Best Practice for Complaint Handling to Assure Customer Retention
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.Learning ObjectivesFDA and ISO requirements for complaint handlingEstablishment of complaint handling programWhat constitutes a complaintHow to Handle “non-complaints”The roles of investigation and corrective action in complaint handlingComplaint trending and reportingApplication of risk management to complaint handling programBenefits/Detriments of a Reply to the CustomerWho Should AttendCustomer Service (your “complaint taker”)Regulatory personnelQuality Engineering personnelSales and Marketing personnelCustomer Service personnelR&D personnelManufacturing EngineeringExecutive ManagementConsultants Quality system auditors
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.
Learning Objectives
- FDA and ISO requirements for complaint handling
- Establishment of complaint handling program
- What constitutes a complaint
- How to Handle “non-complaints”
- The roles of investigation and corrective action in complaint handling
- Complaint trending and reporting
- Application of risk management to complaint handling program
- Benefits/Detriments of a Reply to the Customer
Who Should Attend
- 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
