Calibration Certificate Result issued by an accredited external laboratory

#1
Good afternoon,

I am writing to ask for help in managing the calibration certificates issued by an accredited external laboratory.
Following an AS9100 audit, a client of mine was asked to better highlight the acceptability of the calibration results.
I don't know if it is convenient to make a table with the criteria for each family of instruments (eg gauges, micrometers, threaded plugs, etc.) or to write a fixed sentence in the calibration report as evidence of acceptance of results. My client doesn't understand what kind of evaluations he has to make.
Thanks if you can help me.
MJ
 
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dwperron

Trusted Information Resource
#2
Good afternoon,

I am writing to ask for help in managing the calibration certificates issued by an accredited external laboratory.
Following an AS9100 audit, a client of mine was asked to better highlight the acceptability of the calibration results.
I don't know if it is convenient to make a table with the criteria for each family of instruments (eg gauges, micrometers, threaded plugs, etc.) or to write a fixed sentence in the calibration report as evidence of acceptance of results. My client doesn't understand what kind of evaluations he has to make.
Thanks if you can help me.
MJ
AS9100D 7.1.5.1 covers this issue:

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or
measuring is used to verify the conformity of products and services to requirements.

The organization shall ensure that the resources provided:
a. are suitable for the specific type of monitoring and measurement activities being undertaken;
b. are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and
measurement resources.


So the organization is required to determine the "fitness of purpose" of the equipment being used and to document evidence of the fitness for purpose. How this is performed is up to each organization.
If they have done this then they can state that since the equipment being used has been calibrated to manufacturer specifications, then the results are acceptable to their requirements.
 

Tagin

Trusted Information Resource
#3
Following an AS9100 audit, a client of mine was asked to better highlight the acceptability of the calibration results.
Can you please elaborate or explain this more specifically? What comes to my mind is that they are not noting whether the calibration succeeded without any adjustments required; i.e. that the equipment left "AS FOUND". If some adjustment was required during calibration, that should cause your client to initiate an investigation into potential impact on product produced or measured with that equipment. But if they are not checking for that "AS FOUND" status on the cert, not documenting it, and they don't have it in their procedure that it is something to check for each time an item comes back from calibration, then its not clear that they are doing so, or that they are even aware of calibration adjustments as potentially impacting previously produced product.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
In addition to what Tagin mentioned, some calibration certificates have limitations such as, for example, a 0-22” micrometer was only calibrated in the 0-15” range. A Digital Multimeter that only had some functions calibrated.
 
#5
Hallo, thanks everyone for replying.
I have seen that some companies, in the certificates issued by the calibration laboratory, to show that they have verified the certificates themselves write a sentence in the certificate: "The Management, after analyzing the certificate issued by the calibration service provider, certifies that the instrument of calibrated measurement is suitable for use by the company as the mean square error is included within the manufacturing limit deviations of the instrument".
For example I saw it on a certificate of a smooth ring. Do you think I can write that sentence in every kind of certificate of gauges, micrometers, threaded and smooth pads, etc.?
Alternatively, I thought of a sentence like this: "It is declared that, after analyzing the certificate issued by the calibration service provider, the calibrated measuring instrument is suitable for use in relation to the measurements to be made and the expected tolerances".

I have to declare that certificates are suitable for use.

Thanks for your help.
MJ




AS9100D 7.1.5.1 covers this issue:

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or
measuring is used to verify the conformity of products and services to requirements.


The organization shall ensure that the resources provided:
a. are suitable for the specific type of monitoring and measurement activities being undertaken;
b. are maintained to ensure their continuing fitness for their purpose.


The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and
measurement resources.


