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The 8 Discipline

8D
Problem Solving
Process
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Course Objectives
Course Objectives
To enable participants to solve problems by:
Following a discipline problem solving methodology
using the 8 Discipline (8D) Process
Applying the proper quality tools
Identifying true root cause
Implementing Irreversible Corrective Action
Concentrating on Mistake Proofing whenever possible
2

Problem Solving
When do you use a Reactive Problem Solving process?
For high priority problems
When standards and specifications are not being met
When a process is out of control

When formal evidence of problem resolution is required

Important

High

Low

Important and Urgent


8 D Reactive
Problem Solving

Important not Urgent


A Proactive
Improvement Process
(7 Step, Kaizen)

Not Important and


Urgent
Reprioritize Work

Not Important and


Not Urgent
Get a New Job

High

Urgent

Low
3

Problem Solving - Statistical Tools

The formal approach to problem solving


requires that you base your assessment of the
problem and the effectiveness of the solution
on data, not speculation or opinions

Fundamental statistical tools are used


throughout the problem solving process to
ensure measurable results
If the only tool you have is a
hammer everything looks like a nail

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venti
on

idatio
: Val
Step
8

: Pre

: Dia
gn
Caus ose Roo
t
e(s)
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Step
7

: Per
m
Actio anent
n(s)

Step
6

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Step
5

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Step
Actio 4: Imme
di
ns (C
onta ate
inme
nt)

ial A
nalys
is
: Init
Step
3

Flowcharts
Brainstorming
Force Field Analysis
Cause and Effect
Interviewing
Surveying
Market FeedBack Customer Input
Checksheets
Histograms
Pareto Analysis
Run Charts
Pie Charts
Criteria Rating Forms
List Reduction
Weighted Volume
Gantt Chart
PERT Chart
Supplier Input
FMEA
Control Plan

Step
2

Step
1

: De

: Est

fine C

ablis
h Te

once
r

am

Problem Solving - Statistical Tools

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8D Problem Solving

The 8D system is a problem solving process that


Identified problems
Takes interim containment action
Describes problems in measurable terms
Analyzes them using data and basic statistical tools
Finds the true root cause
Corrects the problem by eliminating the root cause
Implements Mistake Proofing to prevent
reoccurrence
Uses Lessons Learned concepts as Prevention
Techniques
6

8D Problem Solving

8
Validation of
Solutions &
Permanent
Control

1
Define concern

2
Establish the
Team

7
Prevent
Recurrence
6
Permanent
Action(s)

8D
Process

5
Diagnose Root
Cause(s)

4
Immediate
Actions
Contain the
Problem

3
Initial
Analysis

8D follows the logic of


the PDCA Cycle
(a.k.a. Shewhart or
Deming Cycle)
7

8D Problem Solving Form (part 1 of 2)


Corrective / Preventive Action Report
Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.roos@hs.utc.com
Value Stream:
Supplier (area where found
if known)

CAPA Champion:
Supplier #
Name &
Contact Info
Product/Process:
Part Number & Name
IR#
Qty

Report No:
07-

CAPA Type:
CA - Supplier

Origination Date:

Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
Final Response Due:

Team Member:

Responsibility:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM


Team Member:

Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS CONTAIN THE PROBLEM


#
1

Task

Owner

Target Date

Status

2
3
4
5

8D Problem Solving Form (part 2 of 2)


5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
#
1

Task

Owner

Target Date

Status

2
3
4
5

Poke Yoke Mistake Proofing Description & Level:

7. PREVENTION
FMEA:
Control Plan:
Work Instructions:
SPC Charts

Reviewed:
Reviewed:
Reviewed:
Reviewed:

Yes
Yes
Yes
Yes

No
No
No
No

Poke Yoke Mistake Proofing Effective: Yes _________

Revised:
Revised:
Revised:
Revised:

