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The Process Industries (PI) SIG article listed below won a Silver Inkwell Award in 2000. We are pleased to share this award-winning article as one example of the kinds of articles created by the SIGs and shared with their membership. 

Implementing Real-Time Data Capture in Pharmaceutical Manufacturing
By Dana Buker, CPIM

Today, more than ever, companies are searching for ways to move products more rapidly through the supply chain, both internally and externally. In support of this, they must also be capable of capturing the relevant product flow data more rapidly and accurately. DuPont Pharmaceuticals recognized this need in the early ’90s, and implemented a real-time data capture system in 1995 for its distribution functions. This system, commonly referred to as ROPICS (Radio-frequency Order Picking and Inventory Control System), was expanded to the manufacturing processes—both continuous and batch—in 1997.

Today, we are tracking the creation, usage, and movement of material from the receiving dock, through the warehouse, into and out of manufacturing, through quality release, and into distribution—all in real time!

Company Background

DuPont Pharmaceuticals is a worldwide business that focuses on research, development, and delivery of pharmaceuticals to treat unmet medical needs in the fights against HIV, cardiovascular disease, central nervous system disorders, cancer, and arthritis-related disorders. DuPont Pharmaceuticals is also a leader in medical imaging. It operates three manufacturing sites that are located in Massachusetts, New York, and Puerto Rico.

Project Background

Throughout the company’s history—and especially with the 1994 advent of a fully integrated and unified ERP package, Business Planning and Control System (BPCS)—emphasis has been placed on multisite involvement to maximize efficiencies and keep costs under control through collaboration and standardization. Although there are differences in areas of the operations at the three manufacturing sites, the company has maintained excellent communication channels so that standardized processes and solutions are implemented wherever possible. This results in reduced support requirements and the ability to speak the same language when it comes to most ERP-related discussions.

The implementation of BPCS made obvious the interdependence among various functional areas such as manufacturing, planning, finance, and customer service. The traditional stovepipe approach to business died quickly as a result of implementing an integrated ERP system. Multifunctional, collaborative teams are the norm rather than the exception at DuPont Pharmaceuticals. Employees recognize the need to work as a team to be successful.

The operations bar code team is no exception. Since its inception in 1997, the team has included representatives from finance, information resources (IR), manufacturing, planning, production planning and inventory control, quality control, validation, and other functions as needed.

Keith Evans from DuPont’s Wilmington IR staff, Dana Buker from manufacturing, and the integrator, Stephen Brazzell from Innovatum, Inc., in Lawrenceville, Georgia, make up a core team that has been in place since the project’s beginning. The continuity of a stable core team is also seen as a key to success.

Approved, recognized, and supported at all levels of the organization, the project owes much of its success to top-level management buy-in throughout the process, as well as impressive levels of participation by, and involvement of, personnel at the manufacturing sites. The commitment and dedication have been phenomenal. The folks at the plants have truly taken ownership of the system and have absolutely no desire to return to the days of (more) pen and paper.

System Development

The Development Process. System selection was one of the first major tasks taken on by the team, which quickly discovered that there are many potential solutions available. However, unlike the two-tier ROPICS, the only viable candidates were of a three-tier architecture. The difference between the two types is that in a three-tier system, a replicated database of critical files is periodically fed to a server between the user and the main database (or host) computer. This is what the client application "talks to" in real time. Added complexity, synchronization, and support considerations made this option unattractive.  ROPICS, on the other hand, updates the host BPCS database in real time with no intermediate stopping points. The functionality required to support manufacturing transactions would need to be expanded in ROPICS; however, more than 70 percent of the design and development work was already done.

The cost analysis also indicated that a three-tier design would be more than $200,000 more expensive to purchase and would take longer to implement. After doing its homework, the team agreed unanimously that the best choice in this case was obvious—ROPICS.

Hardware. The BPCS application runs on IBM AS/400s, which are accessible through dedicated communication lines and a LAN and WAN system developed, installed, and maintained by DuPont employees.

Given DuPont’s established contract with a major hardware provider—Intermec Corporation—the team agreed to build on existing designs and equipment and use Intermec for the hardware. Other potential suppliers were investigated to confirm that the Intermec solution was the best choice. The Intermec hardware consists of hand-held portable computers, 2.4 GHz radio access points, and label printers.

Based on an Intermec survey, radio antennae were positioned strategically throughout the plants to provide needed coverage. Hand-held computers were purchased for each group that would need them, including warehouse, quality control, manufacturing, packaging, and IR (for development and training).

Software. ROPICS is essentially a front-end application for communication with the ERP backbone. Should a decision ever be reached to switch ERP suppliers, simply building the linkage to another back-end system will make it possible to keep ROPICS in place. In that event, implementation, training, and validation efforts would be greatly simplified for the conversion.

The ROPICS package was upgraded to include functionality in support of manufacturing transactions such as shop order issues and receipts, packaging reconciliation, and labor reporting. The existing functions for receiving, put-away, cycle counting, and customer order processing were essentially left as is.

ROPICS communicates data from and to the host with an average response time of less than three seconds. The data sent to the host are validated, and any discrepancies are immediately identified to the user for corrective action. This is especially impressive in the cases of the Atlanta Distribution Center and the Garden City, New York, sites, since the host AS/400s are located hundreds of miles from the sites.

