Vendor Management - Compliance Data Responsibilities Under Different Manufacturing Scenarios

Question:

How do the responsibilities for providing compliance information vary depending on different manufacturing scenarios (ex. Suppliers of commercial off-the-shelf goods versus contract manufacturers)?

Answer:

Here are the three scenarios and how they should be addressed:

Commercial off the Shelf (CotS) components: Company buys a standard catalogue part, compliance information should be requested from and supplied by the manufacturer to customer at no cost. Selling compliant products is a cost of doing business.

Custom parts with Bill of Materials (BoM) controlled by the customer: Company hires a contract manufacturer to build a part using the components and parts specified by customer. In this instance contract manufacturer cannot change a part without the company's approval and instruction (manufacturing change order or MCO), as a result the company that owns the BoM and spec is responsible for ensuring the selected parts are compliant. Contract manufacturer may be engaged to support gathering compliance certificates at time of purchase, but fees often apply.

Custom design with Bill of Materials (BoM) controlled by the contract manufacturer: Company hires a contract manufacturer and sub-contracts engineering services. Contract manufacturer is allowed to select components with the same form, fit, and function as specified by the company's design and specification. Company must include compliance language in the specification or non-compliant parts can be delivered. Provided agreement is in place, contract manufacturer is responsible for acquiring compliance certificates and delivering a compliant finished good.

 

 

 

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