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Omicron Consulting1500 Market StreetPhiladelphia, PA 19102
Implementing RTPM Infrastructure for a Validated
Environment
May 14, 2003 Bill SmithMead Johnson Nutritionals
Mike PurcellOmicron Consulting
Overview
Drivers and ObjectivesVisionInfrastructure PlanningArchitecture/StandardsImplementation StrategyFuturesSummary
Drivers and Objectives
PI Infrastructure in an FDA Compliant Environment
Help Facilitate Validation of Other AreasServe as a Model for Other sitesBalance Implementation to MaximizeCost Effectiveness and Resource UtilizationLeverage Emerging OSI technologies to Expose Process DataPosition PI Infrastructure for the System of Record
Vision
Compliant OSIsoft Infrastructure – Full Validation DocumentationProvide Enterprise Access to Real Time Manufacturing DataBrowser-Based Tools (Thin Client)Proactive NotificationSystem of RecordRapid, Reliable and Informed Decision Making
Infrastructure Planning
Phased ImplementationPhase I: Validation & Batch ConfigurationPhase II: System of Record and Flexible Reporting/NotificationPhase III: Enterprise Integration
Architecture/Standards
Cluster Node 1 Cluster Node 2
RaidArray
PI Home Node(Cluster)
PLCPLCPLCPLC
Cluster Node 1 Cluster Node 2
RaidArray
PI Home Node(Cluster)
HMI (iBatch)EVT Interface
HMI (iBatch)EVT Interface
HMI (iBatch)EVT Interface
Process Control LAN
Process Center
PLCPLCPLCPLC
Cluster Node 1 Cluster Node 2
RaidArray
PI Home Node(Cluster)
HMI (iBatch)EVT Interface
HMI (iBatch)EVT Interface
HMI (iBatch)EVT Interface
Process Control LAN
Process Center
User User UserEnd User Community
Business LAN
Naming Conventions
PI TagsImplement a well-defined naming convention
Utilize SCADA tag names as the corePrefix tags with area abbreviationEnsure naming convention makes it easy for users to find things via wildcard searches
Consolidate from previously used conventions
Module Database Hierarchy
Design a flexible hierarchyEnsure compatible hierarchy with other components:
Event File InterfacePIBaGenRTreports
Make the structure “repeatable”Ease report generation issues by enabling the “general case” reporting
PI System Security
PI PointsThe Interface User to own the data
Only interface can write dataEven PIAdmin cannot write/edit/delete data without first editing security attributes of the point
PIAdmin to own the point (attributes)Interface Admin Group associated with point and data
Group to have read/write access to attributes but read/only to data
PI System Security
PI UsersAll users will have their own PI User IDSOP’s developed for User ID administration
Procedures for adding/deleting/changing users
PI System Security
Custom Application SecurityUtilize Windows NT/Netware Security to determine access rightsUtilize AppName Trust to “proxy” user into PI to allow read/write access for manual data applications
PI System Security
BackupCreate custom cluster version of PISRVSTART and PISRVSTOP batch filesSOP to address backup and recovery
PI Message Log Audit Trail
Allows auditing of:Edits or Deletes to the Data Archive
Does not support logging BLOB auditing
PI Batch Database Changes
Audit trail is written to the PI Message LogMessage logs typically are purged after 15 days
A backup procedure will accommodate longer retention of message log (audit trail)
Real-Time Data Collection
OPC InterfaceMultiple OPC Interfaces
Provide a level of fault-toleranceLogical delineations of data collection
Data in PLC’s is accessed directly from the PLC’s via RSLinxData in SCADA are accessed via the SCADA’s OPC server
Batch Data Collection
EVT Interface for Batch Execution System batch filesPI Batch Generator Interface
New version is currently in developmentProvide for down-stream processing hierarchical batch generationOnly be used where a Batch Execution System does not generate the batch information
Fault-Tolerance
ServerUse Microsoft Windows ClusteringValidation Test Strategy includes testing failure modes
Fault-Tolerance