The small 2" x 2" screens on the hand-held computers represented a design challenge, since the system had to give the users enough information to do their jobs efficiently without exceeding the available real estate. Evans and Brazzell did a fantastic job of identifying the minimum amount of data needed for the transaction and inquiry screens so that the system would be both user friendly and extremely compact.

Procedures and Training. All related procedures were maintained to support the implementation. Site resources were recruited to update system documentation. The revised draft documents became the basis for most of the training, which was developed by team personnel. A training schedule was prepared for each group using the new tools, ultimately training more than 180 new users.

Because this technology—as well as MRP and inventory management concepts—were brand new to most ROPICS users, "basic" users were required to attend a minimum of eight hours of training over a one-month period, while "super" users received a minimum of 16 hours. According to local site policies, all affected procedures for the sites were updated and in final form before implementation.

Testing. The pharmaceutical industry is among the most tightly regulated, with all systems used in the process of manufacturing, packaging, holding, and distributing drugs highly scrutinized and subject to requirements set forth in the Code of Federal Regulations. DuPont Pharmaceuticals manages the BPCS and ROPICS applications under these guidelines; accordingly, the testing process is well documented.

The enhanced version of ROPICS installed at the manufacturing sites was formally tested and documented, with users testing each new or upgraded process under an approved validation plan. This plan consists primarily of an installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ). Each section is made up of a series of test scripts, which can be tied back to the system’s agreed-upon functional requirements. Although the process is resource intensive and time consuming, it is extremely valuable and worthwhile. The testing is also a useful training tool.

The IQ proves that the hardware and software have been properly installed in accordance with vendor specifications and change control procedures. The OQ is used to verify that the newly designed functions will work within the framework of the designed system by properly trained users using appropriate procedures and equipment in the physical location where the transactions will be processed. The PQ tests the performance of the system in the production environment.

More than 100 tests were conducted to prove that the system would perform as expected. As a part of the testing process, any issues discovered were formally addressed and resolved. All IQ and OQ issues must be resolved before implementation. PQ issues must be resolved quickly depending on severity.

Validation and Change Control

The rigorous testing and change control process is an integral part of the system’s validation. Before the start of testing, a validation plan and related protocols are reviewed and approved by all groups. Member(s) of the quality organization must review all test scripts before and after execution. In addition, an overall validation plan including IQ, OQ, and PQ protocols is reviewed and approved by a multifunctional group of responsible personnel, including quality assurance and the validation department. Post-implementation summary reports for each "Q" are written and, finally, a validation summary report is prepared, reviewed, and approved before the administrative documentation can be considered complete.

The company follows a strict change control process for all new systems and upgrades to existing systems. The result is one set of core code at all company sites. The complex system meets the company’s many requirements and yet is controlled and maintainable. Also, because all sites have the same code, the training and testing required to implement and/or expand the utility of the system to all sites are facilitated.

Implementation

Cutover. Before each implementation, a cutover plan is established to verify that all required preproduction tasks have been completed and that the required control and coordination of the implementation process are properly planned and resourced. The heart of the plan is a checklist of tasks to be completed before, during, and after cutover, with responsibility assigned to the primary responsible function.

Consideration is given to system configuration, database maintenance, training, documentation, support, and business resumption (or fallback) plans. Responsible leadership from all functional groups must review and approve the cutover plan before implementation.

On the days of implementation at each site, a final readiness check was conducted, and sign-off on the startup process was collected from the management. Users were prepared, systems were double-checked, and support infrastructure was in place and communicated to the user community. Project team members were assigned to provide on-site, in-area support for all shifts. Team members made routine tours of the facility to address startup questions and resolve any issues that came up. Thanks to adherence to a proven well-documented process and some practice using it, the startups went very smoothly.

Post-Implementation Process. For two weeks after implementation, a post-implementation process (a continuation of the issue-resolution process, as well as ongoing, on-site, in-area team member troubleshooting and assistance) was carried out.

A celebration—generally an all-inclusive, on-site luncheon—was held within a few weeks of each implementation to recognize the support and involvement of all the users in addition to the core team members.

Summary

In just a little more than a year, two manufacturing sites were performing more than 98 percent of their internal supply chain transactions in real time. The resulting benefits include

• real-time, highly accurate inventory information

• data to assist with the identification of bottlenecks and process cycle time

• 15 percent labor reduction in warehousing operations

• 5 percent labor reduction in packaging operations

• 20 percent lead-time reduction in receiving operations through process improvement

• improved scheduling resulting from greater inventory accuracy.

To maintain a competitive advantage, industry must be in the business of speeding up all processes associated with internal and external supply chains, while simultaneously improving overall product quality. DuPont Pharmaceuticals has enthusiastically embraced this philosophy, as exemplified through the project described here.

As of this writing Dana Buker, CPIM,was manufacturing systems manager for DuPont Pharmaceuticals. He has more than 20 years of diverse pharmaceutical manufacturing and planning systems experience and has been a member of APICS since 1982. He can now be reached at (877) 277-3016 or BUKERD@innovatum.com

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