Use of Web Technologies in Batch Management

Transcription

1 Presented at the World Batch Forum North American Conference Orlando, Florida April S. Southgate Drive Chandler, Arizona Fax Use of Web Technologies in Batch Management Chinmoy Roy Leonard Johnson Manager, Automation Engineering DCS System Administrator Genentech, Inc. Genentech, Inc. 1 DNA Way MS New Horizons Way MS 107 South San Francisco, CA Vacaville, CA Telephone; (650) Telephone; (707) croy@gene.com leonardj@gene.com KEY WORDS Networking, supervisory batch control, MES interface, Web access, Batch Assay History Report ABSTRACT Genentech Inc. s bulk manufacturing facility in Vacaville, CA has been in production for the past two years. Application of S88 design concepts has provided the needed flexibility for multi product manufacturing. Furthermore, the DCS has provided the integrated manufacturing environment necessary to trace and track the multitude of process activities required for the production of a single batch. To meet increasing manufacturing capacity requirements, there is an effort underway to maximize yield and plant throughput. There is an increasing recognition that these goals may be realized by decreasing the time for postproduction analysis of batch production data and the generation of a Batch Assay History Report prior to its market release. Yields may be maximized by real time preemption of deviations in batch quality while the batch is in production. Such time demanding requirements are met by using the Web to deploy raw data and processed information to fulfill users data needs; when, where and how they need it. This paper discusses benefits realized through the use of Web technologies for supervisory batch control, batch production data analysis and batch report generation. Copyright 2001 World Batch Forum. All rights reserved. Page 1

2 INTRODUCTION In mid-1999, Genentech successfully commissioned a new, multi-product, biotechnology drug manufacturing facility in Vacaville, CA. The new plant has been designed to fulfill increasing demands on manufacturing capacity. Several design features such as plant layout to match product flow etc. have contributed to maximizing plant output. However, the quest for increased productivity is a constantly evolving activity and does not terminate with the commissioning of a plant. There is an increasing realization that productivity gains can be realized by using the Web to provide enterprise wide production information faster and more efficiently. Considerable improvements in operational efficiency, yield, quality control and reduction in batch release cycle times may be achieved by capitalizing on evolving Web technologies and the Internet to present large volumes of raw data and information in a just in time manner. The IT infrastructure consists of several operating systems ranging from UNIX, Windows 9x, Windows NT etc. THE MANUFACTURING CONTROL SYSTEM The manufacturing process is controlled by a DCS. The DCS Architecture consists of a central server, which communicates with field controllers via a dedicated Ethernet based network. The server executes recipes and orchestrates the phases and control modules resident in the field controllers. Besides providing an execution platform for recipes, the central server also performs functions such as Batch Management, process control data acquisition from field controllers, process alarming and trending, and provides operators the ability to initiate recipes and interact with the process via the HMIs. Genentech's Enterprise wide network User PC DCS Firewall Batch History Data Report P.O.M.S. Other s Trend History User PC Figure 1: Representative Block diagram of the Corporate network Figure 1 is a representative diagram, depicting the DCS server resident on a corporate communication network. This network spans across two major company sites 80 miles apart. It provides ready access to DCS production data and recipes to those who are directly engaged in production such as the Material Management Group, Manufacturing Quality Assurance, Production Management etc. A firewall provides the DCS with the required protection from unauthorized access over the network. Also resident on the network is POMS Corporation s Copyright 2001 World Batch Forum. All rights reserved. Page 2

