M

mioara fekete

Guest
#1
Hello,

I want to talk about an issue raised during the audit ISO / TS.

The NC was

"In the management review it was stated that there was no potential field failure, however during last year there were customer claims related to crimping.(wiring company)."


The question was that based on what it was decided that there is no risk.
We were unable to present any analysis(only the 8D report)of actual and potential field-failures and their impact on quality, safety or the environment.
Can you please advice what kind of analysis we should do?
Also we were asked to present a procedure with the flow of the analysis(how are we going to evaluate if we should ask for a recall or not).

thanks & regards
mioara
 

Stijloor

Super Moderator
Staff member
Super Moderator
#2
Re: Analysis of potential field failures

Hello,

I want to talk about an issue raised during the audit ISO / TS.

The NC was

"In the management review it was stated that there was no potential field failure, however during last year there were customer claims related to crimping.(wiring company)."

The question was that based on what it was decided that there is no risk.
We were unable to present any analysis(only the 8D report)of actual and potential field-failures and their impact on quality, safety or the environment.
Can you please advice what kind of analysis we should do?
Also we were asked to present a procedure with the flow of the analysis(how are we going to evaluate if we should ask for a recall or not).

thanks & regards
mioara
If you received customer complaints about crimping nonconformities; that is considered an actual field failure. I gathered from your post that you performed an 8-D analysis to find out what the root causes were that contributed to the problem. You have to conduct an analysis on this field failure and determine if there are any other possible related field failures. In other words, in what manner was the customer affected and how should you respond to it?

Now what I have presented deals with reactive work; Corrective Action.

Let's now talk about the intent of that clause in ISO/TS 16949:2009.

You are expected to conduct an FMEA prior to process approval/validation to find out if there are any potential failure modes introduced by the crimping process that could possible have an effect (potential field failure) on the customer. That possible failure mode and its effects must be presented to Top Management for preventive actions and necessary resources.

I believe that there was no visible/documented connection between your FMEA process and Management Review.

Hope this helps.

Stijloor.
 

Miner

Forum Moderator
Staff member
Super Moderator
#3
Re: Analysis of potential field failures

I believe that there was no visible/documented connection between your FMEA process and Management Review.
Stijloor is correct. If your Management Review found no potential failure modes then one of two things failed. Either no PFMEA was performed, or a PFMEA was performed and the Management Review was unaware of it. Either issue would be a potential NC as PFMEAs are a requirement of TS16949, and the lack of awarenes of the PFMEA in a Management Review would be an indication of a shallow MR.
 
M

mioara fekete

Guest
#4
Re: Analysis of potential field failures

If you received customer complaints about crimping nonconformities; that is considered an actual field failure. I gathered from your post that you performed an 8-D analysis to find out what the root causes were that contributed to the problem. You have to conduct an analysis on this field failure and determine if there are any other possible related field failures. In other words, in what manner was the customer affected and how should you respond to it?

Now what I have presented deals with reactive work; Corrective Action.

Let's now talk about the intent of that clause in ISO/TS 16949:2009.

You are expected to conduct an FMEA prior to process approval/validation to find out if there are any potential failure modes introduced by the crimping process that could possible have an effect (potential field failure) on the customer. That possible failure mode and its effects must be presented to Top Management for preventive actions and necessary resources.

I believe that there was no visible/documented connection between your FMEA process and Management Review.

Hope this helps.

Stijloor.
Hello,
thanks for your reply.
The failure modes as effects of crimping were available in the PFMEA, management team was aware regarding the effect, 8D report was done and sent to customer.Is true no other anayze was done.
The question is still alive.Is the RPN the relevant indicator which is telling me that there is no risk for the customer?
When should we ask for a recall?
I want to make an internal procedure to highlight step by step what has to be done .
Has anybody any idea?

regards Mioara
 

Kevin Mader

One of THE Original Covers!
Admin
#5
Re: Analysis of Potential Field Failures - Impact on Quality, Safety or the Environme

Mioara,

I’m not sure if I’m following you correctly, but it sounds like there is a disconnect between a potential occurrence vs. and actual occurrence (customer complaints).

