TS 16949 Alternative Risk Assessment FMEA, Apendix C Requirements

[rudolfrm]

Hi friends

The last month we had a audit for TS 16949, and the auditor ask me about the criteria for actions for my FMEA, he told me about the alternative risk assessment on the apendix C from the manual, it talks about SO, SOD, SD evaluations, ¿someone know if this tables are obligatory for my FMEA?

Thank you friends, a nice day

Rudolf

 

[Al Dyer]

Hi rudolfrm

May I ask if you received an N/C or if this was just "friendly" discussion?

Al...

 

[rudolfrm]

Hi Al, Is just a frendly discussion, i have a doudt about it. And want to know if someone can tell me more about their experience audits.

 

[Al Dyer]

Thanks,

My past experience was that a company prepares itself and its workers for complying with the requirements. If there is any question as to your compliance remember that the external auditor is as fallible as we all our and to question all results. As customers paying for an audit we retain the obligation and responsibility to ensure that the auditor up to par.

Just as a small story:

We had an audit (QS9000) where we received an N/C for a corrective action not closed. We submitted the corrective and new procedure which he accepted and closed. At the next review he gave us the same N/C for the same corrective action and wanted to yank our Cert. I talked to him before our close-out meeting and showed him the proof that it was corrected in the proper manner. For whatever reason he would not accept my proof and blew me off before I could finish my discussion. I was upset to say the least.

At the close out meeting with the management team and owner he told us we failed because we had a faulty system. I did speak up and called him on the documentation for his finding. He told the management team that nobody had signed off on our last N/C. I then produced the signed-off proof that the previous N/C had been closed and that he was the one that had closed it.

Awkward moment, but we passed the audit.

Just one way that things can go and there are hundreds of others.

Al...

 

[howste]

Hi friends

The last month we had a audit for TS 16949, and the auditor ask me about the criteria for actions for my FMEA, he told me about the alternative risk assessment on the apendix C from the manual, it talks about SO, SOD, SD evaluations, ¿someone know if this tables are obligatory for my FMEA?

Thank you friends, a nice day

Rudolf

The alternate methods are just other methods that you may choose to use. SO, SOD, and SD are different ways to prioritize the actions you choose to take to reduce risk. Your organization gets to decide how you'll prioritize.

The latest FMEA manual gives you many options for FMEA formats, none of which is mandatory. Your organization can choose the format you'd like unless your customer(s) require a specific format.

 

[rudolfrm]

Thank you friends for yous answer