Review the validity of previous monitoring and measuring results

[T.J. - 2005]

First time posting, Been coming here for years and have gonna alot of help just reading forums. I am kinda shy and the quite type.
As I read "Review the validity of previous monitoring and measuring results when equipment is found out of calibration, and take necessary actions."
I believe I am looking for evidence of assessing and documenting the validity of previous test results when inspection equipment is found to be out of calibration.
Now I know you need to take action to check product measured by device.
But I read this to say " look at previous test results, if device was out of calibration last time. 1 you need to look at how the device is used 2 the frequency of calibration and 3 Personnel using device and determine action needed.
Am I going in the wrong direction here?

 

[Mike S.]

T.J.,

I look at it like this: Say I calibrate my micrometer and find it was measuring + .0005" over actual values, while my procedure says they should read within +/- .0001" to be considered "in cal". Now, I need to determine what (if any) product(s) I measured with these micrometers between the time I knew they were in cal and when I found them out of cal. Say I calibrated them May 1 but did not use them until July 1, and found them out of cal on August 1. So anything I measured between July 1 and August 1 could have been adversely affected by these mics.

For example: Were they used for final inspection during that time? If so, could this have caused me to ship bad product to the customer? If yes, what customer(s) do I need to notify of the potential problem? If I’m lucky, I used them to measure a product with a +/- .005” tolerance and none of them measured more than +/- .002” from the target, so the .0005” error did not cause any rejected product to ship to the customer.

Make any sense? Did this answer your question?

 

[T.J. - 2005]

7.6 The organization shall take appropriate action on the equipmentand any product affected. I'm asking about equipment.
The last measurement resultsshowed the gauge was out of calibration (and of course before putting back on the floor we repaired it, and calibration good) but that was 120 days ago. Does this mean action needs to be taken on the equipment.

 

[Rob Nix]

I don't follow. The "equipment" is your measurement device. You repaired it, therefore you took appropriate action. Is the device still calibrated properly?

I think Mike's reply was right on the money. I don't think it is any more complicated than that. Am I missing something?

 

[T.J. - 2005]

OK thanks,
I guess I was looking to write up corrective action for frequency of calibration if every 120 days the device is out of calibration or training on use etc. Put we are just looking at product here and if we repaired the device. Trying to read more into it i guess.

 

[db]

I guess I was looking to write up corrective action for frequency of calibration if every 120 days the device is out of calibration

You may still need to change your calibration frequency. If you calibrate every 120 days, and each time the device is out of specs, then you really need to have calibration more frequently. One of the "shalls" in 7.6 begins with: "Where necessary to ensure valid results..." If your calibration requency is so far apart, that the device is out of calibration each time, then one could argue that you are in violation of the above.

 

[Icy Mountain]

Good response Mike
In addition, if you calibrate your mics every 3 months and find 1 of 10 out of calibration, causing you to have to notify customers and revisit measurements, you need to re-evaluate and reduce your calibration cycle. Based on data, of course, you might need to calibrate them monthly to make sure that you don't get out of cal conditions. You may also find that they are never out of cal at 3 months and end up (more efficiently and thus more profitably) calibrating every 6 months.

 

[T.J. - 2005]

Toolings argument was it is being calibrated at specified intervals. My argument was I was looking at previous measuring results for equipment and for product.
I am looking at previous measuring results for equipment to see if action is taken for previous out of calibration equipment.
"Where necessary to ensure valid results" are you saying this states "Where necessary to ensure good results"

 

[Icy Mountain]

TJ,
More like "necessary" results. If your device is out of cal by 0.005" every time and you are using it to measure +/- 0.050" then it is a "don't care". Based on data, you need to determine if the out of cal condition matters to the measurement, if it does, then:
1) Make sure that you don't have bad product in customer hands and notify or otherwise correct that situation, then:
2) Check if the device is capable of making the measurement (how it is used)
3) Check if you are calibrating it often enough (frequency)
4) Check if your operators know how to use the device without compromising its capability
5) Correct 2, 3, and 4 if necessary.