Yes
Yes
Yes
Yes

No
No
No
No

No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES


#
1
2

Task

Owner

Target Date

Status

8D Problem Solving Characteristics

Works on problems that are specific,


manageable and well defined
Analyzes all aspects of a problem
Develops rationale for proposed
solutions
Gathers critical data about the
problem and proposed solutions
Team oriented process
Plans how to implement and evaluate
the action successfully
10

8D Process Step 1
1- Define
Concern

8D

11

8D Problem Solving Form Step 1


Corrective / Preventive Action Report
Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.roos@hs.utc.com
Value Stream:
Supplier (area where found
if known)

CAPA Champion:
Supplier #
Name &
Contact Info
Product/Process:
Part Number & Name
IR#
Qty

Report No:
07-

CAPA Type:
CA - Supplier

Origination Date:

Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
Final Response Due:

Team Member:

Responsibility:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM


Team Member:

Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS CONTAIN THE PROBLEM


#
1

Task

Owner

Target Date

Status

2
3
4
5

12

Step 1: Define the Concern


1. Define the issue
2. Identify the problem(s)
3. Analyze and interpret data to narrow down the
problem to be addressed
4. Develop a formal problem statement

13

Step 1: Define the Concern


- The Problem Statement
1. A clear statement of the problem in measurable terms
A.
B.
C.
D.

Based on data, not speculation


No causes - Root cause has not yet been developed
No solutions - Solutions must target the root cause
Not too general

2. The Problem Statement must include:


A. The Current state or as is condition
B. The Desired state or required position
C. The Gap or difference between the current and desired
states
14

Step 1: Define the Concern


- General Process
Develop and Write a Problem Statement
A. Write the Current state statement describing the
present situation.
B. Write the Desired state statement describing the
requirement or specification.

C. Identify the gap.


D. Combine the three to generate the Problem Statement
15

Step 1: Define the Concern - Example


Reported Issues
1. Customer test failure rates are too high
2. Business with this high profile customer is in jeopardy

Problem Topic
Customer test yields are unacceptable

Analysis reflects leads us to the following problem statement


The customers test yield on our product is 75% (current state), the
required yield is 95% minimum (desired state), the customers test yield is
20% less than the acceptable level (gap).

Review of the statement


1. Is it based on data?
2. Are there causes in the statement?
3. Are there solutions in the statement?
4. Is the statement too general?

Yes
No
No
No

Conclusion: The Problem Statement meets the general criteria

16

8D Process Step 2

Define concern

2
Establish
Team

8D

17

8D Problem Solving Form - Step 2


Corrective / Preventive Action Report
Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.roos@hs.utc.com
Value Stream:
Supplier (area where found
if known)

CAPA Champion:
Supplier #
Name &
Contact Info
Product/Process:
Part Number & Name
IR#
Qty

Report No:
07-

CAPA Type:
CA - Supplier

Origination Date:

Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
Final Response Due:

Team Member:

Responsibility:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM


Team Member:

Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS CONTAIN THE PROBLEM


#
1

Task

Owner

Target Date

Status

2
3
4
5

18

Step 2: Establish Team


Membership
Stakeholders
Knowledgeable people / technical experts
People accountable & responsible for problem area
Team Size
Ideally, 4 to 6 members to
Enhance interaction
Promote communication
Drive commitment to the task
Scope, Objective, Roles and Responsibilities

Identify what the team is expected to address


Review the teams availability
Clarify the level of decision-making authority
19

Step 2: Establish Team


- Checklist
Are we on target?
1.

2.

3.

4.

5.

