mdic 1 george serafin deloitte & touche llp mdic open forum quality system maturity model update
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MDIC1
George SerafinDeloitte & Touche LLP
MDIC Open Forum
Quality System Maturity Model Update
MDIC2
Quality System Maturity Model Project Team
Team Members Company
Pat Baird Baxter
Jodie Bastian Stryker
Sarah Deegan Johnson & Johnson
Jeff Fecho (AdvaMed Rep) St. Jude Medical
Bob Kenney Veeva
Bill Murray (Co-Lead) MDIC
Nick Premnath Deloitte
Tim Rew Terumo
Nicole Schumacher Deloitte
George Serafin (Co-Lead) Deloitte
Jason Spiegler (ASQ Rep) Camstar
Dan Torrens CMMI
Francisco Vicenty FDA
Rusty Young CMMI
MDIC3
Background / Objective: Quality System Maturity Model
Background
In May 2015, MDIC presented research on current Maturity Models established across various industries and provided recommendations regarding how specific options can be adopted by MDIC stakeholders including, but not limited to, industry members and the Food & Drug Administration.
Objective
As a result of this research, a quality maturity model work stream was formed to develop and implement a Quality System Maturity Model based on the Capability Maturity Model Integration (CMMI) for the medical device industry that is focused on promoting product quality and patient safety.
MDIC4
Key milestones and overall project timelineJuly2015
August2015
September2015
October 2015
November 2015
December 2015
January 2016
February2016
March 2016
Timeline
CMMI Pilot Development
Connect with Measures Team
Maturity Model Development
Conduct Pilot
Develop Pilot Strategy and Approach
Identify pilot participants
Present pilot plan at CfQ Forum
Kick-off pilot
Complete pilot
Selection of process areas
Adapt CMMI process framework
Present adapted CMMI Model at CfQ Forum
Selected pilot process areas built out
CMMI alignment and identify gaps/enhancements
Develop plans and on-board pilot participants
Define Maturity levels
Approach
MDIC6
Our approach focuses on adapting the CMMI process framework to medical devices then developing content for the selected process areas.
Approach for adapting CMMI process framework for Medical Devices
CMMI Process Framework
Alignment to QSR / ISO
Identify Gaps
Fill in Gaps / Enhance
Leverage and combine CMMI process frameworks for Development, Acquisition, and Service constellations to create a process framework for medical devices
Align combined CMMI process framework to QSR and ISO 13485
Conduct gap analysis and identify any missing elements in the process framework
Address identified gaps and enhance process framework; define maturity levels
MDIC7
The CMMI Framework approximately maps to 80% of Quality System Regulations and ISO 13485 requirements
Mapping of CMMI Process Framework
30%
40%
20%
50%
10%
80%
90%
60%
100%
CMMI Model
Medical Device Profile
70%
Quality Policy & Practice
All three standards align to the following:• Management oversight
• Establishment of organizational standards & practices
• Monitoring & control
• Training
Medical Device Requirements
Both FDA & ISO incorporate requirements specific to Medical Devices which CMMI does not
Risk Management
FDA and ISO are aligned, but address risk management in separate standards focused on patient impact
CMMI focuses only on project risk
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MDIC8
CMMI, ISO and the QSR all incorporate risk differently, with different emphasis. Risk Management is an area where further alignment will be needed.
Risk Management
CMMIProject Risk
ISO 14971Medical Device Risk
FDA GuidanceICH Q9
CMMIRisk management framework
is project-centric
ISO 14971
Medical Devices
FDA addresses risk for medical devices mainly through guidance documents. It also references ISO 14971
Risk Management
ISO addresses risk for medical devices in a separate standard
Level Definitions and Process Area Selection
MDIC10
Maturity Indicator Levels:
Maturity Indicator Levels were defined based on the following areas:
• Processes and Procedures
• IT Systems & Information Management
• Organization
• Governance
• Culture
Maturity Indicator Level Definitions
• Monitoring and Auditing
• Reporting
• Communications and Training
• Risk Management
Maturity indicator levels (MILs) for the Quality System Maturity model are aligned to the CMMI MILs
Level 2Managed
Level 3Defined
Level 4Quantitatively
Managing
Level 5Optimizing
Level 1 Initial
MDIC11
Maturity Indicator Levels - Characterizations
Maturity Indicator Levels (MILs)
Level 1 Initial
Level 2Managed
Level 3Defined
Level 4Quantitatively
Managing
Level 5Optimizing
• 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
• Inconsistent problem resolution
• 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/semi-quantitative
• 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/proactive
• Complete toolbox
• Implementation of methodologies (e.g. Lean/Six-Sigma)
• Proactive Analytics
• Analytics-based quantitative reporting
• Proactive management involvement
• Strategic preventative action
• 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
MDIC12
Selection of focused process area for the pilot study will be based on the following criteria
Process Area Selection for Pilot Study
Ease of Implementation
Process area should be narrow in scope and could easily be implemented in a pilot study
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.
Value to Business
Process area should be of value from a business perspective
Well Defined
Process area should be holistic in terms of people, process, and technology.
Impact on Product Quality
Process area should have a significant impact on patient safety and product quality.
Next Steps
MDIC14
Next Steps – Pilot Study
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
In addition to building out the selected process areas for the pilot, planning for the pilot study will the focus for the next quarter.
Questions?