Root Cause Analysis

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 Disclaimer and Approved use

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 Course Content

 Course Objectives
 What is Root Cause?
 Benefits
 The Problem Solving Process

 Examples and Exercises

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 Course Objectives

Upon completion of this course, participants should be able

to:

 Understand the importance of performing root cause analysis

 Identify the root cause of a problem using the problem solving process
 Understand the application of basic quality tools in the problem solving
process

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 What is a root cause?

ROOT CAUSE =
 The causal or contributing factors that, if corrected, would prevent
recurrence of the identified problem

 The “factor” that caused a a problem or defect and should be permanently

eliminated through process improvement

 The factor that sets in motion the cause and effect chain that creates a
problem

 The “true” reason that contributed to the creation of a problem, defect or

nonconformance

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 What is root cause analysis?

 A standard process of:

 identifying a problem
 containing and analyzing the problem
 defining the root cause
 defining and implementing the actions required to
eliminate the root cause
 validating that the corrective action prevented
recurrence of problem

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 Benefits

By eliminating the root cause…

You save time and money!
 Problems are not repeated
 Reduce rework, retest, re-inspect, poor quality costs, etc…
 Problems are prevented in other areas
 Communication improves between groups and
 Process cycle times improve (no rework loops)
 Secure long term company performance and profits

$$ Less rework = Increased profits! $$

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 Importance of the root cause

Not knowing the root cause can lead to costly band aids.

 The Washington Monument was degrading

Why? Use of harsh chemicals
Why? To clean up after pigeons
Why so many pigeons? They eat spiders and there are a lot of spiders at the
monument
Why so many spiders? They eat gnats and lots of gnats at the monument
Why so many gnats? They are attracted to the light at dusk.
Solution: Turn on the lights at a later time.

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When should root cause analysis
be performed?
When PROBLEMS occur !!

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 How does it differ from what we do
now?

USUAL APPROACH
Firefighting! Problem
Problem
Immediate Containment reoccurs
Identified
Action Implemented elsewhere!

Find
someone to
blame!

PREFERRED APPROACH
Immediate Defined Solutions are
Solutions
Problem Containment Root Cause applied across
validated
Identified Action Analysis company and
with data
Implemented Process never return!

10
 How does it work?

Defect found at “Customer”…

PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

“Customer” can be
Internal or External

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 How does it work?

Contain the problem…

PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Nothing is allowed to further

escape to the customer

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 How does it work?

Contain the root process…

PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Nothing is allowed to further

escape to the next process

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 How does it work?

Prevent the problem…

PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Corrective action implemented

so root cause of problem does
not occur again!

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 But who’s to blame?

 The “no blame” environment is critical

 Most human errors are due to a process error
 A sufficiently robust process can eliminate human errors
 Placing blame does not correct a root cause situation
 Is training appropriate and adequate?

 Is documentation available, correct, and clear?

 Are the right skillsets present?

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 Corrective Actions

3 types of Corrective Action:

 Immediate action

 The action taken to quickly fix the impact of the problem so the “customer” is
not further impacted

 Permanent root cause corrective action

 The action taken to eliminate the error on the affected process or product

 Preventive (Systemic) root cause corrective action

 The action taken to Prevent the error from recurring on any process or product

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 Examples of Corrective Actions

Immediate (step #3)

All current batch of paperwork re-inspected by another
worker for same type of problem
Permanent (step #5)
Form changed to mandate completion of certain fields

Preventive (step #5)

Similar forms with same fields used all over in
company are changed to “mandatory”

If preventive not addressed, problem will return!!

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 Examples of Corrective Actions

Immediate (step #3)

Part removed and replaced in product, retested

Permanent (step #5)

Product redesigned to account for part variability

Preventive (step #5)

Design process changed to require variation
analysis testing on similar supplier parts

If preventive not addressed, problem will return!!