Have we considered is suppliers and/or customers need to


be part of the team?
Do we have the right in-house team members to proceed
to the next step?
Have we considered specific technical expertise needed
for this team?
Have we established the team roles, responsibilities,
scope and objectives?
Have meeting and decision-making processes been
agreed upon?
20

8D Process Step 3
Define concern

Establish the
Team

8D

3
Initial
Analysis

21

8D Problem Solving Form - Step 3


Corrective / Preventive Action Report
Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.roos@hs.utc.com
Value Stream:
Supplier (area where found
if known)

CAPA Champion:
Supplier #
Name &
Contact Info
Product/Process:
Part Number & Name
IR#
Qty

Report No:
07-

CAPA Type:
CA - Supplier

Origination Date:

Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
Final Response Due:

Team Member:

Responsibility:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM


Team Member:

Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS CONTAIN THE PROBLEM


#
1

Task

Owner

Target Date

Status

2
3
4
5

22

Step 3: Initial Analysis - Objectives


A. Assure customer focus by protecting customer from
receiving additional defective product.
B. Interpret the initial data collected, obtaining additional
(more specific) data if necessary to clarify the problem
Consider the standard who, what, when, where,
and how elements
Use the basic statistical tools to clarify the data
and display the findings in an appropriate
format
The collected data should be evaluated against
the standard or specification required to be met
C. Compare the data with business objectives, performance
measures, and applicable standards or specifications

23

Step 3: Initial Analysis


- General Process
1. Identify the issue to be addressed
Ensure the issue is defined correctly by confirming it with
data or by personal observation
2. Assess the magnitude of the issue, considering impact on
Business levels
Internal processes
Customers
3. Identify the problem topics that may surround the issue,
and select the problem target area.

24

Step 3: Initial Analysis


- General Process
4. Brainstorm and record the teams ideas about the problem area
5. Collect data to determine the extent of the problem
Establish what standard or specification applies to the
situation
Consider all available sources of information that may
relate to the problem (including external sources)
6. Develop and implement a general plan for approaching the
problem

25

Step 3: Initial Analysis


- Team Activity
Goals
1. Clarify the issue to be addressed
Review supporting data
Assess the magnitude
2. Brainstorm potential problems surrounding the issue and
ideas related to them
3. Collect supporting data about the problem area(s)
4. Discuss the general plan for approaching the problem(s)
26

Step 3: Initial Analysis


- Team Activity
Goals
5. Analyze the problem data to try to confirm the extent of the
problems
6. Compare the data to business objectives, performance
measures, and applicable standards or specifications
7. Use the collected data to establish the current and desired
states, and determine the gap
8. Redefine the Problem Statement if needed in the Initial
Analysis section (not section 1)
27

Step 3: Initial Analysis


- Checklist
Are we on target?
1. Has data about the problem been taken and reviewed?
2. Has the problem been identified by What, When, Why, Where,
How, and How Much?
3. Has the extent of the problem been defined in measurable
terms?
4. Has the customer provided input to the problem?

28

Step 3: Initial Analysis


- Checklist (continued)
Are we on target?
5. Have the reported issues been identified?
6. Has the problem topic been re-identified in section 3?

7. Have the applicable standards been identified?


8. Has the scope of the problem been defined?
9. Have all in-transit defective materials been identified &
considered (both incoming & outgoing)?
10. Has a general project plan been developed?
29

8D Process Step 4
Define concern

Establish the
Team

8D
Initial Analysis

4
Immediate
Actions
Contain the
Problem

30

8D Problem Solving Form - Step 4


Corrective / Preventive Action Report
Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.roos@hs.utc.com
Value Stream:
Supplier (area where found
if known)

CAPA Champion:
Supplier #
Name &
Contact Info
Product/Process:
Part Number & Name
IR#
Qty

Report No:
07-

CAPA Type:
CA - Supplier

Origination Date:

Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
Final Response Due:

Team Member:

Responsibility:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM


Team Member:

Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS CONTAIN THE PROBLEM


#
1

Task

Owner

Target Date

Status

2
3
4
5

31

Step 4: Immediate Actions


- Contain Problem
- Objectives
1. Identify and select containment action (s)

2. Develop and implement a containment plan


3. Analyze the effectiveness of the
containment actions

32

Step 4: Immediate Actions


Contain the Problem
Containment
Also

known as short term corrective action

Objective

is to take immediate interim action


to prevent the problem from impacting the
customer while the root cause is being
investigated and corrective action is
established and implemented

