Central Service Association Central Service Association Of OntarioOf Ontario

Fahrenheit 270Fahrenheit 270

Failure Modes and Failure Modes and Effects AnalysisEffects Analysis

ISMP CANADA VisionISMP CANADA Vision Independent nonprofit Canadian organizationIndependent nonprofit Canadian organization

Established for:Established for: the collection and analysis of medication error reports the collection and analysis of medication error reports

andand

the development of recommendations for the the development of recommendations for the

enhancement of patient safety.enhancement of patient safety.

Serves as a national resource for promoting safe Serves as a national resource for promoting safe

medication practices throughout the health care medication practices throughout the health care

community in Canada.community in Canada.

ISMP Canada Mission:ISMP Canada Mission:

Committed to the safe use of medication Committed to the safe use of medication through improvement in drug distribution through improvement in drug distribution and drug delivery system design.and drug delivery system design.

Collaborate with healthcare practitioners Collaborate with healthcare practitioners and institutions, schools, professional and institutions, schools, professional organizations, pharmaceutical industry organizations, pharmaceutical industry and regulatory & government agencies to and regulatory & government agencies to provide education about adverse drug provide education about adverse drug events and their preventionevents and their prevention

ObjectivesObjectives

To introduce the principle and application of To introduce the principle and application of FMEA tool/process FMEA tool/process

To discuss its application in healthcare To discuss its application in healthcare facilitiesfacilities

To briefly review the FMEA processTo briefly review the FMEA process

Failure Mode and Effects Failure Mode and Effects AnalysisAnalysis

ISMP Canada one day workshopISMP Canada one day workshop 4 exercises of 45 – 60 minutes4 exercises of 45 – 60 minutes Practce on your own issuesPractce on your own issues

Human Factors Engineering Human Factors Engineering 101101

HFE:HFE: a discipline concerned with design of systems, a discipline concerned with design of systems, tools, processes, machines that take into tools, processes, machines that take into account human capabilities, limitations, and account human capabilities, limitations, and characteristicscharacteristics

Human Factors EngineeringHuman Factors Engineering

Research and practical applications Research and practical applications designed to improve the interface of designed to improve the interface of humans with systemshumans with systems

Develops practical design principles that Develops practical design principles that account for the psychological and physical account for the psychological and physical characteristics of peoplecharacteristics of people

Human Factors Engineering Human Factors Engineering PrinciplesPrinciples

Simplify key processesSimplify key processes Standardize work processesStandardize work processes Anticipate that human make errorsAnticipate that human make errors Use checklistsUse checklists Improve label designImprove label design Promote effective team functioningPromote effective team functioning

Constraint:

Hydromorphone 10 mg

was removed

The “Brain Flip” Needed in The “Brain Flip” Needed in HealthCareHealthCare

EngineeringEngineering Begin with premise that Begin with premise that

anything can and will go anything can and will go wrongwrong

Don’t expect humans to Don’t expect humans to perform perfectly or perform perfectly or without variationwithout variation

Design systems Design systems accordingly and are accordingly and are proactiveproactive

Health CareHealth Care Errors are the result of Errors are the result of

human failureshuman failures Humans generally Humans generally

perform flawlesslyperform flawlessly Perfect performance is Perfect performance is

the expectationthe expectation Use re-training, and Use re-training, and

punishment to root out punishment to root out bad applesbad apples

Human Factors – Human Factors – Guiding PrincipleGuiding Principle

Fit the task or tool to Fit the task or tool to the human, not the the human, not the other way around.other way around.

High Reliability High Reliability Organizations (HRO) Organizations (HRO)

CharacteristicsCharacteristics

Collective preoccupation with the Collective preoccupation with the possibility of failure”possibility of failure”

Expect to make errors and train their Expect to make errors and train their workforce to recognize and recover workforce to recognize and recover from themfrom them

Continual rehearsal of familiar scenarios Continual rehearsal of familiar scenarios of failureof failure

FMEA DefinitionFMEA Definition

FMEA is a FMEA is a team-basedteam-based systematicsystematic and and proactiveproactive approach for identifying the ways approach for identifying the ways that a process or design can that a process or design can failfail, , whywhy it it might fail, the might fail, the effectseffects of that failure and of that failure and how it can be made saferhow it can be made safer..

