Achieving FSMA Compliance with BRC Global Standards · Mandatory recall authority ... FSMA Guidance...
Transcript of Achieving FSMA Compliance with BRC Global Standards · Mandatory recall authority ... FSMA Guidance...
Achieving FSMA Compliance
with BRC Global Standards
Brought to you by:
Today’s Session
• Your host: Jill Bender, VP Marketing, SafetyChain
• Before we begin:
– Recording link sent via email next week
– For your privacy only panelists displayed
– Trouble hearing audio via speakers? Use call-in number
Speaker & Agenda
• John Kukoly, Director, BRC Americas
• Agenda
– FSMA Key Components
– How BRC Scheme Supports FSMA Preventive Control Rules
– What BRC’s New Tool – Voluntary FSMA Module – Entails
– Next Steps for Companies Currently or Looking to Become – BRC Certified
– About Session Sponsors
– Audience Q&A
What is FSMA?
• Regulation
• Preventive Controls (Human Food)
• Preventive Controls (Animal Food)
• Produce Safety
• Foreign Supplier Verification Program
• Third Party Accreditation
• Sanitary Transport
• Intentional Adulteration
Key FSMA Provisions
Increased inspection authority
Increased records access
Mandatory recall authority
Import controls
Mandatory preventive controls
Fee-based services
Administrative detention
Facility registration
What’s New for Manufacturers?
• HACCP to HARPCPreventive
controls
• 21 CFR 117 (formerly 21 CFR 110)
cGMP update
Preventive Controls Areas of Concern?
Covers production and storage of food and feed
Domestic and foreign
Current global manufacturing practices (cGMP’s), prerequisites, HARPC and FSMS
US sites must have
US operations must verify at suppliers
Focus on FDA cGMP’s and 21 codes of federal regulation (CFR)
What’s REALLY New?
• Legal responsibility
– Agent in charge
– Qualified Individual
• PCQI
• Prevention strategy
• Food safety is no longer a document or program, it is now a
systematic approach to organizational operation.
• It is not a one time project, rather a new reality
Business Type & Compliance Timeline?
Exemptions??
?
Very small (< $1 million)
Subject to PMO
Small (< 500 FTE)
Everyone else
3 years
3 years
2 years
1 years
FSVP – 6 months
after PC’s
Preventive Controls:
What Direction is BRC Taking?
The Acheson Group has completed a review of BRC Food 7 against the basic FSMA Preventive Controls for Human Food
BRC commissioned a full technical review of prescriptive requirements – resulting in Module 15 and FSMA Guidance
FSPCA, HARPC for BRC, Internal Auditor, Validation training for PCQI
What Module did BRC Develop?
The Way it Works
• The CB adds it to your next upcoming audit
• Any findings, prior to deadlines, do not impact audit grade
• Site decides response, closure
• Results documented in AVM report
• Takes 3 to 4 hours extra added to audit
Provide an Example?
Another Example?
Action Plan for Achieving Compliance?
• Plot timelines
• Gap analysis
• Supply chain project
• PCQI
• FDA strategy
Next Steps?
BRC Certified?
• Contact your CB to add the AVM to your next audit, or a follow
up audit
Not BRC Certified?
• Contact BRC to see how simple it is to add BRC to your
existing program
Resources
Free from www.BRCBookshop.com
• BRC Food 7 Standard
• FSMA Module and checklist
Free from www.BRCGlobalStandards.com
• Acheson Report on BRC vs PC
• FSMA Module training webinar
Thoughts? Questions?
How SafetyChain Helps with GFSI Program
Management + FSMA Compliance
Comprehensive System for:
• Vendor approval & supply chain controls
• Food safety & quality program management
[Incl. Supplier Compliance, HACCP & HARPC]
• 24/7 inspection, inquiry & audit-readiness
• Central repository of all data & records for
trending, continuous improvement
About Global Food Safety Resource™
• Trusted online information hub for all food businesses
in global market and supply chains
• Expertise & food safety best practices to help meet
regulatory / industry compliance
Content: Food Safety Regulations & Standards, Food Safety
Culture, Food Science & Technology and more
Media: Articles, Whitepapers, Videos, Social Media
Webinars & More
Resources: Event / Conference Updates, Resource Links,
Food Safety Solutions
Responsive Mobile Platform in 60 Languages
Sign up for Complimentary Membership: www.globalfoodsafetyresource.com
Together, we can make food safe™
Q&A … Plus More Info!
• Session Recording – Sent Next Week
• BRC Global Standard Resources BRC Food 7 Standard; FSMA Module and checklist - www.BRCBookshop.com
BRC vs PC Acheson Report; FSMA Module training webinar - www.BRCGlobalStandards.com
• Upcoming Webinars – www.SafetyChain.com
Aug. 17: How SafetyChain Helps Improve FSQA Operations + Demo
Aug. 26: FSMA Fridays with Dr. David Acheson
Sept. 14: Assessing Gaps in Your Food Safety Programs
• GFSR Information Hub – www.globalfoodsafetyresource.com