Typically,

containment involves sorting,


screening or testing with rework as
required, and sequestering effected product
or materials while awaiting disposition

33

Step 4: Immediate Actions


- Contain Problem
- General Process
1. Brainstorm and select interim containment action (s)
2. Verify extent of containment activities encompass
incoming & outgoing in-transit materials.
3. Plan for implementation
4. Implement containment actions
5. Verify interim actions are in place and effective
34

Step 4: Contain Problem Brainstorm (1)


Uses the creative capacity of a group of people to generate ideas
Uses
Identifying problem areas
Finding potential causes of problems
Generating alternative solutions
Guidelines
No evaluation or criticism
Encourage wild ideas
Build on ideas of others
Strive for quantity
Types
Structured
Members participate in sequence verbally (Round Robin)
Members write their ideas down in the session (Slip method)
Unstructured
Random verbal input (Free wheeling)
35

Step 4: Contain Problem Brainstorm (2)


General Approach:

1. Identify a facilitator to guide the session


Keep session moving
Promote a volume of ideas
Prompt and ask questions

2. Identify the recorder of ideas (scribe)


Ideas should be recorded as closely to
what is said as possible
Use a flip-chart to keep ideas visible
3. Define the Problem
4. Define the time period for the brainstorm
session
36

Step 4: Contain Problem


The Implementation Plan
Planning
Objective is to ensure that formal actions are taken in a
systematic fashion
A structured and trackable plan, using a formal tool such as a
Gantt chart is recommended
General Process
1. Break tasks into achievable steps.
2. Assign task responsibilities.
3. Set up time frame and milestones.
4. Create a document for tracking the progress of the
implementation
5. Additional consideration for inclusion in the plan are strategies
for communicating and gaining commitment, contingency
plans, and measures to evaluate the effects
37

Step 4: Contain Problem


- The Implementation Plan
Gantt Chart

ID
1
2
3

Task Name

Locate product
Evaluate product
Screen product

Start

2/15/00
2/16/00
2/17/00

Finish

eb
Resource Names 2/15

2/15/00 Material Handler


2/16/00 Engineering
2/17/00 Production Tester

2/18

2/21

2/24

Material Handler
Engineering
Production Tester

38

Step 4: Contain Problem


- Team Activity
Goals
1. Select the containment action (s) to be taken
2. Develop any necessary plans
3. Implement the action (s)
4. Verify the containment actions are in place and effective

39

Step 4: Contain Problem - Checklist


1. Have potential containment actions been identified?
2. Have containment actions been identified?
3. Have containment actions been implemented?

Are we on target?

4. Are the containment actions effective at protecting the customer


from defects?
5. Have containment actions been verified?
6. Do we have the right team members to proceed to the next step?
7. Have we communicated our Containment plan to our customer?
40

8D Process Step 5

Define concern

Establish the
Team

8D
Initial
Analysis

5
Diagnose
Root Cause

Immediate
Actions
Contain the
Problem

41

8D Problem Solving Form Step 5


5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
#
1

Task

Owner

Target Date

Status

2
3
4
5

Poke Yoke Mistake Proofing Description & Level:

7. PREVENTION
FMEA:
Control Plan:
Work Instructions:
SPC Charts

Reviewed:
Reviewed:
Reviewed:
Reviewed:

Yes
Yes
Yes
Yes

No
No
No
No

Poke Yoke Mistake Proofing Effective: Yes _________

Revised:
Revised:
Revised:
Revised:

