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FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Supply Chain Controls:
Ensuring Regulatory Compliance and Consumer Safety
Liliana Casal-Wardle
Executive Senior Director, Food Safety & Supply Chain Risk Management
The Acheson Group - TAG
Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS
Casual but Professional Format
✔Ask questions! (Q&A at end)
✔Only panelists are displayed
✔Recording link will be shared
✔Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS
Featured FSMA Friday Speaker & Host
FSMA FRIDAYS
Jim Albright
Liliana Casal-Wardle
Executive Sr. Director, Food Safety & Supply Chain Risk
● 25 years of experience in the private industry.
● Held technical and global leadership roles managing food safety
and product quality at The Hershey Company from 2002 to 2019.
● Specific areas of expertise include Food Safety, Food Safety
Culture, Food Science, Food Defense, Cleaning & Sanitation
practices, Environmental Microbiological Monitoring Programs,
GFSI requirements and Quality Assurance, amongst others.
● Ph.D. in Organic Chemistry from the University of Buenos Aires.
● Certified SQF Practitioner and a FSMA Preventive Controls
Qualified Individual (PCQI).
FSMA FRIDAYS
UPDATED GUIDANCE FOR FOREIGN SUPPLIER VERIFICATION PROGRAM
FSMA Updates
The most important modifications :
The symbol “UKN” for importers no longer acceptable after July 24, 2022. Importers MUST have a
valid DUNS number or submitter will be rejected by the CBP’s electronic entry system.
You can register your facility at http://dnb.com/duns-number.html
Released April, 27, 2022
FSMA FRIDAYS
CGMPs: education and training are required
Management must ensure that food handlers are
qualified
● Quality Control Systems
● Employee Health and employee practices
Plant and Grounds
● Sanitary Operations: Cleaning and sanitation
and Environmental Microbiological
Monitoring Program
● Sanitary Facilities and Controls
● Sanitary design of Equipment and Utensils
● Processes and Controls
● Raw Materials
● Manufacturing Operations
● Warehousing and Distribution
● Defect Action Levels (DALs)
The Food Safety Plan
Hazard
Analysis
Process
Controls
Allergen
Controls
Sanitation
Controls
Supply
Chain
Controls
Recall
Plan
FSMA: Preventive approach to control food safety risks
Applies to a specific product or family of similar ones Apply to all products manufactured at the site
FSMA FRIDAYS
Supply chain control program:
• When an identified hazard requires a preventive control that will be
managed at the supplier level.
• Raw materials and other ingredients that require a Supply Chain
control must be sourced from approved suppliers.
• If there is a need for emergency sourcing from unapproved suppliers'
verification activities must be put in place.
• Facilities do not need to have a supply-chain program if they control
the hazard in their own facility, or if a subsequent entity (such as
another processor) will control the hazard, and the facility follows
applicable requirements.
• Brokers or Distributors can conduct supplier verification activities, but
these should be reviewed and assessed by the receiver.
FSMA: When is a Supply Chain Control Program required?
If a facility controls a hazard by their own, they DO NOT require a
supplier control program.
FSMA FRIDAYS
● Hazard analysis and Food Safety Plan
● Implemented GMP program
● Environmental Monitoring Program
● Cleaning and Sanitation programs
● Validations for critical processes that
control the risk
● Specifications and copies of CoAs
● Their own Supplier Control Program for
their suppliers
● History of recalls and management of
incidents: CAPAs
● Management of consumer complaints
● GFSI audits or other certifications
● Copies of regulatory audits
● Copies of their recall program
● Allergen Management program
● Copies of labels of their products
● Capabilities for product traceability
● Recall plan
● Inspection and sampling programs for
receiving and shipping
● Management of internal audits
Supplier Approval Program:
Understanding their risk management programs and practices
FSMA FRIDAYS
How do you monitor your suppliers’ performance?
Focus on Performance and CHANGE:
● Review performance by developing integrated scorecards together with the cross
functional teams
● Review compliance to the programs, GFSI trends, and completed corrective actions
Review trends of performance for leading and lagging indicators:
● EMMP
● Preventive Controls Compliance
● Master Sanitation Schedule Compliance
● Management of incidents and near misses
Work with your suppliers to implement Continuous Improvement Programs:
● Food Safety capital investment programs
● Incentives and recognition programs for the workforce
● Education and training
● Empowerment of the workforce through the understanding of the programs to
manage food safety risks and their roles and responsibilities
FSMA FRIDAYS
The Toolbox: Digital Tools
There are multiple benefits for companies that leverage them
Agile communication of real-time data
Easily accessible capabilities for trending of results
Trends can easily become visual aids used for education, training and recognition
The use of digital tools has grown in the industry
FSMA FRIDAYS
Success relies on
Ongoing Bilateral compliance
Enhanced communication
REWARDS AND RECOGNITION
Shared tools for continuous
improvement
Ready to support each other
Your Procurement team leads the development of a network of PREFERRED SUPPLIERS
Long term contracts are in place and honored by the two parts
Scorecard of supplier performance: positive trends of
compliance with food safety and quality standards, verified on
time deliveries, consistency on long term costs , NO Surprises
Strategies that work for effectiveness of supply chain controls
FSMA FRIDAYS
FSMA FRIDAYS
FSMA FRIDAYS
Every step of the Supply Chain Supply Chain impacts consumers
Food is both a necessity
and indulgence
On every step of the supply
chain there are risks that to
manage to guarantee the
health and safety of the
consumers.
FSMA FRIDAYS
Food safety awareness: The eyes of the consumers
Consumers recognize the efforts to
guarantee safe food and retailers share
their strong commitment to food safety
Engagement and loyalty of suppliers is
strengthened by consumers recognition
towards a reliable brand
The expectations of consumers are
independent of their geographical
location
FSMA FRIDAYS
• FSMA has established the criteria for the management
of supply chain hazards of high severity and probability.
Ensuring Regulatory Compliance and Consumer Safety
• Preventive controls managed at the supplier level are
Supply Chain Controls and they must effectively control
and mitigate the biological, physical and chemical risks.
• They must be designed to assess the risk of food fraud
and mitigate it when it impacts food safety.
• The ongoing effectiveness of the Supply Chain controls
relies on the strength of the supplier approval programs
management of emergency sourcing and ongoing
monitoring of performance of existing suppliers .
Q & A
FSMA FRIDAY
✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
Resources & Future Events
FSMA FRIDAYS
Download: Mitigating Labor Shortages
with Plant Management Software

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Supply Chain Controls: Ensuring Regulatory Compliance and Consumer Safety

  • 1. FSMA Fridays Webinar Series Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers Supply Chain Controls: Ensuring Regulatory Compliance and Consumer Safety Liliana Casal-Wardle Executive Senior Director, Food Safety & Supply Chain Risk Management The Acheson Group - TAG
  • 2. Monthly Industry Update: ✔FSMA Related News ✔Regulation Changes & Updates ✔Industry Trends ✔Q&A with TAG What is FSMA Fridays? FSMA FRIDAYS
  • 3. Casual but Professional Format ✔Ask questions! (Q&A at end) ✔Only panelists are displayed ✔Recording link will be shared ✔Audio issues: use call-in number Watch prior FSMA Friday recordings at safetychain.com > Resources > FSMA Fridays Before We Get Started FSMA FRIDAYS
  • 4. Featured FSMA Friday Speaker & Host FSMA FRIDAYS Jim Albright Liliana Casal-Wardle Executive Sr. Director, Food Safety & Supply Chain Risk ● 25 years of experience in the private industry. ● Held technical and global leadership roles managing food safety and product quality at The Hershey Company from 2002 to 2019. ● Specific areas of expertise include Food Safety, Food Safety Culture, Food Science, Food Defense, Cleaning & Sanitation practices, Environmental Microbiological Monitoring Programs, GFSI requirements and Quality Assurance, amongst others. ● Ph.D. in Organic Chemistry from the University of Buenos Aires. ● Certified SQF Practitioner and a FSMA Preventive Controls Qualified Individual (PCQI).
  • 5. FSMA FRIDAYS UPDATED GUIDANCE FOR FOREIGN SUPPLIER VERIFICATION PROGRAM FSMA Updates The most important modifications : The symbol “UKN” for importers no longer acceptable after July 24, 2022. Importers MUST have a valid DUNS number or submitter will be rejected by the CBP’s electronic entry system. You can register your facility at http://dnb.com/duns-number.html Released April, 27, 2022
  • 6. FSMA FRIDAYS CGMPs: education and training are required Management must ensure that food handlers are qualified ● Quality Control Systems ● Employee Health and employee practices Plant and Grounds ● Sanitary Operations: Cleaning and sanitation and Environmental Microbiological Monitoring Program ● Sanitary Facilities and Controls ● Sanitary design of Equipment and Utensils ● Processes and Controls ● Raw Materials ● Manufacturing Operations ● Warehousing and Distribution ● Defect Action Levels (DALs) The Food Safety Plan Hazard Analysis Process Controls Allergen Controls Sanitation Controls Supply Chain Controls Recall Plan FSMA: Preventive approach to control food safety risks Applies to a specific product or family of similar ones Apply to all products manufactured at the site
  • 7. FSMA FRIDAYS Supply chain control program: • When an identified hazard requires a preventive control that will be managed at the supplier level. • Raw materials and other ingredients that require a Supply Chain control must be sourced from approved suppliers. • If there is a need for emergency sourcing from unapproved suppliers' verification activities must be put in place. • Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements. • Brokers or Distributors can conduct supplier verification activities, but these should be reviewed and assessed by the receiver. FSMA: When is a Supply Chain Control Program required? If a facility controls a hazard by their own, they DO NOT require a supplier control program.
