4. Jensen Nano-Risk Innovation Governance Framework and .... Jensen... · Schematic structure of the portfolio, programme, and project governance relationships in an organizational

Copenhagen, October 7, 2019Project #686239, Funded by the Horizon 2020 Framework Programme of the European Union

The Phase-Gate Nano-Risk Innovation Governance Framework

and Guidance Professor Keld Alstrup Jensen, Ph.D., M.Sc.

[email protected] written contributions by

Khara Grieger (NCSU, USA)

mailto:[email protected]

Copenhagen, October 7, 2019

Design of Overall Work Progress

Sensitivity analysisand performance testing

Refinement and next generation methods

Stakeholder consultationInterviews and surveys

Sensitivity, calibration, Performance assessment

Operational database and structure development

Filling data gaps and new case studies

Aligning with stakeholders

Model developmentand testing Database development

User testingof models

Framework development

Conceptual frameworkdevelopment

Alignment with Cooper Stage Gate® and

stakeholder needs

Final comprehensivedatabases

Primary testdatabases

Demonstration usingdatabase case studies

Implementation and stakeholder training

Development of guidance Documents

&

Collecting modelsCollecting of existing data

Year

1

2

3

3.5

Integration into the NRG Portal


Some requirements to the portal and nano-riskinnovation governance framework (WP1,4,7,8)• Access to nano-information• Based on state-of-the-art knowledge • Allowing for human and environmental exposure, hazard, and risk

characterization considering different exposure and release scenarios• Qualified for and aligned with existing regulatory frameworks• Considering existing and future generations of NMs• Flexible and easy to use for a wide range of specialists • Managing confidential issues regarding proprietary data• Documented (e.g. algorithms and parameters that influence the results and

decisions of the system)• Ensuring principles of reliability, effectiveness and efficiency, transparency and

open access, long-term sustainability • Linked to exhaustive databases/libraries (e.g. nanomaterials properties)• ….


Users:industry, service

providers, regulators, NGO’s etc.


The Nano-Risk Innovation Governance Framework and Project Management Design§ A two-layer structure with: 1) A governance layer - an accountable governance board

established to manage the governance project and make “go”, “rework” or “stop” decisions of the project layer results and answers.

2) An operational project layer - specific governance sub-projects are established to generate and provide all the knowledge, data and documentation needed to develop and launch the innovation and answer to questions raised by the governance board.

Reflects structure in e.g., ISO 21505:2017


Conceptual Nano-Risk Innovation GovernanceFramework and Project Management Design

• Run projects• Get knowledge• Assess

knowledge• Report• Answer questions

Project leader

Portfolio Governance

Phase-Gate Nano-Risk Innovation Governance Board

MonitoringScreen

Ideascreen

Gate 1

Scopingscreen

Gate 2

Business-casescreen

Gate 3

R&Dscreen

Gate 4

Validationscreen

Gate 5

LaunchScreen

Gate 6

Ideation Scoping Business case R&D Testing &

ValidationReview & Launch

Portfolio Monitoring

Gate 7

ProjectPhase 1

ProjectPhase 2

ProjectPhase 3

ProjectPhase 4

ProjectPhase 5

ProjectPhase 6

ProjectPhase 7

Phase-Gate Nano-Risk Innovation Governance Sub-Project Leaders

Proj

ect 1

Proj

ect 2

Proj

ect 3

Proj

ect 4

Proj

ect 5

Proj

ect …

.

Proj

ect .

…

Proj

ect …

.

Proj

ect …

.

?

Proj

ect .

…

Proj

ect .

…

Mon

itorin

gpr

ojec

ts

• Define criteria• Set projects• Set questions• Score answers• Decide ?

Answ

ers

Que

stio

ns


Adaptability and Flexibility

§ The user defines– Which innovation project phases and gates they need for

their specific project.– The specific projects needed to address the innovation

governance project.– Decides and select which methods and tools they wish to use

to gather and generate the information.needed for theirinnovation governance assessments. It is the result that countsand will be scored.

– the type of answer / result scoring of sub-project and innovaiton governance project quesitons (e.g., yes, no, maybe and/or scaling).


Project Phase and Gate-specific guidance


Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 Phase 7

Idea description XBrainstorming events X XTechnical NM or NM-product description X X X X XInternal stakeholder event and dialogue X X X XExternal stakeholder event and dialogue X X X X XNanomaterial and -product characteristics X XFinancial cost-benefit X X X XInsurance aspects X X X XMarketing and production X (plan) X (plan) X….Documentation X X X X X X X

MonitoringScreen

Ideascreen

Gate 1

Scopingscreen

Gate 2

Business-casescreen

Gate 3

R&Dscreen

Gate 4

Validationscreen

Gate 5

LaunchScreen

Gate 6


ValidationReview &

LaunchPortfolio

Monitoring

Gate 7

ProjectPhase 1

ProjectPhase 2

ProjectPhase 3

ProjectPhase 4

ProjectPhase 5

ProjectPhase 6

ProjectPhase 7

Development projects


Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 Phase 7

Technical data sheet development X X X XCollecting existing health and safety data X X X XSafety Data Sheet development X XOccupational RA Pre-RA Pre-RA Pre-RA Pre-RA X X XConsumer RA Pre-RA Pre-RA Pre-RA Pre-RA X X XEnvironmental RA Pre-RA Pre-RA Pre-RA Pre-RA X X XSbD STOP analysis and testing X X X X X XIntern. safety comm., training/instruction X X X XExt. safety comm., training and instructions X X X XRegulatory compliance X X X XSocietal and ethical impact assessment X X X XDocumentation X X X X X X X

