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Potential Failure and RCA
Helene Eckrich & Leon Spackman
Potential Failure and Root Cause Analysis:Key Tools to Identify Potential Failures andSolve Problems to Attain High Reliability
Workshop B // March 6, 2014 // 8:15am-noon
Attaining High Reliability and Safety for Patients –
Collaborating for Change. Patient Safety Collective of the
Southwest (PSCS). March 6-7, 2014; Albuquerque, NM
CE Disclosure
In compliance with the ACCME/NMMS Standards for Commercial
Support of CME:
Helene Eckrich, RN, MSN
Leon Spackman, MS
have been asked to advise the audience that each has no relevantfinancial relationships to disclose or does have relevant financial
relationships to disclose which they will disclose here.
Attaining High Reliability and Safety for Patients –
Collaborating for Change. Patient Safety Collective of the
Southwest (PSCS). March 6-7, 2014; Albuquerque, NM
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Key Tools to Identify Potential Failures and SolveProblems to Attain High Reliability
Patient Safety Conference March 2014*
Potential Failure and Root Cause Analysis
Leon SpackmanPMP, LSS Master Black
BeltManager, PMOTriCore ReferenceLaboratories
Helene
EckrichRN, MSN
Agenda
*
● Introductions
● What is FMEA?
➢When do you use it?
➢How to use a FMEA worksheet?
➢How do you interpret a FMEA?
➢Pareto Charts--show results
● Root Cause Analysis
➢Develop a Fishbone Diagram
● Summary
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FMEA vs Root Cause Analysis
● FMEA will address risks that have not yet happened
➢Identify potential events that may happen in thefuture
➢Identify the effect
➢Prioritize
● Root Cause Analysis will identify the Root Cause ofan event that has already occurred
➢
Focus on prevention so it doesn’t happen again ➢Find Root Cause(s) not symptoms
3
Risks in Healthcare
● Medication Errors
● Hospital Infections
● Surgical Errors➢Wrong patient, wrong site, wrong procedure
➢Retention of foreign bodies
●Delay in Treatment●Safety Issues (slips, trips, falls)
Costs: $20 Billion - $1 Trillion
Source: The Joint Commission 4
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What is FMEA?
*
FMEA--a tool to identify risks in your process● Can be used in multiple places in process
improvement➢Determine where problems are➢Help identify cause/effect relationships➢Highlight risks in solutions and actions to take
● Starts with input from processes
● Identifies three risk categories➢Severity of impact➢Probability of occurrence➢ Ability to detect the occurrence
Patient Safety Conference March 20145
When to Use
*
● Early stages (Define) to understand processand identify problem areas
● Analyze data (Analyze) to help identify rootcauses
● Determine best solutions (Improve) withlowest risk
● Close out stage (Control) to documentimprovement and identify actions needed tocontinue to reduce risk
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FMEA Worksheet
*
Process or Product
Name
Prepared by: Page _____ of ______
Person Responsible Date (Orig) ___________ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure Effect
Sev Potential Causes Oc
c
Current Controls Det RP
N
Actions
Recommended
Sev Oc
c
Det RP
N
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
Patient Safety Conference March 20147
How To Complete the FMEA
General Suggestions
● Use large white board or flip chart with aFMEA form drawn on it during the generationphase
● Focus the team on the specific area of study(product or process)
● Have process map available
● Have all subassemblies and component partof a product
* Patient Safety Conference March 20148
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Process Mapping
● Before we can identify risk (FMEA)or Root Causes, we must understandand define our process
● Mapping provides a clear, visual wayto examine processes
● Helps identify redundancies, waste,
and weaknesses
9
Why Map Processes?
The way it really functions.
What the customer expects, and is willing to pay for.
The way you think it is.
