16 Guidel<strong>in</strong>eQuality AssuranceDesign TechnicalSpecificationsDesign FunctionalSpecificationsSelectVendors<strong>for</strong>PrototypeInstallPrototypeRunPrototype XandCollectDataPer<strong>for</strong>mImpactAnalysisDocumentLessonsLearnedVerify XExitCriteriaConduct XPilot SiteSurveyCreate XPilot PlanProject ManagementCommunication PlanFig. 12 Overview <strong>of</strong> <strong>the</strong> prototype phase.Quality AssuranceDesign TechnicalSpecificationsDesign FunctionalSpecificationsSelectVendors<strong>for</strong>PilotInstallPilotSystemRunPilot XandCollectDataProject ManagementCommunication PlanPer<strong>for</strong>mImpactAnalysisDocumentLessonsLearnedVerify XExitCriteriaConduct XDeploymentSite SurveysCreate XDeploymentPlanFig. 13 Overview <strong>of</strong> <strong>the</strong> Pilot Phase.Quality AssurancePlan <strong>for</strong>DeploymentPrepareToGo LiveGoLiveOperateEn<strong>for</strong>ce System StandardsMonitor SystemMeasure ResultsIdentify Successes and Areas <strong>for</strong> ImprovementProject ManagementCommunication PlanFig. 14 Overview <strong>of</strong> <strong>the</strong> Deploy Phase.This can be accomplished by mapp<strong>in</strong>g exist<strong>in</strong>g processes,identify<strong>in</strong>g challenges associated with <strong>the</strong>m, analys<strong>in</strong>ghow <strong>RFID</strong> can enable improvements, anddevelop<strong>in</strong>g redesigned <strong>RFID</strong>-enabled processes. Processesthat might be analysed are listed <strong>in</strong> Table 7. As a result <strong>of</strong>this workflow ⁄ process-oriented analysis, a set <strong>of</strong> systemrequirements to support those improvements should becompiled.7.1.2 Phase II – The Prototype PhaseThe second phase <strong>of</strong> <strong>the</strong> project roadmap is outl<strong>in</strong>ed <strong>in</strong>Fig. 12. The objective <strong>of</strong> <strong>the</strong> prototype is to demonstrate <strong>the</strong>functionality and test <strong>the</strong> limits <strong>of</strong> <strong>the</strong> <strong>RFID</strong> solution <strong>in</strong> arealistic, yet safe and secure environment that emulates <strong>the</strong>targeted processes. Per<strong>for</strong>mance metrics and necessarycheck po<strong>in</strong>ts are identified to evaluate <strong>the</strong> <strong>RFID</strong>-enabledprocesses. Process results are compared and analysed toconfirm per<strong>for</strong>mance expectations and to discover potentialflaws and limitations <strong>in</strong> <strong>the</strong> new system.7.1.3 Phase III – The Pilot PhaseThe third phase <strong>of</strong> <strong>the</strong> project roadmap is outl<strong>in</strong>ed <strong>in</strong>Fig. 13. The pilot phase <strong>in</strong>volves real processes <strong>in</strong> limitedsites with basic <strong>in</strong>tegration to back-end productionsystems. The pilot phase is methodologically similar to<strong>the</strong> prototype phase. However, <strong>the</strong> pilot phase has anexpanded scope <strong>in</strong> terms <strong>of</strong> processes and back-end<strong>in</strong>tegration. All processes <strong>in</strong>cluded <strong>in</strong> <strong>the</strong> new system areplaced <strong>in</strong> actual production <strong>in</strong> this phase, but <strong>for</strong> alimited set <strong>of</strong> sites and products. In terms <strong>of</strong> systems<strong>in</strong>tegration, this phase could <strong>in</strong>corporate all ma<strong>in</strong>l<strong>in</strong>e<strong>in</strong>tegration with core back-end systems. The pilot phasecould also <strong>in</strong>clude collection <strong>of</strong> per<strong>for</strong>mance metrics <strong>in</strong>order to verify and estimate <strong>the</strong> anticipated benefits from<strong>RFID</strong> implementation.7.1.4 Phase IV – The Deploy PhaseThe f<strong>in</strong>al phase <strong>of</strong> <strong>the</strong> project <strong>in</strong>volves full scale deployment<strong>of</strong> <strong>the</strong> systems and processes and is outl<strong>in</strong>ed <strong>in</strong>Ó 2010 The Author(s)Journal compilation Ó 2010 International Society <strong>of</strong> Blood <strong>Transfusion</strong>, Vox Sangu<strong>in</strong>is (2010) 98 (Suppl. 2), 1–24
