Letter of Guarantee - EN 12546-3 (Mechanical & Physical testing on an ice pack)

[VHoneyghan]

We have a line of plastic food container products being sold to a UK customer. One of the products in the line was tested at an independent lab to meet EN 12546-3 (Mechanical & Physical testing on an ice pack). I now need to write a Letter of Guarantee for the other products in the line stating that they also meet the requirements in the Standard since they are manufactured with the same resins, the same molding process, at the same factory, etc.
Does anyone have a professional template for this type of Letter of Guarantee?
Thank you in advance.
Vanessa

[DavidPhillips]

Are you sure that it is acceptable to make a mechanical test on one product and then guarantee your customer that all other products are the same simply because the process parameters are the same?

How do you guarantee that the resin is always the same qaulity from your supplier, and that the moulding process has not changed (temperature, etc)

Surely you need to make systematic mechanical tests a part of your control process?

[VHoneyghan]

Thank you for your reply. We're not quite so technical on plastic food storage containers. This is what the customer asked for, to conduct the test on 1 style and write a letter of guarantee on the others. But I'd like to see an example of a letter of guarantee. Do you know where I could find one?
Vanessa

[DavidPhillips]

Sorry I cant help you on that point - I am connected with materials and component testing equipment and processes.

I am sure someone here will help.

Best regards,
David Phillips

[MIREGMGR]

Originally Posted by DavidPhillips

Are you sure that it is acceptable to make a mechanical test on one product and then guarantee your customer that all other products are the same simply because the process parameters are the same?

The concept of challenge-device validation is relatively well established in food and medical contexts for qualification of relatively broad ranges of products that are technically similar and have the same general intended use, but are different-sized. Qualification testing of one (or sometimes two or more) product sizes representing the worst-routine-case in regard to relevant performance stresses and functional parameters, is carried out under worst-routine-case conditions, with test-success regarded as indicative that in less-challenging sets of circumstances all of the product variants will perform successfully as well.

Unfortunately I have no specific experience with EN 12546-3 so I can't address the OP question, except:

In the US legal system (I don't know about UK, and I don't know what the legal jurisdiction might be in the hopefully unlikely case of a dispute), "guaranteeing" something has a particular legal meaning that might not be something you would want to do in a normal business context.

Perhaps your customer would be satisfied with a statement from you that you have "validated" the range of products per EN 12546-3, if that standard supports that terminology.

[harry]

There is a sample for shrink films in the web which you should be able to use as an example.

As mentioned in the previous post, the implications could be enormous - Get Proper Legal Advice to protect yourself and your organization.

[VHoneyghan]

Thank you all for your help. This is a great site. I started coming on when we were ISO 13485 certified for Medical Devices. Our company is moving away from medical devices and into children's product. It doesn't look like there is much here for children's safety regulations. Anyone have any good sites that have forums on childrens' safety for plastic food storage items -regulations in regards to CPSA of 2008, Toy Safety ASTM F963, etc?

[MIREGMGR]

Originally Posted by VHoneyghan

doesn't look like there is much here for children's safety regulations. Anyone have any good sites that have forums on childrens' safety for plastic food storage items -regulations in regards to CPSA of 2008, Toy Safety ASTM F963, etc?

Heh. This is probably the best place for them to be discussed...they just don't have their own specific forum yet, so that people like you that are looking for a place like this can discover each other via a Google search that hits on the right title-terms.

Maybe you should suggest a new forum for your new interests.