Complaint Time-to-Closure Analysis

5-Year Trend Analysis & Performance Metrics

Performance Trend Analysis

Significant Progress: From 2021 to 2024, complaint closure time improved by 57 days (41% reduction), demonstrating excellent process optimization. The current performance is consistently better than the 90-day internal target.

2025 Performance: The 4-day increase to 86 days represents a 4.9% deterioration from the prior year but remains well within the target and is explained by documented operational challenges.

2025 Impact Factors Analysis

  • Validation of New Complaint Closure Workflow: Process validation activities likely caused temporary delays.
  • Resources Diverted to 3870 510(k): FDA submission activities diverted quality resources.
  • New Building Relocation: Physical relocation disrupted established workflows and temporarily impacted efficiency.

Historical Performance Excellent

The 41% reduction in closure time from 2021-2024 demonstrates effective process optimization. Performance has remained consistently better than the 90-day target.

Current State Assessment Good

2025 performance at 86 days remains strong despite operational challenges. The 4-day increase is manageable and likely temporary.

Customer Response Time Excellent

Providing customers a response in 50 days, well before the final 86-day closure, is a key process strength. This ensures customer satisfaction by delivering a timely initial resolution.

Strategic Recommendations

Short-term: Monitor Q3-Q4 performance - closure time. Long-term: Consider adjusting the internal target from 90 to 80 days to reflect the new, improved process capability. Customer Focus: Maintain the strong 50-day customer response time.

Complaint Time-to-Closure Analysis

5-Year Trend Analysis & Performance Metrics

2025 Impact Factors Analysis

  • Validation of New Complaint Closure Workflow: Process validation activities likely caused temporary delays.
  • Resources Diverted to 3870 510(k): FDA submission activities diverted quality resources.
  • New Building Relocation: Physical relocation disrupted established workflows and temporarily impacted efficiency.

Historical Performance Excellent

The 41% reduction in closure time from 2021-2024 demonstrates effective process optimization. Performance has remained consistently better than the 90-day target.

Current State Assessment Good

2025 performance at 86 days remains strong despite operational challenges. The 4-day increase is manageable and likely temporary.

Customer Response Time Excellent

Providing customers a response in 50 days, well before the final 86-day closure, is a key process strength. This ensures customer satisfaction by delivering a timely initial resolution.

Strategic Recommendations

Short-term: Monitor Q3-Q4 performance - closure time. Long-term: Consider adjusting the internal target from 90 to 80 days to reflect the new, improved process capability. Customer Focus: Maintain the strong 50-day customer response time.