The study, titled "Total Product Lifecycle Management: Lowering Costs while Increasing Quality," found that most medical device companies do not use software applications to help them migrate to a TPLC program.
According to the TPLC study, less than 10 percent of companies use and keep a fully electronic database of records to be reviewed by regulatory agencies.
A TPLC approach focuses on sharing information among the various product life cycle stages, and by extension, between different departments.
TPLC also encourages the use of preventative actions over corrective actions, an approach that shifts focus away from rapid event closure in favor of developing solutions that prevent the occurrence of a problem in advance of its manifestation.
In the true spirit of TPLC, the knowledge gained during these exercises must be transferred to manufacturing to help manufacturing engineers and quality engineers better understand the process.
It is difficult, if not impossible, to manage the TPLC using disconnected and unstructured systems and processes, as shown in Figure 5 on page 119.
With the current move away from "testing quality into products" to a more proactive strategy of "designing quality into products and processes," the ability to control the TPLC process has become a critical factor to ensuring product quality.
As the FDA increases its emphasis on a TPLC model, those medical device manufactures working within an integrated Product Life Cycle and Quality Management infrastructure will be able to meet even the strictest requirements for product development.
Upon accessing the part from the global repository, the engineer can view a complete history of all changes, nonconformances, complaints and corrective and preventative actions (CAPAs) associated with the part--in the true spirit of TPLC (See Figure 8).