When a tool fails calibration how do you track what product was checked with it?

[Big Jim]

Re: When a tool fails calibration how do you track which product was checked with it?

First is that I am not an aerospace auditor. My response was particularly with reference to the ISO 9001. The CAR is only when the procedure is not effectively mapped to the standard's requirement.

You should remember that control of monitoring and measuring equipment is not one of the required written procedures.

 

[somashekar]

Re: When a tool fails calibration how do you track which product was checked with it?

You should remember that control of monitoring and measuring equipment is not one of the required written procedures.

Absolutely ..... and there is a difference between procedure and written procedure (documented procedure)
Every element of the QMS would have a procedure including ... When a tool fails calibration how do you track which product was checked with it?

 

[somashekar]

Re: When a tool fails calibration how do you track which product was checked with it?

What you are talking about walking seed is exactly what I want to avoid in the first place! I was thinking about having a database (excel) with each tool number. Then at final acceptance having my inspector's log the jub number and date under each tool that they used on the job. I was thinking this would be a simple way that I could look up what jobs the failed tool was used on as well as keeping it relatively effortless for my inspectors. Your thoughts?

Hi locust.
If you are comfortable and fine with what you say, do go ahead.
Imagine that three things can happen when a tool fails calibration:
When you get to know that it has failed, there are chances that many products were inspected using it and you would not mostly know when exactly the fail occured and how.
1. Good parts were inspected and passed as good (and vice versa)
No Issues
2. Good products were inspected and rejected as bad.
You build up false defectives and do an RCA and perhaps find that a tool failed calibration. Your customer is effected for deliveries. The rejected products are in your control and you take up appropriate disposition.
3. Bad products were inspected and passed as good.
Danger. Customer can get bad products and this can be serious. You may have to recall and that gets real worse. When you do an RCA and find that a tool failed calibration and further ... If you do not have a procedure to answer your question in the subject line which products will you recall ???
Your question is also a very important aspect of traceability per ISO 9001 clause 7.5.3.
I hope you can now appreciate how important it is to understand the interaction between the processes of the quality management system as you go ahead and implement one.

 

[Big Jim]

Re: When a tool fails calibration how do you track which product was checked with it?

Absolutely ..... and there is a difference between procedure and written procedure (documented procedure)
Every element of the QMS would have a procedure including ... When a tool fails calibration how do you track which product was checked with it?

Please explain "every element of the QMS would have a procedure". I don't seem to find that in my copy of the standard.

 

[somashekar]

Re: When a tool fails calibration how do you track which product was checked with it?

Please explain "every element of the QMS would have a procedure". I don't seem to find that in my copy of the standard.

Every element of anything (including QMS) would have a procedure (A way of doing that thing) some get to being documented procedure and the rest just procedure ...

 

[Bunny]

The auditor is not out of line and is not asking for a detailed written procedure, but to know a process is in place to handle such an incident. All you have to do is determine how you would trace the use of the piece of test equipment that was out of calibration and mention as much in the procedure. All the details about how you would investgate the failure, determine if recall is needed, etc is outside of that written procedure. Each case would be different based on the type of test equipment, what it was used for, how long it was used, when it fell out of calibration, etc.

 

[Big Jim]

Re: When a tool fails calibration how do you track which product was checked with it?

Every element of anything (including QMS) would have a procedure (A way of doing that thing) some get to being documented procedure and the rest just procedure ...

I still don't find that. Can you quote the part of the standard that says that?

 

[Hodgepodge]

Re: When a tool fails calibration how do you track which product was checked with it?

Locust30,






Big Jim may be right about the “requirement” for such a system, however, IM&TE will eventually be found out of tolerance. You are on the right track. A good plan can help save some time when it counts. Follow the advice of Jennifer Kirley:

• Minimize the number of instruments used for final inspection - avoid using multiples of the same type of instrument where possible
• Have a quick performance check at the beginning of each day or shift
• Keep track of who uses what
• Lay out a general plan of what instrument is used for what part at what inspection stage.

BradM’s previous post lays the foundation for why you care in the first place.

First, it sounds a bit like there are some vital processes maybe not in place, including remedial action. So, if you don't mind, let's back up a bit

Ok, it was out of tolerance. By how much? Did you have an acceptable tolerance between the instrument and the process? Did the magnitude of error have a significant impact on the process? Say I have a pressure gauge with a 2 psi tolerance. The process tolerance is 10 psi. If the gauge was out by 2.5 psi, it has no impact whatsoever on the process; and we're pretty much done.

If the instrument is used to calibrate other instruments, did we make a bunch of adjustments? Was anything adjusted? We're there more than the usual amount of adjustments?

If it is process-related, are there secondary checks of some kind that can verify if that error had any process-impact? Is there a secondary verification of some kind to provide confidence that there were no significant changes/deviations?

The calibration itself-Could it have been from shipping it out? Are there any in-house verifications of some kinds that can minimize the impact?

Risk-the instrument risk must be determined. The frequency may need to be shortened; and/or implementing some in-house verification of some sort.

Sorry... I really did not answer your question at all. But stepping back and taking a critical view of the entire process might lead you do a solution to your problem, and possibly minimizing investigations.

Calibration failures can and will occur. Minimizing their impact is within your reach, though, and can significantly minimize product recalls and having to track down where the device has been used.

See the attached spreadsheet to see a simple method of tracking tool use through excel. Macros have to be enabled for the search to work. If you can use it and need it altered for any reason, just let me know & I’ll help you out.

 

[Big Jim]

Re: When a tool fails calibration how do you track which product was checked with it?

Locust30,



Big Jim may be right about the “requirement” for such a system, however, IM&TE will eventually be found out of tolerance. You are on the right track. A good plan can help save some time when it counts. Follow the advice of Jennifer Kirley:
BradM’s previous post lays the foundation for why you care in the first place.


See the attached spreadsheet to see a simple method of tracking tool use through excel. Macros have to be enabled for the search to work. If you can use it and need it altered for any reason, just let me know & I’ll help you out.

As with many other posts in this thread, this is excellent advice. I absolutely agree that it is a good idea to know how you may handle awkward circumstances.

 

[Ramansrin]

Re: When a tool fails calibration how do you track which product was checked with it?

Dear Joy,
I differ with you on the explanation given by you on Location. The location according to me is at which area of inspection, the instrument is used (Incoming / inprocess / Final) and the parameters checked by that instrument in that location.
By this the acceptance criteria calculation and the impact of the errors can be easily identified