  • 8. FSMA FRIDAYS ● Hazard analysis and Food Safety Plan ● Implemented GMP program ● Environmental Monitoring Program ● Cleaning and Sanitation programs ● Validations for critical processes that control the risk ● Specifications and copies of CoAs ● Their own Supplier Control Program for their suppliers ● History of recalls and management of incidents: CAPAs ● Management of consumer complaints ● GFSI audits or other certifications ● Copies of regulatory audits ● Copies of their recall program ● Allergen Management program ● Copies of labels of their products ● Capabilities for product traceability ● Recall plan ● Inspection and sampling programs for receiving and shipping ● Management of internal audits Supplier Approval Program: Understanding their risk management programs and practices
  • 9. FSMA FRIDAYS How do you monitor your suppliers’ performance? Focus on Performance and CHANGE: ● Review performance by developing integrated scorecards together with the cross functional teams ● Review compliance to the programs, GFSI trends, and completed corrective actions Review trends of performance for leading and lagging indicators: ● EMMP ● Preventive Controls Compliance ● Master Sanitation Schedule Compliance ● Management of incidents and near misses Work with your suppliers to implement Continuous Improvement Programs: ● Food Safety capital investment programs ● Incentives and recognition programs for the workforce ● Education and training ● Empowerment of the workforce through the understanding of the programs to manage food safety risks and their roles and responsibilities
  • 10. FSMA FRIDAYS The Toolbox: Digital Tools There are multiple benefits for companies that leverage them Agile communication of real-time data Easily accessible capabilities for trending of results Trends can easily become visual aids used for education, training and recognition The use of digital tools has grown in the industry
  • 11. FSMA FRIDAYS Success relies on Ongoing Bilateral compliance Enhanced communication REWARDS AND RECOGNITION Shared tools for continuous improvement Ready to support each other Your Procurement team leads the development of a network of PREFERRED SUPPLIERS Long term contracts are in place and honored by the two parts Scorecard of supplier performance: positive trends of compliance with food safety and quality standards, verified on time deliveries, consistency on long term costs , NO Surprises Strategies that work for effectiveness of supply chain controls FSMA FRIDAYS FSMA FRIDAYS
  • 12. FSMA FRIDAYS Every step of the Supply Chain Supply Chain impacts consumers Food is both a necessity and indulgence On every step of the supply chain there are risks that to manage to guarantee the health and safety of the consumers.
  • 13. FSMA FRIDAYS Food safety awareness: The eyes of the consumers Consumers recognize the efforts to guarantee safe food and retailers share their strong commitment to food safety Engagement and loyalty of suppliers is strengthened by consumers recognition towards a reliable brand The expectations of consumers are independent of their geographical location
  • 14. FSMA FRIDAYS • FSMA has established the criteria for the management of supply chain hazards of high severity and probability. Ensuring Regulatory Compliance and Consumer Safety • Preventive controls managed at the supplier level are Supply Chain Controls and they must effectively control and mitigate the biological, physical and chemical risks. • They must be designed to assess the risk of food fraud and mitigate it when it impacts food safety. • The ongoing effectiveness of the Supply Chain controls relies on the strength of the supplier approval programs management of emergency sourcing and ongoing monitoring of performance of existing suppliers .
  • 15. Q & A FSMA FRIDAY
  • 16. ✔ FSMA Friday Session Recordings & Content Library ✔ TAG Newsletter ✔ Global Food Safety Consultants AchesonGroup.com ✔ FSMA Friday LinkedIn Group ✔ Q&A, Articles & Updates … Join FSMA FRIDAYS! Resources & Future Events FSMA FRIDAYS Download: Mitigating Labor Shortages with Plant Management Software