Managing Risks to Support Product Quality: A Deep Dive into Failure Mode and Effects Analysis Software

In our blog from February I wrote about how Picis continues to expand best practice to support the development and quality of our products. In this encore blog, I’d like to take a closer look at one of the steps and one of our most important risk management processes: the Failure Mode and Effects Analysis (FMEA).

With every feature or improvement, we add to our product, we go through the FMEA process. Our goal is to identify, analyze and prevent new risks that may occur in our software when we add or change features. This is not about whether the software has a bug or is designed incorrectly, but about exposing the design to the various workflows and scenarios that can occur in a hospital environment.

For example, there is no way to determine if the person using our product left the computer unattended to go to another room for an emergency, then someone else accessed and viewed information that should not be shared. This is not a bug, the functionality works fine, but there is a big risk that the information will be exposed. Adding the automatic logout feature is a precaution against possible risk. This way we can detect that the user has not accessed the computer for a certain period of time, the system logged them out and now they will have to log in when they return to the workstation. 

Any new feature can have multiple scenarios and failure mode and effects analysis is the process utilized to check the scenarios and the potential impact of the designed workflow.

How does our FMEA work?

The first step of the process is to bring together the different experts in our team: 

  • Engineers create and develop the actual functionality
  • Quality analysts assess where the most common problems occur in each function
  • Product specialists develop the workflows and know the needs of our customers
  • Support brings the knowledge of how our customers utilize our applications
  • Regulatory team ensures that we’re adhering to compliance and regulatory guidelines
  • Clinicians help to evaluate potential changes to the products and workflow

Next, the entire team will brainstorm potential failure modes, list the potential impact of each failure mode, determine a severity level for each failure mode, define a plan to eliminate or reduce the high-risk failure modes and assign responsible parties and deadlines.

FMEA is a team-based activity; we need the different views of our various stakeholders to perform an in-depth analysis. The focus is on problem prevention and with the knowledge gained we should be able to improve our process and design, but we can also use it to improve test plans. 

For us, FMEA is a mandatory step when we develop new functionalities to assess if there is a potential for new risks to be introduced. Failure mode and effects analysis has become a risk management tool that has also helped us to continuously improve our software.

About the Author

Marc Lloses Padilla, Vice President, Research and Development

Marc Lloses brings over 20 years of experience in the engineering world. Prior to joining the Picis team, Lloses worked on Ericsson Mobile R&D and on Siemens Dematic. At Ericsson he was in a pure engineering role, working with the research of new software for mobile platforms. Moving on to Siemens Dematic he was in a more customer-focused role, creating custom solutions for automated storing.

Since 2004 Lloses has been working at Picis, evolving from Senior Developer to Team Lead, Manager and Director. During these years, he has been leading the development of all the Perioperative applications while empowering the team to be innovating but at the same time following ISO quality standards for a healthcare company.

Mr. Lloses earned a bachelor’s degree in Computers Engineer from UPC (Barcelona) and after that, he graduated in Audiovisual Communication at UOC (Barcelona) while he was already working. He also took a Master on Design Patterns at UOC.