Slide 1: OnTrak with ReposiTrak
OnTrak with ReposiTrak Thought Leadership Webinar Series Are You Ready for FSMA Intentional Adulteration Inspection? REPOSITRAK.COM 1
Slide 2: ReposiTrak Compliance Management
World’s Largest Network of Supply Chain Partners Sharing Documents and Data Improve Product Safety, and Reduce Cost & Risk ReposiTrak® Used in 100+ countries and Compliance 100,000+ connections in the Management ReposiTrak network. Get the most from the network! • Many of you and your suppliers are
Slide 3: Exclusively Endorsed in the Industry
Exclusively Endorsed in the Industry “ReposiTrak augments our food and drug safety efforts…with a proven, comprehensive and easy-to-implement solution that doesn’t require systems changes and is extremely cost effective.” – Hilary Thesmar, PhD, RD, CFS FMI VP for Food Safety Programs “We see the Rep
Slide 4: Easily Identify Your Risk Areas And Process Failures
Easily Identify Your Risk Areas And Process Failures One-Minute Compliance Check Makes Reporting & Performance Tracking Easy 4 4
Slide 5: We Know You’re Busy, So Our Team Does the Heavy Lifting for You
We Know You’re Busy, So Our Team Does the Heavy Lifting for You üCloud-based system • Nothing to install, you just need an internet browser üSet-up is easy • We just need your supplier list and document requirements to get started, and you can be live in 30 days üWe do all the supplier follow-up for
Slide 6: Want to Make Your Sales Team Happy?
Want to Make Your Sales Team Happy? ReposiTrak helps you connect with new customers in the Marketplace so you can sell more! 6 6
Slide 7: OnTrak with ReposiTrak
OnTrak with ReposiTrak Thought Leadership Webinar Series Are You Ready for FSMA Intentional Adulteration Inspection? REPOSITRAK.COM 7
Slide 8: OnTrak with ReposiTrak
OnTrak with ReposiTrak Are You Ready for FSMA Intentional Adulteration Inspection? Rod Wheeler Founder and CEO The Global Food Defense Institute REPOSITRAK.COM 8
Slide 9: Don’t Press the Panic Button….Yet!
Don’t Press the Panic Button….Yet! Are you ready for FSMA Intentional Adulteration Rule Compliance? Webinar: FSMA’s IA Rule: Are You Ready for FSMA I.A. Rule Compliance, March of 2020? Presented By: Presented By: Rod Wheeler, The Global Food Defense Institute
Slide 10: Rod Wheeler
Rod Wheeler Founder & CEO Global Food Defense Institute • HOMELAND SECURITY AND GLOBAL FOOD DEFENSE AND LAW ENFORCEMENT • EXPERT, ROD WHEELER IS THE FOUNDER AND CEO OF THE GLOBAL FOOD DEFENSE • INSTITUTE WHICH PROVIDES EDUCATIONAL, TRAINING AND CERTIFICATION PROGRAMS • FOR THE FOOD, AGRICULTURAL AND
Slide 11: Objectives
OBJECTIVES WHAT THE FSMA KEY ACTIVITY TYPE DEVELOPING INTENTIONAL AREAS REDZONES ADULTERATION RULE REQUIRES 3 THINGS TO DO NOW TO ENSURE CONVERT YOUR ASSESSMENT TO COMPLIANCE YOUR FOOD DEFENSE PLAN • Understand FSMA’s IA Rule
Slide 12: Suspicious incident on a farm
Quick Reminder: Ensure your Crop Dusters are secured and locked at all times when not in use. We recently had a suspicious incident on a farm! Mohamed Atta, who piloted one of the planes that struck the World Trade Center, and some associates repeatedly visited a fertilizer company in Belle Glade, F
Slide 13: FSMA Intentional Adulteration Rule: What’s Required?
FSMA INTENTIONAL ADULTERATION RULE WHAT’S REQUIRED? 21 CFR 121 THE GLOBAL FOOD DEFENSE INSTITUTE
Slide 14: Vulnerability Assessment Mitigation
VULNERABILITY ASSESSMENT MITIGATION WEBINAR QUIZ 6
Slide 15: Food defense focuses on protecting the food supply
FOOD DEFENSE FOCUSES ON PROTECTING THE FOOD SUPPLY FROM INTENTIONAL CONTAMINATION.
