Supplier Quality Management (SQM) Programs & Enterprise Software Systems
Supplier Quality Management - 19 March 2015
Supply chain security and supplier management are important issues for the global pharmaceutical industry. Over the last few years several tragic events have occurred because of deliberate adulteration or counterfeiting of raw materials used in the manufacture of pharmaceuticals. Regulatory agencies around the world expect companies to have robust Supplier Quality Management (SQM) processes and procedures that will mitigate supply chain risks.
Fundamental to any SQM program is the establishment of an Approved Supplier List (ASL). SOPs for the qualification, approval and auditing of suppliers are also minimum requirements.
Typically supplier performance is measured in 3 major categories:
1. Supplier Quality Performance
2. Supplier Deliver Performance
3. Supplier Responsiveness
Enterprise Quality Management Software (EQMS) and Laboratory Information Management Systems (LIMS) systems typically provide the support for category #1 (Supplier Quality Performance).
The following capabilities available in EQMS support SQM programs:
• Document Control (Specifications, Sampling procedures, Inspection methods, Test methods)
• Non-conformance Management
• CAPA/SCAR (Supplier Corrective Action Report)
• Audit Management
• Change Management
• Reports and Analytics
Laboratory Information Management Systems (LIMS) are designed specifically to collect the data necessary to evaluate the capability of the suppliers manufacturing processes and the overall quality performance of a supplier.
Inventory Management (IM), Materials Requirements Planning (MRP) and/or Enterprise Resource Planning (ERP) systems typically provide the data for category #2 (Supplier Delivery Performance).
Category #3 (Supplier Responsiveness) is a subjective evaluation determined by Quality and Supply Chain Operations departments.
Would you like to learn more about SQM and SOLABS QM? Contact us here!
About the Author
Brian Graeff is the currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and API’s with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.