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Copyright Country Fare Consulting LLC, 2013 All Rights Reserved “ The U.S. Food and Drug Administration (FDA) counsel that supply chain management is one.

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Presentation on theme: "Copyright Country Fare Consulting LLC, 2013 All Rights Reserved “ The U.S. Food and Drug Administration (FDA) counsel that supply chain management is one."— Presentation transcript:

1 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved “ The U.S. Food and Drug Administration (FDA) counsel that supply chain management is one key to compliance with the Food Safety Modernization Act (FSMA). Shortly after enactment of FSMA, FDA Deputy Commission Michael Taylor explained that food companies must be vigilant in managing their supply relationships because responsibility for FSMA compliance and safe food production and processing falls on each food company.” 1 SVM™ - Food/Produce

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3 COMPANY BACKGROUND A few minutes about us. 3

4 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Our Mission Protect Consumers Protect our Client’s Brand COMPANY BACKGROUND 4

5 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Global Food Safety Supply Chain Management & Consulting Country Fare Consulting, LLC COMPANY BACKGROUND Food, Packaging Manufacturers, Distribution Centers, Warehouses - Food/Non-Food, Produce Supply Chain, Cross Docks – Terminal Markets Brokers Supply Chain Verification Management Foreign Supplier Verification (FSMA Compliant) Expert review of Audits & Corrective Actions HACCP Review and Evaluation Consultation Operating in 47 Countries –All Regions Managing 11 CB Relationships Oversee 1,500+ Supplier/Vendors  2,000+ Facilities 2013 – Managed 2,500+ Audits  Corrective Actions Services Scope Current Profile 5

6 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Our Organization Charles F. Cook Ph.D. 35+ years Experience Academia, Food Manufacturing, Food Safety, Quality, Regulatory Affairs, Audit Management  Founder & Managing Partner Cook & Thurber  Founder & Managing Partner Country Fare Consulting  Advisor – Consultant FDA/USDA  United Fresh Harmonized Calibration Committee  Trade Association Technical Committees  Adjunct at Univ. of Wis. Leadership Team Jean Thurber-Cook 23 Years Medical Profession  Law Firm Administrator  Founder & Managing Partner Cook & Thurber  Founder & Managing Partner Country Fare Consulting 5 Full-time administrators Over 20 on-demand experts Our Staff & Consultants COMPANY BACKGROUND 6 Jennifer Welsh 18+ years Telecom Industry Senior Quality Project Manager, Country Fare Consulting

7 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Our Technology Partner COMPANY BACKGROUND Cloud Technologies for Operations, Quality & Food Safety Drive Performance, Protect your Brand Mitch Porche, President & CEO 7

8 DEFINING THE PROBLEM Food Safety risk is increasing; problem and solution is getting more complex 8

9 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Recent Headlines October 2013 USDA – 12 Recalls Listeria Salmonella E.Coli Allergens Foreign Materials October 2013 FDA – 18 Recalls E.Coli – pumpkin Non potable water-cookies Cyclospora – Salads Listeria – Salads Spoilage – Cheese Allergens – Pasta Listeria, Salmonella – Cheese Lead – Spices Salmonella - Peppers 9

10 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Recent Headlines Food Business News Report – August 3, 2013 – Percentage of outbreaks linked to leafy vegetables. Dairy on the increase CDC Report “ Surveillance for food borne disease outbreaks in US 1998 – 2008” – FDA concerned about tree nut safety – Packaged salads may be source of Cyclospora outbreak (Not confirmed – Damaged Brand) Canadian Study – 594 samples of packaged salad Cyclospora 1.7% Cryptosporidum5.9% Giardia1.8% DEFINING THE PROBLEM | RISK IS INCREASING 10

11 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Recent Marler Blog Quotes What were the Wal-Mart and Kroger expectations from the audit? What are your expectations from and AUDIT? “ The relationship between retailers and auditor is a conspiracy” “ These retailers set the specifications for fresh fruit and ignored them” “ I would urge US Attorney to consider leveling criminal charges against the retailers Wal-Mart and Kroger “ and against Primus the auditing firm.” DEFINING THE PROBLEM | RISK IS INCREASING 11

12 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved “ One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.” DEFINING THE PROBLEM | RISK IS INCREASING California Supreme Court Ruling | 25 States 12

13 DEFINING THE PROBLEM It’s getting more complex 13

14 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Food and Packaging Product Relationship & Traceability DEFINING THE PROBLEM | GETTING MORE COMPLEX 14 Distribution Center Re-DC, ExporterWarehouseManufacture Vendor 1 Co- packer 2 3

