DFMEA & PFMEA Lead Responsibility

K

KWB64

#1
Fellow Quality Professionals,

Just taking a little survey here; in your organizations, what functional area has lead responsibility for Design FMEA? What about Process FMEA? Please don't confuse my question with functional area for facilitation; I think regardless of function, who ever has the expertise can "lend a hand" in facilitation. I'm wondering about functional area that owns, maintains, and manages the FMEA.

In my organization there is a belief that FMEA are the responsibility of the Quality "Department". I disagree; in my opinion Design Engineering / Product Engineering should take the lead, with cross functional support and participation for DFMEA. Process Engineering / Manufacturing Engineering should take the lead role with cross functional support for PFMEA.

I appreciate your feedback.

Thanks,
KWB64
 
Last edited by a moderator:
Elsmar Forum Sponsor

bgot62

Starting to get Involved
#3
This post could not have come at a better time for me. We are a small production company just coming out of the "mom and pop dirt floor garage " era, I am very new to being the quality department and we are just starting these types of exercises. I fight this mentality everyday.

:mad:
 

Stijloor

Staff member
Super Moderator
#4
Fellow Quality Professionals,

Just taking a little survey here; in your organizations, what functional area has lead responsibility for Design FMEA? What about Process FMEA? Please don't confuse my question with functional area for facilitation; I think regardless of function, who ever has the expertise can "lend a hand" in facilitation. I'm wondering about functional area that owns, maintains, and manages the FMEA.

In my organization there is a belief that FMEA are the responsibility of the Quality "Department". I disagree; in my opinion Design Engineering / Product Engineering should take the lead, with cross functional support and participation for DFMEA. Process Engineering / Manufacturing Engineering should take the lead role with cross functional support for PFMEA.

I appreciate your feedback.

Thanks,
KWB64
I'm curious: Are you an automotive supplier? The reason that I am asking is that in the automotive supplier business a "multidisciplinary approach" for Quality Planning, FMEA and Control plans is required. You are absolutely correct. Tell your colleagues at work that your friends at The Cove Forums support you! :agree1:

Stijloor.
 
K

KWB64

#5
Stijloor,

We are not an automotive supplier; we are an OEM of heavy construction equipment with very low volumes (for us high volume might be 100 machines / year, less than 20 / year is common). We need some serious culture change here! Quality is too much about the Quality Department. The most common answer to every quality escape is inspection. The Quality Team is trying to emphisize proactive approahes.
 

Chennaiite

Never-say-die
Trusted Information Resource
#6
Fellow Quality Professionals,

Just taking a little survey here; in your organizations, what functional area has lead responsibility for Design FMEA? What about Process FMEA? Please don't confuse my question with functional area for facilitation; I think regardless of function, who ever has the expertise can "lend a hand" in facilitation. I'm wondering about functional area that owns, maintains, and manages the FMEA.
Thanks,
KWB64
Why not, if your Quality Department is good(skilled) enough to own, maintain and manage ?
 

raghu_1968

Involved In Discussions
#7
Fellow Quality Professionals,

Just taking a little survey here; in your organizations, what functional area has lead responsibility for Design FMEA? What about Process FMEA? Please don't confuse my question with functional area for facilitation; I think regardless of function, who ever has the expertise can "lend a hand" in facilitation. I'm wondering about functional area that owns, maintains, and manages the FMEA.

In my organization there is a belief that FMEA are the responsibility of the Quality "Department". I disagree; in my opinion Design Engineering / Product Engineering should take the lead, with cross functional support and participation for DFMEA. Process Engineering / Manufacturing Engineering should take the lead role with cross functional support for PFMEA.

I appreciate your feedback.

Thanks,
KWB64
FMEA is the cross functional team approach.

Hence Quality person may also part of the CFT and it does not mean that Quality department is responsible for activities with respect to FMEA.

Regards / Raghu
 

Chennaiite

Never-say-die
Trusted Information Resource
#8
I absolutely agree with you and if you have the newest AIAG FMEA standard, it will also agree with your statement.

Quality is a participant in both design and process FMEA but does not lead.
I dont think AIAG FMEA Manual - IV talks about specific leader. Or did i miss somefing?:confused:
 
Last edited:
D

David DeLong

#9
I dont think AIAG FMEA Manual - IV talks about specific leader. Or did i miss somefing?:confused:
Page 69 AIAG 4th edition states "The PFMEA is developed and maintained by a multi-disciplinary team typically led by the responsible engineer."

Page 17 of the 4th edition states "The DFMEA is developed and maintained by a multi-disciplinary team typically led by the design responsible engineer from the responsible design source."

This makes sense unless you have a small shop where personnel wear many hats. In a small shop, the Designer would still lead the DFMEA while a knowledgeable person in manufacturing would lead the PFMEA.
 

Jim Wynne

Staff member
Admin
#10
Page 69 AIAG 4th edition states "The PFMEA is developed and maintained by a multi-disciplinary team typically led by the responsible engineer."

