Supplier No-Change Agreement - Seeking Example

[Viki N.]

Good morning.

I have been seaching the cove for information/sample of a supplier no-change agreement. Does anyone out there currently use one of these? My company is trying to get ready to upgrade to ISO 13485 and is FDA registered.

According to 21 CFR-Part 820.50, "Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device." The way this reads tells me we need to have an agreement for each of our suppliers to sign. Am I correct on this?

If anyone knows of a sample or template agreement, please let me know. I have already checked clinivation.

Thanks much,
Viki

 

[Jim Howe]

Good morning.

I have been seaching the cove for information/sample of a supplier no-change agreement. Does anyone out there currently use one of these? My company is trying to get ready to upgrade to ISO 13485 and is FDA registered.

According to 21 CFR-Part 820.50, "Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device." The way this reads tells me we need to have an agreement for each of our suppliers to sign. Am I correct on this?

If anyone knows of a sample or template agreement, please let me know. I have already checked clinivation.

Thanks much,
Viki

I am not familiar with your document but this sounds much like the no change clause in defense contracts. It usually stated that once the Purchase Order was approved the supplier could not change:

1) the process
2) the plant
3) sub-tier suppliers
4) key personnel (i.e., QA Manager, etc.)

I do not recall a seperate form for this. It was a line item on either the Contract, the SOW (statement of work), or the Purchaser Order.

For example, a few years back when I was hired as the new QA Manager at WRE (the now defunct Western Reserve Electronics) in Twinsburg, Ohio. My first duty was to travel to Detroit, Mich. to be properly introduced and approved by GD, the Customer, (General Dynamics).

One of my duties as QA manager and Customer Representative (actually carried the M1A1 and A2 Abrahms Tank stamp) was to oversee the multitude of PO's for violation of the no change agreements. Most often it would be a change in a sub-tier supplier that would trigger my outrage. We could still do the change but only after GD approved.

So do you need a form, not unless it specifically states that you do. It does says "where possible". But in the absence of a form it should be a line item as described above.
Hope this helps!

 

[Vincnet]

Hi Vicky,

we do not have a specific statement.
what we do is that if we need a no change statement this means that the material is key to the final product's performances and in this case we have a full supliers contract, defining both specifications of the product volumes of orders in the year, delays etc ... and we include there the no changes clause.

V

 

[Viki N.]

Thanks to both of you for your replies and suggestions!

Viki

 

[cspofford1]

We use our PO agreements & terms

On our standard Purchase Order Agreements & Terms, there is a section regarding changes to processes. As far as FDA is concerned, this should cover the requirement.

 

[Bridget]

I agree

We also put the notice on our purchase orders, but unfortunately this is often overlooked by office personnel just entering the orders!
Bridget

 

[S Roche Hendrix]

We put a general statement in our Supplier Specifications as follows. These documents are sent to the supplier and they approve. This approved copy is maintained.

"7.0 REQUIREMENTS FOR CHANGE IN PROCESS OR RAW MATERIALS

7.1 The supplier must receive prior permission from _____ before making any changes in: 1. How the material is manufactured; 2. Location of manufacturing; 3. Process or equipment of manufacturing; 4. Suppliers of raw materials; 5. Test methods used to confirm specification compliance."


Unfortunately we have had cases where although this was agreed to, the supplier made changes that affected our process / product without notification / approval. Their logic was if their final test met our specification they did not need to notify us.

In our world of continual improvement and cost reductions, it is not always straight forward how "improvements" will affect the customer. The decision to notify is not always so easy.

S