| An Approved Supplier List is not enough! | | | | integral to preventing disaster. |
| Many manufacturer's in the pharmaceutical, | | | | Formal monitoring of the supplier and service base |
| Medical Device and Biotechnology industries treat | | | | accomplished with a cross functional team can |
| their supplier and service base with a "If it's not | | | | greatly reduce the risk of a problem with a |
| broken, don't fix it..." attitude. Those concerned | | | | supplier or service provider resulting in significant |
| with ongoing compliance and business continuity | | | | business interruption or product recall. Building a |
| have at least generated an Approve Supplier List | | | | system of risk assessment and providing a |
| based on a quality survey or audit along with | | | | stream of key performance and quality indicators |
| some business performance indicators. Maybe, a | | | | to the management team is the, "ounce of |
| Quality Agreement has been put in place for key | | | | prevention worth a pound of cure". |
| suppliers and contract manufacturers. In today's | | | | Some good questions to start with are: |
| business environment with a trend toward | | | | · "What suppliers and service providers |
| outsourcing activities, this approach to supply chain | | | | have the greatest impact on my business?" |
| management is just too antiquated. | | | | · "Is the impact based on volume, |
| True supplier control governance should take the | | | | complexity, cost?" |
| form of a risk-based assessment of suppliers and | | | | · "How much control can I exercise of |
| a routine management evaluation for those | | | | this supplier base?" |
| identified as critical or major. Categorization of | | | | · "Is the partner required to inform me of |
| suppliers and service providers based on Quality | | | | changes?" |
| Agreement status, Audit status, nonconformist | | | | · "Do I have a contingency plan in the |
| and corrective action status, supply critical and | | | | event the provider does not meet their |
| business performance indicators to name a few is | | | | commitments for my products? |