Search the Elsmar Cove!
**Search ALL of** with DuckDuckGo including content not in the forum - Search results with No ads.

dfmea (design fmea)

  1. optomist1

    Share a DFMEA template please

    Can anyone share a DFMEA template...a cursory search revealed DFMEA matrices, but no DFMEA template....additionally for those Cove software experts, please share any current experience re: validation and vetting of deliverable software, tools, processes etc...Thank You
  2. P

    Detection rating for a user (surgeon) related failure mode in DFMEA

    Hi Guys I have a question about detection rating for a user related failure mode in DFMEA. This failure happens if the surgeon is not following the instructions provide in 'info for use'. I could not find any relevant thread so am posting here. Let me know if this thread is not appropriate...
  3. Marc

    DFMEA (Design FMEA) - Definition

    From Experience in: Airbag Restraint Systems Anti-Lock Brake Systems DoD Aerospace High Reliability Electronics In your Design FMEA you are doing a risk analysis of the product function. In short - If the product fails, what is the potential risk? If you really are into it, there was a series...
  4. Shawn Mosby

    DFMEA when the supplier doesn't have design responsibility

    I have a supplier that I have approved and who is running an APQP process for the first products that they will deliver to us. We are demanding a level 3 PPAP and part of the submitted documentation should be the DFMEA. The design of the product we are requesting has been done by my company and...
  5. O

    How to create robustness checklist from p diagram

    Hi everyone, I m recently working on dFMEA for ac lines and I completed all the p-diagrams. Now I need to continue on the robustness checklist. But the links on the file are not working and I need your support to understand how to create rcl from p diagram. Anyone experienced in this? Thanks.
  6. T

    DFMEA/PFMEA and SCCAF alignment

    Hello everybody, I work as a quality engineer for the past year and I am very much interested in DFMEA/PFMEA and SCCAF The engineers where I work are unable to tell me the following: 1 ) should DFMEA and PFMEA be aligned in terms of SC and CC (Significant and Critical Characteristics). When I...
  7. 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...
  8. 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...
  9. C

    Design for Assembly in DFMEA - Failure Effect of Sub-System(s)

    Hello all, Another recurring problem that I am facing For System A to work, it needs Sub-Systems A.1 and A.2 to be assembled together. In general, a failure of Sub-System A.1 or Sub-System A.2 will lead to a failure of System A. What happens when a Design failure of Sub-System A.1 will mean...
  10. D

    Design FMEA for a component - Should I make the following assumptions?

    Hello, When doing a design FMEA for a component should you make the following assumptions? -The component meets its specifications (e.g. for a plastic part its meets the dimensions and tolerances specified on the drawing) -The component is suitably designed to meet its intended function...
  11. 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...
  12. Proud Liberal

    DFMEA / PFMEA linkage - Where in the standards do I find it?

    Is there any requirement (current or upcoming) for suppliers to have access to customer's DFMEA in order to complete their PFMEA? I know it's a "best practice", but not all customers are willing to share them. If so, where in the standards do I find it?
  13. D

    Introducing an existing product into automotive context - DFMEA needed?

    Hi, we have products (fluids) that were designed years ago, that are now being introduced into OEM Automotive applications. The products were originally designed for non-automotive applications, so the design work was done according the ISO 9001 guidelines. Will an auditor have the...
  14. J

    IATF 16949 Product Safety

    Hello, I am new at creating documents and Iam very lost. We are being audited to the new standard and we do not have a Product Safety procedure written. Because of the nature of our business, we do not have any products that fall in this category at the moment. Does anyone have a procedure we...
  15. R

    Development of Design FMEA - Functional Requirements

    In FMEA manual there are 13 categories specified as functional requirements which may be included during design stage e.g. General, Safety......Design for Manufacturability. Now if we take the example of Design for Manufacturability we have been told by customer to split potential failure...
  16. N

    DFMEA, Drawings and PFMEA of an Assembly Process

    Hi all !! Im currently assigned to complete a PFMEA of an assembly process, for starters I know to look for info, in the DFMEA, component drawings, similar processes, other PFMEAS, and probably some others that I am omiting. Anyways when I look in the component drawings I find some...
  17. N

    YS Class in DFMEA & Process Control Measures

    Hi All I am a little stumped! In my DFMEA I have a Sev 8, Occ 3, Det 3 that relates to leakage of an air valve. This does not call for a YS / YC. The reason for occurrence 3 is that we have robustly captured the specification for leakage. We are not design responsible for the valve. We...
  18. R

    DFMEA Severity 9-10 with Occurrence 3 and Detection 3 - Actions

    If you end up with a failure mode with Severity 9-10 with Occurrence 3 and Detection 3 what approach shall we have? Would it be ok to state "no action" if we can not bring O & D down without design change ? We understand that a design change can solve the dilemma but if that's not the way...
  19. G

    Is it compulsory to make DFMEA for proto parts making organisation

    Sirs, My company is making prototype parts for an Automobile OEM. We are not doing any product design activity for those parts. So is it compulsory for my organisation to make Design FMEA. If not then conducting Design FMEA comes under whose responsibility for the above said scenario. Thanks...
  20. K

    Determining Effect of Failure without a DFMEA (Design FMEA)

    I just started working with process FMEAs at an organization that does not design products. How do you determine the effect of a failure and the severity without your customer's design FMEA or other input? We can SWAG but not real comfortable with that approach.
Top Bottom