Welcome to Root Cause Analysis & The Global 8D Problem...

Operational Excellence Consulting LLC – Frank G Adler, PhD – Managing Partner

1 October 2015 – v 3.0

Welcome to

Root Cause Analysis & The Global 8D Problem

Solving Process

Quality Day Conference 2015:

“Creating & Sustaining a Quality Culture”

October 30, 2015

Frank G. Adler, Ph.D.

Principal & Managing Partner

Operational Excellence Consulting LLC

[email protected]

www.operational-excellence-consulting.com

2 October 2015 – v 3.0

Agenda & Key Learning Points:

1. Discuss the differences and synergy between Six Sigma, Lean

Management and the 8D Problem Solving Process

2. Provide an overview of the 8D Problem Solving Process

3. Describe the purpose and objective of each phase of the 8D

Problem Solving Process

4. Introduce the 8D Problem Solving Worksheet and some of the

key problem-solving tools integrated into the 8D Problem

Solving Process

5. Illustrate the 8D Problem Solving Process using a simple case

study

Agenda & Key Learning Points

mailto:[email protected]



http://www.operational-excellence-consulting.com/






3 October 2015 – v 3.0

Six Sigma → Reducing Process Variability

Process

Inputs Process

Outputs

Customer

The Process

Step

1

Step

2

Step

3

Step

4

6M’s = MANPOWER

MEASURE

METHODS

MATERIALS

MACHINES

MOTHER NATURE

Y’s X’s

)x,...,x,x,f(x=Y k321

4 October 2015 – v 3.0

Six Sigma → The Roadmap to Reduce Variation

Improved Process

Define

Measure X1 X3 X7 X14…

X24 X32 X38

Analyze X3 X14…

X21 X24 X38

Improve X3 X14 X16 X38

Control

X1 X2 X3 X4 X5 X6 X7… X37 X38 X39 X40

X3 X14 X38

1st “Hit List”

10 - 15 X’s

Screened List 8 - 10 X’s

Found Critical Xs

4 - 8 X’s

Controlling Critical Xs

3 - 5 X’s

All Xs • Process Variables Maps

• Cause &Effects Matrix

• Capability Study

• MSA

• Process FMEA

• Multi-Vari Studies

• Hypothesis Testing

• Design of Experiments (DOE)

• Mistake Proofing

• Control Plans

• Project Charter

Project Ys


5 October 2015 – v 3.0

Lean → The Five Lean Principles

Define Value - Specify value from the Customer

perspective.

Map Value Stream - Identify the value stream for each

product or service and challenge all of the non-value

adding steps (wastes) currently necessary to create and

deliver this product or service. Add nothing than value.

Create Flow - Make the product or service creation and

delivery process flow through the remaining value-added

steps.

Establish Pull – Introduce pull based on Customer demand between all process steps where

continuous flow is possible.

Pursuit Perfection – Manage toward perfection so that the number of steps and the amount

of time and information needed to create and deliver products or services is optimized.

“All we are doing is looking at the time line, from the moment the customer

gives us an order to the point when we collect the cash. We are reducing the

time line by reducing the non-value added activities.”

Taiichi Ohno

6 October 2015 – v 3.0

Lean → The 7 “Deadly” Wastes

Lean defines non-value added activities as “waste”. Waste elimination is one of

the most effective ways to increase the profitability of any business. The seven

wastes originated in Japan, where waste is known as “Muda."

T – I – M – W – O – O - D

Inventory

Over-Processing

Waiting

Transportation

Defects

Motion

Over-Production

The 7 Wastes


7 October 2015 – v 3.0

Lean → The Roadmap to Reduce Lead Time

Improved Process

Define

Measure

X1 X3 X7 X14… X24 X32 X38

Analyze

X3 X14… X21 X24 X38

Improve X3 X14 X16 X38

Control

X1 X2 X3 X4 X5 X6 X7… X37 X38 X39 X40

X3 X14 X38

1st “Hit List”

Screened List

Found Critical Xs

Controlling Critical Xs

All Xs

• Value Stream Map

• MSA

• Spaghetti Diagram

• Waste Walk

• Ohno Circle

• 5S Visual Workplace

• Quick Changeover (SMED)

• Kanban & Pull Systems

• Mistake-Proofing & Poka-Yoke

• Standardized Work

• Control Plans

• Project Charter

Project Ys

8 October 2015 – v 3.0

“Change-Induced” vs. “Day-One-Deviation”

Change

Performance SHOULD

Past Present

DE

VIA

TIO

N

Performance ACTUAL

Performance SHOULD

Present

DE

VIA

TIO

N

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.

