Medical equipment manufacturers are held to the FDA's strict design standards known as quality system regulations (QSRs) and meeting them is not always an easy task. A new system known as collaborative production management (CPM) promises to make the process of meeting QSRs a little easier. CPM encompasses a multitude of functions such as production and process controls, process validation, device master records and device history records. CPM is also compatible with CPM systems in other facilities and merges with enterprise resource planning (ERP) and product data management (PDM) systems around the globe.

CPM can help a medical device manufacturer meet a particularly tough QSR, such as the one requiring that a product's components be traceable throughout production. The production of an electronic medical device usually involves the following steps: a printed circuit-board line, an assembly and test line, and a packaging and shipping line. At the start, surface-mount devices are attached to a circuit-board using automation, followed by an automated optical sensor inspecting each piece. The board and its support components are then mounted in the housing and tested. Problems detected at this stage will be reworked and sent back for final testing. After final testing and approval, the product is packed up with its instructions and put into a shipping container. Three material storage areas are also included in the production line for attaching parts onto the surface-mount devices and final assembly machines. In addition, there are a couple of work-in-process queues that act as storage buffers between each major stage in the production line. These queues allow differences in production rates and product mix among the three main sections of the assembly process.

As one can see, the management of medical component information throughout the production process is a complicated task, precisely what CPM seeks to eliminate. First, it gives a serial number to each circuit board and copies this number onto a work order. Then the system links the circuit board to all related documentation including bills of materials, engineering changes, manufacturing instructions, and design information. CPM also links all parties involved in the process and it does so in real time. Therefore, when an engineering change notice comes in, it is immediately carried out through the CPM system.

Traceability also involves tracking component lots to the final product, in other words, tracking the lot number of each individual surface-mount device as well as all the other components that make up the electronic instrument. The lot information is read from the component boxes, reels, or other bulk materials as they are mounted onto the equipment or put into bins at the assembly line. This record links the component lot number and the subassembly or end item that links the components. If it is determined that a certain component lot is deficient, the medical instruments that received the faulty components can be easily located and recalled. While units remain in the manufacturing facility, they can be tracked to an individual station, and once they have been shipped, they can be tracked to their final destinations.

When the product arrives at a workstation, the latest bill-of-materials information is automatically consulted. If the component setup does not conform to that bill of materials, the process stops until the problem is resolved.

Of course, as is the case with adopting any production solution, the benefits should ultimately outweigh the costs. In addition to helping a manufacturer reach quality system regulation compliance, CPM can help cut the time, energy, and costs associated with relying on a paper based system. CPM automates and improves paper based record-keeping by saving information from each step in the production process for the device history record, thus making it easier to meet future QSRs as well.

Source: Satisfying Product Requirements with CPM
Steven A. Vogel
Medical Design News, Nov. 5, 2001
http://www.medicaldesignnews.com/full_story.php?WID=909