10
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Process Symbols
Boundary
Task
Decision
EmbeddedProcess
ReferenceDocument
MultipleDocuments
Connector
DataBase
11
Putting It All Together
N o
Yes
DataBase
12
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Process to Change Oil in a Car
*
5000miles
driven
Drive caron lift
Fill withnew oil
Drain Oil ReplaceFilter
Take Caroff lift
ProcessComplete
Patient Safety Conference March 2014
Select Oil
GetCorrect
Oil
Wrong
13
How to Complete the FMEA
*
Step 1. Complete header information
Step 2. Identify steps in the process
Step 3. Brainstorm potential ways the area ofstudy could
theoretically fail (failure modes)
Patient Safety Conference March 201414
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FMEA Worksheet
*
Process or ProductName Change Oil in Car Prepared by: Leon Page _1____ of __1____
Person Responsible Leon Mechanic Date (Orig) __6 March 2014 __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure Effect
Sev Potential
Causes
Oc
c
Current Controls Det RP
N
Actions
Recommended
Sev Oc
c
Det RP
N
Fill withnew oil
NewOil—Mechanic
Wrongtype ofoil
Enginewear
No oiladded
EngineFailure
Sev - Severity of the failure (what impact will it have on our process?)Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about itRPN – Risk Priority Number (multiply Sev, Occ, and Det)
Patient Safety Conference March 201415
How to Complete the FMEA
Step 4 ● For each failure mode, determine impact or
effect on the product or operation using criteriatable (next slide)
● Rate this impact in the column labeled SEV
(severity)
* Patient Safety Conference March 201416
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Severity (SEV) Rating
SEV Severity Product/Process Criteria
1 None No effect
2 Very Minor Defect would be noticed by most discriminating customers. A portion of the product may have to bereworked on line but out of station
3 Minor Defect would be noticed by average customers. A portion of the product (
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How to Complete the FMEA
Step 5
● For each potential failure mode identify one ormore potential causes
● Rate the probability of each potential causeoccurring based on criteria table (next slide)
● Place the rating in the column labeled OCC(occurrence).
* Patient Safety Conference March 201419
FMEA Occurrence (OCC Rating)
OCC Occurrence Criteria
1 Remote 1 in 1,500,000 Very unlikely to occur
2 Low 1 in 150,000
3 Low 1 in 15,000 Unlikely to occur
4 Moderate 1 in 2,000
5 Moderate 1 in 400 Moderate chance to occur
6 Moderate 1 in 80
7 High 1 in 20 High probability that the event will occur
8 High 1 in 8
9 Very High 1 in 3 Almost certain to occur
10 Very High > 1 in 2
* Patient Safety Conference March 2014 20
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FMEA Worksheet
*
Process or Product
Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person Responsible Leon Mechanic Date (Orig) __6 March 2014___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure Effect
Sev Potential
Causes
Oc
c
Current Controls Det RP
N
Actions
Recommended
Sev Oc
c
Det RP
N
Fill withnew oil
NewOil—Mechanic
Wrongtype ofoil
Enginewear
2 Mis-labeled 3
No oil
added
Engine
Failure
10 Hurrying 3
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
Patient Safety Conference March 2014 21
How to Complete the FMEA
Step 6
● Identify current controls or detection
● Rate ability of each current control to prevent or
detect the failure mode once it occurs usingcriteria table (next slide)
● Place rating in DET column
* Patient Safety Conference March 201422
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FMEA Detection (DET) Rating
DET Detection Criteria
1 AlmostCertain
Current Controls are almost certain to detect/prevent the failure mode
2 Very High Very high likelihood that current controls will detect/prevent the failuremode
3 High High Likelihood that current controls will detect/prevent the failure mode
4 Mod. High Moderately High likelihood that current controls will detect/prevent thefailure mode
5 Moderate High Likelihood that current controls will detect/prevent the failure mode
6 Low Low likelihood that current controls will detect/prevent failure mode
7 Very Low Very Low likelihood that current controls will detect /prevent the failure
mode8 Remote Remote likelihood that current controls will detect/prevent the failure mode
9 Very Remote Very remote likelihood that current controls will detect/prevent the failuremode
*Patient Safety Conference March 2014 23
FMEA Worksheet
*
Process or Product
Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person Responsible Leon Mechanic Date (Orig) __6 March 2014___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
Potential Causes Oc
c
Current Controls DetRPN Actions
Recommended
Sev Oc
c
Det RP
N
Fill with
new oil
New Oil
fromsupplier
Wrong type
of oil
Engine wear 2 Misread oil chart
for vehicle
3 None 9
No oiladded
EngineFailure
10 Hurrying 3 Engine light 3
Sev - Severity of the failure (what impact will it have on our process?)Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
Patient Safety Conference March 2014 24
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How to Complete the FMEA
Step 7 Multiply SEV, OCC and DET ratings and place the value in the RPN(risk priority number) column. The largest RPN numbers should getthe greatest focus. For those RPN numbers which warrantcorrective action, recommended actions and the person responsiblefor implementation should be listed.
