Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA
If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits.
The Value of a Risk-based Approach
A quality risk-based approach to internal audits allows you to assess the importance and performance of each area to be audited, and to use your results to devote your auditing time and resources to these critical business areas. Based on this risk assessment, you may also decide that certain areas of your business don’t need as much oversight. (more…)