Are suppliers required to hand over process validation reports?

[irfank]

We have a supplier that is refusing to provide process validation reports and insists these are only available during an on-site audit.
Since we don't have a quality agreement with the supplier, is there any other way to request these?

 

[malasuerte]

We have a supplier that is refusing to provide process validation reports and insists these are only available during an on-site audit.
Since we don't have a quality agreement with the supplier, is there any other way to request these?

Pretty standard - so no, you don't have options.

If you required these, they should have been part of the SOW/Contract. Going on-site to see these things (and others) is pretty standard. This is our standard process - all info like this must be done on-site.

 

[Ron Rompen]

I agree with malasuerte that the supplier is within their rights to refuse to provide you this documentation, and instead to counter-offer that it can be viewed during an on-site visit.
HOWEVER, with that being said, it would definitely raise some red flags for me (especially if they are located at a sufficient distance that an on-site visit is unlikely). What is it that they are trying to conceal? Are they registered with ISO/IATF?

 

[Ed Panek]

We supply medical devices to a few pharma companies. They do not have direct access to our QMS documentation with the exception of a remote screen share or onsite audit but taking them offsite is not permitted.

 

[somashekar]

We have a supplier that is refusing to provide process validation reports and insists these are only available during an on-site audit.
Since we don't have a quality agreement with the supplier, is there any other way to request these?

This seems to be typical of outsourced process in your quality management system. Within the quality agreement you establish with your outsourced supplier, you need to capture such requirements of providing the process validation reports for your review and recording as a part of your controls exercised. These have to be discussed and agreed upfront with your supplier and signed off in the Quality agreement. This is exactly what you are expected to do where the standard says ... The controls shall be proportionate to the risks involved and the ability of the external party to meet the requirements... (see clause 4.1.5)

 

[Ronen E]

What is it that they are trying to conceal?

Probably that they didn't validate the process at all...?

 

[Zero_yield]

Probably that they didn't validate the process at all...?

Well, they said they're available during an onsite visit, so that's easily provable or disprovable (time and budget allowing).

 

[Tidge]

HOWEVER, with that being said, it would definitely raise some red flags for me (especially if they are located at a sufficient distance that an on-site visit is unlikely). What is it that they are trying to conceal?

This behavior would not raise red flags for me; as it is very likely that the supplier doesn't want copies of their documentation out floating around outside of their control... with or without NDAs. Even the most amateurish (my opinion) process validation documents can reveal important business practices; good ones could serve as blueprints for competitors.

 

[Ronen E]

(time and budget allowing)

As Ron has put it:

(especially if they are located at a sufficient distance that an on-site visit is unlikely)

In that case an invitation to view on-site would be an empty one, and it's possible that such an invitation is made well-knowing that it will not be accepted. I'm not saying anything about the likelihood of that being the case, just pointing out it's possible.
It's a little like a rigged game of "Chicken".

 

[Zero_yield]

In that case an invitation to view on-site would be an empty one, and it's possible that such an invitation is made well-knowing that it will not be accepted. I'm not saying anything about the likelihood of that being the case, just pointing out it's possible.
It's a little like a rigged game of "Chicken".

Well, following up on what Tidge mentioned, the company I work for doesn't even generally send controlled documents to external auditors (even for a remote audit, it's done through screen share, like Ed Panek referenced).

Maybe they'd be down for screen sharing with your SMEs during a remote/desk audit?