1

The 8 Discipline
8D
Problem Solving
Process
2
ourse Objectives
To enable participants to solve problems by:
ollowing 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
Course Objectives
3
!roblem Solving
High
Low
Urgent
High
I
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p
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a
n
t
Important and Urgent
"8 D Reactive
ProbIem SoIving"
Important not Urgent
A Proactive
Improvement Process
(7 Step, Kaizen)
Not Important and
Not Urgent
"Get a New Job"
Not Important and
Urgent
"Reprioritize Work"
Low
When do you use a Reactive ProbIem SoIving process?
or 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
4
!roblem Solving - Statistical Tools
If the only tool you have is a
hammer everything looks like a nail
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
undamental statistical tools are used
throughout the problem solving process to
ensure measurable results
5
!roblem Solving - Statistical Tools

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lowcharts X X X X X
Brainstorming X X X
orce ield Analysis X X X X
Cause and Effect X X
nterviewing X X X X X X
Surveying X X X X X X
Market eedBack -
Customer nput X X X X X X X X
Checksheets X X X X X
Histograms X X X X X
!areto Analysis X X X X X
Run Charts X X X X X
!ie Charts X X X X X
Criteria Rating orms X X X X
List Reduction X X X X
Weighted Volume X X X X X
Gantt Chart X X X X X
!ERT Chart X X X X
Supplier nput X X X X X
MEA X X
Control !lan X X
6
D !roblem Solving
The 8D system is a problem solving process that 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
orrects the problem by eliminating the root cause
Implements Mistake Proofing to prevent
reoccurrence
Uses "Lessons Learned" concepts as Prevention
Techniques
7
D !roblem Solving
4
Immediate
Actions -
Contain the
ProbIem
3
InitiaI
AnaIysis
2
EstabIish the
Team
1
Define concern
7
Prevent
Recurrence
8
VaIidation of
SoIutions &
Permanent
ControI
5
Diagnose Root
Cause(s)
6
Permanent
Action(s)
8D
Process
8D follows the logic of
the PDCA Cycle
(a.k.a. Shewhart or
Deming Cycle)
8
D !roblem Solving orm (part 1 of 2)
Corrective / Preventive Action Report

Report No:
07-


Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.rooshs.utc.com
CAPA Champion:
Supplier #
Name &
Contact InIo
CAPA Type:
CA - Supplier
Origination Date:

Value Stream:
Supplier (area where Iound
iI known)
Product/Process:
Part Number & Name
IR#
Qty
Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
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
5




9
D !roblem Solving orm (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




10
D !roblem Solving Characteristics
orks 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
11
D !rocess Step 1
1- Define
Concern
8D
12
D !roblem Solving orm Step 1
Corrective / Preventive Action Report

Report No:
07-


Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.rooshs.utc.com
CAPA Champion:
Supplier #
Name &
Contact InIo
CAPA Type:
CA - Supplier
Origination Date:

Value Stream:
Supplier (area where Iound
iI known)
Product/Process:
Part Number & Name
IR#
Qty
Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
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
5




13
Step 1: Define the Concern
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
14
Step 1: Define the Concern
- The !roblem Statement
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
15
Step 1: Define the Concern
- General !rocess
Develop and Write a Problem Statement
A rite the 'Current state" statement describing the
present situation
B rite the 'Desired state" statement describing the
requirement or specification
C Identify the gap
D Combine the three to generate the Problem Statement
16
Reported Issues
1. Customer test failure rates are too high
2. Business with this high profile customer is in jeopardy
ProbIem Topic
Customer test yields are unacceptable
AnaIysis refIects Ieads us to the foIIowing probIem 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. s it based on data? Yes
2. Are there causes in the statement? No
3. Are there solutions in the statement? No
4. s the statement too general? No
ConcIusion: The ProbIem Statement meets the generaI criteria
Step 1: Define the Concern - Example
17
D !rocess Step 2
2
EstabIish
Team
Define concern
8D
18
D !roblem Solving orm - Step 2
Corrective / Preventive Action Report

