GS1 Standards Document GS1 Global Traceability Standard GS1 Standards Document Business Process and System Requirements for Full Supply Chain Traceability GS1 Global Traceability Standard Issue 1.3.0, November 2012 November 2012, Issue 1.3.0 All contents copyright © GS1 2010-2012 Page 1 of 67 GS1 Standards Document GS1 Global Traceability Standard Document Summary Document Item Current Value Document Title GS1 Standards Document GS1 Global Traceability Standard Date Last Modified November 2012 Current Document Issue Issue 1.3.0 Status Ratified Related CR 05-000309 08-000130 09-000143 11-000281 Document Description This document is the GS1 Global Traceability Standard. It describes the traceability process independent from the choice of enabling technologies. It also defines minimum requirements for all organisations, industry sectors, countries, and corresponding GS1 Standards to be used in combination with information management tools. Log of Changes in Issue 1.3.0 Issue No. Date of Change Changed By Summary of Change 1.0 Sep-2007 John Ryu Initial Version Diane Taillard 1.1 Jan-2009 Janice Kite Changes to reflect application to Healthcare sector. Posted for eBallot. 1.1.0 Feb-2009 John Ryu Errata Update based on eBallot Approval and Comment Reference Summary of Changes 1.1.0 Feb-2009 Mike Mowad Convert document to final issue, no content changes. 1.2.0 Oct 2009 John Ryu Process Change Request 9-143 1.2.1 Jan 2010 John Ryu Incorporate Public Review Comments 1.2.2 Mar-2010 John Ryu eBallot Approved 1.3.0 July 2012 John Ryu Process Change Request 11-281 1.3.0 November 2012 John Ryu eBallot approved WR 11-281 and update for publication Disclaimer Whilst every effort has been made to ensure that the guidelines to use the GS1 standards contained in the document are correct, GS1 and any other party involved in the creation of the document HEREBY STATE that the document is provided without warranty, either expressed or implied, of accuracy or fitness for purpose, AND HEREBY DISCLAIM any liability, direct or indirect, for damages or loss relating to the use of the document. The document may be modified, subject to developments in technology, changes to the standards, or new legal November 2012, Issue 1.3.0 All contents copyright © GS1 2010-2012 Page 2 of 67 GS1 Standards Document GS1 Global Traceability Standard requirements. Several products and organisation names mentioned herein may be trademarks and/or registered trademarks of their respective organisations. November 2012, Issue 1.3.0 All contents copyright © GS1 2010-2012 Page 3 of 67 GS1 Standards Document GS1 Global Traceability Standard Table of Contents 1. Overview .................................................................................................................................... 6 1.1. Business Opportunity and Business Needs ....................................................................................... 6 1.2. Business Intention .............................................................................................................................. 6 1.3. Business Justification ......................................................................................................................... 7 1.4. Audience ............................................................................................................................................ 7 2. Acknowledgements ................................................................................................................... 8 2.1. Traceability and Event Sharing Standards Maintenance Group ........................................................ 8 3. References ............................................................................................................................... 10 4. Scope ....................................................................................................................................... 10 4.1. Overall Business Context ................................................................................................................. 10 4.2. In Scope ........................................................................................................................................... 11 4.2.1. Immediate Phase ................................................................................................................... 12 4.2.2. Subsequent Phases ............................................................................................................... 12 4.3. Out of Scope .................................................................................................................................... 12 5. General Definition .................................................................................................................... 13 5.1. Initial Challenges .............................................................................................................................. 13 5.2. Assumptions ..................................................................................................................................... 13 5.3. Dependencies .................................................................................................................................. 13 6. Business Process Analysis .................................................................................................... 14 6.1. Business Scenario for Traceability ................................................................................................... 14 6.1.1. Business Process Participants Descriptions .......................................................................... 14 6.1.2. Business Scenario Overview.................................................................................................. 18 6.1.3. Current Business Scenario (“as is”) ....................................................................................... 27 7. Business Requirements and Rules Analysis......................................................................... 30 7.1. Business Requirements ................................................................................................................... 30 7.2. Technical Requirements .................................................................................................................. 36 7.3. Business Rules ................................................................................................................................ 36 8. Structured Business Scenarios .............................................................................................. 40 8.1. Structured Business Scenario for Perform Traceability ................................................................... 40 8.1.1. Use Case Diagram: Perform Traceability ............................................................................... 40 8.1.2. Use Case Definition: Align Master Data ................................................................................. 42 8.1.3. Use Case Definition: Record Traceability Data ...................................................................... 44 8.1.4. Use Case Definition: Request Trace ...................................................................................... 46 8.1.5. Use Case Definition: Recall Product ...................................................................................... 48 8.1.6. Activity Diagram ..................................................................................................................... 51 November 2012, Issue 1.3.0 All contents copyright © GS1 2010-2012 Page 4 of 67 GS1 Standards Document GS1 Global Traceability Standard 8.1.7. Sequence Diagrams ............................................................................................................... 51 9. Business Object Analysis ....................................................................................................... 52 9.1. Business Object Life-Cycle Discussion ............................................................................................ 52 9.1.1. State Diagram(s) .................................................................................................................... 54 9.1.2. Business Object relationship discussion ................................................................................ 54 10. Conceptual Solution (Examples) ..................................................................................... 54 11. Implementation Considerations ...................................................................................... 54 11.1. Contact your GS1 organisation to get expert advice ....................................................................... 54 11.2. Model the supply chain where traceability is to be accomplished ................................................... 54 11.3. Determine priority business needs ................................................................................................... 55 11.4. Describe the physical flow of products ............................................................................................. 55 11.5. Define Traceability Partners’ roles ................................................................................................... 55 11.6. Model the Process (for each Physical Process that is Relevant) .................................................... 56 11.6.1. Identify the level of the Traceable Item .................................................................................