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

  1. a) Start with the basic components of the process
  1. Start with the basic components of the process
  2. Number the components of the process
  3. Select a component to diagram in more detail

Step 2:

Diagram the process and sub-processes

  1. 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)

  1. 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)

  1. 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

•     Share results

  • 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

http://www.ihi.org/

  • Post category:Pharm.D
  • Post last modified:April 14, 2021