FMEAs are initiated as soon as a concept is thought of / selected, even before features are determined. You do not need to have dimensions / parameters to initiate.Many do however choose to wait until the final features are locked in to begin the component
FMEA. They lose the benefit of the tool to provide direction.
FMEA is first and foremost a "PROACTIVE" tool. If you wait until prototypes, and find out you need a change, you initiate a viscous cost cycle that may result in project overruns.
I have been in the Reliability arena (as a manager) for over 35 years and this is what I teach my students in an FMEA class that I have been doing for 15 years.
FMEA's are Design and Process development tools
A structured "Preventive" analytical process which is intended to identify all concievable failure modes associated with a system ( product / process ) and detail actions taken to minimize / eradicate the likelihood of occurrence and undesirable outcomes.
It is a "Proactive" tool which provides management direction by attempting to determine :"Where are we? vs. Where do we want to be"?
It is a "Communication" medium which can be utilized for the promotion of on-going continuous improvement efforts.
It is a requirement for doing business in corporate america / world at large.
It is a "Training Aid" for new personnel , or personnel transferring into / between technical areas , who need to be brought up to speed quickly on the products / processes developed in that area.
When is the process started?
When new systems / products / processes are being designed.
When existing systems / products / processes are being revised.
When existing systems / products / processes are being used in new applications or environments.
During and after a problem solving study ( recurrence prevention).
For System FMEA :After system needs and functions have been defined , yet prior to hardware selection.
For DFMEA : After product needs and functions have been defined , yet prior to hardware selection, design approval and manufacturing release.
For PFMEA :After receipt of preliminary product drawings.
When is it updated?
Whenever a revision is considered to a product design / application / environment / material / its manufacturing / assembly process.
When is it completed?
Design : Initially when released for production. CIP/DFM/DFA /Field activities can force upgrade.
Process : When the process is removed from the production line/manufacturing facility.
Typical Information that can be found in the Current Design Controls -"Prevention/Detection Column" :
NOTE : If historical data non-existant , then the following would be found in the
"Recommended Actions / Actions taken " column of the FMEA (if applicable).
Assembly builds.
Bench Mode Verification Analysis.
Circuit Derating.
Color Coded.
Control Note on Print : Burr.
Control Note on Print : Cleanliness.
Control Note on Print : Coating.
Control Note on print : Dimensional.
Control Note on Print : Finish.
Control Note on Print : Materials Process.
Design for Manufacturing / Assembly.
Design of Experiments.
Design Reviews.
Finite Element Analysis.
Historical Capability Analysis.
Historical development data reviews.
Historical Warranty Data Review.
Historical Test results.
Lessons Learned Reviews.
Limit Stack Analysis.
Maintainability / Serviceability study.
Materials Evaluation Analysis.
ORCAD or System Simulation.
Overstress Testing.
Pspice Circuit Simulation.
Quality Function Deployment.
Redundancy.
Service Label.
Sneak Circuit Analysis.
Software Diagnostics & Failsafe.
Statistical Process Control.
Stress Derating.
Test to Failure.
Vehicle builds.
Warning Label.
Warning note in service manual.
Warning notices & / instructions.
Worst Case Analysis/Design Margin Evaluations.
List tests performed here : Functional , Life cycle durability , …
Some or all may even be included in the "Recommended Actions , Actions Taken " column if they have not been done in the past.
Please find attached and
APQP overview of what is done and when.
Hope this helps.
Mike (ASQ Fellow).