Potential Failure and RCA - Welcome to …healthinsight.org/documents/nm/sw_patient_safety/March6...7/2/2014 1 Potential Failure and RCA Helene Eckrich & Leon Spackman Potential Failure

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Potential Failure and RCA

Helene Eckrich & Leon Spackman

Potential Failure and Root Cause Analysis: Key Tools to Identify Potential Failures and Solve 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 relevant

financial relationships to disclose or does have relevant financial

relationships to disclose which they will disclose here.




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Key Tools to Identify Potential Failures and Solve

Problems to Attain High Reliability

Patient Safety Conference March 2014 *

Potential Failure and Root Cause

Analysis

Leon Spackman

PMP, LSS Master Black

Belt

Manager, PMO

TriCore Reference

Laboratories

Helene

Eckrich

RN, 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

Patient Safety Conference March 2014

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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 the

future

➢Identify the effect

➢Prioritize

● Root Cause Analysis will identify the Root Cause of

an 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 2014 5

When to Use

*

● Early stages (Define) to understand process and identify problem areas

● Analyze data (Analyze) to help identify root causes

● Determine best solutions (Improve) with lowest risk

● Close out stage (Control) to document improvement and identify actions needed to continue 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)


How To Complete the FMEA

General Suggestions

● Use large white board or flip chart with a

FMEA form drawn on it during the generation

phase

● Focus the team on the specific area of study

(product or process)

● Have process map available

● Have all subassemblies and component part

of a product

* Patient Safety Conference March 2014 8

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Process Mapping

● Before we can identify risk (FMEA)

or Root Causes, we must understand

and define our process

● Mapping provides a clear, visual way

to 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.

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Process Symbols

Boundary

Task

Decision

Embedded Process

Reference Document

Multiple Documents

Connector

Data Base

1

1

Putting It All Together

No

Yes

Data

Base

12

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Process to Change Oil in a Car

*

5000

miles

driven

Drive car

on lift

Fill with

new oil

Drain Oil Replace

Filter

Take Car

off lift Process

Complete

Patient Safety Conference March 2014

Sele

ct Oil

Get

Correct

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 of

study could

theoretically fail (failure modes)


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FMEA Worksheet

*

Process or Product

Name

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


N

Actions

Recommended

Sev Oc

c

Det RP

N

Fill with new oil

New Oil—Mechanic

Wrong type of oil

Engine wear

No oil added

Engine Failure







Step 4

● For each failure mode, determine impact or

effect on the product or operation using criteria

table (next slide)

● Rate this impact in the column labeled SEV

(severity)


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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 be reworked on line but out of station

3 Minor Defect would be noticed by average customers. A portion of the product (<100%) may have to be reworked on line but out of station

4 Very Low Defect would be noticed by most customers. 100% of the product may have to be sorted and a portion (<100%) reworked

5 Low Comfort/convenience item(s) would be operable at a reduced level of performance. 100% of the product may have to be reworked

6 Moderate Comfort/convenience item(s) would be inoperable. A portion (<100%) of the product may have to be scrapped

7 High Product would be operable with reduced primary function. Product may have to be sorted and a portion (<100%) scrapped.

8 Very High Product would experience complete loss of primary function. 100% of the product may have to be scrapped

9 Hazardous Warning

Failure would endanger machine or operator with a warning

10 Hazardous w/out Warning

Failure would endanger machine or operator without a warning


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


N

Actions

Recommended

Sev Oc

c

Det RP

N

Fill with new oil

New Oil—Mechanic

Wrong type of oil

Engine wear

2

No oil added

Engine Failure

10






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Step 5

● For each potential failure mode identify one or

more potential causes

● Rate the probability of each potential cause

occurring based on criteria table (next slide)

● Place the rating in the column labeled OCC

(occurrence).


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


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FMEA Worksheet

*

Process or Product

Name



Process

Step

Key

Process

Input

Potential

Failure

Mode

Potential

Failure Effect

Sev Potential

Causes

Oc

c


N

Actions

Recommended

Sev Oc

c

Det RP

N

Fill with new oil

New Oil—Mechanic

Wrong type of oil

Engine wear

2 Mis-labeled 3

No oil added

Engine Failure

10 Hurrying 3







Step 6

● Identify current controls or detection

● Rate ability of each current control to prevent or

detect the failure mode once it occurs using

criteria table (next slide)

● Place rating in DET column

* Patient Safety Conference March 2014

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FMEA Detection (DET) Rating

DET Detection Criteria

1 Almost Certain

Current Controls are almost certain to detect/prevent the failure mode

2 Very High Very high likelihood that current controls will detect/prevent the failure mode

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 the failure 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 mode

