9.1.1.1 Monitoring and measurement of manufacturing processes Interpretation

[Kostas M]

Hello everyone, I need your help

We are during the IATF audit and we have a serious argument with the auditor. The auditor interprets the requirement d of the subject clause that we need to report down the actual measurements of each characteristic based on the sample size and frequency on the control plan. Our frequency of the majority of the part characteristics is 1 piece per spindle, every hour of production and each of the parts that we produce has about 40 dimensions. Considering that each of our machines has 8 spindles, we are talking that the operators has to report the actual results of 320 measurements every hour of production. Total 2,560 measurements per shift. This is impossible.

With our process, the operators inspect the characteristics and report on our records "OK" as evidence of our hourly inspections. Also, we enter variable data twice per shift in our SPC system for monitoring the stability and capability of the special characteristics.

Our interpretation of the requirement d is that we have actual measurements such as the 1st piece report and the dimensional layout of the PPAP process.
Please let me know your thoughts

Thank you


The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following:

a) measurement techniques;

b) sampling plans;

c) acceptance criteria;

d) records of actual measurement values and/or test results for variable data;

 

[Golfman25]

You need a number. The powers that be don’t like “ ok.” Too easy to fudge.

Here’s your out. Measure all the samples required. Record only the high and the low Of the batch. By definition all the other parts will fall within those two ends. Good luck.

 

[qusys]

Hello everyone, I need your help

We are during the IATF audit and we have a serious argument with the auditor. The auditor interprets the requirement d of the subject clause that we need to report down the actual measurements of each characteristic based on the sample size and frequency on the control plan. Our frequency of the majority of the part characteristics is 1 piece per spindle, every hour of production and each of the parts that we produce has about 40 dimensions. Considering that each of our machines has 8 spindles, we are talking that the operators has to report the actual results of 320 measurements every hour of production. Total 2,560 measurements per shift. This is impossible.

With our process, the operators inspect the characteristics and report on our records "OK" as evidence of our hourly inspections. Also, we enter variable data twice per shift in our SPC system for monitoring the stability and capability of the special characteristics.

Our interpretation of the requirement d is that we have actual measurements such as the 1st piece report and the dimensional layout of the PPAP process.
Please let me know your thoughts

Thank you


The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following:

a) measurement techniques;

b) sampling plans;

c) acceptance criteria;

d) records of actual measurement values and/or test results for variable data;

Is this operation done manually by the operator or is there manufacturing electronic system for this?
How did you agree with your customer in the product approval phase?

 

[Mikey324]

Agreeing with Golfman, "OK" normally doesn't satisfy. Unless, you are talking about a pass/fail test, say for fit. OK is different for everyone.

My questions is, is this a new manufacturing process?
9.1.1.1 "The organization shall perform process studies on all new manufacturing processes to verify process capability and to provide additional input for process control, including those for special characteristics." "The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following:
d) records of actual measurement values and/or test results for variable data;


It sounds like you are recording actual measurement values. Maybe just not for every single measurement. This makes me question, if it's not important enough to document what measurements you're getting at your current frequency, are measurements at that frequency really necessary?

 

[UncleFester]

"Our frequency of the majority of the part characteristics is 1 piece per spindle, every hour of production and each of the parts that we produce has about 40 dimensions. Considering that each of our machines has 8 spindles, we are talking that the operators has to report the actual results of 320 measurements every hour of production. Total 2,560 measurements per shift. This is impossible."

OK - firstly, if you have documented in your control plan that you will do this, then that's what you're expected to do. You may need to look at simplifying or clarifying exactly what you want to control, depending on what dimensions are significant or critical. However, if you have submitted the control plan to your customer and had this accepted, you may need a conversation with them as to how you go able simplifying the controls. This would have a knock-on effect to your FMEA, based on drawings or specifications for the part you're making.

 

[Kostas M]

Agreeing with Golfman, "OK" normally doesn't satisfy. Unless, you are talking about a pass/fail test, say for fit. OK is different for everyone.

My questions is, is this a new manufacturing process?
9.1.1.1 "The organization shall perform process studies on all new manufacturing processes to verify process capability and to provide additional input for process control, including those for special characteristics." "The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following:
d) records of actual measurement values and/or test results for variable data;


It sounds like you are recording actual measurement values. Maybe just not for every single measurement. This makes me question, if it's not important enough to document what measurements you're getting at your current frequency, are measurements at that frequency really necessary?

Hello Mikey,

Yes we collect and analyze the actual measurements of the critical characteristics. No it is not a new manufacturing process. My understanding is that you need to verify the implementation of the control plan. It does not say you need to verify it every hour of production. The control plan has been verified during the first piece inspection, the PPAP and it is verified every year with the annual validation.

 

[Kostas M]

Is this operation done manually by the operator or is there manufacturing electronic system for this?
How did you agree with your customer in the product approval phase?

The customer has agreed with our control plan. Speaking with the customer, they do in their process exactly what we do in ours regarding the inspections. They document only the actual measurements of the critical characteristics

 

[Mikey324]

I guess I'm having trouble understanding the NC statement. Can you list the exact statement from the auditor?

 

[Golfman25]

Hello Mikey,

Yes we collect and analyze the actual measurements of the critical characteristics. No it is not a new manufacturing process. My understanding is that you need to verify the implementation of the control plan. It does not say you need to verify it every hour of production. The control plan has been verified during the first piece inspection, the PPAP and it is verified every year with the annual validation.

That's is going to depend upon what your control plan says. There is a spot to list the sample size and frequency. Our for example, we check most dimensions at setup, which is indicated. Then the few critical dimensions get checked in process at the stated size and frequency depending up how many pcs. we are making. What does your Control plan say?