IQVIA Quality Compliance
As the Life Sciences industry continues to experience an unprecedented level of change in regulatory requirements and oversight on a global scale, organizations worldwide are feeling ongoing pressure to demonstrate their quality compliance.
To help organizations take stock of where they presently stand, we asked a cross-section of IQVIA Quality Compliance subject matter experts to share their perspective on the most effective way to assess the health of a Quality Management System. Consider these quality system assessment insights and think about how they might help you run your own organization’s quality compliance health check.
What is the one key metric to examine when assessing the health of your Quality Management System?
Overdue CAPA closures is a key indicator of the quality status of a manufacturer and one that a regulator will look at during inspections/audits. Overdue CAPAs are an indication of the lack of attention to processing CAPAs and/or poor definition of the CAPA needs and timelines in the original CAPA plan. – Phil Johnson, Senior Principal, IQVIA Quality Compliance
Cost of Quality is the most important metric to a business, however, it is most often overlooked. Even more important is both the cost of poor quality and the investments made in good quality. This metric often is often a leading indicator for other metrics such as throughput and defects. For example, the better the quality, the lower the defects, and in return, the lower the cost of quality. – Joshua Center, Associate Director, Sales Engineering, IQVIA Quality Compliance
The one key metric to examine would be “Number of Rejects,” that is the number of times that a record was rejected back to a previous stage of a workflow. This is an indicator of several components of a Quality Management System, including how user-friendly the process is, how well users are trained to understand the process and system, and how seriously each player takes responsibility for completing their role completely, and getting it right the first time. – Devora Perich Grieco, Senior Manager, HighPoint Solutions, an IQVIA Company
Audit findings provide a glimpse into the performance of your Quality Management System. Whether the audit has no findings, observations for improvements or recommendations, and/or minor or major findings, it allows your company to analyze the information, identify trends and determine the next steps to take. – Krystal Young, QA Business Analyst, IQVIA Quality Compliance
We usually see a suite of metrics to monitor quality and any compliance risks associated with assets. Typical equipment analysis metrics, trending reports and KPIs that can provide quality-related insight into assets include: Mean Time Between Failure (MTBF), Planned vs. Unplanned Work, Overall Bad Actor Rating, Past Due Work, Calibration Interval Analysis, Lifecycle Cost Analysis, Average Time ‘In Progress’ for Maintenance, Calibration and Validation Work, Time to Complete Work Orders, Trending Asset Failures, and Asset Maintenance and Calibration Cost Trending. All of these metrics provide the necessary information to make strategic decisions for high-risk assets given the assets’ maintenance and calibration history, and can detect any compliance risks. – Jim Erickson, President, Blue Mountain Quality Resources
Viewing the Right the First Time metric as a percentage is quite insightful into the health of your QMS. Quality greats like Crosby and Deming would agree that there is no such thing as good enough and that 100% right the first time is the goal (think zero defects). If your organization’s QMS effectively defines what you should do and how you should do it, and documents that you’ve in fact done it the way you’re supposed to do it, your organization’s Right the First Time metric should be in great shape. – Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance
The numbers of complaints received per month is a metric that companies use to assess the health of their QMS. The goal is to have a decreased number of complaints per subsequent month. – Kevin Lee, Manager, Sales Engineering, IQVIA Quality Compliance
A Powerful Foundation for Building a Mature Quality System
IQVIA’s integrated SmartSolve® EQMS platform enables quality to become a centralized hub for continuous improvement throughout your business. Build, scale, and evolve your quality system as the demands on it grow, significantly enhancing the quality of your operations, products, and services.
The Case for Quality System Transformation
Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.