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1 2/11/2013 v8.0
The 8D (Disciplines) Problem Solving Process
by Operational Excellence Consulting LLC
2 2/11/2013 v8.0
8D Problem Solving Process – History
 The 8D Problem Solving methodology despite what is generally thought has not
been created by Ford but by the U.S. Department of Defense (DOD) in 1974.
The standard, which described the 8D, was named: “MIL-STD 1520 Corrective
Action and Disposition System for Nonconforming Material”.
 In the late 1990s, Ford developed a revised version of the 8D Problem Solving
Process that they call "Global 8D" (G8D) which is the current global standard for
Ford and many other companies in the automotive supply chain.
 The 8D Problem Solving Process has been employed significantly outside the
auto industry. As part of lean initiatives and continuous-improvement processes
it is employed extensively in the food manufacturing, health care, and high-tech
industries.
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The purpose of this workshop is to introduce you to the 8D Problem Solving
Process and provide you and your team with an effective methodology and the
basic tools to identify the underlying root cause(s) of a problem or performance
gap.
We will have a simple case study throughout the course so that you can apply
and practice the key learning points.
Learning Outcome:
• Understanding the 8D Problem Solving Process
• Describe the purpose and objective of each phase of the 8D Problem
Solving Process
• Understand and apply key problem-solving tools in each phase of the
8D Problem Solving Process
• Use of assessing questions at the end of each phase of the 8D Problem
Solving Process
General Objectives & Key Learning Points
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Challenge #1 – Fire Fighting vs. Problem Solving
Fire Fighting is associated with the “Heroic Mentality”
Fire Fighting Problem Solving
Perception – Memory – Emotion Data – Information – Analysis
Problem Description & Analysis
The cause is defined in relation
to the symptom
The cause is defined in relation
to the true problem
Root Cause Analysis
The solution is applied to the
“obvious” cause
The solution is applied & verified
to the “root” cause(s)
Solution Development
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Challenge #2 – Making the Investment
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Challenge #3 – If it ain’t broke …
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Problem Solving Process - The Terminology
 Symptom – A quantifiable event or effect, experienced by a Customer
(internal & external), that may indicate the existence of one or more problems.
 Problem – A deviation from an expectation or standard; a perceived gap
between the existing state and a desired state. In the context of the 8D
Problem Solving Process the cause(s) of the problem is not known.
 Possible Cause – Any cause, identified for example through Process Variables
Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem
or Failure Mode effect may occur.
 Most Likely Cause – A cause, identified based on available or collected
data, that best explains the Problem Description or Failure Mode.
 Root Cause – A verified cause that convincingly supports and explains
ALL facts available and thus accounts for the problem; verified passively
and actively, by making the problem come and go. Root causes are the
fundamental, underlying reasons for a Problem or Failure Mode, e.g.
management policies, product design, system design, process capabilities,
technology constraints, unclear or wrong standard operating procedures, and
human errors.
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Why Armies of Knights Lose Battles?
Loss of Battle
Loss of Rider
Loss of Horse
Loss of Shoe
Loss of Nail
…
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Why Armies of Knights Lose Battles?
Cause SymptomProblem
Window of Consideration
Loss
of
Nail
Loss
of
Shoe
Loss
of
Rider
Loss
of
Horse
Loss
of
Battle
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The 8D Problem Solving Process – Benefits
 High Performance Work Teams
8D Problem Solving Teams play a key role in their
organization by being empowered to find root causes, implement
corrective actions, prevent any recurrence and recommend
process improvements. These teams have the authority,
responsibility and accountability for solving the problem.
 Process Excellence
By using a standard process to solve problems and
communicate lessons learned across the organization, teams can
become more efficient and effective, which means that problems
will be solved quickly.
 Customer Satisfaction
By identifying the symptoms, implementing emergency response
actions, and protecting the internal and external Customers
from adverse effects of the problem, teams can resolve
problems and achieve Customer Satisfaction.
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Problem Solving Process - The Tool Box
“If the only tool you have is a hammer, every problem looks like a nail.”
Abraham Maslow
→ You need the right tools for the right tasks.
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The 8D Problem Solving Process – What is Needed?
 The symptom has been defined and quantified.
 The Customer who experienced the symptom has been
identified.
 Measurements taken to quantify the symptom demonstrate
that a performance gap exist, and/or the priority (severity,
urgency, growth) of the symptom requires initiation of the
process.
 The cause(s) of the problem or performance gap is unknown.
 Management is committed to dedicate the necessary
resources to fix the problem at the root-cause level and to
prevent recurrence.
 Symptom complexity exceeds the ability of one person to
resolve the problem.
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“Never use a cannon to kill a fly.”
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Ground Fruit
Logic, Intuition and Basic Tools
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Low Hanging Fruit
Basic Tools, 8D Problem Solving
and Lean
Bulk of Fruit
8D Problem Solving, Lean
and Six Sigma
= Opportunity
Process Entitlement
Sweet or Stretch Fruit
Lean, Six Sigma
and Design for Six Sigma
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The 8D (Disciplines) Problem Solving Process
1
• Establish the Team
2
• Describe the Problem
3
• Develop Interim Containment Actions
4
• Define and Verify Root Causes and Escape Points
5
• Choose and Verify Permanent Corrective Actions
6
• Implement and Validate Permanent Corrective Actions
7
• Prevent Recurrence
8
• Recognize Team and Individual Contributions
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An 8D Problem Solving Process Report
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The 8D Problem Solving Process
1
• Establish the Team
2
• Describe the Problem
3
• Develop Interim Containment Actions
4
• Define and Verify Root Causes and Escape Points
5
• Choose and Verify Permanent Corrective Actions
6
• Implement and Validate Permanent Corrective Actions
7
• Prevent Recurrence
8
• Recognize Team and Individual Contributions
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Purpose: Establish a small group of people with the process and/or product
knowledge, allocated time, authority, and skills in the required technical
disciplines to solve the problem and implement corrective actions.
 Review the problem or improvement opportunity
 Review priorities, scope and complexity
 Identify if a team is needed
 Identify team members and establish the team
 Nominate a team leader and project champion
 Establish basic team guidelines
 Consider team building exercises
“Establish the Team” Key Activities
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Problem Solving & Improvement Project Selection
 Is the problem or improvement opportunity related to the organization’s
strategic and operational objectives?
 Does the problem impact customer satisfaction?
 Does a Champion or Owner exist that is responsible for the problem?
 Do we have the resources (people, time, money) to successfully complete
the project?
 Is there an objective measure or metrics in place to be improved?
 Can the project been completed in a reasonable amount of time?
 What is the likelihood of success?
 …
Every organization should develop its own Project Selection Criteria to
ensure it works on the right projects at the right time.
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The Champion Role
When championing a project and project team, you
 have ownership of the system or process under consideration
 have authority to make changes
 make resources available to the team
 remove barriers that hold the team back from solving the problem
 challenge and/or support team decisions
 attend meetings as required
 use appropriate questions to monitor the team’s
progress
 create an environment for empowerment of the team
 celebrate, recognize & reward the team after
successfully solving the problem
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The Team Leader Role
When leading, you
 are the team’s business manager and spokesperson
 work with the team to set objectives and tasks
 ask for and summarize member’s opinions
 direct the use of the 8D Problem Solving Process
 focus on the meeting’s purpose and agenda
 may give information to the team
 direct and facilitate decision-making
 summarize decisions
 explicitly give up the leadership role when participating in the discussion
 …
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The Team Member Role
When acting as a team member, you
 provide technical input
 carry out assignments
 offer information and ideas
 give descriptive feedback
 clarify issues
 …
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The Facilitator Role
When facilitating, you
 ensure that all members have the opportunity to contribute
 focus on how the team is working together
 give and ask descriptive feedback
 act as team builder
 focus on team maintenance
 draw attention to communication skills
 ensure the team starts and finishes effectively
 help team members to increase awareness of,
and make contact with, each other
 …
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Basic Team Guidelines
Develop Basic Team Guidelines that the team commits to …
 Talk from personal experience and examples
 Speak to, not about, people present
 Say “I” – not “we”, “you”, “one”, “the team”, …
 Say “I would like …” or “it would help me if …” – not “you should …” or
“we should …”
 Make statements before questions
 Trace opinions to observations
 Describe not judge
 Restate and build on proposals
 Recognize that feelings affect team meetings
 …
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New York University NYU – Our Code
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The Problem Solving Team:
 Are the people affected by the problem represented?
 Does each person have a reason for being on the team?
 Do the team members agree on membership?
 Is the team large enough to include all necessary inputs, but small
enough to act effectively?
 The Champion of the team has been identified?
 The Team Leader has been identified?
 Need for a Facilitator to coach the process has been
considered?
 Have all the roles and responsibilities been reviewed
and are agreed upon?
“Phase D1” Checklist Questionnaire
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8D Problem Solving Process Report – Phase D1
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The 8D Problem Solving Process
1
• Establish the Team
2
• Describe the Problem
3
• Develop Interim Containment Actions
4
• Define and Verify Root Causes and Escape Points
5
• Choose and Verify Permanent Corrective Actions
6
• Implement and Validate Permanent Corrective Actions
7
• Prevent Recurrence
8
• Recognize Team and Individual Contributions
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Purpose: Describe the internal or external problem by identifying “what is wrong
with what” and detailing the problem in quantifiable terms.
 Develop a Problem Statement
 Develop a Problem Description using the “IS – IS NOT Matrix”
 Develop a flowchart of the process and identify critical process steps with
respect to the Problem Description
 Develop a Fishbone Diagram or Process Variables Map to identify possible
causes?
 Determine whether this problem describes a “something changed” or
a “never been there” situation
 Establish a high-level project plan, including milestones,
project goals and objectives
“Describe the Problem” Key Activities
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Problem Solving in “Dilbert Inc.”
“What’s is the Problem we need to solve?”
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“If I had an hour to save the world I would spend 59 minutes defining
the problem and one minute finding solutions.”
Albert Einstein
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How would you get started?
Company ABC produces a part for an automotive manufacturer.
The length of the part is critical and needs to be between 60mm
and 72mm.
Unfortunately, the Customer has complaint now several times
over the last 3 months that some of the parts from company ABC
are too long. This causes major equipment issues at the
Customer’s production facility.
How would you get started?
________________________________________________________
________________________________________________________
________________________________________________________
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How would you get started?
Company ABC produces a part for an electronics manufacturer.
Unfortunately, a major Customer has complaint several times in
the last 2 months over late deliveries. This causes major
production shortages at the Customer’s production facility.
How would you get started?
________________________________________________________
________________________________________________________
________________________________________________________
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How would you get started?
The Finance Manager of Company ABC contact the Operations
Managers to discuss the significant amount of scrap cost the
company incurs every month.
The company currently is not able to meet its cost targets due to
the huge amount of material that needs to be scrap and the
additional costs due to rework or new production. In some cases
this also results in late orders and thus causes Customer
complaints.
How would you get started?
________________________________________________________
________________________________________________________
________________________________________________________
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Run Chart & Example
 Visualizes the process performance over time
 Helps identify trends or shifts over time
 Allows tracking process performance against set goals
94.0%
94.5%
95.0%
95.5%
96.0%
96.5%
97.0%
97.5%
98.0%
98.5%
On-Time Delivery 2012 (Direct & Non-Stock Orders)
Series1
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Pareto Chart & Example
 Helps to define which problems should be solved and in which order
 Presents the 20/80 – Rule
 20% of the problems often create 80% of all the costs and/or complaints
 Analyzes defect categories over a specific time frame (e.g. 3 months)
Missing Part
Position
Incorrect
Part Broken Wrong Color Stains Others
Number of Defects 40 15 10 8 6 11
Cum. Percentage 44% 61% 72% 81% 88% 100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0
5
10
15
20
25
30
35
40
45
50
Pareto Chart - Outgoing Inspection Defects
Number of Defects
Cum. Percentage
You may need to define meaningful defect categories and categorize your
data, before you can determine which problems to solve first
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Histogram
A histogram provides graphical presentation and a first estimation
about the location or center, spread and shape of the distribution of the
process.
0 10 20 30 40 50
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How to create Histogram?
Step 1: Collect at least 50 data points, but better 75 to 100 points, and organize
your data into a table. Sort the data points from smallest to largest and calculate
the range, means the difference between your largest and smallest data point, of
your data points.
Actual Measurements
Part Hole Size
1 2.6
2 2.3
3 3.1
4 2.7
5 2.1
6 2.5
7 2.4
8 2.5
9 2.8
10 2.6
Sorted Measurements
Part Hole Size
5 2.1
2 2.3
7 2.4
6 2.5
8 2.5
1 2.6
10 2.6
4 2.7
9 2.8
3 3.1
Minimum = 2.1
Maximum = 3.1
Range = 1.0
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How to create Histogram?
Step 2: Determine the number of bars or bins to be used to create the histogram
of the data points. Calculate the width of one bar by dividing the range of your
data by the number of bars selected.
Number of Bars:
less than 50
50 - 100
100 - 250
over 250
5 or 7
5, 7, 9 or 11
7 - 15
11 - 19
Number of Data Points:
Minimum = 2.1
Maximum = 3.1
Range = 1.0
Bar Width = 0.2 (5 Bars)
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How to create Histogram?
Step 3: Calculate the “start” and “end” point of each bar and count how many
data points fall between “start” and “end” point of each bar.
Start End
Bar 1 2.1 2.1 + 0.2 = 2.3
Bar 2 2.3 2.5
Bar 3 2.5 2.7
Bar 4 2.7 2.9
Bar 5 2.9 3.1
Minimum = 2.1
Maximum = 3.1
Range = 1.0
Bar Width = 0.2 (5 Bars)
Sorted Measurements
Part Hole Size Bar
5 2.1 1
2 2.3 2
7 2.4 2
6 2.5 3
8 2.5 3
1 2.6 3
10 2.6 3
4 2.7 4
9 2.8 4
3 3.1 5
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How to create Histogram?
Step 4: Draw the histogram indicating by the height of each bar the number of
data points that fall between the “start” and “end” point of that bar.
Sorted Measurements
Part Hole Size Bar
5 2.1 1
2 2.3 2
7 2.4 2
6 2.5 3
8 2.5 3
1 2.6 3
10 2.6 3
4 2.7 4
9 2.8 4
3 3.1 5
0
1
2
3
4
5
NumberofDataPoints
2.1 2.3 2.5 2.7 2.9 3.1
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Histogram – Different Patterns of Variation
1. The bell-shaped distribution:
Symmetrical shape with a peak in the middle of the range of
the data.
Some process outcomes fall outside the acceptable limits.
Solving this problem requires reducing the normal variation of
the process through the application of the Six Sigma roadmap
and tools.
2. The double-peaked distribution:
A distinct valley in the middle of the range of the data with
peaks on either side.
This pattern is usually a combination of two bell-shaped
distributions and suggests that two distinct processes (e.g.
machine, operator, method, material, …) are at work.
Solving this problem requires the identification of the root
cause for the two distribution using the 8D Problem Solving
Process and tools.
LSL USL
LSL USL
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Histogram – Different Patterns of Variation
3. Outliers:
The normal process is of symmetrical shape
with a peak in the middle of the range of the
data (Type 1).
However, several process outcomes are very
different from the normal process results and
are causing the problem.
Solving this problem requires the identification
of the root cause for the two distribution using
the 8D Problem Solving Process and tools.
LSL USL
What can cause outliers in your process?
________________________________________________________
________________________________________________________
________________________________________________________
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There are two steps to develop a good Problem Statement.
The first step is used to identify the object and the defect and develop the
initial Problem Statement.
The object and the defect are defined by asking “What is wrong with what?”
 “What is wrong?” is the defect
 The defect is an unwanted characteristic present in a product or
process – broken, missing, wrong, too short, …
 “… with what?” is the object
 The object is the name given to a specific product, process or
service that exhibits the defect
The Problem Statement (Step 1)
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Identifying Possible Causes
 Symptom – A quantifiable event or effect, experienced by a Customer
(internal & external), that may indicate the existence of one or more problems.
 Problem – A deviation from an expectation or standard; a perceived gap
between the existing state and a desired state. In the context of the 8D
Problem Solving Process the cause(s) of the problem is not known.
 Possible Cause – Any cause, identified for example through Process Variables
Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem
or Failure Mode effect may occur.
 Most Likely Cause – A cause, identified based on available or collected
data, that best explains the Problem Description or Failure Mode.
 Root Cause – A verified cause that convincingly supports and explains
ALL facts available and thus accounts for the problem; verified passively
and actively, by making the problem come and go. Root causes are the
fundamental, underlying reasons for a Problem or Failure Mode, e.g.
management policies, product design, system design, process capabilities,
technology constraints, unclear or wrong standard operating procedures, and
human errors.
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The 5 Why’s
Description: The 5 Why’s Analysis helps to identify the final problem statement or in
some cases even the root cause. It helps to distinguish between the symptom of a
problem and the problem itself and it encourages the team to reach an answer that is
fundamental and actionable.
Procedure:
Step 1: Develop an initial problem statement of the specific problem to be solved. Write it
in the upper left corner of a piece of paper, flip chart or white board.
Step 2: Ask “Why?” this problem does or could occur. Write the cause (object & defect)
underneath the initial problem statement.
Step 3: The cause identified in Step 2 now becomes a new problem statement. Repeat
Step 2 and ask “Why?”, e.g. “Why would this situation occur?", again.
Step 4: Continue Step 2 and Step 3 until you cannot for certain answer the question or
reach an answer that is fundamental and actionable.
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The Problem Statement (Step 2)
Once the initial problem statement (object & defect) is established, the second step is
to use the “5 Why’s” and ask “Why would this situation occur?” or “Why is that
happening to that object?”
The objective is to refine the initial problem statement to
 determine the problem, rather than the symptom of the problem
 focus efforts on a single problem with a single root cause
 get as near as possible to the root cause using existing knowledge &
information
 check if the root cause of the problem is really unknown
Result #1 - If you are certain that you have found the root cause, then you can
immediately go to Phase 4 “Define and Verify Root Cause” and test your root cause
theory.
Result #2 - If the cause is unknown and there is a need to find the root cause, then
the last object and defect with an unknown cause is the final Problem Statement.
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Problem Statement – Example 1
What is the Problem Statement (Object & Defect)?
WHY? → The tool was not in inventory.
WHY? → The Supplier did not deliver the replacement tools.
WHY? → The Supplier did not receive our Purchase Order on-time.
WHY? → We did not submit the Purchase Order on time.
WHY? → We did not have the “right” rework tool.
WHY? → We don’t know.
Initial Problem
Statement
Final Problem
Statement
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Problem Statement – Example 2
What is the Problem Statement (Object & Defect)?
WHY? → The door frame had been “over-ground”.
WHY? → Team member did not use the grinder properly.
WHY? → Customer is complaining.
Initial Problem
Statement
Actionable
Cause
WHY? → There are grinding marks on the door frame.
WHY? → Team member was not properly trained.
→ Most Likely Cause or Root Cause
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Developing a Problem Statement
Problem Statement: ____________________________
Problem Statement: ____________________
The Computer “dumps its memory”.
The Fuse blows.
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Case Study Group Work 1
The Task:
 Read the introduction to the “Felt Tip Marker” Case Study
 Develop the Problem Statement for the Case Study
5 Minutes
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“Change-Induced” vs. “Day-One-Deviation”
Change
Performance SHOULD
Past Present
DEVIATION Performance ACTUAL
Performance SHOULD
Present
DEVIATION
Day One
When the process performance once met
the SHOULD and no longer does, then
you have a “Change-Induced” problem.
When a condition required for achieving the
SHOULD never existed, then you have a
“Day-One-Deviation” problem.
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The Problem Description
The Problem Description defines the boundaries of the problem, in terms of what it is
and what it is not but could be.
Scientific description of any event can be made by providing information on
 What the problem is and what it is not but could be? - Identity
 IS - The long brackets are missing,
 IS NOT - The short brackets are not missing (but could be)
 Where the problem is and where it is not but could be? - Location
 IS - The order entry defects are in direct ship orders
 IS NOT - The order entry defects are not in stock orders (but could be)
 When the problem occurs and when it does not but could? - Timing
 IS - The clips started breaking in early 2010
 IS NOT – The clips did not break before early 2010 (but could have)
 How big the problem is and how big it is not but could be? - Size
 IS - About 50% of the paychecks
 IS NOT – Not all paychecks are incorrect (but could be)
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Case Study Group Work 2
The Task:
 Define “What?” – “Where?” – “When?” – “How Big?” questions
should John and his organization asked to develop a good Problem
Description for the “Felt Tip Marker” Case Study Problem?
 Capture your questions on a flip chart and be prepared to share
your results with the rest of the group.
