Setting FMEA Scope - Trying to prevent infant mortality rate


Steven Sulkin

We are just starting FMEA's and I am trying to prevent infant mortality. I have two questions.

First Question
How narrow/broad to set the scope of FMEA's?

I have two concerns here. First, I dont want to manage 400 FMEA's. Second, I dont want the scope too narrow or broad to be of use. In your experience how should I set my scope?

To put a reference to this:
Scope 1: lense (too narrow?)
Scope 2: overhead projector (too broad?)

Second Question
How do you keep up your FMEA's? I am adding an FMEA review as part of the Corrective Action protocol (8-D), design review, and change board. It seems almost perenoid that every time we make a change we have to review FMEA's. Do most folks have a formal review schedule? Are the 8-D, Design review, and change board enough?

Thanks in advance.


Retired Old Goat
Staff member
The scope of the FMEA is receiving to shipping. The level of detail is in line with your product and processes. There is no hard - fast rule regarding level of detail.I don't think 'Lens' is too small a detail - but, what about the lens? Wrong focal length? Clarity? These are things I would think about.

FMEAs are typically kept up by the product engineer or whoever 'plays' that functionary.

If you check out:

<a href="" target=blank>NC Database - Sample Record </a>

You will see a place for FMEA and control plan review. As well as a print and other reviews. You make them part of the whole process. You review them and - if they need it - you update them. Typically there is going to be at least one problem during a year which would trigger a review of the documents.

On the other hand, as an auditor I would want to see that they are reviewed at least once yearly even if there are no problems. I don't think a yearly review is a requiment, though. I can't remember QS9000 stating a yearly review is required.

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