Yes
Yes
Yes
Yes

No
No
No
No

No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES


#
1
2

Task

Owner

Target Date

Status

42

Step 5: Diagnose True Root Cause


- Objectives

1. Identify the probable cause (s) of the problem

2. Select the root cause

3. Identify and clarify potential corrective actions

43

Step 5: Diagnose True Root Causes


- General Process
1. Identify Probable Causes
A. Review customer requirements

B. Brainstorm and organize possible causes


(e.g., cause and effect diagram)
C. Identify probable causes

D. Rank causes by correlation to effect: Strong, Moderate or Weak


2. Analyze Probable Causes
A. Select probable causes for data collection
B. Determine collection method (e.g., Checksheet)
C. Collect / analyze / display data to identify root causes preventing
the "desired state from being reached
44

Step 5: Diagnose True Root Causes


- General Process
3. Select Root Causes for Action
A. Prioritize root causes
B. Select root cause(s) to work on
C. Determine if taking action is within the scope
or the team or if additional resources need to
be enlisted
D. Develop and implement experiments to test
and validate root causes
E. Revise problem statement (if required)

45

Step 5: Diagnose True Root Causes


- Cause and Effect Analysis
Cause and Effect Diagram
A structured form of Brainstorming
Identify, explore, and display a problem (effect) and all
possible causes

Uses
Analysis of a problem
Guide for discussion
Illustrate level of technology
Evaluate knowledge of a process
Collection of data
Education tool
46

Step 5: Diagnose True Root Causes


- Cause and Effect Analysis
Most common cause categories (6-Ms)

Manpower
Machine

Materials
Methods

Milieu (environment)
Measurement
47

Step 5: Diagnose True Root Causes


- Cause and Effect Analysis

Name:

(6-Ms)

Date:
Time-frame:

Causes
Material

Method

Milieu (Environment)

Unavailable

Effect

Didnt Order
Not on bill

(Current State)

Missing
Parts

Training

Manpower

Set Up

Machine

Measurement
48

Step 5: Diagnose True Root Causes


- Cause and Effect Analysis
Name:

(6-Ms)

Date:
Time-frame:

Causes
Material

Method

Milieu (Environment)

Unavailable
Didnt Order
Not on bill

Effect
(Current State)

Missing
Parts
B
Training

Manpower

C
Set Up

Machine

Measurement

Relationship to Effect
A= Strong
B = Moderate
C = Weak
49

Step 5: Diagnose True Root Causes


- Team Activity
Goals
1. Brainstorm the possible causes of the
problem, using a cause and effect diagram
2. Rank the possible causes and collect
supporting data
3. Select the root cause target(s)
4. Run tests to confirm the root cause(s), if
necessary
5. Revise the problem statement, if necessary
50

Step 5: Diagnose True Root Causes


- Checklist
1. Has the problem statement been reviewed?

2. Have probable causes been identified?

Are we on target?

3. Has data been collected on the probable causes?


4. Have true root causes been prioritized and selected?
5. Have potential corrective actions / solutions been identified and
clarified?
6. Do we have the right team members to proceed to the next step?

51

Step 5: Diagnose True Root Causes


- Checklist
TRUE ROOT CAUSE VERIFICATION QUESTIONS
Or How to tell if you have designated the True Root Cause

Are we on target?
1. Can you ask Why one more time and
get another controllable root cause?

2. Can we turn the problem on and off with this root cause?

3. Is this root cause controllable?

52

Step 5: Diagnose True Root Causes


- Objectives
1. Evaluate the potential corrective action(s)
2. Select the corrective action(s) to be taken
3. Develop and agree upon a corrective action
implementation plan

53

Step 5: Diagnose True Root Causes


- Develop Corrective Action Plan
- Objectives
1. Evaluate the potential corrective action(s)

2. Select the corrective action(s) to be taken


3. Develop and agree upon a corrective action
implementation plan

54

Step 5: Diagnose True Root Causes


- Develop Corrective Action Plan
- General Process
1. Select the general corrective action criteria considering:
Time
Resource
Control
Cost
2. Use the criteria to select the best corrective action
Get input from all team members
Brainstorm a list of ideas
Assess benefits and drawbacks
Combine ideas
Vote on best potential corrective action(s) - Ideas must be
actionable and within the scope of the team