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 The Difference between
Permanent vs. Preventive Corrective Actions
Permanent Preventive
 Trained employee on proper machine use  Made training a requirement to new employees working in that
area

 Changed product design to make parts easier to assemble  Changed design guidelines to not allow for use of part in full
manually scale production


 All documents that are critical to project are identified with red
 Specific customer document critical to project is identified with folders
red folder

 Update all customers with latest software revision to fix problem

 Check for those software bugs added to checklist and
performed prior to release of software

 Fallen patient given full-time assistant to provide help moving

 Process developed to identify “at risk” patients for falls who
around hospital require assistant

 Ethics training developed and provided to all employees
 Employee fired for ethical violation

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 Problem Solving Process

1
Identify
8 Problem 2

Validate Identify
Team
7 3
Problem
Follow Up
Plan Solving Immediate
Action

Process
Complete Root
Plan Cause

Action
6 Plan 4

5
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 Step #1

Identify the Problem

Very important!
 Clearly state the problem the team is to solve
 Teams should refer back to problem statement to avoid getting
off track
 Use 5W2H approach
 Who? What? Why? When? Where? How? How Many?

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 Step #1

5W2H
 Who? Individuals/customers associated with problem
 What? The problem statement or definition
 When? Date and time problem was identified
 Where? Location of complaints (area, facilities, customers)

 Why? Any previously known explanations

 How? How did the problem happen (root cause) and how will the problem
be corrected (corrective action)?
 How Many? Size and frequency of problem

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 Step #2

Identify Team
When a problem cannot be solved quickly by an individual, use a
team!

 Should consist of domain knowledge experts

 Small group of people (4-10) with process and product knowledge,
available time and authority to correct the problem
 Must be empowered to “change the rules”
 Should have a designated Champion
 Membership in team is always changing!

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 Step #2

Key Ideas for Team Success

 Define roles and responsibilities

 Identify external customer needs
 Identify internal customer needs
 Appropriate levels of organization present
 Clearly defined objectives and outputs
 Solicit input from everyone!
 Good meeting location
 near work area for easy access to info
 quiet for concentration and avoiding distractions

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 Step #2

Roles and Responsibilities

 Champion: Mentor, guide and direct teams, advocate to upper

management
 Leader: day-to-day authority, calls meetings, facilitation of team, reports
to Champion
 Record Keeper: Writes and publishes minutes
 Participants: Respect all ideas, keep an open mind, know their role
within team

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 Step #3

Immediate Action

 Must isolate effects of problem from customer

 Usually “Band-aid” fixes
 100% sorting of parts

 Re-inspection before shipping

 Rework

 Recall parts/documents from customer or from storage

 Only temporary until corrective action is implemented (very costly, but

necessary)
 Must also verify that immediate action is effective

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 Step #3

Verify Immediate Action

 Immediate action = activity implemented to screen, detect and/or

contain the problem

 Must verify that immediate action was effective
 Run Pilot Tests
 Make sure another problem does not arise from the temporary
solutions

 Ensure effective screens and detections are in place to prevent further

impact to customer until permanent solution is implemented.

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 Step #4

Root Cause

 Brainstorm possible causes of problem with team

 Organize causes with Cause and Effect Diagram
 “Pareto” the causes to identify those most likely or occurring most often
 Use 5 Why? method to further define the root cause of symptoms
 May involve additional research/analysis/investigation to get to each
“Why?”
 Must identify the process that caused the problem
 if root cause is company-wide, elevate these process issues (outside of
team control) to upper management to address

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 Step #4

Tools
 brainstorming  5 Why
 flowcharting  failure mode, effect & criticality
 cause & effect diagrams analysis
 pareto charts  fault tree analysis
 barrier analysis
 change analysis

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 Step #4

5 Why’s

 Ask “Why?” five times

 Stop when the corrective actions do not change
 Stop when the answers become less important
 Stop when the root cause condition is isolated

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 What is a Cause-Effect Diagram?

