ISO 9001 Clause 7.6 - Calibration - Audit finding

R

RosieA

#1
Our internal document on calibration states:

"Test and measurement equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.

T & ME suitability shall be reviewed on a semi-annual basis per QOP-120, Management Review."

In an audit recently, the Auditor asked our QE, who also supervises the Cal Lab, how the measurement uncertainty of a device is determined and how uncertainties are compared to measurement capabilities. The Supervisor is new and does not have a strong background in calibration, and was unable to answer the question. A little research showed that the individual who wrote the document knew a lot about measurement uncertainty, but he left years ago, and no one on the current staff understands this topic at all. We are not making highly refined or precise measurements with our gauges, nor are we in an industry where such measurements are an expectation.

In writing up the audit finding, I am stuck. 7.6 does not mention anything about measurement uncertainty, although there is a reference to see ISO 10012-1 and -2 for guidance.

We do not claim conformance to any calibration standards, like 17025. We only certify to 9001:2000.

I think this is a case where the document should have been revised to remove this reference, making it a document control issue, vs a calibration issue.

Opinions?
 
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J

Justin

#2
For ISO 9001:2000, I whole heartedly agree. The quick fix would be to just rewrite the procedure and exclude the part about measurement uncertainty. The bottom line is that the procedure should reflect the actual process. Since your company does not currently use measurement uncertainty in its calibration process, it shouldn't be there. However, the auditor was correct in initiating the finding as calibration related because the procedure was where the problem is. For you, it is a document control issue from this point forward.

HAVE A GREAT WEEKEND EVERYONE :agree1:
 
D

Don Palmer

#3
Justin said:
For ISO 9001:2000, I whole heartedly agree. The quick fix would be to just rewrite the procedure and exclude the part about measurement uncertainty. The bottom line is that the procedure should reflect the actual process. Since your company does not currently use measurement uncertainty in its calibration process, it shouldn't be there. However, the auditor was correct in initiating the finding as calibration related because the procedure was where the problem is. For you, it is a document control issue from this point forward.

HAVE A GREAT WEEKEND EVERYONE :agree1:
I agree! :agree1:
 
D

dokes

#4
I agree that rewriting the procedure will CORRECT this nonconformity, but will not be effective CORRECTIVE ACTION to prevent a similar event in the future. What process does the organization have in place to review processes, procedures, competencies, etc. when an individual leaves a position and is replaced? The individual responsible for the lab should have known that the procedure requirements were not being fulfilled.
 
B

begum

#5
7.6 Calibrate monitoring and measuring devices

Dear All

7.6 Calibrate monitoring and measuring devices

7.6 for education as in the IWA 2: 2003 guidelines refers to tests and exams.

Can anyone please tell me what is required to show compliance especially
for "calibrate monitoring and measuring devices."?

thanks

Begum(Ms)
Malaysia
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
RosieA,

Remember, measurement uncertainty has two properties.....

One, it is one of two critical components of traceability to National or international standards such as those maintained by NIST.

Two, it is a mathematical description of the errors associated with a given measurement. All measurements at our level of science has errors, there are no exceptions. You can use MU to identify and control risk.

For a little more on the risk control bit, check the Feb 2005 issue of Quality Digest, article named In or Out.

So, getting rid of MU is not necessarily the best approach.....learning to understand and work with it is a better approach. If you have questions about learning to use it, contact me off-line.

Hope this helps.

Hershal
 
J

Justin

#7
RosieA said:
Our internal document on calibration states:

We are not making highly refined or precise measurements with our gauges, nor are we in an industry where such measurements are an expectation.
I also agree that MU is better understood than ignored, but for RosieA, her company doesn't look like they need it. I on the other hand, have to meet Aerospace requirements that must take MU into account.
And as for the department not knowing that they weren't even in compliance, that is a TRAINING issue big time.
 
R

RosieA

#8
dokes said:
I agree that rewriting the procedure will CORRECT this nonconformity, but will not be effective CORRECTIVE ACTION to prevent a similar event in the future. What process does the organization have in place to review processes, procedures, competencies, etc. when an individual leaves a position and is replaced? The individual responsible for the lab should have known that the procedure requirements were not being fulfilled.
Yup, that's an issue. Both the calibration supervisor and the QA Manager (me) are fairly new and the guy who wrote this left 5-6 years ago, so there's been a procedural gap there for many years. Gotta address that. Actually, I asked my best auditor to go look hard at calibration because I was pretty sure we had problems like this. We'll use what he found to address the gaps.
 
#9
RosieA said:
...so there's been a procedural gap there for many years. Gotta address that.
Okay, so there has been a procedural gap for many years. My question is, what has been the effect? Have bad things happened because of this gap? What are the possible bad things that could happen because of this gap?(alright, I should have said, "my questions are,") The answer to these questions can help in determining what your response should be.
 
R

RosieA

#10
Good questions. I have two years worth of scrap and returns data at my desk, and can't see any issues from them, but need to go back 5-6 years to see if there has been any major change from that era.
 
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