Supplier Management Program

8/26/15 version

• After logging into Adobe Connect, adjust your laptop speakers based on the Adobe Connect music pod volume

•

• For technical assistance contact Michael Clark at michael.clark@fda.hhs.gov

• Visit and for slides and

other event files

1

Supplier Management Program

8/26/15 version

FSMA TRAINING: SUPPLIER MANAGEMENT PROGRAMS

2

Supplier Management Program

8/26/15 version

3

Warm Welcome Kathy Gombas Senior Advisor,

CFSAN Office of Food Safety Co-Lead, FSMA Training Workgroup

Supplier Management Program

8/26/15 version 4

Food Safety Culture 101 – March 19 Systems Thinking – April 28

Environmental Monitoring - June 25 Supplier Management Programs - Aug 27

Minimizing Allergens Risk - Oct 22 Food Safety Culture 201 – Nov 12

Events for sharing industry best practices & FDA perspectives: 2015 Sessions

Supplier Management Program

8/26/15 version

Agenda

5

• 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

Supplier Management Program

8/26/15 version

Human Food Industry Best Practices

Warren Stone, MBA Senior Director of Science Policy, Compliance & Inspection Grocery Manufacturers Association

6

Supplier Management Program

8/26/15 version

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

Supplier Management Program

8/26/15 version

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

Supplier Management Program

8/26/15 version

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.

Prior Knowledge

9

Supplier Management Program

8/26/15 version

Suppliers are • ingredient providers • food-contact packaging providers • re-packers • co-manufacturers • brokers • third party warehouses • others

What’s a supplier?

10

Supplier Management Program

8/26/15 version

Supplier Management Network

11

Supplier Management Program

8/26/15 version

• 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

Seasoned Veggie Snack

12

Supplier Management Program

8/26/15 version

CEO: “The big lesson I learned is, always monitor suppliers and not take anything for granted.”

Lesson Learned

13

Supplier Management Program

8/26/15 version

• 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 D3 – China

Source: Sara Lee

Source: Amy Schoenfeld, New York Times

Single Standard for Safety

14

Supplier Management Program

8/26/15 version

Industry historically has managed supply chain risks by addressing BOTH the INGREDIENT and the SUPPLIER, their successes, their failures and opportunities for improvement.

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.

Common goal: Protect the consumer!

Same Objective, Different Approach

15

Supplier Management Program

8/26/15 version

• 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.

Same Objective, Different Approach

As such, successful supply management programs must be risk-based and flexible.

16

Supplier Management Program

8/26/15 version

• Risk/Food Safety Assessment

• Global Food Safety Initiative Certification

• Pre-Assessment • Audit Approval

• Audit Program • Certificate of Analysis • Testing • Performance Monitoring

• Supplier Quality Expectations HACCP Specifications

• Supplier Development • Improvement Programs • Industry Benchmarking

Continuous Improvement

Policy/ Contracts

Selection & Approval Accountability

Food safety systems assess, manage and mitigate risk

Risk-based, Flexible SMP

17

Supplier Management Program

8/26/15 version

• 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.

Role of Verification Activities in Supplier Management

18

Supplier Management Program

8/26/15 version

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.

Carefully Design Supplier Management Approach

19

Supplier Management Program

8/26/15 version

• 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)

Potential Supplier Assessment Considerations

20

Supplier Management Program

8/26/15 version

• Foreign material potential • Allergen management practices • History of compliance • 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?

Potential Supplier Assessment Considerations

21

Supplier Management Program

8/26/15 version

Available in: • English • Spanish • Mandarin • French • Russian • Japanese

http://www.gmaonline.org/downloads/technical-guidance-and-tools/GMA_SupplyChain2.pdf

:

Food Supply Chain Handbook

22

Supplier Management Program

8/26/15 version

• 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

Food Supply Chain Handbook Tools

23

Supplier Management Program

8/26/15 version

• 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.

Summary / Conclusions

24

Supplier Management Program

8/26/15 version

Questions & Answers

Q & A – Use the Adobe Connect pod to type your questions

25

Supplier Management Program

8/26/15 version

Animal Food Industry Best Practices

Dave Fairfield Vice President, Feed Services National Grain and Feed Association

26

Supplier Management Program

8/26/15 version

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

Supplier Management Program

8/26/15 version

First U.S. Feed Manufacturing Firm: 1875 - Blatchford’s

Waukegan, Illinois

Source: FMT V, 2005

DFS Inc., Newell, Iowa - Today

What does the animal feed and pet food supply/distribution chain look like and why?

Animal Food Supply / Distribution Chain

28

Supplier Management Program

8/26/15 version

Supply & Delivery System

29

Supplier Management Program

8/26/15 version Source: FDA, USDA

11,652 Domestic

Animal Food Facilities

6,062 Animal Food Only Facilities

5,130 Commercial Animal Feed

Facilities

546 Integrated

Animal Feed Facilities

386 Pet Food Facilities

• 1,400 Domestic Animal Food Ingredient Facilities

• 1,843 Foreign Animal Food Only Facilities

• 9,000 Domestic Grain Elevators • 400,000 Domestic Grain Farmers

Structure of Animal Food Industry

30

Supplier Management Program

8/26/15 version

SMP Practices Across Segments

31

Supplier Management Program

8/26/15 version

1. Ingredient selection • Nutrient content • Relative value • Safety considerations • Palatability • Handling characteristics

2. Ingredient specifications • Safety • Quality • Nutrients

SMP Components & Implementation

32

Supplier Management Program

8/26/15 version

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

SMP Recommended Components: Supplier Selection

33

Supplier Management Program

8/26/15 version

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

Supplier Management Program

8/26/15 version

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 Type of Assay Frequency

Animal Protein

Products

~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Vegetable Protein

Products

~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Fats/Oils ~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Grain ~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Grain Co-Products

~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Macro Minerals

~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Trace Minerals

~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

Vitamins ~~~~~~ ~~~~~~

~~~~~~ ~~~~~~

SMP Recommended Components: Ingredients Analysis

35

Supplier Management Program

8/26/15 version

6. Supplier performance review • Non-conformances • Corrective actions • Trends • Supplier audits • Communicate • Communicate • Communicate

Act Plan

Do Check Like any component of a food safety system, the goal is continuous

improvement!

SMP Recommended Components: Supplier Performance

36

Supplier Management Program

8/26/15 version

• 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

Summary

37

Supplier Management Program

8/26/15 version

Questions & Answers

Q & A – Use the Adobe Connect pod to type your questions

38

Supplier Management Program

8/26/15 version

FDA Wrap-up Q & A Panel

Jenny Murphy Consumer Safety Officer Center for Veterinary Medicine

39

Supplier Management Program

8/26/15 version

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.

Events for sharing industry best practices & FDA perspectives: Upcoming events

40

Supplier Management Program

8/26/15 version

PC Rule Readiness Training Resources

http://inside.fda.gov:9003/CFSAN/CFSANStaffCollege/FoodSafetyModernazationAct/ucm449590.htm

https://www.foodshield.org/blog-training-news/fsma-pc-rule-readiness-environmental-monitoring-june-25-2015/

41

Supplier Management Program

8/26/15 version

Email Questions (State and FDA): For questions about FSMA and FSMA implementation, please email fsmafaqs@fda.hhs.gov

Feedback Form (FDA): For feedback to help us implement FSMA effectively, please use FDA’s FSMA feedback form at http:/sharepoint.fda.gov/orgs/OFVM/FSMAOpsStrategy/SitePages/Home.aspx /

Registered participants will receive an evaluation survey shortly. Thank you for your help ensuring quality events.

Feedback

42