In a recent warning letter, the FDA Auditor cited:
“Failure of [the] quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with cGMP.”
As evidence, the auditor explained that the organization had:
- Approximately 84 open and past due deviation investigations
- Multiple past due investigation also lacked procedurally required extensions to the due date
The auditor also noted:
“Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions are recorded.”
Incomplete, inadequate, and past due investigations (and effectiveness checks) are a red flag for auditors and an indicator that your process might not be under control. A well-managed Quality Management System can help you stay on top of this common problem. While it can’t do the investigation for you, your eQMS can provide:
- Timely training and access to procedural documents
- Tracking and trending tools that help you know when a problem is brewing
- Robust framework for conducting, documenting, and closing the investigation
- Up-to-date information on investigation status, action items, and effectiveness checks
In today’s data-driven environment, findings such as the one mentioned above can be prevented. Along with a well-managed eQMS, utilizing report metrics is crucial for monitoring performance, enabling informed decision-making, and driving operational efficiency.
Key benefits of effective report metrics include:
1. Identifying trends and patterns
2. Measuring success (e.g., on-time closures)
3. Enhancing accountability and transparency
4. Optimizing resource allocation
5. Driving continuous improvement
Report metrics are indispensable tools that offer valuable insights, drive informed decision-making, and foster a culture of accountability and continuous improvement. By leveraging the power of metrics in your eQMS , organizations can monitor and manage the quality process to stay in front of overdue timelines, ultimately Keeping you in Compliance.
