Product Tracing in Food Systems & Mock Traceback IFT Recommendations to FDA. Sarah D. Ohlhorst, MS, RD IFT Staff Scientist

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Product Tracing in Food Systems & Mock Traceback IFT Recommendations to FDA. Sarah D. Ohlhorst, MS, RD IFT Staff Scientist"

Transcription

1 Product Tracing in Food Systems & Mock Traceback IFT Recommendations to FDA Sarah D. Ohlhorst, MS, RD IFT Staff Scientist

2 Overview Who is IFT and what were we asked to do Key findings and recommendations Mock tomato trace-back exercise Questions

3 What is IFT? Institute of Food Technologists Scientific and professional society Individuals in food science, food technology, and related professions; working in industry, academia, and government Over 18,000 members Offices in Chicago, IL, and Washington, D.C. Contract work with FDA since 1999 TO6 on product tracing issued Oct 2008 TO7 mock trace-back issued June 2009 Both tasks submitted Sept. 15, 2009

4 What is Product Tracing? The ability to follow the movement of a food through specified stage(s) of production, processing, and distribution Companies typically record what they receive and who they received it from, and what they ship and who they shipped it to Economic and public health impacts Immediate: trace food forward to prevent sale and consumption Preventive: trace food back to determine cause of the issue, and prevent it from happening again Cost to industry, society in the billions

5 Task Scope of Work Identify current and future product tracing systems (US and international; food and other industries) Review from harvest through processing and distribution to points of service Beyond BT Act Focus on produce and FDA-regulated food products Examine accessibility of information to public health regulatory officials Consider cost

6 Task Approach: Collaborated with Core Expert Panel and Subpanels Stephen Arens, MBA; GS1 US, NJ Frank Busta, Ph.D.; National Center for Food Protection & Defense, MN Martin Cole, Ph.D.; Formerly with National Center for Food Safety & Technology, IL Art Davis; Formerly with The Sholl Group/Green Giant Fresh, MN Helen Jensen, Ph.D.; Department of Economics, Iowa State University, IA Brenda Lloyd; UFPC/YUM! Brands, KY Benjamin Miller, MPH; Department of Agriculture, MN Gale Prince; Formerly with Kroger; Your Food Safety Coach, OH Subpanels: State Trace-back Investigators; Food Industry; Agricultural Economists; Systems/Technology Experts

7 Task Approach: Engaged Over 200 Stakeholders 55+ food companies throughout the supply chain Animal feed Produce Ingredients & Processed foods Distributors Retail & Foodservice Trade associations Consumer groups Technology providers

8 Questions Answered 1. What systems and technologies are out there? 2. What is done in other industries? 3. What is required in other countries? 4. What are food companies doing? 5. What should food companies be doing? 6. How much will it cost to implement full product tracing?

9 Assessment of technologies 3 categories of solution providers Cold chain management; other quality/ safety-related service Provide medium/ unique identifiers Software as a service Technologies in use to be adapted Accounting Batching WMS, etc. Some custom or legacy in-house systems Some have the ability to capture key data elements

10 Other Industries Explored Automotive Pharmaceutical Toy industry Parcel Clothing Appliance Animal identification

11 Findings from around the globe Codex documents and ISO standards EU, Canada, Australia, other developed regions have explored product tracing Private tracing initiatives worldwide Rest of the world - some lack food safety regulatory structure

12 Key Findings Food production and distribution are global and complex Technology to trace exists, and continues to evolve Most firms believe they are in compliance with Bioterrorism Act (maintaining 1-step up/back records) The lack of common data elements in the supply chain may not provide complete product tracing Paper recordkeeping is prevalent, dominant There are many industry initiatives, current and in development Product tracing costs vary, tend to be inaccurately estimated

13 Overarching Issues Paperwork generally lacks complete information No standards exist for capturing/expressing information Within a facility, internal systems often differ and are not electronically linked not interoperable Companies receive different information from different suppliers, and have to provide different information to different customers Lot meaning is confused and internal tracing is prevented

14 Barriers and Motivators to Tracing Barriers Suppliers don t routinely provide information Customers uninterested Bulk/commingling Lack of data sharing standards Cost Motivators Fear of regulation or imposed standards Improvement of other processes (inventory control) Improvement of consumer confidence Cost to do business

15 How product tracing impacts regulators Quickly, accurately locate the source If not, increase exposure and can t determine the cause Quickly, accurately determine the scope If not, consumer exposure continues and industry damage remains broad Provide targeted consumer advice Reduce multiple recalls after initial recall Currently struggle with one up and one back Gaps at farms and points of service

16 IFT Guiding Criteria Simple User friendly Leverages existing industry systems Controls cost Increases likelihood of adoption Globally accepted Standardized ways to express key data elements Suitable for global food supply (not US centric)

17

18

19 Barcode vs. RFID Medium is less important than the information it carries

20 IFT Core Recommendations Identify Critical Tracking Events (CTEs) when product is moved, transformed, etc. Similar in concept to Hazard Analysis and Critical Control Points (HACCP) already widely used throughout food industry Maintain records for each CTE in agreed upon, standardized formats that link incoming/outgoing product This ensures internal tracing All firms should be able to provide key data elements for all CTEs in an electronic form, within 24 hours of request by FDA Training/education on CTEs and key data elements should be developed Product tracing should be required part of regulatory or 3 rd party audits

