Looking for an electronic system for FMEA in Healthcare
Grace Duffy
111 Posts
One of our joint QMD/HCD Healthcare Quality and Improvement Committee members has a client looking for an electronic application for FMEA. Does one exist? It seems that FMEA is all about the discussion and discovery. Maybe some genius has automated that process.

Let us know if you are aware of anything out there.


Grace Duffy
8 Replies
Check out APiS-IQ. It is an amazing FMEA software and the North American team in Michigan are outstanding when it comes to customer service and teaching. They have personal experience in the manufacturing and healthcare industries.
Grace Duffy
111 Posts
Great suggestion, Michael. Thank you!!!
Check out Intellaquest. I have just started to look at their software, and it sounds impressive. It ties all of the FMEA, Control Plan, LPA, Corrective Actions, Calibration system, etc together.

An FMEA is all about the discussion and process taking into account actual failures and potential failures. I think that automating it would defeat the purpose and make for a weaker result. It is intended to be a living document updated when there are new failures, new technologies and equipment etc. Jim.
Grace Duffy
111 Posts
Thank you, Jim. I wondered about that when I first heard of the interest in an automated FMEA. I am curious about the two applications suggested in this discussion. I will look to see how they encourage the discussion and interactive communication you recognize as so important.

James: I agree - the discussion is where the value is. We currently do them in Excel, in a room with a cross functional team. Same thing with Excel, it needs to be an active discussion but the form helps to organize the information. The weakness is that it does not automatically link to Control Plans and LPAs, so there is rework and the opportunity for the link between the documents to be broken. Automation and digitization can be helpful, but the leaders an team need to make sure they don't loose effectiveness due to the process being easier. Similar to thee benefit of learning to do math on paper before doing it on a calculator or in Excel.
An automated or electronic FMEA is just a tool for collecting the data calculating and tracking the information. In both Aerospace and Automotive the FMEA builds into a Dynamic Control Plan
(DCP) and Inspection and Test Plan (ITP etc.

Its a lot of paperwork and the data from one feeds teh inputs in another. Further all three are part of the PPAP (Pre Prodcution Part Approval Process) which also will have additional linked data. An automated system reduces data entry and related errors as well as makes assembling the package a breeze.

The systems were never meant nor are they capable of substituting for the people and the process involved in developing the Failure modes and Effects Analysis and related action plans.

The only specialized tool I know is iQ-RM by AHP, but I don't know how much customization it requires before you start using it.