55

Step 5: Diagnose True Root Causes


- Develop Corrective Action Plan
- General Process
3. Develop an implementation plan
Include action items and a schedule
Arrange for resources (including supplier and
customer, if needed)
Assign and review responsibilities
Consider applicable measures, contingency
plans, and pilot tests (if appropriate)

56

Step 5: Diagnose True Root Causes


- Develop Corrective Action Plan
- Team Activity
Goals
1. Brainstorm a list of corrective action ideas

2. Decide the best potential corrective action(s)

3. Develop a corrective action plan


57

Step 5: Diagnose True Root Causes


- Develop Corrective Action Plan
- Checklist
1. Have potential corrective actions / solutions
been filtered and combined?
2. Have criteria for selection been identified?

Are we on target?

3. Has a corrective action plan been developed?


4. Has the impact of the corrective action on other processes or
customers been evaluated?

5. Based on evaluation, will the corrective action / solution totally


eliminate the defect associated with the root cause?
6. Do we have the right team members to proceed to the next step?

58

8D Process Step 6

Define concern

Establish the
Team

6
Permanent
Action(s)
Diagnose
True Root
Cause(s)

8D
Initial Analysis
Immediate
Actions
Contain the
Problem

59

8D Problem Solving Form Step 6


5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
#
1

Task

Owner

Target Date

Status

2
3
4
5

Poke Yoke Mistake Proofing Description & Level:

7. PREVENTION
FMEA:
Control Plan:
Work Instructions:
SPC Charts

Reviewed:
Reviewed:
Reviewed:
Reviewed:

Yes
Yes
Yes
Yes

No
No
No
No

Poke Yoke Mistake Proofing Effective: Yes _________

Revised:
Revised:
Revised:
Revised:

Yes
Yes
Yes
Yes

No
No
No
No

No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES


#
1
2

Task

Owner

Target Date

Status

60

Step 6: Permanent Actions


- Objectives
1. Test the intended corrective action(s) and
adjust the plan if required
2. Implement the corrective action(s) and
verify that the root cause has been
eliminated

3. Remove the containment action and verify


that the problem does not recur

61

Step 6: Permanent Actions


- General Process
1. Prepare for implementation
A. Review the problem statement
B. Restate the root cause
C. Review the corrective action plan
D. Train / review plan with all effected personnel
2. Implement the corrective action
A. Implement the corrective action plan
B. Remove the interim (short term) containment action
C. Track implementation progress
D. Continuously communicate with all effected personnel

62

Step 6: Permanent Actions


- General Process
3. Evaluate the effectiveness of the action
A. Collect results data for evaluation of the effectiveness of the
corrective action (s)
Note: Include customer feedback
B. Analyze data in comparison with:
Previous analysis
Business objectives
Desired state
C. Determine if there is still a gap
4. Complete evaluation
A. Address the gap (if any)
B. Identify and address new problem areas created by the
solution(s), if applicable
C. Designate Mistake Proof Method and Level

63

Mistake Proofing
LEVEL I DEVICES (e.g.: Railroad Crossing Signs)
Physical devices that prevent the error at the source.
Designing errors out up front through thorough quality planning.
One way fits, required actions in order to operate equipment, etc.
LEVEL II DEVICES (e.g.: Railroad Crossing Flashing Lights and Bar Across Road)
Warning devices like Control Charts, buzzers, lights, alarms that require a
human response.
Control Chart
Helps to determine if the variation within the measured output is strictly
due to the system (common causes) or if something out of the ordinary
(special causes) has occurred.
Do we need managements involvement to help solve this problem or can
the Operator handle it locally?