21 Foodservice Supply Chain Critical Tracking Events (CTEs) Item Tracing Ingredients - Raw Materials Manufact urer Distributo r Operator Production Receipt Delivery courtesy of Brenda Lloyd, YUM Brands CTE CTE Receipt CTE Packaging Shipping Inventory Storage Case Opened CTE Shipping CTE Prep Waste CTE Transfer

22 Firms Perceptions of Cost Generally couldn t provide estimates expensive Often assigned costs to things other than product tracing Very few data exist Institute of Food Technologists

23 Benefits vs. costs at the firm level Benefits Improved supply chain management Inventory control Access to contracts and markets More targeted recalls Types of costs Capital investment and start up Software and associated fees Equipment Consultants Labor and training Materials and supplies Change in operations Institute of Food Technologists

24 Costs: Sector and Societal Implications Societal costs Lower healthcare costs: loss of life Loss of consumer confidence Major psychological and emotional damages due to massive outbreaks Indirect loss in economic output and productivity losses Additional considerations Loss of market share if traceability systems are not similar for whole sector Lack of adequate capital, labor, and technology expertise The probability of occurrence of a triggering event/year vs. costs and benefits per sector needs to be assessed more

25 Another Product Tracing Task Scope of work: Conduct mock trace-back/ forward of tomatoes using existing data from entire supply chain and visualization software Tomatoes selected due to 2008 Salmonella saintpaul outbreak Subcontracted with Harvard, Microsoft, TIBCO FDA and tomato supply chain participated IFT s portion of the task was to do a comparison with other technologies

26 What we asked technology providers The ability of each platform to store data, including how much data can be stored and for how long; The management of all data; The ability of the system to accept data in multiple formats; How data are shared and how access is enabled or restricted; If product tracing extends from points of service to points of processing and production through point of sale; The precision of the platform to locate a source of contamination, product s movements or characteristics and more; How quickly information (source of contamination, etc.) can be provided and communicated; and, The applicability of the platform to national and international food industries.

27

28 Mock Trace-back/ forward Summary Findings: Data exists How FDA would receive data is TBD QA of data was substantial (standardizing date, for example; making sure it matched up, etc.) Visualization showed potential to expedite tracebacks/ forwards (as long as data were good) There are many commercially available systems that could be tested using these data Communication and collaboration are valuable

29 Moving Forward IFT s full reports available at FDA/FSIS collected public comments Many industry initiatives are underway What will Congress do? Clear objectives must be set for members of the food supply chain Allow industry to determine how to reach those objectives

30 Thank You! Any Questions? Sarah Ohlhorst, IFT Staff Scientist ;

31 Institute of Food Technologists Headquarters 525 W. Van Buren Street Suite 1000 Chicago, IL ift.org Washington, D.C. Office 1025 Connecticut Avenue, NW Suite 503 Washington, D.C ift.org 2010 Institute of Food Technologists

Product Tracing in Food Systems Executive Summary

Product Tracing in Food Systems Executive Summary Product Tracing in Food Systems Executive Summary IFT examined traceability (product tracing) in food systems under contract with the US Food and Drug Administration Center for Food Safety and Applied

More information

Product Tracing in Food Systems:

Product Tracing in Food Systems: Product Tracing in Food Systems: Developing a Product Tracing Plan Using Critical Tracking Events and Key Data Elements 2011 Institute of Food Technologists (IFT). All rights reserved. Product Tracing

More information

Food Traceability Best Practices in the Age of Big Data

Food Traceability Best Practices in the Age of Big Data in the Age of Big Data Increasing regulations and big data are compelling food manufacturers to adopt automated traceability solutions as part of their quality programs. 1 InfinityQS International, Inc.

More information

Fresh Business Practices for Food & Beverage to Meet Today s Top 3 Issues

Fresh Business Practices for Food & Beverage to Meet Today s Top 3 Issues to Meet Today s Top 3 Issues Prepared exclusively for Sage Software by Industry Directions, Inc. www.industrydirections.com Table of Contents Intro...3 Appealing and Fresh... 3 Compliant and Safe... 4

More information

Eight Must-Have ERP Features for Food Processors

Eight Must-Have ERP Features for Food Processors Eight Must-Have ERP Features for Food Processors Plex Online White Paper At a Glance This paper summarizes the eight features a food or beverage processor must have in its ERP software. Benefits of an

More information

Enterprise Information Management for the Food and Beverage Industry

Enterprise Information Management for the Food and Beverage Industry Enterprise Information Management for the Food and Beverage Industry Integrate information across systems, functions, and the supply chain Today s global business and regulatory environments are too complex

More information

Track/Trace Solutions. for the Manufacturing Industry

Track/Trace Solutions. for the Manufacturing Industry Track/Trace Solutions for the Manufacturing Industry Today s manufacturers, regardless of what they produce, have no choice but to follow private sector and government required mandates. As examples, two

More information

Forum on Microbial Threats Session VII Threat Reduction Research and Policy Opportunities

Forum on Microbial Threats Session VII Threat Reduction Research and Policy Opportunities Forum on Microbial Threats Session VII Threat Reduction Research and Policy Opportunities Frank Busta, Director National Center for Food Protection and Defense Foodborne Threats to Health: The Policies

