InSiteLive Product Description

Transcription

1 InSiteLive Product Description Release Rev. A

2 Notices Copyright 2002 Camstar Systems, Inc. All Rights Reserved. The contents of this document are copyrighted and cannot be reproduced in any form without the written permission of Camstar Systems, Inc. The information contained in this document is subject to change. Revisions may be issued from time to time, and Camstar assumes no responsibility to advise customers or prospects of changes. Information in this document is proprietary. Camstar has taken care to ensure the accuracy and reliability of the information in this document. However, no responsibility, financial or otherwise, can be accepted for any consequence arising from the use of this material. EXCEPT AS EXPRESSLY PROVIDED IN THE CAMSTAR LICENSE AGREEMENT, CAMSTAR MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE REGARDING LICENSED PROGRAMS, RELATED DOCUMENTATION, OR MARKETING MATERIALS. InSite and InSiteLive are trademarks of Camstar Systems, Inc. Microsoft, MS, and MS-DOS are registered trademarks, and Microsoft Windows, SQL Server, Microsoft Visual Basic, Microsoft Visual C++, Microsoft Visual Interdev, Microsoft IIS, and Microsoft ASP, are trademarks of Microsoft Corporation. All other product names are trademarks or registered trademarks of their respective companies or organizations. Document History InSiteLive Product Description Publication No Rev. A January 4, 2002 Printed in U.S.A.

3 Contents InSiteLive Product Description 1 InSiteLive and the Virtual Factory An Overview InSiteLive The Factory Information Model Benefits of Using InSiteLive InSiteLive Modeling The Physical Model Process Model InSiteLive Execution Tracking InSiteLive Shop Floor InSiteLive Security System Security InSiteLive Archiving InSiteLive Internationalization Multilanguage and Personalization InSiteLive Technology Architecture InSiteLive Object Modeling System Requirements Modules of the Virtual Factory 27 DRAFT of 1/4/02 InSiteLive Product Description iii

4 iv InSiteLive Product Description DRAFT of 1/4/02

5 InSiteLive Product Description InSiteLive and the Virtual Factory Live information is the key component for successful global manufacturing. Live means realtime manufacturing information delivered and exchanged in a beneficial, usable manner to the entire enterprise. It means clear views-and clear decisions. In order to go live companies need to see and manage all elements of manufacturing, especially across multiple locations, processes and associated enterprises. This is precisely why Camstar has developed the Virtual Factory suite of products. Virtual Factory, Camstar's collaborative manufacturing execution (CME) solution, is anchored by InSiteLive, and includes 6 powerful modules. It acts as a collaboration hub allowing live information to be freely shared among Product Lifecycle Management (PLM), Capacity Requirements Management (CRM), Enterprise Resource Planning (ERP) and Supply Chain Managment (SCM) systems and between manufacturing sites, partners and customers. This allows companies to see and manage live production information from distributed facilities. The Virtual Factory makes the enterprise live by managing multiple locations, processes and companies as a single factory. The foundation of the Virtual Factory is Camstar's manufacturing execution solution, InSiteLive, which provides management of and visibility into live production information. Designed to meet the challenges of today s complex manufacturing environments, InSiteLive provides a highly flexible, Internet-based platform for managing all elements of your manufacturing operations - materials, equipment, processes, and personnel - across multiple plants. It provides real-time execution information to plant personnel to manage critical manfuacturing variables such as yield, throughput, order status and machine status. InSiteLive makes this live production information available to the Virtual Factory, allowing it to be freely shared among manufacturing, enterprise planning and logistics, product management, partners and customers. Additional integrated modules in the Virtual Factory are described in the Appendix. An Overview InSiteLive A model-based solution, InSiteLive represents a new generation of software built on a configurable, extensible application platform. InSiteLive can be easily configured to meet the specific requirements of each product, process, and plant. This flexibility allows your company to standardize its applications across the entire enterprise without compromising functionality, visibility, or control. InSiteLive s enterprise-wide approach delivers: The visibility and control of operational details necessary to reduce costs and increase efficiency In-depth manufacturing information that is shared throughout the enterprise and supply chain, allowing management to make wise decisions about production The necessary infrastructure to support a flexible, responsive manufacturing model InSiteLive Product Description 1 of 24

6 Benefits of Using InSiteLive The Factory Information Model Combined with real-time visibility into factory floor operations, InSiteLive s factory information model gives you control over production activities across the enterprise while enabling you to adapt easily to changing customer requirements and business practices. The factory information model is composed of your factory s: Physical model, consisting of definitions for the enterprise, factories, locations, and resources Processing model, consisting of definitions for the product, the workflow, and processing steps Tracking and executions, the aspect of your factory information model where all the activity takes place, based on the configurations of your physical and processing models Figure 1: The InSiteLive Factory Information Model Benefits of Using InSiteLive With InSiteLive, you enjoy: Power and extensibility via state-of-the-art MES platform product technology and features: Flexible workflow model Multilevel WIP tracking User-extended data model Integrated security Terminology based on user ID Increased customer responsiveness: Real-time visibility for schedule and commit dates, location and priority of customer product, and full detail of product history Priority-control dispatching to meet changing delivery dates Proactive control of the customer order on the floor, enforcing customer-specific processing and quality requirements 2 of 24 InSiteLive Product Description DRAFT of 1/4/02

7 The Factory Information Model Improved quality and process: Real-time quality data checks, yield monitoring, and automatic system actions Online delivery of documents to operators, and recipes for machines when and where they are needed Collection and analysis of quality and yield data to identify trends and correct process problems Improved cost and process control: Collection of data from the manufacturing process for cost analysis Detailed reporting on operational data such as yield, rework, scrap, and product mix or grading Reduction of paperwork handling and lost paperwork Simplified integration with external information systems: Point to framework integration architecture (LiveConnect) designed for integration of shop floor information with Enterprise applications such as ERP, PLM and SCM. Utilizes XML document transfer, and can communicate with a number of other formats. The use of industry-standard interface technologies (XML and ActiveX). This facilitates the task of integration with systems such as Corrective and Preventative Action (CAPA), graphical work instructions, and equipment cell control systems, operator certification, and machine calibration. Modeling InSiteLive begins with a model of a manufacturing process and provides easy-to-use tools for configuring this model to any production environment. The data used in the model controls software function. As a result, your InSiteLive implementation is: Adaptable to changes in your business Flexible enough to accommodate a wide range of production types and styles Easy to maintain and upgrade Execution InSiteLive supplies a comprehensive set of execution transactions that manage the flow of work through your manufacturing operations and provides a real-time view of production activity. With InSiteLive, you can track production activity in the way that best reflects your operation. InSiteLive provides an intuitive user interface that is tailored to your processes, terminology, and business practices to simplify transactions. DRAFT of 1/4/02 InSiteLive Product Description 3 of 24

8 The Physical Model InSiteLive Modeling InSite uses a data-driven model that adapts the application to the manufacturing style of each plant. This model includes the physical definition of each factory and the processing specifications. The InSiteLive Modeler provides simple, graphical tools accessed through a browser from the intranet or network. The model is tailored to specify exactly how your production processes work. When production processes change, you can easily revise the model to adapt to those changes. InSiteLive also makes it easy to add locations as you establish new manufacturing facilities. All components needed to configure the InSiteLive factory information model are available through the Modeler s web application pages. The user has immediate access to modeling and security tools, while using the sections for modeling and configuration. This layout allows direct access to specifications and other modeling objects. A workflow consists of multiple process steps, each of which references a specification or another workflow which consists of its own steps. Of the multiple revisions of the workflows available, the revision of record is checked. Figure 2: InSiteLive Modeler Page The Physical Model The physical definition is a representation of the enterprise that describes the physical layout, locations, and resources. The definition includes: Enterprise: An enterprise is composed of a group of factories. Any number of InSiteLive installations can constitute one enterprise. 4 of 24 InSiteLive Product Description DRAFT of 1/4/02

9 InSiteLive Modeling Factory: A factory is any division, department, section, or group that is identified for accounting and reporting purposes. A factory often represents but is not limited to a physical manufacturing plant. Location: A location is a designated place or locale in a factory. Locations are commonly used to designate aisles and rack spaces. Resource: A resource is the equipment and other nonmaterial items used in the manufacturing process. Resources can be assigned to one or more resource groups for reporting, analysis, and validation. Process Model The process model is used to manage and control how a product is manufactured, and to give operations the complete set of instructions to ensure the highest quality. Processing is defined using a workflow, a series of steps for performing any type of work. Individual steps within a workflow contain rules and instructions for processing and collecting data. The hierarchy allows for any number of combinations, so any style of manufacturing can be modeled. For example, the same operation can be performed many times, but will require different detailed specifications. Or the same specification can be used at selected operations for various products on their unique workflows. Operation: What to perform. Includes user codes, transaction rules and so on. Document: Supporting information. Written instructions, schematics, videos. Workflow Product Operation X Spec A Step 1 Spec: How to perform step. Contains detailed instructions. Sub Workflow Step 4 Step 2 Operation Y Spec B Step 5 Spec C Step 3 Figure 3: Processing Model Components The InSiteLive processing model includes: Product: The items produced or used within a factory. Products can be finished goods, components, or raw materials. A manufactured product has an associated workflow. InSiteLive provides product family assignments to simplify maintenance. When a product is associated with a product family, all of the products in that family default to the attributes defined for the family. If a product family attribute is changed, the changes automatically apply to all products within the family. In addition, you can override attributes for a particular product within the family. Workflow: A workflow consists of a sequence of steps that define the route and processing required for manufacturing a product. DRAFT of 1/4/02 InSiteLive Product Description 5 of 24

