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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)
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
Copenhagen, October 7, 2019
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)• ….
Copenhagen, October 7, 2019
Users:industry, service
providers, regulators, NGO’s etc.
Copenhagen, October 7, 2019
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
Copenhagen, October 7, 2019
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
Copenhagen, October 7, 2019
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).
Copenhagen, October 7, 2019
Project Phase and Gate-specific guidance
Copenhagen, October 7, 2019
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
Ideation Scoping Business case R&D Testing &
ValidationReview &
LaunchPortfolio
Monitoring
Gate 7
ProjectPhase 1
ProjectPhase 2
ProjectPhase 3
ProjectPhase 4
ProjectPhase 5
ProjectPhase 6
ProjectPhase 7
Development projects
Copenhagen, October 7, 2019
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
Ideation Scoping Business case R&D Testing &
ValidationReview &
LaunchPortfolio
Monitoring
Gate 7
ProjectPhase 1
ProjectPhase 2
ProjectPhase 3
ProjectPhase 4
ProjectPhase 5
ProjectPhase 6
ProjectPhase 7
Health, safety, societal-related projects
Copenhagen, October 7, 2019
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!
Copenhagen, October 7, 2019
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
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
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
Copenhagen, October 7, 2019
§ 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]
Copenhagen, October 7, 2019
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.
Copenhagen, October 7, 2019
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 &
LaunchPortfolio
Monitoring
Gate 7
ProjectPhase 1
ProjectPhase 2
ProjectPhase 3
ProjectPhase 4
ProjectPhase 5
ProjectPhase 6
ProjectPhase 7
Copenhagen, October 7, 2019
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