15 Minutes
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The “IS – IS NOT” Matrix
PROBLEM SOLVING PROCESS WORKSHEET
Problem Statement
(What is wrong with what?):
Red Felt Tip Marker Leaks
IS IS NOT DISTINCTIONS CHANGES
TEST FOR MOST LIKELY CAUSES
(+) (-) (?)
Describe what does occur
Describe what does not occur, but
could occur
What could explain the IS-IS NOT?
(People, Methods, Material,
Machines, Environment)
What has changed in, on, around or
about this distinction? When
did it change?
<Define Possible Root Cause
Theory>
What?
Object:
Defect:
Where?
Where is the object when the
defect is observed? Where is the
defect on the object? Are there
any pattern or trends identifiable?
When?
When was the defect observed
first? Can or was the defect be
observed before, during or after
other events? When since has the
defect occurred? Are there any
pattern or trends identifiable?
How Big?
How many objects have the
defect? What is the size of a single
defect? How many defects are on
each object? Are there any
pattern or trends identifiable?
1
2
3
4
5
2
3
4
5
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The “IS – IS NOT” Matrix
The “IS – IS NOT” Matrix in the 8D Problem Solving Process Worksheet identifies
where to start looking for possible causes by isolating the what, when, where and how
big about the problem statement.
Step 1: Enter the Problem Statement.
Step 2: Use the “IS” column to describe what objects are effected and what the defect
is. Use the “IS NOT” column to describe what could be effected and occur but does not.
Step 3: Use the “IS” column to describe where the event occurs. This can be
geographical, physical, or on an object. Use the “IS NOT” column to describe where the
problem could occur but does not.
Step 4: Use the “IS” column to describe when the problem occurs. When did it happen
first? What pattern of reoccurrence? Also, when the event occurs in relation to other
events. Use the “IS NOT” column to describe when the problem could occur but does
not.
Step 5: Use the “IS” column to describe the extent of the problem. How many objects
or occurrences had problems? How many problems? How serious are they? Use the
“IS NOT” column to describe how big or small the problem could be but is not.
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Case Study Group Work 3
The Task:
 Review the “Felt Tip Marker” Case Study (Part 2) thoroughly
 Develop & document the Problem Description for the Case Study
 Capture your “Is – Is Not” statements on a flip chart and be
prepared to share your results with the rest of the group.
20 Minutes
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Identifying Possible Causes
 Symptom – A quantifiable event or effect, experienced by a Customer
(internal & external), that may indicate the existence of one or more problems.
 Problem – A deviation from an expectation or standard; a perceived gap
between the existing state and a desired state. In the context of the 8D
Problem Solving Process the cause(s) of the problem is not known.
 Possible Cause – Any cause, identified for example through Process Variables
Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem
or Failure Mode effect may occur.
 Most Likely Cause – A cause, identified based on available or collected
data, that best explains the Problem Description or Failure Mode.
 Root Cause – A verified cause that convincingly supports and explains
ALL facts available and thus accounts for the problem; verified passively
and actively, by making the problem come and go. Root causes are the
fundamental, underlying reasons for a Problem or Failure Mode, e.g.
management policies, product design, system design, process capabilities,
technology constraints, unclear or wrong standard operating procedures, and
human errors.
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Identifying “All” Possible Causes
To learn more about a specific problem and to identify “all” possible
causes, the 8D Problem Solving Team needs to better understand the
process that causes the problem.
These tools work very well in a team environment to ensure that
everyone has a voice and every voice is being heard.
Select the Fishbone Diagram or Process Variables Map based on the
problem you need to solve and/or your personal or team’s preference.
The following tools are widely used to facilitate this activity.
 Process Flowchart Map
and
 Fishbone Diagram or Process Variables Map
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Process Mapping → Two Types of Process Maps
Most problem solving projects will require a process map, as most problems are
associated with a process that is failing. The team needs to understand how
that process works or at least is intended to work, as well as identify all
process inputs and critical process outputs.
1. Process Flowchart Map
 Focuses on the activities of the process and the sequence of these
activities
 A graphical description of a work flow or activities using standard
symbols for each of the activities
2. Process Variables Map
 Focuses on the inputs and outputs of a process and its steps
 Critical first step towards successful process improvement through
identifying, reducing, and removing “sources of variation”
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Objectives of a Process Flowchart Map
A Process Flowchart is a graphical process description of the work
flow or activities using standard symbols for each of the activities.
Different types of activities are described with standard symbols. The
problem areas in the process are often relatively easy to discover when
assessing the flowchart.
An ellipse shows the start and the end point of the process.
A box describes an activity or process step.
A diamond shows a decision making step.
An arrow shows the direction from one activity to another.
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Preparing a Process Flowchart Map
 Team Effort
 Process Owners / Leaders, Workers, Supervisors, Technicians /
Engineers / Developers, Upstream and Downstream
Representatives (Suppliers and Customers)
 Inputs to Mapping
 Brainstorming and operator knowledge / experience
 Operator manuals / standard work instructions
 Process Control Plans
 Paper & Post-It Notes or PowerPoint
 A White Board or Paper and Post-It Notes work
best when developing a Process Flowchart Map
 Final documentation can be done in PowerPoint
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Process Flowchart Map
Loading
PCB
Supporting
PCB (x/y table)
Recognizing
PCB
Picking-Up
Component
Pre-Turning
Component
Measuring
Component
Thickness
Inspecting
Component
(Dimensions, Shape)
Final-Turning
Component
Placing
Component
Removing
PCB Support
Unloading
PCB
Bringing Mounting
Head and Nozzles
to Start Position
Start
End
Reject
Component ?
Reject
Component ?
Next
Component ?
Yes
No
Yes
No
Yes
No
Dropping
Component in Box
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Brainstorming is used to generate a large number of ideas in a short period of
time.
 Step 1: Review the topic or problem to be discussed. Make sure the entire
team understands the subject of the brainstorm. Clarify if you are looking
for possible causes or possible solutions.
 Step 2: Allow a couple of minutes for everyone to think about the task and
write down some ideas.
 Step 3: Invite the team members to call out their ideas, randomly or in
turns around the table. Make sure that the team builds upon each others
ideas (1 + 1 > 2), allow clarifications but avoid discussions or evaluations.
 Step 4: Record all ideas, e.g. on post-its, and stick them on a
flip chart visible to everyone.
 Step 5: Continue with Step 3 and 4 until several minutes
silence produces no more ideas.
Brainstorming – Process
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When brainstorming, remember …
Brainstorming – Guidelines
Use plain English.
Avoid to be
judgmental.
Spell out an acronym
when you use it for
the first time.
Build on others ideas.
Be specific. Be open & honest.
Do not criticize.
Have an open mind.
Be aware of your opinions.
“Dig deep” and probe.
Challenge yourself.
Include & engage others.
No side discussions.
Only one idea at time.
Encourage
wild ideas.
Explain, but
don’t discuss.
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The Fishbone Diagram, sometimes also called Cause-and-Effect Diagram or
Ishikawa Diagram, is another way of looking at the possible causes of a
problem. It organizes large numbers of potential causes into pre-defined
categories, e.g. 5Ms & 1 E or 4 Ps, or team-defined categories.
Fishbone or Ishikawa Diagram
5M’s + 1E = MEN
MEASURE
METHODS
MATERIALS
MACHINES
+ ENVIRONMENT
4P’s = PLANT
POLICIES
PEOPLE
PROCEDURES
Machines
Materials Methods
Environment
Trunk
Primary Possible Cause Category
Main Branch
Minor Branch
Second-Level
Possible Causes
Men/People
Problem
Statement
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Fishbone or Ishikawa Diagram
Alternative 2 (Team-defined Categories)
Step 1: Draw a horizontal trunk line and to
the right end of this line write the
Problem Statement.
Step 2: Brainstorm for all possible causes.
Step 3: Group the possible causes into
categories and give each category a
name (min. 2, max. 6 categories).
Step 4: Draw a main branch for each
category and put a category name at
the end of each branch.
Step 5: Add minor branches and the
identified possible causes under
each major branch.
Step 6: Check that the diagram is complete
and logical.
Alternative 1 (Pre-defined Categories)
Step 1: Draw a horizontal trunk line and
to the right end of this write the
Problem Statement.
Step 2: Draw the main branches and put
the name of the main categories,
e.g. 4Ms & 1E, at the end of the
main branches.
Step 3: Brainstorm for all possible causes
Step 4: Add minor branches and the
identified possible causes under
each major branch.
Step 5: Check that the diagram is
complete and logical.
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Possible Causes using a Fishbone Diagram #1
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Possible Causes using a Fishbone Diagram #2
Employee Turnover
too high
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Objectives of a Process Variables Map
 Process Variables Maps should include:
 All value-added and non-value-added process steps
 Major activities and/or tasks in each process step
 Process Inputs for each process step
 Process Outputs for each process step
 Process Control and Data Collection Points if applicable
 The Process Variables Map documents the process as it is actually
performed, not necessarily as it is supposed to be performed
 Key deliverable from the Process Variables Map is a complete list of
all the Process Inputs within the project scope
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Preparing a Process Variables Map
 Team Effort
 Process Owners / Leaders, Workers, Supervisors, Technicians /
Engineers / Developers, Upstream and Downstream Representatives
(Suppliers and Customers)
 Inputs to Mapping
 Brainstorming and operator knowledge / experience
 Operator manuals / standard work instructions
 Customer specifications
 5Ms + 1E - Machine (Equipment), Methods (Procedures & Instructions),
Measurement (Gages & Data Collection), Materials (Raw Materials &
Information), Manpower (Personnel), Environment (Mother Nature)
 Excel Template
 Process Variables Map – Template.xls
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Process Variables Map – Template
Process:<Name of Process>
Process Inputs Type Process Step Output
INPUTS Input 1
Process Step 1
Think 5 M's & 1 E Input 2
Man Input 3
Machine Input 4
Material Input 5
Method Input 6
Measure Input 7
Environment Input 8
Type: Input 1
Process Step 2
C = Controlled Input 2
NC = Not Controlled Input 3
Input 4
Input 5
Input 6
Input 7
Input 8
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Step 1: Identify Process Steps & Key Tasks
 Include all value-added and non value-added steps and key tasks
 Hint: Process Step Names are verbs or gerunds
Manufacturing: SMT Assembly
Answer Phone
Greet customer –
Gather customer
Information – Collect
order details – Provide
delivery time
Complete Order Form
Complete and enter
order information into
order management
system
Make Pizza
Prepare & make
pizza – Package
Pizza
Deliver Pizza
Transport Pizza to
customer’s location
Service: Pizza Delivery
Print Solder Paste
Print solder paste on
Printed Circuit Board
(PCB)
Place Components
Place components
on PCB
Inspect PCB
Inspect presence of
components and
solder joints
Reflow PCB
Reflow PCB in
reflow oven
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Outputs
Print Solder
Paste
Print solder paste
on PCB
Paste Location
Paste Amount
Paste Volume
…
Component Presence
Component Type
Component Location
Component Orientation
…
Place
Components
Place components
on PCB
Step 2: List Critical Outputs for each Process Step
Hint: Outputs should
be measurable
criteria of the process
step
Include both process and product outputs
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Outputs
Time to answer
Accuracy of
customer info
Order / quantity
Delivery time
Accuracy of order
information
Accuracy of
pricing info
Speed to
complete form
Step 2: List Critical Outputs for each Process Step
Answer Phone
Greet customer
Get customer
information
Get order
information
Time needed
Complete
Order Form
Complete & enter
into production
system
Outputs
Outputs
Temperature of
the pizza
Time to complete
Time to deliver
Correct quantity
Correct order
Pizza Temperature
Pizza Condition
Make Pizza
Prepare and make
pizza
Package
Label customer’s
pizza
Deliver Pizza
Transport pizza
to customer’s
location
Outputs
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Step 3: List & Classify Process Inputs
 List all Process Inputs (usually specific attributes of the input which
could be the cause of a problem or failure mode) for each process
step
 Classify Inputs
 Controlled (C): These are inputs that you adjust or control while
the process is running (Examples: speed, feed rate, pressure,
temperature, experience level of worker, data system size)
 Uncontrolled (U): Noise variables. These are things you cannot,
or do not currently, control (Examples: ambient temperature,
humidity, order quantity, training hours of worker)
 Could be due to the expense or difficulty controlling them
This step is where the team should spend most of its time.
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Outputs
Print
Solder Paste
Print solder paste
on PCB
Paste Location
Paste Amount
Paste Volume
…
Step 3: List & Classify Process Inputs
Inputs Type
Solder Paste Type C
Solder Paste Viscosity C
Stencil Condition C
Operator Experience C/U
Paste Printing Machine C/U
Preventive Maintenance C
Ambient Temperature U
Ambient Humidity U
…
Outputs
Answer Phone
Greet customer
Get customer
information
Get order
information
Time needed
Time to answer
Accuracy of customer
information
Order / quantity
Delivery time
Information from customer C
Greeting script C
Answering procedure C
Telephone system U
Number of calls U
Inputs Type
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Step 4: Add Internal & External Specifications
 Document any known operating specification or requirements for
each Input and Output if applicable
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Case Study Group Work 4
The Task:
 Develop a Process Variables Map for the “Coffee Making Process” or one of
your own processes following the 4 Steps just discussed, to identify “all”
possible causes.
 Capture your Process Variables Map using the Excel template or a flip chart
and be prepared to share your results with the rest of the group.
30 Minutes
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Problem Statement:
 The initial question “What’s wrong with what?” has been answered?
 The “5 Why’s” were used to asking questions “Do we know for certain
why this is occurring?”
 A final problem statement (or specific root cause) has been defined
(object and defect) and documented?
Problem Description:
 A thorough “IS – IS NOT” Analysis has been performed (what, where,
when, how big) and documented?
 The problem description has been confirmed as to what
the Customer and/or affected party(s) are experiencing?
 Physical evidence of the problem has been obtained?
“Phase D2” Checklist Questionnaire
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“Phase D2” Checklist Questionnaire
Problem Description (cont.):
 Determination has been made as to whether this problem describes a
“Change-Induced” or a “Day-One-Deviation” situation?
 A Process Flow Chart & Fishbone Diagram or a Process Variables Map
has been developed, documented and verified to identify possible
causes?
 Process detail has been reviewed to determine where this problem first
appears?
 Problem pattern(s) has been considered / evaluated?
 Similar components and/or parts have been reviewed for
the same problem?
 All required data has been collected and analyzed?
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“Phase D2” Checklist Questionnaire
Project Management:
 The Project Champion has reviewed and supports the problem
description (if applicable)?
 Necessity of reviewing the problem with the Executive or Functional
Management Team has been evaluated?
 Consideration has been made for setting aside financial resources?
 All required resources are part of the team or accessible to
the team as required?
 The 8D Problem Solving Process Worksheet & Project Documentation
has been updated?
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8D Problem Solving Process Report – Phase D2
…
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1
• Establish the Team
2
• Describe the Problem
3
• Develop Interim Containment Actions
4
• Define and Verify Root Causes and Escape Points
5
• Choose and Verify Permanent Corrective Actions
6
• Implement and Validate Permanent Corrective Actions
7
• Prevent Recurrence
8
• Recognize Team and Individual Contributions
The 8D Problem Solving Process
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“Develop Interim Containment Actions” Key Activities
Purpose: Define, verify and implement Interim Containment Action to isolate
the effects of the problem from any internal and/or external Customer until
Permanent Corrective (Preventive) Action are implemented.
 Define potential Interim Containment Action
 Verify effectiveness of potential Interim Containment Action
 Select and implement Interim Containment Action
 Validate effectiveness of implemented Interim
Containment Action with the Customer
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Key Concepts of Interim Containment Actions
 Typically chosen without much data or knowledge about the situation.
 Temporary “fix” that works against the effect of the problem.
 Protects the downstream process or the Customer from the effect of the
problem.
 Contains the problem from a cost, quality, timing perspective.
 “Buys time” to identify and resolve the root cause of the problem.
 Needs normally to be documented.
 Is not a “Band Aid”, which may be forgotten.
 …
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Interim Containment Actions - Examples
By its nature, an Interim Containment Action will normally be expensive to
implement as it will probably involve an additional process being introduced
and could include:
 100% Inspection
 Rework
 Sorting good from bad
 Field service action
As you can be seen, any one of these actions would add considerable cost,
however are necessary to protect the customer.
Remember that some of the above actions are not 100% effective, even 100%
inspection is subject to variation.
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PDCA or Deming Management Cycle
The “Develop Interim Containment Actions” Phase follows the PDCA Cycle
1. Plan
(Plan & Re-Plan)
2. Do
(Implement)
3. Check
(Monitor)
4. Act
(Evaluate)
Deming
PDCA Cycle
Determine which steps
must be completed to
achieve the plan’s
objectives by the target
date.
Implement and manage
the implementation
plan.
Record the results of
the implementation
phase.
Evaluate the results
and decide if additional
actions need to be
developed.
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“Phase D3” Checklist Questionnaire
Before Implementation:
 The need for a Interim Containment Action has been determined?
 Consultation with the Customer and/or Champion has been
conducted to establish criteria for the Interim Containment Action
selection?
 Based on the criteria established, the Interim Containment Action
provides the best balance of benefit and risk?
 The Interim Containment Action protects the Customer 100% from the
effect of the problem?
 The Interim Containment Action has been verified?
 The Interim Containment Action is cost effective and easy
to implement?
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“Phase D3” Checklist Questionnaire
Planning:
 Appropriate departments have been involved in the planning of the
Interim Containment Action
 Plans, including action steps, have been developed considering who
needs to do what by when?
 The Customer’s viewpoint has been considered for the Interim
Containment Action
 The Customer’s approval has been obtained?
 A validation method for the Interim Containment Action has been
determined?
Post Implementation:
 The validation data indicates that the Customer is being
protected from the symptom of the problem?
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8D Problem Solving Process Report – Phase D3
…
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1
• Establish the Team
2
• Describe the Problem
3
• Develop Interim Containment Actions
4
• Define and Verify Root Causes and Escape Points
5
• Choose and Verify Permanent Corrective Actions
6
• Implement and Validate Permanent Corrective Actions
7
• Prevent Recurrence
8
• Recognize Team and Individual Contributions
The 8D Problem Solving Process
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“Define and Verify Root Causes” Key Activities
Purpose: Isolate and verify the root cause by testing each root cause theory
against the Problem Description and test data. Isolate and verify the place in
the process where the effect of the root cause could have been detected and
contained but was not (escape point).
 Establish any additional data collection plans needed to learn more about
the problem and/or possible causes.
 Utilize the Fishbone Diagram or Process Variables Map created earlier to
identify the most likely cause(s).
 Isolate and verify the most likely cause(s) by testing each Root Cause
Theory against the Problem Description and the
collected data.
 Isolate and verify the place in the process where the
effect of the root cause could have been detected
and contained but was not (escape point).
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“You’re neither right not wrong because people
agree with you. You’re right because your facts
and your reasoning are right.“
Warren Buffett – Investor & Billionaire
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Identifying Most Likely Causes
 Symptom – A quantifiable event or effect, experienced by a Customer
(internal & external), that may indicate the existence of one or more problems.
 Problem – A deviation from an expectation or standard; a perceived gap
between the existing state and a desired state. In the context of the 8D
Problem Solving Process the cause(s) of the problem is not known.
 Possible Cause – Any cause, identified for example through Process Variables
Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem
or Failure Mode effect may occur.
 Most Likely Cause – A cause, identified based on available or collected
data, that best explains the Problem Description or Failure Mode.
 Root Cause – A verified cause that convincingly supports and explains
ALL facts available and thus accounts for the problem; verified passively
and actively, by making the problem come and go. Root causes are the
fundamental, underlying reasons for a Problem or Failure Mode, e.g.
management policies, product design, system design, process capabilities,
technology constraints, unclear or wrong standard operating procedures, and
human errors.
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Strategies to identify “Most Likely Causes”
Eliminating Possible Causes or identifying Most Likely Causes
through
 Process Knowledge
 Experience with similar Situations or Processes
 Logbooks of past Events
 Checks and Audits
 5 Whys Analysis
 Comparative Analysis (Distinctions & Changes)
 Correlation Analysis (Box Plots & Scatter Plots & …)
 Process Failure Mode and Effects Analysis
 …
Possible Causes Most Likely Causes
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Comparative Analysis
 The Comparative Analysis is the third part of the 8D Problem Solving
Process Worksheet.
 The Comparative Analysis connects the facts from the Problem Description
(“IS – IS NOT” Matrix) with the analysis of possible and most likely causes
using the Process Flowchart and the C&E Matrix or Why-Why Diagram or
Fishbone Diagram, as well as any other information and data available.
 Step 1: Compare each “IS” with its corresponding/contrasting “IS NOT”. List
any known distinctions and uncommon factors that could explain the “IS”
and “IS NOT”.
 Ask: What is unique, odd, different, distinctive, unusual about the “IS”?
 Consider the most likely causes identified so far.
 Step 2: List all known changes in distinctions and uncommon factors.
 Ask: What has changed in, on, around or about this distinction and
uncommon factors?
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Comparative Analysis - Example
 Problem Description:
 IS – The Red Makers leak
 IS NOT – The Blue Markers could leak, but are not
 Comparative Analysis:
 Distinctions
 1. Different Color Plastic,
 2. Different Color Ink,
 3. Strawberry Scent in Red Marker
 Changes
 1. New Plastic Supplier (5 weeks ago),
 2. Added Powder to Red Marker (2.5 weeks ago)
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Comparative Analysis
PROBLEM SOLVING PROCESS WORKSHEET
Problem Statement
(What is wrong with what?):
Red Felt Tip Marker Leaks
IS IS NOT DISTINCTIONS CHANGES
TEST FOR MOST LIKELY CAUSES
(+) (-) (?)
Describe what does occur
Describe what does not occur, but
could occur
What could explain the IS-IS NOT?
(People, Methods, Material,
Machines, Environment)
What has changed in, on, around
or about this distinction?
When did it change?
<Define Possible Root Cause
Theory>
What?
Object: Red felt tip marker Blue, black or green marker
Defect: Leaks Totally dry
Where? Tip Barrel (side or base)
Where is the object when the
defect is observed? Where is the
defect on the object? Are there
any pattern or trends
identifiable?
… …
When? First seen two weeks ago Before two weeks ago
When was the defect observed
first? Can or was the defect be
observed before, during or after
other events? When since has
the defect occurred? Are there
any pattern or trends
identifiable?
… …
How Big?
All red felt tip markers
(100%)
Just some red felt tip markers (less
than 100%)
How many objects have the
defect? What is the size of a
single defect? How many
defects are on each object? Are
there any pattern or trends
identifiable?
… …
1
1
1
1
2
2
2
2
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Case Study Group Work 5
The Task:
 Review the “Felt Tip Marker” Case Study (Part 3) thoroughly.
 Perform a Comparative Analysis on the “Felt Tip Marker” Case Study.
 Be prepared to share your results with the rest of the group.
20 Minutes
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Two Types of Data
 Attribute Data - Discrete Data
– Categories
– Good / bad
– Machine 1, Machine 2, Machine 3
– Shift number
– Anything counted
The type of data will determine the tools that can be used.
 Continuous Data - Variable Data
– Time and money are continuous
– Pressure
– Speed
– Height and weight
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Correlation between a Process Input and Output
Process Input = Most Likely Cause
Discrete Continuous
DiscreteContinuous
ProcessOutput=Problem Chi-Square
Analysis
Logistic
Regression
Box Plot
Diagram
Scatter Plot
Diagram
Depending on the data type, different analytical tools can be used to verify
a relationship or correlation between a Process Input or Most Likely Cause
and a Process Output resulting in the problem that needs to be solved.
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The Scatter Plot
A Scatter Plot is a graph of plotted points that shows the relationship
between a continuous process input (X) and a continuous process output (Y).
An 8D Problem Solving Team believes that “X = Temperature ºC” is a root cause for
an increase/decrease in “Y = Ice Cream Sales $”?
0
100
200
300
400
500
600
700
10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0
IceCreamSales(in$)
Temperature (in C)
Scatter Plot – Example & Exercise
Ice Cream Sales
14.2 C
$215
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Scatter Plot – Example
0
100
200
300
400
500
600
700
10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0
IceCreamSales(in$)
Temperature (in C)
Scatter Plot - Example
Ice Cream Sales
What would be the estimated ice cream
sales when the temperature is 13ºC?
What would be the estimated ice cream
sales when the temperature is 22ºC?
Regression Line
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Scatter Plot – A little Bit of Statistics
 With a little bit of statistics we can build a simple equation or model to
predict the “Ice Cream Sales (in $)” for every “Temperature (in ºC)”.
Ice Cream Sales (in $)” = m × Temperature (in ºC) + c
 To determine the parameters “m” and “c”, we need two data points (x → y)
from our regression line, for example (13 ºC → $205) and (22 ºC → $500).
𝑚 =
(𝑦2 − 𝑦1)
(𝑥2 − 𝑥1) =
𝑐 = 𝑦1 − 𝑚 × 𝑥1 =
 How much “Ice Cream Sales (in $)” is our model predicting when the
“Temperature (in ºC)” is 19 ºC ?
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The Box Plot
A Box Plot is a graph of plotted points that shows the relationship between
a discrete process input (X) and a continuous process output (Y).
Input X
Y=
Upper 25%
of Data
Points
Median &
Middle 50% of
Data Points
25%
25%
Lower 25%
of Data
Points
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Box Plot – Example
An 8D Problem Solving Team is tasked with improving the productivity of a
specific work area. The Team believes that the productivity is different for the
three shifts working in this work area and that a root cause is related to the
different work practices the three shifts are using.
Shift 3Shift 2Shift 1
90
85
80
75
70
65
60
Shift
Productivity
Daily Productivity per Shift
(July & August 2013)
107 2/11/2013 v8.0
Fishbone Diagram – Most Likely Causes
Reviewing the Fishbone Diagram created in Phase D2, the team tries to reduce
the large number of possible causes to a short list of most likely causes, using the
Problem Description, Comparative Analysis, data analysis and the team’s
combined process knowledge and experience.
Remember, the root cause(s) convincingly supports and explains ALL facts available
and thus accounts for the problem. So, you need to ask yourself “If this would be
the root cause of the problem, would it explain the Problem Description?”
4M’s = MEN
METHODS
MATERIALS
MACHINES
+ ENVIRONMENT
4P’s = PEOPLE
PLANT
POLICIES
PROCEDURES
Machines
Materials Methods
Environment
Trunk
Primary Possible Cause Category
Main Branch
Minor Branch
Second-Level
Possible Causes
Men/People
Problem Statement
Most Likely
Cause #1
Most Likely
Cause #3
Most Likely
Cause #2
108 2/11/2013 v8.0
Outputs
Print
Solder Paste
Print solder paste
on PCB
Paste Location
Paste Amount
Paste Volume
…
Inputs Type
Solder Paste Type C
Solder Paste Viscosity C
Stencil Condition C
Operator Experience C/U
Paste Printing Machine C/U
Preventive Maintenance C
Ambient Temperature U
Ambient Humidity U
…
Process Variables Map – Most Likely Causes
Most Likely
Cause #1
Most Likely
Cause #2
Similar, using the Process Variables Map created in Phase D2, the team tries to
reduce the large number of possible causes to a short list of most likely causes,
using the Problem Description, Comparative Analysis, data analysis and the
team’s combined process knowledge and experience.
109 2/11/2013 v8.0
Process Failure Mode and Effects Analysis
A Process Failure Mode and Effects Analysis (Process FMEA) is …
 Key tool for process development or improvement teams to identify in
a preemptive manner (before failures occur) all the ways an existing
or new process can fail
An 8D Problem Solving Team utilizes the Process Failure Mode and
Effects Analysis to …
 Analyze and document how critical process inputs can fail and
impact the performance of a process
 Determine possible causes for the failure of critical process inputs
 Identify deficiencies in existing process controls
 Establish the priority of improvement actions
110 2/11/2013 v8.0
Process FMEA – Inputs and Outputs
 Inputs
 Process Flowchart & Fishbone Diagram
 Process Variables Map
 Process Knowledge
 Process Technical Procedures
 Process Operating Procedures
 Outputs
 Potential Failure Modes of critical process inputs, as well as their
impact on process performance and their causes
 List of current process controls to prevent these causes or at
least to their detect failure modes as early as possible
111 2/11/2013 v8.0
Process FMEA – Failure Mode Definition
 The way in which a particular process input being assessed fails or
could fail
 If not detected and either corrected or removed, the undesirable
effect or problem will occur
 Can relate to a product defect or a process input variable that goes
out of specification or fails to perform
 Anything the operator sees as wrong can be a Failure Mode or a
Potential Failure Mode
The Process FMEA scope may be limited to only those Failure
Modes that relate to a specific problem, OR
The Process FMEA may consider anything that could go wrong.
112 2/11/2013 v8.0
Process FMEA – Failure Mode Examples
 Too much / too high / too wide / too late / too fast
 Too little / too low / too thin / too early / too slow
 Too variable / Too much variation
 Cracked / deformed / blemished / dirty / bent / burred
 Incorrect / incomplete information
 Inaccurate reading
 Missed phone call
 Short-circuited / open-circuited / cross-wired
 Set up incorrectly
 Unclear / mistyped
 Incorrect syntax
113 2/11/2013 v8.0
Process FMEA – Effect Definition
 Impact on customer requirements
 Directly resulting from the failure mode
 Frequently external customer focused
 Can also include downstream processes
 State (in physical terms when applicable) what the Customer
(internal or external) will experience
 One Failure Mode can have more than one Effect
 EACH effect should be listed separately
The Effect is the Consequence of the Failure Mode: IF the Failure
Mode occurs, THEN the Effect will happen?
114 2/11/2013 v8.0
Process FMEA – Effect Examples
 Customer complaint (state the specific complaint)
 Fails to meet specification (state the specification)
 Product return / warranty claim (specify problem)
 Scrap / Rework (specify problem)
 Cannot fasten / mount / attach / align
 Does not fit / connect / match / turn on
 Noise
 Damages equipment
 Injures or endangers operator / customer / patient
 Inaccurate data
 Delay
115 2/11/2013 v8.0
Process FMEA – Cause Definition
 One or more variations in the process that lead to the occurrence of
the Failure Mode
 Intent is to identify all the Mechanisms of Failure that are relevant to
the Process FMEA scope
 Should be defined in terms of something that can be controlled or
corrected
 Should be described specifically enough that remedial action can be
identified
 Some causes may require further investigation and data analysis
(Scatter Plot, Box Plot, Hypothesis Testing, Designed Experiments, …)
Note that this is documenting the causes of the Failure Mode, NOT
the causes of the Effect.
116 2/11/2013 v8.0
Process FMEA – Cause Examples
 Improper torque / weld / seal
 Inaccurate measurement / reason code
 Incorrect part, material, or information
 Missing or mislocated part, material, or information
 Wrong procedure / Misunderstood procedure
 Inadequate or insufficient training (on what?)
 Insufficient staffing
 Operator fails to install seal / end user enters data incorrectly (NOT just
“Operator Error”)
 Thermocouple out of calibration (NOT just “Mechanical Problem”)
 Data base field definition incorrect / no connectivity between data bases
 Illegible instructions / hand written information
117 2/11/2013 v8.0
Process FMEA – Current Controls Definition
 Systems, methods, or devices currently in place to prevent causes
from occurring or detect failure modes before they cause the
undesirable effects or minimize the effect
 Prevention consists of mistake proofing (Poka-Yoke), statistical
process control, preventive maintenance, automation, set-up
controls, …
 Controls consists of audits, inspection, laboratory or inline testing,
training, standard operating procedures, work instructions, ...
Which is the better form of process improvement:
Prevention or Detection?
118 2/11/2013 v8.0
Process FMEA – A Step by Step Procedure
1. For each Process Input identified as a most likely cause of the
problem you are trying to solve, determine the ways in which the
process input can go wrong (Failure Modes)
2. For each Failure Mode associated with the process inputs,
determine the Effects of the failures on the customer (internal or
external)
3. Identify potential Causes of each Failure Mode
4. List the Controls you are currently using to prevent each Cause or
to detect the resulting Failure Mode
5. Determine and highlight those potential Causes that could result in
the Failure Mode or Effect you try to eliminate or minimize through
the 8D Problem Solving Process
119 2/11/2013 v8.0
Process FMEA – Summary
Key Process
Input
What is the Key
Process Input?
Potential Failure Mode
In what ways does the
Key Input go wrong?
Potential Failure Effects
What is the Impact on the
Key Output Variables
(Customer Requirements)
Or Internal requirements?
Potential Causes
What causes the Key
Input to go wrong?
Current Controls
What are the existing
Controls and
Procedures (inspection
and test) that prevent
either the cause or the
Failure Mode? Should
include an SOP
Number.
Actions
Recommended
What are the actions
for reducing the
occurrence of the
Cause, or improving
detection? Should
have actions only on
high RPN’s or easy
fixes.
What
is the
Input?
What
can go
wrong
with the
Input?
What is
the Effect
on the
Output(s)?
What are
the
Causes?
What can
be done?
How can
these be
detected or
prevented?
Potential Failure Mode Potential Failure Effects Potential Causes Current Controls Actions
Recommended
120 2/11/2013 v8.0
Process FMEA – An Example
Process Step Key Process Input Failure Mode Effect Cause Current Control
The Process Step
related to the Key
Process Input
What could cause
the Problem?
What can go
wrong?
What is the result of
the Failure Mode?
What could cause the
Failure Mode?
How do we prevent the
Cause or detect the
Failure Mode?
Print Solder Paste
Solder Paste
Viscosity
Viscosity too low
Short-circuit of
solder joints
Storage
temperature too
high
Refrigerator & daily
temperature check
(WI 1234)
Ambient
temperature too
high
None
Storage duration at
work station too
long
Date & time label on
each container &
check label at
beginning of each
shift (WI 6789)
Viscosity too
high
Insufficient solder
joints
Storage
temperature too low
Refrigerator & daily
temperature check
(WI 1234)
Ambient
temperature too low
None
Open solder joints
Storage
temperature too low
Refrigerator & daily
temperature check (WI
1234)
Ambient
temperature too low
None
121 2/11/2013 v8.0
Case Study Group Work 6
The Task:
 Select 2-3 Key Process Inputs as “Most Likely Causes” from your
Process Variable Map for the Coffee Making Process or your own
process
 Develop a Process FMEA for each of the 2-3 “Most Likely Causes”
using the template or flipchart paper and Post-It Notes
 Be prepared to share your results with the rest of the group
Process Step Process Input Failure Mode Effect Cause Current Control
30 Minutes
122 2/11/2013 v8.0
Process FMEA – Risk Priority Number (RPN)
Effects Causes Controls
 The RPN is calculated based on information the team provides
regarding
 the severity of the effects,
 the frequency of the potential failure modes, and
 the current ability of the process to detect the failures before reaching
the customer
 RPNs are not universal or fixed
 Scales can be locally developed – just need to be consistent
RPN = Severity X Occurrence X Detection
123 2/11/2013 v8.0
Process FMEA – Risk Assessment Scale
Rating Severity of Effect Likelihood of Occurrence Ability to Detect
10 Hazardous without warning
Very high:
Can not detect
9 Hazardous with warning
Failure is almost inevitable
Very remote chance of detection
8 Loss of primary function
High:
Remote chance of detection
7
Reduced primary function
performance
Repeated failures
Very low chance of detection
6 Loss of secondary function
Moderate:
Low chance of detection
5
Reduced secondary function
performance
Occasional failures
Moderate chance of detection
4
Minor defect noticed by most
customers
Moderately high chance of detection
3
Minor defect noticed by some
customers Low:
High chance of detection
2
Minor defect noticed by
discriminating customers
Relatively few failures
Very high chance of detection
1 No effect Remote: Failure is unlikely Almost certain detection
124 2/11/2013 v8.0
Process FMEA – Summary
Key Process
Input
What is the Key
Process Input?
Potential Failure Mode
In what ways does the
Key Input go wrong?
Potential Failure Effects
What is the Impact on the
Key Output Variables
(Customer Requirements)
Or Internal requirements?
S
E
V
Howsevereistheeffect
tothecustomer?
Potential Causes
What causes the Key
Input to go wrong?
O
C
C
Howoftendoescause
ofFMoccur?
Current Controls
What are the existing
Controls and
Procedures (inspection
and test) that prevent
either the cause or the
Failure Mode? Should
include an SOP
Number.
D
E
T
Howwellcanyou
detectcauseorFM?
R
P
N
Actions
Recommended
What are the actions
for reducing the
occurrence of the
Cause, or improving
detection? Should
have actions only on
high RPN’s or easy
fixes.
What
is the
Input?
What
can go
wrong
with the
Input?
How
Bad?
S
E
V
What is
the Effect
on the
Output(s)?
How
Often?
What are
the
Causes?
O
C
C
What can
be done?
How
well?
How can
these be
detected or
prevented?
D
E
T
Potential Failure Mode Potential Failure Effects Potential Causes Current Controls Actions
Recommended
125 2/11/2013 v8.0
Process FMEA – An Example with RPN
8D Problem Solving Process - Process Failure Mode & Effects Analysis
Process Step Key Process Input Failure Mode Effect Cause Current Control
The Process Step
related to the Key
Process Input
What could cause
the Problem?
What can go
wrong?
What is the result of
the Failure Mode?
SEV
What could cause the
Failure Mode?
OCC
How do we prevent the
Cause or detect the
Failure Mode?
DET
RPN
Print Solder Paste
Solder Paste
Viscosity
Viscosity too low
Short-circuit of
solder joints
5
Storage temperature
too high
6
Refrigerator & daily
temperature check
(WI 1234)
2 60
5
Ambient
temperature too
high
5 None 10 250
5
Storage duration at
work station too
long
4
Date & time label on
each container &
check label at
beginning of each shift
(WI 6789)
3 60
Viscosity too
high
Insufficient solder
joints
3
Storage temperature
too low
4
Refrigerator & daily
temperature check
(WI 1234)
2 24
3
Ambient
temperature too low
3 None 10 90
Open solder joints 7
Storage temperature
too low
4
Refrigerator & daily
temperature check
(WI 1234)
2 56
7
Ambient
temperature too low
3 None 10 210
126 2/11/2013 v8.0
Process FMEA – Quiz
Sev Occ Det RPN Result Action
1 1 1 1 Ideal Situation No Action
1 1 10 10
10 1 1 10
10 1 10 100
1 10 1 10
1 10 10 100
10 10 1 100
10 10 10 1000 Big trouble! Emergency action!
127 2/11/2013 v8.0
Identifying Root Causes
 Symptom – A quantifiable event or effect, experienced by a Customer
(internal & external), that may indicate the existence of one or more problems.
 Problem – A deviation from an expectation or standard; a perceived gap
between the existing state and a desired state. In the context of the 8D
Problem Solving Process the cause(s) of the problem is not known.
 Possible Cause – Any cause, identified for example through Process Variables
Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem
or Failure Mode effect may occur.
 Most Likely Cause – A cause, identified based on available or collected
data, that best explains the Problem Description or Failure Mode.
 Root Cause – A verified cause that convincingly supports and explains
ALL facts available and thus accounts for the problem; verified passively
and actively, by making the problem come and go. Root causes are the
fundamental, underlying reasons for a Problem or Failure Mode, e.g.
management policies, product design, system design, process capabilities,
technology constraints, unclear or wrong standard operating procedures, and
human errors.
128 2/11/2013 v8.0
Root Cause Theory Testing
The basic question you need to ask is:
If ___________ is the cause of _____________, how does
that explain both the IS and IS NOT?
 Ask about each IS / IS NOT pair
 Eliminate any possible causes that fail
 List all assumptions made
129 2/11/2013 v8.0
Root Cause Theory Testing
 Step 1: Use the 8D Problem Solving Process Worksheet, supported by the
Process Variables Map or Fishbone Diagram and any additional data analysis
used, to formulate Root Cause Theories based on the identified most likely
cause(s) of the problem.
 Step 2: Enter a short description of a Root Cause Theory as header into the last
column of the 8D Problem Solving Process Worksheet.
 Step 3: Assess the Root Cause Theory against each “IS” – “IS-NOT” statement.
 Enter a “+” if the theory explains or does not conflict with the “IS”–“IS-NOT”
statement.
 Enter a “-” if the theory conflicts with the “IS”–“IS-NOT” statement.
 Enter a “?” if you are not sure and further investigation may be necessary.
 The Root Cause(s) convincingly supports and explains ALL “IS”–“IS-NOT”
statements and thus accounts for the problem.
130 2/11/2013 v8.0
Root Cause Theory Testing
PROBLEM SOLVING PROCESS WORKSHEET
Problem Statement
(What is wrong with what?):
Red Felt Tip Marker Leaks
IS IS NOT DISTINCTIONS CHANGES
TEST FOR MOST LIKELY CAUSES
(+) (-) (?)
Describe what does occur
Describe what does not occur, but
could occur
What could explain the IS-IS NOT?
(People, Methods, Material,
Machines, Environment)
What has changed in, on, around or
about this distinction? When
did it change?
<Define Possible Root Cause
Theory>
What?
Object:
Defect:
Where?
Where is the object when the
defect is observed? Where is the
defect on the object? Are there
any pattern or trends identifiable?
When?
When was the defect observed
first? Can or was the defect be
observed before, during or after
other events? When since has the
defect occurred? Are there any
pattern or trends identifiable?
How Big?
How many objects have the
defect? What is the size of a single
defect? How many defects are on
each object? Are there any
pattern or trends identifiable?
2
3
3
3
3
+ - ?
131 2/11/2013 v8.0
Root Cause Theory Testing - Example
PROBLEM SOLVING PROCESS WORKSHEET
Problem Statement
(What is wrong with what?):
Red Felt Tip Marker Leaks
IS IS NOT DISTINCTIONS CHANGES
TEST FOR MOST LIKELY CAUSES
(+) (-) (?)
Describe what does occur
Describe what does not occur, but
could occur
What could explain the IS-IS NOT?
(People, Methods, Material,
Machines, Environment)
What has changed in, on, around or
about this distinction? When
did it change?
<New Plastic Supplier - Plastic is
too porous … ink leaks through.>
What?
Object: Red felt tip marker Blue, black or green marker
Red Plastic - Red Ink - Strawberry
Scent (2.5 weeks ago)
New Plastic Supplier (5 weeks ago) -
Added Powder (2.5 weeks ago)
(-)
Defect: Leaks Totally dry …
Where? Tip Barrel (side or base) (-)
Where is the object when the
defect is observed? Where is the
defect on the object? Are there
any pattern or trends
identifiable?
… … …
When? First seen two weeks ago Before two weeks ago (-)
When was the defect observed
first? Can or was the defect be
observed before, during or after
other events? When since has
the defect occurred? Are there
any pattern or trends
identifiable?
… … …
How Big? All red felt tip markers (100)
Just some red felt tip markers (less
than 100)
(+)
How many objects have the
defect? What is the size of a
single defect? How many defects
are on each object? Are there
any pattern or trends
identifiable?
… … …
132 2/11/2013 v8.0
Case Study Group Work 7
The Task:
 Develop & test 2 - 3 Root Cause Theories for the “Felt Tip Marker”
Case Study.
 Be prepared to share your results with the rest of the class.
20 Minutes
133 2/11/2013 v8.0
Root Cause Verification
 Active Verification is a process where …
 … the problem solver uses the variable thought to be the root cause to
make the effect come and go. Both coming and going are important tests
to confirm root causes.
 Passive Verification is done by observation.
 With passive verification, you look for the presence of the root cause
without changing anything. If you cannot prove the presence of the root
cause, then chances are great that this most likely cause is not the root
cause.
Step 1: Identify, document and perform a passive and/or active
root cause verification method.
Step 2: Continue with the 8D Problem Solving Process if the
passive and/or active root cause verification was successful.
Otherwise, develop and test additional Root Cause Theories.
134 2/11/2013 v8.0
Escape Point Identification
Step 1: Using the Process Flowchart, identify Escape Point(s)
for the verified root cause(s).
Step 2: Determine if Control Points were missing or ineffective
to detect the root cause of the problem at the escape point.
Control System: A control system is a system deployed to monitor the product
or process and ensure compliance to Customer requirements. It consists of
responsibilities, procedures and resources. You may have one or more control
points where the product or process is checked.
Control Point: A control point is a location within the control system where the
product or process is checked for compliance to certain specified require-
ments. There may be multiple locations within a control system.
Escape Point: The escape point is the earliest location in the process, closest
to the root cause, where the problem could have been detected, but was not.
135 2/11/2013 v8.0
“Phase D4” Checklist Questionnaire
Root Cause(s):
 The factual information in the Problem Description has been updated?
 Differences unique to the “IS” when compared to the “IS NOT” have
been identified?
 For a “Change-Induced” problem, changes in or around the differences
have been uncovered?
 The root cause theories developed have been tested against each “IS”
- “IS NOT” statement?
 The final root cause theory accounts for all “IS” - “IS NOT” statements?
 For multiple root causes, the causes were reviewed to
determine if, collectively, they account for all of the problem
description?
 The root cause(s) was/were verified passively and actively?
136 2/11/2013 v8.0
“Phase D4” Checklist Questionnaire
Escape Points:
 The process flow was reviewed and control points associated with the
root cause(s) identified.
 A determination was made as to the existence of a control system to
detect the problem?
 If a control system exists, changes from its original design (if any) have
been identified?
Project Management:
 The Project Champion has reviewed and supports the
analysis, findings and conclusions?
 8D Problem Solving Process Worksheet & Project
Documentation has been updated?
137 2/11/2013 v8.0
8D Problem Solving Process Report – Phase D4
…
138 2/11/2013 v8.0
1
• Establish the Team
2
• Describe the Problem
3
• Develop Interim Containment Actions
4
• Define and Verify Root Causes and Escape Points
5
• Choose and Verify Permanent Corrective Actions
6
• Implement and Validate Permanent Corrective Actions
7
• Prevent Recurrence
8
• Recognize Team and Individual Contributions
The 8D Problem Solving Process
139 2/11/2013 v8.0
“Choose Permanent Corrective Actions” Key Activities
Purpose: Select the best Permanent Corrective Actions to remove the root
cause and to address the escape point in the process. Verify that both
decisions will be successful when implemented and not cause any undesirable
effects.
 Develop solution(s) to remove the root cause(s)
 Develop solution(s) to address the escape point(s)
 Select the best solution(s) to remove the root cause(s)
 Select the best solution(s) to address the escape point(s)
 Verify that effectiveness of the selected solutions
 Verify that selected solutions do not cause any
undesirable effects
140 2/11/2013 v8.0
Many Human Errors are designed into the Process
Reducing & Eliminating
Human Error needs more
than additional Training
141 2/11/2013 v8.0
1. Adjustments
2. Constant equipment / software
changes
3. Dimensionality / spec / critical
condition
4. Many parts / mixed parts
5. Multiple steps
6. Lack of or ineffective standards
7. Rapid repetition
8. High volume
9. Environmental conditions:
A. Material handling
B. Housekeeping
C. Foreign matter
D. Poor lighting
E. Other
10. Other?
Where to spot potential for mistakes …
142 2/11/2013 v8.0
Two Ways of Dealing with Human Errors
 Human Errors are inevitable !!!
Errors can´t be avoided. People will always make mistakes.
 Human Errors can be eliminated !!!
Any kind of mistake people make can be reduced or even eliminated.
People make fewer mistakes if they are supported by a production system
based on the principle that human errors can be prevented.
 An organizations must establish a “mistake-proofing
mindset” that promotes the belief that it is
unacceptable to allow for even a small number of
product or service defects caused by human errors.
143 2/11/2013 v8.0
Sixteen Human Error Modes
1. Omission
2. Excessive / insufficient repetition
3. Wrong order
4. Early / late execution
5. Execution of restricted work
6. Incorrect selection
7. Incorrect counting
8. Misrecognition
9. Failing to sense danger
10. Incorrect holding
11. Incorrect positioning
12. Incorrect orientation
13. Incorrect motion
14. Improper holding
15. Inaccurate motion
16. Insufficient avoidance
144 2/11/2013 v8.0
1. Omission
→ What part of the process is prone to be omitted?
2. Excessive / Insufficient Repetition
→ What part of the process is prone to be excessively repeated?
3. Wrong Order or Sequence
→ In what wrong sequence can the process be executed?
4. Early / Late Execution
→ What execution can be early or late?
5. Execution of Restricted Work
→ What tasks could be executed by unauthorized personnel?
Sixteen Human Error Modes
145 2/11/2013 v8.0
6. Incorrect Selection (or Identification)
→ What object of the process is prone to be incorrectly selected or
identified?
7. Incorrect Counting (or Calculating)
→ What objects of the process can be counted, measured or
calculated incorrectly?
8. Misrecognition (or Misunderstanding or Misreading)
→ What misunderstanding or misreading is prone to occur?
→ What information, risk or failure/error is prone to be overlooked?
→ What miscommunication is prone to occur?
→ What incorrect decision is prone to occur?
Sixteen Human Error Modes
146 2/11/2013 v8.0
9. Failure to Sense Danger
→ What information, risk or failure/error is prone to be overlooked?
10. Incorrect Holding
→ What object of the process are prone to mishandling?
11. Incorrect Orientation
→ What orientation error is prone to occur?
12. Incorrect Positioning
→ What positioning setting error is prone to occur?
13. Incorrect Motion
→ What motion or movement error is prone to occur?
Sixteen Human Error Modes
147 2/11/2013 v8.0
14. Improper Holding
→ What object of the process are prone to mishandling?
15. Inaccurate Motion
→ What motion or movement error is prone to occur?
16. Insufficient Avoidance
→ What can be unintentionally touched, stuck or splashed?
→ What movement can cause harm?
Sixteen Human Error Modes
148 2/11/2013 v8.0
Six Mistake Proofing Principles
1. Elimination seeks to eliminate an error-prone process step by
redesigning the product or process so that the task or part is no longer
necessary.
Example: An example of elimination is the use of ambient-
light sensors to turn outside lighting on and off.
2. Prevention modifies the product or process so that it is impossible to
make a mistake or that a mistake becomes a defect.
Example: An example would be the change from a rectangular to a
round manhole.
149 2/11/2013 v8.0
Six Mistake Proofing Principles
3. Replacement substitutes a more reliable process to improve
repeatability. This includes use of robotics or automation that prevents
a manual assembly error.
Example: An example would be the coin dispenser in food
stores preventing that customers are getting short changed.
4. Facilitation is the most used principle and employs techniques and
combining steps to make a process step easier to perform or less error-
prone. This includes visual controls including color coding, marking or
labeling parts; checklists that list all tasks that need to be performed;
exaggerated asymmetry to facilitate correct orientation of parts.
Example: An example would be to color code parts that are similar in
shape or the use of a slipping-type torque wrench to prevent over
tightening.
150 2/11/2013 v8.0
Six Mistake Proofing Principles
5. Detection involves identifying a mistake before further processing
occurs so that the operator can quickly correct the defect.
Example: Examples would include a weld counter to ensure the correct
number of welds or a software modification that will not allow incorrect
entries.
6. Mitigation seeks to minimize the effects of the mistake. This includes
mechanisms that reduce the impact of a error and defect; products
designed with low-cost, simple rework procedures when an error is
discovered; extra design margin or redundancy in products to
compensate for the effects of errors.
Example: An example would be a smoke or heat detector
detecting a hazardous situation.
151 2/11/2013 v8.0
Poka (= inadvertent error) - Yoke (= avoid)
devices help us avoid defects, even when inadvertent errors are
made.
Poka - Yoke Devices help build Quality
into Processes and Products
Human Errors – Poka-Yoke Devices
The term Poka-yoke (poh-kah yoh-keh) was coined in
Japan during the 1960s by Shigeo Shingo who was one
of the industrial engineers at Toyota.
Toyota: 80-90% of problems
are resolved on the floor
152 2/11/2013 v8.0
Five Key Mistake-Proofing Methods
 Variation Control  Facilitation & Prevention
Use of special jigs, fixtures, or assembly tools that reduce the variation of how parts
are manufactured or assembled
 Workplace Organization  Facilitation
Error prevention by proper organization of the workplace or work station; e.g.
implementation of a 5S Visual Workplace Organization Program
 Identification  Facilitation
Errors are prevented by use of clearly written, visual and easily available materials,
work instructions and tools
 Process Checks  Prevention & Detection
Performance of specific in-process checks to prevent errors, incl. SPC or Pre-Control
 Poka - Yoke Devices  Prevention & Detection
Ensures mistake and errors cannot become defects by automatically detecting error
conditions and immediately rejecting the part or shutting down the process. Poka-
Yoke devices work best when a specific step must be taken to re-start the process
once a mistake or error has been detected.
153 2/11/2013 v8.0
Characteristics of a Good Poka-Yoke Device
Good Poka-Yoke devices, regardless of their implementation, share
many common characteristics:
 they are simple and cheap. If they are too complicated or
expensive, their use will not be cost-effective.
 they are part of the process, implementing what Shingo calls
"100% inspection”.
 they are placed close to where the mistakes occur, providing
quick feedback to the workers so that the mistakes can be
corrected.
154 2/11/2013 v8.0
1. Guide “Pins” of Different Size & Shape
2. Error Detection and Alarms
3. Limit Switches
4. Sensors
5. Vision Systems
6. Counters and Timers
7. Checklists
Human Errors – Seven Best Poka-Yoke Devices
155 2/11/2013 v8.0
Seven Best Poka-Yoke Devices – Guide Pins
1. Guide Pins
Guide pins of different sizes and/or shapes and placed in the proper locations ensure
that parts are being assembled correctly by providing the operator feedback when a
mistake has been made. Guide pins can also be used in jigs to ensure proper
positioning of the part.
Applications
• Proper alignment of a work piece
• Proper orientation of a work piece
Features
• Easy to develop & implement
• May be the result of DFA and DFM activities
(Product Quality Planning)
Human Error Prevention
• wrong order, incorrect selection, incorrect positioning, incorrect orientation, …
156 2/11/2013 v8.0
2. Error Detection & Alarms
In general, an error detection device can provide a visual alarm such as a flashing light
or an audible alarm such as a horn or siren.
These devices signal that a problem is either about to occur or has just happened. With
a warning effect, the response is not automatic; someone has to take action.
Application
• The signal must be triggered by something in the process, usually a sensor.
Features
• For audible warnings, there are sirens, horns, bells, and even voice synthesizers.
• For visual alarms, there are lights that flash, rotate, strobe, or just light up.
Warning: If you do use warnings, the audible or visual signal must stand out from
background noise and lights. If audible alarms are used, be careful not to exceed noise
standards.
Be careful of “alarm silence buttons.” It is easy to silence the alarm and then forget to
take action. Operators need thorough training on how to react to warnings.
Seven Best Poka-Yoke Devices – Error Detection/Alarms
157 2/11/2013 v8.0
3. Limit Switches
Limit switches are electro-mechanical devices that are activated or deactivated when an
object comes in contact with them. They are used to detect the presence or absence of
an object.
Applications
• Proper positioning of safety devices
• Detection presence or absence of an object
• Positioning of a work piece
Features
• Requires physical contact
Human Error Prevention
• Omission, excessive/insufficient repetition, incorrect selection, incorrect counting,
incorrect positioning, incorrect orientation
Seven Best Poka-Yoke Devices – Limit Switches
158 2/11/2013 v8.0
4.1 Proximity Sensors
Proximity sensors emit a high-frequency magnetic field and detect an upset in the field
when an object enters it. They can be used to detect the presence or absence of an
object.
Applications
• Sensing of tank or bin level
• Confirmation of part or object passes by
• Detection presence or absence of object
• Positioning of work piece
Features
• Non-contact - Work in harsh environments - Small sensors are available for
installation in tight areas - Fast response speed
Human Error Prevention
• Omission, excessive/insufficient repetition, incorrect selection, incorrect counting,
incorrect positioning, incorrect orientation, …
Seven Best Poka-Yoke Devices – Sensors
159 2/11/2013 v8.0
4.2 Laser Displacement Sensors
Laser displacement sensors focus a semiconductor laser beam on a target and use the
reflectance of the beam off the target to determine the presence of a target and distance
to it.
Applications
• Measuring distance
• Detection of presence or absence of a feature
• Confirmation of part or object passes by
• Positioning of work piece
Features
• Non-contact - Works in harsh environments - Some devices can achieve
measurement precision down to .004 mils (0.1µm).
Human Error Prevention
• Omission, incorrect selection, incorrect counting, failing to sense danger, …
Seven Best Poka-Yoke Devices – Sensors
160 2/11/2013 v8.0
5. Vision Systems
Vision systems use cameras to look at a surface and then compare the surface viewed to a
“standard” or reference surface stored in the computer. They can be used to detect the
presence or absence of an object, the presence of defects, or to make distance
measurements.
Applications
• Missing or incorrect parts in an automated assembly line
• Poor quality surfaces or components
• Correct orientation of parts or labels
• Ensure correct relative position
• Color detection
Features
• Non-contact - Need to have sufficient light - Flexible (can be reprogrammed for a variety
of applications) - Compact systems are now available.
Human Error Prevention
• Omission, incorrect selection, incorrect positioning, incorrect orientation, misrecognition,
…
Seven Best Poka-Yoke Devices – Vision Systems
Checking for Label Presence,
Color, Orientation, & Alignment.
161 2/11/2013 v8.0
6. Counters & Timers
Counters (optical or electro-mechanical) look at the occurrence of events. They are usually
triggered by some type of sensor. Counters can be programmed to shut down the process
if a set number of events do not occur or if too many events do occur. Timers can shut
down the process if processing time or activity time does not meet or exceeds a preset
level.
Applications
• Ensuring the proper number of events occurred
• Preventing failure of equipment or a component
by timing usage
Features
• Flexible - Easy to use - Easy for people to understand
Human Error Prevention
• excessive/insufficient repetition, incorrect counting, incorrect positioning, incorrect
orientation, …
Seven Best Poka-Yoke Devices – Counters & Timers
Correct Number of Holes
162 2/11/2013 v8.0
7. Checklists
A checklist is a type of informational job aid used to reduce failure by compensating for
potential limits of human memory and attention. It helps to ensure consistency and
completeness in carrying out a task.
Applications
• Shift Start-up
• Product Changeover
• Equipment Set-up
Features
• Easy to develop - Easy to use - Easy for people to understand
Human Error Prevention
• omission, early/late execution, wrong order, misrecognition, …
Seven Best Poka-Yoke Devices – Checklists
163 2/11/2013 v8.0
Human Errors → Poka-Yoke Examples
SIM cards only fit one way. The
right way.
Expose your team to (simple) everyday Mistake-Proofing devices
and examples and make them think about how they could use
these concepts in their own work area.
To which of the seven Poka-Yoke categories does this
solution belong to?
164 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
Never forget your cell phone again.
«Pick to Light»: on an assembly line, if the above light
is green means that you must take the piece. If the
light above the rack is red means that you must not
take that piece.
165 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
Some of you may not remember. I still do and have
lost (and found) a few of them.
Does it fit. Error detection and defect
prevention. → Limit Switches
166 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
It only fits one way by using guide pins and
asymmetric product design. → Guiding “Pin”
Human Error prevention through a visual
workplace.
167 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
An oil change facility puts the dip stick on the
fender protector.
Removing the fender protector will cause the
dip stick to clatter on the floor unless it has been
reinserted. → Workplace Organization
After a patient died from receiving a medication
that was not properly diluted, all of that medication
was diluted before being stored. → Pre-Kitting
168 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
Human Error detection through
automated defect detection devices
such as sensors, limit switches, scales,
… .
Getting the torque on bolts right is very tricky
business for many companies. Huck fasteners
mistake-proof this problem using a hybrid: half
“pop-rivet,” half bolt.
The tension on the bolt is created in a linear fashion
and the “nut” is clamped in place and the excess
bolt length is cut off.
169 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
Well Designed garage door openers have two
safety features: (1) a contact safety reverse
feature, which opens the door if it hits a person or
object, and (2) an infrared beam across the
doorway that causes the door to reverse
automatically if a person or pet who passes
through the beam.
A company called Metric Blue offers metric bolts
tinted blue. Why blue? So that when you have
mixed metric and inch-series parts and fasteners it
is easier to determine which standard you are
working with. Company literature says, “by
differentiating the metric fasteners (and tools)
through our "blue" coating, we've eliminated the
risk of failure or accidents due to mismatched
components.”
170 2/11/2013 v8.0
Human Errors → Mistake-Proofing Examples
Consumer friendly Mistake-Proofing product
design improves usability and Customer
Satisfaction.
… and many more.
Preventing missing weld nuts, with a sensor
linked to a visual & audio alarm. Process will
stop automatically and a corrective action is
required.
171 2/11/2013 v8.0
Case Study Group Work 8
10 Minutes
 Identify and describe 2 or 3 Poka-Yoke devices for the “Coffee
Making Process” or your own process (current in use or could
be used) to prevent likely causes or to detect failure modes.
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
172 2/11/2013 v8.0
Solution Selection Matrix – Basic Example
• Effectiveness Effectiveness of the solution to resolve the root cause or escape
point of the problem
• Cost in local currency Cost to implement the solution
• Time in weeks Time to implement the solution
• Resources Yes = enough resources (own)
Partly = not enough own resources, but more available in the
organization
No = no resources available in the organization
SOLUTION # 1
SOLUTION # 2
SOLUTION # 3
SOLUTION # 4
Effectiveness Cost Time Resources
70 %
90 %
50 %
65 %
20 000
52 000
24 000
18 000
14
5
12
15
Yes
Partly
No
Yes
Global 8D Problem Solving Process Training Module
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Global 8D Problem Solving Process Training Module
Global 8D Problem Solving Process Training Module
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Global 8D Problem Solving Process Training Module

  • 1. 1 2/11/2013 v8.0 The 8D (Disciplines) Problem Solving Process by Operational Excellence Consulting LLC
  • 2. 2 2/11/2013 v8.0 8D Problem Solving Process – History  The 8D Problem Solving methodology despite what is generally thought has not been created by Ford but by the U.S. Department of Defense (DOD) in 1974. The standard, which described the 8D, was named: “MIL-STD 1520 Corrective Action and Disposition System for Nonconforming Material”.  In the late 1990s, Ford developed a revised version of the 8D Problem Solving Process that they call "Global 8D" (G8D) which is the current global standard for Ford and many other companies in the automotive supply chain.  The 8D Problem Solving Process has been employed significantly outside the auto industry. As part of lean initiatives and continuous-improvement processes it is employed extensively in the food manufacturing, health care, and high-tech industries.
