Establish Quality Management System
SOP Feedback and Complaint Management
Handle customer feedback and complaints through systematic investigation, resolution, and corrective action processes.
Summary
Your Feedback and Complaint Management SOP establishes systematic processes for receiving, categorizing, investigating, and resolving customer feedback and complaints to ensure device-related issues are identified early, properly escalated, and addressed through appropriate corrective actions.Why is SOP Feedback and Complaint Management important?
Feedback and complaint management exists because customer experiences provide real-world intelligence about device performance that cannot be captured through pre-market testing alone. It serves as an early warning system for potential safety issues, quality problems, and usability concerns that could impact patient outcomes or regulatory compliance. Your feedback and complaint system demonstrates proactive customer focus rather than reactive problem-solving. It transforms scattered customer communications into systematic data that drives product improvements, informs risk management decisions, and supports post-market surveillance requirements. This protects patients while building trust through responsive customer service.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Complaint handling mandatory under Section 820.198
- Must maintain complaint files with investigation records
- Serious injuries and deaths require MDR reporting (21 CFR Part 803)
- Complaint analysis required for corrective action evaluation
- Integration with design controls and management review required
Special attention required for:
- MDR reporting timelines: 24 hours for deaths, 10 days for serious injuries
- Complaint file maintenance and investigation documentation
- Trending analysis for CAPA qualification
- Integration with post-market surveillance and labeling updates
Guide
Your Feedback and Complaint Management SOP establishes systematic customer communication processes that capture valuable intelligence while ensuring regulatory compliance. Focus on creating efficient workflows that provide meaningful insights without overwhelming your team.Feedback and Complaint Classification and Triage
Implement systematic classification procedures that distinguish between general feedback, customer support requests, formal complaints, and serious incidents. Create clear definitions and examples for each category to ensure consistent handling across your organization. This classification drives appropriate response procedures and reporting requirements. Establish triage procedures that route different feedback and complaint types to appropriate team members with defined response timelines. Include escalation criteria for issues requiring immediate attention such as safety concerns or serious incidents requiring regulatory reporting.Complaint Logging and Documentation
Create standardized complaint logging procedures that capture essential information including customer details, product information, incident description, impact assessment, and resolution actions. Implement systematic numbering and tracking to ensure no complaints are lost or forgotten. Design complaint log templates that facilitate efficient data entry while ensuring completeness for regulatory requirements. Include fields for trending analysis and integration with other quality processes such as CAPA and post-market surveillance.Investigation and Resolution Procedures
Establish systematic investigation procedures appropriate for different complaint types. Technical issues may require engineering analysis, while safety concerns require risk assessment and potential regulatory reporting. Create investigation workflows that involve appropriate subject matter experts. Develop resolution procedures that address root causes rather than just symptoms. Include customer communication requirements, timeline expectations, and criteria for determining when additional actions such as CAPA initiation are necessary.Integration with Quality System
Connect feedback and complaint management to all relevant quality processes including CAPA, post-market surveillance, risk management, and vigilance reporting. Establish clear triggers for escalating complaints to other processes based on severity, frequency, or potential impact. Include complaint trending analysis in management review reporting to identify systemic issues requiring management attention. Use complaint data to inform product improvement decisions and regulatory update requirements.Customer Communication and Service
Establish professional communication procedures that acknowledge customer concerns promptly and provide regular updates during investigation. Create templates for common response scenarios while allowing personalization for specific situations. Develop customer service procedures that resolve simple issues quickly while ensuring potential quality concerns are properly escalated. Include training requirements for customer-facing personnel to recognize and appropriately handle different feedback and complaint types.Example
Scenario
MedTech Solutions receives diverse feedback about their diabetes monitoring app through multiple channels including app store reviews, customer support emails, and direct user communications. They implement systematic procedures to categorize, investigate, and resolve issues while identifying trends that inform product improvements.Feedback and Complaint Management Implementation
Feedback and Complaint Classification System:- General Feedback: App feature requests, positive reviews, general suggestions
- Customer Support: Login difficulties, tutorial requests, account management issues
- Customer Complaints: App crashes, inaccurate readings, sync failures affecting device function
- Serious Incidents: Delayed insulin decisions due to app malfunction, incorrect glucose trend displays
- Complaint ID: COMP-2024-045
- Customer ID: USER7823
- Date Received: March 22, 2024
- Product Version: DiabetesCare App v2.1.3
- Source: Customer support email
- Description: App crashes during glucose trend analysis, requiring restart to view current readings
- Impact Assessment: Potential delay in diabetes management decisions
- Investigation Assigned: Software development team
- Resolution Target: 5 business days
- Initial Assessment: Customer support team logs complaint and performs initial severity assessment
- Technical Investigation: Development team reproduces issue and identifies root cause
- Risk Evaluation: Quality team assesses potential safety impact and regulatory reporting requirements
- Resolution Implementation: Software fix developed and tested
- Customer Communication: Customer notified of resolution and provided updated app version
- Follow-up Verification: Customer confirms issue resolution and satisfaction
- App Crashes: 12 complaints (increase from 8 last month)
- Sync Issues: 5 complaints (stable trend)
- Accuracy Concerns: 2 complaints (decrease from 4 last month)
- Action Required: Investigate app crash trend for potential CAPA initiation
- CAPA Qualification: App crash trend exceeds threshold, CAPA initiated
- Post-Market Surveillance: Complaint data included in quarterly PMS report
- Risk Management: Safety assessment updates based on complaint patterns
- Management Review: Complaint metrics and trends reported quarterly
Q&A
How should customer feedback and complaints be categorized?
How should customer feedback and complaints be categorized?
Categorize feedback into general feedback (suggestions, positive comments), customer support (usage questions), customer complaints (performance or quality issues), and serious incidents (safety-related events). Use clear definitions and provide training to ensure consistent classification across your organization.
What information should be captured in complaint logs?
What information should be captured in complaint logs?
Include complaint ID, customer information, product details, incident description, impact assessment, investigation findings, resolution actions, and closure date. Capture enough detail to support trending analysis, regulatory reporting, and quality improvement decisions while maintaining efficient workflow.
How can increased complaint volume be handled effectively?
How can increased complaint volume be handled effectively?
Implement systematic triage procedures with clear escalation criteria. Use automated tools where possible for initial categorization and routing. Focus investigation resources on complaints with safety implications or trending patterns. Consider outsourcing routine customer support to trained providers.
When do complaints require regulatory reporting?
When do complaints require regulatory reporting?
Report serious incidents (deaths, serious injuries, safety-related malfunctions) according to regulatory timelines. For FDA: 24 hours for deaths, 10 days for serious injuries. For EU: immediate reporting for serious incidents through vigilance system. Use systematic criteria to determine reporting requirements.
How should complaint trends be analyzed and acted upon?
How should complaint trends be analyzed and acted upon?
Establish systematic trending criteria including frequency thresholds, severity assessments, and statistical significance testing. Conduct regular trend analysis and use findings to trigger CAPA investigations, product improvements, or regulatory updates. Include trend data in management review.
What is the best way to manage complaints in the system?
What is the best way to manage complaints in the system?
Log only complaints related to device performance or safety in your formal complaint log. General feedback and support issues that can be resolved with instructions don’t require formal logging. Use systematic categorization and routing to ensure appropriate handling and resource allocation.