Buyer Responsibility – under analysis of RDC -16

Does your supplier have no AFE and does the surgical grade paper it provides not guarantee the sterility of your product? Know that this is not only his problem, but yours! See what it says in Chapter 2, item 2.5:

RESOLUTION – RDC No. 16, OF MARCH 28, 2013

2.5. Purchasing Controls

2.5.1. Each manufacturer must establish and maintain procedures to ensure that components, manufacturing materials and finished products manufactured, processed, labeled or packaged by third parties or stored by them under contract, comply with the specifications. Each manufacturer must also ensure that services performed by third parties comply with the specifications established by him.

2.5.2. Evaluation of suppliers of products and services. Each manufacturer must establish and maintain, according to the impact on the quality of the final product, criteria for assessing suppliers, specifying the requirements, including quality requirements, which they must satisfy.

2.5.3. Each manufacturer must evaluate and select potential suppliers according to their ability to meet previously established requirements, maintaining a record of approved suppliers. Records of the evaluation, as well as its results, must be kept.

2.5.4. Purchase record. Each manufacturer must maintain records of purchase orders that clearly describe or refer to specifications, including quality requirements, for components, manufacturing materials, finished products or services requested or contracted. The approval of orders, including the date and the person’s manual or electronic signature, must be documented.

2.5.5. An agreement should be documented in which suppliers undertake to notify the manufacturer of any change in the product or service, so that the manufacturer can determine whether the change affects the quality of the finished product.

2.5.6. Each manufacturer must review and approve purchasing documents prior to their own.