Life sciences manufacturers have diverse quality management capabilities – from emerging companies that are still struggling with foundational processes and data, to established, global industry leaders that have extensive quality management infrastructures and leverage advanced analytics to meet their quality objectives.
The quality management maturity spectrum checklist outlines the required capabilities in six key areas:
- Policy and Decision Making: What is the level of governance in your quality systems, internal quality oversight and external supplier oversight?
- People/Talent: Have you established a true culture of quality within your company where employees understand their impact on quality and take steps to improve it?
- Process Optimization: Have you optimized processes to reduce complexity and variability and drive greater simplicity and standardization? Does quality permeate throughout your organization with the right quality professionals in the right places at the right times with the right knowledge/skills to drive improvements?
- Integration: Is quality tightly integrated with all other departments/functions, do all stakeholders operate collaboratively within a common, electronic platform, and does this integration extend out to external business partners?
- Data: Do you have a single source of accurate, complete and comprehensive quality data? Have you digitized quality processes and data in order to leverage Industry 4.0 technologies (e.g. AI, ML)?
- Actionable Business Insights: Can your quality team easily perform advanced analytics? Do you have a balanced scorecard with KPIs focused on all quality elements: Product quality, safety, efficacy, continuity of supply and compliance? Are your quality KPIs closely aligned to your broader corporate objectives?
When reviewing this assessment, consider your current level of maturity in each of these areas and whether your capabilities align with where you want to be in your quality management evolution.