AS9100D Clause Brain Fade - Tool was past due for Calibration

[jwdjmd]

During an internal audit (AS9100D), I came across a tool that had a calibration sticker on it indicating that the tool was past due for calibration. I want to write up the department for using this tool but I am at a loss to which clause to write it under.
What clause would cover the fact that operators didn't check the calibration status of the tool before they used it? 7.1.5.2??

I am having a brain fade...

 

[Sidney Vianna]

I want to write up the department for using this tool but I am at a loss to which clause to write it under.

There is no requirement that you have to reference the paragraph of the AS9100 standard in the statement of nonconformity. But, if you want to, what kind of tool is it? a production tool? If so, 8.5.1.1 is an applicable section.

But, if the tool is an inspection tool, 7.1.5.2 would be the appropriate section of AS9100D.

 

[jwdjmd]

It is a radiometer "puck" used in the set up of one of our expose tools. It is calibrated.

There is nothing in the operation's work instruction stating that the operator has to verify the calibration status of the "puck" so that's why I want to write it up against the standard. The sticker is in a prominent place and is very hard to miss. The thing that gets me is that the puck is used daily and it's been past due for calibration for quite awhile and no one stopped to let the engineer know it was past due.

 

[Mike S.]

Looks like you have a few different problems to deal with, but have a look at 8.6 and 9.1.1.

 

[Michael_M]

Based on the limited information, I would probably (and have) written this up under 7.1.5.2 Measurement Traceability. I had found this same thing in a previous audit and since my department is responsible for calibration, this made me sad.

 

[Mike S.]

Based on the limited information, I would probably (and have) written this up under 7.1.5.2 Measurement Traceability. I had found this same thing in a previous audit and since my department is responsible for calibration, this made me sad.

Yep, this is good stuff.

If I was involved in this I would address it as I do many issues where there is a root cause and in addition one or more contributing causes to a problem.

 

[AndyN]

During an internal audit (AS9100D), I came across a tool that had a calibration sticker on it indicating that the tool was past due for calibration. I want to write up the department for using this tool but I am at a loss to which clause to write it under.
What clause would cover the fact that operators didn't check the calibration status of the tool before they used it? 7.1.5.2??

I am having a brain fade...

While this is a laudable thing to identify, as an auditor it's not as helpful as it really should be. One item out of how many gauges? Another thing to discover is what the effect of not being recalled is on the specification of the gauge. For example, I recently audited some torque wrenches which had been calibrated each year for 6 years. The records show that the things don't vary by 0.1%. So, being 5 years late for calibration wouldn't matter!

Auditors can continue to simply write a compliance oriented report or, better still, discover what is effective... This helps drive management support for audit findings instead of "so what?" apathy...

 

[Golfman25]

While this is a laudable thing to identify, as an auditor it's not as helpful as it really should be. One item out of how many gauges? Another thing to discover is what the effect of not being recalled is on the specification of the gauge. For example, I recently audited some torque wrenches which had been calibrated each year for 6 years. The records show that the things don't vary by 0.1%. So, being 5 years late for calibration wouldn't matter!

Auditors can continue to simply write a compliance oriented report or, better still, discover what is effective... This helps drive management support for audit findings instead of "so what?" apathy...

Words to live by. Thanks.

 

[Sidney Vianna]

While this is a laudable thing to identify, as an auditor it's not as helpful as it really should be. One item out of how many gauges? Another thing to discover is what the effect of not being recalled is on the specification of the gauge. For example, I recently audited some torque wrenches which had been calibrated each year for 6 years. The records show that the things don't vary by 0.1%. So, being 5 years late for calibration wouldn't matter!

I fully support Andy's comment and the need to elevate the standards of auditing. Auditing for effectiveness and performance is, undoubtedly, a much more valuable proposition.

But, let's remember, many times during the audit process, the auditor does not have time for the discovery of the context surrounding the nonconforming situation, or upcoming changes to the process at hand.

In the example offered by the OP, I believe that the lack of calibration still needs reporting, so the organization might decide what to do. Such, as correction only, change of calibration frequency, or a full blown corrective action.

Audit for effectiveness is something that I fully support. But we still need to report on audit findings and let the auditees assess the context surrounding the findings and the extent of correction and/or corrective action.

 

[AndyN]

But, let's remember, many times during the audit process, the auditor does not have time for the discovery of the context surrounding the nonconforming situation, or upcoming changes to the process at hand.

In the example offered by the OP, I believe that the lack of calibration still needs reporting, so the organization might decide what to do. Such, as correction only, change of calibration frequency, or a full blown corrective action.

Audit for effectiveness is something that I fully support. But we still need to report on audit findings and let the auditees assess the context surrounding the findings and the extent of correction and/or corrective action.

Agreed, Sidney and thanks for your comments. Since this was an internal audit, I would have hoped for the auditor to do a little more digging. The effect on the process from that point on could be taken into consideration (any later inspections/checks, product failures etc). And why not also recommend that an internal audit be conducted on the calibration system in the next few days?