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1 After logging into Adobe Connect, adjust your laptop speakers based on the Adobe Connect music pod volume For technical assistance contact Michael Clark at Visit and for slides and other event files 1

2 FSMA TRAINING: SUPPLIER MANAGEMENT PROGRAMS 2

3 Warm Welcome Kathy Gombas Senior Advisor, CFSAN Office of Food Safety Co-Lead, FSMA Training Workgroup 3

4 Events for sharing industry best practices & FDA perspectives: 2015 Sessions Food Safety Culture 101 March 19 Systems Thinking April 28 Environmental Monitoring - June 25 s - Aug 27 Minimizing Allergens Risk - Oct 22 Food Safety Culture 201 Nov 12 4

5 Agenda Introductions Warren Stone, Grocery Manufacturers Association Human Food Industry Questions & Answers Dave Fairfield, National Grain and Feed Association Animal Food Industry Questions & Answers Jenny Murphy, FDA Wrap-up 5

6 Warren Stone, MBA Senior Director of Science Policy, Compliance & Inspection Grocery Manufacturers Association Human Food Industry Best Practices 6

7 Questions from Human Food Industry Perspective 1. How do industry approaches and FSMA requirements differ? 2. We always hear about flexibility. What does this mean and why is it important to Supplier Management Programs (SMP)? 3. What are some of the tools used in Supplier Management? 7

8 Key Component Industry appreciates the value of implementing comprehensive, flexible, risk-based, supplier approval and verification programs. Thorough, robust, and risk-based supply chain management is a key component of an overall food safety & quality program. 8

9 Prior Knowledge Long before terms like melamine and PCA entered the food safety vernacular, industry knew Preventing the production and shipment of adulterated food is heavily favored over reliance on corrective action plans once contaminated goods have entered distribution channels. Successful interactions with suppliers are a precursor to effective food safety management. Resources devoted to knowing and building relationships with a company s suppliers represent sound investments. 9

10 What s a supplier? Suppliers are ingredient providers food-contact packaging providers re-packers co-manufacturers brokers third party warehouses others 10

11 Supplier Management Network 11

12 Seasoned Veggie Snack Recalled in 2007 after linked to at least 60 cases of salmonellosis in 19 states Suspected source: dried Chinese vegetable seasonings Company s seasoning supplier had outsourced production to China without the manufacturer s knowledge 12

13 Lesson Learned CEO: The big lesson I learned is, always monitor suppliers and not take anything for granted. 13

14 Wheat gluten France, Poland, Russia, Netherlands, Australia Honey China, Vietnam, Brazil, Uruguay, India, Canada, Mexico, Argentina Calcium proprionate Netherlands Guar gum India Flour enrichments China Beta-carotene Switzerland Vitamin D 3 China Single Standard for Safety Source: Sara Lee Source: Amy Schoenfeld, New York Times 14

15 FSMA supply chain rules address THE INGREDIENT, the hazards, if any, associated with it, and identifying where in the supply chain these hazards are addressed. Same Objective, Different Approach Industry historically has managed supply chain risks by addressing BOTH the INGREDIENT and the SUPPLIER, their successes, their failures and opportunities for improvement. Common goal: Protect the consumer! 15

16 FSMA: includes a focus on ingredient hazards Traditional Industry: ingredient hazards & supplier performance Systems based Programs often focus on the supplier s overall food safety system, rather than only a supplier s control of ingredient-specific hazards. The hazard only approach could overlook significant aspects of a supplier s program that could have an important impact on food safety. As such, successful supply management programs must be risk-based and flexible. Same Objective, Different Approach 16

17 Risk-based, Flexible SMP Food safety systems assess, manage and mitigate risk Supplier Development Improvement Programs Industry Benchmarking Supplier Quality Expectations HACCP Specifications Continuous Improvement Policy/ Contracts Audit Program Certificate of Analysis Testing Performance Monitoring Accountability Selection & Approval Risk/Food Safety Assessment Global Food Safety Initiative Certification Pre-Assessment Audit Approval 17

18 Role of Verification Activities in Supplier Management GMA strongly agrees that a supplier program is a vital component of an effective overall food safety system. While the activities that employed as part of a supplier management program do not directly, significantly minimize or prevent hazards, industry regards them as valuable verification activities. 18

19 Carefully Design Supplier Management Approach No one approach will suffice for all supplier evaluations. In order to be effective, supplier assessment tools must be flexible, risk-based, appropriate and necessary to the particular supplier, the food/ingredient and its role in the customer s overall food safety program. There is NOT one standard checklist. 19

20 Potential Supplier Assessment Considerations History, number and severity, of required supplier action items Antibiotics, other drugs in aquaculture feed Water supply Time delivery factor Repeat non-conformance Temperature and cleanliness of transportation Ship complete load or Less Than Truckload (LTL) 20

21 Foreign material potential Allergen management practices History of compliance Potential Supplier Assessment Considerations Risk assessment based on Good Manufacturing Practices (GMP) and food safety practices Previous audit performance Supplier performance Audits by whom (e.g., company, third-party auditor, etc.) and what for? 21

