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

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.

Acerca del autor

Marc Lloses Padilla, Vicepresidente de investigación y desarrollo

Marc Lloses aporta más de 20 años de experiencia en el mundo de la ingeniería. Antes de unirse al equipo de Picis, Lloses trabajó en Ericsson Mobile R&D y en Siemens Dematic. En Ericsson ocupó un puesto puramente de ingeniero y trabajó en la investigación de un nuevo software para plataformas móviles. Cuando se trasladó a Siemens Dematic ocupó un puesto más centrado en el cliente, y en él creó soluciones personalizadas para el almacenamiento automatizado.

Lloses lleva trabajando en Picis desde 2004, evolucionando desde desarrollador sénior a líder de equipo, gerente y director. Durante estos años, ha liderado el desarrollo de todas las aplicaciones perioperativas al tiempo que ha proporcionado las herramientas al equipo para ser innovadores pero al mismo tiempo seguir los estándares ISO de calidad dispuestos para una empresa de atención médica.

El Sr. Lloses obtuvo una titulación en Informática en la UPC (Barcelona) y después se graduó en Comunicación Audiovisual en la UOC (Barcelona) mientras ya se encontraba trabajando. También cursó un máster en Patrones de diseño en la UOC.