7.6 - Validity of the previous measuring results - Is this what validity means?

[michelle8075]

Having a little trouble, but sure that you guys can help me out and clear my brain up....... (It's Friday before July 4th for goodness sake!)

Here's what I am looking at:

7.6 "In addition, the org shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirments........."

We are a machine tool mfg. (we don't make widgets). Would I be correct in saying that if we for example use a calibrated caliper to measure a feature and it is found to be ok, but then we find somewhere down the product realization process that that part is nonconforming that we have to re-verify that the caliper is still w/i calibration?

If this is so, can I just state that "If previous measuring results are found not to conform to requirements, we send the suspect measuring device to the approripate calibration vendor and compare results of the last know calibration record to the new calibration record" (I know the sentance is chopping, but just for illustration purposes). OR do I even need this documented someplace?

 

[Al Rosen]

Having a little trouble, but sure that you guys can help me out and clear my brain up....... (It's Friday before July 4th for goodness sake!)

Here's what I am looking at:

7.6 "In addition, the org shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirments........."

We are a machine tool mfg. (we don't make widgets). Would I be correct in saying that if we for example use a calibrated caliper to measure a feature and it is found to be ok, but then we find somewhere down the product realization process that that part is nonconforming that we have to re-verify that the caliper is still w/i calibration?

If this is so, can I just state that "If previous measuring results are found not to conform to requirements, we send the suspect measuring device to the approripate calibration vendor and compare results of the last know calibration record to the new calibration record" (I know the sentance is chopping, but just for illustration purposes). OR do I even need this documented someplace?

The equipment referred to is your "caliper". If it is found to be out of calibration (tolerance), then you must determine what the effect was on the product that was inspected using that caliper.

 

[michelle8075]

The equipment referred to is your "caliper". If it is found to be out of calibration (tolerance), then you must determine what the effect was on the product that was inspected using that caliper.

I wish there was a little icon with a light bulb going on next to someone's head! So, what I have to be able to prove is that I have a "Paper-trail" of sorts showing how I know where that "caliper" was used and when vs. the last time it was calibrated for immediate recall.

Is that right?

 

[Rob Nix]

Exactly as Al said, if the caliper is out of calibration, you have to go back to the last things checked with the device to ensure there were no problems (and it should be traceable).

Being machine tool builders ourselves however, we have downplayed this requirement somewhat because, unlike mass producers of parts, we are in some ways our own customer. For example, if we checked a machined detail with a micrometer that was later found out of calibration, but it apparently assembled OK and the machine functions, we don't bother prying to deeply. If the part had been too far out, it would not have assembled and would have been immediately fixed.

 

[Al Rosen]

I wish there was a little icon with a light bulb going on next to someone's head! So, what I have to be able to prove is that I have a "Paper-trail" of sorts showing how I know where that "caliper" was used and when vs. the last time it was calibrated for immediate recall.

Is that right?

Si. You should also be able, from your records, determine whether recall is necessary and if not, justify it.

 

[michelle8075]

Thanks Al & Rob! Your comments were extremely helpful.

I see that as a Machine Tool Builder that this "shall" doesn't have that big of an impact on us. I don't think I can ever recall in the past 4 years I have been employeed here where we have had to face this condition.

One more "shall" down for me! Yeah! I am move on to Measurment & Analysis!

Happy July 4th guys! Hope it is a "blast"