More information

ERP for Food and Beverage Industry Compliance

ERP for Food and Beverage Industry Compliance ERP for Food and Beverage Manufacturers Leverage SYSPRO to Achieve Regulatory Compliance and Food Safety Contents Introduction 3 The Industry 3 Food Safety 4 Regulatory Compliance 4 Brand Protection 5

More information

Meeting the Requirements of FSMA with FSSC 22000

Meeting the Requirements of FSMA with FSSC 22000 Meeting the Requirements of FSMA with FSSC 22000 Kathleen Wybourn & Jacqueline Southee 15 April 2016 Ungraded 1 DNV GL 2016 15 April 2016 SAFER, SMARTER, GREENER Meet Today s Speakers Kathleen Wybourn

More information

PRODUCE FOOD SAFETY: A GROWERS PERSPECTIVE. WILLETTE M. CRAWFORD, Ph.D., MPH Growers Express LLC Salinas, CA March 18, 2008

PRODUCE FOOD SAFETY: A GROWERS PERSPECTIVE. WILLETTE M. CRAWFORD, Ph.D., MPH Growers Express LLC Salinas, CA March 18, 2008 PRODUCE FOOD SAFETY: A GROWERS PERSPECTIVE WILLETTE M. CRAWFORD, Ph.D., MPH Growers Express LLC Salinas, CA March 18, 2008 Who We Are Group of 2 nd & 3 rd generation farmers Vertically integrated grower,

More information

FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005)

FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) Dr.R.MANAVALAN, M.Pharm., Ph.D. Professor and Research Director, Department of Pharmaceutics,

More information

TRACEABILITY IN THE FOOD SUPPLY CHAIN

TRACEABILITY IN THE FOOD SUPPLY CHAIN Department of Health and Human Services OFFICE OF INSPECTOR GENERAL TRACEABILITY IN THE FOOD SUPPLY CHAIN Daniel R. Levinson Inspector General March 2009 Office of Evaluation and Inspections The Office

More information

Improving Patient Safety and Supply Chain Efficiency with GS1 Standards in HEALTHCARE

Improving Patient Safety and Supply Chain Efficiency with GS1 Standards in HEALTHCARE Improving Patient Safety and Supply Chain Efficiency with GS1 Standards in HEALTHCARE 1 GS1 STANDARDS IN HEALTHCARE Together, we re making it possible to follow drugs and medical devices from the manufacturer

More information

US Food Safety Modernization Act:

US Food Safety Modernization Act: US Food Safety Modernization Act: Overview and Impact for Importers and Exporters August 2012 This paper covers important updates related to the US Food Safety Modernization Act (FSMA) and recent changes

More information

Software Development for Medical Devices

Software Development for Medical Devices Overcoming the Challenges of Compliance, Quality and Cost An MKS White Paper Introduction Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software

More information

I-Track Software. A state of the art production and warehouse management system designed for Food and Beverage Manufacturers. Overview 2.

I-Track Software. A state of the art production and warehouse management system designed for Food and Beverage Manufacturers. Overview 2. Overview 2 Features 3 Benefits 4 I-Track Software A state of the art production and warehouse management system designed for Food and Beverage Manufacturers Site Assessment 5 Integrated Plant Floor Execution

More information

Ensuring Food Safety and Achieving Competitive Differentiation through Multi-Dimensional Traceability

Ensuring Food Safety and Achieving Competitive Differentiation through Multi-Dimensional Traceability Traceability 2.0: W H I T E P A P E R Ensuring Food Safety and Achieving Competitive Differentiation through Multi-Dimensional Traceability Executive Summary In response to the many highly publicized large

More information

quality, health & safety and environment training and consulting

quality, health & safety and environment training and consulting quality, health & safety and environment training and consulting QUALMS Group QHSE Training & Consulting is a leading business services provider of applied; Quality, Food Safety, Occupational Health &

More information

Business Standards GS1 US 2009 GS1 US

Business Standards GS1 US 2009 GS1 US Business Standards Supporting Traceability Stephen Arens GS1 US The term standard includes all of the following Common and repeated use of rules, conditions, guidelines or characteristics for products

More information

Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified?

Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified? Safe%Feed/Safe%Food% Overview of Certification Programs: Why Should a Feed Mill Get Certified? Henry Turlington, Ph.D. Director, Quality & Manufacturing Regulatory Affairs American Feed Industry Association

More information

Food Safety and Your Small to Medium Sized Business

Food Safety and Your Small to Medium Sized Business Food Safety and Your Small to Medium Sized Business Contents Introduction 3 Consumer Views on Food Safety 3 News Media Impact on Food Safety 4 Food Safety A Global Issue 4 U.S. Bioterrorism Act 4 European

More information

integrated traceability in fresh foods: Ripe opportunity for real Results

integrated traceability in fresh foods: Ripe opportunity for real Results THE GLOBAL LANGUAGE OF BUSINESS White paper McKinsey & Company, a global management consulting firm, provided expertise and guidance for the development of this white paper. integrated traceability in

More information

2. Aims (tasks, milestones, deliverables) addressed in this progress report (May Aug, 2011)

2. Aims (tasks, milestones, deliverables) addressed in this progress report (May Aug, 2011) Project Title: Food Product Tracing Technology Capabilities and Interoperability PI: Dr. Jennifer Cleveland McEntire Project Start Date: September 2010 End Date: August 2012 Period covered in this report:

More information

Effective Dates and FDA Requirements in the FDA Food Safety Modernization Act Prepared by Hogan Lovells US LLP, February 2011

Effective Dates and FDA Requirements in the FDA Food Safety Modernization Act Prepared by Hogan Lovells US LLP, February 2011 in the FDA Food Safety Modernization Act Prepared by Hogan Lovells US LLP, February 2011 Provision Facility Registration Food facilities are required to register with FDA every 2 years, starting in 2012,

More information

GTIN Product Labeling Requirements for the Produce Distribution Industry

GTIN Product Labeling Requirements for the Produce Distribution Industry GTIN Product Labeling Requirements for the Produce Distribution Industry Maximizing Your Bottom Line while Minimizing Your Risk with Robocom s Warehouse Management System White Paper www.robocom.com Table

More information

Ames, IA 50014, (515) 294-8649, tatry@iastate.edu

Ames, IA 50014, (515) 294-8649, tatry@iastate.edu Management Using Quality Management Systems to Meet Food Traceability Requirements of the Bioterrorism Act of 2002 (Best NAIT 2008 Conference Proceedings Paper) Dr. Chad Laux, CSIT Purdue University -

More information

An Introduction to ISO 22000: Food Safety Management Systems

An Introduction to ISO 22000: Food Safety Management Systems : Food Safety Management Systems Stefan Nygren What is ISO 22000? ISO 22000, Food safety management systems - Requirements for any organization in the food chain, was first published in 2005. The standard

More information

Food Manufacturing Mock Recall (Team) Exercise

Food Manufacturing Mock Recall (Team) Exercise Food Manufacturing Mock Recall (Team) Exercise Practical Application Exercise Mock Recall/Traceability Copyright Team ROI 2012 Recall Process Flow Diagram Key Activities Receive complaint Stop Production/

More information

Food safety a priority? Introducing BSI s Food Safety Service Offering.

Food safety a priority? Introducing BSI s Food Safety Service Offering. Food safety a priority? Introducing BSI s Service Offering. Who we are BSI believes the world should be supplied safe, quality food and we offer a broad range of certification and risk management services.

More information

FOOD DEFENSE STRATEGIES: Four Ways to Proactively Protect Your Brand

FOOD DEFENSE STRATEGIES: Four Ways to Proactively Protect Your Brand FOOD DEFENSE STRATEGIES: Four Ways to Proactively Protect Your Brand Food Defense: Proactively protecting the food supply chain is paramount for protecting company profitability, liability, and survival.

More information

The Values & Benefits of Using a GDSNData Pool. Prepared by: Anthony Hayes Greg Patterson

The Values & Benefits of Using a GDSNData Pool. Prepared by: Anthony Hayes Greg Patterson The Values & Benefits of Using a GDSNData Pool Prepared by: Anthony Hayes Greg Patterson October 2014 Company Overview Around the world 5 Corporations: USA, Canada, Australia, France, Brazil,(Taiwan-Partner)

More information

Manufacturing ERP Implementations

Manufacturing ERP Implementations Manufacturing ERP Implementations 1.1 Manufacturing ERP implementation for Food Processing Industry Hospitality Products for Retail Café chain Providing tools to manage complex, multiple level recipes

More information

Risk reduction in retail and restaurant quality assurance practices

Risk reduction in retail and restaurant quality assurance practices Risk reduction in retail and restaurant quality assurance practices Contents Introduction 1 Challenging factors in manufacturing/production 2 Challenging factors in retail/restaurants 3 Contributing factors

More information

The Four Elements of an Effective Food Safety Management System

The Four Elements of an Effective Food Safety Management System The Four Elements of an Effective Food Safety Management System Plex Online White Paper At a Glance As processors develop and enhance their Food Safety Management Systems (FSMSs), four key components enable

More information

A Natural Products Association Presents. SQF Certification. Josh Grauso Technical Sales Director UL Registrar

A Natural Products Association Presents. SQF Certification. Josh Grauso Technical Sales Director UL Registrar A Natural Products Association Presents SQF Certification June 25, 2015 1:00-2:00pm Josh Grauso Technical Sales Director UL Registrar GoToWebinar Housekeeping: Attendee Participation Your Participation

More information

Infor Food & Beverage for the beverage manufacturing industry

Infor Food & Beverage for the beverage manufacturing industry Food & Beverage Infor Food & Beverage for the beverage manufacturing industry Take your place on the grocer s shelves The beverage industry is under constant pressure to change. Sugary drinks, like sodas,

More information

USDA 3 rd Party Audit Verification Programs

USDA 3 rd Party Audit Verification Programs USDA 3 rd Party Audit Verification Programs Ken Petersen- Staff Assistant Agricultural Marketing Service Fresh Products Branch Good Agricultural Practices & Good Handling Practices Program ASQ- Certified

More information

Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011

Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 World Food Programme Food quality control is necessary to ensure that food aid supplies are safe,

More information

Pharmaceutical Distribution Security Alliance (PDSA)

