Receiving Verification process

[Renea Koski QAM]

We are an OEM (Contract Manufacturer) and ISO 13485:2016 certified and it has come up that we maybe are not be doing our receiving verification correctly.
We have an incoming inspection and that process is ok, but after the inspection we stamp the vendor's CoC with our approval stamp and the inspector signs and dates it. Our customer's get copies of these CoCs with our approvals for their records (and we issue our own CoC. . . )
Someone has brought up that we shouldn't be stamping and writing on the vendor's CoC and we should have a separate form to mark as approved.
We do sign our inspection report as approved, is that enough? In the last 10 years we have always done it this way, by stamping approval and signing the vendor's CoC.
How do you handle this process?

 

[SeanN]

We do not stamp or write anything on vendors' CoCs. We have separate forms (you call these inspection reports) to verify and approve incoming materials. Vendors' CoCs/CoAs usually support (several) approval criteria.

 

[Golfman25]

What’s the difference. We write part information on metal mill certs all the time.

 

[chris1price]

As long as you don't obscure the original data, it shouldn't matter which way you do it.

 

[ChrisM]

"Someone has brought up that we shouldn't be stamping and writing on the vendor's CoC and we should have a separate form to mark as approved."
Why have they brought this up? Who is the "someone"? If that is what your system says you do as evidence that the CoC has been checked/verified, no problem. I am not aware of any requirement in any ISO/automotive/aerospace standard that prohibits you from stamping/writing on a supplier's CoC - indeed the organisation that I currently work for does just this, and we've held ISO9001 and EN9100 approvals for years and years

 

[QuinnM]

Perhaps - All speculation which is dangerous - someone brought this up because a stamp is being used and there maybe no controls on the stamp. In this case stamp controls are not needed because the inspector signs and dates the CoC.

 

[Renea Koski QAM]

Perhaps - All speculation which is dangerous - someone brought this up because a stamp is being used and there maybe no controls on the stamp. In this case stamp controls are not needed because the inspector signs and dates the CoC.

It was the Quality Engineer and he didn't think we should be "modifying" the vendor's documents. If we used a label or form, yes, it would need to be controlled, but a stamp is ok as long as it is signed and dated.

 

[Renea Koski QAM]

"Someone has brought up that we shouldn't be stamping and writing on the vendor's CoC and we should have a separate form to mark as approved."
Why have they brought this up? Who is the "someone"? If that is what your system says you do as evidence that the CoC has been checked/verified, no problem. I am not aware of any requirement in any ISO/automotive/aerospace standard that prohibits you from stamping/writing on a supplier's CoC - indeed the organisation that I currently work for does just this, and we've held ISO9001 and EN9100 approvals for years and years

It was the Quality Engineer and he didn't think we should be "modifying" the vendor's documents. However this is the process this company has used for several years and it is laid out in our procedure and instructions for receiving. I only think he brought it up because he didn't follow our process when he checked in material and I caught it and issued a CAR. . . lol.

 

[Golfman25]

It was the Quality Engineer and he didn't think we should be "modifying" the vendor's documents. However this is the process this company has used for several years and it is laid out in our procedure and instructions for receiving. I only think he brought it up because he didn't follow our process when he checked in material and I caught it and issued a CAR. . . lol.

You aren't "modifying" the vendor's documents. You're adding your own "notes" to it. I think as long as the note is signed/initialed by your company so it is clear it's your note, you should be good to go.

 

[Bev D]

Tell that QE to pound sand - nicely.
Also tell him that the new ISO requirement to assess climate change effects would dictate that you need to conserve paper and the energy to print it. So since there is NO prohibition for approving (not altering the information) the CofC directly on the CofC the approach is valid. Also by keeping to one piece of paper you will have a much better control of maintaining a record that it was reviewed and found to be acceptable.

Sad that thinking has gone out of favor and has been replaced by making stuff up that fits people’s agenda.

I would also add that maybe issuing a CAR was a tad heavy handed. Unless this person routinely does what they want despite the rules.