Dr. Katherine Bond, Director, Office of Strategy, Partnerships
and Analytics, FDA
“Over the next decade FDA will continue to transform
from a predominately domestically focused agency operating
in a globalized economy to an Agency fully prepared
prepared for a regulatory environment in which FDA-
regulated products know no borders.”
FDA global engagement report
April 2012
Four pillars
• Partner with foreign counterparts to create global
coalitions of regulators to insure and improve global
product safety
• Build global data information systems and networks
and proactively share data with peers
• Expand intelligence gathering with an increase focus on
risk analytics and thoroughly modernized IT capabilities
• Effectively allocate agency resources based on risk
leveraging the combined efforts of government
industry and public and private third parties
Four pillars
• Partner with foreign counterparts to create global
coalitions of regulators to insure and improve global
product safety
• Build global data information systems and networks
and proactively share data with peers
• Expand intelligence gathering with an increase focus on
risk analytics and thoroughly modernized IT capabilities
• Effectively allocate agency resources based on risk
leveraging the combined efforts of government
industry and public and private third parties
6 Organizations
15 Relationships
30 Application
Programming
Interface (API)
Handshakes
Achieving this goal by using current standard IT Accepted API
security protocols can quickly become mathematically impossible
12 Organizations
66 Relationships
132 Application
Programming
Interface (API)
Handshakes
We Need New Connectivity Tools For
A Global Solution
• Even 12 Organizational databases connected in prior
example becomes almost unmanageable for IT support
• There is no discoverability in model to avoid redundancy of
data entry and duplication of systems
• There is no ability to perform gap analysis and provide
efficient coordination of all stakeholders
• There is no coordinated access by all participating databases
leaving exposure to security breaches that can’t be seen by
all participants
The Puzzle Analogy
Joe Corby 2013 Food Safety Summit
“ We are building the Food Safety System
one piece of the puzzle at a time”.
Mike Taylor 2012
Partnership for Food Protection
“ The challenge of the integrated Food Safety System is
gluing the pieces of the puzzle together”.
Stakeholders not all on the same page
Ownership of the puzzle pieces, politics, funding allocation and
turf issues are significant challenges to all aspects of an
integrated Food Safety System….
Currently are focused on individual pieces of information
sharing without looking at the big “fully integrated” picture
FSMA and IFSS focus on developing a systems based, integrated,
collaborative approach.
While it easy for public and private organizations to be
focused on their respective piece of the puzzle……
It is critical to know what it will look like when we get there.
• What is the glue that Mike Taylor references?
• What secures it and holds it together?
• How do all the pieces interact?
Developing an Information Sharing
Framework For All Stakeholders
Government
International
Organizations
Academics
Institutes &
Associations
Industry
Secure Interoperability, with scalable and measured
global performance are keys to success
Developing an Information Sharing
Framework For All Stakeholders
• How do we ensure Industry engagement?
• What is the big global picture we are striving for?
• What is the glue to the integrated puzzle?
• What is the WIIFM for all stakeholders?
• What are the definitions for understanding and equivalency?
• How do we achieve interoperability with appropriate security?
• How do we measure success?
Stakeholders must get CCCET (pronounced “set”)
Getting CCCET is applying specific strategies and
solutions that enable standardized, secure and
measurable Communication, Coordination,
Collaboration, Education and Training
Being
• Don’t just say, “we communicated, coordinated or
collaborated.”
– Being CCCET means you have utilized strategies to
ensure the right people were targeted and engaged and
that appropriate feedback mechanisms are in place.
• Don’t just say, “we educated and trained.”
– Being CCCET means not only were the right people
engaged but, you have a strategy to rapidly retrieve who
has this skillset for emergency response.
Being
• Searchable, secure Information sharing vs spam (discoverable)
• Aligned and targeted roles, functions, capability based
information sharing vs titles, program names (applicable)
• Taxonomy indexed/mapped terms vs market basket terminology
(equivalent)
• Sharable, maintained, community based and current
knowledgebase vs key individual and no succession planning.
(participative wiki like vs personal files)
• Integrated, consolidated interpretive metrics mapped to outcomes
vs stand alone metrics and data capture
What is a CCCET Framework?
A CCCET Framework employs standards and tools that engage CCCET
strategies and solutions. This framework helps connect disparate systems
to facilitate effective, interoperable information sharing between you and
partner organizations
Enter data once, use many ways
Get the right information to the right person at the right time.
