Process Failure Modes and Effects Analysis

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Process Failure Modes and Effects Analysis (pFMECAs) are used to assess the risk that manufacturing defects will be present in product shipped to the customer. When properly and thoroughly performed, pFMEAs not only provide an indication of of process risk, but also indicate where process improvements and tests or inspections will have the most impact, thus decreasing potential cost of impacts, as well as potential excessive testing. This potential savings results from pFMEAs assessment of the impact of a manufacturing defect and the likelihood that it will occur, as well as the likelihood that the defect will go undiscovered if it does occur.

Use of the pFMEA tool provides documented evidence that that attention was paid to ensuring that the manufacturing process is capable of producing product that is as free as practical of harmful (based on current standards) defects. However, pFMEA is a two-edged sword. If not performed well, you will have documented evidence of not knowing whether your process is adequate. Therefore it is essential that pFMEAs be conducted properly to be useful for defensive purposes.

AlvaMed has facilitated many risk analyses in general and pFMEAs in particular for various types of medical devices, from disposables and implantables to life-sustaining capital equipment. Our process is efficient and produces detailed FMEAs. Let us facilitate your next FMEA to ensure you have a solid process and sound evidence to support it.

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