Governance – Supplier Controls
An Approved Supplier List is not enough!
Many manufacturers in the pharmaceutical, Medical Device and Biotechnology industries treat their supplier and service base with a “If its not broken, dont 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 todays 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: http://www.innovatgxp.com/Benchmarking/Articles/Articles.html 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: http://innovatgxp.com/
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