Quality Improvement Program Insights
"Explore the success of a voluntary quality improvement program in a medical device context, including the impact of virtual appraisals and the alignment with regulatory guidelines. Learn about the VIP status, industry updates, and global enrollment benefits."
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Presentation Transcript
Case for Quality Voluntary Improvement Program Rob Becker, Edwards Lifesciences Kim Kaplan, ISACA April 26, 2021
Annual Program Adoption (Note: 2021 data is only reflective of a partial year) 2 2
Annual Program Adoption (Note: 2021 data is only reflective of a partial year) 3 3
2020 Program Effectiveness (167 survey respondents: 42 baseline, 125 reappraisal) Appraisal provided broader value add Positive experience with appraisal Net Promoter Score Appraisal identified opportunities to improve product quality Appraisal activities had no conflict with compliance Range: -100 to +100 4 4
2020 Virtual Appraisals (114 survey respondents) Believed they received same or similar value as compared to an on-site approach Had no major difficulties in the remote environment Were somewhat or completely satisfied with the remote approach Recommend the virtual approach for reappraisals or any appraisal Believed training was sufficient to prepare them for remote activities Year 1+ Appraisals Multi-Site Appraisals Some Time Zone Gaps Approved for: 5 5
VIP Status Aligned Charter with Case for Quality Collaborative Community, members and chair to continue through 2021. Approved Strategic and Operationalization Plan. Defined 2021 Objectives and Deliverables. Monthly cadence with ad hoc sub-group meetings. Quarterly collaborative sessions. The Case for Quality Collaborative Community is finalizing the announcement for the formal transition from pilot to program. Additional Regulatory Benefits Reappraisals Multi-Site Appraisals Performance Metrics Medical Device Context FDA to release additional supporting guidelines by end of September. 6 6
Case for Quality VIP Update Industry Participant Rob Becker, Edwards Lifesciences MDIC Case for Quality Forum April 2021
Global Enrollment Virtual appraisals have enabled engagement across our entire manufacturing footprint during a time of unknowns Ireland Multi-site: Year 1 Utah Multi-site: Year 4 Irvine, CA: Year 2 Dominican Republic: Year 1 Puerto Rico: Year 1 Costa Rica: Year 1 Singapore: Year 1 Very engaged and excited to start their CfQ journeys Virtual Appraisals Continued to develop strong relationships with ATL High bar for engagement, but virtual was still effective Y1 Y2 Y4 8 8
Re-Appraisals We are still finding value after 4 years of appraisals Practice Area / Level Assessing new practice areas and increased levels provides more data points about the organization. Investigating a more targeted scope based on site initiatives drives more actionable feedback. Scope Providing objective evidence results in a more holistic assessment. Approach 9 9
Appraisal Feedback Results are largely aligned with corporate initiatives, reinforcing that we are investing in the right areas MES Automated data reporting Automation implementation Escalation criteria & prioritization Metrics directory and standard work Organizational Structure Advanced Project Management Project prioritization Use of lessons learned Involvement of stakeholders 10 10
Shaping the Future We have identified a need to create structure across sites to maximize the benefits seen at a corporate level INTERNAL STANDARDIZATION INTERNAL CfQ COMMUNITY Aligning appraisal timing across sites Establishing site alignment & best practice meetings Integrating into business planning cycle & continuous improvement framework Distributing broader program newsletters Developing an Internal Appraisal Team Member (ATM) pipeline Generating appraisal playbook & tools 11 11
Questions? Rob_Becker@edwards.com kkaplan@isaca.org