3 Production Operation Management System (POMS) server. There are several Enterprise Resource Planning (ERP) servers on the corporate network. One such ERP server is System Software Associates Inc. c Business Planning and Control System (BPCS) server. The application programs in the POMS/ERP servers provide for production planning/control, inventory management and maintenance of lot genealogy. The DCS server communicates with field controllers to load phase and recipe variables and orchestrate the execution of a Batch. It also initiates the real time acquisition of Batch History Data and Process Trend History Data. The Batch History Data is stored in a Batch History Data. The Trend History Data is initially stored in the DCS. This stored data is then transported to a Trend History, which is outside the DCS server domain. This Trend History provides users the access to Trend History and thereby frees the DCS to attend to control related tasks. The DCS is responsible for automated process control and Batch record maintenance. MANUFACTURING INFORMATION: A BATCH CONTROL ACTIVITY After a batch of product is manufactured, various groups within the enterprise need access to the batch s manufacturing data. Such an access is required for review of what transpired in the process during its manufacture in order to assess the suitability of the product for market release. The manufacturing data is captured from the manufacturing floor while the batch is in production by a manufacturing information system. This system, besides capturing the data is also required to present it to the enterprise information system and hence should possess the capability of providing a seamless interface to external entities. The use of S88.01 Batch Standard in the design and implementation of the manufacturing control system facilitates the design of a manufacturing information system. The Control Activity Model provides the necessary framework to determine the appropriate control layers in which the data interchange functional modules may be embedded. The Process Management layer seems a likely layer where information exchange functionality between the manufacturing floor and the enterprise information system may reside. This layer may serve as the repository of several middleware and customized software modules which execute to capture manufacturing floor data and integrate it into the enterprise information systems. These software modules are based on standardized technologies such as OPC, SQL etc. and may be resident in the component servers. In the early to mid 90s, vendors introduced a range of software products for the interchange of such data. Advanced Manufacturing Research, a Boston consulting group, termed these suite of software products as Manufacturing Execution Systems (MES). At Genentech s Vacaville facility, the Production Information Management function is realized through a POMS and a Batch History Data. The Production Planning and Scheduling functions are partially realized via a Material Management and Tracking function in a BPCS and also via manual scheduling. The POMS, the BPCS along with the DCS performs the Recipe Management functions. Copyright 2001 World Batch Forum. All rights reserved. Page 3

4 Figure 2 is a depiction of the components of a manufacturing information system in relation to the Control Activity Model of S88. The MES is a collection of customized software modules and its functionality is dispersed between several servers, each of which, singly or jointly fulfill a function of the Control Activity Model. Some of these modules reside in the DCS, some reside in the POMS while others reside in the BPCS. Recipe Management Production Planning & Scheduling Production Information Management POMS server BPCS ERP server BPCS Scheduling soft. ERP server Batch History srvr Report server POMS server BPCS MES Layer - Shop Order execution - Production reporting - Lot number assignment - Operations reporting - Material Lot verification - Batch History data transport Process Management DCS - Manage Batches - Acquire Hist. Data Unit Supervision DCS - Recipes Process Control Field Controllers - Phase Logic - Control Mod. S88 Control Activity Model Genentech's Manufacturing Information Model Figure 2: Genentech's Implementation vis-à-vis Control Activity Model FUNCTIONAL INTERACTIONS Figure 3 below is a block diagram of major functional interactions between the software systems in Genentech s implementation of the information system at its Vacaville facility. These systems execute in the S88 Control Activity s layers of Process Management and above. Together they provide the Information Exchange Interface for the following: Recipe Interface Schedule Interface Production History Information Interface Copyright 2001 World Batch Forum. All rights reserved. Page 4

5 ERP Consumption, Operations & Production Reporting Shop Order Recipe Initiation DCS Batch Manager Recipe Initiation MES HMI MES Recipe Initiatio Lot Verification Real time Transfer of Batch History Data Grant Password Access Batch History Data Trend Data Verify Electronic Signature On Demand History Data MQA Comments Trend History Report View RT, Historical Trends User Desktops (WEB BROWSER) Information Client Report Initiatio set Lot Flags Note: The boxed entities are servers resident on a communication ne Figure 3: Functional Interactions between Systems The MES provides the Recipe Interface functionality. It serves as a link between the ERP system and DCS resident Control Recipes. Shop orders generated by the ERP system, are used by the MES as unique Lot Number identifiers for Control Recipes. After the MES assigns a Control Recipe its unique Lot Number, it is initiated for execution in the DCS. Via bar code scanners, the ERP system also verifies the IDs and the validity of each production item such as filters, bulk kits, etc. prior to their release to the production floor from the warehouse staging area. The scanned data is then manually populated in the Control Recipes for point-of-use verification of these raw materials. Currently the Scheduling Interface functionality is provided by operators who manually schedule Control Recipes. The software architecture is capable of automatically scheduling Control Recipes from a dynamic scheduling system when one becomes available for use. The Production History Information Interface collects information such as Raw Materials Consumption, New Material Produced from the DCS. It transmits this data to the MES for Copyright 2001 World Batch Forum. All rights reserved. Page 5

