MDIC‘s June Case for Quality Forum, hosted virtually June 14-15, focused on Leadership Engagement and the highly innovative and quality focused Voluntary Involvement Program (VIP).

Welcome 

FDA Program Update

VIP Participant Success Stories

ISACA Presentation

VIP Working Groups Update

Panel

Welcome and Introductions

Joe Sapiente, Francisco Vicenty, Ravi Nabar

FDA Introduction

• FDA Quality Metrics perspective
• Leadership engagement in metrics towards driving continuing improvement

Leadership Presentation

• CfQ Metrics Survey (Pat Shafer, FTI Consulting)
  • Overview
  • Background
  • Scope & Purpose
  • Methodology
• CfQ Metrics Survey Results (Jacqueline Torfin, Leadership Consulting & George Zack)
  • Raw results
  • Analysis
  • Take aways (Interpretation)
• Conclusions

Industry Guest Speakers (Metrics Experiences Highlight)

• Lisa Walker, DISH
• John Kelly III, IBM-Watson
• Jim Brunke, Boeing

Case for Quality Collaborative Community Leadership Presentation

• Gap Analysis of leadership engagement/ metrics in the device industry when benchmarked to other industries
• Future opportunities / Recommendations

Panel

• Panel (60 mins, Virtual, – Leadership and guest speakers, Moderator: Jacqueline Torfin)
  • Francisco Vicenty, FDA-CDRH
  • Lisa Walker, DISH
  • Jim Brunke, Boeing
• Discussion/ questions centered around survey results
• Significance/ importance of metrics in today’s environment
• Leadership engagement in metrics towards driving continuing improvement
• Audience Q&A

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This white paper is a continuation of a transformational CAPA Process Improvement story put in motion in 2018 by MDIC. It was initiated in response to the cry of engineers everywhere within the medical device industry whom, if asked what they like most about their jobs, would point to solving problems and driving product improvements. But what do they like least? Often, they will tell you that it’s the CAPA process. Today’s CAPA process has become highly focused on compliance, many manufacturers taking a “one-size-fits-all” approach. What’s worse, the fear of findings by regulatory bodies leads companies to spend an out-sized amount of time on paperwork, regardless of identified product and/or process risk levels, often slowing down the implementation of improvements.

It was in light of this reality that the MDIC Case for Quality Collaborative Community (CfQcc)1 launched its CAPA Process Improvement program, with the goal of enabling faster continuous improvement through the use of a more efficient and effective CAPA process. This opportunity to work together to improve the CAPA process and enable greater improvement quickly mobilized organizations from around the world to voluntarily join the global CAPA Process Improvement team, including MDIC members from more than 20 medical device organizations and representatives of consulting firms and the FDA.

The team’s true north throughout this multi-year project was to work to enable organizations to achieve faster process and product improvements. To do this, the proposed framework shifts the focus away from documenting just to achieve compliance and moves it toward the central purpose of CAPA: problem-solving. The team recognized that documentation should be commensurate with risk while adding value to the organization and that systems should be implemented to ensure a healthy problem-solving process is in place. The objective was to make today’s CAPA process more effective, efficient, and user friendly—while still meeting the intent of regulations.