Ok in this new problem I am having to solve I have the following issue:
- Failure 1
- 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.
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.
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...
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.
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...
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...
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...
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...
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...
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...
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!
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...
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.