In April 2011, the Food and Drug Administration (FDA) released an update of its strategic priorities, outlining the goals and priority areas that will guide the agency through the next five years. If the FDA is successful in executing its plan, a more mature, better-run organization will no doubt evolve. Not surprisingly, the FDA document included a heavy focus on ensuring product quality.
Is your organization looking ahead as the FDA is taking proactive steps to ensure product quality through optimizing the performance of its quality systems?
Although several business functions within a regulated company are responsible for product quality, it is the Quality Assurance group that is ultimately accountable. As a Quality Assurance leader, do you have a good understanding of how effectively your quality systems perform? When was the last time you assessed your quality system processes to evaluate their compliance and business effectiveness?
Just as the FDA identified its strategic priorities in order to build a stronger, more effective agency, your company would benefit from an assessment to identify the strengths and weaknesses of its quality systems. The idea of undertaking a detailed analysis like this may seem daunting, but there is a straightforward, structured approach.
Assessing Your Organization’s Quality Systems Involves Three Straightforward Steps:
- Determine your organization’s current quality management maturity.
- Go through the assessment process itself to analyze your organization’s quality systems in detail, identifying opportunities, and developing an optimization plan to address the opportunities identified.
- Create a plan for implementing the changes identified in the assessment.
For more, please download our report.