MonitoringScreen

Ideascreen

Gate 1

Scopingscreen

Gate 2

Business-casescreen

Gate 3

R&Dscreen

Gate 4

Validationscreen

Gate 5

LaunchScreen

Gate 6


ValidationReview &

LaunchPortfolio

Monitoring

Gate 7

ProjectPhase 1

ProjectPhase 2

ProjectPhase 3

ProjectPhase 4

ProjectPhase 5

ProjectPhase 6

ProjectPhase 7

Health, safety, societal-related projects


Information gathering

Perform Occupational

pre-RA

Perform Downstream User pre-RA

Perform Environmental

pre-RA

Define risk of fire explosion

Document and review

Start

Information gathering

Perform Occupational

pre-RA

Perform Downstream User pre-RA

Perform Environmental

pre-RA

Define risk of fire explosion

Define disposal/

ermergencyprocedures

Decide on monitoring

needs

Document and review

Training to R&D workers

Start

Early and late Pre-RA (considering all standards)

Phase 1-3 Phase 3-5

CEN/TS 16937:2016), ISO 31000:2018; ISO 31010:2009; ISO 31004: ISO:45001:2018; ISO/TS 12901-1:2012, and ISO/TR 13121:2011),

Pre-RAand innovation decision support

Pre-RAand innovation

risk management

Availability of input parameters defines

choice of tool

Final model/tool alignment and finalization of the nano-risk

assesmennt and management guidance is in preparation!


Platform projects in effect

• Run projects• Get knowledge• Assess

knowledge• Report• Answer questions

Project leader

Portfolio Governance

Phase-Gate Nano-Risk Innovation Governance Board

MonitoringScreen

Ideascreen

Gate 1

Scopingscreen

Gate 2

Business-casescreen

Gate 3

R&Dscreen

Gate 4

Validationscreen

Gate 5

LaunchScreen

Gate 6


ValidationReview & Launch

Portfolio Monitoring

Gate 7

ProjectPhase 1

ProjectPhase 2

ProjectPhase 3

ProjectPhase 4

ProjectPhase 5

ProjectPhase 6

ProjectPhase 7

Phase-Gate Nano-Risk Innovation Governance Sub-Project Leaders

Hum

an R

A

Cons

umer

RA

Envi

ronm

. RA

SDS

SbD

STO

P

Stak

ehol

der

cons

ulta

tion

Proj

ect .

…

Proj

ect …

.

Proj

ect …

.?

Proj

ect .

…

Proj

ect .

…

Mon

itorin

gpr

ojec

ts

• Define criteria• Set projects• Set questions• Score answers• Decide ?

Answ

ers

Que

stio

ns


§ Webpage: www.nanocalibrate.eu§ See also: www.researchgate.net/profile/Keld_Jensen

Thank you for your attention!www.nanocalibrate.eu

www.researchgate.net/profile/[email protected]

[email protected]

http://www.nanocalibrate.eu/

http://www.researchgate.net/profile/Keld_Jensen


Governance frameworks are well-established!

Schematic structure of the portfolio, programme, and project governance relationships in an organizational governance context (ISO 21505:2017). This Nano-Risk Innovation Governance Project framework, guidance and associated caLIBRAte NRIGP tool is designed primarily to address innovation governance of projects as highlighted in the figure.


MonitoringScreen

Ideascreen

Gate 1

Scopingscreen

Gate 2

Business-casescreen

Gate 3

R&Dscreen

Gate 4

Validationscreen

Gate 5

LaunchScreen

Gate 6


ValidationReview &

LaunchPortfolio

Monitoring

Gate 7

ProjectPhase 1

ProjectPhase 2

ProjectPhase 3

ProjectPhase 4

ProjectPhase 5

ProjectPhase 6

ProjectPhase 7


Conceptual nano-risk (innovation) governance framework

Idea screen

Gate 1

ScopingScreen

Gate 2

Go to development

Gate 3

Go to test

Gate 4

Go to Launch

Gate 5

Post-Launchreview

Gate 6

Dis

cove

ryan

d id

eas

Scop

ing

Stag

e 1

Bui

ld

busi

ness

cas

e

Res

earc

h an

d de

velo

pmen

t

Test

ing

and

Valid

atio

n

Laun

ch

Hor

izon

Sc

anni

ng/

Mon

itorin

g

Cooper Stage-Gate® Idea to launch model

Quantitative predictive / Test Data Driven

Qualitative / Semiquantitative predictive

Building and maintainence of confidence in the risk assessment for trustworthyrisk communication and governance

ERM

ERM

ERM

(E)R

M

(E)R

M

(E)R

MF