Pharmaceutical Distribution Security Alliance (PDSA) Pharmaceutical Distribution Security Alliance (PDSA) Our Mission The Pharmaceutical Distribution Security Alliance's (PDSA) mission is to develop and help enact a federal policy proposal that enhances

More information

Sustainability Innovation and Improvements a Case Study. Wende Huehn-Brown, Ph.D., CPIM

Sustainability Innovation and Improvements a Case Study. Wende Huehn-Brown, Ph.D., CPIM Sustainability Innovation and Improvements a Case Study Wende Huehn Brown Ph.D., CPIM October 15, 2012 Biography Wende Huehn-Brown, Ph.D., CPIM Professor: St. Petersburg College Ph.D. : University of Missouri

More information

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran

CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran CONCEPTS OF FOOD SAFETY AND QUALITY MANAGEMENT SYSTEMS Mrs. Malini Rajendran Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards, guidelines and

More information

Real-time Visibility. RFID-enabled Applications for Asset Tracking. Deployment Guide. Delivering Real-Time Visibility to the Enterprise

Real-time Visibility. RFID-enabled Applications for Asset Tracking. Deployment Guide. Delivering Real-Time Visibility to the Enterprise Real-time Visibility RFID-enabled Applications for Asset Deployment Guide Delivering Real-Time Visibility to the Enterprise 2010 OATSystems Assets Across the Value Chain By adding real-time visibility

More information

The Top 5 Software Capabilities for Ensuring Food Safety

The Top 5 Software Capabilities for Ensuring Food Safety The Top 5 Software Capabilities for Ensuring Food Safety How can manufacturers minimize food safety risks? We ve all seen the headlines: Contaminated peanut butter. Metal fragments in cereal. Undeclared

More information

A Recipe for Safe Food: ISO 22000 and HACCP

A Recipe for Safe Food: ISO 22000 and HACCP A Recipe for Safe Food: ISO 22000 and HACCP by John G. Surak Food safety experts insist that the U.S. food supply is one of the safest in the world. However, the Centers for Disease Control and Prevention

More information

ISO/TC 34/SC17 'Management systems for food safety' FAQ

ISO/TC 34/SC17 'Management systems for food safety' FAQ ISO/TC 34/SC17/AG1 Food Safety Management Systems Secretariat: DS, Carina Dalager, cad@ds.dk Date: 2014-10-20 ISO/TC 34/SC17 'Management systems for food safety' FAQ FAQ ISO 22000 and HACCP What does ISO22000

More information

Real-time Visibility for SAP in Supply Chain & Logistics:

Real-time Visibility for SAP in Supply Chain & Logistics: for SAP in Supply Chain & Logistics: Cost Savings from Real-World Deployments Andres Botero Senior Director Supply Chain Execution Solutions SAP Dan Ahearn Director, Market Development OATSystems, Inc.

More information

Chipotle Mexican Grill

Chipotle Mexican Grill CASE STUDY Chipotle Mexican Grill National restaurant chain creates traceability program to advance its commitment to food safety and Food with Integrity CHALLENGE Our Food with Integrity mission is the

More information

Leveraging track and trace in the pharmaceutical industry

Leveraging track and trace in the pharmaceutical industry Leveraging track and trace in the pharmaceutical industry An industry whitepaper 3960 Fabian Way Palo Alto, CA 94303 650-397- 2550 www.frequentz.com Copyright 2014 Frequentz. All rights reserved. The counterfeit

More information

THE HIGH COST OF A PRODUCT RECALL

THE HIGH COST OF A PRODUCT RECALL WHITE PAPER THE HIGH COST OF A PRODUCT RECALL USING PROCESS ANALYTICS SOFTWARE TO MAXIMIZE SAFETY, PRODUCTIVITY AND PROFITS BY CRAIG GUNTHER CONTENTS Introduction 2 Recall Considerations 2 Self Regulation

More information

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY SMG 1312.4 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF GLOBAL AND REGULATORY OPERATIONS AND POLICY OFFICE OF REGULATORY AFFAIRS OFFICE OF OPERATIONS

More information

Best Practices for Traceability in Manufacturing. Why You Need Real-time Track and Trace Solutions Now

Best Practices for Traceability in Manufacturing. Why You Need Real-time Track and Trace Solutions Now Best Practices for Traceability in Manufacturing Why You Need Real-time Track and Trace Solutions Now Editor Jody Costa Jody Costa joined Barcoding, Inc. as Director of Marketing in 2010. With over 10

More information

Food Safety and Quality Management System

Food Safety and Quality Management System Introduction The company has planned, established, documented and implemented a food safety and quality management system for the site, which is maintained in order to continually improve its effectiveness

More information

Supply Chain Management

Supply Chain Management Development Center DePaul University 1 E. Jackson Blvd. Suite 7000 Chicago, IL 60604 Voice: (312) 362-6780 Fax: (312) 362-5893 mdc@wppost.depaul.edu http://www.depaul.edu/~mdc Who Should Attend? The Supply

More information

FOOD SAFETY SYSTEM CERTIFICATION 22000 FSSC 22000

FOOD SAFETY SYSTEM CERTIFICATION 22000 FSSC 22000 FOOD SAFETY SYSTEM CERTIFICATION 22000 FSSC 22000 Certification scheme for food safety systems in compliance with ISO 22000: 2005 and technical specifications for sector PRPs Features Foundation for Food