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
Sev Potential
Causes
Occ Current
Controls
Det RPN Actions
Recommended
Sev Occ Det RPN
Fill withnew oil
New Oilfromsupplier
Wrong typeof oil
Enginewear
2 Misread oilchart forvehicle
3 None 9 54
No oiladded
EngineFailure
10 Hurrying 3 Engine light 3 90
*
SEV * OCC * DET = RPN ( 2 * 3 * 9 = 54 )
Patient Safety Conference March 201425
FMEA Rankings
Severity Occurrence Detection
Hazardous withoutwarning
Very high and almostinevitable
Cannot detect ordetection with verylow probability
Loss of primaryfunction
High repeated failures Remote or lowchance of detection
Loss of secondary
function
Moderate failures Low detection
probability
Minor defect Occasional failures Moderate detectionprobability
No effect Failure Unlikely Almost certaindetection
*
Rating
10
1
High
LowSource: The Black Belt Memory Jogger, Six Sigma Academy
Patient Safety Conference March 201426
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Action Results
*
Step 8
● After corrective action has been taken, placesummary of the results in the ‘Actions
Recommended’ block
● Assign new value for:➢Severity
➢Occurrence
➢
Detection● Calculate new RPN number
Patient Safety Conference March 201427
FMEA Worksheet
*
Process or Product
Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person Responsible Leon Mechanic Date (Orig) __6 March 2014___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure Effect
Sev Potential
Causes
Oc
c
Current Controls DetRPN Actions
Recommended
Sev Occ Det RP
N
Fill with
new oil
New Oil
fromsupplier
Wrong type
of oil
Engine wear 2 Misread oil
chart for vehicle
3 None 9 54
No oiladded
EngineFailure
10 Hurrying 3 Engine light 3 90 Oil level checkedby partner
10 3 1 30
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
Patient Safety Conference March 2014 28
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FMEA Example
*
Process or Product Name: Emergency Room Visit (Heart) Prepared by: Page _____ of ______
Person Responsible: Helene Quality Date (Orig) ___________ Revised __________
Process Step Key
Process
Input
Potential Failure
Mode
Potential
Failure Effect
S
e
v
Potential Causes Occ Current
Controls
D
e
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
et
RPN
Intake Desk Triage Wrong
Assessment
Wait too long
and have
cardiac arrest
10 Did not recognize
heart attack
symptoms —
unusual
symptoms
2 None 9 180
Diagnosis Triage
nurse
report
Waiting for tests
(Labor EKG)
Cardiac
Arrest
10 Understaffed 4 Staffing
patterns
2 80
Treat-ment Testing Inconclusive
Test Results
Send home
instead of
admit —
Cardiac
Arrest
10 Read wrong
patient test
results
2 When
medical staff
saw correctpatient name
and ID
2 40
Patient Safety Conference March 201429
Pareto Chart
*
● Sorted Bar Chart with the bars arranged indescending order from left to right
● Useful in taking a spreadsheet of data andshowing which category stands out from therest.
● Identify where the biggest “pain” occurs in
process● Help determine where to focus our efforts● Based on 80/20 rule
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Pareto Chart—Example
* Patient Safety Conference March 2014
RPNNumber
31
Pareto Chart Hints
● List categories in descending order on horizontalline & frequencies on vertical line
● Look for the 80/20 breakpoint
● Break down tall pole into another Pareto Chart forfurther analysis
● Involve customer/sponsor in selecting area tofocus on
* Patient Safety Conference March 201432
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Group Exercise #1
*
● Build a FMEA to identify problem areas to beaddressed in your process (Breast Surgery)
➢Identify process step(s) to analyze
➢Brainstorm for possible failure modes, effects,causes and detection controls
➢Rate severity, occurrence, and detection
➢ Analyze results with a Pareto Chart
● Report to the group
Patient Safety Conference March 201433
Out Patient Breast Surgery
*
Patien
t
Arrive
s
Holding
Area
(Prep
Patient)
Anesthesia
Operating
Room
PACU
Out Patient
SurgeryUnit
and
Discharge
Go Home
Patient Safety Conference March 201434
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Summary
*
● FMEA identifies risk in our processes➢Impact/Severity
➢Probability of Occurrence
➢Detection
● Helps identify what can go wrong and whatwe should fix
● Can be used in multiple stages of processimprovement
● Pareto Chart—Measures pain in the process
Patient Safety Conference March 201435
Root Cause Analysis
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Overview
● What is a root causeanalysis?
● Why is it important?● How do you do it?● Summary
37
What is Root Cause Analysis
● Event has occurred and we don’t want it tohappen again.
