Medical Device Link.

Originally Published MDDI July 2001

A technology based on the Internet and intranets can automate the tasks required for regulatory compliance.

Steven A. Vogel

Among the regulatory burdens faced by healthcare manufacturers is the fact that the production of medical devices requires adherence to FDA's quality system regulation (QSR). This complex undertaking is made even more difficult for many companies because of a trend toward increased outsourcing to contract manufacturing plants all over the world. Given the added complication that a project's design input often originates from several locations within different companies, the challenge of meeting the QSR requirements can sometimes seem overwhelming.

To assist manufacturers with QSR compliance, systems are beginning to be deployed that make it easier to meet FDA requirements—particularly in such extended, or "virtual enterprise," environments. Built around the Internet and intranets, these systems are collaborative in nature and can reach beyond the walls of a particular manufacturing plant to interact with similar systems in other facilities. Expanding beyond the capabilities of earlier, software-based solutions, they can also interact with enterprise resource planning (ERP) and product data management (PDM) systems anywhere in the world, resulting in networks that can provide unprecedented data integrity throughout the entire medical product life cycle.

This article discusses such collaborative production management (CPM) systems, which are being used by a number of medical manufacturing companies to address various QSR requirements, including the sections dealing with traceability (820.65), production and process controls (820.70), process validation (820.75), device master records (820.181), and device history records (820.184).

Figure 1. The four elements of collaboration.

WHAT IS COLLABORATIVE PRODUCTION MANAGEMENT?

CPM is one of four key elements of collaborative product commerce, or CPC. As defined by the Aberdeen Group, this term describes the technologies used to help companies collaborate on design, sourcing, planning, and manufacturing functions. Figure 1 shows the four constituent elements of CPC. Each of these technologies provides visibility—by tracking design changes, for example—and collaborative tools to allow interaction among team members throughout the extended enterprise.

WEB-CENTRIC SOLUTIONS

The new technology driving collaborative manufacturing solutions is the Internet. Systems have evolved from distributed architectures in the 1980s to client/server architectures in the 1990s to Web-centric solutions today. To further promote interactivity among these systems, the computer language known as extensible markup language (XML) has become the predominant data-interchange mechanism that is recognized by Web-centric clients and servers. The use of Java as a universal Web programming language and the use of common object request broker architecture (CORBA) as a platform-independent middleware are also key ingredients for this architecture.

Figure 2 illustrates the architecture for one current CPM system. Among the important features of this architecture is the ability to interface via Web browsers over a company intranet or the Internet. In addition, the architecture has the ability to scale the solution—that is, to add server hardware and software to process higher transaction volumes as product lines are added—with application servers to meet the performance needs of the problem. Also, the use of XML and HTML as a way of communicating to outside systems allows collaboration with engineering, planning, and sourcing databases located anywhere in the world.

Figure 2. Architecture for a collaborative production management system.

Figure 3. A typical electronic medical device manufacturing line.

CPM AND THE MANUFACTURING PARADIGM

To demonstrate the use of a CPM system to meet the QSR requirements, one can take the example of a case study based on an electronic medical device. The production setup for the device consists of a printed circuit board (PCB) line, a final assembly and test line, and a packaging and shipping line, as shown in Figure 3.

As is typical in medical electronics manufacturing, the first part of the production line is dedicated to circuit board assembly. In this case, products are surface-mount devices (SMDs) that are placed onto the board with high-speed, SMD-placement equipment. The two-sided board requires components to be placed on both sides. The last step in the circuit-card assembly is optical inspection using automated equipment to examine solder joints and component placement.

The second portion of the production line encompasses final assembly and test. In this stage, the circuit card is placed into the final device and additional product components are assembled. After assembly, a procedure is run on the unit to test all functional characteristics. If a problem is detected, a rework process is provided to debug the unit, make necessary repairs, and send it back for more functional testing. A final inspection is carried out to check all visual and cosmetic aspects of the product.

The final manufacturing stage involves packaging and shipping. During this process, the product is put into its final package along with appropriate user instructions, peripheral devices such as power cords, and packaging and wrapping materials. The last step is to place the packaged unit into a shipping container that will be put directly onto a truck, train, or other form of transportation.

The production line also includes three material storage areas for components that are loaded onto the SMD machines and final assembly stations. There are also two work-in-process (WIP) queues used as temporary storage buffers between major parts of the production line. These buffers allow for differences in production rates and product mix among the three main sections of the assembly process.

N-LEVEL TRACEABILITY

Among the major QSR requirements is traceability of components and component lots through their manufacture, assembly into final product units, and packaging and loading into containers for shipping. The first step in this process is the assignment of a serial number at the board level that is then incorporated into a work order. The work order links the board to all product data (bills of materials, engineering changes, manufacturing instructions, design information, etc.). Once this relationship is established, the serial number of the board becomes the means of tracking and managing the product throughout the production process.

