When to Update Supplier Quality Agreements

[Reliable Source]

I work in the Med. Device Industry (ISO 13485, MDSAP, (EU) MDR, etc.). I am a Supplier Quality Engineer faced with the question of when to send updated versions of my company's Supplier Quality Agreements (SQAs) out to our suppliers for review and approval. More specifically, the question is: "Do I have to send out an updated SQA every time the document is update internally, for mostly minor updates, and go through the whole review and approval cycle with every supplier, or can my company exercise some judgement, perhaps during the change control process, and only re-distribute to the supplier(s) SQA's containing significant changes?" Please advise...

 

[ScottK]

I work in the Med. Device Industry (ISO 13485, MDSAP, (EU) MDR, etc.). I am a Supplier Quality Engineer faced with the question of when to send updated versions of my company's Supplier Quality Agreements (SQAs) out to our suppliers for review and approval. More specifically, the question is: "Do I have to send out an updated SQA every time the document is update internally, for mostly minor updates, and go through the whole review and approval cycle with every supplier, or can my company exercise some judgement, perhaps during the change control process, and only re-distribute to the supplier(s) SQA's containing significant changes?" Please advise...

Your organization is updating a template essentially. It's not an agreement until it's executed by both parties.
So it comes down to what the change is. It should be decided at the time the new template is approved what the scope of the activity will be.... do all suppliers need to agree to the the new requirements right away or can they wait until renegotiation time? Your organization needs to make a risk based decision on that.

That being said - for bigger changes or additions I have taken the approach of an addendum to the current agreement. Thus the negotiation is limited to the changes and should be much faster and easier.

 

[Reliable Source]

Great response.

Thanks!