 A Cause-Effect (also called “Ishikawa” or “Fishbone”) Diagram is a

Data Analysis/Process Management Tool used to:

 Organize and sort ideas about causes contributing to a

particular problem or issue
 Gather and group ideas
 Encourage creativity
 Breakdown communication barriers
 Encourage “ownership” of ideas
 Overcome infighting

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 Cause-Effect Diagram

 A Cause-Effect Diagram is typically generated in a group

meeting
 It is a graphical method for presenting and sorting ideas
about the causes of issues or problems

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 Cause-Effect Diagram

 Steps used to create a Cause-Effect Diagram:

 Define the issue or problem clearly
 Decide on the root causes of the observed issue or problem
 Brainstorm each of the cause categories
 Write ideas on the cause-effect diagram. A generic example is shown
below:

Materials Methods

Environment Effect
Equipment People

NOTE: Causes are not limited to the 5 listed categories, but serve as a starting point

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 Cause-Effect Diagram

 Allow team members to specify where ideas fit into the diagram
 Clarify the meaning of each idea using the group to refine the ideas. For
example:

Materials Methods

Incorrect Quantity Late Dispatch

Spillage
Incorrect BOL Shipping Delay
Wrong Destination

Traffic Delays

Shipping
Environment
Wrong Equipment
Problems
Weather Driver
Dispatcher Attitude
Breakdown Dirty Equipment Wrong Directions

Equipment People

© 2004 Superfactory™. 34
All Rights Reserved.
 Cause-Effect Diagram

 After completing the Cause-Effect Diagram, take the following

actions:
 Rank the ideas from the most likely to the least likely cause cause
of the problem or issue
 Develop action plans for identifying the essential data, resources
and tools

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 Expected Outcome

• Individuals have become part of a problem solving team

 The sources of problems and other issues have been identified using
a systematic process
 Team members see issues from a similar perspective
 Ideas and solutions are documented
 Communication is improved
 Team members assume ownership

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 Step #5

Corrective Action Plan

 Must verify the solution will eliminate the problem

 Verification before implementation whenever possible

 Define exactly…
 What actions will be taken to eliminate the problem?

 Who is responsible?

 When will it be completed?

 Make certain customer is happy with actions

 Define how the effectiveness of the corrective action will be measured.

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 Step #5

Verification vs. Validation

(Before) (After)

 Verification
 Assures that at a point in time, the action taken will actually do what is
intended without causing another problem

 Validation
 Provides measurable evidence over time that the action taken worked
properly, and problem has not recurred

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 Step #6

Complete Action Plan

 Make certain all actions that are defined are completed as planned

 If one task is still open, verification and validation is pushed back

 If the plan is compromised, most likely the solution will not be as effective

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 Step #7

Follow Up Plan

 What actions will be completed in the future to ensure that the root cause
has been eliminated by this corrective action?
 Who will look at what data?
 How long after the action plan will this be done?
 What criteria in the data results will determine that the problem has not
recurred?

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 Step #8

Validate and Celebrate

 What were the results of the follow up?

 If problem did reoccur, go back to Step #4 and re-evaluate root cause,

then re-evaluate corrective action in Step #5
 If problem did not reoccur, celebrate team success!

 Document savings to publicize team effort, obtain customer satisfaction

and continued management support of teams

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 What does a good RCA look like?

 The Root Cause is

 Internally Consistent ,
 Thorough, and
 Credible

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 What does a good RCA look like?

The Complete Root Cause Analysis is

• inter-disciplinary, involving experts from the frontline services
• involving of those who are the most familiar with the situation
• continually digging deeper by asking why, why, why at each level of
cause and effect.
• a process that identifies changes that need to be made to systems
• a process that is as impartial as possible

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 What does a good RCA look like?

To be thorough a Root Cause Analysis must include:

• determination of human & other factors
• determination of related processes and systems
• analysis of underlying cause and effect systems through a series of
why questions
• identification of risks & their potential contributions
 determination of potential improvement in processes or systems

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 What does a good RCA look like?

To be Credible a Root Cause Analysis must:

• include participation by the leadership of the organization &
those most closely involved in the processes & systems
• be internally consistent

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 Hints about root causes

 One problem may have more than one root cause

 One root cause may be contributing to many problems
 When the root cause is not addressed, expect the problem
to reoccur
 Prevention is the key!

