Are Supplier Quality Agreements Quality Records ?

[Deb Simpson]

In your organization, do you maintain them in the supplier file or in Legal?

We are often asked to show them to inspectors --FDA and ISO--but they do not represent evidence that a requirement was met . Instead they represent an agreement of what will be met

 

[William55401]

13486:2016 explicitly calls for Quality Agreements. I believe the Supplier History File is the best home for these. You could also consider these a QMS document and keep them there as a special document type. As long as the documents are maintained and available to those who need them, I would not sweat the detail of where. Your Quality Agreement procedure will define their final resting place. Good luck Hope this helps.

 

[Sidney Vianna]

In your organization, do you maintain them in the supplier file or in Legal?

Why the binary choice? It can be filed in both places.

 

[William55401]

No. One document. One home. One system of record. Keep it simple Sidney.

 

[Sidney Vianna]

No. One document. One home. One system of record. Keep it simple Sidney.

One document might have multiple functions. I see no reason why copies cannot be kept in more than one place. If simplicity is the driving factor, one should not be in the medical device world.

 

[yodon]

I see no reason why copies cannot be kept in more than one place.

I agree with @William55401 here. Duplication often leads to things getting out of sync ... which leads to NCs. Certainly the one document can be referenced in both places. especially if managing electronically.

If simplicity is the driving factor, one should not be in the medical device world.

Now THAT'S a fact!

 

[roneljdsilva]

Yes, I believe they should be treated as records within the QMS and must be maintained in the Supplier File. You don't necessarily have to show it during an audit but it's best to be kept in file in case asked for.

Example: (I'm assuming the agreement consists of requirements you intend the supplier to follow to meet the desired quality of products or services they supply to you)

The Supplier Quality Agreement states that the supplier must maintain records for 5 years (retention period).

Now this, in itself isn't sufficient to demonstrate the supplier meets this requirement, however it is a management system requirement from you to your suppliers and is a document (or record) of you providing your suppliers the requirement.

I Quote ISO 9001:2015 Clause 8.4.1

"The organization shall determine the controls to be applied to externally provided processes, products
and services when:
a) products and services from external providers are intended for incorporation into the organization’s
own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of
the organization;
c) a process, or part of a process, is provided by an external provider as a result of a decision by the
organization."

Hope this clarifies

 

[Ed Panek]

I would argue anything that could impact product S&E is in scope.

 

[Ninja]

FWIW, with any 'current' electronic document storage software I've used...the doc can be put in one place, and a reference link in other places.
Also FWIW, I tailored said EDS systems in order to do this...it was not always default.

This accomplishes both "one place, no sync issues" as well as "multiple purposes, multiple places" at the same time.
HTH

 

[Ed Panek]

Yes, a soft link to the original document is ok.