Risk analysis for gauges - Definition and how to determine

[bpillar]

Hello everybody

During our last ISO-TS audit we received an opportunity of improvement regarding the measurement sistems (gauge, tools, etc.). In particular the auditor ask me, in we have in place a risk analysis for each gauges. That means what happen if a gages work not properly or if it's required to repair it.
Do someone can suggest me a quick metod to evaluated each gauge type, and define a risk analysis?

Thanks a lot to who can help me.
Best regards.
Sandro

 

[Al Rosen]

Hello everybody

During our last ISO-TS audit we received an opportunity of improvement regarding the measurement sistems (gauge, tools, etc.). In particular the auditor ask me, in we have in place a risk analysis for each gauges. That means what happen if a gages work not properly or if it's required to repair it.
Do someone can suggest me a quick metod to evaluated each gauge type, and define a risk analysis?

Thanks a lot to who can help me.
Best regards.
Sandro

The evaluation should be by application or where the guage is used rather than by guage type. If a guage measurement is incorrect how severe is the result. What have you done to minimze the risk of this occurring? This post in the medical devices forum describes a technique you can apply to your guages.

 

[bpillar]

That's clear. I will try to understand better looking the link you gave me.

Thanks a lot.
Best regards.
Sandro

 

[KyleB]

I'm also looking for a risk analysis tool that incorporates all our gages. I understand the link is set up like a FMEA, but I need something a little more basic I believe. Looking for examples of what others have done to satisfy this element. Thanks.

 

[Miner]

I don't have an example to share, but have a few ideas to throw out there.

Try brainstorming some major risk categories first. Let's say one major category is Availability. For a gage such as a micrometer or caliper, this is probably low risk. Most facilities would have a few spares that could be substituted if one broke. On the other hand, with a specialized air gage or a CMM, you probably wouldn't have a spare sitting around if they broke, so these would be higher risk.

Another category might be Calibration. If the gage is out of calibration, what is the risk for all of the product inspected with that gage since the last time it was calibrated? If the dimensions are not critical, it would be low risk. If they are critical it would be high risk.

These are just examples meant to stimulate thinking.