i everyone,
We received a minor nonconformity for point 7.1.5.3.1.d of the standard. It states:
The laboratory shall specify and implement, as a minimum, requirements for:
d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.); when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability;
We have an internally manufactured weighing machine that uses load cells. The auditor did not find any normative reference in our calibration procedure. I am not challenging this nonconformity, but I would like to get your advice to avoid recurrence.
What do you do when there are no national or international standards?
The standard says that a methodology must be defined and implemented to verify the capability of the measurement system. Do you have an example of such a method? Is this redundant with the MSA requirement? I asked one of our consultants, who advised me to calculate a Cgk. But does that really make sense?
In short, I would like to understand how you address this point of the standard and what you do when no standards exist especially regarding capability analysis method.
Many thanks in advance.
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IATF 16949 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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IATF 16949 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
IATF 16949 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Just an addon: I'm not lloking for standards regarding loadcell (I found it). What I would like to understand is how we should handle similar situations where no applicable standard is available. In such cases, what type of capability analysis is expected in order to fulfil this requirement?
First, a verification or calibration method for your measuring instrument shall be defined and documented in instructions. You may seek assistance from a calibration company when defining this method. The reference weight device used for verification must be accredited according to ISO 17025.
The verification report must be capable of displaying the reference device's deviations and the acceptable deviation values.
Furthermore, since this is a measuring instrument, it must be included in the annual MSA plan, and an MSA study must be conducted. A Cg/Cgk calculation can be performed using a master sample. For detailed information, you can review the MSA manual Rev. 4.
Thank you for the feedback. Let me clarify some points. We had a documented instruction and method defined using weights accredited ISO17025. But the auditor wanted to see that this method was based on international and national process standard (Such as ASTM, EN ...) and find the reference to this process standard in the instruction. And that was not the case.
Regarding the capability method, I would like to know if referring to the MSA instruction and MSA analysis is enough to fullfill with this requirement. I cannot see any added value to calculate Cgk based on VDA if a complete R&R analysis is already existing based on AIAG MSA
You could investigate whether there is a standard regarding the calibration of load cells for international traceability.
If such a standard exists, you might be referred to the relevant instruction.
Regarding MSA, a GRR study is applicable to measuring instruments where operator influence is a factor—such as calipers, micrometers, and the like.
For instance, it is not typically a suitable method for precision balances. For such devices measuring instruments where operator influence is negligible, a stability study is conducted.
Variations in the equipment over time are monitored and reported using either Cg/Cgk or Cp/Cpk indices. The VDA 5 MSA manual references Cg/Cgk, whereas the AIAG MSA (Revision 4) manual references bias, stability, and linearity studies.
These analyses can be performed using software, or the results can be analyzed graphically using X-R charts.
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Jul 01, 2026