More information

DOCTORAL WORKSHOP PHD ON THE GO. «Study and Analysis of the olive oil process: Quality and Traceability»

DOCTORAL WORKSHOP PHD ON THE GO. «Study and Analysis of the olive oil process: Quality and Traceability» DOCTORAL WORKSHOP PHD ON THE GO «Study and Analysis of the olive oil process: Quality and Traceability» RESEARCH FIELD: The Food Sector is more and more competitive and the food companies have to qualify

More information

2.5 Transparency and engagement:

2.5 Transparency and engagement: 46 / 71 2.5 Transparency and engagement: Building customer dialogue #transparency Company supply chains are scrutinised more today than ever before. There is recognition that brands must take responsibility

More information

HACCP: Hazard Analysis Critical Control Points. Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach

HACCP: Hazard Analysis Critical Control Points. Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach HACCP: Hazard Analysis Critical Control Points Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach Information Adapted from: Hazard Analysis and Critical Control Point

More information

Supplier and External Manufacturer Requirements Manual

Supplier and External Manufacturer Requirements Manual Supplier and External Manufacturer Requirements Manual I am glad to be able to speak with you about our new Supplier and External Manufacturer Management Program. At Ardent Mills we are dedicated to delighting

More information

MRO CHEMICALS. + Regulatory Changes = + Disposal. + Use. Acquisition. More than just MRO Chemicals OWNERSHIP COSTS

MRO CHEMICALS. + Regulatory Changes = + Disposal. + Use. Acquisition. More than just MRO Chemicals OWNERSHIP COSTS TM More than just MRO Chemicals CRC brings something more to your facility. We help you see the big picture and improve the management of your MRO chemicals. MRO CHEMICALS Acquisition + Use + Disposal

More information

Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance

Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance by Tom Savage, NSF International Since 2008, when patient deaths were first linked to

More information

Base Recall Program September 2003

Base Recall Program September 2003 Base Recall Program September 2003 Table of Content 1. Introduction 1 Page 2. Situation 1 Product Recall Plan 1-2 3. Mock Recall Procedure 3 4. Situation 2 Consumer Menu Item Complaint Recall Plan 4-5

More information

White Paper Healthcare Supply Chain Traceability

White Paper Healthcare Supply Chain Traceability Executive Summary This white paper focuses on Healthcare supply chain Traceability, from manufacture to patient, going beyond, for example, what is currently regulated by the US 21 CFR Part 820 and ISO

More information

The Global Ferrous Scrap Metal Markets

The Global Ferrous Scrap Metal Markets The Global Ferrous Scrap Metal Markets Joseph C. Pickard Chief Economist and Director of Commodities Institute of Scrap Recycling Industries, Inc. Platts 2 nd Annual Scrap Seminar March 11, 2013 Chicago,

More information

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205 www.schweppesaustralia.com.au Quality Management Systems 1. Quality Management Systems develop, implement, verify

More information

MILITARY SECRETS DECODED: How You Can Track. Locate Equipment and Assets Like the Military. and

MILITARY SECRETS DECODED: How You Can Track. Locate Equipment and Assets Like the Military. and MILITARY SECRETS DECODED: How You Can Track and Locate Equipment and Assets Like the Military TABLE OF CONTENTS Introduction 2 Auto ID Systems Choosing Barcode, RFID, or Both 3 Total Accountability 4 Turnkey

More information

INTEGRATED ERP FOR FOOD MANUFACTURING. A Strategic Weapon for a Competitive Environment

INTEGRATED ERP FOR FOOD MANUFACTURING. A Strategic Weapon for a Competitive Environment INTEGRATED ERP FOR FOOD MANUFACTURING A Strategic Weapon for a Competitive Environment A Strategic Weapon for a Competitive Environment INTRODUCTION Today, food manufacturers face significant challenges.

More information

A. Background. In this Communication we can read:

A. Background. In this Communication we can read: On RFID The Next Step to THE INTERNET OF THINGS Information of the Presidency 2832nd Council meeting, Competitiveness (Internal Market, Industry and Research), Brussels, 22-23 November 2007 A. Background

More information

Software Development for Medical Devices

Software Development for Medical Devices Software Development for Medical Devices Overcoming the Challenges of Compliance, Quality and Cost Software is fast becoming the differentiator for manufacturers of medical devices. The rewards of software

More information

Proposed Rules under the United States FDA Food Safety Modernization Act

Proposed Rules under the United States FDA Food Safety Modernization Act Proposed Rules under the United States FDA Food Safety Modernization Act Don Kraemer U.S. Food and Drug Administration The following slides describe two proposed FDA food safety regulations and are current

More information

Establishing and Tracking Effective Environmental Performance Metrics

Establishing and Tracking Effective Environmental Performance Metrics Establishing and Tracking Effective Environmental Performance Metrics Introduction Brad Waldron, QEP BS in Environmental Science MS in Environmental Management Vice President of NGE, LLC Over 13 years

More information

2012 FALL P2P. Peer-to-Peer Learning Exchange Research Report. Supply Chain s Role in the Patient Experience. Sponsored by

2012 FALL P2P. Peer-to-Peer Learning Exchange Research Report. Supply Chain s Role in the Patient Experience. Sponsored by 2012 FALL P2P Peer-to-Peer Learning Exchange Research Report Supply Chain s Role in the Patient Experience Sponsored by Introduction The healthcare industry continues to be shaped by the shifting waters