LEVEL III DEVICES (e.g.: Bridge Over Railroad Tracks)


Helps prevent a defect from going onto the next operation (i.e.: kick-out
device on a gage checking bushing diameters).
May prevent an unsafe condition from happening even though an unsafe
act has already occurred (i.e., oil drip pan beneath a machine).
64

Step 6: Permanent Actions


- General Process
5. Standardize changes
A. List the standard process documentation that needs to
be modified to make the change systemic
Consider practices, procedures, and systems
allowed the initial problem to occur
B. Update applicable documentation to formalize control,
provide a vehicle for training, and ensure ISO
compliance such as:
Inspection plans / Procedures
Process Specifications
Machine Operating Instructions
Work Instructions
Standard Operating Procedures
Product / Component Prints and Specifications
Failure Mode & Effects Analysis (FMEAs)

65

Step 6: Permanent Actions


- Class Activity
Goals
1. Review the problem statement, and root cause being
addressed
2. Review the corrective action plan
3. Implement the corrective action plan

4. Evaluate the effectiveness of the corrective action


5. Analyze Mistake Proofing Level (1 2 3)
6. Formalize any system changes
66

Step 6: Permanent Actions


- Checklist
1. Have pilot(s) been conducted?
Are we on target?
2. Has data been collected?
3. Has success been achieved based on closing the problem gap
and addressing customer feedback?
4. Have new problems (if any) been identified?
5. Has a Validation Plan Timeline been established?
6. Do we have the right team members to proceed to the next
step?
67

8D Process Step 7

Define
Concern

7
Prevent
Recurrence

Establish the
Team

8D

Permanent
Action (s)

Diagnose Root
Cause (s)

Initial
Analysis
Immediate
Actions
Contain the
Problem

68

8D Problem Solving Form Step 7


5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
#
1

Task

Owner

Target Date

Status

2
3
4
5

Poke Yoke Mistake Proofing Description & Level:

7. PREVENTION
FMEA:
Control Plan:
Work Instructions:
SPC Charts

Reviewed:
Reviewed:
Reviewed:
Reviewed:

Yes
Yes
Yes
Yes

No
No
No
No

Poke Yoke Mistake Proofing Effective: Yes _________

Revised:
Revised:
Revised:
Revised:

Yes
Yes
Yes
Yes

No
No
No
No

No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES


#
1
2

Task

Owner

Target Date

Status

69

Step 7: Prevent Recurrence - Objectives

1. Verify that the corrective action implementation


plan is being followed
2. Develop and implement the systemic controls
3. Look for other opportunities to use the action taken
4. Review Poke-Yoke or Mistake Proofing Initiatives

70

Step 7: Prevent Recurrence


- General Process
1. Verify that the implementation plan is complete
If there are incomplete items on the plan or other
issues that need to be addressed as a result of
the action, ensure that they are resolved or there
is a formal plan in place for their resolution
Ensure that there are enough checks performed over
time to establish that the results of the action are consistent
2. Review the control plan
Ensure that the controls to monitor critical parameters
associated with the effected process are in place
Evaluate the plan to ensure that unfavorable trends trigger
action prior to nonconformances occurring
71

Step 7: Prevent Recurrence


- General Process
3. Look for additional applications of the action
Other products, processes, operations, customers, etc.
related to the business may benefit from the same
corrective measures
4. Review and update Work Instructions, SPC Charts, and Associated
Forms
5. Review and revise FMEA based on increased occurrence levels and
newly implemented controls
6. Identify implemented Mistake Proof level (1 2 3)
7. Calculate a timeline for when expected Validation activities can
occur based on production planning and quantities.

72

MISTAKE-PROOFING TYPE

Mistake Proofing
PHYSICAL DEVICES

LEVEL 1

WARNING DEVICES

LEVEL 2

INSTRUCTIONS

LEVEL 3

LOW

MEDIUM

HIGH

MISTAKE-PROOFING EFFECTIVENESS
73

Step 7: Prevent Recurrence


- Class Activity
Goals
1. Make sure the corrective action plan and
any system changes are in place

2. Define Mistake Proof level (1-2-3) and the potential for


improving Mistake Proof level.
3. Develop/Revise FMEA
4. Develop/Revise Control Plan
5. Review other products, processes, operations, customers, etc.
that may benefit from the same corrective measures
74