● Practice to solve problems by attempting toidentify and correct the root causes of events,as opposed to simply addressing theirsymptoms.
● Studying the process, analyzing all data, andfinding the real reason for the failure/event
Source: Wikipedia
38
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What is Root Cause Analysis
● Aiming corrective measures at root cause ismore effective than merely treating thesymptoms of a problem
● Must be performed systematically, andconclusions must be backed up by evidence
● There is usually more than one root cause forany given problem
39
Why Root Cause Analysis
● Solves the problem once and for all at theplace that it occurs
● Focuses on prevention, not detection
● Reduces waste
● Frees personnel to do their jobs--not chasesymptoms
40
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● Solving symptoms not root cause
● Emphasis on action vs. solving problems
● Temporary solutions or symptoms can causemany more problems & create waste if theybecome the “preferred solution”
Band-Aid Fixes
41
● Temporary solutions are OK—But youmust document them to ensure they arereplaced with lasting preventative solutions
● If you continue using band aid fixes, youcould have a process like this……
Band Aid Fixes
42
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Root Cause Analysis
• Understand the process – map it
• Gather data
• Identify possible root causes (the vitalfew)
• Tool—Fishbone Diagram• Validate Fishbone Diagram with
data/knowledge• Identify solutions based on root
causes
44
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Gather Data
● Collect data about the event that hasoccurred
● Analyze the data
● Identify key measures in process➢How often has event occurred?
➢What is effect of problem?
45
Brainstorming Definition
●Brainstorming is a grouptechnique for generatinga large quantity of ideasabout a specific topic in
a relatively short periodof time.
46
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Brainstorming
● Get as many ideas as you can
● Organize using tools (Pareto Chart)
● Don’t jump to problem solving until you
have identified the root cause
47
● Call out ideas and collect on flip charts➢Round robin, pass if no idea
➢ Anonymously writes on stickies
➢Record every idea in the speaker’s words
● Don’t criticize until after ideas are generated
● Fast pace--fosters high energy and anythinggoes atmosphere
● Go for Quantity
● Don’t quit at the first pass; pause; and press
on
Brainstorming
48
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“The best way to get a good idea is to get
a lot of ideas.”
-- Linus Pauling
Brainstorming
49
MEASUREMENTS METHODS PEOPLE
ENVIRONMENT TOOLS MATERIALS
(problem to be
analyzed goeshere)
Fishbone
Diagram
Ask “why” each of these
categories affects the problem
When you record a cause, ask
“why” again to identify any sub
causes
50
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MEASUREMENTS METHODS PEOPLE
ENVIRONMENT TOOLS MATERIALS
(problem to be
analyzed goes
here)
Fishbone
Diagram
Causes here
Causes here
Sub causes here
51
Group Activity #2
● Build a Fishbone Diagram based onpatient scenario
● Use markers and paper on table
● Determine the root causes for Heparin
Overdose● Report Out from each group
52
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Report Out
● Each group reports outs
● Please be courteous while othersreporting out
53
Solve the Root Cause
● Verify the root cause
● Brainstorm for solutions to problem
● Select “best” solution(s)
● Implement and measure to ensure
improvement● Monitor and control➢Policies and Procedures
➢ Audits
➢Scorecards
54
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Summary: Root Cause Analysis
● What: Studying the process, analyzing all data,and identify the real reason for the failure/event
● Why do RCA:
➢We often focus on symptoms
➢Need to solve the problem once and for all
➢Gets rid of waste
➢Focuses on prevention not detection
➢Frees up personnel to focus on important tasks
56
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Summary
● FMEA➢Identify Risk
➢Prioritize what has the most effect
● Root Cause➢Prevent an event from happening again
➢Find the Root Cause not a symptom
● Continuous Improvement
57
Continuous Improvement
*
● Process improvement not a linear process
● Never really ends
● Journey not a destination
Define
Measure
AnalyzeImprove
Control
Patient Safety Conference March 201458
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Challenge
*
“We are what we repeatedly d o .
Excellence, therefore, is not an
act but a habit.”
-- Aristotle
Patient Safety Conference March 201459
Questions?
Helene Eckrich RN, MSN Leon Spackman
Manager, PMO
TriCore Reference [email protected] (505) 938-8348 (Work)(505) 999-8982 (Cell)
Attaining High Reliability and Safety for Patients –
Collaborating for Change. Patient Safety Collective of the
Southwest (PSCS). March 6-7, 2014; Albuquerque, NM
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