Quality management plays an important part in ensuring the safety and efficacy of products across the life sciences industry. Quality events—deviations from established standards—are common occurrences in this highly regulated industry.
This means it’s essential for life sciences professionals to understand and manage these events effectively, in order to meet regulatory compliance.
This blog post will explore the practical steps and best practices you can follow for managing quality events.
Understanding Quality Events
First, let’s consider exactly what constitutes a quality event. Quality events are deviations from, established standards or procedures that can occur at any stage of product development, manufacturing or distribution. They manifest in various forms, whether product or component defects, process deviations, or noncompliance. There are a few common causes, including human error, inadequate procedures, equipment malfunction and supply chain issues.
Best Practices for Managing Quality Events
There are five key ways organizations can more effectively manage quality events:
1. Identification and Reporting
Detecting quality events early is essential for minimizing their impact on product quality and, ultimately, patient safety. By implementing effective reporting mechanisms, organizations can ensure that incidents are identified quickly and reported on, enabling them to mitigate potential risks.
2. Investigation and Root Cause Analysis
Your organization should conduct a thorough investigation and root cause analysis to identify any underlying factors that contribute to the event. By identifying the root cause, you’ll be able to then implement corrective and preventive actions (CAPA).
3. Corrective and Preventive Actions
CAPAs are a key component of quality event management. Corrective actions enable organizations to address any immediate issues and preventive actions help mitigate future risks. Taking this proactive approach helps prevent similar quality events from occurring in the future.
4. Documentation and Record-Keeping
Comprehensive documentation of quality events helps you meet regulatory compliance and ensure continuous improvement. Organizations should maintain accurate records of investigations, actions taken and outcomes. This enables you to ensure transparency, accountability and traceability throughout the process.
5. Communication and Collaboration
Effective communication between all stakeholders helps your organization foster a collaborative approach to problem solving. It’s important to encourage cross-functional collaboration so your organization can take advantage of collective insights and expertise, and apply this to the more effective resolution of quality events.
Gain an End-to-End View of All Quality Events
Effectively managing quality events within your organization is important to ensure product safety, quality and compliance.
Follow the best practices listed here to navigate quality events seamlessly and successfully.
Dot Compliance provides a fully validated eQMS solution that provides the analysis, tracking and prevention of quality events.
Book a demo with us to see quality event management in action.