10 Process Model A step within a workflow may also reference a subworkflow. Subworkflows simplify the definition of product routings. When a subworkflow is changed, that change is automatically and instantly reflected in every workflow that includes that subworkflow. Complex workflows can be modeled easily by linking together predefined subworkflows, and subworkflows can be shared among many different workflows. In this way, the subworkflow is defined only once instead of being repeated in every routing where it is used. Step: Within a workflow there are two types of steps: A spec step references a processing specification. A workflow step points to subworkflow. Both kinds of steps include references to the default next step as well as other optional next steps. Together, the default next steps define a default processing path; optional next steps define alternate processing paths. Path: A path is the link between steps in the workflow. Paths are used to predefine and control the allowable next-step(s) for tracking product through the workflow. Alternate path: Each step includes one default path, and can optionally include alternative processing routes through the workflow. Alternate paths are used to predefine the valid options for the next operational step. Path selectors: Path selectors are a unique InSiteLive feature for automatically selecting a processing path based on processing results or other decision criteria. A set of rules for path selection can be associated with each processing step. Operation: An operation is a logical or physical point at which work in process inventory and production activities are tracked. Operations can be grouped together in work centers; and inventory, in-transit, and outside service locations can be designated as operations. Specification: A specification defines the processing to be performed at an operation. A specification references instruction sets, documents, setup information, and resources. Specifications also include detailed scheduling and processing parameter information. Document: A document is a reference to a file that provides text, drawings, and additional instructions and description needed for the specification. Bill of material (BOM) InSiteLive's BOM provides a unique degree of flexibility, allowing a BOM or materials list to be associated with a product, manufacturing order, unit of work, specification, or customer. This flexibility makes InSiteLive ideal for make-to-order and configure-to-order environments as well as for electronic order processing. Because InSiteLive is designed to integrate with other business systems, those applications can automatically update InSiteLive BOMs. An InSiteLive BOM defines the structure of each assembly and subassembly used in production. The structure defines material control parameters and specifies the default BOM for the product as well as valid substitutes. Within the BOM, vendor item numbers can be associated with all components. InSiteLive supports vendor-supplied part numbers and allows you to qualify vendors for different customers or different products. A reference designator can also be defined for each BOM component to denote, for example, the physical location of a component on its target part. InSiteLive supplies full material traceability from initial manufacturing through final customer shipment. The system selects and records raw material lots, subassemblies, and serialized units at each manufacturing step. Material lots, subassemblies, or units can be selected and tracked with or without a BOM structure defined. 6 of 24 InSiteLive Product Description DRAFT of 1/4/02

11 InSiteLive Execution InSiteLive allows you to remove previously-issued components from an assembly and allows you to assign a specific disposition to each component. The material can be returned to stock, reworked to the same assembly, issued to another assembly, or scrapped. Revision management Override processing InSiteLive provides the ability to concurrently maintain multiple revisions of modeling components, such as products, specifications, and workflows. You can freeze revisions, making them available for production and preventing further modifications. You can also specify that a revision is the revision of record (current revision). Then, when a modeling component, the product, for example, refers to its workflow by revision of record, InSiteLive dynamically determines the correct version of a modeling component to use by selecting the revision that is marked as the revision of record. This unique feature lets you define products to use the revision-of-record of a workflow. As new revisions of the workflow are introduced, you do not need to go back to change the product definitions to point to the newly created revision. That is done for you automatically. Revision management features include: The ability to provide revisions for modeling components such as products, workflows, specifications, documents, and setups The ability to reference a specific revision or the revision of record The ability to clone existing revisions to use for creating a new revision, simplifying data entry and model maintenance The ability to freeze a revision to allow it to be used in production, and prevent it from being changed Override processing is a technique used throughout modeling definition. When setting up or maintaining your object model (see Object Modeling, below), you can specify overrides for any field in the model. For example, a workflow is a generic component that describes a sequence of steps for performing work. All products that require identical processing can reference the same multiple-step generic workflow. If, however, the standard run rate (quantity produced per hour) for a particular step might change based on the current product, you can use an override to make a generic workflow specific to the product. In this case, you will use an override for the step to tell InSite to check first if the product has its own run rate. If it does, the product s run rate will override the step s own defined run rate. InSite s override implementation uses dynamic value expressions (DVEs) to provide maximum flexibility. A DVE is an expression or a series of expressions that are resolved dynamically at runtime. Each expression in a DVE references another field from which to get an override value. The field can be from any modeling component. The ability to use a series of expressions means you can specify multiple fields from which to get an override value. And the position of an expression in a series determines the hierarchy of what override value to use. Using InSite s override processing feature gives you the added benefit of minimizing maintenance. When override values are dynamically resolved at runtime, all override expressions that reference another component will automatically reflect any changes made to that component. The result: a change in one component is automatically reflected by all other objects referencing the changed component. InSiteLive Execution InSiteLive's execution features deliver comprehensive production management, yield, resource utilization, and equipment status information. With this information, not only managers and operators but also key players in the supply chain have the visibility to make DRAFT of 1/4/02 InSiteLive Product Description 7 of 24

