AFDO PRE-CONFERENCE WORKSHOP: TRAINING · PDF fileAFDO PRE-CONFERENCE WORKSHOP: ... -Sec. 103 Hazard analysis and risk- ... Five initial working groups have been created:

The Food Safety Preventive Control Alliance (FSPCA):A Public-Private Partnership to Assist Food Industry Compliance with the Preventive Controls regulations

Glenn BlackPurnendu C. Vasavada

Gerald Wojtala

AFDO PRE-CONFERENCE WORKSHOP:

TRAINING ESSENTIALS – ARE YOU PREPARED?

JUNE 2, 2012

FSPCA- Industry Involvement and Response

Glenn Black, Ph.D.Director of Science Operations, Food Protection

GMAChair, FSPC Executive CommitteeChair, FSPC Steering Committee

Agenda

� FSPCA Introduction and Industry involvement and Response - Glenn Black

� FSMA and FSPCA

� FSPCA – Objectives, Governance, and deliverables - P. C. Vasavada

� FSPCA- Training design and development - Gerald Wojtala

� To discuss industry involvement and response to FSMA and FSPCA

� To discuss the FSPCA – mission and objectives, governance, outcomes and deliverables and progress to so far

� To discuss main aspects of the FSPCA training and curriculum

� Summary

Objective

FSMA is historical..

� Involves creation of a new food safety system

� Broad prevention mandate and accountability

�New system of import oversight

� Emphasizes partnerships

� Emphasizes farm-to-table responsibility

�Developed through broad coalition

Main Themes of FSMA

Prevention

Inspections,

Compliance, &

Response

Import Safety

Enhanced

Partnerships

FSPCA- Industry Involvement and Response

The Alliance will solicit response:

� Through trade associations� Directly to companies of interest� Through university extension

� Very small companies

� FDA news releases and IFSH website

FSPCA- Industry Engagement

General Development Process:

� Define Working Group structure� Assign Liaison from Steering Committee

� Provide basic goals & deliverables� Allowing for WG input

� Provide references and seed material� Seek guidance from FDA

� As material is developed to ensure alignment

FSPCA- Working Group Expansion

As curriculum development progresses:� Continuing alignment

� As regulations are released

� WG expansion when needed� Training preview to select groups� Guidance development

� From basic curriculum outline & materials

FSPCA – Objectives, Governance, and deliverables

Purnendu C. Vasavada, Ph.D.FDA – ORISE Fellow

Professor Emeritus- UW River FallsCoordinator,

Food Safety Preventive Controls Alliance

Food

Safety

Preventive

Controls

Alliance

� TITLE I--IMPROVING CAPACITY TO

PREVENT FOOD SAFETY PROBLEMS

- Sec. 103 Hazard analysis and risk-

based preventive controls.

� FSMA requires compliance with

the preventive controls rule.

� Understanding and compliance

with the preventive controls rule

will require education.

FSMA and FSPCA

Hazard Analysis and Preventive Controls/

Food Safety Plans

� Each registered facility would be required to:

�Conduct a hazard evaluation to identify known or

reasonably foreseeable hazards

�Put in place controls to significantly reduce or prevent

hazards

�Monitor the controls, establish corrective actions, and

verify that the plan is working

� verification to include environmental and finished

product testing

� Undergo a hazard re-evaluation every three years

� Provide FDA with a written food safety plan and related

records during an inspection

Industry Needs Help

�How do I do a hazard analysis?

�What hazards are associated with my product?

�Are the controls in my process adequate to

control the hazards associated with my

product?

�What do I need to do that I am not already

doing?

FSPCA � What is FSPCA and Why was it established?

� Food industry, particularly small and medium

companies, may need assistance in understanding the

technical elements of regulations and compliance with

the FSMA requirements.

� FSPCA is a public-private Alliance designed to fulfill this

need.

� It was established by a grant from the FDA to the

Institute for Food Safety and Health (IFSH) at the Illinois

Institute of Technology, Bedford Park IL.

FSPCA Mission and Scope � Develop Food Safety Preventive Controls training

curriculum and modules for food industry personnel,

including a train-the-trainer module for industry food

safety personnel

� Develop delivery mechanisms for FSPC training modules

for the food industry

� Communicate to industry the scientific and technical

elements relevant to the hazard analysis and preventive

controls aspects of the Preventive Controls rule

� Help provide interpretation and guidance for assessing

food hazards and verification tools for preventive controls

for major industry sectors and educational resources for

small and medium-sized companies

FSPCA Governance and Structure

� Executive Committee-Alliance Business

� Steering Committee - key stakeholders with representation from regulatory, academia and industry trade associations.

� Subcommittees and Working Groups – subject matter experts volunteers from all 3 groups –specific food companies encouraged to join WGs.

� FSPCA Coordinator Dr. (PC) Vasavada

FSPCA Working Groups*� Volunteers from industry, academia and FDA..

Five initial working groups have been created:� Hazard Identification and Preventive Controls Curriculum

Development

� Food Categories and Representative Processing

� Allergen Management and Control

� Sanitation, Current Good Manufacturing Practices and

Environmental Monitoring

� Supply Chain and Ingredient Management

* Other WGs may be formed as necessary

FSPCA - Outcomes and Deliverables

�Training Curriculum: Development, delivery and facilitation of a standardized Food Safety Preventive Controls curriculum (with training slides).

�Technical Assistance Network: For the Food industry, with emphasis on small- and medium-sized companies.

�Hazards Guide: Commodity/industry sector-specific.

�Knowledge Gap Identification: Translation of and needs assessment for further enhancement in PC’s.

�Efficacy and impact of the FSPC Alliance programs.

Preventive Controls Education�FDA looks to the Alliance to develop a

standardized curriculum that provides the foundation for training providers who will train individuals to meet the requirements of the preventive controls regulation

�This effort is similar to those for existing preventive controls rules: seafood and juice HACCP

FSPCA-Based Standardized Curriculum*

� Hazard analysis – how to do one, where to get

information on hazards, examples of hazards associated with various foods covered by the regulation

� Preventive controls – how to identify appropriate

PCs, how to determine what parameters must be controlled and how to control them

� Monitoring – how to monitor preventive controls

� Corrective Actions – when and how to apply

� Verification – how to determine that PCs are “effectively and significantly minimizing or preventing the occurrence of identified hazards”

� Recordkeeping – types of records that document the food safety plan (and how to develop a plan)

*To be determined by FSPCA

FSPCA WG Liaisons, Chairs and Vice Chairs

WG Liaisons Chairs/Vice Chairs

Hazard Identification

and Preventive

Controls Curriculum

Development

Glenn Black (GMI)

Ben Chapman(NCSU)

Jeff Barcah

Judy Fraser Heaps

Food Categories and

Representative

Processing

Jason Wan (IIT/IFSH)

Jon Gardner (IDFA)

Kim Young (FDA)

Kurt Deibel (Heinz )

Alejandro Mazzotta

(Campbell’s)

Allergen Management

and Control

Don Schaffner

(Rutgers)

Ram Rao (USDA-NIFA)

Joseph Scimeca

(Cargill)

Sue Estes(Pepsico)

FSPCA WG Liaisons, Chairs and Vice Chairs

WG Liaiosns Chairs/Vice Chairs

Sanitation, Current

Good Manufacturing

Practices and Environmental

David Gombas (United

Fresh)

David Fairfield (NGFA)

Lee Sanders (ABA)

John Allan (AFFI)

Joe Shebuski(Cargill)

Supply Chain and

Ingredient

Management

Donna Garren (AFFI)

John Hoffman (UMN)

Kim Young(FDA)

Steve Mavity (Bumble

Bee)

Faye Feldstein

(Deloitte)

The Curriculum is Just the Beginning

� For education/training to be effective, information on hazards and preventive controls specific to foods being produced by small businesses will be needed.

�Guidance documents

�Food-type specific training modules

� Compendium of methods as a safe harbor

� Analytical methods

�Process methods

Training

Guidance Documents

FSPCA – Progress so far..� FSPCA Executive Committee and Steering

Committee established

� Subcommittees formed

� FSPCA Website launched

� Your involvement and participation is invited!

