Calibration/Worn gages

[Scott Gross]

We have a process where a slot needs to be inspected 100% per our customer. The specification of the slot is .044-.047 and we use a .0442 class "X" GO pin. The problem we are having is the pin will build up stainless from going through the slot so many times that it will measure oversize by the end of the shift, and start rejecting product. We verify the pins at the end of each shift and replace as necessary.

We use a gage trak software program to track gages and have these on a daily cycle. The question is, do we have to scan a new certification everyday into the system for the pins we replace to be compliant with ISO 13485? It is very costly to replace class "X" pins daily, not to mention if we need a 17025/A2LA cert with each one scanned in.

Because we are running to a truncated specification can we get away with just changing them out? We do verify with a .044 class "X" pin at a later process.

 

[dwperron]

We have a process where a slot needs to be inspected 100% per our customer. The specification of the slot is .044-.047 and we use a .0442 class "X" GO pin. The problem we are having is the pin will build up stainless from going through the slot so many times that it will measure oversize by the end of the shift, and start rejecting product. We verify the pins at the end of each shift and replace as necessary.

I'm a bit confused here.
Why are you measuring the slot with a pin that is larger than the accepted minimum dimension? Especially an expensive class X plug.

It seems to make sense to use a .044 class ZZ go pin, with a +0.0002 tolerance. A much more affordable choice. Then you can save your 0.0440 class X plug for the few times when the class ZZ is too large.

 

[Mustapha]

A calibration certificate is unique to each gage. If you are using a new pin each day, then you'd have to have the accompanying certificate for that pin. Could you say that the pin you used on Monday had the exact same calibration as one used on Friday?

A suggestion would be to validate the process that creates the slot so you can do away with 100% inspection. If that isn't possible, you might want to try to shift the cost replacing the pins everyday to the customer to at least offset the cost of buying that many pins. Or if you really need to keep the 100% inspection, maybe look into creating a custom go pin made with the slightly softer material so it doesn't pick up excess material.

 

[BR549]

Is the pin lubricated (oiled) when in use? Might help them last longer.

 

[Funboi]

Why do you think the pin needs calibrating?

 

[Scott Gross]

Why do you think the pin needs calibrating?

I thought that was a requirement of ISO 13485? What if an auditor asked for the calibration records for that pin gage on the floor?

Can we have a system where we don't keep a cert, and just do daily verification and replacement? What would be the correct method of documenting this activity?

 

[Scott Gross]

Is the pin lubricated (oiled) when in use? Might help them last longer.

The parts are medical assemblies, and the next operation is printing, then Teflon coating.

 

[dwperron]

I thought that was a requirement of ISO 13485? What if an auditor asked for the calibration records for that pin gage on the floor?

Can we have a system where we don't keep a cert, and just do daily verification and replacement? What would be the correct method of documenting this activity?

Have a system where at the start of the shift you gauge the pin with a calibrated micrometer.
Record the results in a log for that part.
At the end of the shift gauge the pin again. Record the results in the log.
Assess if the pin is still in tolerance

 

[Funboi]

I thought that was a requirement of ISO 13485? What if an auditor asked for the calibration records for that pin gage on the floor?

Can we have a system where we don't keep a cert, and just do daily verification and replacement? What would be the correct method of documenting this activity?

Did you check what the standard says? Working off what you think is a recipe for problems. The auditor can ask what they like. They are frequently wrong. You decide whether you calibrate or verify or both. As others have stated check the pin before use And then after. Monitor wear.

 

[Matt's Quality Handle]

Have a system where at the start of the shift you gauge the pin with a calibrated micrometer.
Record the results in a log for that part.
At the end of the shift gauge the pin again. Record the results in the log.
Assess if the pin is still in tolerance

If traceability of measurements is important, in this case, the certified micrometer would be the measurement instrument to record.

If the pin is OOT, you should have a reaction plan to quarantine and remeasure anything produced since the last successful verification.