FMEA focuses on how and when a system FMEA focuses on how and when a system will fail, not IF it will fail.will fail, not IF it will fail.

Why FMEA?Why FMEA?

Brings analysis logic into the hospitalBrings analysis logic into the hospital Is a proactive approach for quality and safetyIs a proactive approach for quality and safety Initiates system fixes before a patient dies or Initiates system fixes before a patient dies or

is injured is injured Makes systems more “robust” and enhances Makes systems more “robust” and enhances

performanceperformance Makes systems more “fault tolerant”Makes systems more “fault tolerant” Focuses on systems, not individualsFocuses on systems, not individuals

Everyday FMEAEveryday FMEAYesYes NoNo

Do you take actions to prevent yourself from Do you take actions to prevent yourself from being late to work?being late to work?

Do you take a ‘shortcut’ when you see traffic Do you take a ‘shortcut’ when you see traffic building up in a familiar place?building up in a familiar place?

Do you try to distinguish ‘big problems’ from Do you try to distinguish ‘big problems’ from ‘little problems’?‘little problems’?

Do you see the possibility of eliminating Do you see the possibility of eliminating some problems, but need a better way to some problems, but need a better way to show that to people?show that to people?

FMEA versus RCAFMEA versus RCA (when to use)(when to use)

FMEAFMEA = = Future (preventative)Future (preventative)

RCA RCA == Retrospective (after the event or Retrospective (after the event or close call)close call)

FMEA OriginsFMEA Origins

FMEA in use more than 40 years beginning in FMEA in use more than 40 years beginning in aerospace in the 1960saerospace in the 1960s

1970s and 1980s used in other fields such as 1970s and 1980s used in other fields such as nuclear power, aviation, chemical, electronics nuclear power, aviation, chemical, electronics and food processing fields ( High Reliability and food processing fields ( High Reliability Organizations)Organizations)

Automotive industry requires it from suppliers, Automotive industry requires it from suppliers, reducing the after-the-fact corrective actionsreducing the after-the-fact corrective actions

FMEA is a tool to:FMEA is a tool to:

Analyze a process to see where it is Analyze a process to see where it is likely to fail.likely to fail.

See how changes you are See how changes you are considering might affect the safety of considering might affect the safety of the process.the process.

CCHSA Patient Safety Goals CCHSA Patient Safety Goals 20052005

Create a culture of safety within the Create a culture of safety within the organizationorganization The organization has in place a formal The organization has in place a formal

team/committee whose sole focus is patient team/committee whose sole focus is patient safety, and that does one proactive RCA or safety, and that does one proactive RCA or FMEA a year.FMEA a year.

FMEA StepsFMEA Steps

Step 1Step 1 Select process and assemble the Select process and assemble the teamteam

Step 2 Step 2 Diagram the processDiagram the process

Step 3 Step 3 Brainstorm potential failure modes Brainstorm potential failure modes and determine their effectsand determine their effects

Step 4 Step 4 Identify the causes of failure modesIdentify the causes of failure modes

FMEA Steps (cont)FMEA Steps (cont)

Step 5Step 5 Prioritize failure modesPrioritize failure modes

Step 6 Step 6 Redesign the processesRedesign the processes

Step 7 Step 7 Analyze and test the changesAnalyze and test the changes

Step 8Step 8 Implement and monitor the Implement and monitor the redesigned processesredesigned processes

Step 1

Select a high

risk process and assemble

the team

Step 2 Step 3

FMEA Process Steps

Select a high-risk processSelect a high-risk process

Internal data – aggregate Internal data – aggregate data, significant individual data, significant individual eventsevents

Sentinel EventsSentinel Events

CCHSA Patient Safety CCHSA Patient Safety GoalsGoals

ISMP CanadaISMP Canada

Executive buy-inExecutive buy-in

Select processes with high potential for having an adverse impact on the

safety of individuals served.

High Risk Processes - High Risk Processes - DefinitionDefinition

Those processes in which a failure of Those processes in which a failure of some type is most likely to jeopardize some type is most likely to jeopardize the safety of the individuals served by the safety of the individuals served by the health care organization. Such the health care organization. Such process failures may result in a sentinel process failures may result in a sentinel event.event.