Collaboration is an overriding concept implying that individuals involved in product design, product changes, order fulfillment, manufacturing planning, and manufacturing execution are able to "see" the information and to change information in real time. For example, if an engineering change notice (ECN) is introduced, it immediately becomes enforced in production via the CPM system. If an order is changed, CPM immediately enforces the change.

When the circuit board is placed into the device at the beginning of final assembly, a second serial number is associated with the final unit to track it through the final assembly, test, and rework operations. At this point, the serial number of the circuit board is merged with the serial number of the final unit. This happens again during packaging, when the serial number of the final unit is merged with the serial number of the packaged box containing the unit, instructions, power cords, and other items.

The ability to merge product information into the successive levels of product buildup is referred to as n-level traceability. This process provides a complete product genealogy throughout the manufacturing process.

COMPONENT LOT TRACEABILITY

One of the most important aspects of traceability is the tracking of component lots to the final product. In the electronics example, the lot number of each SMD component at the two SMD placement procedures, as well as the components going onto the end item at final assembly, must be tracked. This is accomplished by reading the lot information on the component boxes, reels, or other forms of bulk material as they are placed onto the equipment or put into bins at the assembly line (bar codes are scanned by operators on the shop floor). This process establishes the link between the component lot number and the subassembly or end item with which the components are associated.

If a component lot is subsequently determined to pose a problem (due to nonconformance, presence of defects, obsolescence, etc.), the finished devices that received components from this lot can be very accurately traced and recalled for further action. If those units are in the manufacturing facility, they can be tracked to individual stations or work queues; if they have been shipped, they can be tracked to their final destinations.

ENGINEERING CHANGES

Another critical tracking problem for medical manufacturers—and especially for contract manufacturers—is the management of ECNs in the production process. The ECNs may be coming from one customer or from several customers, depending on the complexity of the supply chain.

ECNs can occur for a variety of reasons. The product design sometimes changes to incorporate less-expensive materials, especially during the transition from initial product start-up to mass production. A design can also change to address performance or endurance deficiencies, or as a result of concerns over device safety or other regulatory issues.

ECNs must go through a rigorous process of review and sign-off before they can be released for production. When they finally clear this process, they are generally released through a product data management procedure. Once this occurs, the change is implemented according to an effectivity date, which indicates the date on which the change should be implemented on the factory floor. After this date, no product must be made with the previous version of the component.

With CPM, the processing of ECNs can be efficiently achieved. Because each product is identified by a serial number at each level of assembly (n-level traceability), and each serial number is associated with a work order that tracks back to the latest bill of materials, any ECN will immediately be implemented in production at the exact moment it becomes effective. When the product on the assembly line arrives at a workstation and its serial number is read by the system, the latest bill-of-materials information is consulted. If the component setup does not conform to that bill of materials, the process will be stopped until the problem is resolved.

For example, if an ECN changes a resistor that is being placed on a circuit board, the obsolete resistor would be rejected if the operator attempted to load a new reel containing the old part to the machine.

DEVICE HISTORY RECORDS

QSR compliance requires the presence of a complete device history record that represents the as-built configuration of the medical device and incorporates all production results, such as test and rework processes. With paper-based systems, it can be costly, difficult, and time-consuming to collect this information and maintain an effective process over an extended time period. Moreover, the information is often subject to errors.

CPM systems can automate and improve this process, since all information for the device history record is saved as a by- product of the production management system. In addition to the collection of serial-number traceability information described above, CPM systems also capture information at each process step using the XML capabilities of the software. For example, at each test and inspection station, all symptom and defect information is collected and associated with the serial number of the final unit. In the case of units that fail a test, all of the rework information is also captured, including traceability data for rework materials that are added to the unit. Because the exact bill of materials in effect at the time of manufacture is known, the as-built bill-of-materials information is also included in the device history record.

CONCLUSION

CPM systems automate and integrate many of the tasks required to achieve QSR conformance. In an industry that is becoming more extended because of outsourcing and increasingly complex global customer-supplier relationships, this technology represents an important component of a successful manufacturing strategy for medical device companies. As firms become part of an extended supply chain, the need for flexible CPM systems that can integrate with multiple PDM and ERP systems will increase.

Because different medical devices—from custom products to disposables—are fabricated in a wide range of production volumes, CPM systems must be capable of addressing the diverse spectrum of production environments. The use of Web-centric technology with middleware provides an unprecedented level of scaleability and reliability that makes these solutions viable for both low- and high-volume device manufacturing.

Copyright ©2001 Medical Device & Diagnostic Industry