to requirements. This is also outlined in the training document and the work instructions. My question is, is this compliant to ISO9000? I've gone through it word for word, tore apart the work instructions and SOP and couldn't find an audit trap, but I still have an uneasy feeling about going this way. Maybe it's because it's just not something I'm used to having come from a production environment where control plans ruled and EVERYTHING is documented somewhere; but I'm in a quandry. The guys here are stone solid when it comes to making sure their tools are in good shape and what they're using is measuring accurately - we've never had a defect reported due to a gage failure or measuring issue. Any thoughts?
jenboy,

You'll be fine. Do not try to second guess your auditor.

Just make sure the calibrated pins or blocks are available for verifying the measuring device before each use. And remove the FRO stuff.

Toolmakers take care of their tools as second nature and they have no interest in inaccurate measurement.

John
 
H

Hodgepodge

#4
...Here's my fear, the records that we decided to go with is the documentation of any failures and subsequent disposition by the QM after the piece is turned in, and, recording verification results on the Job Order Paperwork (the closest thing we have to a control plan) along with the ID of the calibrated gage used if the results of the measurement were used to dimensionally verify conformance to requirements.
Could you explain this with a bit more detail? Are you recording the gage pin verification (before use) on the Job Order Paperwork?
 

BradM

Staff member
Admin
#5
Hello Jenboy! Thanks for dropping by the Cove!

I took over as QM a year ago in a mold shop that employs 23 toolmakers, CNC operators and machinists. When the company had a calibration finding for uncalibrated devices, the previous QM went through and slapped For Reference Only labels on every gage pin set, gage block set, angle block set and milling machine depth indicator. Coming from a TS environment, I get a real bellyache over FRO gages in the manufacturing process.
I'm probably the only human being left on the planet that believes in For Reference only stickers. :D In theory, an instrument is verified or removed. But reality has always been much more difficult than theory. Thus, I find it useful to label equipment that is not appropriate to use. I find some people need really bright big warnings to say "Hey, don't use this"!

After gage pins were inspected (we have hundreds of them) we knew we needed a tighter control, but, of course, I'm limited by cost. It is 2 bucks a pin to calibrate, a Z mic is out of my budget allowance and doing it on CMM just isn't cost effective.
I'm confused. When you state the gage pins were inspected, are you talking about something initially, or something to do with the activities you describe below?

After talking with some colleagues in the biz, I decided to introduce a verification before use with a calibrated device policy for these types of gages, which, technically, is what the guys have been doing all along. Only this time, we've established criteria in their work instructions and the SOP for visual acceptance and defined actions to take for these gages that fail dimensional or visual verification.
Ok, so you established an internal verification program. Good. :agree1: Have you verified that the program is valid, and assures that you can detect devices that are problematic prior to use?

Here's my fear, the records that we decided to go with is the documentation of any failures and subsequent disposition by the QM after the piece is turned in, and, recording verification results on the Job Order Paperwork (the closest thing we have to a control plan) along with the ID of the calibrated gage used if the results of the measurement were used to dimensionally verify conformance to requirements. This is also outlined in the training document and the work instructions.
OK, so you document the verification within the process/ job in which they were used. That's a good idea. If you can demonstrate at any time that a tool is fit for use, I don't see an issue with that.

My question is, is this compliant to ISO9000? I've gone through it word for word, tore apart the work instructions and SOP and couldn't find an audit trap, but I still have an uneasy feeling about going this way. Maybe it's because it's just not something I'm used to having come from a production environment where control plans ruled and EVERYTHING is documented somewhere; but I'm in a quandry. The guys here are stone solid when it comes to making sure their tools are in good shape and what they're using is measuring accurately - we've never had a defect reported due to a gage failure or measuring issue. Any thoughts?
I'm not versed enough to quote acceptance or anything within an ISO requirement framework. I will state that as a general rule, you want to 1) assure the standards/ tools are providing valid results, and 2) be able to demonstrate that assessment with objective evidence (documentation/ test results). Just make sure that everyone is consistent in how they apply the verifications, and the procedures are valid for picking up problems.
 
J

jenboy

#6
Hodgepodge, The verification results and gage ID's are only recorded on Job Order Paperwork if that operation specifies dimensional results are required for evidence of conformity. If the guys are using the gage for set up, double checking (we encourage, measure 3 times, cut once) and checking something not print or JOP related (max steel or steel safe condition for example) it's not required. What I did was take the standard verbatim..."The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evicence of conformity of product to determined requirements." Measurements required are determined during the planning processes, and transferred to the routing , or JOP.
 
J

jenboy

#7
I drop by quite a bit, actually. I never feel I have much input, but boy do I have alot of questions!
I agree with using the For Reference Only stickers for just that, REFERENCE. But if a device is not adequate for use, I don't see a reason for it to be accessible to manufacturing. The main problem here, is folks have been using those stickers as a loop hole without any controls. I could find no data or study results for why some equipment was calibrated a few years ago, then went to Reference Only.
As for the inspection, that's something I did after I got here. I was a bit perplexed when my calibration due report was telling me these gage pin sets were due, but when I found them, they had FRO stickers. I went through them and recorded missing pins and quarantined questionable pieces with dents, knicks, gouges, pitted areas etc. I was blown away with the condition of some of them.
So far, the program seems to be working out and the floor leads seem to think it makes alot more sense. Thanks so, so much for your input, it gave me some more to chew on!
 
J
#8
Sounds like there has been a lot of "stop gap" type actions taken before you arrived. Something that I am quite familiar with. :notme:

I think you are on the right track and over time you will be able to put together a much more coherent and useful program.
I'm sure you will get a lot of good buy-in from the floor when they start seeing the old beat up pins etc disappear and replaced with nice new pieces.

It just takes a bit of time.

James
 

DRAMMAN

Quite Involved in Discussions
#9
What was the original audit non-conformance for? Was a gage that was supposed to be calibrated not calibrated?

I have never been a supporter of FRO stickers. What does that even mean??? If an employee is using a gauge to make business related decisions then it should be calibrated.
 
J
#10
What was the original audit non-conformance for? Was a gage that was supposed to be calibrated not calibrated?

I have never been a supporter of FRO stickers. What does that even mean??? If an employee is using a gauge to make business related decisions then it should be calibrated.
I agree.

I've heard it supported by such statements as "well we just use that to confirm the material is thick enough. It's going to be machined to a different size later so this measurement is not a "product" measure.

Such a statement is fine, but if a tool is out there...It could easily be used in a way that it shouldn't.

James
 
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