FMEA-Design and FMEA-Process inputs

AgustinEnrique

Starting to get Involved
Hi people!

I'm developing an application flowchart of the APQP in my organization (non-automotive), and I would like to know what are the inputs (phases or activities) necessary for the FMEA-Design and FMEA process.

Could you help me?

Thank you everyone!
 

Miner

Forum Moderator
Leader
Admin
I would recommend the following as pre-work for the DFMEA:
  1. Form a cross-functional team
  2. Define the customer(s)
  3. Scale the DFMEA according to your need (i.e., entire product, changed portion, etc.)
  4. Define the appropriate level (i.e., system, subsystem, component, etc.)
  5. Create a boundary diagram to understand the scope and identify the interfaces
  6. Create an interface matrix to understand the interfaces and relationships
  7. Create/obtain the environmental and operating profiles to understand the stressors
  8. Create a parameter diagram to understand the system and noise factors
Pre-work for PFMEA
  1. Form a cross-functional team
  2. Define the customer(s)
  3. Scale the PFMEA according to your need (i.e., entire process, changed portion, etc.)
  4. Create a detailed process flow diagram to understand the process and operation inputs/outputs
  5. Create a product characteristics matrix to understand which operations create, modify, use, potentially damage or change a product characteristic
 

Bev D

Heretical Statistician
Leader
Super Moderator
Bare bones inputs for Design are the requirements document and expert knowledge of the scientific/engineering disciplines involved in the design. For the process fmea the design output is an essential input. Also expert knowledge.

Of course miner’s advice is excellent

All that said I must provide a note of caution: In my experience, the level of question you have asked is so elementary that writing a cogent useful procedure on fmea will be difficult. Have you had any training on FMEA?
 

Dazzur

Involved In Discussions
Bare bones inputs for Design are the requirements document and expert knowledge of the scientific/engineering disciplines involved in the design. For the process fmea the design output is an essential input. Also expert knowledge.

Of course miner’s advice is excellent

All that said I must provide a note of caution: In my experience, the level of question you have asked is so elementary that writing a cogent useful procedure on fmea will be difficult. Have you had any training on FMEA?

Hi Bev, are you aware of any supplementary reading material for beginners looking to engage with D/FMEAs?

There's no requirement for me in my role to interact with an D/FMEA however it's knowledge I'd like to gain for my own benefit!

I believe I've seen you recommend "ISO 9001:2015 in Plain English" here & elsewhere, which I acquired & has helped me immensly over the past 12 months. Is there any material that explains/demonstrates D/FMEAs in a similar manner? I understand the latter may be considered a more complex topic and such material may not exist.

Have a nice day :)
 

Miner

Forum Moderator
Leader
Admin
The "BEST" FMEA book that I have seen is the FMEA Handbook published by Ford Motor Company. I have version 4.1 published in 2004. I don't know if it is still available, but it is excellent. It covers DFMEA, PFMEA and Concept FMEA and has over twice the content as the AIAG version.

Added: You should be able to download a PDF of version 4.2 from Ford.
 
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Bev D

Heretical Statistician
Leader
Super Moderator
In addition to Miner' excellent advice (I think I'm going to service mark that phrase!)
The Ford document does a great job of covering the mechanics...

I would recommend the following for some advanced thought about the systemic approach to FMEA. Also I have attached a document I used for how FMEA fits into the whole process of development...

Bohn, Roger, “Stop Fighting Fires”, The Harvard Business Review, July-August 2000 Stop Fighting Fires

Wheeler, Donald, “Problem with Risk Priority Numbers, More Mathematical Jabberwocky”, Quality Digest, June 2011. Problems With Risk Priority Numbers

Youssef, Nataly F. and Hyman, William A., “Analysis of Risk: Are Current Methods Theoretically Sound? Applying risk assessment may not give manufacturers the answers they think they are getting”, Medical Device & Diagnostic Industry, October 2009
Analysis of Risk: Are Current Methods Theoretically Sound?

Flag, John, Rethinking Failure Mode and Effects Analysis”, Quality Digest, June 2015 Rethinking Failure Mode and Effects Analysis

Crosby, David, “Words that Kill Quality and Spill Oil”, Quality Digest, July, 2010Words That Kill Quality and Spill Oil

Travis, Gregory, “How the Boeing 737 Max Disaster Looks to a Software Designer”, IEEE Spectrum, April 19, 2019

Haynes, Alfred C., “United Flight 232: Coping with the ‘One-in-a-Billion’ Loss of All Flight Controls”, Flight Safety Foundation, Accident Prevention, Vol 48. No. 6, June 1991. https://flightsafety.org/ap/ap_jun91.pdf

Imran, Muhammad, “The Failure of Risk Management and How to Fix It”, Book Review, Journal of Strategy & Performance Management, 2(4), 2014 pp. 162-165
http://jspm.firstpromethean.com/documents/162-165.pdf
 

Attachments

  • Development Process FMEA CTQ Spec Setting and Controls.pdf
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Bev D

Heretical Statistician
Leader
Super Moderator
Sorry. Measurement system analysis. It is more than just gauge R&R. I believe I have a presentation on this in the resources section that I presented several years ago at an ASQ conference
 

Tidge

Trusted Information Resource
I have witnessed a LOT of confusion(*1) when trying to tie APQP (at the purchaser of components) and FMEA (at the supplier/manufacturer of components) together. There doesn't need to be much confusion.

I'm going to offer an over-simplistic echo of earlier advice and write: Both APQP and FMEA are iterative. The cross-functional team is necessary to do the iterations.

(*1) My experience has been that when one or both sides of the supplier-purchase partnership ask for a "completed" APQP or FMEA process "too early". This falls into the category of unnecessary intransigence, especially when money for ordering prototypes is involved.

I don't think it is fair to ask a supplier to "complete" (that is, have Verification of Effectiveness for all risk controls) certain steps of their manufacturing PFMEA when the buyer is still making changes to the Design Outputs (e.g. prints, drawings, specs). Similarly, it is possible that if the buyer is providing some "risk ratings" as inputs for a supplier's PFMEA, those ratings could change, so suppliers need to have some initial understanding of where they may need to implement controls, even as they recognize that some things may change.
 
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