FMEA Team Factors

There is a renewed and growing recognition of the value that cohesive interprofessional teams with right mix of technical and functional expertise bring to the FMEA process. No individual discipline alone has the requisite knowledge, skills and capability to fully, critically and accurately assess the system, product, process, function or defect under investigation. Healthcare professionals who participate in FMEA teams also benefit from teamwork by gaining broader knowledge of organizational systems and processes and achieving better understanding of team dynamics and interdependencies among departments. Highly engaged participants are more likely to advocate for the necessary changes and take ownership in a collective effort to reduce failures. Although cohesiveness is one of the critical factors for team effectiveness, it is also essential to ensure alignment with the broader organizational goals, values, and performance expectations. Depending on the complexity of issues, team composition and prevailing team dynamics, it may be a good idea to use an external FMEA facilitator that can steer the team in the right direction, ask difficult questions, effectively deal with controversial issues, and challenge assumptions, biases and preconceived notions. The external facilitator may need more time to understand the issues and become familiar with the key stakeholders, but it is important to bring fresh perspectives to the discussion without having a vested interest in supporting any particular decision. In general, the role of the FMEA facilitator is to:

  • Bring a sense of common purpose
  • Monitor and evaluate team progress against goals and make necessary adjustments to the plan
  • Identify roadblocks to success and recommend changes to improve team effectiveness while maintaining a neutral position
  • Facilitate effective team discussions and ensure participation of all team members
  • Observe interactions among team members and take steps to defuse potentially destructive behaviours
  • Detect inconsistencies in the work and provide constructive feedback to the team
  • Keep team meetings within the prearranged time limitations
  • Foster a safe, positive and respectful work environment
  • Make it easier for the team to arrive at its own decisions, solutions and conclusions
  • Identify gaps in knowledge and assist in the development of required competencies

Ability to select, interpret and use the right quality tools and techniques for a given situation is often essential for successful FMEA completion. However, having technical skills alone is not enough to achieve desired outcomes. Leadership skills are equally important because they help maximize team performance, enable effective collaboration, maintain motivation, build an environment of trust, support generation of innovative ideas, and capitalize on the wealth of knowledge within the team.

Potential Pitfalls

Successful application of FMEA depends on a number of factors including organizational commitment to building a culture of safety, availability of resources, teamwork, and necessary infrastructure to support robust FMEA process. As with other quality tools and techniques, FMEA has its own issues and challenges that should be taken into consideration. Some of the common, yet easily avoidable pitfalls associated with FMEA include:

  • Failure to secure ongoing leadership support
  • Failure to define the appropriate scope and depth of analysis
  • Failure to develop a process map as the guiding document for the analysis
  • Failure to establish a cross-functional team and involve subject matter experts (SMEs)
  • Failure to define FMEA ownership, expectations, team norms, roles and responsibilities
  • Dysfunctional and irrational team decision-making caused by groupthink
  • Failure to bring an outside perspective and experience to the team
  • Failure to recognize the need for an independent facilitator
  • Inadequate prerequisite training requirements for the team
  • Failure to ensure the integrity of data and develop data collection plan
  • Conducting physically exhausting and emotionally draining work sessions
  • Creating a long list of relatively trivial failure modes
  • Lack of continuity due to long periods of time between work sessions
  • Lack of meaningful severity, occurrence and detection rating scales
  • Failure to identify, prioritize and effectively address the most critical failure modes
  • Failure to apply error-proofing methods to eliminate the root causes of failure modes
  • Failure to identify complex interactions within dynamic socio-technical work systems
  • Limited understanding of broader organizational influences on human performance
  • Failure to support FMEA process with additional quality tools and techniques
  • Performing FMEA too late in the design and development process
  • Failure to develop and implement measures of effectiveness
  • Failure to drive ongoing system, product, function, or process improvements
  • Lack of trigger mechanisms to periodically review and update completed FMEA
  • Failure to control and maintain the effectiveness of the redesigned process over time
  • Lack of formal procedure for ensuring the confidentiality of FMEA documents