All manufacturing organizations including those in life sciences, are experiencing unprecedented levels of change in the regulatory and quality compliance landscape. In this global economy, value chains are getting longer and longer. Achieving quality and regulatory compliance in this environment can be quite overwhelming. Let’s look at two of the most recent changes in regulations and standards that have either been initiated/implemented, revised, or are in the process of revision, driving the need for an updated approach to Quality Management Systems.
ISO 9001:2015, the new quality standard is less prescriptive than its preceding versions, and focuses on performance, risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization. ISO 13485:2016 also emphasizes risk management and risk-based decision making, and it places additional regulatory requirements on organizations in the extended supply chain. The revised regulation aims to strengthen supplier control processes and increase the focus regarding feedback mechanisms. It also prescribes improved alignment of global regulatory requirements.
“Whether for products or product families, or for customers and suppliers around the globe, this data is essential within a global QMS.”
One additional initiative, the Medical Device Single Audit Program (MDSAP) is a global regulatory initiative, which is likely to be trend setting. The aim of MDSAP is to develop a single audit program that applies internationally and will serve as “The audit”. The goal of the initiative (the pilot concludes in 2016) is to minimize the regulatory burden on Med Device companies and achieve global alignment of regulatory approaches. Regulatory bodies around the world are driving towards global standards, efficiency, and improving the safety and efficacy of products. Navigating these and other regulatory and compliance changes will require organizations to rethink their approach to compliance and regulatory reporting as well as their Quality Management System (QMS).
A global Enterprise QMS which aids in the identification, diagnosis, and ultimately, the prediction and prevention of quality problems across an organization’s value chain is required. This is achieved through operational consistency and compliance. A global Enterprise QMS creates a common language across an organization, through harmonization and the creation of a single source of quality truth. This, in turn, facilitates communication between groups globally, and builds a cooperative, collaborative environment within the organization’s value chain. This value chain extends to suppliers, external service providers and regulators. Organizations operating with silos of quality data will find it very difficult to keep up with evolving standards and regulations and to demonstrate consistent, controlled quality processes. The ability to communicate, and therefore collaborate, within the value chain will be key to an organization’s ability to achieve global compliance. More importantly, it will be critical that they consistently meet their requirements and enhance their customers’ satisfaction.
With a global Enterprise QMS, quality will come out from behind the walls of Quality Assurance and into the organization. With this comes transparency and increased opportunities for collaboration and knowledge transfer, achieved via harmonization and a “Single Source of Quality Truth”. Harmonization is different than standardization 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 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 measurable. It means that wherever the process is in use, the core of the process is common and based on industry best practices such as ISO 9001 or GMP for compliance.
Once an organization has made the decision to think globally about quality management, and the strategy for harmonization is agreed upon, the foundation for your organization’s common language has been established. While establishing a global QMS, common definitions will be required for all system users to share and visualize the quality information generated, and then to act upon it. This means thinking through organizational structures, including virtual entities in your value chain such as your suppliers, as well as your data structures.
In this age of big data, structuring your QMS data is imperative. Properly structured quality data will allow for the aggregation and disaggregation of all that quality data. The goal of properly structured data sets? Turning data into actionable information through its transformation. Data 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 QMS. These data definitions and measurements become the common language for the organization and a “Single Source of Quality Truth”.
The “Single Source of Quality Truth” then acts as a risk mitigation and opportunity identification process. With a common language, sites with common operations/processes and or products can “see” and understand (due to common definitions) when issues are trending, what was done to correct that trend, and they can respond accordingly (risk mitigation). A global Enterprise QMS will act as an early warning system through notifications, dashboards and metrics as well. And when improvements to products or processes/operations are made, that knowledge is available to all, and all can act accordingly (opportunities for improvement).
The pace of change experienced in 2016 from a regulatory and compliance perspective is very likely to continue. This is partially being driven by technology. With the growth of social media, not only has the speed of information greatly increased, so has the speed of response from the consumer. Consumers are more informed, more educated, and therefore, more demanding than ever before. They expect more value, quality, and service. From a quality perspective, that means more requirements to meet in order to achieve customer satisfaction, the mantra of quality.
Through the deployment of a global enterprise QMS synergies that will strengthen the organization will be realized. It will also improve the flexibility and agility of the organization due to the ability to flex resources across and among sites and divisions. There are more tangible benefits as well: a reduction in the overall cost of quality through the reduction of rework, scrap, returns, penalties and fines.