| Section: |
7.4.1 e |
Section Title: Authority for Disapproval of Sources |
| 9100 C Clause |
Purchasing Process: The organization shall:
define the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on the supplier's approval status, and |
| Generic Expectation |
The process needs to define the roles and responsibilities, with authorities for approval and status change of suppliers. The function that objectively approved a supplier also has the ability to objectively disapprove the supplier. The approval is based on the ability of the supplier to provide conforming material within the scope of supplier's approval. |
| Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
| Specific Expectation |
Organization (Buyer) |
Ensure requirements for supplier approval and status change, as well as the exclusive use of approved suppliers are included in contracts. |
| Supplier (Seller) |
The Seller's supplier approval process includes roles, responsibilities and authority, and also describes the supplier status change process. |
| The Seller's processes ensure the function that has supplier approval authority also has supplier disapproval authority. |
| Thresholds for the Seller's supplier disapproval decisions are explained. |
| The Seller's processes for this element are documented. |
| Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
Documented requirements for supplier approval and status change, as well as the exclusive use of approved suppliers. |
| Supplier (Seller) |
Documented procedures for supplier approval and status change, as well as the exclusive use of approved suppliers. |
| Examples (Best Practices) |
Organization (Buyer) |
Ensure that ERP system only allows POs to be placed with approved suppliers. |
| Supplier (Seller) |
Only one defined group has both supplier approval and disapproval authorities. |
