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GS1 Standards Document - Global Traceability Standard for HealthcareGS1 Standards DocumentBusiness Process and System Requirements forSupply Chain TraceabilityGlobal Traceability Standard for HealthcareIssue 1.0.0, Feb-2009Feb-2009, Issue 1.0.0All contents copyright GS1 2009Page 1 of 64
GS1 Standards Document - Global Traceability Standard for HealthcareDocument SummaryDocument ItemCurrent ValueDocument TitleGS1 Standards Document Global Traceability Standard for HealthcareDate Last ModifiedFeb-2009Current Document IssueIssue 1.0.0StatusApprovedRelated CR08-000201Document DescriptionThis document is the GS1 Global Traceability Standard for Healthcare.It describes the traceability process independent from the choice ofenabling technologies. It also defines minimum requirements for allorganisations and countries, and corresponding GS1 Standards to beused in combination with information management tools.Log of Changes in Issue 1.0.0Issue No.Date of ChangeChanged BySummary of Change0.1Jun-2008Janice KiteOriginal draft created0.2Jan-2009Janice KitePost for eBallot0.2.1Feb-2009John RyuErrata Update based on eBallot Approval andCommentReference Summary of Changes1.0.0Feb-2009Mike MowadConvert document to issue based on draftversion 0.2.1, no content changes.DisclaimerWhilst every effort has been made to ensure that the guidelines to use the GS1 standards contained in thedocument are correct, GS1 and any other party involved in the creation of the document HEREBY STATE thatthe document is provided without warranty, either expressed or implied, of accuracy or fitness for purpose, ANDHEREBY DISCLAIM any liability, direct or indirect, for damages or loss relating to the use of the document. Thedocument may be modified, subject to developments in technology, changes to the standards, or new legalrequirements. Several products and organisation names mentioned herein may be trademarks and/or registeredtrademarks of their respective organisations.Feb-2009, Issue 1.0.0All contents copyright GS1 2009Page 2 of 64
GS1 Standards Document - Global Traceability Standard for HealthcareTable of Contents1.Overview .51.1.1.2.1.3.1.4.2.Business Opportunity and Business Needs . 5Business Intention . 5Business Justification . 6Audience . 7Acknowledgements .72.1.2.2.2.3.2.4.Business Requirement Group (BRG) Members. 7Traceability in Healthcare Work Team Participants / Traceability Work Group . 7Project Support . 9Project Advisors . 93.References .94.Scope .94.1.4.2.Overall Business Context . 9In Scope . 104.2.1. Immediate Phase . 114.2.2. Subsequent Phases . 114.3.Out of Scope . 115.General Definition .125.1.5.2.5.3.6.Business Process Analysis .136.1.7.Business Scenario for Traceability . 136.1.1. Business Process Participants Descriptions . 136.1.2. Business Scenario Overview. 176.1.3. Current Business Scenario (“as is”) . 27Business Requirements and Rules Analysis.307.1.7.2.7.3.8.Initial Challenges . 12Assumptions . 12Dependencies . 12Business Requirements . 30Technical Requirements . 36Business Rules . 36Structured Business Scenarios .418.1.Structured Business Scenario for Perform Traceability . 418.1.1. Use Case Diagram: Perform Traceability . 418.1.2. Use Case Definition: Align Master Data . 438.1.3. Use Case Definition: Record Traceability Data . 458.1.4. Use Case Definition: Request Trace . 47Feb-2009, Issue 1.0.0All contents copyright GS1 2009Page 3 of 64
GS1 Standards Document - Global Traceability Standard for Healthcare8.1.5.8.1.6.9.Business Object Analysis .499.1.10.Activity Diagram . 48Sequence Diagrams . 48Business Object Life-Cycle Discussion. 499.1.1. State Diagram(s) . 519.1.2. Business Object relationship discussion . 51Conceptual Solution (Examples) .5110.1.Fully Worked Example: Traceability in the Pharmaceutical Supply Chain . 5111.Implementation Considerations .5612.Test Scenario Summary .56Glossary of Business Terms .5713.Summary of Changes .64Feb-2009, Issue 1.0.0All contents copyright GS1 2009Page 4 of 64
