The 8 Discipline

8D
Problem Solving
Process
1
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

High Important not Urgent

Important and Urgent A Proactive
Important

“8 D Reactive Improvement Process

Problem Solving” (7 Step, Kaizen)
Not Important and Not Important and
Urgent Not Urgent
“Reprioritize Work” “Get a New Job”
Low
High Low
Urgent 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

4
Problem Solving - Statistical Tools

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8
Step
Step

Step

Step

Step

Step

Step

Step
Flowcharts X X X X X
Brainstorming X X X
Force Field Analysis X X X X
Cause and Effect X X
Interviewing X X X X X X
Surveying X X X X X X
Market FeedBack -
Customer Input X X X X X X X X
Checksheets X X X X X
Histograms X X X X X
Pareto Analysis X X X X X
Run Charts X X X X X
Pie Charts X X X X X
Criteria Rating Forms X X X X
List Reduction X X X X
Weighted Volume X X X X X
Gantt Chart X X X X X
PERT Chart X X X X
Supplier Input X X X X X
FMEA X X
Control Plan X X 5
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 1
Validation of Define concern
Solutions &
Permanent
Control
2
7 Establish the
Prevent Team
Recurrence
8D
6 3
Process
Permanent Initial
Action(s) Analysis
4
5 Immediate
Diagnose Root Actions –
Cause(s) Contain the 8D follows the logic of
Problem the PDCA Cycle
(a.k.a. Shewhart or
Deming Cycle)

7
8D Problem Solving Form (part 1 of 2)

Report No:
07-
Corrective / Preventive Action Report
Originator: CAPA Champion: CAPA Type: Origination Date:
Brenda Roos, SQD Supplier # CA - Supplier
(252) 246-8460 Name &
Brenda.roos@hs.utc.com Contact Info
Value Stream: Product/Process: Issue/Date: Due Date:
Supplier – (area where found – Part Number & Name Initial Response (thru step 4)
if known) IR# Due:
Qty Final Response Due:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM

Team Member: Responsibility: Team Member: Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS – CONTAIN THE PROBLEM

# Task Owner Target Date Status
1
2
3
4 8
5
8D Problem Solving Form (part 2 of 2)
5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
# Task Owner Target Date Status
1
2
3
4
5

Poke Yoke – Mistake Proofing Description & Level:

7. PREVENTION
FMEA: Reviewed: Yes No  Revised: Yes No
Control Plan: Reviewed: Yes No  Revised: Yes No
Work Instructions: Reviewed: Yes No  Revised: Yes No
SPC Charts Reviewed: Yes No  Revised: Yes No

Poke Yoke – Mistake Proofing Effective: Yes _________ No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES

# Task Owner Target Date Status
1
2
9
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

Report No:
07-
Corrective / Preventive Action Report
Originator: CAPA Champion: CAPA Type: Origination Date:
Brenda Roos, SQD Supplier # CA - Supplier
(252) 246-8460 Name &
Brenda.roos@hs.utc.com Contact Info
Value Stream: Product/Process: Issue/Date: Due Date:
Supplier – (area where found – Part Number & Name Initial Response (thru step 4)
if known) IR# Due:
Qty Final Response Due:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM

Team Member: Responsibility: Team Member: Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS – CONTAIN THE PROBLEM

# Task Owner Target Date Status
1
2
3
4 12
5
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. Based on data, not speculation
B. No causes - Root cause has not yet been developed
C. No solutions - Solutions must target the root cause
D. 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 customer’s 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? Yes
2. Are there causes in the statement? No
3. Are there solutions in the statement? No
4. Is the statement too general? 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

Report No:
07-
Corrective / Preventive Action Report
Originator: CAPA Champion: CAPA Type: Origination Date:
Brenda Roos, SQD Supplier # CA - Supplier
(252) 246-8460 Name &
Brenda.roos@hs.utc.com Contact Info
Value Stream: Product/Process: Issue/Date: Due Date:
Supplier – (area where found – Part Number & Name Initial Response (thru step 4)
if known) IR# Due:
Qty Final Response Due:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM

Team Member: Responsibility: Team Member: Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS – CONTAIN THE PROBLEM

# Task Owner Target Date Status
1
2
3
4 18
5
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. Have we considered is suppliers and/or customers need to

be part of the team?
2. Do we have the right in-house team members to proceed
to the next step?
3. Have we considered specific technical expertise needed
for this team?
4. Have we established the team roles, responsibilities,
scope and objectives?
5. 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

Report No:
07-
Corrective / Preventive Action Report
Originator: CAPA Champion: CAPA Type: Origination Date:
Brenda Roos, SQD Supplier # CA - Supplier
(252) 246-8460 Name &
Brenda.roos@hs.utc.com Contact Info
Value Stream: Product/Process: Issue/Date: Due Date:
Supplier – (area where found – Part Number & Name Initial Response (thru step 4)
if known) IR# Due:
Qty Final Response Due:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM

Team Member: Responsibility: Team Member: Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS – CONTAIN THE PROBLEM

# Task Owner Target Date Status
1
2
3
4 22
5
 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 team’s 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

