IATF 16949 Clause 10.2.4 - Error Proofing

I'd like to discuss text in 10.2.4 Error-proofing:

"...test frequencies shall be documented in the control plan. (1)

The process shall include the testing of error-proofing devices for failure or simulated failure. (2)

My interpretation of the text:

1st testing is testing of a product or process using e-p device. Frequency esually is 100%, but it could be also 1/50 pieces, or 1/hour etc.

2nd testing is testing of the correct operation (proper working) of the e-p device (Does this device detect nonconforming parts?)

Is this interpretation correct?

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

Hi, from my auditing experience.I would interpret the same way you did.

frequency of testing/inspection in control plan as always (sampling plan, every hour, every shift etc.)

the second test would be tester verification by master OK/NG, if the tester can still sort bad from good.

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

I think 2nd test frequency should also be documented in control plan.

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

jelly1921 said:

I think 2nd test frequency should also be documented in control plan.

Click to expand...

I agree with you that the frequency of error proofing device verification should be documented somewhere.
But in control plan normally they only list controls over product characteristics, and process parameters.

For example:
Product characteristics Measuring equipment Frequency
Dimension Error proofing device 100%

Process parameters Measuring equipment Frequency
Air pressure Pressure gage at M/C start of shift

It would take some modification to include the frequency of the error proofing device in the control plan. How should we write the control plan?

I Agree to Quality Spirit !

We cannot mention the frequency of EP verification in CP. Instead the EP reference will be given in CP. Parallelly we need to maintain a List of EP, in which the verification frequency will be documented among other details.

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

This requirement comes from GM

4.1.22 Error proofing Verification (Reference ISO/TS16949 clauses 7.5.1.1 & 8.5.2.2)
The organization shall have a process for error proof verification including frequency requirements and included in the Process Control Plan.
NOTE – Look at: All Error Proofing Devices are checked for function (failure or simulated failure) at the beginning of the shift, when feasible, otherwise according to the process control plan. Error Proofing Masters/Challenge parts (when used) are clearly identified. Records of verification are available.
Look for: Confirm that a list of error proofing devices is available. Confirm that the method of the error proofing verification is defined and documented in the standardized work. Verify that all error proofing devices are checked for function (failure or simulated failure) at the beginning of the shift, when feasible, otherwise according to the process control plan. Look to see that error proofing masters (when used) are clearly identified. Confirm records of verification are available. Verify that a reaction plan is available in the event of error proofing device failure and is understood by the team member.

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

jelly1921 said:

This requirement comes from GM

4.1.22 Error proofing Verification (Reference ISO/TS16949 clauses 7.5.1.1 & 8.5.2.2)
The organization shall have a process for error proof verification including frequency requirements and included in the Process Control Plan.
NOTE – Look at: All Error Proofing Devices are checked for function (failure or simulated failure) at the beginning of the shift, when feasible, otherwise according to the process control plan. Error Proofing Masters/Challenge parts (when used) are clearly identified. Records of verification are available.
Look for: Confirm that a list of error proofing devices is available. Confirm that the method of the error proofing verification is defined and documented in the standardized work. Verify that all error proofing devices are checked for function (failure or simulated failure) at the beginning of the shift, when feasible, otherwise according to the process control plan. Look to see that error proofing masters (when used) are clearly identified. Confirm records of verification are available. Verify that a reaction plan is available in the event of error proofing device failure and is understood by the team member.

Click to expand...

Do you think that:
Sentence "...test frequencies shall be documented in the control plan."
And sentence "The process shall include the testing of error-proofing devices for failure or simulated failure."
Both are connected with the test of the EP device?
These sentences are in separate paragraphs...

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

10.2.4 is the requirement of error-proofing.
The first paragragh discuss how to define EP with a documented process. Details in PFMEA, test frequency in CP. Here "test" is to verify EP device, not product!
The second paragragh discus how to test.
So they are the same "test"

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

Additional question
Does EP (for example) in tooling (tooling form/shape) should be contained in control plan
-ep operation
-ep verification
?

Re: IATF 16949 Clause 10.2.4 - Error-proofing question

Peters said:

Additional question
Does EP (for example) in tooling (tooling form/shape) should be contained in control plan
-ep operation
-ep verification
?

Click to expand...

Details of the method used shall be documented in the process risk analysis (such as PFMEA) and test frequencies shall be documented in the control plan.
So the test frequencies in CP is OK. And how to use shall be addressed in PFMEA.
But in Annex A: Control Plan: the tooling shall be included as Process Control and EP device as Method. So EP device in a tooling should be listed twice. I think.

How to operate is subject to 8.5.1.2; how to verify is subject to 8.5.1.6 c)