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FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Ranjeet Klair
Food Safety Director
From QMS to FSMS:
Intersecting Compliance, Audit-Readiness & Production
✔Monthly FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS
A global food safety and public
health consulting group made up
of seasoned industry experts
A digital plant management
platform to ensure quality,
maximize yield & optimize labor
Brought to you by:
Meet Your FSMA Friday Speaker
FSMA FRIDAYS
Ranjeet Klair
Food Safety Director
Ranjeet has over 20 years of industry experience
working with Canadian, US, and global food
retailers, production plants, and certification
bodies in food safety, quality assurance, and
regulatory compliance, and has a keen
understanding of FDA, and CFIA requirements on
food imports and import control expectations.
FSMA FRIDAYS
FSMA FRIDAYS
FSMA: Regulatory Updates from the FDA
● User Fees Collected in FY 2022 for reinspection, recalls and VQIP
● FDA did not collect any fees for the re-inspection of domestic food facilities, foreign
food facilities, or importers. In FY 2022, FDA did not collect any fees for the re-
inspection of domestic food facilities, foreign food facilities, or importers.
● In FY 2022, the user fee rate for participation in VQIP was $15,938. This amount was
invoiced to and collected from four VQIP importers, totaling $63,752 invoiced and
collected.
Your FSMA Friday Agenda
FSMA FRIDAYS
• Quality Management System(QMS)
• ISO, Codex, QMS, FSMS, GFSI
• Food Safety Management System(FSMS)
• Connection between Codex, ISO, QMS, FSMS, GFSI
• Integration of QMS FSMS in Food Safety
• Questions
FSMA FRIDAYS
Quality Management System (QMS)
A set of coordinated activities to direct
and control an organization in terms
of quality.
FSMA FRIDAYS
The Key Principles of QMS
• Customer focus
• Leadership
• Involvement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management
Customer
Expectations
Leadership
FSMA FRIDAYS
What is Involved in QMS?
Plan
Do
Check
Act
FSMA FRIDAYS
The Evolution of QMS
ISO 9000
Describe
standard
vocabulary and
fundamentals
ISO 9001
Requirements of
compliance
ISO 9002
Focused to existing
production lines
ISO 9004
Testing and
inspection
ISO 9000
First published in 1987
Later ISO revisions
1994, 2000, 2005, 2008,
and, most recently, 2015
ISO 9001:2015
Introduction of risk-based thinking, context of the
organization, and a focus on leadership and
integration with other management systems
Latest QMS
ISO 9001:2015
FSMA FRIDAYS
Codex Alimentarius
• Codex Alimentarius as an international
food safety and quality standard-setting
body established by the Food and
Agriculture Organization (FAO) and the
World Health Organization (WHO).
• Codex standards contribute to the
establishment and harmonization of
quality management practices in the
food industry.
FSMA FRIDAYS
Codex Alimentarius
• People have the right to expect the food that
they eat to be safe and suitable for consumption.
Foodborne illness and foodborne injury can be
severe or fatal or have a negative impact on
human health over the longer term.
• Outbreaks of foodborne illness can damage
trade and tourism. Food spoilage is wasteful,
costly, threatens food security and can adversely
affect trade and consumer confidence.
FSMA FRIDAYS
Connection #1
Codex
Alimentarius
Codex sets internationally
recognized food safety and
quality standards, focusing
on consumer protection and
fair trade practices.
ISO 22000
A food safety management system by the
ISO which is outcome focused, providing
requirements for any organization in the
food industry with objective to help improve
overall performance in food safety.
Evolution
from QMS
to FSMS
ISO 9001
Developed general management system
standards applicable to various industries,
including ISO 9001 for quality
management.
Contribute to
food safety,
quality, and
international
trade.
FSMA FRIDAYS
Food Safety Management System (FSMS)
A framework to manage food safety
risks, ensuring the production of safe
food products.
The critical nature of food safety in
preserving public health.
