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© 2017 Illumina, Inc. All rights reserved.
Reflections on Illumina’s MDDAP/VIP AppraisalCase for Quality (CfQ) Pilot Program November 12-16, 2018
Ravi Nabar, Ph.D., MBASenior Director Quality- Head of Global QMS and Compliance, Illumina, Inc. | 02/25/2019
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CONFIDENTIAL – FOR INTERNAL USE ONLY
Why participate in the CfQ VIP pilot?
Illumina MissionImprove human health by unlocking the
power of the genome.
CfQ VIP Benefits- Produce high quality devices- Increase patient safety- Elevate product & process quality
Illumina’s Benefits: Regulatory Relief
- Entry into program via FDA vetting(inspectional history)
- Product moves (Class III PMA device)- Reduce burden & disruption of audits- Accelerate clearance, change
review & approval process; fasterTime To Market (TTM)
30-Day Submission- Simplified & bundled notifications- Positive outcomes- Improved quality and compliance- Increases competitive advantage- Participating in site transfer pilot
Site Changes- Streamlined submission- Accelerated approval 1 week- Enhances growth & site expansion- New B6 Facility
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CONFIDENTIAL – FOR INTERNAL USE ONLY
FDA Inspection CFQ VIP Appraisal
Inspection Requirements
• Facility Inspection (Class III PMA device)
• Anticipated in 2019
• No inspection needed• Waive future surveillance
& risk-based inspections
Interaction• 1-2 Investigators @ 5 Days• Inspectors interrogate SMEs & Process
Owners• Audit and compliance-based
• 1-4 Appraisers @ 5 Days• Appraisers conduct group interviews of the
“doers” (practitioners)• Look at practice of foundational quality
capability elements vs. “best” practices
Effort• Large support team with backroom/front
room, etc.• 150+ SMEs & Support Staff
• Minimal support team with no backroom/front room.
• 60+ SMEs (~2-3 hrs. per week) & Support Staff
Time & Cost• 2,400+ person- hrs. support • 2 weeks inspection• Estimated cost $140k
• 120-180+ person-hrs. support• 1-week appraisal• Estimated cost $74k
30-Day/180-day submissions
• Additional information requirements• Complex communications and
coordination• Missed opportunities due to delays
• Simplified & bundled notifications• Positive outcomes• Improved quality and compliance
CfQ VIP Appraisal Benefits
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CONFIDENTIAL – FOR INTERNAL USE ONLY
Illumina CfQ VIP Pilot Appraisal Preparation
Support:• Absolutely No Backroom• No Procedures• No Records• No Scribing• 2 Conference Rooms
Appraisal Team:• Four CMMI Appraisers
(1 lead @ 2 teams)
Resources Needed:• 40+ Participants• 7 interview sessions
@ 1.5 - 2 hrs./ea.
Intake Meetings:• Three 1-hour meetings• CMMI Mentor session
(Coach Lindsey McGowan)• Defined product scope • Set Schedule & duration• Developed & refined list of
interviewees
How is MDDAP different from a regulatory audit?
Is Is NOT
Confidential dialog Audit (observers, back room)Focus on
“run the business” Compliance
Interviewed practitioners
Verification with process owners
Results are ours Audit responses, CAPAs
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Illumina CfQ VIP Pilot Appraisal Scope
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Illumina CfQ VIP Pilot Appraisal Process
● CMMI Model: CMMI Development v2.0
● CMMI Team:
Evaluated in7 interview
sessions@ 1.5 - 2 hrs/ea.
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CONFIDENTIAL – FOR INTERNAL USE ONLY
Illumina On-Site Appraisal ScheduleFinal Appraisal November 12-16, 2018
Session 7 (Included in all sessions): Implementation Infrastructure
7 interview sessions (minimal impact to interviewees)
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Illumina Pilot AppraisalSite Strengths
Sampling: 3 on-market IVD products
● Proactive improvement vs. Reactive Improvement
● Agility Innovation Staying ahead of the market
● Design Transfer Maturity
● Product Integration & Technical Solution
● Strong Core Values
● Focus of Safety and Quality
● Forward looking through “Factory of the Future” automation & Data Analytics
IlluminaConfiguration Management (CM)Estimating (EST)Governance (GOV)Implementation Infrastructure (II)Monitor and Control (MC)Managing Performance and Measurement (MPM)Product Integration (PI)Planning (PLAN)Process Quality Assurance (PQA)Requirements Development and Management (RDM)Technical Solution (TS)
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© 2019 Illumina, Inc. All rights reserved.
Illumina Design Transfer Maturity Index
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Navigating RUO vs Dx product roadmaps
Transparency and informed decision making at all levels of organization
Removing ambiguity in business and compliance risks
Concrete alignment on “all in” activities and their level of robustness
What good looks like relative to product intended use
Illumina Design Transfer Maturity Index (DTMI)Capability Maturity Levels
Level 1 Level 2 Level 3 Level 4 Level 5
Raw
Mat
eria
ls
Raw Material Critical Parameters
Critical parameters established for < 80% of critical components
Critical parameters established for > 80% of critical components
Critical parameters established for all critical components
Impact to product quality is well understood
Critical parameters established for all critical and most non-critical components
Impact to product quality is well understood
Critical parameters established for all components
Operations alignment tool guides the level of robustness appropriate to project type
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Illumina’s MDDAP/VIP Appraisal ReflectionsFeedback & Learnings● Scope: Some practice areas could additionally be considered core for Level 2
Capability Attainment; Two practice areas were determined to be at Level 3
● Time to enroll was short (++)
● Would benefit from some pre-work on common knowledge with terminology between Illumina & CMMI Appraisers
● Required major re-calibrating internally to undo “audit mindset” (++)- Dialogues to build trust & convey pride in work; not to defend compliance- Open-ended dialogue; not binary answers (yes/no)- No scribing; this violates confidentiality of the process- Ushering audit personnel out of the room
● Understanding of what CMMI really means amongst the interviewees
● Communication between the CMMI Appraisers & Illumina staff was extremely cooperative and clear
● Invested a lot of time to refine the list of interviewees- Require practitioners, not process owners- Ensure that the right level of participation was achieved
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Next Steps
1. Define CMMI Performance Metrics
2. Define glidepath to maturity based on appraisal results - Refine Estimation practice area
3. Determine next practice areas for maturity appraisal- Improvements (“PDCA” based) initiated- Extend to other sites?- CMMI Appraiser Training SD (Feb 26 - Mar 1st)
4. Scheduled first MDDAP quarterly check-Feedback from lead assessor positive
Reflections on Illumina’s MDDAP/VIP Appraisal�Case for Quality (CfQ) Pilot Program November 12-16, 2018Why participate in the CfQ VIP pilot?Slide Number 3Illumina CfQ VIP Pilot Appraisal Preparation�Illumina CfQ VIP Pilot Appraisal ScopeIllumina CfQ VIP Pilot Appraisal �Process�Slide Number 8Illumina Design Transfer Maturity IndexIllumina Design Transfer Maturity Index (DTMI)�Capability Maturity LevelsIllumina’s MDDAP/VIP Appraisal Reflections�Feedback & LearningsNext Steps��