Calibration Label issues

[SGCalLab]

I manage an internal calibration lab in a manufacturing facility. The lab is not currently ISO 17025, but we do work for an outside calibration provider.

The facility has their own quality program which we follow, not the calibration company's. In their process, we are to use their calibration due labels, which we punch out the month/year due. Besides the company logo, that's about all there is on the label.

Our lab has been short staffed for many years and we have a lot on our plate. We do the best with what we have, but occasionally, an error on a label, with it having the wrong date, label fell off or maybe one was not put on. Of course our internal quality auditors always seem to find the ones with the bad label. In every instance, the device WAS calibrated properly and on time.

We have recently added a third person to our staff and things are getting more under control. We have a 4-eye check on devices that leave the lab. On fixed items in the plant, we typically had not had the manpower to send a 4-eye person out to look at the label (very large plant).

I feel we are doing the best we can with the amount of tools we have plus the limited manpower we had. We never have any other issues in small or large audits, other than a label now and then. The facility wants us to come up with a root cause analysis to solve this "recurring issue".

It's frustrating since the operators of the tools appear to have no responsibility to report label issues even though they are supposed to. The blame is always on us. The reason seems to be clear that they DO NOT look at the labels. We have an automated email recall of tools when they are due. That's the only way the owners really know the device has been through calibration.

I want to solve this issue, it drives me nuts, but I'm not sure what more we can do on our side. It seems like we are the only lab in the world that has a handful of bad labels over 4-5000 calibrations we perform each year. I have been here for ten years and this has been the manufacturer's only complaint of our work.

Can you help me provide a root cause analysis?

 

[John C. Abnet]

Good day @SGCalLab ;
Simple reminder.

There is no need to have a "calibration sticker". It is reasonable/acceptable to simply have an id/discrete identifier (e.g. serial number). on each device that is linked to/traceable to your calibration status tracking. It is simply not feasible to place/retain "stickers" on all types of devices in all types of situations.

Hope this helps.
Be well.

 

[SGCalLab]

Good day @SGCalLab ;
Simple reminder.

There is no need to have a "calibration sticker". It is reasonable/acceptable to simply have an id/discrete identifier (e.g. serial number). on each device that is linked to/traceable to your calibration status tracking. It is simply not feasible to place/retain "stickers" on all types of devices in all types of situations.

Hope this helps.
Be well.

Thank you John. I wish it was that easy, but here is what the manufacturing facility that we work for says in their process for "Test Equipment":

Test Equipment is marked with a calibration label with month/year of next calibration.

They also appear to allow an RFID tag that could be read by "sensors" through the database.

 

[John C. Abnet]

Thanks for the

Test Equipment is marked with a calibration label with month/year of next calibration.

They also appear to allow an RFID tag that could be read by "sensors" through the database.

Understood...thanks for the feedback.
Sadly, this is likely just a 'boilerplate' statement that someone created years back (with little forethought), and now everyone is stuck with it. It might be advisable for you (your commercial team?) to reach out to them and discuss/revisit the situation?

Aside from that, there are all type of laminate "overs tickers" and other methods out there that I've used/seen available, but on certain devices and in certain environments, those are not good solutions either. Best of luck (Let us know what you learn/determine).

Be well.
John

 

[Scanton]

John C. Abnet is 100% correct.

We do not have date stickers on our thread gauges as they are externally calibrated after set a number of uses and not to a date. I am not paying to calibrate a gauge that has been sitting in a draw unused for a year, that would be stupid and wasteful, although I know companies that do it. All of my gauges have a unique serial number.

We do use "next calibration date" metallic dots on the gauges we calibrate in house like a micrometer, callipers and plain plug gauges. Because of the oil used in the production of our product traditionally come come loose, so in recent years I have been painting them with a clear nail varnish t stop the oil getting under the label, which seems to work.

What are you doing the root cause analysis for, missing labels, no labels or wrong dates, as these are three different problems probably with three different root causes.

 

[SGCalLab]

John C. Abnet is 100% correct.