More information

A GLOBAL CURE FOR HEALTHCARE

A GLOBAL CURE FOR HEALTHCARE A GLOBAL CURE FOR HEALTHCARE A new and independent report by McKinsey & Company has estimated the benefits - in lives and value - of implementing one single global standard in Healthcare To download the

More information

Sustainability Challenges in Sourcing Agricultural Materials

Sustainability Challenges in Sourcing Agricultural Materials Sustainability Challenges in Sourcing Agricultural Materials Hans Jöhr Corporate Head of Agriculture 2 The Nestlé Company The leading food company 98'458 mio CHF in 2006 Swiss based, active world-wide

More information

TRADE SHOW PARTICIPANTS. Trade show presented in East Ballroom Fairmont Hotel, Winnipeg. Company name: Agri Traçabilité International

TRADE SHOW PARTICIPANTS. Trade show presented in East Ballroom Fairmont Hotel, Winnipeg. Company name: Agri Traçabilité International TRADE SHOW PARTICIPANTS Trade show presented in East Ballroom Fairmont Hotel, Winnipeg Company name: Agri Traçabilité International Stand number: (1) Contact name: Linda Marchand E mail: lmarchand@agri

More information

SQF 2000 Guidance. Guidance for Developing, Documenting and Implementing SQF 2000 Systems for General Food Processing. 6th Edition NOVEMBER 2008

SQF 2000 Guidance. Guidance for Developing, Documenting and Implementing SQF 2000 Systems for General Food Processing. 6th Edition NOVEMBER 2008 SQF 2000 for Developing, Documenting and Implementing SQF 2000 Systems for General Food Processing 6th Edition NOVEMBER 2008 Safe Quality Food Institute 2345 Crystal Drive, Suite 800 Arlington, VA 22202

More information

Best Practice In A Change Management System

Best Practice In A Change Management System Quality & Compliance Associates, LLC Best Practice In A Change Management System President Quality & Compliance Associates, LLC Change Control and Its Role in a Continuous Improvement Environment 3 Benefits

More information

BRC Food Safety and Quality Management System. New Issue 7

BRC Food Safety and Quality Management System. New Issue 7 New Issue 7 This is an ideal package for Food Manufacturers looking to meet BRC Global Standard for Food Safety (Issue 7 2015) for Food Safety Quality Management Systems. Our BRC Food Safety Quality Management

More information

High Level Importance: ISO 17025 Microbiology compliance

High Level Importance: ISO 17025 Microbiology compliance High Level Importance: ISO 17025 Microbiology compliance Thamolwan Laoviitayanurak, 3M FSD Professional Service APEC Regional Workshop, BKK Thailand on Aug 25, 2011 3M 2009. All Rights Reserved. Topic

More information

GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS

GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS GUIDELINES FOR FOOD IMPORT CONTROL SYSTEMS SECTION 1 SCOPE CAC/GL 47-2003 1. This document provides a framework for the development and operation of an import control system to protect consumers and facilitate

More information

Overview of U.S. FDA Regulations for Greek Manufacturers and Exporters of Food & Beverages

Overview of U.S. FDA Regulations for Greek Manufacturers and Exporters of Food & Beverages Overview of U.S. FDA Regulations for Greek Manufacturers and Exporters of Food & Beverages Coley Anderson, Director of Industry and Government Relations March 20 th, 2016 Seminar Overview Advantages of

More information

2. Aims (tasks, milestones, deliverables) addressed in this progress report

2. Aims (tasks, milestones, deliverables) addressed in this progress report Project Title: Food Product Tracing Technology Capabilities and Interoperability PI: Dr. Jennifer Cleveland McEntire Project Start Date: September 2010 End Date: August 2011 Period covered in this report:

More information

CONTENTS 1.2 POWERS OF AUTHORISED OFFICERS UNDER THE DAIRY ACT 6 1.3 VICTORIAN DAIRY FOOD SAFETY FRAMEWORK 6

CONTENTS 1.2 POWERS OF AUTHORISED OFFICERS UNDER THE DAIRY ACT 6 1.3 VICTORIAN DAIRY FOOD SAFETY FRAMEWORK 6 CONTENTS 1. INTRODUCTION 5 1.1 OVERVIEW 5 1.2 POWERS OF AUTHORISED OFFICERS UNDER THE DAIRY ACT 6 1.3 VICTORIAN DAIRY FOOD SAFETY FRAMEWORK 6 2. GENERAL PRINCIPLES 9 3. DAIRY FARMS 11 3.1 INTRODUCTION

More information

Hen Housing Research Frequently Asked Questions Final Results March 2015

Hen Housing Research Frequently Asked Questions Final Results March 2015 Hen Housing Research Frequently Asked Questions Final Results March 2015 General Who are the members of CSES? The Coalition is made up of leading animal welfare scientists, academic institutions, nongovernment

More information

Four Best Practices To Improve Quality In The Supply Chain. Lower your supply chain risks and cost of quality

Four Best Practices To Improve Quality In The Supply Chain. Lower your supply chain risks and cost of quality Four Best Practices To Improve Quality In The Supply Chain Lower your supply chain risks and cost of quality 1Introduction 2Quality Risks in the Supply Chain 3 Best Practices to improve quality in the

