Quality Manual - Procedures for Product recall

[k.t]

I realise that there is no reference to product recall in QS9000 or ISO9000:1994 or ISO9K:2K, if were to be added how would it be included within the Manual and Procedures?

Another Uni question I'm afraid. I find it quite worrying that there are no requirements for this within the ISO system, surely this is a vital part of customer service/satisfaction and confidence?


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Kate Thomas

 

[Claes Gefvenberg]

Hi Karen,

I'm not all that familiar with QS9000, so I'll limit my reply to ISO...

In both the 1994 and the 2k issues I'd put it under "Control of nonconforming product". Even though the product has left your premises, a recall would be part of just that. There is also Corrective actions" to consider.

/ Claes Gefvenberg

 

[Eugène]

Hi Kate,

I think you have to place it under 4.8 Identification and Traceability. That's where VDA 6.1 (the German 'QS')refers to. VDA 6.1 has a clause (6) which describes the recall.
It is a bit strange to me that I can't find back something about this subject in TS. During VDA-audits (2nd & 3rd party) it is allways checked. And now it don't seem that important anymore.

[This message has been edited by Eugène (edited 06 September 2000).]

 

[k.t]

Thanks Guys

It astounds me, that this is not considered a major part of QS9000. I appreciate the sections that mention non-conforming products. Surely, it is important that, with customers having the right to sue, personally, anyone who is deemed to have created, manufactured etc, etc etc anything that is defective, that this should be an integral part of any Quality Manual. Maybe I am talking complete rubbish. I don't know enough to actually hold a reasoned debate about it as I do not have access to QS/ISO9000 handbooks, I just get a glimpse every now and again at work, if I'm lucky!!!

Please correct me if I am wrong.




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Kate Thomas

 

[David Mullins]

Kate don't forget, buyer beware!
(Caveat Emptor)

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[Alf Gulford]

Just to muddy things up a bit, as a medical device person I'd have to put recall info under 4.14 since that's where ISO 13485 and EN 46001 place it.

Probably not a consideration for QS folks, just another perspective.