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 Review

 You learned:
 How to identify the root cause
 Why it is important
 The process for proper root cause analysis
 How basic quality tools can be applied to examples

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 Manufacturing

Root Cause Analysis

Example #1

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 Example #1

Identify Problem

Part polarity reversed on circuit board

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 Determine Team

 Team members:
 Team Leader – Terry
 Inspector – Jane
 Worker – Tammy
 Worker - Joe
 Quality Eng – Rob
 Engineer – Sally

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 Immediate Action

 Additional inspection added after this assembly process

step to check for reversed part defects

 Last 10 lots of printed circuit boards were re-inspected to

check for similar errors

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 Root Cause

Part reversed

Why?

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 Root Cause

Part reversed

Worker not sure of correct part orientation

Why?

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 Root Cause

Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Why?

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 Root Cause

Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Engineering ordered it that way from vendor

Why?

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 Root Cause

Part reversed

Worker not sure of correct part orientation

Part is not marked properly

Engineering ordered it that way from vendor

Process didn’t account for possible

manufacturing issues

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 Corrective Action

 Permanent – Changed part to one that can only be placed in correct

direction (Mistake proofed). Found other products with similar problem and
made same changes.

 Preventive - Required that any new parts selected must have

orientation marks on them.

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Root Cause Analysis
Example #2

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 Example #2

Identify Problem

A manager walks past the assembly line and notices a puddle of

water on the floor. Knowing that the water is a safety hazard, she
asks the supervisor to have someone get a mop and clean up the
puddle. The manager is proud of herself for “fixing” a potential
safety problem.

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 Example #2

But What is the Root Cause?

The supervisor looks for a root cause by asking 'why?’

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 Immediate Action

Knowing that the water is a safety hazard, the manager asks the
supervisor to have someone get a mop and clean up the puddle.

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 Root Cause

Puddle of water on the floor

Why?

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 Root Cause

Puddle of water on the floor

Leak in overhead pipe

Why?

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 Root Cause

Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Why?

64
 Root Cause

Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Water pressure valve is faulty

Why?

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 Root Cause

Puddle of water on the floor

Leak in overhead pipe

Water pressure is set too high

Water pressure valve is faulty

Valve not in preventative maintenance program

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 Corrective Action

 Permanent – Water pressure valves placed in preventative

maintenance program.

 Preventive - Developed checklist form to ensure new

equipment is reviewed for possible inclusion in preventative
maintenance program.

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 Example #3

Root Cause Analysis

Example #3

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 Example #3

Identify Problem

Customers are unhappy because they are being shipped

products that don't meet their specifications.

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 Immediate Action

Inspect all finished and in-process product to ensure it meets

customer specifications.

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 Root Cause

Product doesn’t meet specifications

Why?

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 Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from

what customer and sales person agreed to
Why?

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 Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from

what customer and sales person agreed to

Sales person tries to expedite work by calling

head of manufacturing directly
Why?

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 Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from

what customer and sales person agreed to

Sales person tries to expedite work by calling

head of manufacturing directly

Manufacturing schedule is not available for

sales person to provide realistic delivery date
Why?

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 Root Cause

Product doesn’t meet specifications

Manufacturing specification is different from

what customer and sales person agreed to

Sales person tries to expedite work by calling

head of manufacturing directly

Manufacturing schedule is not available for

sales person to provide realistic delivery date

Confidence in manufacturing schedule is not

high enough to release/link with order system

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 Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Why?

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 Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby

creating schedule changes
Why?

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 Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby

creating schedule changes

Expediting and priority changes consume

parts not planned for
Why?

78
 Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby

creating schedule changes

Expediting and priority changes consume

parts not planned for

Manufacturing schedule does not reflect

realistic assembly and test time
Why?

79
 Root Cause
Confidence in manufacturing schedule is not
high enough to release/link with order system

Parts sometimes not available thereby

creating schedule changes

Expediting and priority changes consume

parts not planned for

Manufacturing schedule does not reflect

realistic assembly and test time

No ongoing review of manufacturing standards

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 Corrective Action

 Permanent – Manufacturing standards reviewed and

updated.

 Preventive - Regular ongoing review of actuals vs

standards is implemented.

