Own Brand Labeling Agreement/Contract Review

V

Vitora

#1
Dear colleagues,

Does the agreement with the customer (he relabels our product >> legal manufacture at the end) falls down under 7.2.2 "Review of requirements related to the product" of ISO 13485 (please see bellow).

I've got the opinion that the "own brand labeling" might not :cool:

Thank you in advance.

section 7.2.2 :

"The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

a) product requirements are defined and documented,

b) contract or order requirements differing from those previously expressed are resolved, and

c) the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material."
 
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somashekar

Staff member
Super Moderator
#2
Own Brand Label (OBL) is the regulatory route.
In terms of QMS, you are the organization and the other your customer. The OBL agreement may contain 7.2.2 requirements, however it is not all within the 7.2.2. requirements.
... Welcome to the COVE Vitora ~~~
 
V

Vitora

#3
Thank you.

Yes I know that Own Brand Label (OBL) is the regulatory route.

But the problem is, that one of our OBL agreements has been updated at 2007... and since no one reviewed it and for today we keep supply the product for an "old price" and some additional product (already), which is not listed in an agreement :(
So, I would like to put under "contract review" these OBL agreements as well just for the purpose we are not forgetting about them....

That was the point...
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

Contract review is mostly an internal process, with inputs from the (potential) customer.

To control the currency of your OBL agreements (basically, part of the sale contract), you could state in the agreement that it has an expiry date (e.g. after 12 months) and requires periodic review and renewal. Then insert a clause in your operational SOPs that requires production planners to check the relevant agreement for currency before initiating the production work order. You could have them flag to you (or other responsible role) that an agreement is about to expire in, say, less than 3 months (or another appropriate figure), so you still have time to renew it and keep things running smoothly.

Perhaps an easy way to implement such controls would be via your ERP system.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#5
Ronen puts it well...
An agreement is a period dependent contract, and must be well drafted and continually extended (perhaps annually) after due changes and new requirements considered.
The interaction of the OBL agreement with the customer related process must be built into your ISO13485 QMS. Review how your regulatory process interacts with your customer related process, starting from your quality manual level, drilling downwards...
 
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