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All Measurements taken with a Variable Gage have to be Recorded 100%

John C. Abnet

Teacher, sensei, kennari
Staff member
#11
Good day @jfries2. As noted in other responses, there is indeed a requirement to record actual data and not simply PASS-FAIL result. However, I would caution that we keep this requirement in context of the standard and the intent of the standard. Note the opening line in 9.1.1.1...
" ..shall perform process studies on all new manufacturing....processes..."
While product measurement is indeed a method to verify process capability, this clause is not speaking to the ongoing product verification that may or may not be part of the agreed upon control plan. The control plan is the "contract" with the customer in regards to how/when product will be verified...(assuming it is not contrary to other contractual agreements such as CSR, etc...)

Be well.
 
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Golfman25

Trusted Information Resource
#12
We have a control plan requirement to measure a feature in 3-7 locations, and to record the maximum and minimum measurements. This is being performed and variable data is recorded for the min/max as required. An internal audit recorded a finding against IATF 9.1.1.1.d stating that since 3-7 measurements are required, they should all be recorded. We are debating this and probably splitting hairs, but 9.1.1.1.d does not state that all measurements must be recorded. Thoughts on this?
I think it is common practice to simply record high and low readings -- the assumption being that everything else fell within the high and low. We even had an auditor suggest this. I think it is a valid technique to cut down on data overload. I stick with it and challenge any finding to the contrary.
 

jfries2

Involved In Discussions
#13
Good day @jfries2. As noted in other responses, there is indeed a requirement to record actual data and not simply PASS-FAIL result. However, I would caution that we keep this requirement in context of the standard and the intent of the standard. Note the opening line in 9.1.1.1...
" ..shall perform process studies on all new manufacturing....processes..."
While product measurement is indeed a method to verify process capability, this clause is not speaking to the ongoing product verification that may or may not be part of the agreed upon control plan. The control plan is the "contract" with the customer in regards to how/when product will be verified...(assuming it is not contrary to other contractual agreements such as CSR, etc...)

Be well.
Actually 9.1.1.1 is speaking to the ongoing product verification as well as initial process capability. The second paragraph begins with "The organization shall maintain manufacturing process capability"...... followed with "shall verify that the process flow diagram, PFMEA, and control plan are implemented".....
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#14
The key term is "...maintain process capability..." This clause is not intended to "step on" clauses 8.6 and 9.2.2.4

The original question was ..." We are debating this and probably splitting hairs, but 9.1.1.1.d does not state that all measurements must be recorded. Thoughts on this?'

Short answer: No, all of the measurements do not need recorded. What in the standard or agreement with your customer would cause your organization to believe this to be so?
You indicated that your control plan states "...requirement to measure a feature in 3-7 locations, and to record the maximum and minimum measurements" (I will assume here that it is agreed to by the customer and no other contractual requirements exist). You have met the contractual agreement with the customer (control plan) and not violated any standard requirements (based solely on the content/context of this conversation).
Be well.
 
Last edited:

jfries2

Involved In Discussions
#15
What in the standard or agreement with your customer would cause your organization to believe this to be so?
Thanks for your reply John. I agree with your conclusion. Again, this was an internal audit finding which has led to this discussion. The only obligation to the customer is the control plan, which is being met.
 
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