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