Failure Mode and Effects Analysis (Prospective Risk Assessment)
Learning Objectives
After completing this module, learners will be able to:
- Explain the value of the Failure Mode and Effects Analysis (FMEA) in identifying and correcting system vulnerabilities
- Summarize the steps of the FMEA
- Apply systems theory and human factors engineering principles to conduct the FMEA
Definition:
An FMEA is a prospective, team-based, systems-based approach to:
- Evaluate systems and processes
- Identify and correct vulnerabilities
- Improve overall quality and safety
Focuses on how and when a system will fail, not if it will fail
Importance
An FMEA is a prospective risk assessment to dentify system vulnerabilities before things go wrong and to makes systems more “fault-tolerant”
Who should be involved in an FMEA?
An FMEA should be conducted by an interdisciplinary team to optimize each individual’s unique perspective and experience.
- Include frontline staff and management for multi-level engagement
When should an FMEA be conducted?
- High-risk processes in which a failure is most likely to jeopardize the safety of the individuals served by the health care organization
- Processes where failures would represent a risk to staff members or the organization itself
- When designing a new system or process
Where should an FMEA be conducted?
The FMEA process is applicable to any health care setting in which system vulnerabilities need to be identified and corrected.
Example
Brief Scenario
A pharmacy manager was newly appointed to a busy community pharmacy in an urban area.
As part of her orientation, she reviewed the pharmacy’s policies and procedures. She noted that the procedure for “patient identification during the dispensing process” was not well- described.
Her previous experience with “incorrect patient” errors resulting in patient harm prompted her to analyze this process further before errors occurred at this pharmacy.
Questions
Which of the following are characteristics of an FMEA? Select all that apply.
- Analysis method to identify and correct system vulnerabilities
- Analysis method to identify the individual responsible for a specific incident
- Analysis method that is prospective (forward- looking)
- Analysis method to identify the “root-cause” of a cause” of a specific incident.
Which of the following are examples of high-risk processes in a pharmacy?
- Patient identification process
- Dispensing of high-alert medications
- Dispensing pediatric medications
- All of the above
True or false:
An FMEA focuses on if a system will fail, rather than how or when a system will fail.
False is the correct answer
An FMEA acknowledges that systems will fail and focuses on how and when they will fail.
Steps to Conduct a Failure Mode and Effects Analysis
Step 1: Select process and assemble team
Select process
- Clearly define the topic and specific
process(es) for analysis
- Select the topic based on areas of substantial risk to the organization (i.e., high-risk process)
Assemble team
- Leader
- Facilitator / Advisor
- Subject Matter/Process Experts
- Process-naïve Individual
- Recorder
Step 2: Diagram the process and sub-processes
- a) Start with the basic components of the process
- Start with the basic components of the process
- Number the components of the process
- Select a component to diagram in more detail
Step 2:
Diagram the process and sub-processes
- Diagram the components of the sub-process
Step 3:
Brainstorm potential failure modes
Step 3:
Brainstorm potential failure modes
Failure modes can relate to people, materials, equipment, methods and environment
How do you determine failure modes?
- Consider experience from frontline staff
- Consider failures from other industries
- Consider published literature, including ISMP Canada Safety Bulletins
- Consider plausible worst-case scenarios
- Consider out-of-the-box ideas
Step 3:
Brainstorm potential failure modes
Step 3:
Brainstorm potential failure modes
Step 3:
Brainstorm potential failure modes
Step 4:
Identify effect(s) and cause(s)
Step 4:
Identify effect(s) and cause(s)
- Identify the potential effect(s) of the failure modes
“What would happen if this failure occurred?”
- Review each potential failure mode and identify the effect(s) of the failure, if it were to occur
Step 4:
Identify effect(s) and cause(s)
- Identify the potential cause(s) of the failure modes
“Why might the failure occur?””
- Focus on systems and processes, not individuals
- Consider human factors engineering principles
- Look for features within systems / processes that exacerbate human limitations
Step 4:
Identify effect(s) and cause(s)
What are the potential effect(s) of a pharmacy staff member’s failure to request a second identifier (e.g., date of birth, address) during the patient identification process? Select all that apply.
- Staff member was not trained to ask for a second identifier
- Incorrect prescription released to patient
- Loss of another patient’s confidentiality
- Staff member forgot to ask patient for second identifier
What are the potential effect(s) of a pharmacy staff member’s failure to request a second identifier (e.g., date of birth, address) during the patientid y.
