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