15 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Food and Packaging Product Relationship & Traceability DEFINING THE PROBLEM | GETTING MORE COMPLEX 15 Distribution Center Re-DC, ExporterWarehouseManufacture Vendor 1 Co- packer 2 3 Performance & Compliance  Who are my good suppliers?  Who are my at-risk suppliers?  What trends are in my supply chain?  How do I demonstrate compliance? CB Management  Who are my Certifying Bodies?  Are they credible?  How do they know who, when to audit?  How do they communicate results?  How do the payments work? Supplier Management  Who are my vendors?  What do they supply?  Who do they supply to?  How do I contact them?  Are the certified?  When were they certified?  Have they performed Corrective Actions?

16 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Produce Product Relationship & Traceability DEFINING THE PROBLEM | GETTING MORE COMPLEX 16

17 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Produce Product Relationship & Traceability DEFINING THE PROBLEM | GETTING MORE COMPLEX Supplier Management  Who are my vendors?  What do they supply?  Who do they supply to?  How do I contact them?  Are the certified?  When were they certified?  Have they performed Corrective Actions? CB Management  Who are my Certifying Bodies?  Are they credible?  How do they know who, when to audit?  How do they communicate results?  How do the payments work? Performance & Compliance  Who are my good suppliers?  Who are my at-risk suppliers?  What trends are in my supply chain?  How do I demonstrate compliance? 17

18 IMPACT What does it mean for YOU? 18

19 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved 1.How comfortable are you with your current audit scheme? Are you confident that you are addressing all of your brand standards and risks? 2.How do you stay on top of “Industry Best Practices?” 3.How well do you know your Certifying Bodies? How do you stay on top of their performance? 4.How transparent is your current process? Do you know where your suppliers stand with respect to a). Performance b). Status c). Regulatory compliance Program Questions ARE YOU EFFICIENT?| IMPACT 19

20 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved 1.Are you getting all of the resources you need to meet your Quality, Safety and Brand Standards? 2.What resources are you applying to this program? Is it the “highest and best use?” Is it achieving your goals? 3.How valid is your vendor list and contact information? How much effort do you put into maintaining it? 4.What technologies do you have to support this program? What does it cost? Is it meeting your needs? ARE YOU EFFICIENT?| IMPACT Organizational Questions 20

21 AUDIT STANDARDS What schemes are appropriate, why and what does it mean? 21

22 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved 1.Meet General Industry Standards 2.Meet Minimum Regulations and Guidelines 3.Comparable to Industry Best Practices _______________________________ What are YOUR Specific Expectations? – Industry Best Practices – Regulations and Guidelines – Your Specific Addendums Expectations for Audit Scheme WHAT ARE YOUR EXPECTATIONS?| AUDIT STANDARDS 22

23 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Audit | Measure for Safety Your Brand? ARE YOU AIMING HIGHER?| AUDIT STANDARDS Level of Brand Protection 23

24 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved  Agrees and accepts scheme criteria  Agrees with the scheme weighting and rating  Agrees with scheme audit rating and accept/reject criteria  Is confident with CB’s audit capabilities and performance The selected Scheme and CB represent Your’s assurance of Food Safety Your Accepted Scheme | What does it infer? WHAT DOES IT MEAN?| AUDIT STANDARDS 24

25 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved  Are you supporting an acceptable “Standard of Care”?  Has the program been verified to meet an acceptable “Standard of Care”?  Is the program aligned with the your Mission Statement and implementation strategy? Summary: Scheme Questions ARE YOU CONFIDENT?| AUDIT STANDARDS 25

26 HOW CFC CAN HELP Leverage our people, expertise and technology. A Managed Solution. 26

27 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved A MANAGED SOLUTION Growers | Ranches | Packing Sheds | Harvest Crews | Coolers | Cross Docs | Terminals Country Fare Consulting, LLC 27 Manufacturers | Re-Distribution Centers | Warehouses | Distribution Centers

28 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved End-to-End Solution for Supply Chain Verification Management 1.Management of all Supplier/Vendor Data on Superior Technology Platform 2.Development & Maintenance of Audit Schemes 3.Selection, Management & Performance of Certifying Body’s 4.Manage entire Audit Process 5.Reporting to Vendor & Client 6.Continuous updates & feedback – We’re in this together 7.Technology Platform provides total transparency Service Overview LET US DO THE HEAVY LIFTING| A MANAGED SOLUTION Country Fare DOES NOT conduct audits | No conflict-of-interest 28