More information

Seven Must Have ERP Features for Food Manufacturers

Seven Must Have ERP Features for Food Manufacturers Seven Must Have ERP Features for Food Manufacturers Plex Online White Paper At a Glance This paper summarizes the seven features a food or beverage processor must have in its ERP software. Benefits of

More information

SQF INTERNATIONAL CONFERENCE IDEA EXCHANGE BREAKFAST Thursday, October 30 th, 7:00 a.m. 8:00 a.m. Oceans Ballroom 5-8

SQF INTERNATIONAL CONFERENCE IDEA EXCHANGE BREAKFAST Thursday, October 30 th, 7:00 a.m. 8:00 a.m. Oceans Ballroom 5-8 SQF INTERNATIONAL CONFERENCE IDEA EXCHANGE BREAKFAST Thursday, October 30 th, 7:00 a.m. 8:00 a.m. Oceans Ballroom 5-8 PLEASE NOTE: These questions are starter questions. The facilitator will lead the discussion

More information

Sage ERP Solutions. Managing Business Risk in the Food and Beverage Industry. Prepared exclusively for Sage by Cambashi, Inc. www.cambashi.

Sage ERP Solutions. Managing Business Risk in the Food and Beverage Industry. Prepared exclusively for Sage by Cambashi, Inc. www.cambashi. Managing Business Risk in the Food and Beverage Industry Prepared exclusively for Sage by Cambashi, Inc. www.cambashi.com Table of Contents Introduction...3 One-Stop Solutions for Category Leadership...

More information

FAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean San José, Costa Rica, 6-9 December 2005

FAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean San José, Costa Rica, 6-9 December 2005 Agenda Item 5 Conference Room Document 13 FAO/WHO Regional Conference on Food Safety for the Americas and the Caribbean San José, Costa Rica, 6-9 December 2005 THE FOOD SAFETY REGULATORY SYSTEM IN CANADA

More information

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction

More information

Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved

Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved A whitepaper by: Opportunities in Micro Quality Control According

More information

Inventory Management and Tracking

Inventory Management and Tracking Inventory Management and Tracking Reference Guide National Food Service Management Institute The University of Mississippi Item Number ET109-12 2012 Inventory Management and Tracking Reference Guide National

More information

FSSC 22000. - Food Safety System Certification Scheme - ISO-22000 and PAS 220. CIES Food Safety Conference Barcelona, February 2009

FSSC 22000. - Food Safety System Certification Scheme - ISO-22000 and PAS 220. CIES Food Safety Conference Barcelona, February 2009 FSSC 22000 - Food Safety System Certification Scheme - ISO-22000 and PAS 220 CIES Food Safety Conference Barcelona, February 2009 Cor Groenveld Chairman of the Board Foundation for Certification of Food

More information

Contaminated Products Insurance Application Form

Contaminated Products Insurance Application Form Contaminated Products Insurance Application Form APPLICANT S INFORMATION Name of Applicant Mailing address Contact Person Name: Email and Phone number: Website address Years in operation Business Description:

More information

116th Annual Convention

116th Annual Convention 116th Annual Convention Date: Saturday, October 18, 2014 Time: 10:30 am 12:00 pm Location: Austin Convention Center, Room 19AB, Level 4 Title: Activity Type: Speaker: Understanding the Drug Quality and

More information

Track and trace solution for returnable asset management

Track and trace solution for returnable asset management Track and trace solution for returnable asset management An industry whitepaper 3960 Fabian Way Palo Alto, CA 94303 650-397- 2550 www.frequentz.com Copyright 2014 Frequentz. All rights reserved. Returnable

More information

General Guidance for Developing, Documenting, Implementing, Maintaining, and Auditing an SQF System. Module 2: System Elements. SQF Code, Edition 7.

General Guidance for Developing, Documenting, Implementing, Maintaining, and Auditing an SQF System. Module 2: System Elements. SQF Code, Edition 7. General Guidance for Developing, Documenting, Implementing, Maintaining, and Auditing an SQF System Module 2: System Elements SQF Code, Edition 7.1 M A Y 2 0 1 3 2013 Safe Quality Food Institute 2345 Crystal

More information

Curriculum Innovation Driven by Industry Inputs: Engineering Technology Pathways

Curriculum Innovation Driven by Industry Inputs: Engineering Technology Pathways Curriculum Innovation Driven by Industry Inputs: Engineering Technology Pathways Chad Laux PhD, Diana Sanchez Purdue University West Lafayette, Indiana Abstract Consumers usually take for granted that

More information

Global Food Safety Systems Food-Borne Pathogen Control

Global Food Safety Systems Food-Borne Pathogen Control Global Food Safety Systems Food-Borne Pathogen Control Improving Food Safety Through One Health IOM Forum on Microbial Threats December 14, 2011 Michael C. Robach Vice President, Corporate Food Safety

More information

Insights in Engineering Leadership White Paper! Abstract!

Insights in Engineering Leadership White Paper! Abstract! Insights(in(Engineering(Leadership(White(Paper Food Chain Traceability Insights in Engineering Leadership White Paper Abstract The Food Chain Traceability market is growing with the increasing awareness

More information