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View Full Version : Can I use the CMM after the Calibration has expired?


jleond
4th July 2008, 02:11 PM
The CMM calibration expires 7-19-08 and the service provider will start the new 2008-09 calibration on the week of 7-28-08. My question is: how long can the CMM be used to measure parts after the due date? I heard that we can use it (legally) 30 days after due date. Is this true? Is there a standard that states this or something related to this?

Thanks in advance for your help.

Coury Ferguson
4th July 2008, 02:17 PM
The CMM calibration expires 7-19-08 and the service provider will start the new 2008-09 calibration on the week of 7-28-08. My question is: how long can the CMM be used to measure parts after the due date? I heard that we can use it (legally) 30 days after due date. Is this true? Is there a standard that states this or something related to this?

Thanks in advance for your help.

In my opinion, I don't see a problem with it. I can't address the 30 days after rule.

A Suggestion: Change you Calibration Procedures, stickers and such to only reflect Month/Year only (example: 07/2008). This will help you in the long run.

BradM
4th July 2008, 02:19 PM
Hello there!

In general, calibration intervals are much more of an Art than a Science. The perfect calibration interval is that which find error 50-75% of the unacceptable point, at least that is my opinion.

To your point, it would all depend on what your quality management system states. Do you have procedures that states when calibration is past due?

Without anything documented in your system or anything in writing, it does not look good to use any instrument beyond its due date.

The best thing for you do do is establish a calibration procedure for when instruments are recalled for calibration (like month/year), using an instrument past its due date, tagging, etc. Like in your example, I would make the due date 07/08. That way you have the month to get the work done.

Hopefully that helps.

BradM
4th July 2008, 02:23 PM
In my opinion, I don't see a problem with it. I can't address the 30 days after rule.



Actually, I agree with you. But... there are many auditors who are not as processed-oriented as they should. They would see 7/19/2008, look at their watch and see 7/22/2008, the absence of any procedural exception, and they start writing.

The best thing to do is write up some exception/ some report stating that your organization says it's OK to use, IMHO.

As far as Rule of Thumbs (30 days, etc.), I have seen them all over the place, and again depends on the industry and the people involved.

Coury Ferguson
4th July 2008, 02:27 PM
Actually, I agree with you. But... there are many auditors who are not as processed-oriented as they should. They would see 7/19/2008, look at their watch and see 7/22/2008, the absence of any procedural exception, and they start writing.

The best thing to do is write up some exception/ some report stating that your organization says it's OK to use, IMHO.

As far as Rule of Thumbs (30 days, etc.), I have seen them all over the place, and again depends on the industry and the people involved.

If an Auditor is choosing to be that picky, they need to re-evaluate their techniques. We are talking a couple of days, still within the same month of calibration due date.

I would challenge any Auditor that would write this up as an NC.

Stijloor
4th July 2008, 02:35 PM
If an Auditor is choosing to be that picky, they need to re-evaluate their techniques. We are talking a couple of days, still within the same month of calibration due date.

I would challenge any Auditor that would write this up as an NC.

If I were the auditor, I would look at other instances where devices exceed the stated calibration due date (systemic issue). If this is indeed the case, I would write an NC.

Now, having said that, if you allow deviations from an established requirement, even if it's only one device, where does one "draw the line?"

What do you think?

Stijloor.

Coury Ferguson
4th July 2008, 02:42 PM
If I were the auditor, I would look at other instances where devices exceed the stated calibration due date (systemic issue). If this is indeed the case, I would write an NC.

Now, having said that, if you allow deviations from an established requirement, even if it's only one device, where does one "draw the line?"

What do you think?

Stijloor.

Alright I see you point. I don't totally agree with, but I understand where this is coming from. (added: if it is a systematic problem then I would identify it as a Major NC, but I think we are talking about one CMM)

My question back is: Is there not a master diametrical sphere to check the accuracy of the CMM? And this diametrical sphere is calibrated to be accurate within millionths or even tenths.

That is why I suggested only identifying the stickers with Month/Year would help in the long run.

AndyN
4th July 2008, 02:43 PM
Firstly, there's nothing 'legal' about it - literally or metaphorically. You should have past data that shows for each calibration, what the 'as found' condition was. Compared to the specification limits and the tolerance of the features measured on the cmm, you should be able to write yourself an 'extension' to the recall, based on DATA and the decision you made, based on that.

If your external auditor gives you grief, roll up the deviation, coat the end in Vaseline, and.........

Of course, make sure your extension form is a) mentioned in your procedures etc and b) is a controlled document.

Go for it!!

Stijloor
4th July 2008, 02:49 PM
Alright I see you point. I don't totally agree with, but I understand where this is coming from.

My question back is: Is there not a master diametrical sphere to check the accuracy of the CMM? And this diametrical sphere is calibrated to be accurate within millionths or even tenths.

That is why I suggested only identifying the stickers with Month/Year would help in the long run.

Coury,

Excellent point! :applause:

If the "sticker" says: Month/Year, you have a whole month to perform the necessary calibration. But what I have seen most is: month/day/year.

That's how organizations get "in trouble" during he audit.

Stijloor.

