Third Party Auditing: It’s not Just for Large Plants Anymore Jason Young - jason.young@okstate.edu GFSI Specialist/ Quality Management Specialist Robert M. Kerr Food & Agricultural Products Center http://www.fapc.biz/ Springfield, Illinois June 18 – 20, 2015

Customers Retail Walk In

Restaurant and Grocery Customers Local Restaurant and Grocery Retail Walk In

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

What Are Your Customers Requirements? Laws and Regulations Customer Requirements

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

Customer Requirements? Risks? CDC?

Customer Risks: Recalls and Deaths 1998-1999 6 deaths Listeria monocytogenes 1992-1993 4 deaths E. coli O157:H7

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

Customer Risks: Recalls and Deaths

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

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”

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

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

Regulatory Audits USDA FSIS FDA – Unannounced Inspection Webinar Regulatory Audits USDA FSIS FSIS Directive 5100.1 Rev 4, 5/29/15 EIAO FSA Methodology http://www.fsis.usda.gov/wps/wcm/connect/31bb8000-fb33-4b51-964b-1db9dfb488dd/5100.1.pdf?MOD=AJPERES FDA – Unannounced Inspection Form 482 Notice of Inspection Form 483 Findings http://www.fda.gov/ICECI/Inspections/IOM/ucm127372.htm Internal Auditing for GFSI Food Safety Managment Systems

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

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

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

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

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

Traditional Food Safety Audit Systems Pre-GFSI

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

GFSI Audit GFSI Recognized Schemes Global Markets SQF, BRC, FSSC 22000, GRMS 12 Schemes total http://www.mygfsi.com/schemes-certification/recognised-schemes.html Global Markets Basic Level Intermediate Level

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.

GFSI Benchmarked Standards Examples: http://www.mygfsi.com/about-gfsi/gfsi-recognised-schemes.html Standard Origin Website BRC Global Standard UK www.brcnorthamerica.com Safe Quality Food(SQF) Australia/U.S. http://www.sqfi.com/ FSSC 22000 (ISO 22000 + PAS 220) http://www.foodsafety.sgs.com/ Or http://www.22000-tools.com/

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)

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 17021 Certification Bodies employ Auditors Audit the Food or Ingredient Company GFSI Benchmarked Schemes BRC, SQF, FSSC 22000 Supplier Supplier Supplier

Traditional Food Safety & Sanitation Audit

2007 –Adoption of GFSI Standards by Retailers Wal-Mart http://www.reuters.com/article/ousiv/idUSN0459973720080204 Feb. 2008 - 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

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

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

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

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

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

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.

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.

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)

SQF - 9 sections & GMP Module 2.1 Management Commitment 2.1.2 – Food Safety (HACCP 2.2 Document Control and Records 2.3 Specification and Product Development 2.4 Attaining Food Safety – prerequisites 2.5 Verification 2.6 Product Identification, Trace, Withdrawal and Recall 2.7 Site Security 2.8 Identity Preserved 2.9 Training

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 2011) 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:

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.”

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.

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

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

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

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

Audit Guidance Global Markets Assessor Guideline SQF Guidance http://www.mygfsi.com/market-access/global-markets-programme/overview.html SQF Guidance http://www.sqfi.com/documents/ Primus Guidance http://www.primusgfs.com/

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)

Create a Roadmap

Jason Young - jason.young@okstate.edu For More Information: Jason Young - jason.young@okstate.edu www.mygfsi.com http://www.fapc.biz/gfsi.html gfsinfo@theconsumergoodsforum.com