fmea - failure modes and effects analysis

  1. C

    FMEA - Multiple function failures considerations

    Ok in this new problem I am having to solve I have the following issue: Function 1 - Failure 1 Function 2 - Failure 2 Now when assessing the FMEA it is my understanding that we should focus on assessing the failures independently. We should not assess combinations of failures. However my...
  2. B

    Confusion on the new FMEA guidebook - Are we supposed to replace our FMEAs?

    I have some confusion on the new FMEA guidebook. Are we supposed to replace our FMEAs with the new suggestions? They didn't update the FMEA guide to a new revision level and I believe customers (GM, FORD and FCA) require the AIAG original FMEA. I have heard conflicting information.
  3. Z

    Using FMEA for Knowledge Management

    Does anyone have any experience of using FMEA for managing organisation knowledge?
  4. A

    Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs?

    Hello All, Looking for a thought process here. Do we consider the risks from both Hazard Analysis (HA) and FMEAs such as PFMEA, or only the HA?. The standard speaks about risks which may seem to include all but does it make sense to discuss the risks from FMEAs with clinical benefit?. If...
  5. C

    Detection Action for Failure Effects - AIAG 4th Edition Layout

    Dear all, Sincere apologies if this was discussed before... I'm pretty sure it must have been. So basically in the standard AIAG 4th Edition Layout we have two seperate columns for when the Detection Action is for the Failure Mode and when the Detection Action is for the Failure Cause. What...
  6. S

    Is there any connection between PFMEA and Acceptance Plan

    Is there any connection between PFMEA AND ACCEPTANCE PLAN? (Like for setting up AQL number do we have to go through FMEA document)?
  7. D

    Link between FMEA, flow chart and control plan

    Hello everybody, I am running a discussion with a newbie customer SQA regarding the link between FMEA, flow chart and control plan. As per my knowledge, all the phases I identify in my flow chart shall be reported with the same number (or name) in my FMEA. In my control plan I should report...
  8. C

    PCBA Hardware Component different failure types - How to rate detection?

    Hello all, Let's say that a PCBA uses a specific Resistor in it. We identified in the FMEA two different failure modes: - Resistance too low: This is a design issue in which we wrongly calculate the Resistance value of the component - Short circuit due to silver migration: This is a common...
  9. R

    The difference b/w FMEA & Risk analysis as per iso 14971

    Hi Can somebody help in understanding the difference b/w FMEA & Risk analysis as per iso 14971??
  10. Jimmy123

    What is a Reverse FMEA?

    What’s that? Any advice for this customer request?
  11. I

    What does "Class" mean in an FMEA?

    what does "Class" mean in FMEA?
  12. M

    FMEA/DCP Structure and Quantity - Similar Parts and Processes

    Hey, My boss wants to create a DCP/FMEA for each part we manufacture. That would be over 150 parts, all of which run through the same machines following almost identical process. Should we create 150 documents which are practically identical or one high level document which follows the...
  13. D

    Where does FMEA fit in your ISO 14971 Risk Management process?

    After reading the FAQ and an article titled "Why FMEA is Not ISO 14971 Risk Management," I get that FMEA is only one tool in the process, but I'm trying to understand where FMEA fits in a typical medical device risk management process, and what additional tasks are needed (and in which order...
  14. JT3M

    Looking for FMEA plastic injection molding

    Hi my name is Pie Can someone please help me i am looking for a FMEA for the plastic injection molding. I am interest about the function in the mold such as The ejection system, The cooling system, The airvent system etc. I would appreciate it if someone can help. P.s. in attach file is my...
  15. A

    PFMEA - How long should the recommended actions remain in the recommended actions column?

    How long should the recommended actions remain in the recommended actions column? The person who updates our PFMEA's doesn't ever want to remove them. So there are actions listed from 2 years ago. We are doing an annual validation PPAP and he's updated the PFMEA but he wants to keep it there...
  16. C

    Resource allocation problems in Software DFMEA

    Dear all, While working on Software FMEAs we realized that each piece of software made certain use of common resources: Execution time, RAM, ROM, etc... If a failure of a characteristic of that piece of software is defined as: Execution time is too long Its mother function will only fail in a...
  17. C

    VDA Vol.4 - Evaluation of an FMEA

    Hello all, Anybody has a clear idea on how to understand the sections "Questions about the functions/characteristics-in-the-process"on the Evaluation of an FMEA audit table? Points 2.5 to 2.11 ? Thanks a lot! Manuel
  18. D

    Do you need requirements for a Design FMEA

    Hi all, An example of a template for a design FMEA is given in FMEA 4th Edition Blank P and D FMEA sheets in Excel .xls spreadsheets One part I am struggling with is when you do a design FMEA at the component level, do you need to define the requirements for a component. At the...
  19. D

    System Level FMEA example wanted

    Hello, I was wondering if any one has a link to a good system level FMEA example. I can find examples of DFMEA but I am particularly interested in a good example of a system level FMEA and the process around this. Thanks
  20. G

    Can anyone tell me about Tooling FMEA

    can anyone tell me about the tooling fmea.. pls give me tool design FMEA
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