1. Third Party Auditing: It’s not Just for Large Plants Anymore
Jason Young -
GFSI Specialist/ Quality Management Specialist
Robert M. Kerr Food & Agricultural Products Center
Springfield, Illinois June 18 – 20, 2015

2. Customers
Retail
Walk In

3. Restaurant and Grocery
Customers
Local
Restaurant and Grocery
Retail Walk In

4. Big Box Stores & Distribution Centers
Customers
Big Box Stores & Distribution Centers
Retail Walk In
Local Restaurant & Grocery

5. What Are Your Customers Requirements?
Laws and Regulations
Customer Requirements

6. What is the Law? Meat Inspection Requirements 9 CFR Chapter III
9 CFR 417 HACCP
9 CFR 416 SSOP
9 CFR 430
9 CFR 317

7. Customer Requirements? Risks? CDC?

8. Customer Risks: Recalls and Deaths
6 deaths
Listeria monocytogenes
4 deaths
E. coli O157:H7

9. Customer Risks: Recalls and Deaths
2011
32 deaths
E. Coli O104:H4
2010
33 deaths
Listeria monocytogenes

10. Customer Risks: Recalls and Deaths

11. Customer Requirements
Contracts/Specifications Third Party Audit Creating a food safety system and then having an audit to become “Certified”

12. Food Safety Management Systems
Food Safety - concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
HACCP – Premier Food Safety Tool
Recognized as the best available approach to ensuring the safety of food.
Guideline not Standard
Food Safety System
“The organizational structure, processes, procedures, and resources needed to implement, maintain and continually improve food safety management”

13. Audits Customer Second-party Third-party Internal External Supplier
Customer audits, your organization
Third-party
Independent audit organization
Internal
First Party
Audit your own organization
External
Second-party
You audit your supplier
Supplier

14. Third Party Audit Types
Regulatory – USDA FSIS
Regulatory- FDA – cGMP
Supplier Audits
GMP: Food Safety & Sanitation
GFSI Guidance and Schemes
Global Markets

15. Regulatory Audits USDA FSIS FDA – Unannounced Inspection
Webinar
Regulatory Audits
USDA FSIS
FSIS Directive Rev 4, 5/29/15
EIAO FSA Methodology
FDA – Unannounced Inspection
Form 482 Notice of Inspection
Form 483 Findings
Internal Auditing for GFSI Food Safety Managment Systems

16. Supplier Audits Customer visits your facility OR
May or may not have a checklist or set of criteria
Looking at real time food safety in your facility
Creating Relationship OR
You visit your supplier

17. Customer Risks:
Mid 90’s Advanced Audit Schemes Food Safety and Quality Systems

18. GMP: Food Safety & Sanitation Audit
Traditional Food Safety & Sanitation More than 40 years of audits Criteria
3rd Party Auditing Company
Specific criteria created by Auditing Company
Audit Criteria per customer’s requirement

19. GMP: Food Safety & Sanitation Audit Criteria
Audit Companies – Traditional Criteria
AIB, ASI, Silliker, NSF, Cert ID, SCS Global, etc
Food Safety & Sanitation Standards
Prerequisite and Food Safety Programs
Operational methods & personnel practices
Maintenance for food safety
Cleaning Practices
Integrated pest management
Adequacy of Prerequisite and food safety programs

20. Food Safety & Quality Standards
Food Quality Magazine – by 2002
More than 135 different suppliers standards for food safety
Similar but different criteria and auditing practices
Establishments implement more than one Food Safety, Sanitation, &/or Quality program for Customers
Several customers
Ideal: Single auditing system for all sectors in food and beverage industry

21. Traditional Food Safety Audit Systems
Pre-GFSI

22. Global Food Safety Initiative Origins
May 2000 –International meeting of Food Retailer CEOs identified the major risks to their businesses.
Food Safety
Consumer Protection
Consumer Confidence
Formed a Committee of International Technical Executives -GFSI

23. GFSI Audit GFSI Recognized Schemes Global Markets
SQF, BRC, FSSC 22000, GRMS
12 Schemes total
Global Markets
Basic Level
Intermediate Level

24. GFSI Mission
Continuous improvement in food safety management systems to ensure confidence in the delivery of safe food to consumers
Objectives:
Convergence between food safety standards through maintaining a benchmarking process for food safety management schemes.
Improve cost efficiency throughout the food supply chain through the common acceptance of GFSI recognized standards by retailers around the world.
Provide a unique international stakeholder platform for networking, knowledge exchange and sharing of best food safety practices and information.