BradM
4th July 2008, 02:49 PM
If an Auditor is choosing to be that picky, they need to re-evaluate their techniques. We are talking a couple of days, still within the same month of calibration due date.

I would challenge any Auditor that would write this up as an NC.

I've seen it too many times for it to even be funny. Not only does the auditor comment on it, the organization overreacts and paints them self in a corner.

If I were the auditor, I would look at other instances where devices exceed the stated calibration due date (systemic issue). If this is indeed the case, I would write an NC.

Now, having said that, if you allow deviations from an established requirement, even if it's only one device, where does one "draw the line?"

What do you think?

Stijloor.


Again, I agree with you here. That's why I would be interested to determine what the recall procedure states, what industry, any regulatory pressures, etc.

One of the things I enjoy here on the Cove are what I term two views on things. One is of the frequenters here who are quality professionals and know the Best Practice approach (Coury and Stijloor just in this thread). I learn a lot here.

The other is like our friend who posted the question. They are at the receiving end of many audits by many auditors; and from what I have seen, many of them (the auditors) need to spend some more time around the Cove. Many of the practices/ approaches of auditors here, while I may not necessarily agree with, are far more logical and useful in nature than a lot of the so-called audit findings out there. I see so many burdensome, borderline ridiculous systems which were initiated from audit observations that should have been challenged or discarded altogether.

Functionally and procedurally it is just fine to go a couple of weeks past a due date. But you should have it documented; where good auditors move on to something else, and a not-so-good auditor wastes valuable time arguing about something that does not matter.

BradM
4th July 2008, 02:54 PM
Coury,

Excellent point! :applause:

If the "sticker" says: Month/Year, you have a whole month to perform the necessary calibration. But what I have seen most is: month/day/year.

That's how organizations get "in trouble" during the audit.

Stijloor.

Yes!! This is exactly my point! It's too easy to create a potential topic that is not beneficial for anyone. Man... I'm just happy they are calibrating the equipment and are even cognizant of when it is due!:lol:

Procedurally I always make everything due at month end, and try if I can, to stick in +/-2 weeks for safe measure.

BradM
4th July 2008, 02:57 PM
My question back is: Is there not a master diametrical sphere to check the accuracy of the CMM? And this diametrical sphere is calibrated to be accurate within millionths or even tenths.

That is why I suggested only identifying the stickers with Month/Year would help in the long run.


Good points. Again procedurally, if they are performing routine checks on the equipment with a traceable standard, they can possibly extend the recall dates and the like. Too, if a competent vendor is calibrating your equipment, they should be asking you what recall you desire, not dictating to you what it should be.

Stijloor
4th July 2008, 03:05 PM
Good points. Again procedurally, if they are performing routine checks on the equipment with a traceable standard, they can possibly extend the recall dates and the like. Too, if a competent vendor is calibrating your equipment, they should be asking you what recall you desire, not dictating to you what it should be.

:topic: I guess we're skipping 4th of July picnics and have a celebration here at The Cove.

No :rar: for us today? :D

Stijloor.

BradM
4th July 2008, 03:12 PM
:topic: I guess we're skipping 4th of July picnics and have a celebration here at The Cove.

No :rar: for us today? :D

Stijloor.

:lmao::lmao:
I know, after seeing all the activity, and me posting 3 in a row, I figured there are some bored people. The wife and kids headed to the lake; it's hot out there today.

jleond
7th July 2008, 12:28 PM
Thanks to everyone for your valuable comments. I will document it on my controls to have 15 days after due date for calibraton to be considered valid and ask to the cmm calibration vendor to put month/year on the calibration sticker.

Thanks again to all.

Coury Ferguson
7th July 2008, 12:37 PM
Thanks to everyone for your valuable comments. I will document it on my controls to have 15 days after due date for calibraton to be considered valid and ask to the cmm calibration vendor to put month/year on the calibration sticker.

Thanks again to all.

I would probably apply that sticker to all of your measuring equipment (Month/Year), or you will be in the same boat later.

BradM
7th July 2008, 01:26 PM
I would probably apply that sticker to all of your measuring equipment (Month/Year), or you will be in the same boat later.

Agreed.:agree::agree1: Have the system work for you; not the opposite.

Bob Bonville
11th July 2008, 05:40 PM
The approach I have successfully used in the past is to extend the calibration period for the duration of the period it will be needed for this instance. Once the inspection or test is complete you conditionally certify the product awaiting results of the calibration lab. If the instrument is good you can fully certify the product. If it is not, you have a control over the product that was tested using the instrument and you write a NCMR documenting the issue and perform an investigation into the impact of the out of tolerance condition.

Bob

Bob Bonville
15th July 2008, 05:12 PM
I think Brad has the right idea. If your system has a provision for this issue you are fine. I know in my case we introduced a feature called "Calibration Extension". Using this concept we would extend the calibration period for the time the instrument is needed.

Immediately upon completion of the inspection or test using the instrument in question, the product would be segregated or impounded until the results of the calibration was received. If the results were good, the product was accepted and released for further processing. If the instrument failed calibration a NCR was written until the issue could be fully investigated and resolved.

Bob