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  FMEA and Control Plans
  FMEA blues

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Author Topic:   FMEA blues
posted 04 October 2000 10:19 AM           Edit/Delete Message   Reply w/Quote

My company is in the process of implementing QS 9000 and FMEA is currently one of our biggest headaches. By nature of our products, it is almost impossible to implement FMEA for all of them by the certification audit. Can we set up a FMEA implementation master and at least complete a few of the product FMEA? Will this be acceptable to the QS 9000 auditors? Must we have FMEA for ALL the products by the audit?

Please advise.

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Don Watt
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Posts: 70
From:Notts,United Kingdom
Registered: Mar 2000

posted 04 October 2000 10:34 AM     Click Here to See the Profile for Don Watt   Click Here to Email Don Watt     Edit/Delete Message   Reply w/Quote
Would it be possible for you to group products in "families" and then to develop FMEA's to cover a range of products?

If you can do this it should save you a considerable amount of time & effort.

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Kevin Mader
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From:Seymour, CT USA
Registered: Nov 98

posted 04 October 2000 12:43 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Follow Don's advice. Additionally, you might want to address specific processes individually. You will inevitably reduce the redundancy of effort by doing both.



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Lurker (<10 Posts)

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Registered: Sep 2000

posted 04 October 2000 02:42 PM     Click Here to See the Profile for auditor16949   Click Here to Email auditor16949     Edit/Delete Message   Reply w/Quote
I would suggest you talk to the registrar to establish their policy and to your customers.
If I were carrying out the audit, I would be looking for evidence that your current APQP system works and is generating FMEAs so I would audit a current project. It might be acceptable to establish a breakpoint, jobs created after a certain date have an FMEA, those before don't.
Will your customer give you a waiver?
How did you gained PPAP approval without FMEAs?
If you don't currently have QS-9000 customers and your existing customers have not required FMEAs then generating historic data may not be necessary.
If you do need FMEAs, I would support the advice given by others to create generic documents if possible, this will undoubtedly be the quickest way.
Good luck.

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