High Risk Processes - High Risk Processes - ExamplesExamples

Medication Use Medication Use

Operative and other proceduresOperative and other procedures

Blood use and blood componentsBlood use and blood components

RestraintsRestraints

Infection controlInfection control

Care provided to high-risk populationCare provided to high-risk population

Emergency or resuscitation careEmergency or resuscitation care

Assemble a teamAssemble a team LeaderLeader FacilitatorFacilitator Scribe / RecorderScribe / Recorder Process expertsProcess experts

Include all areas Include all areas involved in the processinvolved in the process

““Outsider” /Naïve personOutsider” /Naïve person 6-10 optimal number6-10 optimal number

Step 1

Select a high risk process

and assemble the team

Step 2

Diagram the Process

Step 3

FMEA Process Steps

Diagram (flow chart) the Diagram (flow chart) the processprocess

Define beginning and end of process under analysis

Chart the process as it is normally done

Using the collective process knowledge of the team, a flow chart is sketched.

Why diagram the process?Why diagram the process?

Diagrams clarify things between membersDiagrams clarify things between members

Narrows the topic – goes from broad topic Narrows the topic – goes from broad topic e.g. narcotic use process to narrow topic e.g. narcotic use process to narrow topic e.g. morphine removed from narcotic e.g. morphine removed from narcotic drawerdrawer

Narcotic Drug Use ProcessNumber Basic Steps

Receive drugs from Pharmacy vendor

Administer drug to patient

Document drug administration and

record waste

Remove from stock one dose at a time as patients request

medication

Dispense to patient care area

Check drugs into pharmacy

1 2 3

4 5 6

Narcotic Drug Use ProcessSelect One Portion of

Process at a Time to Diagram

Receive drugs from Pharmacy vendor

Administer drug to patient

Document drug administration and

record waste

Remove from stock one dose at a time as patients request

medication

Dispense to patient care area

Check drugs into pharmacy

1 2 3

4 5 6

Narcotic Drug Use ProcessDiagram the Sub-Process Steps

Receive request from Patient Care

Area

Technician assembles drug(s)

Technician hand carries to the

Patient Care Area

Pharmacist checks drug against

request

Narcotic and request set out to

be checked

Technician pulls drug from Narcotic

vault / cabinet

Step 1

Select a high risk process

and assemble the team

Step 2

Diagram the Process

Step 3

Brainstorm

potential

failure modes

FMEA Process Steps

Brainstorm potential failure Brainstorm potential failure modes modes

1. People

2. Materials

3. Equipment

4. Methods

5. Environment

Failure modes answer the WHAT could go wrong question

Handy HintsHandy Hints

Failure Modes are the WHATs that could Failure Modes are the WHATs that could go wronggo wrong

Failure Mode Causes are the “WHY”sFailure Mode Causes are the “WHY”s May be more than one cause for each May be more than one cause for each

failurefailure

Narcotic Drug Use ProcessPotential Failure Modes

Receive request from Patient Care Area

Technician assembles

drug(s)

Technician hand carries to the Patient Care

Area

Pharmacist checks drug

against request

Narcotic and request set out to

be checked

Technician pulls drug from

Narcotic vault / cabinet

3A 3B 3C 3D 3E 3F

Request never received

Pharmacy is closed

Request is blank

Potential Failure ModesProcess Steps

Technician doesn’t pull drug

Technician pulls wrong quantity

Technician forgets to set out on counter

Drug diverted while sitting out on counter

Drug slips off the counter or falls through crack

Pharmacist doesn’t check

Pharmacist checks only part of request

Pharmacist checks inaccurately

Technician grabs partial

Technician grabs order for closed unit

Technician mixes up drugs and requests

Technician drops drug or request

Technician hijacked on way to patient care area

Technician mixes up drugs and requests

Technician pulls wrong drug

1 1 1 1 11

2 2 2 2 2 2

333333

Step 1

Select a high risk process

and assemble the team

Step 2

Diagram the Process

Step 3

Failure

Modes

FMEA Process Steps

Step 4

EffectsAnd

Causes

IdentifyIdentify

Effects of the Failure ModesEffects of the Failure Modes

Review each failure mode and identify the Review each failure mode and identify the effects of the failure should it occureffects of the failure should it occur

