Special Characteristics - ISO/TS 16949 Clause 7.3.2.3

[chereele]

Our auditor has just minored us on "identify process control documents including drawings, FMEAs, control plans, and operator instructions related to a specific part number with the customer's special characteristic symbol or the organization?s equivalent symbol or notation to include those process steps that affect special characteristics."

But he didn't give any guidance - FMEA's Control Plans, part specific instruction documents and documents defining machine setup for a specific part number. That makes sense. However, he is suggesting that machine manuals, documents provide by the machine builder, gage instructions, and documentation dealing specifically with the machine should be marked as well.
Much of our equipment is multi use and produces multiple products some with special characteristic some without for multiple customers.

Does anyone have any suggestions on how to address this?

 

[AndyN]

Our auditor has just minored us on "identify process control documents including drawings, FMEAs, control plans, and operator instructions related to a specific part number with the customer's special characteristic symbol or the organization?s equivalent symbol or notation to include those process steps that affect special characteristics."

But he didn't give any guidance - FMEA's Control Plans, part specific instruction documents and documents defining machine setup for a specific part number. That makes sense. However, he is suggesting that machine manuals, documents provide by the machine builder, gage instructions, and documentation dealing specifically with the machine should be marked as well.
Much of our equipment is multi use and produces multiple products some with special characteristic some without for multiple customers.

Does anyone have any suggestions on how to address this?

Hi - can you give us the EXACT wording and any references to TS etc in the "minor"?

 

[chereele]

"7.3.2.3
Statement of Requirement:
TS16949:2009 clause 7.3.2.3 Special characteristics
The organization shall identify special characteristics [see 7.3.3 d)] and
⎯ include all special characteristics in the control plan,
⎯ comply with customer-specified definitions and symbols, and
⎯ identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer's special characteristic symbol or the organization?s equivalent symbol or notation to include those process steps that affect special characteristics.
Statement of Nonconformity:
The process of handling special characteristics is not effective.
Objective Evidence:
Process Control Plan for Ford 77-033-03-1 DL ASSY-OUTER-LFL identified 7 critical characteristics (CC) over 4 operation flow steps that were not identified on the Work Instructions.
Justification:
This issue was not exhibited in the Process Control Plan for 70-077-06-1 & 2 TRE ASSY ? LH BK and 78-046-03-1."

So, that was the write up cut and paste. However, he had a machine manual in his hand when he discovered the 77033031 document and said that it should also have the special characteristic marked in it as well. He doesn't mention that manual at all in his Objective evidence at all.

 

[Helmut Jilling]

Our auditor has just minored us on "identify process control documents including drawings, FMEAs, control plans, and operator instructions related to a specific part number with the customer's special characteristic symbol or the organization?s equivalent symbol or notation to include those process steps that affect special characteristics."

But he didn't give any guidance - FMEA's Control Plans, part specific instruction documents and documents defining machine setup for a specific part number. That makes sense. However, he is suggesting that machine manuals, documents provide by the machine builder, gage instructions, and documentation dealing specifically with the machine should be marked as well.
Much of our equipment is multi use and produces multiple products some with special characteristic some without for multiple customers.

Does anyone have any suggestions on how to address this?

It should be on relevant documents, control plans, FMEAs, drawings, work instructions, and inspection instructions would typically be relevant documents. It would be extremely rare that one would expect to put it on a machine manual, because the manual,does not really control the activity. The five types of docs I mentioned typically control the activities...

 

[chereele]

"Work instructions" meaning documents that control activities specific to creating a product?

The phrase "work instruction" is what is being tripped over.

 

[Helmut Jilling]

"Work instructions" meaning documents that control activities specific to creating a product?

The phrase "work instruction" is what is being tripped over.

I thought the issue was the machine manuals... If the work instructions would benefit from identifying special characteristics, then add them. If the instructions are rather generic or equipment focused..."turn this switch, then press that button"....then what benefit would there? Adding an SC would probably be pointless.

 

[chereele]

Thank you! Yes the focus was machine manuals that was the document he had in his hands and said it should be noted with special characteristics. However, the machine manual is generic and equipment focused. It does involve turn switch and press a button. There would be no benefit in identifying them with special characteristics. What it would guarantee is that every document would have them thereby rendering the whole premise of identifying special characteristic mute.

 

[Grimaskr]

We recently also got this minor. Our special characteristics were dimensions on the product and the finding was that there was no mention of SC in our work instructions.

By work instructions, our auditor was referring to the operator procedures we had authored for the process.

Our solution was to add the TS16949 definition of "SC" to the definitions section of any procedures affecting SCs and add an SC symbol in the margin next to any process step in those work instructions that directly affected or measured an SC.

We're hoping that is enough, but we haven't closed out our minors yet...

 

[Helmut Jilling]

We recently also got this minor. Our special characteristics were dimensions on the product and the finding was that there was no mention of SC in our work instructions.

By work instructions, our auditor was referring to the operator procedures we had authored for the process.

Our solution was to add the TS16949 definition of "SC" to the definitions section of any procedures affecting SCs and add an SC symbol in the margin next to any process step in those work instructions that directly affected or measured an SC.

We're hoping that is enough, but we haven't closed out our minors yet...

Review my post number six. If the work instructions are very specific to that job, to that part number, then putting the SC on the word instruction might be beneficial. If the work instruction is very generic, SC's may not be relevant.