6 onward transmission to the ERP system. The ERP system uses the data received to update its material inventory and Lot Genealogy databases. The Interface also provides for a real time capture and transfer of all Batch Record History Data to a Batch History Data. It also captures and transfers process trend data to a Process Trend Data. USE OF MICROSOFT S DNA-M STRATEGY DNA-M (Windows Distributed internet Applications for Manufacturing) is a software application development model structure and toolset that reduces costs and simplifies the process of deploying, integrating and managing systems for manufacturing enterprises. It allows a wide range of manufacturing software applications to integrate seamlessly, enabling fast, easy information exchange from the manufacturing floor to the executive suites. Its use at Genentech has resulted in gains such as design independence, obsolescence isolation and reduced cost to implement evolving technologies while continuing to derive benefits from existing technologies in installed systems. Design Independence In years past, IT and manufacturing personnel in any enterprise had widely differing information perspectives of their business and this served as a roadblock to a successful implementation of a enterprise wide information system. However, recent advances in software technologies and the proliferation of methodologies such as Object and Component Based Programming and Extensible Markup Language (XML). has made it possible for various groups to independently design and develop their respective information models while ensuring that they adhere to the mapping rules of the enterprise level model. Obsolescence isolation While evolving technologies, have over the last decade, helped to reduce the impact of people in an enterprise having differing information perspectives, the new challenge for designers is to implement enterprise wide information systems that easily adapt to evolving technologies. Additionally, components of the enterprise system that implement newer technology need to be isolated from all the other components of the enterprise system that may not be ready for the new technology while assuring that the information between the components continues to flow. Especially of concern is the manufacturing information/control system. Reduced cost Businesses are requiring lower implementation costs to integrate newer technology components with the ones already existing. At Genentech, use of DNA-M strategy has helped solve the problem of how to best integrate and even migrate the company s existing client/server-based architecture to an Internet- or Intranet-Based Architecture without the need for a major rework and overhaul. It has provided a viable platform for the implementation of a three-tier architecture also known as Thin-Client Computing. Under this strategy, normal applications are broken down into three tiers: the Presentation Services Tier, the Business Services Tier, and Data Tier. These tiers reside on different systems. The application architecture results in a reduced implementation cost since it is highly adaptable to meet both evolving business needs and technologies while allowing for various groups to influence the presentation of their information from a variety of component systems. Application developers at Genentech concentrate on the Copyright 2001 World Batch Forum. All rights reserved. Page 6

7 Business Services Tier to reveal the pertinent evolving information needs, via a standardized Presentation Tier to the user community, while allowing for customized Presentation Tiers. System integration and database performance issues have mostly driven the needs of the Data Service Tier. Data Service Tier changes often are collaboratively implemented with specialized software developers from contract system integrator software houses. The following figure is a diagrammatic representation of Genentech s Manufacturing Information System Architecture in relation to Microsoft s DNA Enterprise Integration Strategy. Presentation Services User PCs Business Business Business Processes Processes Processes Business Services Report Trend Hist. RDBMS File System Data Services Batch History P.O.M.S. Microsoft's three-tiered DNA Architecture Manufacturing Information System's implementation Figure 4: Windows DNA Framework for a Manufacturing Information System THE INFORMATION CLIENT The key component of the information model, that gives users the data where they need it, is the client desktop application where manufacturing information is presented. These desktops are scattered across the enterprise. They are equipped with a Internet Browser to provide server access via an enterprise wide communication network. Users access the servers by typing in the URL addresses such as Copyright 2001 World Batch Forum. All rights reserved. Page 7