GS1 Standards Document - Global Traceability Standard for Healthcare1.Overview1.1.Business Opportunity and Business NeedsBusinesses, end users and authorities in various markets around the world have an interest inestablishing systems to track and trace products at various points of the supply chain. This sharedinterest is never more evident than for healthcare products, but the key principles can be applied toany industry sector served by GS1 that has a need to track and trace product through the supplychain.This document is a standard because it is the definition for GS1 healthcare members (exclusive of anyother definition) of what the process standard for traceability in healthcare encompasses and it showsthe corresponding GS1 numbering, automatic identification data capture (AIDC) or datacommunication standards that must be in place for best practice applications. For example, from nowon a GS1 traceability in healthcare implementation guideline will only be referred to as such if itaddresses all the use cases described in the GS1 Global Traceability Standard for Healthcare.Partners in a supply chain could use various levels of product traceability to enable business needssuch as:1.2. To comply with regulatory requirements and guidance on recalls To reduce business risks above and beyond legal compliance Product recall and withdrawal (notably to achieve a greater degree of precision, todemonstrate control, increase efficiency and reduce the cost of product recall or withdrawal) To comply with a trading or traceability partner’s specifications Efficient logistics management Effective quality management To support product and/or patient safety To provide information to end users and trading or traceability partners To verify the presence or absence of product attributes (e.g., contains latex, single use) Brand protection Product authentication and anti-counterfeit policiesBusiness IntentionThe goal of this document is to create a ‘GS1 Global Traceability Standard for Healthcare’ using theGS1 System of standards. This is a PROCESS standard describing the traceability processindependent from the choice of enabling technologies (see sections 6, 7.3 and 8). It defines minimumrequirements for all stakeholders, organisations and countries and corresponding GS1 Standards tobe used in combination with information management tools (see section 7.1).This is a building block for developing: Traceability systems Country specific traceability user guidelines New GS1 standards that may be required (or leverage of existing standards)Note: Refer to section 11.Feb-2009, Issue 1.0.0All contents copyright GS1 2009Page 5 of 64
GS1 Standards Document - Global Traceability Standard for HealthcareThe intention is therefore to create a foundational framework that is expected to be used by anybusiness, organisation, large or small, and by any country in order to develop specific implementationguidelines or additional requirements. These implementation guidelines will take into consideration, forexample, scope and traceable item hierarchy specific to their business needs (see sections 4, 7, 9,11).This GS1 Global Traceability in Healthcare Standard will maximise use of the well-established,globally acceptable and voluntary GS1 business standards that uniquely identify a “traceable item”,describe the establishment of appropriate and effective records of events, and provide for accuratecommunication about the traceable item between trading or traceability partners.This meets the core need to be able to track forward and trace back (one step up, one step down) atany point along the extended length of the supply chain no matter how many trading or traceabilitypartners and business process steps are involved.This may be used for benchmarking or certification of traceability systems.1.3.Business JustificationHealthcare organisations require consistent traceability solutions spanning the extended supply chainregardless of country.By defining a shared minimum requirement and showing what action is required from organisations,countries, or a group of trading or traceability partners, the GS1 Global Traceability Standard forHealthcare will enable maximum interoperability between traceability systems across the extendedsupply chain whilst accommodating specific business, industry sector, or national requirements.Each partner in the supply chain will have their own objectives in terms of the use of the traceabilitysystem, the lowest level of traceable item and the data required to manage their particular trading ortraceability environment and strategy. Yet partners need to work collaboratively in order to achieve therequired level of traceability across the