Purpose: Failure mode and effects analysis (FMEA) was used to evaluate a smart i.v. pump as it was implemented into a redesigned medication-use process. Summary: A multidisciplinary team conducted a ...

Problems and defects are expensive. Customers understandably place high expectations on manufacturers and service providers to deliver quality and reliability. Often, faults in products and services ...

FMEA is a process for analysis of potential failure modes within a design, process, or product, classified by severity or determination of the effect of failures on the system. Widely used in ...

This process is virtually identical to the one described for device FMEA in IEC 60812. However, process FMEA introduces a third term into the calculation. During manufacture, when a defect that could ...

FMEA is one of the most powerful approaches to safeguarding your projects from failures and defects. It isn’t a cakewalk to implement, but in the right hands, it can make projects run without a hitch.

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to ...

This article is part of PharmTech's supplement "Injectable Drug Delivery." Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature ...