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FSMA FRIDAYS
The Latest Industry News, Updates & Trends
November 2018
MONTHLY INDUSTRY UPDATE
FSMA Related News
Regulation Changes & Updates
Industry Trends
Q&A with TAG
FSMA FRIDAYS
What is FSMA Fridays?
FSMA FRIDAYS
Our Sponsors
FSMA FRIDAYS
Agenda
HELPFUL TIPS
Informal but professional format
Ask Questions (Q&A at end)
Only panelists are displayed
Recording link will be shared
Audio issues: use call-in number
WHAT WE WILL COVER
FSMA News & Updates
FSMA Focus: Intentional Adulteration & Food Defense
Industry Preparedness Survey
Audience Q&A
FSMA FRIDAYS
Presenters
Brian Sharp
President, SafetyChain
Benjamin Miller, PhD, MPH, RS
Senior Director, Food Safety
FSMA NEWS
FSMA FOCUS
Fall 2018
250 Survey Responders
Sponsored by:
FSMA Intentional Adulteration (IA) Rule Background
• Establishes requirements to prevent or significantly minimize acts
intended to cause wide-scale public health harm
• Uses a HACCP-type approach with important differences from the
Preventive Controls for Human Food rule
• Is risk-based and flexible
• Compliance dates:
• July 26, 2021: Very small businesses
[averaging less than $10,000,000 per year in sales]
• July 27, 2020: Small businesses
[business with fewer than 500 FTE employees]
• July 26, 2019: All other businesses!
250 participants
• United States (73%)
• Canada (7%)
• Outside US/CA (20%)
Survey Key Themes: Four Needs
1. Awareness Building
2. Training
3. Plan Revision
4. Preparedness Exercises
Need for Awareness Building
Need for Awareness Building
Need for Training
Two elements to training:
1. General awareness
• Everyone
• FDA online course is sufficient
2. Specific training
• How to implement the mitigation strategies
• Food defense qualified individual
Need for Training
Focus on Individuals at Actionable Process
Steps
• Line workers
• Supervisors
Need for Plan Revision
Need for Plan Revision
Yes
87%
No
9%
Unsure
4%
Does your plan contain a vulnerability
assessment and mitigation strategies?
Need for Plan Revision
Plan developed prior to FDA Guidance? Probably not compliant!
20
Vulnerability
Analysis
Mitigation
Strategies
Monitoring
Corrective
Actions
Verification
Reanalysis
Documentation
KAT or every
“Point, Step,
Procedure”
Training
FDQI &
Awareness
KAT (Key Activity Types)
FDQI (Food Defense Qualified Individual)
Actionable
Process
Steps (3
elements)
Need for Preparedness Exercises
Other questions included:
• IA breach taken place
• Individual facility preparedness
• Understanding risks and potential costs
Survey Results Available in December
Sign-up for TAG’s weekly newsletter or email us to receive results:
info@achesongroup.com
Q & A
FSMA FRIDAYS
Join us on LinkedIn
Connect and continue the
conversation on our
FSMA Fridays LinkedIn Group!
FSMA FRIDAYS
The Acheson Group
Need FSMA Help? TAG is Here to
Help!
Rules & Regulations
Personalized Consultations
Food Safety Plans
FDA Records
GFSI Compliance
Learn more at
AchesonGroup.com | 800-401-2239
FSMA FRIDAYS
SafetyChain Software
Food Quality Management System
Quality Assurance
Food Safety
Supplier Compliance
Learn more at SafetyChain.com
FSMA Friday Session Recording
SafetyChain Beyond Compliance Webinar Series
SafetyChain Demo Day
TAG Newsletter
FSMA FRIDAYS
Resources & Events
Join us next month December 21, 2018

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FSMA Fridays - Intentional Adulteration & Food Defense Industry Preparedness Survey - November 2018

  • 1. FSMA FRIDAYS The Latest Industry News, Updates & Trends November 2018
  • 2. MONTHLY INDUSTRY UPDATE FSMA Related News Regulation Changes & Updates Industry Trends Q&A with TAG FSMA FRIDAYS What is FSMA Fridays?
  • 4. FSMA FRIDAYS Agenda HELPFUL TIPS Informal but professional format Ask Questions (Q&A at end) Only panelists are displayed Recording link will be shared Audio issues: use call-in number WHAT WE WILL COVER FSMA News & Updates FSMA Focus: Intentional Adulteration & Food Defense Industry Preparedness Survey Audience Q&A
  • 5. FSMA FRIDAYS Presenters Brian Sharp President, SafetyChain Benjamin Miller, PhD, MPH, RS Senior Director, Food Safety
  • 8. Fall 2018 250 Survey Responders Sponsored by:
  • 9. FSMA Intentional Adulteration (IA) Rule Background • Establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm • Uses a HACCP-type approach with important differences from the Preventive Controls for Human Food rule • Is risk-based and flexible • Compliance dates: • July 26, 2021: Very small businesses [averaging less than $10,000,000 per year in sales] • July 27, 2020: Small businesses [business with fewer than 500 FTE employees] • July 26, 2019: All other businesses!
  • 10. 250 participants • United States (73%) • Canada (7%) • Outside US/CA (20%)
  • 11.
  • 12.
  • 13. Survey Key Themes: Four Needs 1. Awareness Building 2. Training 3. Plan Revision 4. Preparedness Exercises
  • 14. Need for Awareness Building
  • 15. Need for Awareness Building
  • 17. Two elements to training: 1. General awareness • Everyone • FDA online course is sufficient 2. Specific training • How to implement the mitigation strategies • Food defense qualified individual Need for Training Focus on Individuals at Actionable Process Steps • Line workers • Supervisors
  • 18. Need for Plan Revision
  • 19. Need for Plan Revision Yes 87% No 9% Unsure 4% Does your plan contain a vulnerability assessment and mitigation strategies?
  • 20. Need for Plan Revision Plan developed prior to FDA Guidance? Probably not compliant! 20 Vulnerability Analysis Mitigation Strategies Monitoring Corrective Actions Verification Reanalysis Documentation KAT or every “Point, Step, Procedure” Training FDQI & Awareness KAT (Key Activity Types) FDQI (Food Defense Qualified Individual) Actionable Process Steps (3 elements)
  • 22. Other questions included: • IA breach taken place • Individual facility preparedness • Understanding risks and potential costs Survey Results Available in December Sign-up for TAG’s weekly newsletter or email us to receive results: info@achesongroup.com
  • 23. Q & A
  • 24. FSMA FRIDAYS Join us on LinkedIn Connect and continue the conversation on our FSMA Fridays LinkedIn Group!
  • 25. FSMA FRIDAYS The Acheson Group Need FSMA Help? TAG is Here to Help! Rules & Regulations Personalized Consultations Food Safety Plans FDA Records GFSI Compliance Learn more at AchesonGroup.com | 800-401-2239
  • 26. FSMA FRIDAYS SafetyChain Software Food Quality Management System Quality Assurance Food Safety Supplier Compliance Learn more at SafetyChain.com
  • 27. FSMA Friday Session Recording SafetyChain Beyond Compliance Webinar Series SafetyChain Demo Day TAG Newsletter FSMA FRIDAYS Resources & Events Join us next month December 21, 2018