extended supply chain. Furthermore, having a provenstandard-based traceability process can demonstrate that an organisation has met requirements ofcorporate responsibility.The GS1 Global Traceability Standard for Healthcare will serve as a foundational standard for allcountries to use as a starting point for identifying their specific business requirements. This frameworkwill ensure a common approach and understanding of key principles by users around the world.To demonstrate that these ideas are shared in countries around the world by businesses, legislatorsand regulators, here are some extracts from key reference documents:Europe Building Collaboration to Facilitate Track and Trace“Collaboration between trading partners should be promoted continuously. Through the use ofvoluntary, global business standards each company involved in the supply chain can remainresponsible for selecting the service provider to implement their system in an open, competitive marketplace. The use of voluntary, global business standards improve efficiency and drives down total supplychain costs.”ECR – Using Traceability in the Supply Chain to meet Consumer Safety ExpectationsECR Europe, March 2004, Chapter 4 “Business Needs”, page 16UK - Coding for Success programmeThe UK Department of Health issued a Policy Guidance Document in February 2007 in closecooperation with GS1 UK, GS1 Healthcare and ABHI (Association of British Healthcare Industries):“The Department of Health is recommending that the GS1 System should be adopted throughout thehealthcare system in England [ ] and presents an action plan calling for engagement in GS1Healthcare.”INCLUDE REFERENCEFeb-2009, Issue 1.0.0All contents copyright GS1 2009Page 6 of 64
GS1 Standards Document - Global Traceability Standard for HealthcareBuilding the Business Case for Data Management“Since product record information can differ according to the purpose of product traceability, company,and industry, the management of this information should emphasize the importance of company andindustry initiatives. However, if traceability goals and purposes are the same within an industry, it isdesirable for the management method and product record information (including item code and serialnumber data structure of the product identification code system) to be the same.”Study Group on the Improvement of Product Traceability, Interim Report, April 2003Ministry of Economy, Trade & Industry, Japan, Chapter 3.2 “Efforts which should be shared as much as possible”, page 111.4.AudienceThe audience is all GS1 Member Organisations (MOs), the service provider community that servesthem, business associations and government organisations. This includes all parts of the supply chain,for example: raw material (sometimes called “primary”) producers, processors, manufacturers,wholesalers, healthcare providers, importers/brokers and exporters, third party logistic providers,logistic providers, transporters or carriers and solution providers.The audience includes all senior managers with executive responsibility, managers and employeesworking in production, quality and safety, logistics, information technology, product development,marketing, customer/patient management roles and end users/patients.2.Acknowledgements2.1.Business Requirement Group (BRG) Members2.2.FunctionNameCompany / OrganisationParticipantNot ApplicableTraceability in Healthcare Work Team Participants / TraceabilityWork GroupFunctionName (First, Surname)Company / OrganisationCountryParticipantCyndi PoetkerAbbottUnited StatesParticipantMike WallaceAbbottUnited StatesParticipantRob MennowBoston ScientificUnited StatesParticipantFrédérique FremontCHI Robert Ballanger HospitalFranceParticipantRoger SmartDouglas Pharmaceuticals LtdNew ZealandParticipantDawn FowlerEdwards LifesciencesUnited StatesParticipantConnie JungFood and Drug Administration (FDA)United StatesParticipantIlisa BernsteinFood and Drug Administration (FDA)United StatesParticipantJay CrowleyFood and Drug Administration (FDA)United StatesParticipantTracey HerresGlaxoSmithKleinUnited KingdomParticipantTania SniochGS1 AustraliaAustraliaParticipantYady AnguloGS1 AustraliaAustraliaParticipantBarbara DornerGS1 AustriaAustriaParticipantWilson CruzGS1 BrazilBrazilFeb-2009, Issue 1.0.0All contents copyright GS1 2009Page 7 of 64