29 HOW WE DO IT – OUR APPROACH Outsource the work. You own the program. 29

30 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Setup Vendor Audit Planning Audit Scheduling Audit Management Reporting & Re-factoring Identify auditable units and relationships  Field Operations  Post Harvest Activities  Manufacturer  Distribution Center  Warehouse (Food – non Food) Identify Appropriate Audit Setup vendor profile  Legal name / entity  Location  Contact  Commodities Identify Appropriate Audit Scheme Identify Appropriate Certifying Body Set audit completion dates and assign to CB Monitor schedule pipeline Manage Corrective Action Process  Review Audits & Ratings  Calibration of CB – Shadow Audits Identify High-Risk Vendors and notify Provide Final Audit Reports to vendor and Client Review Ratings Distributions  Review Audits & Ratings  Send Corrective Action Letter Review program, adjust as needed Coordinate with Supplier/Vendor to determine Audit preferences IT ALL COMES DOWN TO PROCESS| A MANAGED SOLUTION Process Overview Notifications to vendor, client and Certifying Body 30 HACCP plan review

31 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Process Overview (Workflow) IT ALL COMES DOWN TO PROCESS| A MANAGED SOLUTION 31

32 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved BUILT ON A POWERFUL TECHNOLOGY PLATFORM| A MANAGED SOLUTION Oversee Relationships & Process  Identify all supply chain process entities linked to specific supplier  Documents all relevant information for each process entity Secure storage data & documents  Food Safety Plans  Crisis Management/Recall plans  Preventive Control  Foreign Supplier Verification  FDA Registration Verification Powerful reporting & insights  Status & performance  Dashboards Powered by Technology 32

33 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved SVM Comparison ServiceSVM Company “A” Company “B” On-line Document Storage & Record Mgt. Set up & management of Supplier/Vendors Audit Planning Audit Scheduling Audit Management Corrective Actions / Preventative Measures Management Reporting and Refactoring Notifications & Escalations Workflow-enabled Technology Customizable Technology Platform Copyright Country Fare Consulting LLC, 2013 All Rights Reserved 33

34 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Total Management Fee per Audit* Service Fee & Technology Fee bundled  CB will incorporate the Total Management Fees with Audit fee paid by vendor  CFC invoices CB monthly for Total Management Fees *Fees dependent on number and type of audits processed Cost Model How the program is financed and who will pay for it? 34

35 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved In Summary  CFC’s Supplier Verification Management (SVM) provides:  Total produce Global supply chain Food Safety Audit Management  Assurance for product safety  Demonstrable due diligence in protecting clients customers and brand integrity  CFC exclusively represents Client’s interest as an extension of the client (Co-source) as an independent contractor  SVM is a “Process-Driven” Service & Technology platform  Client owns the Program. CFC provides expertise, management services and industry focus 35

36 ADDENDUM 36

37 ADDITIONAL SERVICES Other way’s Country Fare Consulting can help. 37 Appendix

38 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Additional Services  General Food Safety & Quality Consulting  Assist Client in Development of Produce Requirements Growers Harvest Crews Packing Sheds Coolers Produce Processors Produce Food Safety Produce Quality 38

39 AUDIT SCHEMES Industry status and developments. 39

40 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Produce Safety  LGMA – Leafy Green Marketing Agreement – California – Arizona (USDA-State) – Other States and Mexico – LGMA “like” with CB’s  Tomato Metrics (T-GAPs) - Tomato Protocol for Fresh Tomato supply chain – CTF (USDA-State) – CB’s  Client Standards AUDIT SCHEMES| PRODUCE SAFETY 40

41 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Produce Safety  Harmonized Scheme (United Fresh) – Field Operations – Post Harvest  USDA (AMS) Audit Schemes – Commodity specific check lists Mushroom Cantaloupe – Farm Review – Field Packing – Harvesting – House Packing – Storage – Transport – Wholesale Distribution – Terminal Markets AUDIT SCHEMES| PRODUCE SAFETY (Continued) 41

42 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Produce Safety  Global GAP – PSS and IFA  Canada GAP  SQF (Level I)  Primus  Primus GFS AUDIT SCHEMES| PRODUCE SAFETY (Continued) 42

