What is the difference between a Concept FMEA and a System FMEA?

Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
This is not meant to be sarcastic, but one is on a system and one is on a concept. If you think about the differences, it should become clear.

Take a concept such as windshield wipers which turn on automatically when it rains. You FMEA the concept, in part for feasibility.

Then let's say you decide to do it and you design a system (combination of mechanical and electronic) and you then FMEA that.

Also see FMEA Basics
 
F

f.dabiri

#3
Thank you for your response Mr.smith
But When I studied these subjects it seems that there is'nt any defference between them.even all of definition in the concept and system FMEA is the same.

Do you have a perfect reference to these type of FMEA?
 
A

Al Dyer

#4
Nothing is perfect. A FMEA is a FMEA, it is a process of determining possible pepples in the road ahead. It really doesn't matter if it is a design, process, system, concept etc... the tools are basically the same.

You used the term feasibility, we all do it but when you come down to it the feasibility and FMEA serve the same purpose. Don't get caught up in symantics.

Just my lowly opinion.

Good Luck!

ASD...
 
D
#5
Is everyone aware that the 3rd edition on the fmea handbook has been released? I ordered mine yesterday.
Al, I wouldn't worry about what you call your fmea as long as you are doing them. And you can do them on anything. If you have a customer request to do concept fmeas then by all means call your fmeas concept fmeas.
 
A

adriano

#7
hello!
I had the same problem in the past when I found the for the fist time the Concept FMEA in a Ford manual (FMEA version 31, section 3);it was decide to use:
-Concept FMEA: in the feasibility phase for the new or updated platforms; only potential customer are considered
-system FMEA: at the early phase of the development of a new system; the requirements have been fixed nd there is a nomination letter from the Customer

ciao
 
Thread starter Similar threads Forum Replies Date
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 1
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
G What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 5
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 5
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
Q What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Difference between uncertainty and expanded uncertainty of measurement General Measurement Device and Calibration Topics 1
S EASA Part 145 - The difference between non-certifying staff and Certifying staff Federal Aviation Administration (FAA) Standards and Requirements 2
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2
I What is the difference between OOS/OOT Imported Legacy Blogs 3
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
Q Difference between Monitor & Measurement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T QA vs. RA - The difference between QA and RA Coffee Break and Water Cooler Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2
K Difference between Medical Electrical Equipment and Medical Equipment System IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Usability Standard - The difference between IEC 60601-1-6 to IEC 62336 Human Factors and Ergonomics in Engineering 1
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
A Difference between ISO 9001:2015 Clauses 8.1 and 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF 16949 Cl. 8.4.2.2 vs 8.6.5 - Is there any difference between these clauses? IATF 16949 - Automotive Quality Systems Standard 7
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
C The difference between a Critical Dimension vs. Critical Characteristic Misc. Quality Assurance and Business Systems Related Topics 2
A ISO 9001:2015 - The difference between 6.1.1b and 6.1.1d - IMHO, d) implies b) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Difference between requirement for 4.4.1a (inputs) and 4.4.1d (resources needed)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R The difference between Feasibility Assessment and Contract Review Contract Review Process 2
V Difference between Non-Conformance, Variance and Deviation ISO 13485:2016 - Medical Device Quality Management Systems 7
A Difference between Environmental Impact and Risk ISO 14001:2015 Specific Discussions 7
A Difference Between Complaints and Feedbacks in terms of Follow-Up Actions Needed Customer Complaints 3
M What is the difference between ISO 9000 and ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H What is the difference between MAUDE Report, MDR and MedWatch? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Similar threads


















































Top Bottom