Setting FMEA Scope - Trying to prevent infant mortality rate

S

Steven Sulkin

#1
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.
 
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Marc

Hunkered Down for the Duration
Staff member
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#2
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="http://Elsmar.com/pdf_files/NC_DBASE.pdf" 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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