Potential Field Failures and their Impact on Quality, Safety and the Environment

[rexlee]

"Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment."
Would anybody here teach me how to do to meet this requirement?

 

[Sam]

"Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment."
Would anybody here teach me how to do to meet this requirement?

Actual failures - I would consider that to be Returned product analysis.

Potential field failures - I would consider similar to preventive action. Take for example, the recent GM recall for the fire hazard associated with the ignition switch. Had the engineers considered the "potential" for this failure a "preventive" action could have been implemented. On the other hand, maybe it was and the "potential" was not determined.

So far this requirement has not been put under the auditor microsoft. But it does have a lot of "potential".

 

[SilverHawk]

Potential Field Failure

I am just wondering if potential field failure could be just like the GM recall case. We heard about the recall but we are not supply to GM but to any OEM.

Could this potential to consider if our products supply to other OEM may face the similar recall? Bythe way, how do we identify the potential failure - is it in terms of $$$ or what kind of KPI??

On the other hands, if we tell the auditor that there is no potentail failure yet but we are monitoring the situations. Do you think it is accepatble?

 

[rexlee]

Thanks very much for sharing your opinion with me.

Our approach is to use the following data to satisfy this requirement:
1.customer return data
2. and quality excersion which goes through MRB (material review board) to dispose as waive or use as it is

Could above be acceptable?

 

[SilverHawk]

Rex, I think it is not enough.

 

[Sam]

Thanks very much for sharing your opinion with me.

Our approach is to use the following data to satisfy this requirement:
1.customer return data
2. and quality excersion which goes through MRB (material review board) to dispose as waive or use as it is

Could above be acceptable?

You will need to show evidence that your products have been reviewed to determine "potential" failure in the field.

 

[Steven Truchon]

Failure Data

During a recent TS evaluation, addressing the subject of field failures, one of our divisions was told by the auditor that they would be required to obtain end-user warranty claim data relating to the parts they supply, or a customer waiver to that requirement. We are currently exploring the validity of this stated requirement.
Any thoughts of this?

Thanks
Steve

 

[Sam]

During a recent TS evaluation, addressing the subject of field failures, one of our divisions was told by the auditor that they would be required to obtain end-user warranty claim data relating to the parts they supply, or a customer waiver to that requirement. We are currently exploring the validity of this stated requirement.
Any thoughts of this?

Thanks
Steve

This is not a TS requirement. but it is apparently a customer requirement since the auditor requested a waiver.
This should have been addressed in a noncomfomance.

 

[towxg]

I think this requir that your management review input includes not only internal analysis data but also data from outside which generated in the saling,using of your product.

 

[antoine.dias]

My opinion :
If, for instance, an FMEA team has identified a potential failure mode and the reponsible manager cannot agree ( perhaps because of budgetary reasons ) with the proposed action to avoid said condition, this should be brought to top management's attention in the management review.
And they have to decide whether they can live with that or not.