25. GFSI Benchmarked Standards
Examples:
Standard
Origin
Website
BRC Global Standard UK
Safe Quality Food(SQF)
Australia/U.S.
FSSC 22000
(ISO PAS 220) Or

26. GFSI Standards - Benchmarked
Consistency in evaluation of content and program requirements is assured by the benchmarking process
Audit execution is overseen by independent accreditation bodies such as UKAS (UK) and ANSI (USA)

27. Accredited Certification - Audit
International Accreditation Forum
e.g., ANAB, ANSI
Peer Review by Sister Accreditation body
ISO/ IEC 17011
Accreditation Bodies
Accredits the Certification Body (CB)
Including witness (shadow ) audits
ISO/IEC Guide 65 or ISO
Certification Bodies employ Auditors
Audit the Food or Ingredient Company
GFSI Benchmarked Schemes
BRC, SQF, FSSC 22000
Supplier
Supplier
Supplier

28. Traditional Food Safety & Sanitation Audit

29. 2007 –Adoption of GFSI Standards by Retailers
Wal-Mart
Feb Suppliers of its private label and certain other food items, like produce, meat and fish, must comply with Global Food Safety Initiative standards
Implemented by July 2009
Tesco
Carrefour
Metro
Migros
Ahold
Delhaize

30. Consumer Goods Forum Retail Members
Back in 2000, food safety was also top of mind with consumers due to several high-profile recalls, quarantines, and negative publicity about our industry. The retailers and manufacturing CEOs agreed that consumer trust needed to be strengthened and maintained, while making the supply chain safer, through the harmonisation of food safety standards and driving cost efficiency, which is why GFSI was created. At this time, food safety was top of mind with consumers due to several high-profile recalls, quarantines, and negative publicity about our industry. The retailers and manufacturing CEOs agreed that consumer trust needed to be strengthened and maintained, while making the supply chain safer. Back in 2000 and to this day, the scope of GFSI remains food safety focused only. GFSI does not deal with environmental or social issues so that it can remain focused on its mission and objectives which are as follows (next slide): 30

31. Consumer Goods Forum Manufacturing Members
Back in 2000, food safety was also top of mind with consumers due to several high-profile recalls, quarantines, and negative publicity about our industry. The retailers and manufacturing CEOs agreed that consumer trust needed to be strengthened and maintained, while making the supply chain safer, through the harmonisation of food safety standards and driving cost efficiency, which is why GFSI was created. At this time, food safety was top of mind with consumers due to several high-profile recalls, quarantines, and negative publicity about our industry. The retailers and manufacturing CEOs agreed that consumer trust needed to be strengthened and maintained, while making the supply chain safer. Back in 2000 and to this day, the scope of GFSI remains food safety focused only. GFSI does not deal with environmental or social issues so that it can remain focused on its mission and objectives which are as follows (next slide): 31

32. Benchmarking – What does this mean?
“Once certified, accepted everywhere”
These are the schemes which have currently been recognised by GFSI. 32

33. BRC - 7 Sections
Senior Management Commitment and Continual Improvement
The Food Safety Plan–(HACCP)
Food Safety and Quality Management System
Site Standards – Prerequisite Programs
Product Control
Process Control
Personnel

34. BRC Audit Scheme
Focus is on 50% documentation and 50% physical inspection (on site)
If a non-conformance is issued, a corrective action must be completed within 28 days of the audit
Major non-conformance – 14 days
All non-conformances must be cleared before a certificate can be issued
Critical non-conformance – no certificate

35. Requirement / question
Ref
Facility
Record
Requirement / question
1.0 SENIOR MANAGEMENT COMMITMENT
1.1 SENIOR MANAGEMENT COMMITMENT AND CONTINUAL IMPROVEMENT
(FUNDAMENTAL) The company’s senior management shall demonstrate they are fully committed to the implementation of the requirements of the Global Standard for Food Safety and to processes which facilitate continual improvement of food safety and quality management.
1.1.1 x
The company shall have a documented policy which states the company's intention to meet its obligation to produce safe and legal products to the specified quality and its responsibility to its customers. This shall be: - Signed by the person with overall responsibility for the site - Communicated to all staff.
1.1.2
The company's senior management shall ensure that clear objectives are defined to maintain and improve the safety, legality, and quality of products manufactured, in accordance with the quality policy and this Standard. These objectives shall be: - Documented and include targets or clear measures of success - Clearly communicated to relevant staff - Monitored and results reported at least quarterly to site senior management.

36. Fundamental requirement –
There must be an implemented and effective Food Safety Plan based on Codex Alimentarius HACCP principles.
Ref
Facility
Record
Requirement / question
2.1 THE HACCP FOOD SAFETY TEAM - CODEX ALIMENTARIUS STEP 1
2.1.1 x
The HACCP plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for Quality/Technical, Production Operations, Engineering, and other relevant functions. The team leader shall have an in-depth knowledge of HACCP and be able to demonstrate competence and experience. The team members shall have specific knowledge of HACCP and relevant knowledge of product, process, and associated hazards. In the event of the company not having appropriate in-house knowledge, external expertise may be used, but day-to-day management of the food safety system shall remain the responsibility of the company.

