Plan systematic corrective and preventive actions addressing quality issues and root causes.
Criteria | Information |
---|---|
CAPA Title | Software Compatibility Issue - Inconsistent Glucose Readings on Specific Smartphone Models |
CAPA Number | CAPA-2024-002 |
Category | Scoring | Score |
---|---|---|
Input Type | Customer complaints (+2) | 2 |
Systemic | Systemic issue (+2) | 2 |
Trend Analysis | Result of trend analysis (+2) | 2 |
Significant Impact | Significant impact on performance (+2) | 2 |
Patient/User Harm | No direct harm (+0) | 0 |
Not Easily Fixed | Cannot be easily fixed (Disagree) | - |
Existing CAPA | No existing CAPAs cover this (Disagree) | - |
CAPA Total Score | 8 |
CAPA Information | Description |
---|---|
Source of CAPA | Post-market surveillance analysis of customer complaints received through support system over 3-month period |
Product and Version Affected | GlucoTrack Mobile App versions 2.1.0-2.1.3, affecting Samsung Galaxy S22 and Google Pixel 6 devices |
Description of Problem | Users report glucose readings varying by ±15% compared to reference meter, occurring intermittently during peak usage hours |
Description of Investigation | Analysis of 47 complaints, device logs, and compatibility testing revealed memory management issues during high CPU load conditions on affected smartphone models |
Root Cause | Inadequate memory allocation handling in glucose calculation algorithm when running on devices with specific Android memory management configurations |
When should unofficial audit recommendations be implemented, and how should they be handled?
How do you determine if a CAPA is required for a particular issue?
What is the difference between corrective and preventive actions?
How should root cause analysis be conducted for CAPAs?
How do you verify CAPA effectiveness?