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

Pe

rce

nt

Ali

gn

me

nt

to Q

SR

an

d I

SO

13

48

5

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?