MDIC Case for Quality Forum Quality System Maturity Model Update

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Lorraine Franklin
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1 Case for Quality Forum Quality System Maturity Model Update George Serafin Deloitte & Touche LLP 1

2 Quality System Maturity Model Project Team Team Members Company Pat Baird Baxter Jodie Bastian Stryker Sarah Deegan Johnson & Johnson Jeff Fecho (AdvaMed Representative) St. Jude Medical Bob Kenney Veeva Bill Murray (Co-Lead, Acting) Nick Premnath Deloitte Tim Rew Terumo Nicole Schumacher Deloitte George Serafin (Co-Lead) Deloitte Jason Spiegler (ASQ Representative) Camstar Dan Torrens CMMI Cisco Vicenty FDA Rusty Young CMMI 2

Jude Medical Bob Kenney Veeva Bill Murray (Co-Lead, Acting) Nick Premnath Deloitte Tim Rew Terumo Nicole

3 Status Report: Quality System Maturity Model 8 Sep 2015 Milestones / Deliverable Key Deliverables / Milestones Due Date Percent Complete Charter Development 4 Jun % Status G Upcoming Activities Activity Target Date Present updates at CfQ Forum 08 Sep 15 Adapt CMMI process framework 24 Sep 15 Develop Pilot Strategy and Approach 24 Jul % G Issues/Risks Actions Adapt CMMI model and define maturity levels Present updates at CfQ Forum 24 Sep % 8 Sep % G G Timeline for updating CMMI framework is aggressive Continuously monitor progress and will work with CMMI to adapt the framework Selected pilot process areas built out 8 Dec 15 0% Identify pilot participants 8 Dec 15 0% Present Pilot Plan at CfQ Forum 8 Dec 15 0% Kickoff Pilot 11 Jan 16 0 % Complete Pilot 31 Mar 16 0 % Results / Accomplishments 3 Conducted ISO / CFR alignment Conducted gap assessment for QSR and ISO Developed construct for maturity levels Held meeting with CMMI Institute to review gap analysis of CMMI model C = Complete G = On Time Y = At Risk R = Late

define maturity levels Present updates at CfQ Forum 24 Sep 15 100% 8 Sep 15 100% G G Timeline for updating CMMI framework is aggressive Continuously monitor progress and will work with CMMI to adapt

4 Key milestones and overall project timeline July 2015 August 2015 September 2015 October 2015 November 2015 December 2015 January 2016 February 2016 March 2016 Maturity Model Development Develop Pilot Strategy and Approach Connect with Measures Team Define Maturity levels CMMI alignment and identify gaps/enhancements Adapt CMMI process framework Timeline Present adapted CMMI Model at CfQ Forum Selection of process areas CMMI Pilot Development Selected pilot process areas built out Identify pilot participants Present pilot plan at CfQ Forum Develop plans and on-board pilot participants Conduct Pilot Kick-off pilot Complete pilot 4

Adapt CMMI process framework Timeline Present adapted CMMI Model at CfQ Forum Selection of process areas CMMI Pilot Development Selected pilot process areas

5 Approach

6 Approach for adapting CMMI process framework for Medical Devices Our approach focuses on adapting the CMMI process framework to medical devices then developing content for the selected process areas. Fill in Gaps / Enhance Identify Gaps Address identified gaps and enhance process framework; define maturity levels Alignment to QSR / ISO Conduct gap analysis and identify any missing elements in the process framework CMMI Process Framework Align combined CMMI process framework to QSR and ISO Leverage and combine CMMI process frameworks for Development, Acquisition, and Service constellations to create a process framework for medical devices 6

Fill in Gaps / Enhance Identify Gaps Address identified gaps and enhance process framework; define maturity levels Alignment to QSR / ISO Conduct gap analysis and

7 Mapping of CMMI Process Framework The CMMI Framework approximately maps to 80% of Quality System Regulations and ISO requirements Quality Policy & Practice Medical Device Requirements Risk Management All three standards align to the following: Management oversight Establishment of organizational standards & practices Monitoring & control Training Both FDA & ISO incorporate requirements specific to Medical Devices which CMMI does not FDA and ISO are aligned, but address risk management in separate standards focused on patient impact Percent Alignment to QSR and ISO % 90% 80% 70% 60% 50% 40% 30% 20% 10% Medical Device Profile CMMI Model CMMI focuses only on project risk 7

control Training Both FDA & ISO incorporate requirements specific to Medical Devices which CMMI does not FDA and ISO are aligned, but address risk management in separate