  • 3. 3 2/11/2013 v8.0 The purpose of this workshop is to introduce you to the 8D Problem Solving Process and provide you and your team with an effective methodology and the basic tools to identify the underlying root cause(s) of a problem or performance gap. We will have a simple case study throughout the course so that you can apply and practice the key learning points. Learning Outcome: • Understanding the 8D Problem Solving Process • Describe the purpose and objective of each phase of the 8D Problem Solving Process • Understand and apply key problem-solving tools in each phase of the 8D Problem Solving Process • Use of assessing questions at the end of each phase of the 8D Problem Solving Process General Objectives & Key Learning Points
  • 4. 4 2/11/2013 v8.0 Challenge #1 – Fire Fighting vs. Problem Solving Fire Fighting is associated with the “Heroic Mentality” Fire Fighting Problem Solving Perception – Memory – Emotion Data – Information – Analysis Problem Description & Analysis The cause is defined in relation to the symptom The cause is defined in relation to the true problem Root Cause Analysis The solution is applied to the “obvious” cause The solution is applied & verified to the “root” cause(s) Solution Development
  • 5. 5 2/11/2013 v8.0 Challenge #2 – Making the Investment
  • 6. 6 2/11/2013 v8.0 Challenge #3 – If it ain’t broke …
  • 7. 7 2/11/2013 v8.0 Problem Solving Process - The Terminology  Symptom – A quantifiable event or effect, experienced by a Customer (internal & external), that may indicate the existence of one or more problems.  Problem – A deviation from an expectation or standard; a perceived gap between the existing state and a desired state. In the context of the 8D Problem Solving Process the cause(s) of the problem is not known.  Possible Cause – Any cause, identified for example through Process Variables Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem or Failure Mode effect may occur.  Most Likely Cause – A cause, identified based on available or collected data, that best explains the Problem Description or Failure Mode.  Root Cause – A verified cause that convincingly supports and explains ALL facts available and thus accounts for the problem; verified passively and actively, by making the problem come and go. Root causes are the fundamental, underlying reasons for a Problem or Failure Mode, e.g. management policies, product design, system design, process capabilities, technology constraints, unclear or wrong standard operating procedures, and human errors.
  • 8. 8 2/11/2013 v8.0 Why Armies of Knights Lose Battles? Loss of Battle Loss of Rider Loss of Horse Loss of Shoe Loss of Nail …
  • 9. 9 2/11/2013 v8.0 Why Armies of Knights Lose Battles? Cause SymptomProblem Window of Consideration Loss of Nail Loss of Shoe Loss of Rider Loss of Horse Loss of Battle
  • 10. 10 2/11/2013 v8.0 The 8D Problem Solving Process – Benefits  High Performance Work Teams 8D Problem Solving Teams play a key role in their organization by being empowered to find root causes, implement corrective actions, prevent any recurrence and recommend process improvements. These teams have the authority, responsibility and accountability for solving the problem.  Process Excellence By using a standard process to solve problems and communicate lessons learned across the organization, teams can become more efficient and effective, which means that problems will be solved quickly.  Customer Satisfaction By identifying the symptoms, implementing emergency response actions, and protecting the internal and external Customers from adverse effects of the problem, teams can resolve problems and achieve Customer Satisfaction.
  • 11. 11 2/11/2013 v8.0 Problem Solving Process - The Tool Box “If the only tool you have is a hammer, every problem looks like a nail.” Abraham Maslow → You need the right tools for the right tasks.
  • 12. 12 2/11/2013 v8.0 The 8D Problem Solving Process – What is Needed?  The symptom has been defined and quantified.  The Customer who experienced the symptom has been identified.  Measurements taken to quantify the symptom demonstrate that a performance gap exist, and/or the priority (severity, urgency, growth) of the symptom requires initiation of the process.  The cause(s) of the problem or performance gap is unknown.  Management is committed to dedicate the necessary resources to fix the problem at the root-cause level and to prevent recurrence.  Symptom complexity exceeds the ability of one person to resolve the problem.
  • 13. 13 2/11/2013 v8.0 “Never use a cannon to kill a fly.” - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Ground Fruit Logic, Intuition and Basic Tools - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Low Hanging Fruit Basic Tools, 8D Problem Solving and Lean Bulk of Fruit 8D Problem Solving, Lean and Six Sigma = Opportunity Process Entitlement Sweet or Stretch Fruit Lean, Six Sigma and Design for Six Sigma
  • 14. 14 2/11/2013 v8.0 The 8D (Disciplines) Problem Solving Process 1 • Establish the Team 2 • Describe the Problem 3 • Develop Interim Containment Actions 4 • Define and Verify Root Causes and Escape Points 5 • Choose and Verify Permanent Corrective Actions 6 • Implement and Validate Permanent Corrective Actions 7 • Prevent Recurrence 8 • Recognize Team and Individual Contributions
  • 15. 15 2/11/2013 v8.0 An 8D Problem Solving Process Report
  • 16. 16 2/11/2013 v8.0 The 8D Problem Solving Process 1 • Establish the Team 2 • Describe the Problem 3 • Develop Interim Containment Actions 4 • Define and Verify Root Causes and Escape Points 5 • Choose and Verify Permanent Corrective Actions 6 • Implement and Validate Permanent Corrective Actions 7 • Prevent Recurrence 8 • Recognize Team and Individual Contributions
  • 17. 17 2/11/2013 v8.0 Purpose: Establish a small group of people with the process and/or product knowledge, allocated time, authority, and skills in the required technical disciplines to solve the problem and implement corrective actions.  Review the problem or improvement opportunity  Review priorities, scope and complexity  Identify if a team is needed  Identify team members and establish the team  Nominate a team leader and project champion  Establish basic team guidelines  Consider team building exercises “Establish the Team” Key Activities
  • 18. 18 2/11/2013 v8.0 Problem Solving & Improvement Project Selection  Is the problem or improvement opportunity related to the organization’s strategic and operational objectives?  Does the problem impact customer satisfaction?  Does a Champion or Owner exist that is responsible for the problem?  Do we have the resources (people, time, money) to successfully complete the project?  Is there an objective measure or metrics in place to be improved?  Can the project been completed in a reasonable amount of time?  What is the likelihood of success?  … Every organization should develop its own Project Selection Criteria to ensure it works on the right projects at the right time.
  • 19. 19 2/11/2013 v8.0 The Champion Role When championing a project and project team, you  have ownership of the system or process under consideration  have authority to make changes  make resources available to the team  remove barriers that hold the team back from solving the problem  challenge and/or support team decisions  attend meetings as required  use appropriate questions to monitor the team’s progress  create an environment for empowerment of the team  celebrate, recognize & reward the team after successfully solving the problem
  • 20. 20 2/11/2013 v8.0 The Team Leader Role When leading, you  are the team’s business manager and spokesperson  work with the team to set objectives and tasks  ask for and summarize member’s opinions  direct the use of the 8D Problem Solving Process  focus on the meeting’s purpose and agenda  may give information to the team  direct and facilitate decision-making  summarize decisions  explicitly give up the leadership role when participating in the discussion  …
  • 21. 21 2/11/2013 v8.0 The Team Member Role When acting as a team member, you  provide technical input  carry out assignments  offer information and ideas  give descriptive feedback  clarify issues  …
  • 22. 22 2/11/2013 v8.0 The Facilitator Role When facilitating, you  ensure that all members have the opportunity to contribute  focus on how the team is working together  give and ask descriptive feedback  act as team builder  focus on team maintenance  draw attention to communication skills  ensure the team starts and finishes effectively  help team members to increase awareness of, and make contact with, each other  …
  • 23. 23 2/11/2013 v8.0 Basic Team Guidelines Develop Basic Team Guidelines that the team commits to …  Talk from personal experience and examples  Speak to, not about, people present  Say “I” – not “we”, “you”, “one”, “the team”, …  Say “I would like …” or “it would help me if …” – not “you should …” or “we should …”  Make statements before questions  Trace opinions to observations  Describe not judge  Restate and build on proposals  Recognize that feelings affect team meetings  …
  • 24. 24 2/11/2013 v8.0 New York University NYU – Our Code
  • 25. 25 2/11/2013 v8.0 The Problem Solving Team:  Are the people affected by the problem represented?  Does each person have a reason for being on the team?  Do the team members agree on membership?  Is the team large enough to include all necessary inputs, but small enough to act effectively?  The Champion of the team has been identified?  The Team Leader has been identified?  Need for a Facilitator to coach the process has been considered?  Have all the roles and responsibilities been reviewed and are agreed upon? “Phase D1” Checklist Questionnaire
  • 26. 26 2/11/2013 v8.0 8D Problem Solving Process Report – Phase D1
  • 27. 27 2/11/2013 v8.0 The 8D Problem Solving Process 1 • Establish the Team 2 • Describe the Problem 3 • Develop Interim Containment Actions 4 • Define and Verify Root Causes and Escape Points 5 • Choose and Verify Permanent Corrective Actions 6 • Implement and Validate Permanent Corrective Actions 7 • Prevent Recurrence 8 • Recognize Team and Individual Contributions
  • 28. 28 2/11/2013 v8.0 Purpose: Describe the internal or external problem by identifying “what is wrong with what” and detailing the problem in quantifiable terms.  Develop a Problem Statement  Develop a Problem Description using the “IS – IS NOT Matrix”  Develop a flowchart of the process and identify critical process steps with respect to the Problem Description  Develop a Fishbone Diagram or Process Variables Map to identify possible causes?  Determine whether this problem describes a “something changed” or a “never been there” situation  Establish a high-level project plan, including milestones, project goals and objectives “Describe the Problem” Key Activities
  • 29. 29 2/11/2013 v8.0 Problem Solving in “Dilbert Inc.” “What’s is the Problem we need to solve?”
  • 30. 30 2/11/2013 v8.0 “If I had an hour to save the world I would spend 59 minutes defining the problem and one minute finding solutions.” Albert Einstein
  • 31. 31 2/11/2013 v8.0 How would you get started? Company ABC produces a part for an automotive manufacturer. The length of the part is critical and needs to be between 60mm and 72mm. Unfortunately, the Customer has complaint now several times over the last 3 months that some of the parts from company ABC are too long. This causes major equipment issues at the Customer’s production facility. How would you get started? ________________________________________________________ ________________________________________________________ ________________________________________________________
  • 32. 32 2/11/2013 v8.0 How would you get started? Company ABC produces a part for an electronics manufacturer. Unfortunately, a major Customer has complaint several times in the last 2 months over late deliveries. This causes major production shortages at the Customer’s production facility. How would you get started? ________________________________________________________ ________________________________________________________ ________________________________________________________
  • 33. 33 2/11/2013 v8.0 How would you get started? The Finance Manager of Company ABC contact the Operations Managers to discuss the significant amount of scrap cost the company incurs every month. The company currently is not able to meet its cost targets due to the huge amount of material that needs to be scrap and the additional costs due to rework or new production. In some cases this also results in late orders and thus causes Customer complaints. How would you get started? ________________________________________________________ ________________________________________________________ ________________________________________________________
  • 34. 34 2/11/2013 v8.0 Run Chart & Example  Visualizes the process performance over time  Helps identify trends or shifts over time  Allows tracking process performance against set goals 94.0% 94.5% 95.0% 95.5% 96.0% 96.5% 97.0% 97.5% 98.0% 98.5% On-Time Delivery 2012 (Direct & Non-Stock Orders) Series1
  • 35. 35 2/11/2013 v8.0 Pareto Chart & Example  Helps to define which problems should be solved and in which order  Presents the 20/80 – Rule  20% of the problems often create 80% of all the costs and/or complaints  Analyzes defect categories over a specific time frame (e.g. 3 months) Missing Part Position Incorrect Part Broken Wrong Color Stains Others Number of Defects 40 15 10 8 6 11 Cum. Percentage 44% 61% 72% 81% 88% 100% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 5 10 15 20 25 30 35 40 45 50 Pareto Chart - Outgoing Inspection Defects Number of Defects Cum. Percentage You may need to define meaningful defect categories and categorize your data, before you can determine which problems to solve first
  • 36. 36 2/11/2013 v8.0 Histogram A histogram provides graphical presentation and a first estimation about the location or center, spread and shape of the distribution of the process. 0 10 20 30 40 50
  • 37. 37 2/11/2013 v8.0 How to create Histogram? Step 1: Collect at least 50 data points, but better 75 to 100 points, and organize your data into a table. Sort the data points from smallest to largest and calculate the range, means the difference between your largest and smallest data point, of your data points. Actual Measurements Part Hole Size 1 2.6 2 2.3 3 3.1 4 2.7 5 2.1 6 2.5 7 2.4 8 2.5 9 2.8 10 2.6 Sorted Measurements Part Hole Size 5 2.1 2 2.3 7 2.4 6 2.5 8 2.5 1 2.6 10 2.6 4 2.7 9 2.8 3 3.1 Minimum = 2.1 Maximum = 3.1 Range = 1.0
  • 38. 38 2/11/2013 v8.0 How to create Histogram? Step 2: Determine the number of bars or bins to be used to create the histogram of the data points. Calculate the width of one bar by dividing the range of your data by the number of bars selected. Number of Bars: less than 50 50 - 100 100 - 250 over 250 5 or 7 5, 7, 9 or 11 7 - 15 11 - 19 Number of Data Points: Minimum = 2.1 Maximum = 3.1 Range = 1.0 Bar Width = 0.2 (5 Bars)
  • 39. 39 2/11/2013 v8.0 How to create Histogram? Step 3: Calculate the “start” and “end” point of each bar and count how many data points fall between “start” and “end” point of each bar. Start End Bar 1 2.1 2.1 + 0.2 = 2.3 Bar 2 2.3 2.5 Bar 3 2.5 2.7 Bar 4 2.7 2.9 Bar 5 2.9 3.1 Minimum = 2.1 Maximum = 3.1 Range = 1.0 Bar Width = 0.2 (5 Bars) Sorted Measurements Part Hole Size Bar 5 2.1 1 2 2.3 2 7 2.4 2 6 2.5 3 8 2.5 3 1 2.6 3 10 2.6 3 4 2.7 4 9 2.8 4 3 3.1 5
  • 40. 40 2/11/2013 v8.0 How to create Histogram? Step 4: Draw the histogram indicating by the height of each bar the number of data points that fall between the “start” and “end” point of that bar. Sorted Measurements Part Hole Size Bar 5 2.1 1 2 2.3 2 7 2.4 2 6 2.5 3 8 2.5 3 1 2.6 3 10 2.6 3 4 2.7 4 9 2.8 4 3 3.1 5 0 1 2 3 4 5 NumberofDataPoints 2.1 2.3 2.5 2.7 2.9 3.1
  • 41. 41 2/11/2013 v8.0 Histogram – Different Patterns of Variation 1. The bell-shaped distribution: Symmetrical shape with a peak in the middle of the range of the data. Some process outcomes fall outside the acceptable limits. Solving this problem requires reducing the normal variation of the process through the application of the Six Sigma roadmap and tools. 2. The double-peaked distribution: A distinct valley in the middle of the range of the data with peaks on either side. This pattern is usually a combination of two bell-shaped distributions and suggests that two distinct processes (e.g. machine, operator, method, material, …) are at work. Solving this problem requires the identification of the root cause for the two distribution using the 8D Problem Solving Process and tools. LSL USL LSL USL
  • 42. 42 2/11/2013 v8.0 Histogram – Different Patterns of Variation 3. Outliers: The normal process is of symmetrical shape with a peak in the middle of the range of the data (Type 1). However, several process outcomes are very different from the normal process results and are causing the problem. Solving this problem requires the identification of the root cause for the two distribution using the 8D Problem Solving Process and tools. LSL USL What can cause outliers in your process? ________________________________________________________ ________________________________________________________ ________________________________________________________
  • 43. 43 2/11/2013 v8.0 There are two steps to develop a good Problem Statement. The first step is used to identify the object and the defect and develop the initial Problem Statement. The object and the defect are defined by asking “What is wrong with what?”  “What is wrong?” is the defect  The defect is an unwanted characteristic present in a product or process – broken, missing, wrong, too short, …  “… with what?” is the object  The object is the name given to a specific product, process or service that exhibits the defect The Problem Statement (Step 1)
  • 44. 44 2/11/2013 v8.0 Identifying Possible Causes  Symptom – A quantifiable event or effect, experienced by a Customer (internal & external), that may indicate the existence of one or more problems.  Problem – A deviation from an expectation or standard; a perceived gap between the existing state and a desired state. In the context of the 8D Problem Solving Process the cause(s) of the problem is not known.  Possible Cause – Any cause, identified for example through Process Variables Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem or Failure Mode effect may occur.  Most Likely Cause – A cause, identified based on available or collected data, that best explains the Problem Description or Failure Mode.  Root Cause – A verified cause that convincingly supports and explains ALL facts available and thus accounts for the problem; verified passively and actively, by making the problem come and go. Root causes are the fundamental, underlying reasons for a Problem or Failure Mode, e.g. management policies, product design, system design, process capabilities, technology constraints, unclear or wrong standard operating procedures, and human errors.
  • 45. 45 2/11/2013 v8.0 The 5 Why’s Description: The 5 Why’s Analysis helps to identify the final problem statement or in some cases even the root cause. It helps to distinguish between the symptom of a problem and the problem itself and it encourages the team to reach an answer that is fundamental and actionable. Procedure: Step 1: Develop an initial problem statement of the specific problem to be solved. Write it in the upper left corner of a piece of paper, flip chart or white board. Step 2: Ask “Why?” this problem does or could occur. Write the cause (object & defect) underneath the initial problem statement. Step 3: The cause identified in Step 2 now becomes a new problem statement. Repeat Step 2 and ask “Why?”, e.g. “Why would this situation occur?", again. Step 4: Continue Step 2 and Step 3 until you cannot for certain answer the question or reach an answer that is fundamental and actionable.
  • 46. 46 2/11/2013 v8.0 The Problem Statement (Step 2) Once the initial problem statement (object & defect) is established, the second step is to use the “5 Why’s” and ask “Why would this situation occur?” or “Why is that happening to that object?” The objective is to refine the initial problem statement to  determine the problem, rather than the symptom of the problem  focus efforts on a single problem with a single root cause  get as near as possible to the root cause using existing knowledge & information  check if the root cause of the problem is really unknown Result #1 - If you are certain that you have found the root cause, then you can immediately go to Phase 4 “Define and Verify Root Cause” and test your root cause theory. Result #2 - If the cause is unknown and there is a need to find the root cause, then the last object and defect with an unknown cause is the final Problem Statement.
  • 47. 47 2/11/2013 v8.0 Problem Statement – Example 1 What is the Problem Statement (Object & Defect)? WHY? → The tool was not in inventory. WHY? → The Supplier did not deliver the replacement tools. WHY? → The Supplier did not receive our Purchase Order on-time. WHY? → We did not submit the Purchase Order on time. WHY? → We did not have the “right” rework tool. WHY? → We don’t know. Initial Problem Statement Final Problem Statement
  • 48. 48 2/11/2013 v8.0 Problem Statement – Example 2 What is the Problem Statement (Object & Defect)? WHY? → The door frame had been “over-ground”. WHY? → Team member did not use the grinder properly. WHY? → Customer is complaining. Initial Problem Statement Actionable Cause WHY? → There are grinding marks on the door frame. WHY? → Team member was not properly trained. → Most Likely Cause or Root Cause
  • 49. 49 2/11/2013 v8.0 Developing a Problem Statement Problem Statement: ____________________________ Problem Statement: ____________________ The Computer “dumps its memory”. The Fuse blows.
  • 50. 50 2/11/2013 v8.0 Case Study Group Work 1 The Task:  Read the introduction to the “Felt Tip Marker” Case Study  Develop the Problem Statement for the Case Study 5 Minutes
  • 51. 51 2/11/2013 v8.0 “Change-Induced” vs. “Day-One-Deviation” Change Performance SHOULD Past Present DEVIATION Performance ACTUAL Performance SHOULD Present DEVIATION Day One When the process performance once met the SHOULD and no longer does, then you have a “Change-Induced” problem. When a condition required for achieving the SHOULD never existed, then you have a “Day-One-Deviation” problem.
