Jason Young GFSI Specialist/ Quality Management Specialist ASQ CQA, CQA-HACCP Robert M. Kerr Food & Agricultural Products Center

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Jason Young GFSI Specialist/ Quality Management Specialist ASQ CQA, CQA-HACCP Robert M. Kerr Food & Agricultural Products Center http://www.fapc.biz/

Food Safety Audits/Global Food Safety Initiative http://www.mygfsi.com http://www.fapc.biz/gfsi.html

Recalls and Deaths 32 deaths E. Coli O104:H4 33 deaths Listeria monocytogenes

Food Safety Management System 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

Example Food Safety Standards Regulatory USDA FSIS Regulatory- FDA - cgmp USDA NACMCF HACCP 1997 Codex HACCP Third Party Audit Standards GFSI Guidance and Schemes BRC 2012 Issue 6 SQF PRIMUS

NACMCF- HACCP Guidelines 5 Preliminary Tasks Assemble the HACCP Team Describe the food and its distribution Describe the intended use and consumers of the food Develop a flow diagram which describes the process Verify the flow diagram

NACMCF-HACCP Guidelines 7 Principles Hazard analysis Critical control points Critical limits Monitoring procedures Corrective actions Verification procedures Record-keeping

Traditional Food Safety & Sanitation More than 40 years of audits Criteria 3 rd Party Audit Specific criteria created by Auditing Company Audit Criteria per customer s requirement Supplier Audit by the Customer Customer Criteria

Traditional Food Safety & Sanitation Criteria Customer or Audit Companies AIB, ASI, Silliker 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

ISO 9000 Quality Management System Less than 100 food companies currently ISO 9000 (qualitydigest.com) Global Customers request ISO 9000 HACCP should be a core part of the Quality System HACCP is not described in ISO 9000 7 principles of HACCP are closely integrated and can be aligned with the QMS elements of ISO 9000

Food Safety and Quality Systems Customer Requirements

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

Origins of GFSI 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 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.

Single Global Standard GFSI Technical Group originally proposed the development of a single Global Standard As a number of Standards already existed, they agreed that the focus should be on ensuring best practice and that all Standards covered relevant issues with regard to food safety. GFSI developed a core document the Guidance Document which contained the key criteria with which all Standards must comply in order to be approved by GFSI. Standards are subjected to Benchmarking against the Guidance Document by a Review Committee.

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 Accreditation Bodies ISO/ IEC 17011 Accredits the Certification Body (CB) Including witness (shadow ) audits Certification Bodies employ Auditors ISO/IEC Guide 65 or ISO 17021 Audit the Food or Ingredient Company Supplier Supplier Supplier GFSI Benchmarked Schemes BRC, SQF, FSSC 22000

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

22 Consumer Goods Forum Retail Members

23 Consumer Goods Forum Manufacturing Members

24 Benchmarking What does this mean? Once certified, accepted everywhere

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/ International Food Standard (IFS) FSSC 22000 (ISO 22000 + PAS 220) Germany http://www.food-care.info/ http://www.foodsafety.sgs.com/ Or http://www.22000-tools.com/

British Retail Consortium (BRC) Global Standard for Food Safety First launched 1998 Initial focus for UK Retailers Wide Global Uptake First Standard to be benchmarked and approved by GFSI Now in its 6 th Issue Redrafted with input from 24 Countries 13 Translations Latest is the N. American Version Technical Advisory Committee for N. America established

BRC Audit Scheme Focus is on 75% documentation and 25% 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

BRC Grade A or B audits allow annual audits Grade C audits require a return visit to verify corrective action and another audit completed within 6 months Grade D does not allow certification It is possible to have a pre-assessment, which identifies non-conformances that do not have to be cleared in 28 days.

BRC - 7 Sections 1. Senior Management Commitment and Continual Improvement 2. The Food Safety Plan (HACCP) 3. Food Safety and Quality Management System 4. Site Standards Prerequisite Programs 5. Product Control 6. Process Control 7. Personnel

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 x 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 Facilit y Recor d Requirement / question 2.1 THE HACCP FOOD SAFETY TEAM - CODEX ALIMENTARIUS STEP 1 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. 2.1.1 x 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. 31

Safe Quality Foods (SQF) 1994 First launched 2003 The Food Marketing Institute acquired Established the SQF Institute (SQFI) division Now in its 7th edition, SQF Code is recognized by GFSI as meeting its benchmark requirements. It is the only GFSI-recognized certification system that links primary production certification to food manufacturing, distribution, and agent/broker management certification.

