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.