7.3.2.2 - Process Design in Remanufacturing - Registration Finding for no DFMEA

[Mike Smith]

Process Design

I was wondering how other Quality professionals handled this situation for TS2.
Manufacturing Process Design Input
7.3.2.2 "The organization shall identify, document and review the manufacturing process input requirements, including:
Product design output data.

The problem is, as a remanufacturer, our facility is not design responsible. During our certification audit, we got hit with a non-conformance for not having a DFMEA. We do not have access, nor will our customers provide a design FMEA. Our customers will not provide any product design output data, stating it is confidential and not relevant any longer since we only provide past model support.
What would be a corrective action or how would you handle this situation?

 

[Marc]

Good question. I'm surprised you were hit with finding for no DFMEA. In QS that wasn't a problem but an e-mail or FAX or such from the customer was sufficient and that was in a manufacturer situation.

I'll let the TS experts handle this one.

 

[SilverHawk]

DFMEA for Manufacturing Process Design???

It is a bit silly and funny to receive an NCR for nnot identifying DFMEA and knowing very well that the Design responsibility rset with the customer and customer has not extend the copy of DFMEA to you.

Take a good look at 7.3.2.2 Manufacturing Process Design Input which call for product desogn output data and customer requirements and under 7.3.3.2 Manufacturing Process Design Output, it also call for manufacturing process FMEAs, etc.

It was ONLy under 7.3.3.1 Product Design Outputs that Design FMEA is the results from 7.3.2.1 Product Design Inputs.

Obviously it is crystal clear that as far as manufacturing process design is concerned, it is not necessary to re-build DFMEA unless and until the customer is so kind enough to share their DFMEA with you!!!!

Submit the NCRs to IAOB/IAFT for the comments so that for the CBs next witness audit, the witness auditor would be able to query the silly and stupid TS2 auditor.

We have enough of the below par auditors floating around without giving any value-added services. They should be shot right on the spot when the day is hot out in the basketball court!!!!

Better still, ask the auditor to read the above clauses.... and seek their views.

 

[Cari Spears]

SilverHawk - I was right there with ya, until about the 5th paragraph. How 'bout we just contact the technical guy at the registrar?

Mike - many times that I've disagreed with an auditor, all I did was contact the technical function at our registrar. It did not matter which registrar it was at the time (I've worked with 3 or 4 now over the last 10 years or so), most issues were dropped before an appeals process was even considered. Good luck - keep us informed.

 

[SilverHawk]

5th. Para

Hi Cari,

At tiems we have to face the TS2 auditor! Each time we have a discusssion with the technical guys, they are accommodating. Even the General Manager of CB is most happy to "talk it out". But at times, the auditors do get out of hands.

There is one TS2 auditor hoping from TUV to Moody and now to Lloyds. Is he not happy or he is an issue? This TS2 auditor changed three CBs within this 2 years!!!!

If we have to face this auditor, we can discuss with the technical guy but there are different type of auditors' behaviour.

Yes,! Perhaps, not all auditors are the same but we have to have integrity!

 

[wslabey]

I was wondering how other Quality professionals handled this situation for TS2.
Manufacturing Process Design Input
7.3.2.2 "The organization shall identify, document and review the manufacturing process input requirements, including:
Product design output data.

The problem is, as a remanufacturer, our facility is not design responsible. During our certification audit, we got hit with a non-conformance for not having a DFMEA. We do not have access, nor will our customers provide a design FMEA. Our customers will not provide any product design output data, stating it is confidential and not relevant any longer since we only provide past model support.
What would be a corrective action or how would you handle this situation?

That type of response or finding makes no sense if the customer refuses to give you the DFMEA. By not providing you, the manufacturer, with a DFMEA the customer has waived that portion of the requirement for you. It would probably help if the customer supplied you with a letter saying they do not require their suppliers to have a copy of the DFMEA. Receiving that letter from the customer is like getting a "get out of jail free card" come audit time.

I do have a question regarding significant characteristics. Proper DFMEAs have significant characteristics identified. Without having the DFMEA, how did the customer communicate to your firm the SC's so you could include them in your Control Plan?

 

[db]

I was wondering how other Quality professionals handled this situation for TS2.
Manufacturing Process Design Input
7.3.2.2 "The organization shall identify, document and review the manufacturing process input requirements, including:
Product design output data.

Product design output data is much more than just a FMEA. In the case of remanufacturing, is there value in having a DFMEA available? If not, then the point is...well, pointless.

If a DFMEA is available, great. If not, then what other types of data do you have? Specifications, drawings, etc.

The important thing here is; "Where is the shall?" If I can show product design output data (see 7.3.3.1), without a DFMEA, then where is the nonconformance? What "shall" was violated? You've met 7.3.2.2 by showing specs, drawings, and other data, so the "shall" was met. The auditor would have to show me a "shall" that specifically mentions DFMEA, and it aint there.

 

[Sam]

I was wondering how other Quality professionals handled this situation for TS2.
Manufacturing Process Design Input
7.3.2.2 "The organization shall identify, document and review the manufacturing process input requirements, including:
Product design output data.

The problem is, as a remanufacturer, our facility is not design responsible. During our certification audit, we got hit with a non-conformance for not having a DFMEA. We do not have access, nor will our customers provide a design FMEA. Our customers will not provide any product design output data, stating it is confidential and not relevant any longer since we only provide past model support.
What would be a corrective action or how would you handle this situation?

Apparently the auditor is seeing something that leads them to believe that you are doing more than re-manufacturing.
By re-manufacturing do you mean that you are re-conditioning an item to original specifications? If so, is it all rework or is repair involved? If all you do is rework in accordance with customer specifications, then I would say you would not need a DFMEA. However, if you are doing repair then I would say you need a DFMEA or at the least approved repair procedures.

 

[rangotango]

The clause does NOT state "the organisation shall..."

but the design output shall

This means YOU do not have to provide it but if you customer provides it you're okay

whoopee!!

Rangotango