22 Food Supply Chain Handbook : Available in: English Spanish Mandarin French Russian Japanese 22

23 Food Supply Chain Handbook Tools Supplier Management Supplier Pre-assessment & Review Change Control Documentation & Recordkeeping Supplier Documentation (Letters of Guarantee, Certificates of Analysis, etc.) Auditing Internal & External Foreign Material Control Label Control Programs Design Controls Inventory Controls Regulatory Compliance Food Defense Sanitation Programs Food Safety Employee Training Environmental Monitoring Allergen Management Control of Non-conforming Product (Hold & Release) Product & Ingredient Tracing 23

24 Summary / Conclusions Supply chain management is an integral component of a successful food safety system. Risk-based, flexible, appropriate, and tailored approaches to supply chain management should be employed throughout the food supply chain. Industry has traditionally approached this by evaluating the supplier as well as the ingredient, while FSMA is approaching this by addressing ingredient hazards, if any. Both approaches can be used to protect the consumer and augment the overall public health. 24

25 Questions & Answers Q & A Use the Adobe Connect pod to type your questions 25

26 Animal Food Industry Best Practices Dave Fairfield Vice President, Feed Services National Grain and Feed Association 26

27 Questions from Animal Food Industry Perspective 1. What does the animal feed and pet food supply/distribution chain look like and why? 2. How do supplier management program (SMP) practices differ across the supply chain segments? 3. What are the main components of supplier management programs for animal feed and pet food and how are they implemented? 27

28 Animal Food Supply / Distribution Chain DFS Inc., Newell, Iowa - Today First U.S. Feed Manufacturing Firm: Blatchford s Waukegan, Illinois What does the animal feed and pet food supply/distribution chain look like and why? Source: FMT V,

29 Supply & Delivery System 29

30 11,652 Domestic Animal Food Facilities 6,062 Animal Food Only Facilities Structure of Animal Food Industry 1,400 Domestic Animal Food Ingredient Facilities 1,843 Foreign Animal Food Only Facilities 9,000 Domestic Grain Elevators 400,000 Domestic Grain Farmers 5,130 Commercial Animal Feed Facilities 546 Integrated Animal Feed Facilities 386 Pet Food Facilities Source: FDA, USDA 30

31 SMP Practices Across Segments 31

32 1. Ingredient selection Nutrient content Relative value Safety considerations Palatability Handling characteristics SMP Components & Implementation 2. Ingredient specifications Safety Quality Nutrients 32

33 SMP Recommended Components: Supplier Selection 3. Supplier selection Inform potential suppliers of required safety and quality specifications As appropriate to the ingredient and potential supplier: Assess the supplier s operations and product safety practices and conformance to regulatory requirements Second- and/or third-party audits may be used to provide assurances Procure representative samples of the ingredient for evaluation Request and receive certificates of analysis Request references from previous purchasers 33

34 4. Receiving ingredients Verify accuracy and completeness of shipping documents and label Inspect product prior to unloading Obtain representative sample Evaluate the sample Physical characteristics Quick tests Reference samples Retain the representative sample for an appropriate length of time Reject and/or quarantine products that deviate from required specifications SMP Recommended Components: Receiving 34

35 SMP Recommended Components: Ingredients Analysis 5. Laboratory analysis of ingredients Follow an established schedule to assay ingredients Frequency may be based upon: Risk to product safety Variability of ingredient History of supplier Select a qualified laboratory Recognized methodology Product Animal Protein Products Vegetable Protein Products Fats/Oils Grain Grain Co-Products Macro Minerals Trace Minerals Type of Assay Frequency Vitamins 35

36 SMP Recommended Components: Supplier Performance 6. Supplier performance review Non-conformances Corrective actions Trends Supplier audits Communicate Communicate Communicate Like any component of a food safety system, the goal is continuous improvement! Act Check Plan Do 36

37 Summary The U.S. animal food supply chain consists of many different segments (pet food, complete animal feed, ingredients, concentrates, premixes, etc.), with each part having its own product safety considerations The sophistication of a given supplier management program is dictated by risk (associated with raw materials, ingredients, finished product, and facility), industry segment and company needs Building supplier relationships is key - effective communication is essential 37

38 Questions & Answers Q & A Use the Adobe Connect pod to type your questions 38

39 FDA Wrap-up Q & A Panel Jenny Murphy Consumer Safety Officer Center for Veterinary Medicine 39

40 Events for sharing industry best practices & FDA perspectives: Upcoming events Minimizing Allergens Risk - Oct 22 Food Safety Culture 201 Nov 12 We want your input on CY2016 topics. Please contact Kathy Gombas or Jenny Murphy. 40

41 PC Rule Readiness Training Resources FSAN/CFSANStaffCollege/ FoodSafetyModernazationA ct/ucm htm og-training-news/fsma-pcrule-readinessenvironmental-monitoringjune / 41

42 Questions (State and FDA): Feedback For questions about FSMA and FSMA implementation, please Feedback Form (FDA): For feedback to help us implement FSMA effectively, please use FDA s FSMA feedback form at epages/home.aspx / Registered participants will receive an evaluation survey shortly. Thank you for your help ensuring quality events. 42