ISO 9001 Clause 8.3 Rework Verification - Re-verification to demonstrate conformity

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qltyscope1

Quality Pros:
Please let me know your input to the following question regarding especifically:
ISO 9001 clause 8.3 Control of Nonconforming Product "when nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements"
Elaborate on its meaning, please provide an example, and advise how to effectively meet this requirement. How have you seen this requirement being met in other companies? Are records necessary? Thank You.
 

Colin

Quite Involved in Discussions
Re: 8.3 Rework verification

If you have manufactured a product, inspected it and found it to be out of specification, it is most likely to be deemed nonconforming product.

In some instances you will have to scrap the defective product but in other situations you may be able to do some remedial work and bring it back into specification.

What the clause is telling us is that the product should then be subject to further inspection to verify that it is now correct.

As for records, if you documented the nonconforming product there should normally be somewhere to verify that you successfully (or not) cured the problem and that it is now conforming.
 
Q

qltyscope1

Re: 8.3 Rework verification

This requirement states "product shall be subject to re-verification" to demonstrate conformity to reqs? then re-verification is equivalent to re-inspection? and records could be: a signature of approval, or an ok and initials, or a more formal doc? must this method be written in the 8.3 Control of nonconforming procedure? in order to be specific? I believe an auditor might ask questions such as these?
 
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iamtroll

Re: 8.3 Rework verification

Generally I think that this could take two paths. If you have an internal nonconformance then depending on your NCR documentation, your verification could be documented on your NCR. If your nonconformance is external and you supply evidence of conformance to your customer, you would need to supply new evidence of conformace to your customer along with CAPA documentation if requested. The method that you use in either of these situations should be defined in your QMS that way you relieve yourself and your auditor from guessing how you would address them.
 

Colin

Quite Involved in Discussions
Re: 8.3 Rework verification

Certainly it should be written into your N/C procedure and yes, if a signature is what you use to verify conformance then that should do it.

Re-verification simply means that you cannot assume that because someone tells you they have corrected the problem then it is OK. The clause is asking you to re-verify (by whatever means you originally chose). If you used inspection as a method of verification then re-inspect. If not, use whatever method suits you (or your customer). Just make sure it is OK before it leaves!
 
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pldey42

Re: 8.3 Rework verification

IIRC TL 9000 has a similar requirement. The re-verification might involve testing as well as inspection. The reason is not just to verify that the defect has been removed, but also to assure that fresh defects have not been introduced by the rework. Records would be as appropriate for the re-inspection or re-testing performed.

Hope this helps,
Pat
 
Q

qltyscope1

Re: 8.3 Rework verification

pldey42: Thanks for the info, very informative.
 
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