The US Food and Drug Administration (FDA) recently announced its support of the Case for Quality Voluntary Improvement Program (VIP) through a final Guidance published in September. VIP delivers improved organizational performance and product quality, with the ultimate goal of providing reliable and safe treatments to patients faster.
The Voluntary Improvement Program was developed in collaboration with the medical device industry, FDA, the Medical Device Innovation Consortium (MDIC) and ISACA.
Enterprise-wide Continuous Improvement: A Case Study
The Voluntary Improvement Program leverages a tailored version of ISACA’s Capability Maturity Model Integration (CMMI) framework and appraisal methodology, to help medical device manufacturers better understand, measure and improve their capabilities to deliver high-quality products. By using the CMMI framework, organizations are able to identify improvement opportunities and create a prioritized roadmap to reach their goals. VIP’s unique approach builds trust and transparency throughout an organization and with the FDA.
The CMMI model includes Practice Areas that support an organization’s governance, measurements, and infrastructure. Governance helps leadership communicate and align strategic priorities to the teams, departments and individuals across the organization. Measurements ensure the organization understands what success looks like and how to achieve it. Infrastructure determines the skills, funding, resources, and processes needed for staff to deliver against organizational goals to the level of success desired.
One device maker believed the program could help them deliver on its business goals to:
- Maintain lean, efficient operations while meeting all necessary legal and regulatory compliance requirements
- Sustain and demonstrate its competitive edge.
Participating in VIP was a natural fit for their growth stage, and they began their multi-year improvement journey.
To address opportunities identified in the first-year appraisal around managing performance and measurement, they created a metric summary that contained all of the monitored process outputs and the operational definitions of each (what, when, where, how, and who). Then examined what was measured and why and verified the metrics were aligned and useful to the business. The list now contains metrics related to planning and production outputs as well as quality systems.
In the second appraisal, the device maker received improvement opportunities around decision analysis and resolution, governance, and risk and opportunity management. In response, they analyzed this feedback and took a series of actions to address opportunities in these Practice Areas.
- Decision Analysis and Resolution (DAR): Created a process for capturing formal decisions (including matrix, work instructions, how and when)
- Governance (GOV): Created a process to ensure corporate goals cascaded to individual departments and showed direct links between those corporate goals, department goals and measurable objectives
- Risk and Opportunity Management (RSK): Applied risk management principles to critical equipment to prioritize and anticipate risks
As a result of these improvement opportunities, they were able to reduce their complaint time cycle from 95 days to 69 days - a 27% reduction - in one year. The appraisal helped them select appropriate metrics which enhanced visibility within the organization and ensured employee collaboration.
The Voluntary Improvement Program provided them with insight for baselining and optimizing key organizational capabilities and critical business processes while improving the interaction between functions. This insight gave them a new appreciation for the importance of a codified approach to organizational processes.
Moreover, they saw the quantitative and qualitative results of the processes they perform every day, which provided employees with a full sense of ownership and accomplishment, creating a better work environment.
The Ultimate Goal: Improved Patient Outcomes
Participation in the Voluntary Improvement Program identifies opportunities for organizations to improve how they implement processes and their overall business performance. While device makers already have a rigorous quality culture, the CMMI framework enhances this commitment to quality to focus on continuous improvement and improving patient outcomes.
As one VIP participant noted, ultimately the program benefits customers and patients: “We can get high-quality products to our customers more quickly, and that can save lives.”