Guidel<strong>in</strong>e 17Fig. 14. This phase requires rigorous methods <strong>for</strong> operat<strong>in</strong>gand manag<strong>in</strong>g <strong>the</strong> system dur<strong>in</strong>g and after deployment.7.2 Tips <strong>for</strong> Change Management, Validation andQualification<strong>RFID</strong> systems can be used to improve and automate processesand to complement o<strong>the</strong>r data management systems.The adoption <strong>of</strong> an <strong>RFID</strong> system is a complex process thatrequires change control documentation, process validation,and qualification <strong>of</strong> system components to facilitate safeimplementation. Today, different templates to guide changemanagement, validation and qualification are readily available.The ISBT WPIT Validation Task Force published <strong>in</strong> 2010<strong>the</strong> second version <strong>of</strong> <strong>the</strong> ‘‘ISBT <strong>Guidel<strong>in</strong>es</strong> <strong>for</strong> Validation<strong>of</strong> Automated Systems <strong>in</strong> Blood Establishments’’ [23]. Itspurpose was to supplement exist<strong>in</strong>g validation referencematerial <strong>for</strong> GMP regulatory compliance, which was morerelevant to <strong>the</strong> field <strong>of</strong> pharmaceutical manufactur<strong>in</strong>g, andto provide guidance <strong>for</strong> <strong>the</strong> application <strong>of</strong> <strong>the</strong> validationprocess <strong>for</strong> automated systems <strong>in</strong> blood bank<strong>in</strong>g, i.e. systemsthat have some degree <strong>of</strong> computer control. The comprehensivere-write <strong>of</strong> <strong>the</strong> guidel<strong>in</strong>es has expanded upon<strong>the</strong> scope <strong>of</strong> validation activities covered and considered<strong>the</strong> follow<strong>in</strong>g developments (see 10.3.3):• GAMP5 Ò : In 2008 Version 5 replaced Version 4 <strong>of</strong> <strong>the</strong>Good Automated Manufactur<strong>in</strong>g Practice <strong>Guidel<strong>in</strong>es</strong>(GAMP ⁄ ISPE)• ASTM E2500: The ‘‘Standard <strong>for</strong> Specification, Design &Verification <strong>of</strong> Pharmaceutical & BiopharmaceuticalManufactur<strong>in</strong>g Systems & Equipment’’• ICH Q8, ICH Q9, ICH Q10: The purpose <strong>of</strong> <strong>the</strong> InternationalConference on Harmonisation (ICH) <strong>of</strong> TechnicalRequirements <strong>for</strong> Registration <strong>of</strong> Pharmaceuticals <strong>for</strong>Human <strong>Use</strong>7.2.1 Change ControlThe change control section <strong>of</strong> ‘‘ISBT <strong>Guidel<strong>in</strong>es</strong> <strong>for</strong> Validation<strong>of</strong> Automated Systems <strong>in</strong> Blood Establishments’’describes <strong>the</strong> procedures used to ensure that changes are<strong>in</strong>troduced <strong>in</strong> a controlled, co-ord<strong>in</strong>ated manner and areapproved by management be<strong>for</strong>e implementation [23].As <strong>the</strong> first step, <strong>the</strong> aim <strong>of</strong> <strong>the</strong> implementation has to bedef<strong>in</strong>ed. The reasons <strong>for</strong> implement<strong>in</strong>g <strong>RFID</strong> and <strong>the</strong> possibletechnical solutions may vary as described <strong>in</strong> Chapter 3.Depend<strong>in</strong>g on <strong>the</strong>se reasons, <strong>the</strong> follow<strong>in</strong>g questions <strong>in</strong> <strong>the</strong>change control document must be answered:1. What will be improved, e.g. methods and ⁄ or devices(workflow, identification process, patient safety)?2. What are <strong>the</strong> possible alternatives from <strong>the</strong> technical,safety, and f<strong>in</strong>ancial po<strong>in</strong>ts <strong>of</strong> view?3. What are <strong>the</strong> affected process steps?4. Which responsible persons are to be <strong>in</strong><strong>for</strong>med and mustagree (bus<strong>in</strong>ess and quality management, Qualified Person<strong>in</strong> EU countries)?5. Are a project plan, risk analysis, validation and ⁄ or qualificationnecessary?6. Are key documents, e.g. SOPs, to be changed?7. Will implementation <strong>of</strong> <strong>RFID</strong> result <strong>in</strong> changes to <strong>the</strong>regulatory status and ⁄ or <strong>the</strong> manufactur<strong>in</strong>g or test<strong>in</strong>gprocess <strong>of</strong> drugs, and must <strong>the</strong>se changes be reported to<strong>the</strong> authorities?8. What k<strong>in</strong>d <strong>of</strong> tra<strong>in</strong><strong>in</strong>g is necessary <strong>for</strong> <strong>the</strong> staff<strong>in</strong>volved?Implementation <strong>of</strong> <strong>RFID</strong> systems <strong>of</strong>ten requires both validation<strong>of</strong> new processes and qualification <strong>of</strong> technicalcomponents. The risk <strong>of</strong> any change dur<strong>in</strong>g validation andqualification, as well as <strong>the</strong> entire life cycle, must be evaluated,documented, and controlled.7.2.2 Qualification and ValidationQualification and validation processes should be used dur<strong>in</strong>g<strong>the</strong> full lifecycle <strong>of</strong> <strong>the</strong> <strong>RFID</strong> application throughdesign, development, <strong>in</strong>stallation, and operational phases.7.2.3 Per<strong>for</strong>mance QualificationThe objective <strong>of</strong> per<strong>for</strong>mance qualification is to demonstratethat <strong>the</strong> computerized process will consistentlyproduce acceptable output under normal operat<strong>in</strong>g conditions.This task evaluates whe<strong>the</strong>r <strong>the</strong> aims <strong>of</strong> <strong>the</strong> <strong>in</strong>stallationare reached, e.g. a reduction <strong>in</strong> <strong>the</strong> rate <strong>of</strong> <strong>in</strong>correct transfusionsor easier identification <strong>of</strong> blood products <strong>in</strong> a process.Ano<strong>the</strong>r objective <strong>of</strong> this task is <strong>the</strong> collection and evaluation<strong>of</strong> problems and failures such as hardware breakdowns,<strong>RFID</strong> tag malfunctions, or reader problems. As aresult <strong>of</strong> <strong>the</strong> analysis, a change <strong>in</strong> <strong>the</strong> system or its componentsmay be necessary. This type <strong>of</strong> change, depend<strong>in</strong>g on<strong>the</strong> complexity and <strong>the</strong> validation ⁄ qualification model chosen,could be documented as part <strong>of</strong> <strong>the</strong> per<strong>for</strong>mance qualificationor <strong>in</strong> separate change management documentation.Because <strong>of</strong> <strong>the</strong> usual extended timeframe <strong>of</strong> <strong>the</strong> whole lifecycle,certification <strong>of</strong> completion <strong>of</strong> <strong>the</strong> per<strong>for</strong>mance qualificationby responsible persons can be difficult and <strong>of</strong>tenmay require <strong>in</strong>volvement <strong>of</strong> <strong>the</strong> direct head <strong>of</strong> <strong>the</strong> departmentor person <strong>in</strong> charge.8. Economic Justification and Return onInvestment (ROI)8.1 Blood CentersA study was done <strong>in</strong> <strong>the</strong> USA to assess applicability <strong>of</strong> <strong>RFID</strong><strong>in</strong> transfusion medic<strong>in</strong>e. Three blood centers <strong>in</strong> <strong>the</strong> USA(BloodCenter <strong>of</strong> Wiscons<strong>in</strong>, Milwaukee, WI; CarterÓ 2010 The Author(s)Journal compilation Ó 2010 International Society <strong>of</strong> Blood <strong>Transfusion</strong>, Vox Sangu<strong>in</strong>is (2010) 98 (Suppl. 2), 1–24
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