Step 7: Prevent Recurrence - Checklist


1. Has the problem statement been reviewed?
Are we on target?
2. Has the Corrective Action plan been reviewed and
all the steps implemented?
3. Has all the appropriate paperwork been reviewed
and revised to assure prevention?
4. Have new problems (if any) been formally
addressed?
5. Has the customer confirmed that the problem has
been resolved to their satisfaction?
75

8D Process Step 8

8
Validation of
Solutions &
Permanent
Controls

Define concern

Prevent
Recurrence

Establish the
Team

8D
Permanent
Actions (s)

Diagnose Root
Cause (s)

Initial Analysis

Immediate
Actions Contain
the Problem

76

8D Problem Solving Form Step 8


5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
#
1

Task

Owner

Target Date

Status

2
3
4
5

Poke Yoke Mistake Proofing Description & Level:

7. PREVENTION
FMEA:
Control Plan:
Work Instructions:
SPC Charts

Reviewed:
Reviewed:
Reviewed:
Reviewed:

Yes
Yes
Yes
Yes

No
No
No
No

Poke Yoke Mistake Proofing Effective: Yes _________

Revised:
Revised:
Revised:
Revised:

Yes
Yes
Yes
Yes

No
No
No
No

No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES


#
1
2

Task

Owner

Target Date

Status

77

Step 8: Validation of Solutions &


Permanent Control Measures
- Objectives
1. Validate all corrective actions and Mistake Proofing
implementations are still in place and effective over time.

2. Recognize the contributions of everyone involved


3. Communicate the outcome of this validation process to
those effected (both internal & external)
4. Support customer focus by proving that the organization
appreciates & recognizes emphasis on prevention
78

Step 8: Validation of Solutions &


Permanent Control Measures
- General Process
1. Ensure that internal personnel effected
by the action taken are aware of it
2. Validate that the original corrective actions are still
effective over time
3. Communicate the action to those outside of the
organization who may benefit from knowledge of it
4. Reward and recognize the success of those involved in
79
the process

Step 8: Validation of Solutions &


Permanent Control Measures
- Class Activity (page 1 of 2)
1. This activity cannot take place until after the designated time from
established in Step 6.

2. Validation Criteria: After this time frame - Analyze current data from
the process to validate the effectiveness of the corrective action
implementation
3. Revise Validation timeline if validation criteria has not been met.
4. Return to step 1 if problem reoccurs or if process cannot be
validated as a result of the analyzed data .
80

Step 8: Validation of Solutions &


Permanent Control Measures
- Class Activity (page 2 of 2)
5. Ensure that all internal & external personnel effected by the
action (s) are aware of it.
6. Verify customer (internal & exterior) satisfaction
7. Recognize the teams accomplishments

81

Step 8: Validation of Solution


Celebrate & Communicate
Success - Checklist
Are we on target?
1. Have changes been communicated to the customer as required?
2. Have changes been communicated across the organization as
required?
3. Have the changes been communicated to other sites where the
same process is performed?

4. Has the 8D team been recognized?


82

8D Problem Solving

Are we on target?
83

8D Problem Solving

The objective of this


8-D Process
is to

PREVENT
REOCCURANCE
84

8D Problem Solving

8D Problem Solving
follows the logic of
the PDCA Cycle
(a.k.a. Shewhart or Deming Cycle)
85

8D Problem Solving

Validation of
Solutions &
Permanent
Controls

Define Concern

Prevent
Recurrence

2
Establish the
Team

8D
Process

Permanent
Action (s)

Initial Analysis

4
5

Diagnose
Root Cause (s)

Immediate
Actions
Contain the
Problem

86

8D Problem Solving
If you have any questions please contact:
Brenda Roos, SQD

(252) 246-8460
Email: brenda.roos@hs.utc.com

87

The 8 Discipline

8D
Problem Solving
Process
88

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