Slide 16: Is your facility a hard target or soft target?
SOFT TARGET: A SOFT-TARGET IS A PERSON OR THING WHO, DUE TO THEIR ACTIONS AND/OR A LACK OF APPROPRIATE PROTECTIVE MEASURES, IS AT THE MERCY OF EXISTING RISKS AND THUS REPRESENTS AN EASY TARGET. HARD TARGET: A HARD-TARGET IS A PERSON WHO, DUE TO THEIR ACTIONS AND/OR APPROPRIATE PROTECTIVE MEASURES, I
Slide 17: Mitigation Strategies to Protect Food Against Intentional Adulteration
21 CFR 121 Mitigaton Strategies to Protect Food Against Intentional Adulteration Food Defense Plan Food Defense Qualified Individual Vulnerability (Qualified Assessment Individuals) Management Mitigation Components Strategies 9
Slide 18: To Comply with the I.A. Rule
TO COMPLY WITH THE I.A. RULE • DEVELOP AND IMPLEMENT A WRITTEN FOOD DEFENSE PLAN THAT INCLUDES (21 CFR 121.126): • A VULNERABILITY ASSESSMENT, INCLUDING REQUIRED EXPLANATIONS, TO IDENTIFY SIGNIFICANT VULNERABILITIES AND ACTIONABLE PROCESS STEPS (21 CFR 121.130(C)); • MITIGATION STRATEGIES, INCLUDING
Slide 19: Education, Experience & Training Requirements of Personnel
EDUCATION, EXPERIENCE & TRAINING REQUIREMENTS OF PERSONNEL • INDIVIDUALS WHO PERFORM ACTIVITIES REQUIRED UNDER SUBPART C (FOOD DEFENSE MEASURES); • • INDIVIDUALS ASSIGNED TO ACTIONABLE PROCESS STEPS; • • INDIVIDUALS PERFORMING OR OVERSEEING FOUR SPECIFIC ACTIVITIES (FOOD DEFENSE QUALIFIED • INDIVIDU
Slide 20: Who should conduct your vulnerability assessment?
Who should conduct your vulnerability assessment? • INDIVIDUAL(S) CONDUCTING OR • MUST BE A QUALIFIED INDIVIDUAL, OVERSEEING: I.E., HAVE THE EDUCATION, TRAINING, OR EXPERIENCE (OR A COMBINATION • THE PREPARATION OF THE FOOD THEREOF) NECESSARY TO PROPERLY DEFENSE PLAN, PERFORM THE ACTIVITIES (21 CFR
Slide 21: Image #1
IMAGE #1 What’s the Vulnerability? What mitigation strategy would you suggest? 13
Slide 22: Educational requirement for conducting a vulnerability assessment
GLOBAL FOOD DEFENSE INSTITUTE VARIOUS WAYS TO ACHIEVE THE EDUCATIONAL REQUIREMENT FOR CONDUCTING A VULNERABILITY ASSESSMENT AND GAINING FOOD DEFENSE AWARENESS 14
Slide 23: Example of FSPCA Training Requirement
EXAMPLE OF FSPCA TRAINING REQUIREMENT %/ƫ3. ! ƫ0+ Rod Wheeler %*ƫ.!+#*%0%+*ƫ"+.ƫ$2%*#ƫ/1!//"1((5ƫ+),(!0! 0$!ƫ++ ƫ"!05ƫ.!2!*0%2!ƫ+*0.+(/ƫ((%*!ƫ+1./!č FSPCA Intentional Adulteration Vulnerability Assessments !(%2!.! ƫ5ƫ ! ƫ */0.10+. Caitlin Hickey +),(!0! ƫ+* 05/06/2019 +!.0ƫ.'!00Čƫƫ* ƫ%.!0+. !.( ƫ+&0
Slide 24: Example of FSPCA Training Requirement
EXAMPLE OF FSPCA TRAINING REQUIREMENT %/ƫ3. ! ƫ0+ Rod Wheeler %*ƫ.!+#*%0%+*ƫ"+.ƫ$2%*#ƫ/1!//"1((5ƫ+),(!0! 0$!ƫ++ ƫ"!05ƫ.!2!*0%2!ƫ+*0.+(/ƫ((%*!ƫ+1./!č )63&$,QWHQWLRQDO$GXOWHUDWLRQ,GHQWLILFDWLRQDQG ([SODQDWLRQRI0LWLJDWLRQ6WUDWHJLHV +),(!0! ƫ+* 07/18/2019 +!.0ƫ.'!00Čƫƫ* ƫ%.!0+. !.( ƫ+&0(Čƫ4!10%2!ƫ%.!0+.
