Process FMEA with the effect "brakes are broken" - Is it nonconformity?

Peters

Quite Involved in Discussions
#1
Problem during the TS audit.
Process FMEA team found some technical requirements with the effect "brakes are broken". They gave severity 9 or 10. They didn't identified special characteristics because the design documentation for these requirements didn't contain special characteristics. Would you write NC Report?
 
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Jim Wynne

Leader
Admin
#2
Re: Is it nonconformity?

Problem during the TS audit.
Process FMEA team found some technical requirements with the effect "brakes are broken". They gave severity 9 or 10. They didn't identified special characteristics because the design documentation for these requirements didn't contain special characteristics. Would you write NC Report?
If there's a requirement for everything with a severity rating of 9 or 10 to be identified as an SC, it's a customer-specific requirement (or a requirement of your company). In order for a nonconformity to be identified, a specific requirement has to be unfulfilled. What's the requirement in your case?
 

Peters

Quite Involved in Discussions
#3
Re: Is it nonconformity?

What's the requirement in your case?
Well...
Usually FMEA is main tool for special characteristics identification.
If problem connected with effect with severity 9/10 is not special characteristic - what effect could indicate special characteristic? What can be more dangerous?

PS. In Ford FMEA Handbook there is table with special characteristics "The following table contains the possible characteristic designations for both Design and Process FMEAs"
In this table:
Process -∇ - A Critical Characteristic - Severity = 9, 10 - Special Control
Required
 

Jim Wynne

Leader
Admin
#4
Re: Is it nonconformity?

Well...
Usually FMEA is main tool for special characteristics identification.
If problem connected with effect with severity 9/10 is not special characteristic - what effect could indicate special characteristic? What can be more dangerous?
What could be more dangerous is a high severity rating coupled with high occurrence and/or detection ratings.

PS. In Ford FMEA Handbook there is table with special characteristics "The following table contains the possible characteristic designations for both Design and Process FMEAs"
In this table:
Process -∇ - A Critical Characteristic - Severity = 9, 10 - Special Control Required
That's a requirement only if Ford is your customer. Personally, I think it's a mistake to get overly excited about high severity numbers if the risk is reasonably low.
 
D

Duke Okes

#5
Whether it is a special characteristic would be decided by design engineers as part of design FMEA. Then that designation would be carried into the process FMEA. Severity rankings in process FMEA should come from design FMEA.
 

Chennaiite

Never-say-die
Trusted Information Resource
#6
Problem during the TS audit.
Process FMEA team found some technical requirements with the effect "brakes are broken". They gave severity 9 or 10. They didn't identified special characteristics because the design documentation for these requirements didn't contain special characteristics. Would you write NC Report?
If designating characteristics with Severity 9 or 10 as Special is neither the requirement of your Customer nor of internal guidelines/Product design outputs, the answer to your question is - No.
Nevertheless, if you get a feeling that, it is supposed to be considered Special (Standards apart), you can only end up to the extent of giving feedback to the concerned.

It is not appropriate for the auditors, internal or external, to challenge the adequacy of the Design.
 
T

tbsiva

#7
No standard says that Failure mode having a severity of 9 and 10 needs to be designated as special characteristic. Only based on this, an auditor cannot write a NCR.

But you need to demonstrate the logic on defining special charateristic.. For ex : a failure mode having a severity of 4 or 5 is designated as special charateristic whereas in other case a failure mode of 9 or 10 severity ranking has not been classified as special characteristic... The logic has to be justified
 

Jim Wynne

Leader
Admin
#8
Whether it is a special characteristic would be decided by design engineers as part of design FMEA. Then that designation would be carried into the process FMEA. Severity rankings in process FMEA should come from design FMEA.
This is generally true but many, if not most, automotive suppliers have no access to DFMEAs and must go by the drawing as far as design intent goes. It's possible that a supplier could have a different strategy in developing PFMEAs, one that's based on "the organization's" own risks, exclusive of end-use risks. The rationale might be that if you make the product to the specifications, design intent is taken care of, and what's left is risk for the supplier.
 
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