12 Tracking decisions and improve production cost and efficiency. InSiteLive is especially designed to be integrated with other factory, enterprise, or supply chain systems, and can also operate in stand-alone mode. The results of the execution are invaluable data for manufacturing analysis and to supply other business systems with a current and accurate view of production. Tracking While InSiteLive's modeling capabilities define the way the factory works, the system's execution transactions reflect the actual movement of work through production and create a complete record of everything that happens to material being processed. Step Move Non Standard Rework Start Step Step Step Step Step Move Move Move Move Move In Tracking Transactions: Move Move In Move Non Standard Thruput Rework Transfer Hold Release Start (Unit or Group) Serialize Ship Collect Data Change Quantity Defect Change Attribute Split Combine Associate Disassociate Component Issue Component Return Component Defect Component Distribute Figure 4: Tracking the Product Through Production InSiteLive transactions are used to record container and resource activity on the shop floor. Each transaction performs a unique function and records specific information in the application database. The transaction information is then available for status tracking and performance analysis. The trigger for collection and recording data is activity that occurs at a machine or work center, usually involving a batch of material. In InSiteLive, processing activities are mapped to transactions. These transactions record data identifying both the resource used and the container (unit of work). This data then provides information for utilization, throughput, yield analysis, genealogy and traceability, feed-forward and feed-back for process control, and correlation for process improvement and order status. InSiteLive transactions include many common data elements such as: The operator who performed the work and the operator who recorded the transaction The machine where the work was performed The container identifying the associated product Quality data associated with the material, unit, machine or process The transaction s time stamp, both local and GMT for enterprise collaboration of data Work in Process Tracking InSiteLive provides multilevel Work-in-Process (WIP) tracking capabilities that enable you to collect and report status genealogy and quality information to any level of detail. 8 of 24 InSiteLive Product Description DRAFT of 1/4/02

13 InSiteLive Execution WIP tracking focuses on component or product units moving through the production process. The unit of work for each product is flexible and conforms to the characteristics of the product being manufactured. InSiteLive uses the generic term container to identify a unit of work. You decide the specific terminology that matches your operations; for example, a lot, batch, tray, tank, or serial number. Because the system supports multiple and unlimited levels of containers containers within containers you can define and track products to any level of detail. For example, batches can contain multiple lots, which in turn, contain serialized units. InSiteLive's unique multilevel tracking capabilities maximize efficiency by minimizing transaction volume. As the containers move through the manufacturing process, even if they split apart and combine with other containers to mirror processing activity, traceability is maintained. Figure 5: Multilevel Containers InSiteLive's unique multilevel tracking: Identifies each discrete batch moving through production Supplies complete forward and backward traceability and genealogy Maintains comprehensive product status and history Allows unlimited nesting of containers Allows containers to be combined and split with complete traceability even through multiple splits and combines Maintains traceability as batches move through the standard workflow or outside the standard workflow Resource tracking Resources, the non-material items used in manufacturing, can also be tracked in InSiteLive. InSiteLive offers a resource-centric tracking model that establishes resources in addition to batches as the focal point for data collection and factory monitoring. Information from resource tracking transactions allows managers to schedule equipment in advance and enables timely responses to problems. For example, when equipment goes down, InSiteLive can log the event and its cause, change the machine's status, and send alarms to maintenance. Maintenance can log the status after making the necessary repairs. By tracking work in process through the equipment, InSiteLive provides equipment utilization and efficiency information. You also have complete traceability of the WIP units that were processed on the equipment. InSiteLive s resource tracking: Monitors and tracks the status and history of resources within a factory Maintains resource logs online, eliminating the need for manual logs at machines DRAFT of 1/4/02 InSiteLive Product Description 9 of 24

