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