| Section: |
7.4.1 c |
Section Title: Purchasing Process |
| 9100 Clause |
The organization shall:
define the necessary actions to take when dealing with suppliers that do not meet requirements; |
| Generic Expectation |
The organization's procedures shall clearly define what actions shall be taken when supplier performance falls below specified levels or does not meet the defined level of acceptable performance. Evidence of these actions should also be part of maintained records. |
| Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
| Specific Expectation |
Organization (Buyer) |
The Buyer should maintain a procedure that clearly states the minimum requirements for suppliers listed on their approved supplier register. |
| The Buyer should maintain a procedure that clearly states the actions to be taken when a supplier does not meet the defined level of acceptable overall performance within a defined timeframe. |
| The Buyer should state in the contractual documents any unique actions that the Buyer expects to be accomplished by the Seller if the Seller does not meet a certain and defined level of performance. Include any documentation and reporting requirements. |
| Supplier (Seller) |
Seller must understand the possible performance actions that may be required by the Buyer and ensure they are capable of performing them. |
| Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
Existence of a contractual document clause explaining expectations of any unique actions and reporting requirements when a Seller does not meet Buyer's performance requirements. |
| Records of Supplier performance and evidence of actions taken for suppliers who have fallen below minimum criteria. |
| Supplier (Seller) |
A contractual document review process that ensures the Seller understands and accepts all performance related actions that have been flowed down. |
| Examples (Best Practices) |
Organization (Buyer) |
The existence of a process describing the method that calculates supplier performance indices and the levels at which actions by the Seller must be initiated and what those actions are. |
| The process also includes actions to be taken with high performing suppliers. |
| Supplier (Seller) |
Seller works with the Buyer to periodically review where the Seller stands in the Buyer's performance indices. |