14 Tracking Records actual units processed on the equipment, with date and time stamps Records production throughput (quantity worked) at a machine when the units are moved from the operation Records production throughput (quantity worked), without requiring movement of the associated units. This is particularly useful for accurately recording production when a run crosses shift boundaries Maintains control over which resources are used for products at specific process steps Records calibration data for historical and analytical purposes Data collection Statistical Process Control Inquiries InSiteLive's flexible data collection model makes it easy to track yield rates and quality data to very fine levels of detail by including data collection as part of any execution transaction. InSiteLive's data collection transactions are user-configured, can be linked with either a container or a resource, and can capture an unlimited variety of information such as temperature, weight, moisture, and product performance indicators. Data can be collected both manually and from automated operations. Once the data collection definition has been created, information can be captured in different combinations throughout the workflow. For example, Move and Rework transactions might both be used at a workflow step. Specific data collection, such as an oven temperature, might also be required at that step. A single data collection definition for that oven temperature is mapped to both transactions so that the required data is collected, no matter which transaction is used. When the operator moves or reworks the material from the workflow step, the system automatically selects the correct data collection definition. Using InSiteLive s Statistical Process Control (SPC) features, manufacturing can maintain consistent product quality and work through issues before they become problems. You can automatically update and display control charts from the quality data that you collect in InSiteLive, and take actions when needed. SPC can be configured to Filter data to create specific charts for certain processes, products and equipment Set rules to identify an out-of-control condition Automatically take actions when an out-of-control condition occurs Displaying charts to the operator based on rules Operators can annotate data points, and engineering can review and analyze the charts after the fact. InSiteLive inquiries provide up-to-the-second information about container (WIP) and resource status and activity. Work in process information includes: WIP status by operation, product, and others Queues at work centers and equipment Throughput by operation, resource, product, and others Rework status and activity Yield - loss and bonus - information, including reasons Resource information includes: Availability Current status Down reason 10 of 24 InSiteLive Product Description DRAFT of 1/4/02

15 InSiteLive Execution Next expected status change Materials information includes: Inventory on hand or issued to floor stock Reorder levels History information includes: Complete genealogy of all units used to manufacture a product Details of every processing step - operator, resource, quantities, quality data, and exception reasons Figure 6: Complete history and genealogy are available at any time. Reporting Using LiveView, operations and management have access to a number of analysis and activity reports that provide both summary and detailed production information. Because InSiteLive contains complete history and live statuses, many types of reports are widely used. Here are some examples: Reports, many with drill down: Production Activity Static WIP Material Starts Yield Analysis Cycle Time Scrap Rework DRAFT of 1/4/02 InSiteLive Product Description 11 of 24

16 Tracking Component Issue WIP Completions (Ships) Unit Status WIP On Hand Unit History Operator History (Activity) Special graphs: Yield% by Workflow Step Cycle Time by Workflow Step WIP On Hand by Workflow Step Scrap Count by Reason Rework Count by Reason Product status Yield tracking InSiteLive initiates production with a Start transaction, which can be entered manually or can come automatically from production schedules and work orders received from another system. Start creates a container that moves through a workflow. Containers can also be grouped to simplify subsequent transactions. As the container moves through the workflow processing steps, the system: Captures when processing begins Moves containers to the next step in the workflow automatically Captures rework processing Splits off defective material for rework and combines the good material into other containers to continue processing Calculates yield loss and bonus Captures measurements for quality and engineering Products can be processed at different resources without losing the container structure or losing processing visibility. With proper authorization, the system also allows containers to be moved to any operation, whether or not the operation is part of the workflow. To simplify data capture, InSiteLive groups the transactions together to reflect a common processing sequence. For example, in a single transaction, you can record an increase or decrease in product quantity, record partial or full processing, and move the container to the next step in the workflow. InSiteLive allows container attributes to be changed as necessary while maintaining complete traceability. Examples of attributes include priority, owner, due date and product. The system records both the former and new attribute values. The system also records changes in quantity for yield loss and bonus. The system records the container, the amount of quantity change, the reason for the change, and the kind of change. As InSiteLive updates quantities, it stores the change history for traceability, process improvement efforts, and quantity balancing. InSiteLive offers detailed yield and rework tracking by a wide variety of categories including reason code, shift, operator, product, operation, process, machine, and time period. The system also records material defects and reason codes for defects that do not require the defective material to be removed or scrapped. 12 of 24 InSiteLive Product Description DRAFT of 1/4/02

