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 FMEA 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. It has become a risk management tool that has also helped us to continuously improve our software.

À propos de l'auteur

Marc Lloses Padilla, Vice-président, Recherche et développement

Marc Lloses possède plus de 20 années d'expérience dans l'univers de l'ingénierie. Avant de se joindre à l'équipe de Picis, Lloses a œuvré au sein du Service de recherche et de développement d'Ericsson Mobile et de Siemens Dematic. Chez Ericsson, il occupait un poste axé très fortement sur l'ingénierie, travaillant avec l'équipe de recherche afin de créer de nouveaux logiciels pour les plateformes mobiles. Chez Siemens Dematic, il occupait un poste davantage axé sur la clientèle dans le cadre duquel il se consacrait à la création de solutions sur mesure de stockage automatisé.

Lloses travaille chez Picis depuis 2004, où il a occupé les postes de développeur principal, chef d'équipe, cadre et directeur. Au cours de ces années, il a dirigé le développement de l'ensemble des applications périopératoires en plus d'aider l'équipe à innover tout en respectant les normes de qualité ISO s'appliquant à une entreprise de soins de santé.

M. Lloses a obtenu un baccalauréat en génie informatique de l'UPC (Barcelone). Par la suite, il a obtenu un diplôme en communications audiovisuelles de l'UOC (Barcelone) tout en travaillant. Il a également obtenu une maîtrise en modèles de conception de l'UOC.