  • 52. 52 2/11/2013 v8.0 The Problem Description The Problem Description defines the boundaries of the problem, in terms of what it is and what it is not but could be. Scientific description of any event can be made by providing information on  What the problem is and what it is not but could be? - Identity  IS - The long brackets are missing,  IS NOT - The short brackets are not missing (but could be)  Where the problem is and where it is not but could be? - Location  IS - The order entry defects are in direct ship orders  IS NOT - The order entry defects are not in stock orders (but could be)  When the problem occurs and when it does not but could? - Timing  IS - The clips started breaking in early 2010  IS NOT – The clips did not break before early 2010 (but could have)  How big the problem is and how big it is not but could be? - Size  IS - About 50% of the paychecks  IS NOT – Not all paychecks are incorrect (but could be)
  • 53. 53 2/11/2013 v8.0 Case Study Group Work 2 The Task:  Define “What?” – “Where?” – “When?” – “How Big?” questions should John and his organization asked to develop a good Problem Description for the “Felt Tip Marker” Case Study Problem?  Capture your questions on a flip chart and be prepared to share your results with the rest of the group. 15 Minutes
  • 54. 54 2/11/2013 v8.0 The “IS – IS NOT” Matrix PROBLEM SOLVING PROCESS WORKSHEET Problem Statement (What is wrong with what?): Red Felt Tip Marker Leaks IS IS NOT DISTINCTIONS CHANGES TEST FOR MOST LIKELY CAUSES (+) (-) (?) Describe what does occur Describe what does not occur, but could occur What could explain the IS-IS NOT? (People, Methods, Material, Machines, Environment) What has changed in, on, around or about this distinction? When did it change? <Define Possible Root Cause Theory> What? Object: Defect: Where? Where is the object when the defect is observed? Where is the defect on the object? Are there any pattern or trends identifiable? When? When was the defect observed first? Can or was the defect be observed before, during or after other events? When since has the defect occurred? Are there any pattern or trends identifiable? How Big? How many objects have the defect? What is the size of a single defect? How many defects are on each object? Are there any pattern or trends identifiable? 1 2 3 4 5 2 3 4 5
  • 55. 55 2/11/2013 v8.0 The “IS – IS NOT” Matrix The “IS – IS NOT” Matrix in the 8D Problem Solving Process Worksheet identifies where to start looking for possible causes by isolating the what, when, where and how big about the problem statement. Step 1: Enter the Problem Statement. Step 2: Use the “IS” column to describe what objects are effected and what the defect is. Use the “IS NOT” column to describe what could be effected and occur but does not. Step 3: Use the “IS” column to describe where the event occurs. This can be geographical, physical, or on an object. Use the “IS NOT” column to describe where the problem could occur but does not. Step 4: Use the “IS” column to describe when the problem occurs. When did it happen first? What pattern of reoccurrence? Also, when the event occurs in relation to other events. Use the “IS NOT” column to describe when the problem could occur but does not. Step 5: Use the “IS” column to describe the extent of the problem. How many objects or occurrences had problems? How many problems? How serious are they? Use the “IS NOT” column to describe how big or small the problem could be but is not.
  • 56. 56 2/11/2013 v8.0 Case Study Group Work 3 The Task:  Review the “Felt Tip Marker” Case Study (Part 2) thoroughly  Develop & document the Problem Description for the Case Study  Capture your “Is – Is Not” statements on a flip chart and be prepared to share your results with the rest of the group. 20 Minutes
  • 57. 57 2/11/2013 v8.0 Identifying Possible Causes  Symptom – A quantifiable event or effect, experienced by a Customer (internal & external), that may indicate the existence of one or more problems.  Problem – A deviation from an expectation or standard; a perceived gap between the existing state and a desired state. In the context of the 8D Problem Solving Process the cause(s) of the problem is not known.  Possible Cause – Any cause, identified for example through Process Variables Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem or Failure Mode effect may occur.  Most Likely Cause – A cause, identified based on available or collected data, that best explains the Problem Description or Failure Mode.  Root Cause – A verified cause that convincingly supports and explains ALL facts available and thus accounts for the problem; verified passively and actively, by making the problem come and go. Root causes are the fundamental, underlying reasons for a Problem or Failure Mode, e.g. management policies, product design, system design, process capabilities, technology constraints, unclear or wrong standard operating procedures, and human errors.
  • 58. 58 2/11/2013 v8.0 Identifying “All” Possible Causes To learn more about a specific problem and to identify “all” possible causes, the 8D Problem Solving Team needs to better understand the process that causes the problem. These tools work very well in a team environment to ensure that everyone has a voice and every voice is being heard. Select the Fishbone Diagram or Process Variables Map based on the problem you need to solve and/or your personal or team’s preference. The following tools are widely used to facilitate this activity.  Process Flowchart Map and  Fishbone Diagram or Process Variables Map
  • 59. 59 2/11/2013 v8.0 Process Mapping → Two Types of Process Maps Most problem solving projects will require a process map, as most problems are associated with a process that is failing. The team needs to understand how that process works or at least is intended to work, as well as identify all process inputs and critical process outputs. 1. Process Flowchart Map  Focuses on the activities of the process and the sequence of these activities  A graphical description of a work flow or activities using standard symbols for each of the activities 2. Process Variables Map  Focuses on the inputs and outputs of a process and its steps  Critical first step towards successful process improvement through identifying, reducing, and removing “sources of variation”
  • 60. 60 2/11/2013 v8.0 Objectives of a Process Flowchart Map A Process Flowchart is a graphical process description of the work flow or activities using standard symbols for each of the activities. Different types of activities are described with standard symbols. The problem areas in the process are often relatively easy to discover when assessing the flowchart. An ellipse shows the start and the end point of the process. A box describes an activity or process step. A diamond shows a decision making step. An arrow shows the direction from one activity to another.
  • 61. 61 2/11/2013 v8.0 Preparing a Process Flowchart Map  Team Effort  Process Owners / Leaders, Workers, Supervisors, Technicians / Engineers / Developers, Upstream and Downstream Representatives (Suppliers and Customers)  Inputs to Mapping  Brainstorming and operator knowledge / experience  Operator manuals / standard work instructions  Process Control Plans  Paper & Post-It Notes or PowerPoint  A White Board or Paper and Post-It Notes work best when developing a Process Flowchart Map  Final documentation can be done in PowerPoint
  • 62. 62 2/11/2013 v8.0 Process Flowchart Map Loading PCB Supporting PCB (x/y table) Recognizing PCB Picking-Up Component Pre-Turning Component Measuring Component Thickness Inspecting Component (Dimensions, Shape) Final-Turning Component Placing Component Removing PCB Support Unloading PCB Bringing Mounting Head and Nozzles to Start Position Start End Reject Component ? Reject Component ? Next Component ? Yes No Yes No Yes No Dropping Component in Box
  • 63. 63 2/11/2013 v8.0 Brainstorming is used to generate a large number of ideas in a short period of time.  Step 1: Review the topic or problem to be discussed. Make sure the entire team understands the subject of the brainstorm. Clarify if you are looking for possible causes or possible solutions.  Step 2: Allow a couple of minutes for everyone to think about the task and write down some ideas.  Step 3: Invite the team members to call out their ideas, randomly or in turns around the table. Make sure that the team builds upon each others ideas (1 + 1 > 2), allow clarifications but avoid discussions or evaluations.  Step 4: Record all ideas, e.g. on post-its, and stick them on a flip chart visible to everyone.  Step 5: Continue with Step 3 and 4 until several minutes silence produces no more ideas. Brainstorming – Process
  • 64. 64 2/11/2013 v8.0 When brainstorming, remember … Brainstorming – Guidelines Use plain English. Avoid to be judgmental. Spell out an acronym when you use it for the first time. Build on others ideas. Be specific. Be open & honest. Do not criticize. Have an open mind. Be aware of your opinions. “Dig deep” and probe. Challenge yourself. Include & engage others. No side discussions. Only one idea at time. Encourage wild ideas. Explain, but don’t discuss.
  • 65. 65 2/11/2013 v8.0 The Fishbone Diagram, sometimes also called Cause-and-Effect Diagram or Ishikawa Diagram, is another way of looking at the possible causes of a problem. It organizes large numbers of potential causes into pre-defined categories, e.g. 5Ms & 1 E or 4 Ps, or team-defined categories. Fishbone or Ishikawa Diagram 5M’s + 1E = MEN MEASURE METHODS MATERIALS MACHINES + ENVIRONMENT 4P’s = PLANT POLICIES PEOPLE PROCEDURES Machines Materials Methods Environment Trunk Primary Possible Cause Category Main Branch Minor Branch Second-Level Possible Causes Men/People Problem Statement
  • 66. 66 2/11/2013 v8.0 Fishbone or Ishikawa Diagram Alternative 2 (Team-defined Categories) Step 1: Draw a horizontal trunk line and to the right end of this line write the Problem Statement. Step 2: Brainstorm for all possible causes. Step 3: Group the possible causes into categories and give each category a name (min. 2, max. 6 categories). Step 4: Draw a main branch for each category and put a category name at the end of each branch. Step 5: Add minor branches and the identified possible causes under each major branch. Step 6: Check that the diagram is complete and logical. Alternative 1 (Pre-defined Categories) Step 1: Draw a horizontal trunk line and to the right end of this write the Problem Statement. Step 2: Draw the main branches and put the name of the main categories, e.g. 4Ms & 1E, at the end of the main branches. Step 3: Brainstorm for all possible causes Step 4: Add minor branches and the identified possible causes under each major branch. Step 5: Check that the diagram is complete and logical.
  • 67. 67 2/11/2013 v8.0 Possible Causes using a Fishbone Diagram #1
  • 68. 68 2/11/2013 v8.0 Possible Causes using a Fishbone Diagram #2 Employee Turnover too high
  • 69. 69 2/11/2013 v8.0 Objectives of a Process Variables Map  Process Variables Maps should include:  All value-added and non-value-added process steps  Major activities and/or tasks in each process step  Process Inputs for each process step  Process Outputs for each process step  Process Control and Data Collection Points if applicable  The Process Variables Map documents the process as it is actually performed, not necessarily as it is supposed to be performed  Key deliverable from the Process Variables Map is a complete list of all the Process Inputs within the project scope
  • 70. 70 2/11/2013 v8.0 Preparing a Process Variables Map  Team Effort  Process Owners / Leaders, Workers, Supervisors, Technicians / Engineers / Developers, Upstream and Downstream Representatives (Suppliers and Customers)  Inputs to Mapping  Brainstorming and operator knowledge / experience  Operator manuals / standard work instructions  Customer specifications  5Ms + 1E - Machine (Equipment), Methods (Procedures & Instructions), Measurement (Gages & Data Collection), Materials (Raw Materials & Information), Manpower (Personnel), Environment (Mother Nature)  Excel Template  Process Variables Map – Template.xls
  • 71. 71 2/11/2013 v8.0 Process Variables Map – Template Process:<Name of Process> Process Inputs Type Process Step Output INPUTS Input 1 Process Step 1 Think 5 M's & 1 E Input 2 Man Input 3 Machine Input 4 Material Input 5 Method Input 6 Measure Input 7 Environment Input 8 Type: Input 1 Process Step 2 C = Controlled Input 2 NC = Not Controlled Input 3 Input 4 Input 5 Input 6 Input 7 Input 8
  • 72. 72 2/11/2013 v8.0 Step 1: Identify Process Steps & Key Tasks  Include all value-added and non value-added steps and key tasks  Hint: Process Step Names are verbs or gerunds Manufacturing: SMT Assembly Answer Phone Greet customer – Gather customer Information – Collect order details – Provide delivery time Complete Order Form Complete and enter order information into order management system Make Pizza Prepare & make pizza – Package Pizza Deliver Pizza Transport Pizza to customer’s location Service: Pizza Delivery Print Solder Paste Print solder paste on Printed Circuit Board (PCB) Place Components Place components on PCB Inspect PCB Inspect presence of components and solder joints Reflow PCB Reflow PCB in reflow oven
  • 73. 73 2/11/2013 v8.0 Outputs Print Solder Paste Print solder paste on PCB Paste Location Paste Amount Paste Volume … Component Presence Component Type Component Location Component Orientation … Place Components Place components on PCB Step 2: List Critical Outputs for each Process Step Hint: Outputs should be measurable criteria of the process step Include both process and product outputs
  • 74. 74 2/11/2013 v8.0 Outputs Time to answer Accuracy of customer info Order / quantity Delivery time Accuracy of order information Accuracy of pricing info Speed to complete form Step 2: List Critical Outputs for each Process Step Answer Phone Greet customer Get customer information Get order information Time needed Complete Order Form Complete & enter into production system Outputs Outputs Temperature of the pizza Time to complete Time to deliver Correct quantity Correct order Pizza Temperature Pizza Condition Make Pizza Prepare and make pizza Package Label customer’s pizza Deliver Pizza Transport pizza to customer’s location Outputs
  • 75. 75 2/11/2013 v8.0 Step 3: List & Classify Process Inputs  List all Process Inputs (usually specific attributes of the input which could be the cause of a problem or failure mode) for each process step  Classify Inputs  Controlled (C): These are inputs that you adjust or control while the process is running (Examples: speed, feed rate, pressure, temperature, experience level of worker, data system size)  Uncontrolled (U): Noise variables. These are things you cannot, or do not currently, control (Examples: ambient temperature, humidity, order quantity, training hours of worker)  Could be due to the expense or difficulty controlling them This step is where the team should spend most of its time.
  • 76. 76 2/11/2013 v8.0 Outputs Print Solder Paste Print solder paste on PCB Paste Location Paste Amount Paste Volume … Step 3: List & Classify Process Inputs Inputs Type Solder Paste Type C Solder Paste Viscosity C Stencil Condition C Operator Experience C/U Paste Printing Machine C/U Preventive Maintenance C Ambient Temperature U Ambient Humidity U … Outputs Answer Phone Greet customer Get customer information Get order information Time needed Time to answer Accuracy of customer information Order / quantity Delivery time Information from customer C Greeting script C Answering procedure C Telephone system U Number of calls U Inputs Type
  • 77. 77 2/11/2013 v8.0 Step 4: Add Internal & External Specifications  Document any known operating specification or requirements for each Input and Output if applicable
  • 78. 78 2/11/2013 v8.0 Case Study Group Work 4 The Task:  Develop a Process Variables Map for the “Coffee Making Process” or one of your own processes following the 4 Steps just discussed, to identify “all” possible causes.  Capture your Process Variables Map using the Excel template or a flip chart and be prepared to share your results with the rest of the group. 30 Minutes
  • 79. 79 2/11/2013 v8.0 Problem Statement:  The initial question “What’s wrong with what?” has been answered?  The “5 Why’s” were used to asking questions “Do we know for certain why this is occurring?”  A final problem statement (or specific root cause) has been defined (object and defect) and documented? Problem Description:  A thorough “IS – IS NOT” Analysis has been performed (what, where, when, how big) and documented?  The problem description has been confirmed as to what the Customer and/or affected party(s) are experiencing?  Physical evidence of the problem has been obtained? “Phase D2” Checklist Questionnaire
  • 80. 80 2/11/2013 v8.0 “Phase D2” Checklist Questionnaire Problem Description (cont.):  Determination has been made as to whether this problem describes a “Change-Induced” or a “Day-One-Deviation” situation?  A Process Flow Chart & Fishbone Diagram or a Process Variables Map has been developed, documented and verified to identify possible causes?  Process detail has been reviewed to determine where this problem first appears?  Problem pattern(s) has been considered / evaluated?  Similar components and/or parts have been reviewed for the same problem?  All required data has been collected and analyzed?
  • 81. 81 2/11/2013 v8.0 “Phase D2” Checklist Questionnaire Project Management:  The Project Champion has reviewed and supports the problem description (if applicable)?  Necessity of reviewing the problem with the Executive or Functional Management Team has been evaluated?  Consideration has been made for setting aside financial resources?  All required resources are part of the team or accessible to the team as required?  The 8D Problem Solving Process Worksheet & Project Documentation has been updated?
  • 82. 82 2/11/2013 v8.0 8D Problem Solving Process Report – Phase D2 …
  • 83. 83 2/11/2013 v8.0 1 • Establish the Team 2 • Describe the Problem 3 • Develop Interim Containment Actions 4 • Define and Verify Root Causes and Escape Points 5 • Choose and Verify Permanent Corrective Actions 6 • Implement and Validate Permanent Corrective Actions 7 • Prevent Recurrence 8 • Recognize Team and Individual Contributions The 8D Problem Solving Process
  • 84. 84 2/11/2013 v8.0 “Develop Interim Containment Actions” Key Activities Purpose: Define, verify and implement Interim Containment Action to isolate the effects of the problem from any internal and/or external Customer until Permanent Corrective (Preventive) Action are implemented.  Define potential Interim Containment Action  Verify effectiveness of potential Interim Containment Action  Select and implement Interim Containment Action  Validate effectiveness of implemented Interim Containment Action with the Customer
  • 85. 85 2/11/2013 v8.0 Key Concepts of Interim Containment Actions  Typically chosen without much data or knowledge about the situation.  Temporary “fix” that works against the effect of the problem.  Protects the downstream process or the Customer from the effect of the problem.  Contains the problem from a cost, quality, timing perspective.  “Buys time” to identify and resolve the root cause of the problem.  Needs normally to be documented.  Is not a “Band Aid”, which may be forgotten.  …
  • 86. 86 2/11/2013 v8.0 Interim Containment Actions - Examples By its nature, an Interim Containment Action will normally be expensive to implement as it will probably involve an additional process being introduced and could include:  100% Inspection  Rework  Sorting good from bad  Field service action As you can be seen, any one of these actions would add considerable cost, however are necessary to protect the customer. Remember that some of the above actions are not 100% effective, even 100% inspection is subject to variation.
  • 87. 87 2/11/2013 v8.0 PDCA or Deming Management Cycle The “Develop Interim Containment Actions” Phase follows the PDCA Cycle 1. Plan (Plan & Re-Plan) 2. Do (Implement) 3. Check (Monitor) 4. Act (Evaluate) Deming PDCA Cycle Determine which steps must be completed to achieve the plan’s objectives by the target date. Implement and manage the implementation plan. Record the results of the implementation phase. Evaluate the results and decide if additional actions need to be developed.
  • 88. 88 2/11/2013 v8.0 “Phase D3” Checklist Questionnaire Before Implementation:  The need for a Interim Containment Action has been determined?  Consultation with the Customer and/or Champion has been conducted to establish criteria for the Interim Containment Action selection?  Based on the criteria established, the Interim Containment Action provides the best balance of benefit and risk?  The Interim Containment Action protects the Customer 100% from the effect of the problem?  The Interim Containment Action has been verified?  The Interim Containment Action is cost effective and easy to implement?
  • 89. 89 2/11/2013 v8.0 “Phase D3” Checklist Questionnaire Planning:  Appropriate departments have been involved in the planning of the Interim Containment Action  Plans, including action steps, have been developed considering who needs to do what by when?  The Customer’s viewpoint has been considered for the Interim Containment Action  The Customer’s approval has been obtained?  A validation method for the Interim Containment Action has been determined? Post Implementation:  The validation data indicates that the Customer is being protected from the symptom of the problem?
  • 90. 90 2/11/2013 v8.0 8D Problem Solving Process Report – Phase D3 …
  • 91. 91 2/11/2013 v8.0 1 • Establish the Team 2 • Describe the Problem 3 • Develop Interim Containment Actions 4 • Define and Verify Root Causes and Escape Points 5 • Choose and Verify Permanent Corrective Actions 6 • Implement and Validate Permanent Corrective Actions 7 • Prevent Recurrence 8 • Recognize Team and Individual Contributions The 8D Problem Solving Process
  • 92. 92 2/11/2013 v8.0 “Define and Verify Root Causes” Key Activities Purpose: Isolate and verify the root cause by testing each root cause theory against the Problem Description and test data. Isolate and verify the place in the process where the effect of the root cause could have been detected and contained but was not (escape point).  Establish any additional data collection plans needed to learn more about the problem and/or possible causes.  Utilize the Fishbone Diagram or Process Variables Map created earlier to identify the most likely cause(s).  Isolate and verify the most likely cause(s) by testing each Root Cause Theory against the Problem Description and the collected data.  Isolate and verify the place in the process where the effect of the root cause could have been detected and contained but was not (escape point).
