Good afternoon,

I am struggling with ISO 9001:2000 clause 7.6 Control of Monitoring and Measuring Devices.

In particular, this statement:

"....the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to the requirements."

This makes sense to me - if your gage is wrong, you need to recalibrate the gage, and recheck your parts. However, how do I put this in to practice? If it takes 3 days to get my gage recalibrated at an outside lab, do I hold all my material in house waiting on gage calibration results?

I like the theory, just not sure how to comply with it in practice.

Suggestions are much appreciated.


Thanks,

Emily

Good afternoon,

I am struggling with ISO 9001:2000 clause 7.6 Control of Monitoring and Measuring Devices.

In particular, this statement:

"....the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to the requirements."

This makes sense to me - if your gage is wrong, you need to recalibrate the gage, and recheck your parts. However, how do I put this in to practice? If it takes 3 days to get my gage recalibrated at an outside lab, do I hold all my material in house waiting on gage calibration results?

I like the theory, just not sure how to comply with it in practice.

Suggestions are much appreciated.


Thanks,

Emily

Emily,

Do you only have one gage? Or do you have a backup gage? Part of planning the inspection/testing process is to determine how many gages you would need taking in consideration possible gage failure.

But to answer your question, if you only have one gage, and it's out for recalibration, you must put suspect product on hold until the gage arrives.

Stijloor.

I'm referring to basic calipers, and we have multiple sets. But, the problem still exists. If you don't know whether the gage is defective, how do you know to use the other set of calipers in the meantime? We could be measuring our products thinking we are correct, send out the gage, and find out from the lab that it's out of calibration.

That's where I'm stuck.

Good afternoon,

I am struggling with ISO 9001:2000 clause 7.6 Control of Monitoring and Measuring Devices.

In particular, this statement:

"....the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to the requirements."

This makes sense to me - if your gage is wrong, you need to recalibrate the gage, and recheck your parts. However, how do I put this in to practice? If it takes 3 days to get my gage recalibrated at an outside lab, do I hold all my material in house waiting on gage calibration results?

I like the theory, just not sure how to comply with it in practice.

Suggestions are much appreciated.


Thanks,

EmilyTypically, we do the same thing with gages that we do with tooling and with supplies used in operating our businesses - we have redundant backups, especially on those things which would bring our business to a standstill if they get broken, lost, or otherwise unsuitable for use.

As a good business practice, organizations have planned maintenance of the operating machines and instruments used in manufacturing a product. When in the course of normal maintenance of gages, it comes time to send the gage out for calibration and certification to an NIST Standard, most businesses switch to the backup and make the newly calibrated gage the backup when it returns.

If we are discussing a very expensive instrument like a CMM, a Profilometer, or a super micrometer, of which many companies cannot afford to keep a spare, then damage or other breakdown probably will halt production until the instrument is repaired or replaced. Some folks are able to ameliorate that delay by getting or renting a "loaner" until the original is repaired. It's simply a cost analysis - which is less injurious to the business - paying for a loaner for a few days or weeks or shutting down production for the same period?

Thanks Wes. I suppose I wasn't very clear in my original posting. We have backups, but what if we don't know the original gage was nonconforming? We used the backup while the original was out for cal, shipped the product, then found out the original was not measuring properly.


Thanks,

Emily

I'm referring to basic calipers, and we have multiple sets. But, the problem still exists. If you don't know whether the gage is defective, how do you know to use the other set of calipers in the meantime? We could be measuring our products thinking we are correct, send out the gage, and find out from the lab that it's out of calibration.

That's where I'm stuck.
If you don't know whether the gage is defective, how do you know to use the other set of calipers in the meantime? We could be measuring our products thinking we are correct, send out the gage, and find out from the lab that it's out of calibration.
You could try verifying the calipers you have with gage blocks that are traceable to N.I.S.T. before using them.

Hmmm...use gage blocks everytime I use the calipers? Then, what if the gage blocks are out of tolerance and we don't realize it? I know, I'm getting myself mired in the details, but I'm trying to figure out how to comply with the requirement, which I like, but can't see how to achieve.

Thanks!

I'm referring to basic calipers, and we have multiple sets. But, the problem still exists. If you don't know whether the gage is defective, how do you know to use the other set of calipers in the meantime? We could be measuring our products thinking we are correct, send out the gage, and find out from the lab that it's out of calibration.

That's where I'm stuck.

Long time ago, when I was a machinist, we used "shop standards." Every time at shift start and at the start of a new job, we were required to perform a quick check to ensure that our mikes and calipers were still "speaking the truth." If we found a gage out of calibration, we turned it in to the gage lab for recalibration. Then we checked out another gage from the tool crib. Bottom line: think about acquiring shop standards. They are available and will not break the budget.

See attached picture.

Stijloor.

Hmmm...use gage blocks everytime I use the calipers? Then, what if the gage blocks are out of tolerance and we don't realize it? I know, I'm getting myself mired in the details, but I'm trying to figure out how to comply with the requirement, which I like, but can't see how to achieve.

Thanks!

I think you overanalyze this situation too much. Compared to your calipers, there's a very low likelihood that the gage blocks or standards will be out of calibration. Read my other post about shop standards.

Stijloor.

Thank you to everyone for their comments. Is this truly what everyone does? Verify their gages at the start of each shift or at some interval? It's a great thing to strive for, but it seems a bit idealistic. Maybe not?