8 All users who gain access to the enterprise network, may access the Report. The Report functions as a Web. It services operator requests by accessing data either from the Batch History or the Trend History. A subset of users, through a level of access security, may collaboratively review Batch records prior to their market release. These reviews are conducted via frequent exchange of information and answers to queries between Quality and Manufacturing personnel. The servers provide the capability to conduct it in an electronic domain. Users may select a specific Batch ID from a search results list of completed batches, batches completed during a specified date range, etc. and may then generate a Batch Report for the selected Batch. The report list events that may have occurred during the production of a Batch. They also display the cause and duration of delays caused by pending operator actions or units awaiting the availability of other process units. Such delays are automatically flagged for easier analysis thereby reducing the analysis time. Maintenance personnel may view Equipment Usage History reports to assist them in proactive maintenance of equipment, thereby improving equipment availability. Process engineers, manufacturing and process science personnel may review Batch Records and review process performance with the intent to improve the process yield. Since information is now available in a centralized location on the Report, the review may be conducted from the convenience of their office desktops and at a pace that matches their work schedules. WEB TECHNOLOGIES MEETING BUSINESS NEEDS Business needs at any enterprise is in constant evolution and Genentech is no exception. Genentech personnel, to meet the changing needs, are increasingly using web technologies. The following table is a current list of business needs which are being met by the use of web technologies. Copyright 2001 World Batch Forum. All rights reserved. Page 8

9 Web Technology Application DCS Query II Windows MQA Online DNA Post-Batch Comment Entry DCS Access Request Forms User Customizable Pages Static HTML Off-Hours On Call Contacts Trend Data ASP Scripts Real-Time Reports Historical Reports Log Files Business Need met Displays real time Batch History Data, allowing for timely intervention, up-to-the-second scheduling and plant performance analysis. Exception-based Batch History Data for review, and batch status tracking. Additional data entry in Batch History record after batch has completed. Consistent distribution of the correct revisions of forms. Web skilled users build custom web home pages, which may become standardized web pages. Leverages employee input for standard page design. Provides a consistent means for the facility to acquire DCS support. Posted at 15-minute intervals, allows anyone in the company to monitor common process data. Reports generated from the DCS, Trend, etc. are stored on the Web server for subsequent viewing. Assures all employees get the same consistent information and prevents unnecessary regeneration of common reports on the DCS server. The real-time reports are archived, which allows for comparisons of similar batches that are executed months or years apart. System and user log files are placed on the web-server allowing for diagnosis of batch events, and root-cause analysis of system component failure. THE BUSINESS IMPACT The real impact of such applications have resulted in the reduction in batch approval cycle times, optimization of material inventory and usage, maximization of asset utilization through proactive scheduling of equipment maintenance, electronic generation of work orders, and providing ready access to thousands of manufacturing related documents, etc. The key is to provide the required information to those who need it, when, how and where they need it. Users have reported that these web-based systems allow them to assess the validity of the data being reported from the system, as they can view system configurations to determine items such as the frequency of data collection. The ease of use not only saves time from previous Genentech systems (10 hours to collect relevant data, down to 1 hour), but also allows for Copyright 2001 World Batch Forum. All rights reserved. Page 9

10 investigations of process anomalies that may have been deemed too resource intensive to perform previously. Previous data-mining operations that required personnel to scan batch reports to determine batch run-times, could take as long as 30 days to complete for only a certain category of recipes. Now, run times for all recipes can be calculated and statistically analyzed in minutes. Quality Assurance reviews originally took place at batch completion, which required hours of additional review time for typical batch executions. Now batch reviews can take place as the batch runs, minimizing the amount of review time post batch completion, and increasing the reliability of information during investigations of untypical executions. REFERENCES Frank E. Redmond III, Microsoft Corporation: Introduction to Designing and Building Windows DNA Applications, June 1999 (White Paper). R. Parapar: Genentech Synopsis Project, System Functional Specification, Vacaville MES/DCS Integration, SFS Rev Robert Daly: Special Report: Cracking the Code of Microsoft s DNA, Managing Automation, March 1999 Copyright 2001 World Batch Forum. All rights reserved. Page 10