17 InSiteLive Execution Material Control Returns and Repairs Work-in-Process (WIP) Messaging Alerts Electronic Signature InSiteLive includes powerful material control capabilities for all types of production environments, providing a single solution for companies that have both discrete and process manufacturing operations. The system provides material lot, subassembly, and serialized unit control and tracking to meet the detailed traceability requirements of assembly operations. This makes InSiteLive a superior solution for manufacturers that want an enterprise standard to meet the needs of repetitive process, repetitive discrete, and make-to-order manufacturing environments. The system also supports unique BOM structures and customer job-specific material requirements. InSiteLive supports both serialized and nonserialized environments, issuing material to an assembly in a specified sequence and setting up appropriate inventory containers. InSiteLive also supplies reference designators to describe the location or orientation of a part on the assembly. InSiteLive s Returned Material Authorization (RMA) capability is designed to track and analyze product that has been returned from the customer or is being repaired in the field. Complete traceability is maintained, including the entire manufacturing process, shipment to customer, return and disposition, corrections and results, and shipment again. The return or repair activity can be entered through a browser by the customer or field technician. When an RMA is acknowledged, is sent to the originator. When the return or repair is initiated, the units are re-opened in InSiteLive with the RMA number and reason code. Users can review RMA queues, status, turns, and repeat returns and history by product, customer, and so on. Returns and repair functions are easily integrated with specialized applications such as CAPA, and with ERP order management. InSiteLive s WIP message capability enforces processing and sends special notifications when a container of material reaches a specific processing point. WIP messages can be used to: Display a reminder or special processing instructions to the person doing the work Notify an engineer that units have reached a specific location Place a material on hold when it reaches a specific point Require an operator or supervisor to acknowledge that the special instructions provided by the WIP Message have been reviewed The display of WIP Messages is controlled by user-established filtering. For example, you can attach a specific message to all units that reach a specific operation, or only those of a certain product or specification. Messages and notifications can include text variables, making it possible to include transaction data and other variable information resolved at runtime and displayed with the text. The text that is presented can also be recorded with the transaction s history. InSiteLive can trigger alert messages that make management and engineering aware of exceptions in manufacturing. Messages can be delivered in the form of to personal computers, wireless devices, or in the form of a LiveView report. In environments where electronic signatures are required and audited, users can be required to sign with password for each step of work that is performed. The signer can be the individual, verifier, team or a supervisor who confirms the signature of another person. Signatures are accompanied by a description of the work the person is signing. These features meet the criteria set by FDA 21 CFR Part 11 for electronic signatures. DRAFT of 1/4/02 InSiteLive Product Description 13 of 24

18 Tracking Corrective and Preventative Action (CAPA) Companies that use CAPA applications to manage exceptions and issues can integrate with InSiteLive to effectively control manufacturing procedures issues. The relationship is complementary: When an exception occurs during manufacturing, the CAPA application is notified and the units are assigned an issue and corrective action number. They must then be handled according to the corrective action defined in the CAPA application. Examples include rework, further testing and return to vendor. When all the corrective action tasks are completed, either in InSiteLive or elsewhere, the CAPA application notifies InSiteLive that the units can either be released for shipment. These features meet the criteria set by the FDA and other quality programs for corrective actions. 14 of 24 InSiteLive Product Description DRAFT of 1/4/02

19 InSiteLive Shop Floor InSiteLive Shop Floor With InSiteLive, a number of interfaces are available for directing shop floor users and for connecting to factory equipment. These include a web interface, a browser-based user interface with zero client code, and direct integration with the shop floor equipment and automatic data acquisition. Both types of interfaces have several applications, and they can be mixed in the production environment to achieve a high degree of flexibility and usefulness. The web user interfaces provides the interaction between the shopfloor employees and the day-to-day production tasks they need to perform. It initiates InSiteLive transactions against materials, resources, and inquiries within an easy-to-use graphical interface that you can customize according to your requirements. The following web form illustrates the power of the InSiteLive. In the example, the form is designed to reflect the way an operator works at a specific task (polish visual inspection) on the shop floor. From this one form, an operator can view essential documentation about the product and the procedure, collect data and select one or more actions to perform. With each action, InSiteLive records all the detailed information about work being performed. In addition, this type of form can communicate directly with the equipment to inquire or change status. Work instructions in graphical form Access to all information needed Unit of work being processed Indication that work has been completed Figure 7: The InSiteLive web user interface is configurable, and provides the operator with all the information needed to properly perform the tasks. InSiteLive's user interfaces support deployment via the Internet (external) or Intranet, or via the company network (LAN or WAN). For Internet-oriented implementations, InSiteLive supplies a Web-based.NET framework for shopfloor transactions and inquiries, with tools for creating specialized forms. Forms and their maintenance are centralized on the web server, so each client work station requires only a browser. DRAFT of 1/4/02 InSiteLive Product Description 15 of 24

20 System Security To further minimize maintenance and overhead, the architecture supports Windows CE devices as workstations, and can utilize radio-frequency (RF) communication devices. For direct integration with equipment in a high-volume situation, InSiteLive connects directly to Supervisory Control and Data Acquisition (SCADA) platforms using the COM interface. InSiteLive Security InSiteLive's security system is integrated with Windows 2000 system security, giving system administrators a familiar interface for managing system security. Administrators already using Windows security tools do not need to learn another tool. Security features include: Single logon to integrate InSite user IDs with Windows 2000 system user IDs The ability to define security by user and/or groups of users Authentication required to access InSite applications The ability to disable or hide unauthorized menu options Function-level access to individual data entities (create versus change versus delete) System Security InSiteLive fully supports Windows 2000 login and authentication security, as well as security permissions for individual transactions. Service security controls access to all InSiteLive transactions. You can also specify function level security within a transaction. For example, you can manage access by granting create, modify, delete, and view authority individually. Employee Transactions Permission for the Employee (or Group) Figure 8: The InSiteLive Modeler s Security Window 16 of 24 InSiteLive Product Description DRAFT of 1/4/02

