Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions
The definition of Quality is widely accepted as the achievement of customer expectations through conformance to their requirements. It makes sense then, that a Quality Management System (QMS) supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction. But establishing a QMS is a tall order in our global economy where value chains are getting longer and longer.
For organizations in Life Sciences, where the ultimate end user (customer) is a patient, and regulatory compliance is mandatory in all countries the organization serves, the task can seem quite daunting. So why would anyone want to complicate it even further by implementing a global Enterprise Quality Management System?
The Value of Thinking Globally
The value of a global Enterprise QMS is derived from its ability to aid in the identification, diagnosis, and ultimately, the prediction and prevention of quality problems across an organization’s value chain. This is achieved through operational consistency and adherence to operational protocol. A global Enterprise QMS creates a common language across an organization, which facilitates communication between groups globally and builds a cooperative environment within the organization.
Harmonization is the Key
Achieving this nirvana is only possible through harmonization. Harmonization is different than standardization, where everything is exactly the same, because it also takes into account regional/local needs, and considers that which is unique to a process or product. When a process, whether a Corrective and Preventive Action (CAPA), a Complaint, or a Change Request (to name only a few QMS components) is truly harmonized, at its heart is a DNA strand that is consistent and measureable. It means that wherever the process is in use, the core of the process is common.
Harmonized processes should reflect industry best practices such as ISO 9001 or GMP for compliance. By engaging consistent quality processes, not only will an organization achieve synergies that will strengthen the organization, it will also improve the agility of the organization due to the ability to flex resources across and among sites and divisions.
Recognize the Single Source of Quality Truth
If your organization has made the decision to think globally about quality management, and the strategy for harmonization is agreed upon, you’re laying the foundation for your organization’s common language. While establishing your global Quality Management System, common definitions will be required for all system users to share and visualize the quality data generated, and then to act upon it. This means thinking through organizational structures, including virtual entities in your value chain such as your suppliers. It also means organizing your data structures.
In this age of big data, structuring your QMS information is imperative. The goal of properly structured data sets? Turning data into actionable information through its transformation. When properly structured, quality data can be aggregated and disaggregated. It may be transformed into KPIs, metrics, and measures that can be used consistently at a site, division, or business unit level. Whether for products or product families, or for customers and suppliers around the globe, this data is essential within a global Quality Management System. These data definitions and measurements become the common language for the organization: the Single Source of Quality Truth.
Mitigate Risk and Identity Opportunities with a Common Language
Once your organization has established its global single source of truth, this common language aids organizational risk mitigation and control, and the identification of opportunities for operational improvement. ISO 9001:2015 directs organizations to address risks and opportunities that can affect product and service conformity. A global enterprise-wide Quality Management System facilitates global communication between groups. If one site in an enterprise is achieving higher quality than other sites in the organization, the visibility of this discrepancy makes it possible not only to identify an opportunity for improvement; it provides the insight needed to investigate how all sites might attain a universally equivalent level of quality. Conversely, should an unexpected adverse result start trending at one site, it can serve as a preventive warning to other sites, thereby mitigating broader potential risk.
Quality Nirvana is Attainable
The value of thinking globally about your organization’s Enterprise Quality Management System far outweighs the cost of implementation. The benefits to your organization are many. Synergies will be created throughout the enterprise that:
- improve communication between groups globally;
- aid in the identification, diagnosis, prediction, and prevention of quality problems; and,
- reveal opportunities for quality improvement.
However, the greatest benefit achieved by thinking globally about enterprise quality management is the golden opportunity to introduce your customers to quality nirvana by consistently meeting their requirements and enhancing their satisfaction.
Get Started with a Global Quality Management System Today
To manage your global quality processes with an enterprise-wide Quality Management System, consider the power of SmartSolve®, from Pilgrim Quality Solutions. SmartSolve is a highly configurable platform for achieving compliance with industry regulations across global operations. It features an integrated business analytics component, letting you visualize up-to-the-minute insight from your SmartSolve quality management solutions and putting you on the road to finding your single source of quality truth.
Find Your Path to Quality Nirvana
Life Science Technology Roadmap
Today’s leading organizations are harmonizing quality processes by implementing a next-generation, global Quality Management System. Find your path to Quality nirvana by downloading this Life Science Technology Roadmap white paper from LNS Research.