Does Torque Gage Need Validation?

[aufa_fadhli]

Hi All,

Currently, measurement of torque of cap is conducted manually (twisted by hand). The inspector will twist the part (cap) that attached on torque gauge until loose then record the result. Based on this, my company just design new semi auto torque machine to reduce variance due to different operator. The inspector only put on the machine jig and let the machine twist the cap until loose. Speed of motor will be in fix setting.

Based on ISO 13485:2016 Clause 7.6 Control of monitoring and measuring equipment which states " As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified or both......

So, does this new system need validation?, or is calibration enough?. Since ISO only states "be calibrated or verified or both"
If do validation, is Gauge R&R study suitable for this case?

Thanks in Advance

Aufa

 

[somashekar]

Hi All,

Currently, measurement of torque of cap is conducted manually (twisted by hand). The inspector will twist the part (cap) that attached on torque gauge until loose then record the result. Based on this, my company just design new semi auto torque machine to reduce variance due to different operator. The inspector only put on the machine jig and let the machine twist the cap until loose. Speed of motor will be in fix setting.

Based on ISO 13485:2016 Clause 7.6 Control of monitoring and measuring equipment which states " As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified or both......

So, does this new system need validation?, or is calibration enough?. Since ISO only states "be calibrated or verified or both"
If do validation, is Gauge R&R study suitable for this case?

Thanks in Advance

Aufa

Hi Aufa.
Based on your explanation, you have to verify the torque applied by the semi auto torque machine periodically with a calibrated torque gauge.
I would suggest you have a torque gauge and have it calibrated, and verify the semi auto machine daily before the beginning of work and record the same.

 

[Nadaabo]

I agree with somashekar.

You only need to calibrate tool that you use to validate what you're producing. If the torque value is required in order to qualify if the part is pass or fail, then it does need to be calibrated or verified and you can use a calibrated torque gauge for that.

If the tool is only used to help the operator assemble, then you should verify it's in good condition, but calibration is not necessary.

You should have a procedure to verify that the tool works well (no loose parts, no damage, etc.) periodically depending on how often you use it.

 

[aufa_fadhli]

Thanks for your responds,

Yes, this torque is to qualify the part PASS or FAIL.
What kind of verification to be conducted?. Since the torque test is destructive testing? any recommended statistical tools? or the way to set up verification?

Aufa

 

[somashekar]

Thanks for your responds,

Yes, this torque is to qualify the part PASS or FAIL.
What kind of verification to be conducted?. Since the torque test is destructive testing? any recommended statistical tools? or the way to set up verification?

Aufa

You are testing the torque applied by the semi-auto torque machine using the torque gauge.
This is not distructive.
Your semi-auto torque machine can be set to various torque.
You set on the semi-auto machine to such required torque, and verify it using the torque gauge that the machine applies that much
torque.
Initially, when you do not know how much torque is required to be applied, you may conduct some destructive tests till you reach your required torque. There after you only verify the torque applied by semi-auto machine. When you change the cap material or any other changes you may need to check if the torque set is still good or you need to readjust.