We do not have date stickers on our thread gauges as they are externally calibrated after set a number of uses and not to a date. I am not paying to calibrate a gauge that has been sitting in a draw unused for a year, that would be stupid and wasteful, although I know companies that do it. All of my gauges have a unique serial number.

We do use "next calibration date" metallic dots on the gauges we calibrate in house like a micrometer, callipers and plain plug gauges. Because of the oil used in the production of our product traditionally come come loose, so in recent years I have been painting them with a clear nail varnish t stop the oil getting under the label, which seems to work.

What are you doing the root cause analysis for, missing labels, no labels or wrong dates, as these are three different problems probably with three different root causes.

Just to give everyone a little insight, the plant we work at is in the US and the parent company is German with multiple plants across the world. The program is for every plant and in the US we are the only plant with an internal calibration lab.

The root cause analysis would be for all three issues you mentioned. At one time or another we've had one of those issues. In the recent audit finding that I have to reply to, out of 24 similar items, one device had a one year tag on it instead of two years. The second item was a fixed scale that was done by a third party scale company. No label was put on. (This was in an area that is very difficult for me to access on my own).

 

[malasuerte]

Just to give everyone a little insight, the plant we work at is in the US and the parent company is German with multiple plants across the world. The program is for every plant and in the US we are the only plant with an internal calibration lab.

The root cause analysis would be for all three issues you mentioned. At one time or another we've had one of those issues. In the recent audit finding that I have to reply to, out of 24 similar items, one device had a one year tag on it instead of two years. The second item was a fixed scale that was done by a third party scale company. No label was put on. (This was in an area that is very difficult for me to access on my own).

So - there are a couple of thoughts I have here. I can help with some ideas if you would like to discuss in depth.

But simply put, there are a few choices:

1. If you keep the requirement, Change the mindset of the organization - Your Quality Internal Audit program should be viewed as an ally to catch times when the requirement is not met and add a Response Flow which directs that 'any tool missing label, etc needs to be sent in immediately"
2. If you keep the requirement, figure out how to ensure the labels can be secured better (additional tape, a sleeve, etc)
3. If you keep the requirement, put in a different process with Calibration Coordinators in the plant in each of the areas responsible for management of tools.
4. Change the requirement, as noted above - you could go off the ID only.
5. Change the requirement, go off the ID only, improve your inventory management cycles (Calibration) - I often find inefficiencies in how the calibration cycles are set

Anyways - I have more thoughts, and been through it all, but would need some more info to work through what would work best.

Feel free to DM

 

[dwperron]

"I am not paying to calibrate a gauge that has been sitting in a draw unused for a year"

You should come visit my lab and see how we have gauges - pins, plugs, and rings especially, that change size without being used. It is a reality based on the crystalline structure of the steel degrading with time. You just can't assume they will always be the same size just because they aren't being used:

Why Gages Can Grow In Dimension - Meyer Gage

 

[dwperron]

"It's frustrating since the operators of the tools appear to have no responsibility to report label issues even though they are supposed to. The blame is always on us. The reason seems to be clear that they DO NOT look at the labels. "

In our organization we have a requirement that the users of the tool must make the determination as to whether a tool is required to be calibrated for the job (our work instructions will define that requirement), and if it does require calibration that they must validate that it is in a calibrated state. They can do that with a label, barcode, a database, a log, whatever meets the situation. That way the users know that they are responsible when they use an out of date tool. And their supervisors are responsible for them being trained in this practice.

 

[Mike S.]

"I am not paying to calibrate a gauge that has been sitting in a draw unused for a year"

You should come visit my lab and see how we have gauges - pins, plugs, and rings especially, that change size without being used. It is a reality based on the crystalline structure of the steel degrading with time. You just can't assume they will always be the same size just because they aren't being used:

Why Gages Can Grow In Dimension - Meyer Gage

Interesting but the report says "Any growth detected after the first year will most likely be considered within the range of measurement uncertainty or be explained away as being from different technician, equipment or laboratory variation. "

So for most of us, why be concerned about growth?