Thanks,

Emily

Hmmm...use gage blocks everytime I use the calipers? Then, what if the gage blocks are out of tolerance and we don't realize it? I know, I'm getting myself mired in the details, but I'm trying to figure out how to comply with the requirement, which I like, but can't see how to achieve.

Thanks!

Emily, calibration is about risk and cost. The less risk will cost more. You need to find a happy middle ground for your application. What is your risk of impact from out of calibration equipment? The higher the risk, the more you need to tighten the process.

You have these sets of calipers. You can measure product with two instruments, you can check them every day, once a week, before every use with gauge blocks, send them out more frequently,etc.

Now you have this out of tolerance report. Hopefully, you had them calibrated at a competent vendor. Thus, they will report the values and their uncertainty. Determine if the measured error impacts your process at the point of failure. If it does, well, depending on the industry, requirements, etc., you may need to contact customers for follow-up, recall, spot checks, etc.

Now, some of this I offer is very vague and high level. There is a multitude of options, depending on your needs. Have you documented remedial action in your procedures?

I hope something here helps.

Thank you to everyone for their comments. Is this truly what everyone does? Verify their gages at the start of each shift or at some interval? It's a great thing to strive for, but it seems a bit idealistic. Maybe not?

Thanks,

Emily

Again, depending on the risk and the like, yes they do. Some verify before each application and after.

If the gage is in fact out of calibration, the calibration lab will determine by how much. Your product may still be within the specified tolerances (i.e. +/- .005) if your parts measured at the median dimension. If the gage was badly out of specification, you should notify the customer(s) and let them decide if they want the product re-inspected. All product still in-house should be reinspected with a known good instrument. If you notifiy the customer be sure you have prepared your root cause corrective action for them to review. Their first concern after impact to them will be "how did this happen?".

Good Luck,
Rob

:bigwave:

Good day, You can use your back-up and how to make it sure
or validate that your product is ok with the use of original measuring
tool if you are practicing keeping of master sample you can correlate
this to your affected product or you can use your keep sample when
the time the gage was OK.
Hope this would help

Dmimore

Good afternoon,

I am struggling with ISO 9001:2000 clause 7.6 Control of Monitoring and Measuring Devices.

In particular, this statement:

"....the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to the requirements."

This makes sense to me - if your gage is wrong, you need to recalibrate the gage, and recheck your parts. However, how do I put this in to practice? If it takes 3 days to get my gage recalibrated at an outside lab, do I hold all my material in house waiting on gage calibration results?

I like the theory, just not sure how to comply with it in practice.

Suggestions are much appreciated.


Thanks,

Emily


Emily,
What has your history been in regards to calibration and gages being out of tolerance? How have you dealt with the out of tolerance condition? Has the out of tolerance condition had an impact on your production? What corrective actions were taken to resolve (1) the production, (2) the gage? Was the out of tolerance condition caused by operator error, was retraining required?
These are questions I would go through and possible but into your procedure/work instruction to deal with the out of tolerance conditions when they occure.

Phil

Emily,
What has your history been in regards to calibration and gages being out of tolerance? How have you dealt with the out of tolerance condition? Has the out of tolerance condition had an impact on your production? What corrective actions were taken to resolve (1) the production, (2) the gage? Was the out of tolerance condition caused by operator error, was retraining required?
These are questions I would go through and possible but into your procedure/work instruction to deal with the out of tolerance conditions when they occure.

Phil


Thanks Phil - we really don't have any history. The gages have never been calibrated, and I am setting up the QMS from scratch. I think your comments and everyone else's have really helped (combined with a good night's sleep :) )

I now have a lot of good advice to go on. I got myself mired in all the "what-if's".

Thanks everyone for your help!

Emily

<snip> I am setting up the QMS from scratch.

Hi Emily,

If you have to set up a QMS from scratch, please do come back here often.

My Fellow Covers are very eager to help someone who is willing to learn and eventually will help others.

Happy Easter!

Stijloor.

Thank you! I have visited MANY times. It helps to get other people's opinions of how to interpret the standard.

Happy Easter to you too!

Use the Risk Based approach and decide what measurements can affect your product compliance. Once you map those measurements start to collect the used calibration tool ID for each batch or product; Meaning make the calibration tool ID part of your product DHR. Now you will be able to traced back products that were measured with defective calibration tool. Remember that once you detected such an incident, you might end with a detailed analysis that will explain why despite of tool being out of spec the product is still comply. For example, if the tool exceed at 6% and all your measurements after adding this deviation will be still in range.
In my current factory important measurements are done twice with two different tools in order to eliminate the probability.

I got myself mired in all the "what-if's
Emily

Easy to do..."lost in the supermarket" by the Clash

Sometimes it's too easy. Most "good" machinists zero check a mike before they use it. A fast, free verification.

If the dimension really really matters, a single shop floor gage block is really really cheap investment. A lot of mikes ship with a non certified block, good enough for a gut check at least.

Or they can measure something else (edge of table, plug gage) that is always at hand just as a reality check.

And a skilled machinist will often just sort of feel "this seems weird" and bring the gage to the cal lab for a check.

For a really really important dimension, there is usually another downstream check that could catch the upstream error. If there isn't
you may want to think of setting something up.

Often times when this crops up, terrible production and sales pressure comes to bear on quality. Good luck.