Dr. Katherine Bond, Director , Office of Strategy, Partnerships and Analytics, FDA
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Transcript of Dr. Katherine Bond, Director , Office of Strategy, Partnerships and Analytics, FDA
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 preparedprepared for a regulatory environment in which FDA-regulated products know no borders.”
FDA global engagement reportApril 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
30 Application Programming Interface (API) Handshakes
15 Relationships
Achieving this goal by using current standard IT Accepted API security protocols can quickly become mathematically impossible
12 Organizations
132 Application Programming Interface (API) Handshakes
66 Relationships
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
Mike Taylor 2012 Partnership for Food Protection
“ The challenge of the integrated Food Safety System is gluing the pieces of the puzzle together”.
Joe Corby 2013 Food Safety Summit
“ We are building the Food Safety System one piece of the puzzle at a time”.
The Puzzle Analogy
Ownership of the puzzle pieces, politics, funding allocation and turf issues are significant challenges to all aspects of an integrated Food Safety System….
Stakeholders not all on the same page
FSMA and IFSS focus on developing a systems based, integrated, collaborative approach.
Currently are focused on individual pieces of information sharing without looking at the big “fully integrated” picture
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?
While it easy for public and private organizations to be focused on their respective piece of the puzzle……
Developing an Information Sharing Framework For All Stakeholders
Secure Interoperability, with scalable and measured global performance are keys to success
GovernmentInternationalOrganizations
AcademicsInstitutes & Associations
Industry
• 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?
Developing an Information Sharing Framework For All Stakeholders
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
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 waysGet the right information to the right person at the right time.
What is a CCCET Framework?
Developing CCCET based Information Sharing Framework to Comply with FSMA
Entity/People/Activity Unique Identifiers &
Aliases
Organizations, AgenciesIndividuals
Roles, FunctionsProducts, Supply Chains
Credentials, Certifications, Education, Training,
Audits, Accreditation
•
Security at individual level
Entity/People/Activity Relationships &
Connections
Leverage Community of SME’s to Build Relationships
Of Disparate Systems(Crowd Sourcing)
•
Data DiscoveryValue propositions
Entity/People Associated Activity
Performance Measures
Discover and aggregate existing/new metrics from all sources to tell the story
•
Outcomes based Performance
Reporting FSMA, NIPPPPD-8, HSPD-9
Tools of the CCCET Framework
Registry of Entities & Data
Relationship of Entities & Data
Presentation of Performance
Entity/People/Activity Unique Identifiers & Aliases
Entity/People/Activity Relationships & Connections
Entity/People Associated Activity Performance Measures
• 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 needsactivity/process, role/function, agency/organization,
industry/commodity, tool/program/app, workgroup, project, committee and law,/regulation/requirement
Who Has Food Safety Credentials?
FDA
NEHAFSCR
6 Organizations
12 API Programmed Handshakes
15 Relationships
6 Organizations15 Relationships12 API programing
Who Has Food Safety Training and Certificates associated with these Credential Holders?
FDA
NEHAFSCR
IFPTI
6 Organizations15 Relationships12 API programing
What are the roles, agencies and contact information associated with these individuals?
FDA
NEHAFSCR
IFPTI
NCFPDCoreSHIELD
FDA
Who Else Has NEHA worked with on Food Safety Credentials In Credential Registry
NEHAFSCR
NEHAFSCR- Org 1
NEHAFSCR- Org 2
NEHAFSCR- Org 3
15 Organizations69 Relationships
24 API Programmed Handshakes
3 Trusted Enterprise Relationships
IFPTI
NCFPDCoreSHIELD
NEHAFSCR- Org 4
NEHAFSCR- Org 5
NEHAFSCR- Org 6
FDA
Who Else Besides NEHA have Food Safety Credentials?
NEHAFSCR
NEHAFSCR- Org 1
NEHAFSCR- Org 2
NEHAFSCR- Org 3
IFPTI
NEHAFSCR- Org 5
NEHAFSCR- Org 6
NEHAFSCR- Org 4
NCFPDCoreSHIELD
15 Organizations69 Relationships
24 API Programmed Handshakes
3 Trusted Enterprise Relationships
FDA
NEHAFSCR
NEHAFSCR- Org 1
NEHAFSCR- Org 3
IFPTI
NEHAFSCR- Org 4 NEHA
FSCR- Org 5
NEHAFSCR- Org 6
Who Else Has Food Safety Credentials Declared but not validated?
NEHAFSCR- Org 2
NCFPDCoreSHIELD
15 Organizations69 Relationships
24 API Programmed Handshakes
3 Trusted Enterprise Relationships
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
FSMA reporting
National Outcomes
NIPP dashboard
SCOREcard CCCET Panel Environment
Picture worth a thousand words
IFPTI Training Database
• 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)
Through this improved:
Communication, Coordination, Collaboration, Education & Training
The Food and Agriculture Sector will be CCCET
In SummaryThis 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.