Sales FMEA - Application of FMEA to contract review and sales process
During a recent BSI routine visit we were asked to demonstrate the application of FMEA to the contract review/sales process. We manufacture/supply a fairly 'standard' product range. The auditor suggested a 'checklist' but this sounds a bit of 'overkill'. Any suggestions gratefully received.
Sorry it was a routine audit by BSI against ISO 9001:2000
Nothing to be sorry about... Ok, then: Now I wonder why the auditor asked for an FMEA? There is certainly nothing in ISO9001 that requires it. Do you have a procedure that requires you to use it?
Since your products pretty much seem to come off the shelf, your review of requirements may be fairly straightforward? Perhaps this old thread could be of interest: 7.2.2 Review of Requirements Related to the Product .
Nothing to be sorry about... Ok, then: Now I wonder why the auditor asked for an FMEA? There is certainly nothing in ISO9001 that requires it. Do you have a procedure that requires you to use it?
Since your products pretty much seem to come off the shelf, your review of requirements may be fairly straightforward? Perhaps this old thread could be of interest: 7.2.2 Review of Requirements Related to the Product .
/Claes
Good advice. . . IMHO, A Process is a Process and can be prone to a multitude of Failure Modes. . with corresponding effects. I think it is overkill in the Contract Review area to use a FMEA, but you might want to give some consideration to using an automotive tool called an AQP checklist. AQP=Advanced Quality Plan. It addresses all needed requirements, resources, timelines and milestones. More suited to new product introduction but a tool none-the-less.
Again, it may be a bit of overkill, but it does eliminate error by omission. A failure Mode in itself. The checklist can be as long or short or detailed as needed in your case.
IMO, I think your auditor MAY have been looking at consistency in the process.
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If something is over engineered. . . it will probably be under manufactured! (Jim Eustace 1993)
Sales FMEA - Application of FMEA to contract review and sales process
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