  • 93. 93 2/11/2013 v8.0 “You’re neither right not wrong because people agree with you. You’re right because your facts and your reasoning are right.“ Warren Buffett – Investor & Billionaire
  • 94. 94 2/11/2013 v8.0 Identifying Most Likely Causes  Symptom – A quantifiable event or effect, experienced by a Customer (internal & external), that may indicate the existence of one or more problems.  Problem – A deviation from an expectation or standard; a perceived gap between the existing state and a desired state. In the context of the 8D Problem Solving Process the cause(s) of the problem is not known.  Possible Cause – Any cause, identified for example through Process Variables Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem or Failure Mode effect may occur.  Most Likely Cause – A cause, identified based on available or collected data, that best explains the Problem Description or Failure Mode.  Root Cause – A verified cause that convincingly supports and explains ALL facts available and thus accounts for the problem; verified passively and actively, by making the problem come and go. Root causes are the fundamental, underlying reasons for a Problem or Failure Mode, e.g. management policies, product design, system design, process capabilities, technology constraints, unclear or wrong standard operating procedures, and human errors.
  • 95. 95 2/11/2013 v8.0 Strategies to identify “Most Likely Causes” Eliminating Possible Causes or identifying Most Likely Causes through  Process Knowledge  Experience with similar Situations or Processes  Logbooks of past Events  Checks and Audits  5 Whys Analysis  Comparative Analysis (Distinctions & Changes)  Correlation Analysis (Box Plots & Scatter Plots & …)  Process Failure Mode and Effects Analysis  … Possible Causes Most Likely Causes
  • 96. 96 2/11/2013 v8.0 Comparative Analysis  The Comparative Analysis is the third part of the 8D Problem Solving Process Worksheet.  The Comparative Analysis connects the facts from the Problem Description (“IS – IS NOT” Matrix) with the analysis of possible and most likely causes using the Process Flowchart and the C&E Matrix or Why-Why Diagram or Fishbone Diagram, as well as any other information and data available.  Step 1: Compare each “IS” with its corresponding/contrasting “IS NOT”. List any known distinctions and uncommon factors that could explain the “IS” and “IS NOT”.  Ask: What is unique, odd, different, distinctive, unusual about the “IS”?  Consider the most likely causes identified so far.  Step 2: List all known changes in distinctions and uncommon factors.  Ask: What has changed in, on, around or about this distinction and uncommon factors?
  • 97. 97 2/11/2013 v8.0 Comparative Analysis - Example  Problem Description:  IS – The Red Makers leak  IS NOT – The Blue Markers could leak, but are not  Comparative Analysis:  Distinctions  1. Different Color Plastic,  2. Different Color Ink,  3. Strawberry Scent in Red Marker  Changes  1. New Plastic Supplier (5 weeks ago),  2. Added Powder to Red Marker (2.5 weeks ago)
  • 98. 98 2/11/2013 v8.0 Comparative Analysis PROBLEM SOLVING PROCESS WORKSHEET Problem Statement (What is wrong with what?): Red Felt Tip Marker Leaks IS IS NOT DISTINCTIONS CHANGES TEST FOR MOST LIKELY CAUSES (+) (-) (?) Describe what does occur Describe what does not occur, but could occur What could explain the IS-IS NOT? (People, Methods, Material, Machines, Environment) What has changed in, on, around or about this distinction? When did it change? <Define Possible Root Cause Theory> What? Object: Red felt tip marker Blue, black or green marker Defect: Leaks Totally dry Where? Tip Barrel (side or base) Where is the object when the defect is observed? Where is the defect on the object? Are there any pattern or trends identifiable? … … When? First seen two weeks ago Before two weeks ago When was the defect observed first? Can or was the defect be observed before, during or after other events? When since has the defect occurred? Are there any pattern or trends identifiable? … … How Big? All red felt tip markers (100%) Just some red felt tip markers (less than 100%) How many objects have the defect? What is the size of a single defect? How many defects are on each object? Are there any pattern or trends identifiable? … … 1 1 1 1 2 2 2 2
  • 99. 99 2/11/2013 v8.0 Case Study Group Work 5 The Task:  Review the “Felt Tip Marker” Case Study (Part 3) thoroughly.  Perform a Comparative Analysis on the “Felt Tip Marker” Case Study.  Be prepared to share your results with the rest of the group. 20 Minutes
  • 100. 100 2/11/2013 v8.0 Two Types of Data  Attribute Data - Discrete Data – Categories – Good / bad – Machine 1, Machine 2, Machine 3 – Shift number – Anything counted The type of data will determine the tools that can be used.  Continuous Data - Variable Data – Time and money are continuous – Pressure – Speed – Height and weight
  • 101. 101 2/11/2013 v8.0 Correlation between a Process Input and Output Process Input = Most Likely Cause Discrete Continuous DiscreteContinuous ProcessOutput=Problem Chi-Square Analysis Logistic Regression Box Plot Diagram Scatter Plot Diagram Depending on the data type, different analytical tools can be used to verify a relationship or correlation between a Process Input or Most Likely Cause and a Process Output resulting in the problem that needs to be solved.
  • 102. 102 2/11/2013 v8.0 The Scatter Plot A Scatter Plot is a graph of plotted points that shows the relationship between a continuous process input (X) and a continuous process output (Y). An 8D Problem Solving Team believes that “X = Temperature ºC” is a root cause for an increase/decrease in “Y = Ice Cream Sales $”? 0 100 200 300 400 500 600 700 10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 IceCreamSales(in$) Temperature (in C) Scatter Plot – Example & Exercise Ice Cream Sales 14.2 C $215
  • 103. 103 2/11/2013 v8.0 Scatter Plot – Example 0 100 200 300 400 500 600 700 10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 IceCreamSales(in$) Temperature (in C) Scatter Plot - Example Ice Cream Sales What would be the estimated ice cream sales when the temperature is 13ºC? What would be the estimated ice cream sales when the temperature is 22ºC? Regression Line
  • 104. 104 2/11/2013 v8.0 Scatter Plot – A little Bit of Statistics  With a little bit of statistics we can build a simple equation or model to predict the “Ice Cream Sales (in $)” for every “Temperature (in ºC)”. Ice Cream Sales (in $)” = m × Temperature (in ºC) + c  To determine the parameters “m” and “c”, we need two data points (x → y) from our regression line, for example (13 ºC → $205) and (22 ºC → $500). 𝑚 = (𝑦2 − 𝑦1) (𝑥2 − 𝑥1) = 𝑐 = 𝑦1 − 𝑚 × 𝑥1 =  How much “Ice Cream Sales (in $)” is our model predicting when the “Temperature (in ºC)” is 19 ºC ?
  • 105. 105 2/11/2013 v8.0 The Box Plot A Box Plot is a graph of plotted points that shows the relationship between a discrete process input (X) and a continuous process output (Y). Input X Y= Upper 25% of Data Points Median & Middle 50% of Data Points 25% 25% Lower 25% of Data Points
  • 106. 106 2/11/2013 v8.0 Box Plot – Example An 8D Problem Solving Team is tasked with improving the productivity of a specific work area. The Team believes that the productivity is different for the three shifts working in this work area and that a root cause is related to the different work practices the three shifts are using. Shift 3Shift 2Shift 1 90 85 80 75 70 65 60 Shift Productivity Daily Productivity per Shift (July & August 2013)
  • 107. 107 2/11/2013 v8.0 Fishbone Diagram – Most Likely Causes Reviewing the Fishbone Diagram created in Phase D2, the team tries to reduce the large number of possible causes to a short list of most likely causes, using the Problem Description, Comparative Analysis, data analysis and the team’s combined process knowledge and experience. Remember, the root cause(s) convincingly supports and explains ALL facts available and thus accounts for the problem. So, you need to ask yourself “If this would be the root cause of the problem, would it explain the Problem Description?” 4M’s = MEN METHODS MATERIALS MACHINES + ENVIRONMENT 4P’s = PEOPLE PLANT POLICIES PROCEDURES Machines Materials Methods Environment Trunk Primary Possible Cause Category Main Branch Minor Branch Second-Level Possible Causes Men/People Problem Statement Most Likely Cause #1 Most Likely Cause #3 Most Likely Cause #2
  • 108. 108 2/11/2013 v8.0 Outputs Print Solder Paste Print solder paste on PCB Paste Location Paste Amount Paste Volume … Inputs Type Solder Paste Type C Solder Paste Viscosity C Stencil Condition C Operator Experience C/U Paste Printing Machine C/U Preventive Maintenance C Ambient Temperature U Ambient Humidity U … Process Variables Map – Most Likely Causes Most Likely Cause #1 Most Likely Cause #2 Similar, using the Process Variables Map created in Phase D2, the team tries to reduce the large number of possible causes to a short list of most likely causes, using the Problem Description, Comparative Analysis, data analysis and the team’s combined process knowledge and experience.
  • 109. 109 2/11/2013 v8.0 Process Failure Mode and Effects Analysis A Process Failure Mode and Effects Analysis (Process FMEA) is …  Key tool for process development or improvement teams to identify in a preemptive manner (before failures occur) all the ways an existing or new process can fail An 8D Problem Solving Team utilizes the Process Failure Mode and Effects Analysis to …  Analyze and document how critical process inputs can fail and impact the performance of a process  Determine possible causes for the failure of critical process inputs  Identify deficiencies in existing process controls  Establish the priority of improvement actions
  • 110. 110 2/11/2013 v8.0 Process FMEA – Inputs and Outputs  Inputs  Process Flowchart & Fishbone Diagram  Process Variables Map  Process Knowledge  Process Technical Procedures  Process Operating Procedures  Outputs  Potential Failure Modes of critical process inputs, as well as their impact on process performance and their causes  List of current process controls to prevent these causes or at least to their detect failure modes as early as possible
  • 111. 111 2/11/2013 v8.0 Process FMEA – Failure Mode Definition  The way in which a particular process input being assessed fails or could fail  If not detected and either corrected or removed, the undesirable effect or problem will occur  Can relate to a product defect or a process input variable that goes out of specification or fails to perform  Anything the operator sees as wrong can be a Failure Mode or a Potential Failure Mode The Process FMEA scope may be limited to only those Failure Modes that relate to a specific problem, OR The Process FMEA may consider anything that could go wrong.
  • 112. 112 2/11/2013 v8.0 Process FMEA – Failure Mode Examples  Too much / too high / too wide / too late / too fast  Too little / too low / too thin / too early / too slow  Too variable / Too much variation  Cracked / deformed / blemished / dirty / bent / burred  Incorrect / incomplete information  Inaccurate reading  Missed phone call  Short-circuited / open-circuited / cross-wired  Set up incorrectly  Unclear / mistyped  Incorrect syntax
  • 113. 113 2/11/2013 v8.0 Process FMEA – Effect Definition  Impact on customer requirements  Directly resulting from the failure mode  Frequently external customer focused  Can also include downstream processes  State (in physical terms when applicable) what the Customer (internal or external) will experience  One Failure Mode can have more than one Effect  EACH effect should be listed separately The Effect is the Consequence of the Failure Mode: IF the Failure Mode occurs, THEN the Effect will happen?
  • 114. 114 2/11/2013 v8.0 Process FMEA – Effect Examples  Customer complaint (state the specific complaint)  Fails to meet specification (state the specification)  Product return / warranty claim (specify problem)  Scrap / Rework (specify problem)  Cannot fasten / mount / attach / align  Does not fit / connect / match / turn on  Noise  Damages equipment  Injures or endangers operator / customer / patient  Inaccurate data  Delay
  • 115. 115 2/11/2013 v8.0 Process FMEA – Cause Definition  One or more variations in the process that lead to the occurrence of the Failure Mode  Intent is to identify all the Mechanisms of Failure that are relevant to the Process FMEA scope  Should be defined in terms of something that can be controlled or corrected  Should be described specifically enough that remedial action can be identified  Some causes may require further investigation and data analysis (Scatter Plot, Box Plot, Hypothesis Testing, Designed Experiments, …) Note that this is documenting the causes of the Failure Mode, NOT the causes of the Effect.
  • 116. 116 2/11/2013 v8.0 Process FMEA – Cause Examples  Improper torque / weld / seal  Inaccurate measurement / reason code  Incorrect part, material, or information  Missing or mislocated part, material, or information  Wrong procedure / Misunderstood procedure  Inadequate or insufficient training (on what?)  Insufficient staffing  Operator fails to install seal / end user enters data incorrectly (NOT just “Operator Error”)  Thermocouple out of calibration (NOT just “Mechanical Problem”)  Data base field definition incorrect / no connectivity between data bases  Illegible instructions / hand written information
  • 117. 117 2/11/2013 v8.0 Process FMEA – Current Controls Definition  Systems, methods, or devices currently in place to prevent causes from occurring or detect failure modes before they cause the undesirable effects or minimize the effect  Prevention consists of mistake proofing (Poka-Yoke), statistical process control, preventive maintenance, automation, set-up controls, …  Controls consists of audits, inspection, laboratory or inline testing, training, standard operating procedures, work instructions, ... Which is the better form of process improvement: Prevention or Detection?
  • 118. 118 2/11/2013 v8.0 Process FMEA – A Step by Step Procedure 1. For each Process Input identified as a most likely cause of the problem you are trying to solve, determine the ways in which the process input can go wrong (Failure Modes) 2. For each Failure Mode associated with the process inputs, determine the Effects of the failures on the customer (internal or external) 3. Identify potential Causes of each Failure Mode 4. List the Controls you are currently using to prevent each Cause or to detect the resulting Failure Mode 5. Determine and highlight those potential Causes that could result in the Failure Mode or Effect you try to eliminate or minimize through the 8D Problem Solving Process
  • 119. 119 2/11/2013 v8.0 Process FMEA – Summary Key Process Input What is the Key Process Input? Potential Failure Mode In what ways does the Key Input go wrong? Potential Failure Effects What is the Impact on the Key Output Variables (Customer Requirements) Or Internal requirements? Potential Causes What causes the Key Input to go wrong? Current Controls What are the existing Controls and Procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP Number. Actions Recommended What are the actions for reducing the occurrence of the Cause, or improving detection? Should have actions only on high RPN’s or easy fixes. What is the Input? What can go wrong with the Input? What is the Effect on the Output(s)? What are the Causes? What can be done? How can these be detected or prevented? Potential Failure Mode Potential Failure Effects Potential Causes Current Controls Actions Recommended
  • 120. 120 2/11/2013 v8.0 Process FMEA – An Example Process Step Key Process Input Failure Mode Effect Cause Current Control The Process Step related to the Key Process Input What could cause the Problem? What can go wrong? What is the result of the Failure Mode? What could cause the Failure Mode? How do we prevent the Cause or detect the Failure Mode? Print Solder Paste Solder Paste Viscosity Viscosity too low Short-circuit of solder joints Storage temperature too high Refrigerator & daily temperature check (WI 1234) Ambient temperature too high None Storage duration at work station too long Date & time label on each container & check label at beginning of each shift (WI 6789) Viscosity too high Insufficient solder joints Storage temperature too low Refrigerator & daily temperature check (WI 1234) Ambient temperature too low None Open solder joints Storage temperature too low Refrigerator & daily temperature check (WI 1234) Ambient temperature too low None
  • 121. 121 2/11/2013 v8.0 Case Study Group Work 6 The Task:  Select 2-3 Key Process Inputs as “Most Likely Causes” from your Process Variable Map for the Coffee Making Process or your own process  Develop a Process FMEA for each of the 2-3 “Most Likely Causes” using the template or flipchart paper and Post-It Notes  Be prepared to share your results with the rest of the group Process Step Process Input Failure Mode Effect Cause Current Control 30 Minutes
  • 122. 122 2/11/2013 v8.0 Process FMEA – Risk Priority Number (RPN) Effects Causes Controls  The RPN is calculated based on information the team provides regarding  the severity of the effects,  the frequency of the potential failure modes, and  the current ability of the process to detect the failures before reaching the customer  RPNs are not universal or fixed  Scales can be locally developed – just need to be consistent RPN = Severity X Occurrence X Detection
  • 123. 123 2/11/2013 v8.0 Process FMEA – Risk Assessment Scale Rating Severity of Effect Likelihood of Occurrence Ability to Detect 10 Hazardous without warning Very high: Can not detect 9 Hazardous with warning Failure is almost inevitable Very remote chance of detection 8 Loss of primary function High: Remote chance of detection 7 Reduced primary function performance Repeated failures Very low chance of detection 6 Loss of secondary function Moderate: Low chance of detection 5 Reduced secondary function performance Occasional failures Moderate chance of detection 4 Minor defect noticed by most customers Moderately high chance of detection 3 Minor defect noticed by some customers Low: High chance of detection 2 Minor defect noticed by discriminating customers Relatively few failures Very high chance of detection 1 No effect Remote: Failure is unlikely Almost certain detection
  • 124. 124 2/11/2013 v8.0 Process FMEA – Summary Key Process Input What is the Key Process Input? Potential Failure Mode In what ways does the Key Input go wrong? Potential Failure Effects What is the Impact on the Key Output Variables (Customer Requirements) Or Internal requirements? S E V Howsevereistheeffect tothecustomer? Potential Causes What causes the Key Input to go wrong? O C C Howoftendoescause ofFMoccur? Current Controls What are the existing Controls and Procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP Number. D E T Howwellcanyou detectcauseorFM? R P N Actions Recommended What are the actions for reducing the occurrence of the Cause, or improving detection? Should have actions only on high RPN’s or easy fixes. What is the Input? What can go wrong with the Input? How Bad? S E V What is the Effect on the Output(s)? How Often? What are the Causes? O C C What can be done? How well? How can these be detected or prevented? D E T Potential Failure Mode Potential Failure Effects Potential Causes Current Controls Actions Recommended
  • 125. 125 2/11/2013 v8.0 Process FMEA – An Example with RPN 8D Problem Solving Process - Process Failure Mode & Effects Analysis Process Step Key Process Input Failure Mode Effect Cause Current Control The Process Step related to the Key Process Input What could cause the Problem? What can go wrong? What is the result of the Failure Mode? SEV What could cause the Failure Mode? OCC How do we prevent the Cause or detect the Failure Mode? DET RPN Print Solder Paste Solder Paste Viscosity Viscosity too low Short-circuit of solder joints 5 Storage temperature too high 6 Refrigerator & daily temperature check (WI 1234) 2 60 5 Ambient temperature too high 5 None 10 250 5 Storage duration at work station too long 4 Date & time label on each container & check label at beginning of each shift (WI 6789) 3 60 Viscosity too high Insufficient solder joints 3 Storage temperature too low 4 Refrigerator & daily temperature check (WI 1234) 2 24 3 Ambient temperature too low 3 None 10 90 Open solder joints 7 Storage temperature too low 4 Refrigerator & daily temperature check (WI 1234) 2 56 7 Ambient temperature too low 3 None 10 210
  • 126. 126 2/11/2013 v8.0 Process FMEA – Quiz Sev Occ Det RPN Result Action 1 1 1 1 Ideal Situation No Action 1 1 10 10 10 1 1 10 10 1 10 100 1 10 1 10 1 10 10 100 10 10 1 100 10 10 10 1000 Big trouble! Emergency action!
  • 127. 127 2/11/2013 v8.0 Identifying Root Causes  Symptom – A quantifiable event or effect, experienced by a Customer (internal & external), that may indicate the existence of one or more problems.  Problem – A deviation from an expectation or standard; a perceived gap between the existing state and a desired state. In the context of the 8D Problem Solving Process the cause(s) of the problem is not known.  Possible Cause – Any cause, identified for example through Process Variables Mapping, Brainstorming or a Fishbone Diagram, that describes how a Problem or Failure Mode effect may occur.  Most Likely Cause – A cause, identified based on available or collected data, that best explains the Problem Description or Failure Mode.  Root Cause – A verified cause that convincingly supports and explains ALL facts available and thus accounts for the problem; verified passively and actively, by making the problem come and go. Root causes are the fundamental, underlying reasons for a Problem or Failure Mode, e.g. management policies, product design, system design, process capabilities, technology constraints, unclear or wrong standard operating procedures, and human errors.
  • 128. 128 2/11/2013 v8.0 Root Cause Theory Testing The basic question you need to ask is: If ___________ is the cause of _____________, how does that explain both the IS and IS NOT?  Ask about each IS / IS NOT pair  Eliminate any possible causes that fail  List all assumptions made
  • 129. 129 2/11/2013 v8.0 Root Cause Theory Testing  Step 1: Use the 8D Problem Solving Process Worksheet, supported by the Process Variables Map or Fishbone Diagram and any additional data analysis used, to formulate Root Cause Theories based on the identified most likely cause(s) of the problem.  Step 2: Enter a short description of a Root Cause Theory as header into the last column of the 8D Problem Solving Process Worksheet.  Step 3: Assess the Root Cause Theory against each “IS” – “IS-NOT” statement.  Enter a “+” if the theory explains or does not conflict with the “IS”–“IS-NOT” statement.  Enter a “-” if the theory conflicts with the “IS”–“IS-NOT” statement.  Enter a “?” if you are not sure and further investigation may be necessary.  The Root Cause(s) convincingly supports and explains ALL “IS”–“IS-NOT” statements and thus accounts for the problem.