21 InSiteLive Archiving Individual transactions can be restricted to specified users or groups of users. For example, the Start transaction can be restricted to production control personnel. All maintenance transactions, such as adding employees, can be restricted to system administrators. InSiteLive lets you maintain security for groups of users as well as individual users. A user may belong to any number of security groups. InSiteLive automatically applies changes to a group's security parameters to all users in the group. InSiteLive Archiving Archiving is an efficient way to manage the size of the application database by keeping the active WIP information in the production database and moving inactive data to an archive database. Archived data remains available for queries and for re-activation of returned material. InSiteLive s archiving feature: Provides archiving capabilities for retaining manufacturing records and searching stored offline data Supports multiyear traceability and recall of all manufacturing process and container control data Allows real-time access into archived data retained on disk Supports user-defined retention periods for how long container and process data remains in the production database Provides archiving while transactions and inquiries are actively processing InSiteLive Internationalization Multilanguage and Personalization Fundamental to InSiteLive is the support for global deployment. For example, transaction timestamps are recorded in both GMT and local time to facilitate collaboration and analysis of data across multiple time zones. Screen layouts were carefully designed to support variable length labels without compromising usability or functionality. In order to further support and simplify global deployment, international settings from the Microsoft Windows Control Panel have been integrated into the InSiteLive applications. InSiteLive provides built-in features to support multiple languages and internationalization, including: Support for multiple user interface languages simultaneously, including the ability to toggle between languages Programs that respond to standard Windows Control Panel international settings Externalized strings for all languages to allow localization and end-user modification Support for both single-byte and double-byte character sets through the use of Unicode InSiteLive s unique and patented technology supports multiple languages and terminology personalization. All predefined InSiteLive messages, field labels, menu captions, and so on are stored in an external database. This allows for the descriptions to be stored in any language and/or changed to whatever terminology you want to use. Based on which dictionary is assigned to the current user, the system first looks for user-defined descriptions, then retrieves the selected language. If no language has been selected, InSiteLive will then default to English. DRAFT of 1/4/02 InSiteLive Product Description 17 of 24

22 Multilanguage and Personalization To simplify support, InSiteLive provides the ability to toggle between languages while logged on with the click of a button. For example, an operator interacts with the system in Japanese or Spanish while at the same time a system administrator can view the same screen in English. Instant toggle between languages Figure 9: Multilingual Support for InSiteLive User Interfaces InSiteLive is implemented in a number of different languages, including total localization in Japanese. Both English characters and Japanese characters can be displayed in the Modeler and Navigator applications, user guides and online help, and web reports. The Japanese localization utilizes the InSiteLive multilingual technology, including the native use of Unicode.. 18 of 24 InSiteLive Product Description DRAFT of 1/4/02

23 InSiteLive Technology InSiteLive Technology Architecture The InSiteLive platform is built on Windows.NET technology, using a model-driven approach that adapts the application to the way your factory works. InSiteLive's configurable platform allows installations to be tailored to unique requirements without modifying the core logic. Data-driven program logic rather than hard-coded logic allows InSiteLive applications to be tailored without changing program code or recompiling. In addition to reducing or even eliminating the need for custom programming, InSiteLive's data-driven approach also simplifies upgrades and makes new functionality available immediately, without disrupting operations. Figure 10: The InSiteLive Shop Floor Architecture High volume and high reliability Distributed architecture InSiteLive is designed for high volumes and high reliability. The servers can be clustered for load balancing and redundancy, using Microsoft s Application Server Clustering. The client application logic is isolated from the client logic and the database, so configurations and upgrades have minimal impact on production. InSiteLive uses a distributed architecture for maximum flexibility and scaling. The system takes advantage of distributed processing in the following ways: Depending on organizational needs, InSiteLive can be installed as a single-server system or distributed across many servers. InSiteLive servers can be segregated to deliver resources and provide processing horsepower where the tasks require it. This distributed architecture includes a set of components that isolates the complexities of distributed processing and provides support for multiple databases, security, and end-user configuration options. DRAFT of 1/4/02 InSiteLive Product Description 19 of 24