FSMA FRIDAYS
QMS and FSMS Overlap
Elements of QMS
Elements of FSMS
Overall Benefits
1. Quality Policy and Objectives
2. Document Control
3. Process Management
4. Training and Competence
5. Monitoring and Measurement
6. Continuous Improvement
● Streamlined management process
● Efficient resource utilization
● Enhanced risk identification and mitigation
● Reduced duplication of efforts
1. Hazard Analysis and Critical Control Points (HACCP)
2. Good Manufacturing Practices (GMP)
3. Traceability and Recall Procedures
4. Allergen Management
5. Supplier Control
6. Training and Awareness
FSMA FRIDAYS
FSMS and ISO
FSMS Principles
1. Hazard Analysis
2. Prerequisite Programs
3. Critical Control Points (CCPs)
4. Monitoring and Verification
5. Corrective Actions
6. Documentation
7. Continuous Improvement
ISO Management Principles
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision
making
7. Relationship management
FSMA FRIDAYS
ISO QMS to FSSC22000 FSMS
ISO 22000
Provides common
framework across
supply chain to
manage requirements,
communication and
continual improvement
of the system
PRPs
Sector specific
prerequisite programs
(ISO/TS standards/
BSI PAS)
FSSC 22000
Adds specific
requirements to ensure
consistency, integrity,
governance and
management of the
scheme
FSMA FRIDAYS
GFSI
• Global Food Safety Initiative
• A private organization that benchmarks and approves
various food safety management schemes, aiming to
enhance food safety throughout the supply chain
• GFSI-recognized schemes incorporate elements of
QMS to ensure consistent quality and safety practices
FSMA FRIDAYS
FSMS and GFSI
GFSI
• Global Food Safety Initiative
benchmarks and recognizes food
safety standards that incorporate the
principles of an effective FSMS.
When a company implements a GFSI-
recognized standard, it means that
their FSMS has been assessed and
found to meet global food safety
expectations
FSMS
• Ability to consistently provide safe
foods and products that meet
customer and applicable statutory
and regulatory requirements
• Addressing risks associated with its
objectives
• The ability to demonstrate conformity
to specified fsms requirements
FSMA FRIDAYS
Connection #2
Codex
Alimentarius
Codex sets internationally
recognized food safety and quality
standards, focusing on consumer
protection and fair trade practices.
Acknowledged
GFSI
A retailers-driven initiative for the continuous
improvement of food safety management systems, with
the ambition to ensure confidence in the delivery of safe
food to consumers worldwide.
ISO 22000
A food safety management system by the ISO
which is outcome focused, providing requirements
for any organization in the food industry with
objective to help improve overall performance in
food safety.
GFSI benchmarked
standard in addition
to other standards
Evolution
from QMS
to FSMS
ISO 9001
Developed general management system
standards applicable to various industries,
including ISO 9001 for quality management.
Contribute to
food safety,
quality, and
international
trade
FSMA FRIDAYS
Integrating QMS and FSMS
• Increased efficiency
• Reduced duplication of efforts
• Improved communication
• A holistic approach to managing quality and food safety
Benefits:
FSMA FRIDAYS
Food Safety Plan with FSMS
Hazard
Analysis
Preventive
Controls
Monitoring
Corrective
Actions
Verification
Reanalysis
FSMA FRIDAYS
Food Safety Culture with FSMS
https://sqfcode.com/new-codex-general-principles-of-food-hygiene/
FSMA FRIDAY
Questions?