Slide 25: Example of The Global Food Defense training certificate
Example of The Global Food Defense training certificate
Slide 26: Image #2
IMAGE #2 What’s the Vulnerability? What mitigation strategy would you suggest? 18
Slide 27: “Think Like a Criminal”
“THINK LIKE A CRIMINAL” STEP ONE IN CONDUCTING YOUR FOOD DEFENSE ASSESSMENT:
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Slide 29: Image #3
IMAGE #3 What’s the Vulnerability? What mitigation strategy would you suggest? 21
Slide 30: Exemptions to the I.A. Rule
Exemptions to the I.A. Rule Very Small Business (sales are less than 3 million in 3 consecutive years) Holding of food (except bulk liquids) Packaging (repackaging) where food is not exposed Farms (subject to the produce safety rule) Alcoholic beverages Animal food or feed On Farm Manufacturing (egg
Slide 31: FDA Focuses on Three Primary Forms of Intentional Adulteration
FDA FOCUSES ON THREE PRIMARY FORMS OF INTENTIONAL ADULTERATION Acts of Terrorism against the Food and agricultural Supply. Disgruntled Employees Economically Motivation Adulteration
Slide 32: Image #4
IMAGE #4 What’s the Vulnerability? What mitigation strategy would you suggest? 24
Slide 33: Actionable Process Step
Actionable Process Step-this is what you are trying to determine from your assessment! Important! A point, step or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an accept
Slide 34: Significant Vulnerability
FDA-A vulnerability for which a prudent person knowledgeable about food defense would employ food defense measures because of the potential for serious health adverse consequences (SACOHDA) and the degree of accessibility to that point in the food process SIGNIFICANT Can occur at a particular point
Slide 35: Rule Requirements of Food Facilities
Prepare and implement a Have conducted a security written food defense plan vulnerability and risk assessment Develop “actionable process Provide security awareness steps,” mitigation strategies, training for its employee’s procedures for monitoring, corrective actions and verification. RULE REQUIRE
Slide 36: FDA / FSMA Food Defense Strategies Database
FDA / FSMA FOOD DEFENSE STRATEGIES DATABASE HTTPS://FOOD DEFENSE MITIGATION STRATEGIES DATAGASE
Slide 37: Image #5
IMAGE #5 What’s the Vulnerability? What mitigation strategy would you suggest? 29
Slide 38: Written into law in January of 2011
Prevention Written into law in January Full compliance inspections Increased Inspections by the of 2011 starting March 2020 FDA and Third Party Auditors Concern about food that “presents a threat of Serious Import of food safety Enhanced Partnerships Adverse Health Consequences or Death to Humans or
Slide 39: FSMA/I.A. Rule Requirements
1 2 3 4 Monitoring: Establishing Corrective actions: The Verification: Ensure that and implementing response if mitigation monitoring is being Training and procedures that monitors strategies are not properly conducted and recordkeeping: personnel the mitigation strategies implemented. appropriate d
Slide 40: Begin your assessment - Review the following
Begin your assessment- Review the following: Locks, lockers and Key Alarm system testing Video/CCTV Signage Lighting control and operation Contractor screening Background checks and Inventory control and Security guard force Visitor control and controls screening procedures accountability operations
Slide 41: Image #6
IMAGE #6 What’s the Vulnerability? What mitigation strategy would you suggest? 33
Slide 42: What Personnel Should Be Involved in Conducting the Assessment?
