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.
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...
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...
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...
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...
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...
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...
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?
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...
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...
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...
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...
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...
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...
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.
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.
I have another PPAP to do - but this one asks for Design FMEA
I have done 4 Process FMEAs. Slowly getting my head around it
But customers must confuse me with Design FMEA
Have no clue where to start - but more importantly
Does it really apply to us - we are in the liquid...
Good Day Colleagues!
Can you recommend an excellent training provider for DFMEA & DVP&R?
The target audience will be a group of high-level product design engineers, but their product is non-automotive.
This Group would like to implement these tools which they have bench-marked in automotive...
If the product we are designing includes air springs to cushion a load should leaking be considered a Potential Failure Mode on our DFMEA? There is some thought here that leaks are a process failure not a design failure so leaks shouldn't be on our DFMEA but on our PFMEA.