Ranjeet Klair
Food Safety Director
From QMS to FSMS:
Intersecting Compliance, Audit-Readiness, & Production
FSMA FRIDAYS
Industry eGuides
Webinars & Videos
Success Stories
Solution Consultation
More Resources
safetychain.com/resources/downloads
More on Boosting Food Safety
E: info@achesongroup.com
W: achesongroup.com

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FSMA Webinar Series: Intersecting QMS, FSMS Compliance

  • 1. FSMA Fridays Webinar Series Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers Ranjeet Klair Food Safety Director From QMS to FSMS: Intersecting Compliance, Audit-Readiness & Production
  • 2. ✔Monthly FSMA Related News ✔Regulation Changes & Updates ✔Industry Trends ✔Q&A with TAG What is FSMA Fridays? FSMA FRIDAYS A global food safety and public health consulting group made up of seasoned industry experts A digital plant management platform to ensure quality, maximize yield & optimize labor Brought to you by:
  • 3. Meet Your FSMA Friday Speaker FSMA FRIDAYS Ranjeet Klair Food Safety Director Ranjeet has over 20 years of industry experience working with Canadian, US, and global food retailers, production plants, and certification bodies in food safety, quality assurance, and regulatory compliance, and has a keen understanding of FDA, and CFIA requirements on food imports and import control expectations.
  • 4. FSMA FRIDAYS FSMA FRIDAYS FSMA: Regulatory Updates from the FDA ● User Fees Collected in FY 2022 for reinspection, recalls and VQIP ● FDA did not collect any fees for the re-inspection of domestic food facilities, foreign food facilities, or importers. In FY 2022, FDA did not collect any fees for the re- inspection of domestic food facilities, foreign food facilities, or importers. ● In FY 2022, the user fee rate for participation in VQIP was $15,938. This amount was invoiced to and collected from four VQIP importers, totaling $63,752 invoiced and collected.
  • 5. Your FSMA Friday Agenda FSMA FRIDAYS • Quality Management System(QMS) • ISO, Codex, QMS, FSMS, GFSI • Food Safety Management System(FSMS) • Connection between Codex, ISO, QMS, FSMS, GFSI • Integration of QMS FSMS in Food Safety • Questions
  • 6. FSMA FRIDAYS Quality Management System (QMS) A set of coordinated activities to direct and control an organization in terms of quality.
  • 7. FSMA FRIDAYS The Key Principles of QMS • Customer focus • Leadership • Involvement of people • Process approach • Improvement • Evidence-based decision making • Relationship management Customer Expectations Leadership
  • 8. FSMA FRIDAYS What is Involved in QMS? Plan Do Check Act
  • 9. FSMA FRIDAYS The Evolution of QMS ISO 9000 Describe standard vocabulary and fundamentals ISO 9001 Requirements of compliance ISO 9002 Focused to existing production lines ISO 9004 Testing and inspection ISO 9000 First published in 1987 Later ISO revisions 1994, 2000, 2005, 2008, and, most recently, 2015 ISO 9001:2015 Introduction of risk-based thinking, context of the organization, and a focus on leadership and integration with other management systems Latest QMS ISO 9001:2015
  • 10. FSMA FRIDAYS Codex Alimentarius • Codex Alimentarius as an international food safety and quality standard-setting body established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). • Codex standards contribute to the establishment and harmonization of quality management practices in the food industry.
  • 11. FSMA FRIDAYS Codex Alimentarius • People have the right to expect the food that they eat to be safe and suitable for consumption. Foodborne illness and foodborne injury can be severe or fatal or have a negative impact on human health over the longer term. • Outbreaks of foodborne illness can damage trade and tourism. Food spoilage is wasteful, costly, threatens food security and can adversely affect trade and consumer confidence.
  • 12. FSMA FRIDAYS Connection #1 Codex Alimentarius Codex sets internationally recognized food safety and quality standards, focusing on consumer protection and fair trade practices. ISO 22000 A food safety management system by the ISO which is outcome focused, providing requirements for any organization in the food industry with objective to help improve overall performance in food safety. Evolution from QMS to FSMS ISO 9001 Developed general management system standards applicable to various industries, including ISO 9001 for quality management. Contribute to food safety, quality, and international trade.
