Failure Modes and Effects Analysis (FMEA)

Paramit relies on the Failure Modes and Effects Analysis (FMEA) process to identify potential failures in the manufacturing process, determine their effect on the quality of the finished product, and then identify corrective actions to mitigate these risks. A key goal in the FMEA process is to reduce or eliminate the complexities which drive up manufacturing costs or present potential quality concerns. While it's not feasible to anticipate every possible failure, Paramit's Design for Manufacturability (DFM) review in combination with FMEA allows our manufacturing engineers to create a prioritized action list which results in a higher quality product.

With the increasing complexity of medical devices and instruments, more and more OEMs struggle to design products that can be manufactured cost effectively. Traditionally, OEM engineers designed products they could easily build in-house, using tools and techniques that suited their internal manufacturing environment. When an OEM outsources manufacturing, engineers must adapt product design to the manufacturer's equipment, taking into consideration the manufacturer's machine performance and history of rework. The best way to address these concerns is to design products for cost effective manufacturability, quality and reliability early in the development cycle and then identify gaps during a DFM and FMEA review process.

An FMEA exposes weaknesses and potential failures by assigning values to the severity of the failure should it occur, predicting the probability that the failure will occur, and then evaluating the likelihood that testing will detect the failure before the product advances to the next stage in the manufacturing process. The early and consistent use of FMEAs in the DFM review process allows the Paramit and OEM engineering teams to design out failures, reduce risks, and build reliable, safe, best-in-class products.