  • 130. 130 2/11/2013 v8.0 Root Cause Theory Testing PROBLEM SOLVING PROCESS WORKSHEET Problem Statement (What is wrong with what?): Red Felt Tip Marker Leaks IS IS NOT DISTINCTIONS CHANGES TEST FOR MOST LIKELY CAUSES (+) (-) (?) Describe what does occur Describe what does not occur, but could occur What could explain the IS-IS NOT? (People, Methods, Material, Machines, Environment) What has changed in, on, around or about this distinction? When did it change? <Define Possible Root Cause Theory> What? Object: Defect: Where? Where is the object when the defect is observed? Where is the defect on the object? Are there any pattern or trends identifiable? When? When was the defect observed first? Can or was the defect be observed before, during or after other events? When since has the defect occurred? Are there any pattern or trends identifiable? How Big? How many objects have the defect? What is the size of a single defect? How many defects are on each object? Are there any pattern or trends identifiable? 2 3 3 3 3 + - ?
  • 131. 131 2/11/2013 v8.0 Root Cause Theory Testing - Example PROBLEM SOLVING PROCESS WORKSHEET Problem Statement (What is wrong with what?): Red Felt Tip Marker Leaks IS IS NOT DISTINCTIONS CHANGES TEST FOR MOST LIKELY CAUSES (+) (-) (?) Describe what does occur Describe what does not occur, but could occur What could explain the IS-IS NOT? (People, Methods, Material, Machines, Environment) What has changed in, on, around or about this distinction? When did it change? <New Plastic Supplier - Plastic is too porous … ink leaks through.> What? Object: Red felt tip marker Blue, black or green marker Red Plastic - Red Ink - Strawberry Scent (2.5 weeks ago) New Plastic Supplier (5 weeks ago) - Added Powder (2.5 weeks ago) (-) Defect: Leaks Totally dry … Where? Tip Barrel (side or base) (-) Where is the object when the defect is observed? Where is the defect on the object? Are there any pattern or trends identifiable? … … … When? First seen two weeks ago Before two weeks ago (-) When was the defect observed first? Can or was the defect be observed before, during or after other events? When since has the defect occurred? Are there any pattern or trends identifiable? … … … How Big? All red felt tip markers (100) Just some red felt tip markers (less than 100) (+) How many objects have the defect? What is the size of a single defect? How many defects are on each object? Are there any pattern or trends identifiable? … … …
  • 132. 132 2/11/2013 v8.0 Case Study Group Work 7 The Task:  Develop & test 2 - 3 Root Cause Theories for the “Felt Tip Marker” Case Study.  Be prepared to share your results with the rest of the class. 20 Minutes
  • 133. 133 2/11/2013 v8.0 Root Cause Verification  Active Verification is a process where …  … the problem solver uses the variable thought to be the root cause to make the effect come and go. Both coming and going are important tests to confirm root causes.  Passive Verification is done by observation.  With passive verification, you look for the presence of the root cause without changing anything. If you cannot prove the presence of the root cause, then chances are great that this most likely cause is not the root cause. Step 1: Identify, document and perform a passive and/or active root cause verification method. Step 2: Continue with the 8D Problem Solving Process if the passive and/or active root cause verification was successful. Otherwise, develop and test additional Root Cause Theories.
  • 134. 134 2/11/2013 v8.0 Escape Point Identification Step 1: Using the Process Flowchart, identify Escape Point(s) for the verified root cause(s). Step 2: Determine if Control Points were missing or ineffective to detect the root cause of the problem at the escape point. Control System: A control system is a system deployed to monitor the product or process and ensure compliance to Customer requirements. It consists of responsibilities, procedures and resources. You may have one or more control points where the product or process is checked. Control Point: A control point is a location within the control system where the product or process is checked for compliance to certain specified require- ments. There may be multiple locations within a control system. Escape Point: The escape point is the earliest location in the process, closest to the root cause, where the problem could have been detected, but was not.
  • 135. 135 2/11/2013 v8.0 “Phase D4” Checklist Questionnaire Root Cause(s):  The factual information in the Problem Description has been updated?  Differences unique to the “IS” when compared to the “IS NOT” have been identified?  For a “Change-Induced” problem, changes in or around the differences have been uncovered?  The root cause theories developed have been tested against each “IS” - “IS NOT” statement?  The final root cause theory accounts for all “IS” - “IS NOT” statements?  For multiple root causes, the causes were reviewed to determine if, collectively, they account for all of the problem description?  The root cause(s) was/were verified passively and actively?
  • 136. 136 2/11/2013 v8.0 “Phase D4” Checklist Questionnaire Escape Points:  The process flow was reviewed and control points associated with the root cause(s) identified.  A determination was made as to the existence of a control system to detect the problem?  If a control system exists, changes from its original design (if any) have been identified? Project Management:  The Project Champion has reviewed and supports the analysis, findings and conclusions?  8D Problem Solving Process Worksheet & Project Documentation has been updated?
  • 137. 137 2/11/2013 v8.0 8D Problem Solving Process Report – Phase D4 …
  • 138. 138 2/11/2013 v8.0 1 • Establish the Team 2 • Describe the Problem 3 • Develop Interim Containment Actions 4 • Define and Verify Root Causes and Escape Points 5 • Choose and Verify Permanent Corrective Actions 6 • Implement and Validate Permanent Corrective Actions 7 • Prevent Recurrence 8 • Recognize Team and Individual Contributions The 8D Problem Solving Process
  • 139. 139 2/11/2013 v8.0 “Choose Permanent Corrective Actions” Key Activities Purpose: Select the best Permanent Corrective Actions to remove the root cause and to address the escape point in the process. Verify that both decisions will be successful when implemented and not cause any undesirable effects.  Develop solution(s) to remove the root cause(s)  Develop solution(s) to address the escape point(s)  Select the best solution(s) to remove the root cause(s)  Select the best solution(s) to address the escape point(s)  Verify that effectiveness of the selected solutions  Verify that selected solutions do not cause any undesirable effects
  • 140. 140 2/11/2013 v8.0 Many Human Errors are designed into the Process Reducing & Eliminating Human Error needs more than additional Training
  • 141. 141 2/11/2013 v8.0 1. Adjustments 2. Constant equipment / software changes 3. Dimensionality / spec / critical condition 4. Many parts / mixed parts 5. Multiple steps 6. Lack of or ineffective standards 7. Rapid repetition 8. High volume 9. Environmental conditions: A. Material handling B. Housekeeping C. Foreign matter D. Poor lighting E. Other 10. Other? Where to spot potential for mistakes …
  • 142. 142 2/11/2013 v8.0 Two Ways of Dealing with Human Errors  Human Errors are inevitable !!! Errors can´t be avoided. People will always make mistakes.  Human Errors can be eliminated !!! Any kind of mistake people make can be reduced or even eliminated. People make fewer mistakes if they are supported by a production system based on the principle that human errors can be prevented.  An organizations must establish a “mistake-proofing mindset” that promotes the belief that it is unacceptable to allow for even a small number of product or service defects caused by human errors.
  • 143. 143 2/11/2013 v8.0 Sixteen Human Error Modes 1. Omission 2. Excessive / insufficient repetition 3. Wrong order 4. Early / late execution 5. Execution of restricted work 6. Incorrect selection 7. Incorrect counting 8. Misrecognition 9. Failing to sense danger 10. Incorrect holding 11. Incorrect positioning 12. Incorrect orientation 13. Incorrect motion 14. Improper holding 15. Inaccurate motion 16. Insufficient avoidance
  • 144. 144 2/11/2013 v8.0 1. Omission → What part of the process is prone to be omitted? 2. Excessive / Insufficient Repetition → What part of the process is prone to be excessively repeated? 3. Wrong Order or Sequence → In what wrong sequence can the process be executed? 4. Early / Late Execution → What execution can be early or late? 5. Execution of Restricted Work → What tasks could be executed by unauthorized personnel? Sixteen Human Error Modes
  • 145. 145 2/11/2013 v8.0 6. Incorrect Selection (or Identification) → What object of the process is prone to be incorrectly selected or identified? 7. Incorrect Counting (or Calculating) → What objects of the process can be counted, measured or calculated incorrectly? 8. Misrecognition (or Misunderstanding or Misreading) → What misunderstanding or misreading is prone to occur? → What information, risk or failure/error is prone to be overlooked? → What miscommunication is prone to occur? → What incorrect decision is prone to occur? Sixteen Human Error Modes
  • 146. 146 2/11/2013 v8.0 9. Failure to Sense Danger → What information, risk or failure/error is prone to be overlooked? 10. Incorrect Holding → What object of the process are prone to mishandling? 11. Incorrect Orientation → What orientation error is prone to occur? 12. Incorrect Positioning → What positioning setting error is prone to occur? 13. Incorrect Motion → What motion or movement error is prone to occur? Sixteen Human Error Modes
  • 147. 147 2/11/2013 v8.0 14. Improper Holding → What object of the process are prone to mishandling? 15. Inaccurate Motion → What motion or movement error is prone to occur? 16. Insufficient Avoidance → What can be unintentionally touched, stuck or splashed? → What movement can cause harm? Sixteen Human Error Modes
  • 148. 148 2/11/2013 v8.0 Six Mistake Proofing Principles 1. Elimination seeks to eliminate an error-prone process step by redesigning the product or process so that the task or part is no longer necessary. Example: An example of elimination is the use of ambient- light sensors to turn outside lighting on and off. 2. Prevention modifies the product or process so that it is impossible to make a mistake or that a mistake becomes a defect. Example: An example would be the change from a rectangular to a round manhole.
  • 149. 149 2/11/2013 v8.0 Six Mistake Proofing Principles 3. Replacement substitutes a more reliable process to improve repeatability. This includes use of robotics or automation that prevents a manual assembly error. Example: An example would be the coin dispenser in food stores preventing that customers are getting short changed. 4. Facilitation is the most used principle and employs techniques and combining steps to make a process step easier to perform or less error- prone. This includes visual controls including color coding, marking or labeling parts; checklists that list all tasks that need to be performed; exaggerated asymmetry to facilitate correct orientation of parts. Example: An example would be to color code parts that are similar in shape or the use of a slipping-type torque wrench to prevent over tightening.
  • 150. 150 2/11/2013 v8.0 Six Mistake Proofing Principles 5. Detection involves identifying a mistake before further processing occurs so that the operator can quickly correct the defect. Example: Examples would include a weld counter to ensure the correct number of welds or a software modification that will not allow incorrect entries. 6. Mitigation seeks to minimize the effects of the mistake. This includes mechanisms that reduce the impact of a error and defect; products designed with low-cost, simple rework procedures when an error is discovered; extra design margin or redundancy in products to compensate for the effects of errors. Example: An example would be a smoke or heat detector detecting a hazardous situation.
  • 151. 151 2/11/2013 v8.0 Poka (= inadvertent error) - Yoke (= avoid) devices help us avoid defects, even when inadvertent errors are made. Poka - Yoke Devices help build Quality into Processes and Products Human Errors – Poka-Yoke Devices The term Poka-yoke (poh-kah yoh-keh) was coined in Japan during the 1960s by Shigeo Shingo who was one of the industrial engineers at Toyota. Toyota: 80-90% of problems are resolved on the floor
  • 152. 152 2/11/2013 v8.0 Five Key Mistake-Proofing Methods  Variation Control  Facilitation & Prevention Use of special jigs, fixtures, or assembly tools that reduce the variation of how parts are manufactured or assembled  Workplace Organization  Facilitation Error prevention by proper organization of the workplace or work station; e.g. implementation of a 5S Visual Workplace Organization Program  Identification  Facilitation Errors are prevented by use of clearly written, visual and easily available materials, work instructions and tools  Process Checks  Prevention & Detection Performance of specific in-process checks to prevent errors, incl. SPC or Pre-Control  Poka - Yoke Devices  Prevention & Detection Ensures mistake and errors cannot become defects by automatically detecting error conditions and immediately rejecting the part or shutting down the process. Poka- Yoke devices work best when a specific step must be taken to re-start the process once a mistake or error has been detected.
  • 153. 153 2/11/2013 v8.0 Characteristics of a Good Poka-Yoke Device Good Poka-Yoke devices, regardless of their implementation, share many common characteristics:  they are simple and cheap. If they are too complicated or expensive, their use will not be cost-effective.  they are part of the process, implementing what Shingo calls "100% inspection”.  they are placed close to where the mistakes occur, providing quick feedback to the workers so that the mistakes can be corrected.
  • 154. 154 2/11/2013 v8.0 1. Guide “Pins” of Different Size & Shape 2. Error Detection and Alarms 3. Limit Switches 4. Sensors 5. Vision Systems 6. Counters and Timers 7. Checklists Human Errors – Seven Best Poka-Yoke Devices
  • 155. 155 2/11/2013 v8.0 Seven Best Poka-Yoke Devices – Guide Pins 1. Guide Pins Guide pins of different sizes and/or shapes and placed in the proper locations ensure that parts are being assembled correctly by providing the operator feedback when a mistake has been made. Guide pins can also be used in jigs to ensure proper positioning of the part. Applications • Proper alignment of a work piece • Proper orientation of a work piece Features • Easy to develop & implement • May be the result of DFA and DFM activities (Product Quality Planning) Human Error Prevention • wrong order, incorrect selection, incorrect positioning, incorrect orientation, …
  • 156. 156 2/11/2013 v8.0 2. Error Detection & Alarms In general, an error detection device can provide a visual alarm such as a flashing light or an audible alarm such as a horn or siren. These devices signal that a problem is either about to occur or has just happened. With a warning effect, the response is not automatic; someone has to take action. Application • The signal must be triggered by something in the process, usually a sensor. Features • For audible warnings, there are sirens, horns, bells, and even voice synthesizers. • For visual alarms, there are lights that flash, rotate, strobe, or just light up. Warning: If you do use warnings, the audible or visual signal must stand out from background noise and lights. If audible alarms are used, be careful not to exceed noise standards. Be careful of “alarm silence buttons.” It is easy to silence the alarm and then forget to take action. Operators need thorough training on how to react to warnings. Seven Best Poka-Yoke Devices – Error Detection/Alarms
  • 157. 157 2/11/2013 v8.0 3. Limit Switches Limit switches are electro-mechanical devices that are activated or deactivated when an object comes in contact with them. They are used to detect the presence or absence of an object. Applications • Proper positioning of safety devices • Detection presence or absence of an object • Positioning of a work piece Features • Requires physical contact Human Error Prevention • Omission, excessive/insufficient repetition, incorrect selection, incorrect counting, incorrect positioning, incorrect orientation Seven Best Poka-Yoke Devices – Limit Switches
  • 158. 158 2/11/2013 v8.0 4.1 Proximity Sensors Proximity sensors emit a high-frequency magnetic field and detect an upset in the field when an object enters it. They can be used to detect the presence or absence of an object. Applications • Sensing of tank or bin level • Confirmation of part or object passes by • Detection presence or absence of object • Positioning of work piece Features • Non-contact - Work in harsh environments - Small sensors are available for installation in tight areas - Fast response speed Human Error Prevention • Omission, excessive/insufficient repetition, incorrect selection, incorrect counting, incorrect positioning, incorrect orientation, … Seven Best Poka-Yoke Devices – Sensors
  • 159. 159 2/11/2013 v8.0 4.2 Laser Displacement Sensors Laser displacement sensors focus a semiconductor laser beam on a target and use the reflectance of the beam off the target to determine the presence of a target and distance to it. Applications • Measuring distance • Detection of presence or absence of a feature • Confirmation of part or object passes by • Positioning of work piece Features • Non-contact - Works in harsh environments - Some devices can achieve measurement precision down to .004 mils (0.1µm). Human Error Prevention • Omission, incorrect selection, incorrect counting, failing to sense danger, … Seven Best Poka-Yoke Devices – Sensors
  • 160. 160 2/11/2013 v8.0 5. Vision Systems Vision systems use cameras to look at a surface and then compare the surface viewed to a “standard” or reference surface stored in the computer. They can be used to detect the presence or absence of an object, the presence of defects, or to make distance measurements. Applications • Missing or incorrect parts in an automated assembly line • Poor quality surfaces or components • Correct orientation of parts or labels • Ensure correct relative position • Color detection Features • Non-contact - Need to have sufficient light - Flexible (can be reprogrammed for a variety of applications) - Compact systems are now available. Human Error Prevention • Omission, incorrect selection, incorrect positioning, incorrect orientation, misrecognition, … Seven Best Poka-Yoke Devices – Vision Systems Checking for Label Presence, Color, Orientation, & Alignment.
  • 161. 161 2/11/2013 v8.0 6. Counters & Timers Counters (optical or electro-mechanical) look at the occurrence of events. They are usually triggered by some type of sensor. Counters can be programmed to shut down the process if a set number of events do not occur or if too many events do occur. Timers can shut down the process if processing time or activity time does not meet or exceeds a preset level. Applications • Ensuring the proper number of events occurred • Preventing failure of equipment or a component by timing usage Features • Flexible - Easy to use - Easy for people to understand Human Error Prevention • excessive/insufficient repetition, incorrect counting, incorrect positioning, incorrect orientation, … Seven Best Poka-Yoke Devices – Counters & Timers Correct Number of Holes
  • 162. 162 2/11/2013 v8.0 7. Checklists A checklist is a type of informational job aid used to reduce failure by compensating for potential limits of human memory and attention. It helps to ensure consistency and completeness in carrying out a task. Applications • Shift Start-up • Product Changeover • Equipment Set-up Features • Easy to develop - Easy to use - Easy for people to understand Human Error Prevention • omission, early/late execution, wrong order, misrecognition, … Seven Best Poka-Yoke Devices – Checklists
  • 163. 163 2/11/2013 v8.0 Human Errors → Poka-Yoke Examples SIM cards only fit one way. The right way. Expose your team to (simple) everyday Mistake-Proofing devices and examples and make them think about how they could use these concepts in their own work area. To which of the seven Poka-Yoke categories does this solution belong to?
  • 164. 164 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples Never forget your cell phone again. «Pick to Light»: on an assembly line, if the above light is green means that you must take the piece. If the light above the rack is red means that you must not take that piece.
  • 165. 165 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples Some of you may not remember. I still do and have lost (and found) a few of them. Does it fit. Error detection and defect prevention. → Limit Switches
  • 166. 166 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples It only fits one way by using guide pins and asymmetric product design. → Guiding “Pin” Human Error prevention through a visual workplace.
  • 167. 167 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples An oil change facility puts the dip stick on the fender protector. Removing the fender protector will cause the dip stick to clatter on the floor unless it has been reinserted. → Workplace Organization After a patient died from receiving a medication that was not properly diluted, all of that medication was diluted before being stored. → Pre-Kitting
  • 168. 168 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples Human Error detection through automated defect detection devices such as sensors, limit switches, scales, … . Getting the torque on bolts right is very tricky business for many companies. Huck fasteners mistake-proof this problem using a hybrid: half “pop-rivet,” half bolt. The tension on the bolt is created in a linear fashion and the “nut” is clamped in place and the excess bolt length is cut off.
  • 169. 169 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples Well Designed garage door openers have two safety features: (1) a contact safety reverse feature, which opens the door if it hits a person or object, and (2) an infrared beam across the doorway that causes the door to reverse automatically if a person or pet who passes through the beam. A company called Metric Blue offers metric bolts tinted blue. Why blue? So that when you have mixed metric and inch-series parts and fasteners it is easier to determine which standard you are working with. Company literature says, “by differentiating the metric fasteners (and tools) through our "blue" coating, we've eliminated the risk of failure or accidents due to mismatched components.”
  • 170. 170 2/11/2013 v8.0 Human Errors → Mistake-Proofing Examples Consumer friendly Mistake-Proofing product design improves usability and Customer Satisfaction. … and many more. Preventing missing weld nuts, with a sensor linked to a visual & audio alarm. Process will stop automatically and a corrective action is required.
  • 171. 171 2/11/2013 v8.0 Case Study Group Work 8 10 Minutes  Identify and describe 2 or 3 Poka-Yoke devices for the “Coffee Making Process” or your own process (current in use or could be used) to prevent likely causes or to detect failure modes. ________________________________________________________ ________________________________________________________ ________________________________________________________ ________________________________________________________ ________________________________________________________
  • 172. 172 2/11/2013 v8.0 Solution Selection Matrix – Basic Example • Effectiveness Effectiveness of the solution to resolve the root cause or escape point of the problem • Cost in local currency Cost to implement the solution • Time in weeks Time to implement the solution • Resources Yes = enough resources (own) Partly = not enough own resources, but more available in the organization No = no resources available in the organization SOLUTION # 1 SOLUTION # 2 SOLUTION # 3 SOLUTION # 4 Effectiveness Cost Time Resources 70 % 90 % 50 % 65 % 20 000 52 000 24 000 18 000 14 5 12 15 Yes Partly No Yes