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Tooling and Equipment Manufacturer (TE Supplement) Registration Audit

B

Bryon C Simmons

#1
#1
Hey,all

Survived a TE registration audit today. Our registrar is the first to be granted accreditation for TE registration. We had a few issues, ( can count them on one hand)...was an interesting audit.

Our primary customer for this is Ford, having been involved in the Q1 process this year for TE suppliers, we decided to do third party registration...(why not shoot the moon, right?) Implementing the R&M disciplines turned out to be more of a challenge than I had thought, but we got it done. We are already QS-9000, and upgraded to the Third Edition, as evidenced by our registrar; this adds something more to our bag of tricks.

Audit went well.....some interpretation issues, which I expected, due to the "newness" of the TE supplement. Outside of that, we will shortly be TE compliant, as evidenced by third party audit, complete with certificate.

Are others attempting the registration route? If so, where are you in your journey?

Bryon
 
QMS for Medical Device Companies
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Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
#2
Congratulations and I hope you continue to stick around and help out with questions here!
 
M

mibusha

#3
#3
Bryon,

Congratulations!
We are having our pre-assessment on January 14 &15. It is my plan to register to ISO 9001 and TE at the same time. I agree with you on the R&M requirements. Our engineering department had some or even close to all of the information but it was stashed who knows where. Most of them did not know a FMEA from a Control Plan and do not know much about LCC MTBF and all the other requirements. I have one champion though who is helping me in that respect(In fact, the engineering dept is where most of my efforts have had to be made).

Another area I've had to work hard in is gage calibration. We had no system at all of documentation.

The last one I'll mention is writing procedures. There were procedures but alas, nothing written down. Upon investigation I found many errors crept into the process through this crack.

I would be happy to hear more details about the "interpretations" and anything else worth mentioning. In particular regarding TE.

Michael
[email protected]
 
M

mibusha

#4
#4
Bryon,

Also I agree with Marc. Stick around and help all us "kids" for awhile. This year I have received much more advice than I have given. Next year I hope to be able to reverse that a bit. I guess that's the nature of these forums.

Michael
 
B

Bryon C Simmons

#5
#5
Hey again.

Mike,


In response to your gage calibration situation..remember, that TE does not require all of the R&R stuff that QS does, when it comes to hand held gauges.....ISO doesnt require it at all....will save you some work there. Just remember with the calibration thing, that everything is traceable to NIST, including your tape measures, if you use them at all. Tape measures are difficult to control. There is usually more of those types of gauges than any other.

Noted your remark about the Control Plan/FMEA, hadda laugh. Pre-QS days.... nobody in my company understood the difference either.


I can tell you this.....Ford requires that their engineers, (whoever you are working with for your particular projects), MUST sign off on the Control Plan. This is important, and will be checked during your audit. The other two dont require it.

My other piece for advice would be this..if there are parts of the TE standard that do not apply to your product, (and there almost surely is), GET A WRITTEN WAIVER FROM YOUR CUSTOMER(S) I did this, and it saved my butt.

Marc, I will do the best I can to help out. There are some gray areas in this TE thing...we are gonna learn together.


Bryon


Marc, I will try and be as helpful as I can. There are lots of gray areas in this TE thing.
 
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