Must we have FMEA for ALL the products by the registration audit?

D

Daniel

#1
#1
Hi.

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.
 
GAGEpack - Gage & Calibration Management
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D

Don Watt

#2
#2
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.
 
A

auditor16949

#3
#3
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.
 
Kevin Mader

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#4
#4
Follow Don's advice. Additionally, you might want to address specific processes individually. You will inevitably reduce the redundancy of effort by doing both.

Regards,

Kevin
 
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