Maintaining rigorous quality management systems and compliance is critical in the highly regulated medical device industry. Device makers must meet regulatory requirements while ensuring product safety and efficacy. Medical device quality management involves continuous process improvement, risk analysis, strong supplier controls, and extensive documentation. Here are 5 key elements of quality management for medical device…
The cost of quality (COQ) quantifies the expenditures and losses associated with maintaining quality. Tracking COQ enables organizations to gauge quality program effectiveness and identify areas for improvement. Here are steps to measure and reduce your quality costs: 1. Define COQ Categories Typical categories include prevention costs (training, process improvement), appraisal costs (testing, audits), internal…
Many quality teams still rely on manual, paper-based systems that are inefficient in today’s fast-paced environment. Automating quality management processes brings immense benefits but also requires careful change management for adoption. Here are the best practices for transitioning from manual to automated QMS processes: Create a Detailed Implementation Roadmap Define each stage from initial training…
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Human errors in quality processes can lead to compliance issues, product defects, slower workflows, and even safety risks. But quality management system (QMS) software can significantly reduce human errors by automating tasks, enforcing compliance, and streamlining processes. Here are 5 key ways QMS software reduces human errors: 1. Automated Workflows Automating manual workflows in a…
Industry 4.0 and smart manufacturing present new opportunities and challenges for quality management. To keep pace, Quality 4.0 focuses on leveraging technology like sensors, analytics, and machine learning for real-time control and continuous improvement. Here are 4 ways organizations can prepare for the future of quality: 1. Implement Real-Time Data Collection Remote monitoring technologies like…
Monitoring the right quality metrics and KPIs (Key Performance Indicators) allows managers to identify issues, measure progress, and drive continuous improvement. But with so many potential data points to track, it’s essential to focus on the vital few metrics that provide meaningful insights. Here are 12 recommended quality metrics and KPIs that every quality manager…
Effective document control is essential for managing quality and compliance in regulated industries. But many organizations make common document control mistakes that create risk and inefficiencies. In this post, we cover the top 5 document control mistakes that quality and compliance professionals should avoid. 1. Inadequate Access Controls Uncontrolled access to documents leads to potential…
The pharmaceutical industry is one of the most regulated and scrutinized sectors in the world. The quality and safety of pharmaceutical products are vital for protecting and promoting public health, as well as for ensuring consumer trust and confidence. However, achieving and maintaining high standards of quality and safety is not an easy task. It…
If you work in the manufacturing industry, you know how important it is to maintain accurate and detailed batch records. But have you ever considered using electronic batch records? This ultimate guide will cover everything you need to know about electronic batch records and how they can revolutionize your manufacturing processes. We will start by…