May be 1 effect or > 1May be 1 effect or > 1

Must be thorough because it feeds into the Must be thorough because it feeds into the risk ratingrisk rating

IfIf failure occurs, failure occurs, then whatthen what are the are the consequencesconsequences

Identify root causes of Identify root causes of failure modesfailure modes

Focus on systems & Focus on systems & processes, not individualsprocesses, not individuals

Asks why?, not who?Asks why?, not who?

Prospective application of Prospective application of RCARCA

Critical to identify Critical to identify allall root root causes and their causes and their interactionsinteractions

Single Point WeaknessSingle Point Weakness

• A step so critical that its failure will result in a A step so critical that its failure will result in a system failure or adverse eventsystem failure or adverse event

• Single point weaknesses and existing control Single point weaknesses and existing control measures “modify” the scoringmeasures “modify” the scoring Single point weaknesses should all be acted uponSingle point weaknesses should all be acted upon IF effective control measures are in place, it would IF effective control measures are in place, it would

cancel the need to take further action (risk is cancel the need to take further action (risk is mitigated)mitigated)

Step 1

Select a high risk

process and assemble the team

Step 2

Diagram the

Process

Step 3

Brainstorm potential failure

modes and determine

their effects

FMEA Process Steps

Step 4

Identify causes of

failure modes

Step 5

Prioritize Failure Modes

Prioritize failure modesPrioritize failure modes

Score severity of effect of failure modeScore severity of effect of failure mode

Score frequency of occurrence of failure Score frequency of occurrence of failure modemode

Score likelihood of detection Score likelihood of detection (detectability) of failure prior to the (detectability) of failure prior to the impact of the effect being realizedimpact of the effect being realized

SeveritySeverity

The seriousness and severity of the effect (to the The seriousness and severity of the effect (to the process or system or patient) of a failure if it should process or system or patient) of a failure if it should

occur.occur.

Score based upon a “reasonable worst case scenario”Score based upon a “reasonable worst case scenario”

Severity Description ScoreNo effect 1

Slight 2Moderate 3

Major 4Severe / Catastrophic 5

FrequencyFrequency Also known as occurrence – it is the Also known as occurrence – it is the

likelihood or number of times a specific likelihood or number of times a specific failure (mode) could occurfailure (mode) could occur

Frequency Description ScoreYearly 1

Monthly 2Weekly 3Daily 4

Hourly 5

DetectabilityDetectabilityThe likelihood of detecting a failure or the effect The likelihood of detecting a failure or the effect

of a failure BEFORE it occursof a failure BEFORE it occurs

Many events are detectable or obvious after Many events are detectable or obvious after they occur but that is not a FMEA detectable event they occur but that is not a FMEA detectable event

by definition.by definition.

Detectability Description ScoreAlways 1Likely 2

Unlikely 3Never 4

Examples of DetectabilityExamples of Detectability

Break away locksBreak away locks Emergency drug boxes with pop up pinEmergency drug boxes with pop up pin Ampoules Ampoules Low battery alarmLow battery alarm

Calculate the Risk Priority NumberCalculate the Risk Priority Number

Determine the impact of the failure on the patient or Determine the impact of the failure on the patient or the system using the severity, frequency and the system using the severity, frequency and detectability parametersdetectability parameters

Multiply three scores to obtain a Risk Priority Number Multiply three scores to obtain a Risk Priority Number (RPN) or Criticality Index (CI)(RPN) or Criticality Index (CI)

Also assign priority to those with a high severity score Also assign priority to those with a high severity score even though the RPN may be relatively loweven though the RPN may be relatively low

RPN = Severity x Occurrence x Detection

Step 1

Select a high risk

process and assemble the team

Step 2

Diagram the

Process

Step 3

Brainstorm potential failure

modes and determine

their effects

FMEA Process Steps

Step 4

Identify causes of

failure modes

Step 5

Prioritize Failure Modes

Step 6

Redesign the

Process

Redesign the processRedesign the process

Apply strategies to decrease Apply strategies to decrease occurrence, decrease occurrence, decrease severity, or increase severity, or increase detectiondetection