  • 13. FSMA FRIDAYS Food Safety Management System (FSMS) A framework to manage food safety risks, ensuring the production of safe food products. The critical nature of food safety in preserving public health.
  • 14. FSMA FRIDAYS QMS and FSMS Overlap Elements of QMS Elements of FSMS Overall Benefits 1. Quality Policy and Objectives 2. Document Control 3. Process Management 4. Training and Competence 5. Monitoring and Measurement 6. Continuous Improvement ● Streamlined management process ● Efficient resource utilization ● Enhanced risk identification and mitigation ● Reduced duplication of efforts 1. Hazard Analysis and Critical Control Points (HACCP) 2. Good Manufacturing Practices (GMP) 3. Traceability and Recall Procedures 4. Allergen Management 5. Supplier Control 6. Training and Awareness
  • 15. FSMA FRIDAYS FSMS and ISO FSMS Principles 1. Hazard Analysis 2. Prerequisite Programs 3. Critical Control Points (CCPs) 4. Monitoring and Verification 5. Corrective Actions 6. Documentation 7. Continuous Improvement ISO Management Principles 1. Customer focus 2. Leadership 3. Engagement of people 4. Process approach 5. Improvement 6. Evidence-based decision making 7. Relationship management
  • 16. FSMA FRIDAYS ISO QMS to FSSC22000 FSMS ISO 22000 Provides common framework across supply chain to manage requirements, communication and continual improvement of the system PRPs Sector specific prerequisite programs (ISO/TS standards/ BSI PAS) FSSC 22000 Adds specific requirements to ensure consistency, integrity, governance and management of the scheme
  • 17. FSMA FRIDAYS GFSI • Global Food Safety Initiative • A private organization that benchmarks and approves various food safety management schemes, aiming to enhance food safety throughout the supply chain • GFSI-recognized schemes incorporate elements of QMS to ensure consistent quality and safety practices
  • 18. FSMA FRIDAYS FSMS and GFSI GFSI • Global Food Safety Initiative benchmarks and recognizes food safety standards that incorporate the principles of an effective FSMS. When a company implements a GFSI- recognized standard, it means that their FSMS has been assessed and found to meet global food safety expectations FSMS • Ability to consistently provide safe foods and products that meet customer and applicable statutory and regulatory requirements • Addressing risks associated with its objectives • The ability to demonstrate conformity to specified fsms requirements
  • 19. FSMA FRIDAYS Connection #2 Codex Alimentarius Codex sets internationally recognized food safety and quality standards, focusing on consumer protection and fair trade practices. Acknowledged GFSI A retailers-driven initiative for the continuous improvement of food safety management systems, with the ambition to ensure confidence in the delivery of safe food to consumers worldwide. ISO 22000 A food safety management system by the ISO which is outcome focused, providing requirements for any organization in the food industry with objective to help improve overall performance in food safety. GFSI benchmarked standard in addition to other standards Evolution from QMS to FSMS ISO 9001 Developed general management system standards applicable to various industries, including ISO 9001 for quality management. Contribute to food safety, quality, and international trade
  • 20. FSMA FRIDAYS Integrating QMS and FSMS • Increased efficiency • Reduced duplication of efforts • Improved communication • A holistic approach to managing quality and food safety Benefits:
  • 21. FSMA FRIDAYS Food Safety Plan with FSMS Hazard Analysis Preventive Controls Monitoring Corrective Actions Verification Reanalysis
  • 22. FSMA FRIDAYS Food Safety Culture with FSMS https://sqfcode.com/new-codex-general-principles-of-food-hygiene/
  • 23. FSMA FRIDAY Questions? Ranjeet Klair Food Safety Director From QMS to FSMS: Intersecting Compliance, Audit-Readiness, & Production
  • 24. FSMA FRIDAYS Industry eGuides Webinars & Videos Success Stories Solution Consultation More Resources safetychain.com/resources/downloads More on Boosting Food Safety E: info@achesongroup.com W: achesongroup.com