Developing CCCET based Information
Sharing Framework to Comply with FSMA
Entity/People/Activity
Unique Identifiers &
Aliases
Entity/People/Activity
Relationships &
Connections
Organizations, Agencies
Individuals
Roles, Functions
Products, Supply Chains
Credentials, Certifications,
Education, Training,
Audits, Accreditation
Leverage Community of
SME’s to Build Relationships
Of Disparate Systems
(Crowd Sourcing)
Discover and aggregate
existing/new metrics from
all sources to tell the story
•
•
Data Discovery
Value propositions
Outcomes based
Performance
Reporting FSMA, NIPP
PPD-8, HSPD-9
•
Security at individual level
Entity/People
Associated Activity
Performance
Measures
Tools of the CCCET Framework
Entity/People/Activity
Unique Identifiers & Aliases
Entity/People Associated Activity
Performance Measures
Registry of Entities & Data
Presentation of Performance
Relationship of Entities & Data
Entity/People/Activity
Relationships & Connections
• Uses Wiki like pages to hold, organize and align data to be shared
• Wiki approach allows community to provide resources to data
index and meta-tag alignment of who, what, where, how, what,
why within a common framework.
• Wikis employ CCCET strategies to organize data
• CCCET –wiki pages are templated to specific informational needs
activity/process, role/function, agency/organization,
industry/commodity, tool/program/app, workgroup, project,
committee and law,/regulation/requirement
Who Has Food Safety Credentials?
6 Organizations
FDA
15 Relationships
12 API Programmed
Handshakes
NEHA
FSCR
Who Has Food Safety Training and Certificates
associated with these Credential Holders?
6 Organizations
15 Relationships
12 API programing
FDA
IFPTI
NEHA
FSCR
What are the roles, agencies and contact information
associated with these individuals?
6 Organizations
15 Relationships
12 API programing
FDA
IFPTI
NCFPD
CoreSHIELD
NEHA
FSCR
Who Else Has NEHA worked with on Food Safety Credentials
In Credential Registry
15 Organizations
69 Relationships
NEHA
NEHA
FSCR- Org 1
FSCR- Org 2
FDA
24 API Programmed
Handshakes
3 Trusted Enterprise
Relationships
IFPTI
NEHA
FSCR- Org 3
NCFPD
CoreSHIELD
NEHA
FSCR
NEHA
FSCR- Org 4
NEHA
FSCR- Org 5
NEHA
FSCR- Org 6
Who Else Besides NEHA have Food Safety Credentials?
15 Organizations
69 Relationships
NEHA
NEHA
FSCR- Org 1
FSCR- Org 2
FDA
24 API Programmed
Handshakes
3 Trusted Enterprise
Relationships
IFPTI
NEHA
FSCR- Org 3
NCFPD
CoreSHIELD
NEHA
FSCR
NEHA
FSCR- Org 4
NEHA
FSCR- Org 5
NEHA
FSCR- Org 6
Who Else Has Food Safety Credentials Declared but not validated?
15 Organizations
69 Relationships
NEHA
NEHA
FSCR- Org 1
FSCR- Org 2
FDA
24 API Programmed
Handshakes
3 Trusted Enterprise
Relationships
IFPTI
NEHA
FSCR- Org 3
NCFPD
CoreSHIELD
NEHA
FSCR
NEHA
FSCR- Org 4
NEHA
FSCR- Org 5
NEHA
FSCR- Org 6
But……..
Are we actually accomplishing
anything?????
SCORECARD - Sector Critical Objectives Realized Effectiveness is a
CCCET Framework product that helps to align/collate disparate CRE and
Connect the Dots relationally based outputs into meaningful metrics.
HSPD9 reporting
PPD-8 reporting
IFPTI Training Database
FSMA reporting
National Outcomes
NIPP dashboard
SCOREcard
CCCET Panel Environment
Picture worth a thousand words
• A SCOREcard is a compilation of activities aligned under
Goals/Objectives.
• Other Scorecards can use same activities for different
Outcome reporting
• Activities are discoverable within the CCCET Framework
search engine for association to other related
measurements.
• Activities can be compiled, aggregated and summarized
from local to state to federal or within organizations
• Uses Activity/Process CCCET Wiki pages to hold, organize and align
activity data to be shared
• Scorecard forces all Activities to define “What’s Good and What’s
Bad” on simple 1-5 color coded scale
• Enables ability to stack and aggregate and associate activity based
metrics/measurements mapped to these CCCET wikis
• Enables additional attributes (goals, tasks, subjective
measurements) to also be gathered and tracked for seeing
measured progress
Other SCOREcard Inputs to Tell the Story
FSMA Sec.108 Implementation
CIFOR Implementation
ISO 17025 Implementation
Food Code Adoption
Recall Effectiveness
3rd Party Auditor Engagement
(FSMA Sec. 307 Implementation)
In Summary
This Food and Agriculture Sector Information Sharing Environment (ISE)
facilitates development and implementation of best practices while
enhancing gap analysis, emergency response capability, and sector metrics.
Through this improved:
Communication,
Coordination,
Collaboration,
Education &
Training
The Food and Agriculture Sector will be
CCCET