We make check fixtures. Low volume one-off parts not mass produced. We do not use Control Plans or FMEAs. Our culture here does not recognize the normal "mass production" type product development tools normally found. We have procedures, work instructions and process flows but we don't practice SPC or the typical 5 phase APQP. On our pre-assessment we received a minor NC for "No evidence of FMEA or statistical process control being addressed as required by the AS9100B:2004 standard."

I know FMEAs and Control plans and the like, but I cannot even begin to fathom teaching this type of mindset and these tools to this company in time to satisfy the above charge.

This company has been around for a long time. They have a real way (documented) of doing things and are quite successful in their field. How do we jump this hurdle?

I'm thinking that I'll have to develop the FMEAs and SPC based on processes rather than product and with individual teams where over time the culture adapts. But there's that "time" thing again. Any ideas?

I hope you all had a wonderfull Christmas and a Happy New Year!

Oldrice-:cool:

On our pre-assessment we received a minor NC for "No evidence of FMEA or statistical process control being addressed as required by the AS9100B:2004 standard."New year, old challenges. Get back with the auditor and ask him/her to specify exactly where in the standard such requirements are.

The auditor is mistaken. You should have challenged the finding. There are no such requirements in the AS9100 document.

We make check fixtures. Low volume one-off parts not mass produced. We do not use Control Plans or FMEAs. Our culture here does not recognize the normal "mass production" type product development tools normally found. We have procedures, work instructions and process flows but we don't practice SPC or the typical 5 phase APQP. On our pre-assessment we received a minor NC for "No evidence of FMEA or statistical process control being addressed as required by the AS9100B:2004 standard."

I know FMEAs and Control plans and the like, but I cannot even begin to fathom teaching this type of mindset and these tools to this company in time to satisfy the above charge.

This company has been around for a long time. They have a real way (documented) of doing things and are quite successful in their field. How do we jump this hurdle?

I'm thinking that I'll have to develop the FMEAs and SPC based on processes rather than product and with individual teams where over time the culture adapts. But there's that "time" thing again. Any ideas?

I hope you all had a wonderfull Christmas and a Happy New Year!

Oldrice-:cool:Why are they pursuing AS9100?

Do as Sidney says....the auditor is making stuff up (hopefully he doesn't work for us).

Now if you guys have specified that you will use FMEA, APQP, SPC and all that stuff the game is changed.

We make check fixtures. Low volume one-off parts not mass produced. We do not use Control Plans or FMEAs. Our culture here does not recognize the normal "mass production" type product development tools normally found. We have procedures, work instructions and process flows but we don't practice SPC or the typical 5 phase APQP. On our pre-assessment we received a minor NC for "No evidence of FMEA or statistical process control being addressed as required by the AS9100B:2004 standard."

I know FMEAs and Control plans and the like, but I cannot even begin to fathom teaching this type of mindset and these tools to this company in time to satisfy the above charge.

This company has been around for a long time. They have a real way (documented) of doing things and are quite successful in their field. How do we jump this hurdle?

I'm thinking that I'll have to develop the FMEAs and SPC based on processes rather than product and with individual teams where over time the culture adapts. But there's that "time" thing again. Any ideas?

I hope you all had a wonderfull Christmas and a Happy New Year!

Oldrice-:cool:

Even if it were a legitimate finding, the auditor should cite the requirement. You should ask for that citation now, if you don't have it already.

Why are they pursuing AS9100?

Our aerospace customers are requesting it.

Oldrice-
(currently in a reading frenzy of the AS standard - more later.)

Our aerospace customers are requesting it.

Oldrice-
(currently in a reading frenzy of the AS standard - more later.)Asking inappropriately, I think.

We could have a case here of an auditor, used to perform automotive assessments, thrown into an AS9100 audit, and did not read the 9100 standard carefully....

We could have a case here of an auditor, used to perform automotive assessments, thrown into an AS9100 audit, and did not read the 9100 standard carefully....

I had thought of that as well, and that may be the case.

I had thought of that as well, and that may be the case.

It's possible. There's a couple other issues we have with the results as well. Config Mgmt is one. I think we cover it, and the Doc Control and Records, no problem, we are admitedly a bit weak in the supplier controls department and we have a plan for that.

Seems a couple of you think we were thrown into the AS9100 pool wrongly - can you explain this please? Our Supplier Quality team we deal with at one specific large A&D contractor stipulated that further business required us to be on their list and in order to do that we had to be AS9100. So here we are. That being said, we have automotive customers but we're NOT going into TS16949 territory. Not if I can help it.

Thanks for all the help! ! !

Oldrice-:thanx:

Even if it were a legitimate finding, the auditor should cite the requirement. You should ask for that citation now, if you don't have it already.

Hi Jim,

As much as I consider this event an 'official' event, I do realize it's a pre-assessment and requires no real response from us. That being said, I learned a lot about our auditor - let's just say he was pre-assessed as well. Anyway, I participated in the PA, took notes, tried to keep things focused and in short time had accomplished our goal of discovering where we stand.

The only reference to the standard he made in regard to this non-conformance specifically was 'AS9100B 8.1' where it states that "statistical techniques may be used to support ...FMEAs" (I'm paraphrasing here, that's not verbatim). Which looks like fluff to me but I wanted a bit more confidence here. In our actual audit I will without a doubt be requiring data to back up anything they find. Yes, it will be him. Nice guy too. We really like him.

Thanks everyone, Thank you Jim,


Oldrice-
Sleepless in Detroit

Seems a couple of you think we were thrown into the AS9100 pool wrongly - can you explain this please? Look at this thread (http://elsmar.com/Forums/showthread.php?t=13229). AS9100 requirements are primarily intended for QMS's of suppliers providing flight hardware. If you have to "implement" artificial controls in your system, such as FAI, CM, etc..., just to comply with AS9100, you will be adding costs with no significant improvement in return. Not mentioning the additional costs and controls of the ICOP Scheme that will affect your certification, once again, without measurable returns.

It's possible.Our Supplier Quality team we deal with at one specific large A&D contractor stipulated that further business required us to be on their list and in order to do that we had to be AS9100. By June, I'll bet.:(

Hi Jim,

As much as I consider this event an 'official' event, I do realize it's a pre-assessment and requires no real response from us. That being said, I learned a lot about our auditor - let's just say he was pre-assessed as well. Anyway, I participated in the PA, took notes, tried to keep things focused and in short time had accomplished our goal of discovering where we stand.

The only reference to the standard he made in regard to this non-conformance specifically was 'AS9100B 8.1' where it states that "statistical techniques may be used to support ...FMEAs" (I'm paraphrasing here, that's not verbatim). Which looks like fluff to me but I wanted a bit more confidence here. In our actual audit I will without a doubt be requiring data to back up anything they find. Yes, it will be him. Nice guy too. We really like him.

Thanks everyone, Thank you Jim,


Oldrice-
Sleepless in Detroit


As you say, this requirement is in the NOTE,so it is just a suggestion,
it is not a NCR. you can reject this NCR.