So the organization is required to determine the "fitness of purpose" of the equipment being used and to document evidence of the fitness for purpose. How this is performed is up to each organization.
If they have done this then they can state that since the equipment being used has been calibrated to manufacturer specifications, then the results are acceptable to their requirements.
Can you please elaborate or explain this more specifically? What comes to my mind is that they are not noting whether the calibration succeeded without any adjustments required; i.e. that the equipment left "AS FOUND". If some adjustment was required during calibration, that should cause your client to initiate an investigation into potential impact on product produced or measured with that equipment. But if they are not checking for that "AS FOUND" status on the cert, not documenting it, and they don't have it in their procedure that it is something to check for each time an item comes back from calibration, then its not clear that they are doing so, or that they are even aware of calibration adjustments as potentially impacting previously produced product.
In addition to what Tagin mentioned, some calibration certificates have limitations such as, for example, a 0-22” micrometer was only calibrated in the 0-15” range. A Digital Multimeter that only had some functions calibrated.
 

dwperron

Trusted Information Resource
#7
Hallo, thanks everyone for replying.
I have seen that some companies, in the certificates issued by the calibration laboratory, to show that they have verified the certificates themselves write a sentence in the certificate: "The Management, after analyzing the certificate issued by the calibration service provider, certifies that the instrument of calibrated measurement is suitable for use by the company as the mean square error is included within the manufacturing limit deviations of the instrument".
For example I saw it on a certificate of a smooth ring. Do you think I can write that sentence in every kind of certificate of gauges, micrometers, threaded and smooth pads, etc.?
Alternatively, I thought of a sentence like this: "It is declared that, after analyzing the certificate issued by the calibration service provider, the calibrated measuring instrument is suitable for use in relation to the measurements to be made and the expected tolerances".

I have to declare that certificates are suitable for use.

Thanks for your help.
MJ
How in the world is a calibration lab able to know if a tool is "suitable" for your use?
AS9100 requires your organization to make, document, and retain that determination.
AS9100 requires that the tools are suitable, not the certificates.
The boilerplate on the calibration certificate is cute, but worthless.
 

Brakeman

Starting to get Involved
#8
I interpreted the 17025 and 9001 requirements to mean that someone has to be the authority to review the required MSA along with the calibrations and to determine if the gauge is acceptable to use for the measurement. That is the statement that we required in our gauge system, not our certs. But I guess the certs could be signed to show evidence of review, which is a requirement, as the calibrator is not a company authorized representative unless specifically contracted to do so.
 
#9
Thanks for replying.
The company performs work on customer specifications and, based on the measurements and tolerances on the drawing, uses the most suitable tools. During last AS9100 audit, the auditor requested the following:
"The organization has established the acceptance criteria for measurement instrumentation, however it is suggested to improve the register to better formalize the acceptance process".
In another similar situation, to close this OFI, a company wrote this: "The Management, after analyzing the certificate issued by the calibration service provider, certifies that the instrument of calibrated measurement is suitable for use by the company as the mean square error is included within the manufacturing limit deviations of the instrument".
I wonder if this type of sentence can be suitable for all instruments or not.

Thanks for helping.
MJ


If you want to do that, it is your prerogative, but I do not agree the AS9100 standard requires that to be done.
How in the world is a calibration lab able to know if a tool is "suitable" for your use?
AS9100 requires your organization to make, document, and retain that determination.
AS9100 requires that the tools are suitable, not the certificates.
The boilerplate on the calibration certificate is cute, but worthless.
I interpreted the 17025 and 9001 requirements to mean that someone has to be the authority to review the required MSA along with the calibrations and to determine if the gauge is acceptable to use for the measurement. That is the statement that we required in our gauge system, not our certs. But I guess the certs could be signed to show evidence of review, which is a requirement, as the calibrator is not a company authorized representative unless specifically contracted to do so.
 

dwperron

Trusted Information Resource
#10
"The Management, after analyzing the certificate issued by the calibration service provider, certifies that the instrument of calibrated measurement is suitable for use by the company as the mean square error is included within the manufacturing limit deviations of the instrument".

That statement is gobbledygook.
You need a statement that says that the calibration results have been reviewed and that they are adequate for your measurement processes.

When someone in a future AS9100D audit asks you to show your instruments are adequate for the job you will need to be able to present evidence that you comply with this:

7.1.5.1
"The organization shall ensure that the resources provided:
a. are suitable for the specific type of monitoring and measurement activities being undertaken;
 
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