43 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Preferred Audit Schemes Audit Schemes Preferred by Country Fare Consulting  LGMA - Leafy Greens  Harmonized (amenable to all commodities)  Tomato Metrics Why we prefer them  Broad stakeholder input – no proprietary ownership  Continued stakeholder management and review  Non-scored – does not give false sense of security  (Accurate assessment of performance) Client determines accept/reject level  Possible Ratings – Acceptable – Minimally Meets Audit Expectations – Not Acceptable (IAR’s) AUDIT SCHEMES| PREFERRED 43

44 UNITED FRESH - HARMONIZATION Background and interpretation 44

45 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved “Develop a harmonized food safety standard and checklist for GAP audits, and globally-acceptable auditing process, necessary to protect consumers from potential hazards that may contaminate produce at that state of the supply chain, and that will build efficiencies into the supplier audit process.” One audit by any credible third party, acceptable to all buyers Vision UNITED FRESH| VISION 45

46 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Scope of Work A single, generic checklist for GAP/GHP audits  Focused on food safety practices of pre and post farm gate produce operations (as defined by the scope of the FDA GAPs)  With clearly defined requirements that minimize opportunity for misunderstanding, misinterpretation and “standards creep” by operations and auditors  Globally recognized, but specifically applicable to North America buyers UNITED FRESH| SCOPE 46

47 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Scope of Work  Requirements that are risk-based, science-based, attainable, auditable and verifiable  Considers all microbiological, chemical and physical hazards “reasonably likely to occur”, consistent with potential hazards addressed in FDA regulatory guidance's  Scalable to all size fresh produce operations  Considerate of regional and commodity specific food safety needs  Sufficiently non-prescriptive to be accepting of equivalent food safety practices UNITED FRESH| SCOPE (Continued) 47

48 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Cross-Functional Participation  Wide spectrum of produce industry (leafy greens, tree fruit, melons, mushrooms, berries, root crop) representation – Growers and other pre-harvest activities (Trade Associations) – Processors – Food service – Retail – State and Federal Regulatory Agencies UNITED FRESH| PARTICIPATION 48

49 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Process to Harmonization McDonaldsWegmansChiquita Fresh YUM BrandsAholdSun World International Pro*ActKrogerDiMare Company US FoodserviceLoblawsGreen Giant Fresh DardenSafewaySunkist Growers Jack in the BoxSchnucksCastellini Company SYSCOPublixMcEntire Produce SUBWAY®Wal-MartDole Food Company MarkonFood LionTaminura & Antle River RanchSupervaluThe Giumarra Companies Del Monte FreshCostcoC.H. Robinson Taylor Farms14 Produce Associations Identified a small but influential Steering Committee of major industry representatives with the ability to drive broad industry acceptance of common standards: UNITED FRESH| PROCESS 49

50 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Process to Harmonization  Standard to be freely accessible on United Fresh and other Association websites  Auditors to be calibrated by train-the-trainer sessions for consistent use of the standard  Process for use of the standard by auditing bodies and auditors. Free use of the standard  While consistent use of the standard is critical, management of the audit process and auditor performances is in the hands of CB’s UNITED FRESH| PROCESS (Continued) 50

51 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved  United Fresh to be the Secretariat of the standard, responsible to the industry for maintaining the standard and serving as point of contact for inquiries and request for change  Technical Working Group (TWG) to remain responsible for content of the standard  United Fresh to be responsible for periodic (semi-annual) meetings of the TWG to assess the standard  Process must be formalized to solicit input, incorporate new science and feedback from audits, make and communicate changes to the standards Process to Harmonization UNITED FRESH| PROCESS (Continued) 51

52 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved  Making the standard freely available for its intended use, while assuring it is financially sustainable  Managing how the standard is used by audit organizations  Auditor training and calibration  Process to resolve disputes on interpretation of the standard  Process to update, adjust the standard as needed  Process to accept audits using the standard Process to Harmonization UNITED FRESH| PROCESS (Continued) 52

53 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Audit Features  Excellent training tool, easy to use and understand  Audit output non-scored – buyers free to make purchase decisions based on number of conformances or non-conformances  Audit rating not biases toward high scores giving a false sense of security UNITED FRESH| AUDIT FEATURES 53

54 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved Where we are now… * Some conditions may apply; please check with your customer/buyer These produce-buying companies (and others) endorse* audits using the Harmonized Standards UNITED FRESH| WHERE ARE WE? 54

55 Copyright Country Fare Consulting LLC, 2013 All Rights Reserved These audit organizations (and others) are using or plan to use the Harmonized Standards for GAP audits. Audit Firms have Global reach. Where we are now… UNITED FRESH| WHERE ARE WE? (Continued) 55


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