Report No:
07-
Corrective / Preventive Action Report
Originator: CAPA Champion: CAPA Type: Origination Date:
Brenda Roos, SQD Supplier # CA - Supplier
(252) 246-8460 Name &
Brenda.roos@hs.utc.com Contact Info
Value Stream: Product/Process: Issue/Date: Due Date:
Supplier – (area where found – Part Number & Name Initial Response (thru step 4)
if known) IR# Due:
Qty Final Response Due:

1. BRIEF DESCRIPTION OF PROBLEM

2. ESTABLISH CROSS-FUNCTIONAL TEAM

Team Member: Responsibility: Team Member: Responsibility:

3. INITIAL ANALYSIS

4. IMMEDIATE ACTIONS – CONTAIN THE PROBLEM

# Task Owner Target Date Status
1
2
3
4 31
5
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

eb
ID Task Name Start Finish Resource Names 2/15 2/18 2/21 2/24
1 Locate product 2/15/00 2/15/00 Material Handler Material Handler
2 Evaluate product 2/16/00 2/16/00 Engineering Engineering
3 Screen product 2/17/00 2/17/00 Production Tester 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 Immediate
Diagnose Actions –
Root Cause Contain the
Problem

41
8D Problem Solving Form – Step 5
5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
# Task Owner Target Date Status
1
2
3
4
5

Poke Yoke – Mistake Proofing Description & Level:

7. PREVENTION
FMEA: Reviewed: Yes No  Revised: Yes No
Control Plan: Reviewed: Yes No  Revised: Yes No
Work Instructions: Reviewed: Yes No  Revised: Yes No
SPC Charts Reviewed: Yes No  Revised: Yes No

Poke Yoke – Mistake Proofing Effective: Yes _________ No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES

# Task Owner Target Date Status
1
2
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-M’s)

Manpower

Machine

Materials

Methods

Milieu (environment)

Measurement
47
Step 5: Diagnose True Root Causes
- Cause and Effect Analysis
Name: Date:
(6-M’s) Time-frame:
Causes
Material Method Milieu (Environment)
Unavailable

Didn’t Order Effect

Not on bill (Current State)
Missing
Parts

Training Set Up

Manpower Machine Measurement

48
Step 5: Diagnose True Root Causes
- Cause and Effect Analysis
Name: Date:
(6-M’s) Time-frame:
Causes
Material Method Milieu (Environment)
Unavailable

Didn’t Order
A Effect
Not on bill (Current State)
Missing
Parts
B C
Relationship to Effect
Training Set Up
A= Strong
B = Moderate
C = Weak
Manpower Machine Measurement
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
55
actionable and within the scope of the team
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 8D
Permanent Initial Analysis
Action(s)
Immediate
Diagnose Actions –
True Root Contain the
Cause(s) Problem

59
8D Problem Solving Form – Step 6
5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
# Task Owner Target Date Status
1
2
3
4
5

Poke Yoke – Mistake Proofing Description & Level:

7. PREVENTION
FMEA: Reviewed: Yes No  Revised: Yes No
Control Plan: Reviewed: Yes No  Revised: Yes No
Work Instructions: Reviewed: Yes No  Revised: Yes No
SPC Charts Reviewed: Yes No  Revised: Yes No

Poke Yoke – Mistake Proofing Effective: Yes _________ No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES

# Task Owner Target Date Status
1
2
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 management’s 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
65
 Failure Mode & Effects Analysis (FMEA’s)
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 Establish the
Prevent Team
Recurrence
8D
Permanent Initial
Action (s) Analysis

Immediate
Diagnose Root Actions –
Cause (s) Contain the
Problem

68
8D Problem Solving Form – Step 7
5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
# Task Owner Target Date Status
1
2
3
4
5

Poke Yoke – Mistake Proofing Description & Level:

7. PREVENTION
FMEA: Reviewed: Yes No  Revised: Yes No
Control Plan: Reviewed: Yes No  Revised: Yes No
Work Instructions: Reviewed: Yes No  Revised: Yes No
SPC Charts Reviewed: Yes No  Revised: Yes No

Poke Yoke – Mistake Proofing Effective: Yes _________ No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES

# Task Owner Target Date Status
1
2
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
MISTAKE-PROOFING TYPE

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 Define concern
Solutions &
Permanent
Controls
Prevent Establish the
Recurrence Team

8D
Permanent Initial Analysis
Actions (s)

Immediate
Diagnose Root Actions – Contain
Cause (s) the Problem

76
8D Problem Solving Form – Step 8
5. DIAGNOSE ROOT CAUSE(S)

6. PERMANENT ACTION
# Task Owner Target Date Status
1
2
3
4
5

Poke Yoke – Mistake Proofing Description & Level:

7. PREVENTION
FMEA: Reviewed: Yes No  Revised: Yes No
Control Plan: Reviewed: Yes No  Revised: Yes No
Work Instructions: Reviewed: Yes No  Revised: Yes No
SPC Charts Reviewed: Yes No  Revised: Yes No

Poke Yoke – Mistake Proofing Effective: Yes _________ No __________

8. VALIDATION OF SOLUTIONS & PERMANENT CONTROL MEASURES

# Task Owner Target Date Status
1
2
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 team’s 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

8 1
Validation of Define Concern
Solutions &
Permanent
Controls
7 2
Prevent Establish the
Recurrence 8D Team
Process
6 3
Permanent Initial Analysis
Action (s)
4
Immediate
5 Actions
Diagnose – Contain the
Root Cause (s) 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