8 Risk Management CMMI, ISO and the QSR all incorporate risk differently, with different emphasis. Risk Management is an area where further alignment will be needed. CMMI Risk management framework is project-centric CMMI Project Risk Risk Management ISO ISO addresses risk for medical devices in a separate standard ISO Medical Device Risk FDA Guidance ICH Q9 Medical Devices FDA addresses risk for medical devices mainly through guidance documents. It also references ISO

CMMI Risk management framework is project-centric CMMI Project Risk Risk Management ISO 14971 ISO addresses risk for

9 Level Definitions and Process Area Selection

10 Maturity Indicator Level Definitions Maturity indicator levels (MILs) for the Quality System Maturity model are aligned to the CMMI MILs Maturity Indicator Levels: Level 1 Initial Level 2 Managed Level 3 Defined Level 4 Quantitatively Managing Level 5 Optimizing Maturity Indicator Levels were defined based on the following areas: Processes and Procedures IT Systems & Information Management Organization Governance Culture Monitoring and Auditing Reporting Communications and Training Risk Management 10

Optimizing Maturity Indicator Levels were defined based on the following areas: Processes and Procedures IT Systems &

11 Maturity Indicator Levels - Characterizations Maturity Indicator Levels (MILs) Level 1 Initial Level 2 Managed Level 3 Defined Level 4 Quantitatively Managing Level 5 Optimizing Inconsistent application & results Project or unit specific Execution dependent on individuals No formal training program Sporadic or non-existent Qualitative No RM framework Sporadic or non-existent Qualitative No RM framework Focus on testing & meeting specs Lagging metrics Ad hoc reporting No management review Inconsistent problem resolution Defined locally Governance structure Improved application & results Enforcement inconsistent Developed of SMEs or project teams Selective training Formal risk methodologies applied Project/unit specific No RM Framework Often pro-forma Lagging metrics Internally focused QA/compliance driven Reporting internal to local units Limited or ad hoc Management Review Defined & consistent for regulated activities Consistent inputs/outputs Quality by Design Formal training program by roles & responsibilities Beginning RM framework Risk integrated into processes Quantitative/semiquantitative Well-defined toolbox & procedures Analytics Two-way communication with management Improved problem resolution Processes defined & institutionalized Consistently applied with consistent results Automation Formal training syllabi by roles & responsibilities Active tracking & reporting RM framework institutionalized Risk fully integrated & specialized to processes Quantitative/predictive/proa ctive Complete toolbox Implementation of methodologies (e.g. Lean/Six-Sigma) Proactive Analytics Analytics-based quantitative reporting Integrated Automation Fully life cycle management framework Change management Centers of excellence Fully trained, highly skilled Focus on professional & personal development Predictive risk used strategically Drives business opportunities Patient focus Analytics driven, predictive Incorporate business metrics Cost of Quality Continuous Improvement Inconsistent problem resolution Proactive management involvement Strategic preventative action 11

No RM framework Focus on testing & meeting specs Lagging metrics Ad hoc reporting No management review Inconsistent problem resolution Defined locally Governance structure Improved application &

12 Process Area Selection for Pilot Study Selection of focused process area for the pilot study will be based on the following criteria Value to Business Process area should be of value from a business perspective Impact on Product Quality Process area should have a significant impact on patient safety and product quality. Well Defined Process area should be holistic in terms of people, process, and technology. Size Agnostic Process area should be relevant to small, medium, and large organizations Alignment to Metrics Team Process area should align with the Metrics and Measures work stream. Ease of Implementation Process area should be narrow in scope and could easily be implemented in a pilot study 12

Well Defined Process area should be holistic in terms of people, process, and technology.

13 Next Steps

14 Next Steps Pilot Study In addition to building out the selected process areas for the pilot, planning for the pilot study will the focus for the next quarter. Pilot Study Develop 1-2 process areas (process areas will be determined based off of selection criteria) Identify at least 3 companies that will participate in pilot study FDA will shadow pilot assessment to gain an understanding of how maturity is assessed Next Steps Process Area Model Development Company Identification Execution Identification of potential process areas Analysis and selection of 1-2 process area Incorporate measures work stream output into maturity model Determine resources required Frame out incentives Reach out to companies to determine interest in pilot study Selection of at least 3 companies Develop execution plan / schedule for assessors and FDA members Perform maturity model assessment 14

assessment to gain an understanding of how maturity is assessed Next Steps Process Area Model Development Company Identification Execution Identification of potential process areas Analysis and

15 Questions?

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