GS1 Standards Document - Global Traceability Standard for HealthcareFunctionName (First, Surname)Company / OrganisationCountryParticipantAlicia DuvalGS1 CanadaCanadaParticipantMichael SadiwnykGS1 CanadaCanadaParticipantJuan Pablo VialGS1 ChileChileParticipantMarcos SquellaGS1 ChileChileParticipantSlobodan RomacGS1 CroatiaCroatiaParticipantGena MorganGS1 EPCglobalUnited StatesParticipantBettina BartzGS1 GermanyGermanyParticipantAna Paula ManieroGS1 Global OfficeBelgiumParticipantBrian BennettGS1 Global OfficeUnited StatesParticipantDiane TaillardGS1 Global OfficeBelgiumParticipantElvire TeviGS1 Global OfficeBelgiumParticipantJanice KiteGS1 Global OfficeBelgiumParticipantJanice KiteGS1 Global OfficeBelgiumFacilitatorJohn RyuGS1 Global OfficeUnited StatesParticipantTom HeistGS1 Global OfficeUnited StatesParticipantUlrike KreysaGS1 Global OfficeBelgiumParticipantPete AlvarezGS1 Global Office (GDSN)United StatesParticipantGary HartleyGS1 New ZealandNew ZealandParticipantAlice MukaruGS1 SwedenSwedenParticipantTomas WenneboGS1 SwedenSwedenParticipantBob CelesteGS1 USUnited StatesParticipantDennis HarrisonGS1 USUnited StatesParticipantCarin GriffithsJohnson & JohnsonAustraliaParticipantSteve TadevichMcKessonUnited StatesParticipantSue ThomsonNational Council for Prescription DrugPrograms (NCDPD)United StatesParticipantJudi FinesilverNational Health Service (NHS), Purchasingand Supply Agency (PaSA)United KingdomParticipantArne HenstenNorwegian Industry Assoc. & EU CENTraceability Task ForceNorwayParticipantScott CameronNovartisCanadaParticipantJonathan KayOxford Radcliffe NHS TrustUnited KingdomParticipantMark WalchakPfizerUnited StatesParticipantTim MarshPfizerUnited StatesParticipantFeargal McGroartySt James’s HospitalIrelandParticipantRobert H. PerryThe Association for Healthcare Resource &Materials Management (AHRMM)United StatesParticipantJan-Joost van WalsumUniversity Medical Center Groningen(UMCG)NetherlandsOn behalf of GS1, we would like to thank the Wo
the corresponding GS1 numbering, automatic identification data capture (AIDC) or data communication standards that must be in place for best practice applications. For example, from now on a GS1 traceability in healthcare implementation guideline will only be referred to as such if it
Foodstuffs GS1 NPC Supplier Guidelines Version 2.2 Page 4 of 28 GS1 PRODUCTFLOW / NPC PROCESSES As a supplier to Foodstuffs you will need to: Register for GS1 ProductFlow and work with GS1 to achieve GS1 Product Flow Certified status. Foodstuffs will then "activate" your company in the Foodstuffs eXchange to be a ProductFlow user.
healthcare industry through local support initiatives like GS1 Healthcare US in the United States. About GS1 Healthcare US GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to help improve patient safety and supply chain efficiency.
industry through local support initiatives like GS1 Healthcare US in the United States. ABOUT GS1 HEALTHCARE US GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency.
GS1 , under its IP Policy, seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in the Work Group that developed this GS1 AIDC Fresh Foods Sold at Point -of-Sale Implementation Guideline to agree to grant to GS1 members a royalty-free licence or a RAND licence to Necessary Claims, as that term is defined in the GS1
Introduction The GS1 System is the most widely used supply chain standards system in the world and comprises the standards, guidelines, solutions and services created in formalised and collaborative processes. . GS1 identification standards, known as GS1 Identification Keys, bring value by permitting secure and portable identification across .
GS1 Standards make it possible for companies to leverage the power of information by identifying, capturing, and sharing data about products, locations, and more. GS1 is a global, not-for-profit organization with more than 110 member organizations (MOs) serving business around the world. GS1 is neutral, user-driven, and user-governed. 15
international standard upon which individual GS1 Member Organizations can develop user documentation. Electronic Data Interchange The use of Electronic Data Interchange (EDI) is an integral part of the GS1 System philosophy. Full details on the EDI standards are contained in EANCOM and GS1 XML. EANCOM is an implementation guideline of the
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