� FSPCA Working Groups established

Steering Committee

Subcommittees

Working Groups

Executive Committee

E mail: [email protected]

http://www.iit.edu/ifsh/alliance/index.shtml

Visit FSPCA Website…http://www.iit.edu/ifsh/alliance/index.shtml

www.iit.edu/ifsh

IFSH home page

Click on FSPCA

Your involvement and Input is welcome!� Join working groups

� Share subject matter expertise and

educational material (case study, forms,

charts, best practice tips, etc.)

� Let us know how you can help

� Participate/respond to survey /

questionnaire

� Sign up for the FSPCA Update

FSPCA- Training design and development

Gerald Wojtala

International Food Protection Training Institute

Battle Creek, MI.

FSPCA Steering Committee

FSPC Curriculum Design and Development WG

FSPCA training course development

�Course design and development – a scientific

process

�Audience analysis - knowledge gap and needs

assessment

�Course inventory/ catalog

�Curriculum framework

�Course design, Delivery modes

� Instructor development

� Evaluation and Certification

Curriculum Framework

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Curriculum Framework

Course Design Document

� Mission/ content area

� Target Audience and Level

� Scope, Duration

�Resource requirements

�Reference list

� Instructor/student ratio

�Practical exercise statements

�Evaluation strategy

Course Outline that covers:

Target Audience

�~200,000 firms

�Small – medium sized firms?

�What level of employee?

� Sr. management

�Regulatory Affairs Specialist

�QA /QC Managers

�Front line employees

�Regulators

�Needs Survey

Who Needs to Demonstrate the Knowledge or Skill?

Delivery Format Considerations

�Utilize best modality needed to assure most efficient transfer of knowledge and skills

� Blended training formats

� Instructor-led, Distance learning

- Webinars, computer based learning, pod casts, videoconferencing, etc.

� Case Studies

� Exercises

�Additional Resources (model plans?)

Evaluation of Training Effectiveness

� Kirkpatrick’s 4 Levels

To what degree targeted outcomes occur

To what degree participants

acquire the intended KSA,

confidence, and commitment


react favorably to the training


apply what they learned when

they are back on the job

Type of AssessmentLevel 3 – how do measure if learning took place?

�Will be based on analysis considerations and could include:

�Pre & post tests

�Instructor observation

�Focus groups

�Interviews

�Skill demonstration

�Written plan

�Other appropriate methods

Training Support Package

�Instructor guide/ lesson plan

�Participant manual

�Audio/ visual materials

�Special support materials

�Comprehensive Hazards Guide

Train the Trainer

• Instructor Quality

• Instructor Management

• Instructor Selection

Instructors

� Universities/ extension and outreach

� Industry/ trade associations

� Private providers/ consultants

� In-house

� Agencies/ regulators

� International

Where will we find acceptable instructors and

do we need to incentivize them?

Your Input is invited !

� Join working groups

� Share subject matter expertise

� Participate in surveys and pilot training programs

(when organized) .

contact us at [email protected]

Summary� FSMA focus on assuring food safety through Hazard Analysis

and Risk-Based Preventive Controls (section 103).

� Recognized need to assist small- and medium-sized businesses with interpretation of the regulation, training and technical information to be compliant with the FSMA regulations

� FSPCA is an alliance of key stakeholders from academia, government, trade Associations, and other relevant organizations designed to assist the industry, especially small-and medium-sized businesses, in complying with the Preventive Controls regulations.

� FSPCA will serve the industry needs by developing standardized training and technical resources and providing a link between the FDA and food companies in communication of technical elements of FSMA

� The FSPCA welcomes your comments and suggestions

Acknowledgement� IFPTI and AFDO

� Dr. Bob Brackett (IFSH), Dr. Jenny Scott(FDA), Dr. John Larkin (FDA), and the FSPCA Steering Committee

For further information and questions -

Contact: [email protected]

Visit http://www.iit.edu/ifsh/alliance/index.shtml

THANK YOU !