Potential effects of not requesting a second
- Staf iden Inco
identifier are that the patient receives the incorrect prescription, and that another patient’s confidentiality is breached.
cond
Loss of another patient’s confidentiality
- Staff member forgot to ask patient for second identifier
Step 4:
Identify effect(s) and cause(s)
Step 4:
Identify effect(s) and cause(s)
Tips
- FAILURE MODES are the WHATs that could go wrong
- Failure mode EFFECTS are the OUTCOMEs if the failure mode occurs (plausible worst-case scenario)
- Failure mode CAUSES are the WHYs a failure mode occurs (may be more than one per failure mode)
Step 5:
Prioritize potential failure modes
Step 5:
Prioritize potential failure modes
- Score severity of the effect of failure mode (1-5)
- Score frequency of occurrence of failure mode (1-5)
- Score detectability of failure mode before outcome (1-4)
Step 5:
Prioritize potential failure modes
Severity
Step 5:
Prioritize potential failure modes
Frequency
Step 5:
Prioritize potential failure modes
Detectability
Examples of detectability safeguards
Step 5:
Prioritize potential failure modes
Prioritize potential failure modes
Step 5:
• Determine a “cut-off” criticality score
- Plan to address 60-70% of identified failure modes
- Those with highest criticality scores
- Any failure modes with a severity of 5, regardless of criticality score
Step 6:
Redesign the Process(es)
Step 6:
Redesign the Process(es)
Step 6:
Redesign the Process(es)
Step 6:
Redesign the Process(es)
Make SMART Recommendations
- Specific
- Measurable
- Attainable
- Reasonable
- Timely
Failure Mode and Effects Analysis Steps to Conduct an FMEA
This is the correct list of matching strategies to level of effectiveness
Step 6:
Redesign the Process(es)
Step 6:
Redesign the Process(es)
- Consider the impact of proposed changes on long- term success
- Attempt to use higher-leverage strategies whenever possible
- Prioritize recommendations by the strength of the action and its relation to best practices
Step 7:
Analyze and test the changes
Step 7:
Analyze and test the changes
Assess the impact of recommended changes by
recalculating the criticality score:
• Will the change decrease severity, decrease frequency, and/or increase detectability?
- If you choose to move forward with a redesign option, will the overall criticality score decrease?
Step 7:
Analyze and test the changes
- Conduct an FMEA of the redesigned process if a substantial change has occurred
- Use simulation or usability tests to assess processes for unanticipated problems
- Use the “Plan-Do-Study-Act” cycle to evaluate an improvement in practice
- Conduct a pilot test to ensure that a redesigned process will work as intended
Step 8:
Implement and monitor redesign
Step 8:
Implement and monitor redesign
Purposes of Measurement
- Assess current status to determine if actions are effective
- Monitor to ensure changes are maintained
- Provide feedback to staff about impact of patient safety efforts
Step 8:
Implement and monitor redesign
• Communicate the reasons for process changes
- Find “change agents” to champion the new
process
- Define the process and outcome measures
- Monitor changes over time
Step 8:
Implement and monitor redesign
Improvements are not always maintained
- Sustainability not considered
- Not everyone agrees
- Not aligned with core values
- Insufficient training provided
- No measurement of changes
- “Bolted on” to current practice
- Project with end date
Which of the following statements are true?
Select all that apply.
- Monitoring the effects of process changes can help ensure the changes are maintained over time
- Results showing the impact of process changes should only be shared within the FMEA team
- New risks may be inadvertently introduced by process changes
- The reasons a process is being changed should be shared with frontline staff
Submit
Which of the following statements are true?
Select all that apply.
Monitoring the effects of process changes can help ensure the changes are maintained over time
- Results showing the impact of process changes should only be shared within the FMEA team
New risks may be inadvertently introduced by process changes
The reasons a process is being changed should be shared with frontline staff
Submit
FMEA Steps Overview
Key Learning Points
- FMEA is a prospective analysis method to identify and correct system vulnerabilities
- The 8 steps of an FMEA outline how to identify failure modes in a process; assess potential effects, causes, and criticality scores; and develop, implement, and monitor actions for improvement
- The FMEA relies on a systems approach and human factors engineering principles for effective solutions
Additional Resources
Institute for Safe Medication Practices Canada
https://www.ismp-canada.org/index.htm
Canadian Patient Safety Institute
https://www.patientsafetyinstitute.ca/en/Pages/default.aspx
Institute for Healthcare Improvement
