Automotive Contexts of FMEA

When is an FMEA considered Completed?

An FMEA is a living document, and in that sense, must be updated whenever significant changes
occur in the design or manufacturing/assembly process. The FMEA is “complete” when matched with a
released/signed-off product or process. Remember that subsequent updates may be required. At any
point the FMEA should reflect the actual present design or process. A periodic FMEA review and update
schedule should be developed and followed.

• A Concept FMEA is considered “complete” when the System Design Specifications are frozen and the
design functions are defined.

• A Design FMEA is considered “complete” when the product design is released for production or
program has reached sign-off.

• A Process FMEA is considered “complete” when all operations have been considered, when all
Special Characteristics have been addressed, and when the Control Plan has been completed.

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