Are FMEA's necessary to apply for QS9000

FMEA's are necessary before you can be QS-9000 registered. FMEA's can be one of the most useful requirements of the standard.

Both Design and Process FMEAs are required.

Don't forget control plans and the entire APQP process. In addition, you must be a tier 1 to Ford, GM and/or Chrysler or the requirement must be flowed down. It's not a 'cake walk'.

I have been led to believe FMEA's are required only when requested by the customer. I do not have my FMEA book with me, but this also has been verified with consultants. Am I in for a rude awakening? FMEA's are very good for a company, but also very costly to a small comapany;extremely time consuming.

QS9000 unambiguously requires:

Design FMEA
Process FMEA
Process Control Plan
Process Flow Diagram

No exceptions.

What consultant says you can register to QS9000 without these documents?

I beg to differ with you about the cost. If you do your documentation on your equipment you only do it once. Thereafter there will be regular minor updates as problems are solved and as other problems surface - but the main work is done during the initial effort.

Yes - if you believed otherwise you are in for a surprise. I know of no company which has been excused from this with the exception of design FMEAs for designs older than 5 years - which is in its self suspect, actually.

ISO9001 does NOT specifically require them but it does required a defined design process.

[This message has been edited by Marc Smith (edited 10-04-98).]

Listen to Marc and not your consultant. PPAP requires FMEA. It may be implied in other areas but if you read the PPAP manual FMEA is required.

Although I agree that FMEA's are time consuming they save so much time and money in the long run, they are well worth the effort. An ounce of prevention.....

I work in procurement quality in aerospace, a fairly long way from QS9000. Many of my suppliers are small jobs shops, 10-25 employees.

However, when working with the quality managers, I haul out the QS manuals on FMEA and APQP and touch on some of the concepts.

The manuals present logical and structured approach to providing quality product that, in the long run, is cheaper for the supplier and my company.

By no means do I expect them to do full blown FMEAs, control plans, etc.;I may order 250 separate parts a year from a shop in small lots of 6 - 12 pieces.

But manuals do get the management of these small shops thinking about quality from a systems/process approach. And that can hurt either of us.

So if I do not have a FMEA for every order on the shop floor, am I not in compliance?

Dawn,

You wouldn't need FMEAs for every shop order on the floor. Compliance is determined by your PPAP/APQP records. You need to produce Design and Process FMEAs as part of your PPAP preparation and submittal for products sold to your OEM. They are living documents that need to be revisited periodically to determine if RPN values have changed and that all possibilities have been considered.

As others have stated before, this is a great tool in risk analysis for any product, OEM or otherwise. I recommend them strongly. Good luck.

Hi.

My company ( job shop environment), produces an average of 100 different part numbers a day. We are QS-9000 compliant, etc. etc. I do NOT have FMEA, etc. for everything. It would take me years to do that.

What I have done, is what was mentioned....for jobs that are sold DIRECTLY to Chrysler/Ford/GM...for PPAP purposes, I have FMEA, etc. This constitutes about 50 different FMEA/Control Plans for me. I am starting to get requests from other non-Big Three customers, requesting FMEA.....my database is starting to grow. A good, well-planned FMEA can work wonders for you. It is a good practice to get into. Also, Ford requires that Ford engineers sign off on your FMEA/Control Plans. Don't forget that.

As part of your normal APQP activities, you would be developing FMEA and Control Plans.....especially if you submit for PPAP.

Hope this helps.

Bryon

Bryon,

Do you use a select group of folks to make up your cross-functional FMEA team or do you select new groups for each planned event?

Kevin

Our shop also has many part numbers. However, we have been using the idea of "families of parts" for FMEAs and control plans to cut down on the number of them we have to do. We have a "base" FMEA/control plan for a part and then add to it as needed.

If you download the FMEA file in the pdf_files directory both concepts are presented.

I suggest you consider this:

Produce an FMEA for each process, machine or operation. That way, no matter what you run, there is an existing FMEA. You have a bunch of small FMEAs, but they're good for all of your products.

When bringing a new product on board, all you have to do is briefly review FMEAs for the planed processes.

Simplicity.

General Comment: Folks, the first thing I get is "This will take forever and be a real burdon over time." The initial push to get the first ones done is significantly time consuming. BUT - once you get the initial ones done the overhead is typically very low. So yes - it's a real pain if you don't have any FMEAs at all, but once they're done it's not over bearing from a maintenance point of view.

NOTE: Remember there is the issue of Control Plans.

[This message has been edited by Marc Smith (edited 01-29-99).]