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Root Cause Analysis
Example #4

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 Example #4

Identify Problem

Department didn’t complete their project on time

© 2004 Superfactory™. 83
All Rights Reserved.
 Determine Team

 Team members:
 Boss – Jim
 Worker – Tom
 Worker - Karen
 Project Mgr – Bob
 Admin – Sally

84
 Immediate Action

 Additional resources applied to help get the project team

back on schedule

 No new projects started until Root Cause Analysis

completed

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 Root Cause

Didn’t complete project on time

Why?

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 Cause and Effect

Procedures Personnel
Lack of worker
knowledge
Poor project plan
Poor project
mgmt skills Lack of resources

Didn’t complete
project on time

Inadequate Poor Inadequate

computer documentation computer system
programs

Materials Equipment

87
 Cause and Effect

Procedures Personnel
Lack of worker
knowledge
Poor project plan
Poor project
mgmt skills Lack of resources

Didn’t complete
project on time

Inadequate Poor Inadequate

computer documentation computer system
programs

Materials Equipment

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 Root Cause

Didn’t complete project on time

Resources unavailable when needed

Why?

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 Root Cause

Didn’t complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Why?

90
 Root Cause

Didn’t complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Lack of specifics given to

Human Resources Dept
Why?

91
 Root Cause

Didn’t complete project on time

Resources unavailable when needed

Took too long to hire Project Manager

Lack of specifics given to

Human Resources Dept

No formal process for submitting job opening

92
 Corrective Action

 Permanent – Hired another worker to meet needs of next

project team

 Preventive - Developed checklist form with HR for

submitting job openings in the future

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 Example #5

Root Cause Analysis

Example #5

94
 Example #5

Identify Problem

High pyrogen count on finished medical catheter product

using molded components.

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 Immediate Action

Immediate Action (and panic!)

 Quarantine all finished and in-process product

(over $2 million worth!)
 Analyze location of pyrogen to find common denominator

96
 Panic-Driven Action

Panic-driven Immediate Reaction

(without root cause analysis)

 Pyrogen traced to molding cooling water leak

 Holy cow!… cooling water system hasn’t been cleaned in 15 years!
 Shut down 24/7 molding operation for 2 days to clean cooling water system
 Implement system for weekly analysis of cooling water for pyrogens
 Threaten to fire anyone who doesn’t report a cooling water leak

97
 Panic-Driven Action - Results

Results of Panic-driven Immediate Reaction

(without root cause analysis)

 Day 1 after cooling water system cleaning: water tests clean of pyrogens
 Day 2: cooling water is saturated with pyrogens. Uh oh.
 All operators and technicians reporting “possible water leaks” on all presses, all molds, all shifts…
“just in case”.
 Molding operation shuts down. Operations manager nearly fired.
 “Help” flying in from corporate offices and other molding plants.
 Hourly conference calls to give status updates to executives.


98
 Logic Returns

There must be a better way! How about trying something called

“Root Cause Analysis”?

99
 Root Cause

Pyrogens on molded components

Why?

100
 Root Cause

Pyrogens on molded components

Parts released from molding even though they

had been sprayed with leaking cooling water
Why?

101
 Root Cause

Pyrogens on molded components

Parts released from molding even though they

had been sprayed with leaking cooling water

Disposition of contaminated parts procedure

does not discuss water
Why?

102
 Root Cause

Pyrogens on molded components

Parts released from molding even though they

had been sprayed with leaking cooling water

Disposition of contaminated parts procedure

does not discuss water

Oil, grease, dust, human contact believed to

be primary sources of contamination
Why?

103
 Root Cause

Pyrogens on molded components

Parts released from molding even though they

had been sprayed with leaking cooling water

Disposition of contaminated parts procedure

does not discuss water

Oil, grease, dust, human contact believed to

be primary sources of contamination

No formal evaluation of contamination sources,

types, severity, and disposition action.

104
 Corrective Action

 Permanent – Disposition of contaminated parts procedure

re-written to include water.

 Preventive - Formal study of contamination sources,

consequences, and disposition requirements.

105