Thursday, July 15, 2010

Governance - Supplier Controls

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An Approved Supplier List is not enough!

Many manufacturer's in the pharmaceutical, Medical Device and Biotechnology industries treat their supplier and service base with a "If it's not broken, don't fix it..." attitude. Those concerned with ongoing compliance and business continuity have at least generated an Approve Supplier List based on a quality survey or audit along with some business performance indicators. Maybe, a Quality Agreement has been put in place for key suppliers and contract manufacturers. In today's business environment with a trend toward outsourcing activities, this approach to supply chain management is just too antiquated. 

True supplier control governance should take the form of a risk-based assessment of suppliers and a routine management evaluation for those identified as critical or major. Categorization of suppliers and service providers based on Quality Agreement status, Audit status, nonconformist and corrective action status, supply critical and business performance indicators to name a few is integral to preventing disaster.

Formal monitoring of the supplier and service base accomplished with a cross functional team can greatly reduce the risk of a problem with a supplier or service provider resulting in significant business interruption or product recall. Building a system of risk assessment and providing a stream of key performance and quality indicators to the management team is the, "ounce of prevention worth a pound of cure". 

Some good questions to start with are:

·       "What suppliers and service providers have the greatest impact on my business?"
·       "Is the impact based on volume, complexity, cost?"
·       "How much control can I exercise of this supplier base?"
·       "Is the partner required to inform me of changes?"
·       "Do I have a contingency plan in the event the  provider does not meet their commitments for my products?"

Look at: for a series of articles on Quality System Governance covering:
· Supplier and Service Provider Controls
· Site mater validation planning
· Corrective and Preventive Action (CAPA)
· Post Market Surveillance - Making Complaints Work for You
Looking for resources and tools? Go to:

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