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

SQF Category FSC (Suppliers Scope of Certification) 1 Production, Capture and Harvesting of Livestock and Game Animals 2 Growing and Harvesting of Animal Feeds 3 Growing and Production of Fresh Produce 4 Fresh Produce Pack house Operations 5 Extensive Broad Acre Agriculture Operations and Seed Production 6 Harvest and Intensive Farming of Fish 7 Slaughterhouse, Boning and Butchery Operations 8 Processing of Manufactured Meats and Poultry GFSI Industry Scopes Al: Farming of Animals Fl: Production of Single Ingredient Feed (available 2011) Bl: Farming of Plant Products D: Pre-processing of Plant Products Bll: Farming of Grains and Pulses All: Farming of Fish and Seafood C: pre-process handling of animal products El: Processing of Perishable Animal Products Applicable SQF Code Modules Module 2: System elements Module 5: GAP for farming of animal products Module 2: System elements Module 3: GAP for single feed production Module 2: System elements Module 7: GAP for farming of fruit and vegetable products Module 2: System elements Module 10: GMP for pre-processing of plant products Module 2: System elements Module 8: GAP for farming of grains and pulses Module 2: System elements Module 6: GAP for farming of fish Module 2: System elements Module 9: GMP for pre-processing of animal products Module 2: System elements Module 11: GMP for processing of food products 9 Seafood Processing: El: Processing of Module 2: System elements

SQF Audit Process There are 3 different certification levels that can be obtained for each of the codes Level 1 - Food Safety Fundamentals Level 2 - Certified HACCP Based Food Safety Plans Level 3 - Comprehensive Food Safety and Quality Management System

SQF Audit Process Audits are required annually Audit time requirements are estimated to be a 1 day desktop audit followed by a 2 day audit at the plant to verify implementation and compliance to the program

SQF Audit Process The initial audit process is in 2 parts Part 1 is submission of the facilities SQF program for a desk top audit evaluation. (off site can be on site) Part 2 is an in-plant evaluation of implementation of the SQF program as written and review of execution of the programs

GFSI vs. Regulatory Requirements GFSI is not regulatory Customer Driven GFSI exceeds regulatory requirements

Criteria SQF meets regulation 2.4.1 Food Legislation (Regulation) (M) 2.4.1.1 The organization shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of its origin and destination. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, nutritional, allergen and additive labeling, and to relevant established industry codes of practice. 2.4.1.2 The methods and responsibility for ensuring the organization is kept informed of changes to relevant legislation, scientific and technical developments and relevant industry codes of practice shall be documented and implemented.

Criteria BRC meets regulation Legal used 35 time throughout criteria 1.2 ORGANIZATIONAL STRUCTURE, RESPONSIBILITIES, AND MANAGEMENT AUTHORITY The company shall have a clear organizational structure and lines of communication to enable effective management of product safety, legality, and quality. 4.1 External Standards The production site shall be of suitable size, location, construction, and design to reduce the risk of contamination and facilitate the production of safe and legal finished products. 5.4.1 Product Packaging..confirm it conforms to relevant food safety legislation.

HACCP: Food Safety Modernization Act(FSMA) Prepare a Hazard Analysis and Risk-Based Preventive Controls All registered facilities must conduct a hazard analysis and develop and implement a written preventive controls plan. Facilities will be required to establish preventive controls consistent with internationally recognized principles of Hazard Analysis and Critical Control Points (HACCP) Congress used some different terms but these proposed rules will seem familiar to those who are currently following Codex Michael Taylor

HACCP: GFSI - SQF SQF 2000 Section 4.4.3 A food safety plan prepared in accordance to the HACCP method SQF Edition 7 Section 2.4.3 A food safety plan prepared in accordance to the steps in CODEX or NACMCF. Must describe methods and results of a hazard analysis to identify hazards associated with all inputs and process steps including rework.

Records: FSMA Section 101 expands FDA authority to inspect records (excludes farms and restaurants). Each person who manufactures, processes, packs, distributes, receives, holds, or imports an article of food must permit inspection of records where FDA believes that there is a reasonable probability of serious adverse health consequences or death.

Records: SQF Requirements: Define methods and responsibility for monitoring, activities, verifying and retaining records Includes inspections, analyses, and essential activities Must legible, authorized, accessible, stored properly, retained

GFSI Vision: Safe Food for Consumers Everywhere Mission: Driving continuous improvement in food safety to strengthen consumer confidence worldwide Reduce food safety risks Manage cost GFSI Develop competencies and capacity building Knowledge exchange and networking 47

GFSI Advisory Council A body of experts composed of academics, nongovernment organization members and government members. Will provide perspectives on the implementation of GFSI s strategic objectives. 48

GFSI Stakeholder Groups Wider group of food business stakeholders Annual meetings Opportunity to influence GFSI strategy Share knowledge and best practice with other food safety experts in keeping with the GFSI mission 49

50 GFSI Strategy for the Future

Companies accepting GSFI recognised schemes

For More Information: www.mygfsi.com http://www.fapc.biz/gfsi.html gfsinfo@theconsumergoodsforum.com Search Global Food Safety Initiative Sign up for the Newsletter on www.mygfsi.com Jason Young jason.young@okstate.edu