In a risk management program, original assumptions need to be re-challenged when objective evidence refutes them. In this case, it sounds like your PFMEA indicated that the potential for crimping errors had a given RPN (low) and that further mitigation might be unnecessary (business decision?). Once you had the occurrence, new objective evidence is needed that shows that the original assumptions were challenged to determine if they are still valid, else you will need to assign a new RPN (and perhaps new control plans/mitigations). Based on the magnitude of the effect for the customer complaints you received, your 8D report should indicate to the reader (the auditor) that risk management activities were reviewed and determined relevant or were changed to reflect the new observed conditions. For this, you may need to know more about how the product you manufactured is used (if you aren’t the manufacturer of record).

I suggest you take a look into risk management here at the Cove. Do a few key word searches and see if you pick up something useful. In the end, you need to respond to the finding: why was there a disconnect between what was reported at MR (potential) and the complaint you received (actual).

Regards,

Kevin
 
Q

QualityQ

Guest
#6
Re: Analysis of Potential Field Failures - Impact on Quality, Safety or the Environme

Hello,
Regarding this close our ISO 16949 auditor said that actual and potential "field failures" refer to "Gemba" which means the shop floor in short terms. I didn't find his interpretation correct.

Till this year regarding this close, we were always analysing our warranty datas and looking for possible problems which may cause warranty issues.

I still haven't changed our way of analysis. But soon we'll have an ISO 16949 audit.
What do you think about that?

Best regards,
Elif
 

qusys

Quite Involved in Discussions
#7
Re: Analysis of Potential Field Failures - Impact on Quality, Safety or the Environme

Hello,
Regarding this close our ISO 16949 auditor said that actual and potential "field failures" refer to "Gemba" which means the shop floor in short terms. I didn't find his interpretation correct.

Till this year regarding this close, we were always analysing our warranty datas and looking for possible problems which may cause warranty issues.

I still haven't changed our way of analysis. But soon we'll have an ISO 16949 audit.
What do you think about that?

Best regards,
Elif
Elif, probably your TS auditor was not properly correct in his interpretation.
Actual failures are the RMA of your customers, where you should have G8D and all actions in place, while potential field failures have to be intended as the potential failures of your product in exercise that you supply to your final customer.
For instance, customer representative should inform himself with customers and have their documented feedbacks as one of the input in mgmt review.
Also the interpretation regarding FMEA is correct, so both the item will cover the item.Hope this helps:bigwave:
 
Q

QualityQ

Guest
#8
Re: Analysis of Potential Field Failures - Impact on Quality, Safety or the Environme

Hello,
Thanks for the info.
When you say RMA, do you mean (Returned Material Authorization)?
When you say the final customer, you mean the one who drives the car, right?

But how can I be sure that your interpretation is the correct one? Because I cannot convince him, at all?
 

qusys

Quite Involved in Discussions
#9
Re: Analysis of Potential Field Failures - Impact on Quality, Safety or the Environme

Hello,
Thanks for the info.
When you say RMA, do you mean (Returned Material Authorization)?
When you say the final customer, you mean the one who drives the car, right?

But how can I be sure that your interpretation is the correct one? Because I cannot convince him, at all?
Yes, RMA are the return from the field
Yes final customer could be intended as the driver of the car, but also as the manufacturer car you sell your product to.
Consider that 5.6.2.1 is also associated with 7.5.1.7 clause of ISO TS, where it is required a process to communicate information on service concern to design, engineering and manufacturing activities.
Besides, 5.6.2.1 also deals with the impact of safety, quality and environment. You can think to the potential impact of heavy metal (Pb)of which is done a marmit, just in case of break.
As to intepretation, I collected this info based upon my experience with CB auditor, recognized consultant and literature.
Hope this helps:bigwave:
 
M

mioara fekete

Guest
#10
Re: Analysis of Potential Field Failures - Impact on Quality, Safety or the Environme

Hello,
Regarding this close our ISO 16949 auditor said that actual and potential "field failures" refer to "Gemba" which means the shop floor in short terms. I didn't find his interpretation correct.

Till this year regarding this close, we were always analysing our warranty datas and looking for possible problems which may cause warranty issues.

I still haven't changed our way of analysis. But soon we'll have an ISO 16949 audit.
What do you think about that?

Best regards,
Elif
Hello Elif,

the questions will be :
-have you analyze the failure? yes
-is the failure a potensional field failure?No
-how you decide that?

In our plant it was prepared a procedure in which is the responsability of the quality engineer to contact the resident eng or the customer quality and decide regarding the field failure.The final result is recorded on one enclosure(table)with the names of the involved people.

regards
Mioara
 

Top