Best Practices For A Compliant, Lean Supplier Management Program

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain folks!

This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Also covered will be a discussion of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request.

Areas Covered in the Session :

Supplier Selection

• Review of FDA and ISO requirements
• Types of suppliers that must be qualified
• Defining critical suppliers
• Outsourced processes
• Recommended Practices

Supplier Assessment

• Review of FDA and ISO requirements
• Recommended Practices
• Documentation requirements

Supplier Nonconformance: Supplier Corrective Action Requests

• Pre-notification?
• Best Practices for Issuance
• Evaluation/Acceptance of Supplier Response
• Tracking effectiveness

Who Should Attend:

This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:

• Supply chain management
• Buyers
• Purchasing management
• CAPA Coordinators
• Regulatory management
• QA management
• Executive management
• Internal auditors

Course Director: JEFF KASOFF

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.