Assessing Potential Field Failures (TS 16949 Requirements)

[Mikey324]

Hello, new to the forum. During a recent TS audit, our auditor noted a NC for assessment of potential field failures. We discuss actual failures in mgt. review each month. We did not have record of assessment of potential failures. We do have a PFMEA.

I was curious if a scheduled PFMEA review by manufacturing, quality, sales, etc, would be an effective countermeasure for this NC if results of this review were reported and discussed in mgt. review.

Thank you in advance.

Mike

[Stijloor]

Mike,

Potential field failures are discovered during DFMEA and PFMEA. If any of those are discovered, they need to be communicated to Top Management and included in Management review for resolution.

The automotive industry is very worried that Top Management is not aware of these potential field failures.

Stijloor.

[Mikey324]

In Reply to Parent Post by Stijloor

Mike,

Potential field failures are discovered during DFMEA and PFMEA. If any of those are discovered, they need to be communicated to Top Management and included in Management review for resolution.

The automotive industry is very worried that Top Management is not aware of these potential field failures.

Stijloor.

Thank you for the fast reply. To clarify a little, i guess i'm asking if a scheduled review and reporting system would be effective as a countermeasure. We, as a company, sometimes talk about and do things but fail to document it. Its not that the leg work isn't getting done. It just fails to go on paper somewhere.

[Stijloor]

In Reply to Parent Post by Mikey324

Thank you for the fast reply. To clarify a little, i guess I'm asking if a scheduled review and reporting system would be effective as a countermeasure. We, as a company, sometimes talk about and do things but fail to document it. Its not that the leg work isn't getting done. It just fails to go on paper somewhere.

As a counter measure, you need to make the review of actual and potential field failures an item on the management review agenda.

If you happen to have a documented procedure for Management Review (not required, but handy), include this as an item.

This review and any decisions and actions must be recorded. Then you're OK.

Stijloor.

[Mikey324]

In Reply to Parent Post by Stijloor

As a counter measure, you need to make the review of actual and potential field failures an item on the management review agenda.

If you happen to have a documented procedure for Management Review (not required, but handy), include this as an item.

This review and any decisions and actions must be recorded. Then you're OK.

Stijloor.

Thank you. We have actual failures listed as a management review agenda item but do not have potential listed. I suppose this is what helped draw attention. This is something that i have added to the next reviews agenda. PFMEA review (not design resp) seems to be the best option as a tool to assess possible failures, and one of the few ways i can think of to look at it.