Key Staff members on all shifts (security, safety, H.R. , Legal, Operations, Quality, Engineering, shipping/receiving, warehouse, finance, etc.) WHAT Observing the facility functioning at various hours covering all shifts. This PERSONNEL includes night time observations. SHOULD BE Interviewing and e
Slide 43: 7 Specific Areas to Focus On for Your Assessment
7 SPECIFIC AREAS TO FOCUS ON FOR YOUR ASSESSMENT THE GLOBAL FOOD DEFENSE INSTITUTE
Slide 44: #1 Key Activity Types (KAT)
#1 KEY ACTIVITY TYPES (KAT) THE GLOBAL FOOD DEFENSE INSTITUTE
Slide 45: Image #7
IMAGE #7 What’s the Vulnerability? What mitigation strategy would you suggest? 37
Slide 46: Considerations for each KAT during assessment
WITH EACH KAT AND WHILE CONDUCTING YOUR ASSESSMENT, CONSIDER THE FOLLOWING WHEN LOOKING AT EACH AREA..(CRITICAL) 1. ACCESSIBILITY OR EASE OF ACCESS TO THE AREAS OF EACH OF THE ACTIVITY TYPES; 2. VULNERABILITY OF CONTAMINATION OR INTERFERENCE OF THE PROCESS OR INGREDIENTS OF THE ACTIVITY TYPE; 3. CRI
Slide 47: Key Activity Type: Bulk Liquid Receiving and Holding
KEY ACTIVITY TYPE BULK LIQUID RECEIVING AND HOLDING A step in which a bulk liquid is received and unloaded from an inbound conveyance or loaded into an outbound conveyance where a contaminant can be intentionally introduced and if it is, it is likely that the contaminant will be distributed througho
Slide 48: Image #8
IMAGE #8 What’s the Vulnerability? What mitigation strategy would you suggest? 40
Slide 49: Key Activity Type: Liquid Storage & Handling
KEY ACTIVITY TYPE LIQUID STORAGE & HANDLING Where liquid is contained in bulk storage tanks or in holding, surge, or metering tanks where a contaminant could have been intentionally introduced and if it is, the contaminant could potentially be distributed in the food supply. Let’s go to: FDA Food De
Slide 50: Key Activity Type: Secondary Ingredient Handling
KEY ACTIVITY TYPE SECONDARY INGREDIENT HANDLING Staging areas, preparation areas, or a rework step where a contaminant could be intentionally introduced into the product and eventually distributed into the food supply. Let’s Go To: FDA Food Defense Strategies Database
Slide 51: Key Activity Type: Mixing and Similar Activities
KEY ACTIVITY TYPE MIXING AND SIMILAR ACTIVITIES Mixing Rooms, Blending, homogenizing and grinding areas where a contaminant could be intentionally introduced into the product and eventually distributed into the food supply. Let’s go to: FDA Food Defense Strategies Database
Slide 52: What Is a Red/Restricted Zone?
WHAT IS A RED/RESTRICTED ZONE? Focused Security Screening and Inspection before being granted entry into key and critical areas of a food plant; Increased vetting of employees who will be working in the key and critical areas of a plant as identified by the Vulnerability Assessment. Internal Control
Slide 53: Develop REDZONES for each Key Activity Type
Develop REDZONES for each Key Activity Type
Slide 54: #2 Review of Food Defense Programs
#2 REVIEW OF FOOD DEFENSE PROGRAMS Food Defense Facility parking Facility access Last vulnerability Employee locker Plans program policies control policies assessment results policy Contractor, visitor Original visitor log Evacuation policy Employee internet and other guest Security incident in regi
Slide 55: #3 Outside Security Measures
#3 OUTSIDE SECURITY MEASURES Establish a perimeter around the Lighting should be part of PM program property and checked periodically • Physical barriers to prevent unauthorized entry • Use of light meters • Fencing, vegetation, barriers, signage • Number all light units and map Doors, windows, roof
Slide 56: #4 Inside Security Measures
#4 INSIDE SECURITY MEASURES Lobbies should be protected Visitors, guests and other non-plant • Access Control employees (contractors, • Visitor sign-in logs salespeople, truck drivers, etc.) • Identification checks and verification with contact Provide security and other person Inspection of persona