Page 17 of the 4th edition states "The DFMEA is developed and maintained by a multi-disciplinary team typically led by the design responsible engineer from the responsible design source."

This makes sense unless you have a small shop where personnel wear many hats. In a small shop, the Designer would still lead the DFMEA while a knowledgeable person in manufacturing would lead the PFMEA.
I've worked in situations where the FMEA process (both varieties) is lead by an engineer, and others where a QA person does it. What's important is not who leads the process, but how effective the process is. I'm not sure where AIAG gets the idea that an engineering lead is "typical." On the whole I'd want someone who (a) understands the FMEA process, (b) knows how to run a meeting, and (c) has the confidence of the team. The department that person works in is largely irrelevant.
 
Thread starter Similar threads Forum Replies Date
C DFMEA (Design FMEA) and PFMEA (Process FMEA) - Who should lead? FMEA and Control Plans 14
P Equipment URS, pFMEA and dFMEA ISO 14971 - Medical Device Risk Management 3
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
T DFMEA/PFMEA and SCCAF alignment FMEA and Control Plans 19
I Making a process PFMEA, no DFMEA (non-automotive toll manufacturer) FMEA and Control Plans 1
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N DFMEA, Drawings and PFMEA of an Assembly Process FMEA and Control Plans 12
C DFMEA vs. PFMEA Relationship: The cause in DFMEA becomes Failure in the PFMEA FMEA and Control Plans 2
N What is the relationship between a DFMEA and PFMEA? FMEA and Control Plans 1
S DFMEA countermeasures in PFMEA FMEA and Control Plans 18
V Simple Representation for Scope of DFMEA and PFMEA FMEA and Control Plans 4
E IQRM PFMEA/DFMEA Software FMEA and Control Plans 11
T DFMEA & PFMEA - Special Characteristics Identification FMEA and Control Plans 14
V Failure Modes & Causes in dFMEA & pFMEA FMEA and Control Plans 3
T DFMEA (Design FMEA) - We already have a PFMEA (Process FMEA) FMEA and Control Plans 5
C Does the PFMEA Severity have to match the DFMEA Severity? FMEA and Control Plans 3
P DFMEA, PFMEA and Control Plan examples (e.g.: for a pen) wanted for training FMEA and Control Plans 2
U Example of DFMEA & PFMEA for a throttle body (Butterfly valve) FMEA and Control Plans 2
N How to Calculate RPN in Design FMEA (DFMEA) vs. Process FMEA (PFMEA) FMEA and Control Plans 9
A DFMEA, PFMEA and KCC's (Key Control Characteristics) Relationships FMEA and Control Plans 11
W Actual examples of FMEA (DFMEA, PFMEA) for Car Assembly Process IATF 16949 - Automotive Quality Systems Standard 5
G The difference between DFMEA and PFMEA FMEA and Control Plans 4
L Special Characteristics in DFMEA (Design FMEA) - Carry over to PFMEA? FMEA and Control Plans 9
Ron Rompen Development of the PFMEA - SEVERITY scores not derived from the DFMEA - Ford FMEA and Control Plans 13
M Connection between DFMEA and PFMEA - What must be transferred to the PFMEA? FMEA and Control Plans 9
Y Design (DFMEA) and Process (PFMEA) FMEA Failure Mode Identification Design and Development of Products and Processes 8
A PFMEA - Is having the DFMEA An Absolute Requirement when doing a PFMEA FMEA and Control Plans 19
O AIAG VDA DFMEA Template Required FMEA and Control Plans 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M How to complete structure Analysis and Function analysis sections' columns of AIAG-VDA DFMEA form FMEA and Control Plans 0
Jimmy123 Handling nonfunctional requirements in DFMEA FMEA and Control Plans 5
Jimmy123 P-Diagram vs DFMEA FMEA and Control Plans 4
C Function definition for DFMEA FMEA and Control Plans 1
G DFMEA buy-in strategies for Design Engineers APQP and PPAP 22
optomist1 DFMEA - Real Life Drama FMEA and Control Plans 25
optomist1 Share a DFMEA template please Document Control Systems, Procedures, Forms and Templates 2
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
Marc Definition DFMEA (Design FMEA) - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
S DFMEA when the supplier doesn't have design responsibility APQP and PPAP 15
C Design for Assembly in DFMEA - Failure Effect of Sub-System(s) FMEA and Control Plans 5
C Resource allocation problems in Software DFMEA FMEA and Control Plans 4
D Introducing an existing product into automotive context - DFMEA needed? IATF 16949 - Automotive Quality Systems Standard 8
N YS Class in DFMEA & Process Control Measures FMEA and Control Plans 1
R DFMEA Severity 9-10 with Occurrence 3 and Detection 3 - Actions FMEA and Control Plans 3
G Is it compulsory to make DFMEA for proto parts making organisation APQP and PPAP 1

Similar threads

Top Bottom