Goal:Goal: prevent harm to the prevent harm to the patientpatient

Simplification, automation, Simplification, automation, standardization, fail-safe standardization, fail-safe mechanisms, forcing mechanisms, forcing functions, redundancyfunctions, redundancy

Evaluating Redesign Evaluating Redesign Options Options

Don’t just pick training and policy development. Don’t just pick training and policy development. They are basic actions but not very strong or They are basic actions but not very strong or long lastinglong lasting

Go for the permanent fixes when possibleGo for the permanent fixes when possible

Elimination of the step or the function is a very Elimination of the step or the function is a very strong actionstrong action

Most actions are really controls on the systemMost actions are really controls on the system

Sometimes your team might have to accept Sometimes your team might have to accept some of the failure modes as “un-fixable”some of the failure modes as “un-fixable”

Rank Order of Error Reduction Rank Order of Error Reduction Strategies Strategies

1.1. Forcing functions and constraintsForcing functions and constraints

2.2. Automation and computerizationAutomation and computerization

3.3. Simplify, standardize and differentiateSimplify, standardize and differentiate

4.4. Reminders, check lists and double check Reminders, check lists and double check systemssystems

5.5. Rules and policiesRules and policies

6.6. EducationEducation

7.7. InformationInformation

8.8. Punishment (no value)Punishment (no value)

Step 1

Select a high risk

process and assemble the team

Step 2

Diagram the

Process

Step 3

Brainstorm potential failure

modes and determine

their effects

FMEA Process Steps

Step 4

Identify causes of

failure modes

Step 5

Prioritize Failure Modes

Step 6

Redesign the

Process

Step 7

Analyze and Test the Changes

Analyze and test the Analyze and test the changeschanges

Conduct FMEA of re-Conduct FMEA of re-designed processdesigned process

Use simulation testing Use simulation testing whenever possiblewhenever possible

Conduct pilot testing Conduct pilot testing in one area or one in one area or one sectionsection

Step 1

Select a High Risk

Process and Assemble a

Team

Step 2

Diagram the

Process

Step 3

Brainstorm Potential Failure

Modes and Determine

Their Effects

FMEA Process Steps

Step 4

Identify Causes of

Failure Modes

Step 5

Prioritize Failure Modes

Step 6

Redesign the

Process

Step 7

Analyze and Test the Changes

Step 8

Implement and

Monitor the Redesigned Processes

Implement and monitor the Implement and monitor the redesigned processredesigned process

Communicate Communicate reasons for process reasons for process changeschanges

Find change agentsFind change agents Define process and Define process and

outcome measuresoutcome measures Share resultsShare results Monitor over timeMonitor over time

Gains using FMEAGains using FMEA

Safety minded culture Safety minded culture Proactive problem resolutionProactive problem resolution Robust systems Robust systems Fault tolerant systemsFault tolerant systems Lower waste and higher qualityLower waste and higher quality

‘‘Emphasis on prevention Emphasis on prevention may reduce risk of may reduce risk of

harm to both patients harm to both patients and staff.’and staff.’

Failure Modes and Effects Analysis (FMEA), IHI and Quality Health Failure Modes and Effects Analysis (FMEA), IHI and Quality Health Care.org, 2003Care.org, 2003

ReferencesReferences

McDermott- The Basics of FMEAMcDermott- The Basics of FMEA

Stamatis – Failure Mode Effect Analysis: FMEA Stamatis – Failure Mode Effect Analysis: FMEA from Theory to Execution (2from Theory to Execution (2ndnd ed) ed)

JCAHO – Failure Mode and Effects Analysis in JCAHO – Failure Mode and Effects Analysis in Health Care. Proactive Risk ReductionHealth Care. Proactive Risk Reduction

Manasse, Thompson (Lin, Burkhardt) -Logical Manasse, Thompson (Lin, Burkhardt) -Logical Application of Human Factors In Process and Application of Human Factors In Process and Equipment Design (in press).Equipment Design (in press).