Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

Complaint management is one of the most cross-functional parts of a quality system. Customer service may take the complaint, sales and marketing may contact the customer for details, regulatory affairs decides if it is reportable, QA investigates the root cause, R&D or manufacturing engineering may help with corrective action, and quality engineering trends the data.

This 60-minute complaint handling webinar sets out the FDA and ISO requirements behind each of those roles: defining, documenting and implementing a complaint handling system, and reviewing, investigating and correcting complaints.

It also explains what counts as a complaint, how to handle non-complaint feedback, how to apply risk management to complaint handling using a specific risk management system, and the pros and cons of replying to the customer.

• Explain FDA and ISO requirements for complaint handling
• Establish and document a complaint handling program
• Decide what counts as a complaint and handle non-complaint feedback
• Use investigation and corrective action effectively in complaint handling
• Trend and report complaints
• Apply risk management to a complaint handling program
• Weigh the benefits and drawbacks of replying to the customer

• FDA and ISO requirements for complaint handling
• Establishing a complaint handling program
• Defining, documenting and implementing the system
• What counts as a complaint
• How to handle non-complaints
• The roles of investigation and corrective action
• Complaint trending and reporting
• Applying risk management to complaint handling
• Benefits and drawbacks of replying to the customer

Because complaints pass through so many departments, gaps in the process can lead to regulatory findings and lost customers. A clear, compliant system supports both regulatory compliance and customer retention.

This session helps everyone involved understand their responsibilities. It suits customer service, regulatory, quality engineering, sales and marketing, R&D and manufacturing engineering staff, executive management, consultants and quality system auditors.

• Customer Service (your “complaint taker”)
• Regulatory personnel
• Quality Engineering personnel
• Sales and Marketing personnel
• Customer Service personnel
• R&D personnel
• Manufacturing Engineering
• Executive Management
• Consultants 
• Quality system auditors

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.