Slide 57: Image #9
IMAGE #9 What’s the Vulnerability? What mitigation strategy would you suggest? 49
Slide 58: #5 Materials Receiving/Loading Security
Are product and ingredient suppliers Are supplier (continuing) guarantees required to provide evidence of food on file for all ingredients and defense programs? packaging? Is a formalized ingredient and packaging testing program in place to Does the facility receive Bulk observe suspicious or adulte
Slide 59: #6 Facility Operations: Labels, Seals, CCTV, Physical Barriers
#6 FACILITY OPERATIONS: LABELS, SEALS, CCTV, PHYSICAL BARRIERS, ETC. Is access to food safety Are food safety detection Are air supply systems into manufacturing components devices monitored and facility inspected and/or limited and controlled? (retort inspected on a regular tested on a regular basi
Slide 60: #7 Shipping/Product Storage
#7 SHIPPING/PRODUCT STORAGE Are finished goods Are written procedures Are inspections appropriately established for inspection conducted of all segregated from raw of all vehicles prior to outbound vehicles prior materials or hazardous loading (bulk and non- to loading? chemicals? bulk)? Is mail han
Slide 61: Image #10
IMAGE #10 What’s the Vulnerability? What mitigation strategy would you suggest? 53
Slide 62: Completing Your Food Defense Plan
COMPLETING YOUR FOOD DEFENSE PLAN THE GLOBAL FOOD DEFENSE INSTITUTE
Slide 63: FDA Food Defense Plan Builder / GFDI REDI Plan Builder
FDA FOOD DEFENSE PLAN BUILDER GFDI FOOD DEFENSE AND EMERGENCY READINESS PLAN BUILDER (REDI) Additional Material needed for plans: Emergency Contact List (Corporate & Local Facility) Supplier Emergency Contact Information Building Schematics including evacuation plan for various types of emergencies
Slide 64: FDA Food Defense Plan Builder
FDA FOOD DEFENSE PLAN BUILDER 56
Slide 65: Global Food Defense Plan Builder Plus Assessment
GLOBAL FOOD DEFENSE PLAN BUILDER PLUS ASSESSMENT 57
Slide 66: GFDI Vulnerability Assessment
GFDI VULNERABILITY ASSESSMENT FOOTER 58
Slide 67: Upcoming Food Defense Public Courses
Upcoming Food Defense Public Courses February 25 @ Food Defense 9:00 am - Management February 26 @ 5:00 pm Orlando Florida • www.myfooddefense.com
Slide 68: Webinar Vulnerability Workshop Review
Webinar Vulnerability Workshop Review
Slide 69: Image #1
IMAGE #1 What’s the Vulnerability? What mitigation strategy would you suggest? 61
Slide 70: Image #2
IMAGE #2 What’s the Vulnerability? What mitigation strategy would you suggest? 62
Slide 71: Image #3
IMAGE #3 What’s the Vulnerability? What mitigation strategy would you suggest? 63
Slide 72: Image #4
IMAGE #4 What’s the Vulnerability? What mitigation strategy would you suggest? 64
Slide 73: Image #5
IMAGE #5 What’s the Vulnerability? What mitigation strategy would you suggest? 65
Slide 74: Image #6
IMAGE #6 What’s the Vulnerability? What mitigation strategy would you suggest? 66
Slide 75: Image #7
IMAGE #7 What’s the Vulnerability? What mitigation strategy would you suggest? 67
Slide 76: Image #8
IMAGE #8 What’s the Vulnerability? What mitigation strategy would you suggest? 68
Slide 77: Image #9
IMAGE #9 What’s the Vulnerability? What mitigation strategy would you suggest? 69
Slide 78: Image #10
IMAGE #10 What’s the Vulnerability? What mitigation strategy would you suggest? 70
Slide 79: Q&A
Q&A
Slide 80: Global Food Defense Training and Assessments Services - Contact Us
Global Food Defense Training and Assessments Services-Contact Us: 202-368-3007 or email: info@myfooddefense.com
Slide 81: Thank You!
THANK YOU! Global Food Defense Institute www.myfooddefense.com (202) 368.3007
Slide 82: OnTrak with ReposiTrak
OnTrak with ReposiTrak Are You Ready for FSMA Intentional Adulteration Inspection? Want to discuss further? Contact us to learn more. tjohnson@repositrak.com REPOSITRAK.COM 10