24 Architecture The InSiteLive architecture consists of multiple tiers: User and System Interfaces Application Client (program and/or user interface) Application and Data Servers Database Interfaces and Application Client Application and Data Servers InSiteLive's architecture separates the user interface from the client logic from the application logic, making it possible to 1) provide 100% thin client work stations to the users, and 2) tailor the user view of an application without affecting the application logic. Because InSiteLive's user interface implementation is separate from all business application logic and is built with intelligent controls, the system simplifies many tasks: Maintaining user interface forms and logic is centralized on the web server, rather than on individual workstations. Creating new InSiteLive forms using industry-standard tools is simple. Customizing InSiteLive's interface to fit special requirements does not affect application logic or compromise system integrity. Wherever a transaction originates, be it a form delivered with InSiteLive, a custom form, or an interface to another system, the application logic to process the request is always exactly the same. This approach allows InSiteLive to be easily integrated with existing systems and even custom forms while ensuring the integrity of the application processing. Clients can be either remote or local, allowing users to access InSiteLive via the Internet, WAN or LAN. The InSiteLive Application Server(s) contains the InSiteLive application and factory information model that encapsulate the business rules and logic. InSiteLive provides a single set of application code that scales from a single server to a geographically distributed network of servers. Distributed object management components hide this complexity and allows the application logic to operate on single or multiple servers from the same code base. The InSiteLive Application Server provides the foundation for defining factory-unique rules and logic. These rules and logic are implemented with two powerful InSiteLive constructs: configurable data objects (CDOs) and configurable logic flows (CLFs). CDOs provide the mechanism for defining the data elements unique to each factory. CLFs provide the ability to tailor application logic without programming and to integrate custom logic without modifying InSiteLive source code. InSiteLive combines all the power of working with Object Technology in the Application Server with the benefits of using industry-standard relational databases to store and retrieve information. The Data Server is responsible for translating between the objects and the database. This component supplies important benefits: All references above the InSiteLive Data Server are done from an object (data and methods) perspective. The application code is not concerned with how data is mapped from objects to the RDBMS tables and vice versa. Access methods and optimization procedures used to support different databases, such as IBM DB2, Microsoft SQL Server, and Oracle, are located in a single system component. 20 of 24 InSiteLive Product Description DRAFT of 1/4/02

25 InSiteLive Technology Database XML interface Java and ActiveX interfaces All InSiteLive configuration and application data are stored in industry-standard relational databases. For maximum performance and consistent support across different databases, InSiteLive only uses the database for storage and retrieval. All installations use the same application logic, regardless of the database. All access to the database is done through simple ODBC calls. To support business-to-business collaboration and web-based interfaces, InSiteLive includes a native extensible markup language (XML) interface to execute transactions and retrieve information. Using InSiteLive's XML interface, you have access to all InSiteLive transactions from any user interface or application, using development languages such as Java and VB ActiveX. It is ideal for transferring information among disparate systems. The XML interface is an essential component of the Virtual Factory modules LiveConnect and LiveRelay. In addition, this interface is ideal for remote order entry and online order inquiries. InSiteLive's published interfaces are public Java and ActiveX interfaces that provides a standard set of functions to enable any client application to communicate with the InSiteLive servers. InSiteLive applications, customer-developed applications, or third party applications can all use these published interfaces to interact with InSiteLive, execute transactions, and retrieve information. Developers can call the published interface functions from any Java or ActiveX-compliant development tool. Table 1: InSiteLive supports multiple technologies Type of Client XML XML COM Platform ActiveX Java ActiveX Connection Method Sockets Sockets DCOM DRAFT of 1/4/02 InSiteLive Product Description 21 of 24

26 InSiteLive Object Modeling InSiteLive Object Modeling The InSiteLive platform uses configuration data rather than source code to define application objects and their behavior. The InSiteLive Designer is a graphical application for managing this configuration data. Two basic constructs in the InSiteLive platform are configurable data objects (CDOs) and configurable logic flows (CLFs). CDOs define the data elements or fields of each InSiteLive object and reference CLFs to control their behavior. All information about CDOs and CLFs are stored as data, allowing the system function to be extended and modified easily without changes to source code. Configurable data objects (CDOs) CDOs are user-definable data structures that can be used to represent a service or data. Client applications interact with service CDOs for application functionality by setting the value of specific fields, executing the service, and retrieving the result through other fields within the service. Data CDOs are application objects that represent attributes of the factory such as product definitions, work centers, machines, and material being produced. Configurable data objects (CDOs) Fields of the selected CDO Properties of the selected field Figure 11: The InSiteLive Designer Displaying Configurable Data Objects (CDOs) 22 of 24 InSiteLive Product Description DRAFT of 1/4/02

27 InSiteLive Technology Configurable logic flows (CLFs) CLFs link together InSiteLive components called executions to perform specific functions and are the mechanism for implementing user-definable methods. All InSiteLive application logic is provided through the use of CLFs executing in the specified sequence on the Application Server. InSiteLive supplies a comprehensive library of executions for tasks like arithmetic, searching data structures, database queries, and data validation. The selected CLF s executions Selection list of executions to add to the selected CLF CLF name Transaction Definition Transaction Data Events Logic Flow Check Status Balance Quantity Notify Supervisor Custom Function : : : : Auto numbering } } } Standard executions Custom executions Standard executions Figure 12: The InSiteLive Designer Displaying Configurable Logic Flows (CLFs) DRAFT of 1/4/02 InSiteLive Product Description 23 of 24