8 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 failure mode


FMEA Worksheet

*

Process or Product

Name



Process

Step

Key

Process

Input

Potential

Failure

Mode

Potential

Failure

Effect

S

e

v

Potential Causes Oc

c

Current Controls Det RPN Actions

Recommended

Sev Oc

c

Det RP

N

Fill with new oil

New Oil from supplier

Wrong type of oil

Engine wear 2 Misread oil chart for vehicle

3 None 9

No oil added

Engine Failure

10 Hurrying 3 Engine light 3






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Step 7 Multiply SEV, OCC and DET ratings and place the value in the RPN (risk priority number) column. The largest RPN numbers should get the greatest focus. For those RPN numbers which warrant corrective action, recommended actions and the person responsible for 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 with new oil


Wrong type of oil

Engine wear

2 Misread oil chart for vehicle

3 None 9 54

No oil added

Engine Failure

10 Hurrying 3 Engine light 3 90

*

SEV * OCC * DET = RPN ( 2 * 3 * 9 = 54 )


FMEA Rankings

Severity Occurrence Detection

Hazardous without warning

Very high and almost inevitable

Cannot detect or detection with very low probability

Loss of primary function

High repeated failures Remote or low chance of detection

Loss of secondary function

Moderate failures Low detection probability

Minor defect Occasional failures Moderate detection probability

No effect Failure Unlikely Almost certain detection

*

Rating

10

1

High

Low Source: The Black Belt Memory Jogger, Six Sigma Academy


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Action Results

*

Step 8

● After corrective action has been taken, place

summary of the results in the ‘Actions

Recommended’ block

● Assign new value for: ➢Severity

➢Occurrence

➢Detection

● Calculate new RPN number


FMEA Worksheet

*

Process or Product

Name



Process

Step

Key

Process

Input

Potential

Failure

Mode

Potential

Failure Effect

Sev Potential

Causes

Oc

c

Current Controls Det RPN Actions

Recommended

Sev Occ Det RP

N

Fill with new oil


Wrong type of oil

Engine wear 2 Misread oil chart for vehicle

3 None 9 54

No oil added

Engine Failure

10 Hurrying 3 Engine light 3 90 Oil level checked by partner

10 3 1 30






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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

t

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 correct

patient name

and ID

2 40


Pareto Chart

*

● Sorted Bar Chart with the bars arranged in descending order from left to right

● Useful in taking a spreadsheet of data and showing which category stands out from the rest.

● 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

R

P

N

Nu

m

be

r

31

Pareto Chart Hints

● List categories in descending order on horizontal

line & frequencies on vertical line

● Look for the 80/20 breakpoint

● Break down tall pole into another Pareto Chart for

further analysis

● Involve customer/sponsor in selecting area to

focus on


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Group Exercise #1

*

● Build a FMEA to identify problem areas to be

addressed 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


Out Patient Breast Surgery

*

Patien

t

Arrive

s

Holding

Area

(Prep

Patient)

Anesthesia

Operating

Room

PAC

U

Out Patient

Surgery

Unit

and

Discharge

Go Home


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Summary

*

● FMEA identifies risk in our processes ➢Impact/Severity

➢Probability of Occurrence

➢Detection

● Helps identify what can go wrong and what

we should fix

● Can be used in multiple stages of process

improvement

● Pareto Chart—Measures pain in the process


Root Cause Analysis

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Overview

● What is a root cause analysis?

● 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 to happen again.

● Practice to solve problems by attempting to identify and correct the root causes of events, as opposed to simply addressing their symptoms.

● Studying the process, analyzing all data, and finding 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 is more effective than merely treating the symptoms of a problem

● Must be performed systematically, and conclusions must be backed up by evidence

● There is usually more than one root cause for any given problem

39

Why Root Cause Analysis

● Solves the problem once and for all at the

place that it occurs

● Focuses on prevention, not detection

● Reduces waste

● Frees personnel to do their jobs--not chase

symptoms

40

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● Solving symptoms not root cause

● Emphasis on action vs. solving problems

● Temporary solutions or symptoms can cause

many more problems & create waste if they

become the “preferred solution”

Band-Aid Fixes

41

● Temporary solutions are OK—But you

must document them to ensure they are

replaced with lasting preventative solutions

● If you continue using band aid fixes, you

could 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 vital

few)

• 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 has

occurred

● Analyze the data

● Identify key measures in process

➢How often has event occurred?

➢What is effect of problem?

45

Brainstorming Definition

●Brainstorming is a group

technique for generating

a large quantity of ideas

about a specific topic in

a relatively short period

of 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 anything

goes 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 goes

here)

Fishbone

Diagram

Ask “why” each of these

categories affects the problem

When you record a cause, ask

“why” again to identify any sub

causes

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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 on

patient 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 others

reporting 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

Analyze Improve

Control


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Challenge

*

“We are what we repeatedly do.

Excellence, therefore, is not an

act but a habit.”

-- Aristotle


Questions?

Helene Eckrich RN, MSN Leon Spackman

Manager, PMO TriCore Reference Laboratories [email protected] (505) 938-8348 (Work) (505) 999-8982 (Cell)




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