InterfacesUse multiple OPC InterfacesFailure of a single interface will stop data from being collected from a section of the facility rather than the whole facilityRun the interfaces on a Windows 2000 cluster to provide high reliabilityUse Buffering to protect against network outages and PI server outages
Alarming and Notification
PI-ACE BasedUse Module Database for Configuration
Allow multiple instances of the same codeEach instance runs in a context (module) and uses the Aliases defined in that context
Use PI-SQC and PI-ALARMS for more complex triggering of notifications
Reporting Tools
PI-DataLinkPossible add-ins for things such as:
Cycle time analysisBatch Hierarchy Reporting
Note: Next Version of the Excel portion of BatchView will not access Batch Database
Training to provide users with Ad-hoc query capabilities
Reporting Tools
PI-ProcessBookNext Version of BatchView will support
Batch DatabaseHierarchical BatchesBatch TrendsGant Charts
Reporting Tools
PI-ICEWeb based access to PI Data, Trends, and DiagramsUses “Web parts” to allow end-user customizationExtensible via PI-ICE SDK
Build custom Web parts such as:Batch Cycle TimeBatch HierarchyBatch Discrete Data Reporting
Reporting Tools
RTreportsEarly Adopter ProgramKey batch reporting toolSupports
PI Batch DatabaseHierarchical BatchesCustom Calculations
Designed to be 21CFR11 Compliant
Implementation Strategy
Phase I
Validation & Batch ConfigurationFirst Half of 2003
Define Architecture/StandardsCompliant PI Server InstallationInterface Consolidation and Validated ImplementationBatch Infrastructure Implementation (EVT) System of Record Prototype (ICE, ACE, RTreports)Quality ReportingcGMP Training
Phase I
Server ValidationBuild Cluster as the Validated Server Using PI 3.3 SR2Generate Validation PlanGenerate URS, FRS, GDSRequirements Traceability MatrixGenerate and Execute IQ/OQGenerate SOPs (Backup, Administration, Operations, Audit)Generate Traceability Matrix
Phase I
Validated ImplementationOPC Interface Design
Multiple Interfaces Providing a Level of Fault-tolerance
Generate DDS (Detail Design Document)Specific ImplementationAppendix Listing All Tags
Generate and Execute IQ/OQFunctional Test Specification (FTS)Structural Test Specification (STS)
Phase I
Batch Infrastructure Implementation (EVT)Generate DDSEVT Generates Tags/MDB so DDS does not Have Tag ListGenerate and Execute
IQ/OQTest Plan
Phase I
Manual Data Entry Yield ApplicationSeparate Validation Validation Plan, FRS, DDS, IQ/OQ, Unit Test Plan, Integration Test Plan, System Acceptance Test Plan, Traceability Matrix, PQLeverage MDB for Correlation
Phase I
System of Record Proof of ConceptNon-validated, Read-only, Demonstrates Capabilities Installation of PI-ICE and Configuration of ScreensInstallation of PI-ACE and Generation of NotificationsInstallation of RTreports and Generation of Reports
Phase I
Quality Reporting FoundationShaped by Feedback from Proof of ConceptGeneration of URS and FRS
Phase I
cGMP TrainingPI Client ToolsPI-ICEAdministration
Phase II - System of Record
Central RepositoryReliable Decision MakingFully Validated - End to EndQuality Data – Batch Release21 CFR Part 11 Compliant
Phase II - System of RecordQuality Needs
Specification ComplianceAnalysis ToolsInternal AuditsBatch Release CriteriaCertificates of AnalysisRoot cause analysisSQC
Phase II - System of Record
Regulatory NeedsException ReportingException AnalysisRegulatory Compliance ReportsEnvironmental
Phase II - System of Record
Manufacturing NeedsBatch SummaryUtility ReportsDetail by Unit, Product, etc.Yield, Efficiency, ThroughputCIP/SIP
Phase II
July 2003 - March 2004MDB & PIBAGEN for non-iBatchValidated Implementation
PI-RTreportsPI-ICENotification/PI-ACE
Other Automation AreasCommunicate Findings to Other Sites
Phase III (futures)
Packaging & Enterprise IntegrationMarch 2004 - September 2004Evaluations Integration/Migration
SAP RLINKMaintenance Management System
Automation Integration of PackagingEvaluate PLM IntegrationOther Site Implementations
Questions & Answers
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Omicron Consulting1500 Market StreetPhiladelphia, PA 19102
Implementing RTPM Infrastructure for a Validated
Environment
May 14, 2003 Bill SmithMead Johnson Nutritionals
Mike PurcellOmicron Consulting