37. The SQF Code, Edition 7 Supplier selects relevant module(s)
Module 2 SQF System Elements (applies to all Suppliers) Module 3 GAP for Single Feed Production (TBD) Module 4 GAP for Compound Feed Production (TBD) Module 5 GAP for Farming of Animal Products Module 6 GAP for Farming of Fish Module 7 GAP for Farming of Plant Products Module 8 GAP for Farming of Grains and Pulses Module 9 GMP for Pre-processing of Animal Products Module 10 GMP for Pre-processing of Plant Products Module 11 GMP for Processing of Food Products Module 12 GMP for Transport and Distribution of Food Module 13 GMP for Production of Food Packaging Module 14 GMP for Food Brokers (TBD) Module 15 GMP for Food Retail, Food Service (TBD) Module 16 SQF Multi-site Program
Supplier selects relevant module(s)

38. SQF - 9 sections & GMP Module
Management Commitment
2.1.2 – Food Safety (HACCP
Document Control and Records
Specification and Product Development
Attaining Food Safety – prerequisites
Verification
Product Identification, Trace, Withdrawal and Recall
Site Security
Identity Preserved
Training

39. Applicable SQF Code Modules
SQF FSC
Category
(Suppliers Scope of Certification)
GFSI Industry Scopes
Applicable SQF Code Modules 1
Production, Capture and Harvesting of Livestock and Game Animals
Al: Farming of Animals
Module 2: System elements
Module 5: GAP for farming of animal products 2
Growing and Harvesting of Animal Feeds
Fl: Production of Single Ingredient Feed (available )
Module 3: GAP for single feed production 3
Growing and Production of Fresh Produce
Bl: Farming of Plant Products
Module 7: GAP for farming of fruit and vegetable products 4
Fresh Produce Pack house Operations
D: Pre-processing of Plant Products
Module 10: GMP for pre-processing of plant products 5
Extensive Broad Acre Agriculture Operations and Seed Production
Bll: Farming of Grains and Pulses
Module 8: GAP for farming of grains and pulses 6
Harvest and Intensive Farming of Fish
All: Farming of Fish and Seafood
Module 6: GAP for farming of fish 7
Slaughterhouse, Boning and Butchery Operations
C: pre-process handling of animal products
Module 9: GMP for pre-processing of animal products 8
Processing of Manufactured Meats and Poultry
El: Processing of Perishable Animal Products
Module 11: GMP for processing of food products 9
Seafood Processing:

40. Global Markets Program http://www. mygfsi
“A capacity building program for small and/or less developed businesses that will develop effective food safety management systems through a systematic continuous improvement process.”

41. Global Markets Program
Small and Less Developed businesses
their size,
the lack of technical expertise,
the economic resources,
or the nature of their work
Less developed business - refers to the status of the food safety management system and NOT to the number of staff or volume of production.

42. Global Markets Program
Basic Level – 30% GFSI Scheme Criteria
Food Safety Management Systems
Good Manufacturing Practices
Control of Food Hazards
Intermediate Level – 70% GFSI Scheme Criteria
Basic Level plus
Codex Standard - General Principles Of Food Hygiene
SSOP’s and SPS
HACCP

43. Global Markets Program
INTERMEDIATE- 70%
BASIC – 30%
Food Safety Management Systems
Management Responsibility
General Documentation Requirements
Procedures
Complaint Handling
Control of Measuring & Monitoring Devices
Product Analysis
Purchasing
Supplier Approval and Performance Monitoring
Training
GMP
Facility and Equipment Maintenance
Staff Facilities
Waste Management
Storage and Transport
HACCP and Additional Requirements
HACCP
Food Defense
Food Safety Management Systems
Specifications including Product Release
Traceability
Food Safety Incident Management
Control of Non-Conforming Product
Corrective Action
GMP
Personal Hygiene
Facility Environment
Cleaning and Disinfection
Product Contamination Control
Pest Control
Water Quality
Control of Food Hazards
Control of Food Hazards - General and Specific
Control of Allergens

44. The Requirements: Complete Overview (3/3)
GFSI Recognized Schemes for Manufacturing
100%
GFSI Guidance Document Requirements (6.1th Edition)
Part III
12 Months
70%
Matching Level
Global Markets Basic Level +
Intermediate Level
12 Months
30%
Global Markets
Basic Level

45. How to Prepare Identify Which Audit Scheme Have never had an audit?
Per customer requirement.
Have never had an audit?
Start with the Global Markets Program
Most all auditing companies can audit
Obtain a copy of the standard
Obtain a copy of the guidance

46. Audit Guidance Global Markets Assessor Guideline SQF Guidance
SQF Guidance
Primus Guidance

48. GAP Assessment
Determine what programs you already have and what programs you need.
Your team
Consultant
Trained in SQF or BRC
Others – food safety team from local manufacturer or their QA.
Online – food safety programs/SOPs
Pre- Audit (similar to GAP assessment)

49. Create a Roadmap

50. Jason Young - jason.young@okstate.edu
For More Information:
Jason Young -