8D Problem Solving Process Lean or Six Sigma DMAIC Process

Special Cause Variation Common Cause Variation


9 October 2015 – v 3.0

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. Root causes are

the fundamental, underlying reasons for a Problem or Failure Mode.

10 October 2015 – v 3.0

The 8D Problem Solving Process

1 • Establish the Team

2 • Describe the Problem

3 • Develop Interim Containment Actions

4 • Define and Verify Root Cause(s) and Escape Point(s)

5 • Choose and Verify Permanent Corrective Actions

6 • Implement and Validate Permanent Corrective Actions

7 • Prevent Recurrence

8 • Recognize Team and Individual Contributions


11 October 2015 – v 3.0

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

12 October 2015 – v 3.0

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


13 October 2015 – v 3.0










14 October 2015 – v 3.0

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 (5 Whys)

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 “day-one-deviation” situation

Establish a high-level project plan, including milestones,

project goals and objectives

“Describe the Problem” Key Activities


15 October 2015 – v 3.0

“If I had an hour to save the world I would spend 59 minutes defining

the problem and one minute finding solutions.”

Albert Einstein

16 October 2015 – v 3.0




problems.













17 October 2015 – v 3.0

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)

18 October 2015 – v 3.0

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


19 October 2015 – v 3.0

Problem Statement & 5 Whys – Example

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.

We did not have the “right” rework tool.

WHY? → We don’t know.

Initial Problem

Statement

Final Problem

Statement

20 October 2015 – v 3.0

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)


21 October 2015 – v 3.0

The “IS – IS NOT” Matrix

8D 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

22 October 2015 – v 3.0




problems.













23 October 2015 – v 3.0

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

24 October 2015 – v 3.0

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. 6Ms or 4 Ps, or team-defined categories.

Fishbone or Ishikawa Diagram

6M’s = MEN

MEASURE

METHODS

MATERIALS

MACHINES

+ MOTHER NATURE

4P’s = PLANT

POLICIES

PEOPLE

PROCEDURES

Machines

Materials Methods

MotherNature

Trunk

Primary Possible Cause Category

Main Branch

Minor Branch

Second-Level

Possible Causes

Men/People

Problem

Statement


25 October 2015 – v 3.0

Process Variables Map

Process Step Inputs & Characteristics (Xs) Type Process Step Process Step Outputs & Characteristics (Ys)

INPUTS Coffee Machine (clean) C "Clean" Coffee Machine

Think 6 M's Coffee Maker or Operator (experienced) U Coffee Machine plugged in Power Outlet

Man Power Outlet (functional) C

Machine

Material

Method

Measure

Mother Earth

Coffee Machine (clean) C Filter in Coffee Machine

Coffee Maker or Operator (experienced) U Water in Coffee Machine

Coffee Powder (right, fresh) C/U

Coffee Filter (right size, non-defective) C/U

Spoon (clean, right size) C

Instructions (correct) C

Coffee Machine (clean) C "Correct" Amount of Water in Coffee Machine

Coffee Maker or Operator (experienced) U

Coffee Pot (clean, non-broken) C

Water Faucet (functional) C

Water (clean, fresh) C/U

Instructions (correct) C

Process: Coffee Making Process

Preparing Coffee

Machine

(1. Checking for

Cleanliness

2. Checking that

machine is plugged into

power outlet)

Adding Water into

Coffee Machine

(1. Filling coffee pot with

water

2. Filling water into

coffee machine)

Adding Coffee into

Coffee Machine

(1. Getting coffee filter

2. Placing coffee filter

into coffee machine

3. Getting coffee powder

4. Adding coffee powder

into coffee filter)

26 October 2015 – v 3.0











27 October 2015 – v 3.0

“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

28 October 2015 – v 3.0

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.

…


29 October 2015 – v 3.0










30 October 2015 – v 3.0

“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).


31 October 2015 – v 3.0

“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

32 October 2015 – v 3.0




problems.













33 October 2015 – v 3.0

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

34 October 2015 – v 3.0

Comparative Analysis





(+) (-) (?)


could occur



What has changed in, on, around or about this distinction?

When did it change?


What? Object: Red felt tip marker Blue, black or green marker

Defect: Leaks Totally dry

Where? Tip Barrel (side or base)



… …

When? First seen two weeks ago Before two weeks ago


observed before, during or after other events? When since has the defect occurred? Are there


… …

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


35 October 2015 – v 3.0

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?

36 October 2015 – v 3.0




problems.













37 October 2015 – v 3.0

Root Cause Theory Testing





(+) (-) (?)


could occur



What has changed in, on, around or about this distinction? When

did it change?


What?

Object:

Defect:

Where?



When?


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 + - ?

38 October 2015 – v 3.0

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.


39 October 2015 – v 3.0

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.

40 October 2015 – v 3.0

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.


41 October 2015 – v 3.0










42 October 2015 – v 3.0

“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


43 October 2015 – v 3.0

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

44 October 2015 – v 3.0

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.


45 October 2015 – v 3.0


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.

46 October 2015 – v 3.0


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.


47 October 2015 – v 3.0










48 October 2015 – v 3.0

Purpose: Plan and implement selected Permanent Corrective Actions,

remove the Interim Containment Action. Monitor long-term results.

Implement the best solution(s) to remove the root cause(s)

Implement the best solution(s) to address the escape point(s)

Validate the effectiveness of the implemented solutions from the

Customer perspective

Monitor the effectiveness of the implemented solutions and assure that

they do not cause any undesirable effects

Remove Interim Containment Action

“Implement Corrective Actions” Key Activities


49 October 2015 – v 3.0










50 October 2015 – v 3.0

Purpose: Modify the necessary systems, including policies, methods,

and procedures, to prevent recurrence of the problem and similar ones.

Identify opportunities to improve and standardize systems, policies,

methods and procedures for the present problem

Identify opportunities to improve and standardize systems, policies,

methods and procedures for similar problems

“Prevent Recurrence” Key Activities


51 October 2015 – v 3.0

Process Control Plan – Objective

A Control Plan is a written statement of an organization’s quality planning

actions for a specific process, product, or service.

The Objective of an effective Process Control Plan is to

operate processes consistently on target with minimum variation,

which results in minimum waste and rework

assure that product and process improvements that have been

identified and implemented become institutionalized

provide for adequate training in all standard operating procedures,

work instructions and tools

Customer

Requirements

Product & Part

Characteristics

Process

Input & Output

Characteristics

Process

Controls

Process

Control

Plan

52 October 2015 – v 3.0











53 October 2015 – v 3.0

“Recognize the Team” Key Activities

Purpose: Complete the team experience and sincerely recognize both team

and individual contributions. Celebrate success and identify lessons learned.

Perform a final review of the problem solving project

Finalize and archive project documentation

Recognize the team’s success and individual contributions

Capture lessons learned and integrate findings into the 8D Problem

Solving Process

Reward and celebrate

54 October 2015 – v 3.0

“The rate at which organizations learn may soon become the only sustainable source of competitive advantage.

Peter Senge

Frank G Adler, Ph.D.

Principal & Managing Partner

Operational Excellence Consulting LLC

Phone: + 1 (888) 372 - 8705

Email: [email protected]

Website: www.operational-excellence-consulting.com

OPERATIONAL EXCELLENCE

C O N S U L T I N G






Welcome to Root Cause Analysis & The Global 8D Problem...

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