Report No:
07-


Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.rooshs.utc.com
CAPA Champion:
Supplier #
Name &
Contact InIo
CAPA Type:
CA - Supplier
Origination Date:

Value Stream:
Supplier (area where Iound
iI known)
Product/Process:
Part Number & Name
IR#
Qty
Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
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
5




19
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
Step 2: Establish Team
20
ave 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 ave we considered specific technical expertise needed
for this team?
4 ave we established the team roles, responsibilities,
scope and objectives?
5 ave meeting and decision-making processes been
agreed upon?
Step 2: Establish Team
- Checklist
re we on target?
21
D !rocess Step 3
3
InitiaI
AnaIysis
Establish the
Team
Define concern
8D
22
D !roblem Solving orm - Step 3
Corrective / Preventive Action Report

Report No:
07-


Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.rooshs.utc.com
CAPA Champion:
Supplier #
Name &
Contact InIo
CAPA Type:
CA - Supplier
Origination Date:

Value Stream:
Supplier (area where Iound
iI known)
Product/Process:
Part Number & Name
IR#
Qty
Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
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
5




23
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
Step 3: nitial Analysis - Objectives
24
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
Identify the problem topics that may surround the issue,
and select the problem target area
Step 3: nitial Analysis
- General !rocess
25
Step 3: nitial Analysis
- General !rocess
Brainstorm and record the team's ideas about the problem area
5 ollect 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)
Develop and implement a general plan for approaching the
problem
26
Step 3: nitial Analysis
- Team Activity
Goals
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)
27
Step 3: nitial 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 )
28
as data about the problem been taken and reviewed?
2 as the problem been identified by hat, hen, hy, here,
ow, and ow Much?
3 as the extent of the problem been defined in measurable
terms?
4 as the customer provided input to the problem?
Step 3: nitial Analysis
- Checklist
re we on target?
29
5 ave the reported issues been identified?
6 as the problem topic been re-identified in section 3?
7 ave the applicable standards been identified?
8 as the scope of the problem been defined?
9 ave all in-transit defective materials been identified &
considered (both incoming & outgoing)?
as a general project plan been developed?
Step 3: nitial Analysis
- Checklist (continued)
re we on target?
30
D !rocess Step 4
4
Immediate
Actions -
Contain the
ProbIem
nitial Analysis
Establish the
Team
Define concern
8D
31
D !roblem Solving orm - Step 4
Corrective / Preventive Action Report

Report No:
07-


Originator:
Brenda Roos, SQD
(252) 246-8460
Brenda.rooshs.utc.com
CAPA Champion:
Supplier #
Name &
Contact InIo
CAPA Type:
CA - Supplier
Origination Date:

Value Stream:
Supplier (area where Iound
iI known)
Product/Process:
Part Number & Name
IR#
Qty
Issue/Date:

Due Date:
Initial Response (thru step 4)
Due:
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
5




32
Step 4: mmediate Actions
- Contain !roblem
- Objectives
1. dentify and select containment action (s)
2. Develop and implement a containment plan
3. Analyze the effectiveness of the
containment actions
33
Step 4: mmediate Actions
Contain the !roblem
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
34
Brainstorm and select interim containment action (s)
2 Verify extent of containment activities encompass
incoming & outgoing in-transit materials
Plan for implementation
Implement containment actions
5 Verify interim actions are in place and effective
Step 4: mmediate Actions
- Contain !roblem
- General !rocess
35
&ses the creative capacity of a group of people to generate ideas
Uses
Identifying problem areas
inding potential causes of problems
Generating alternative solutions
uidelines
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 (ree wheeling)
Step 4: Contain !roblem Brainstorm (1)
36
Step 4: Contain !roblem Brainstorm (2)
eneral Approach:
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
37
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
eneral Process
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
Step 4: Contain !roblem
The mplementation !lan
38
Gantt Chart
Step 4: Contain !roblem
- The mplementation !lan
ID Task Name Start Finish Resource Names
1
ocate product 2/15/00 2/15/00 Material Handler
2
Evaluate product 2/16/00 2/16/00 Engineering
3
Screen product 2/17/00 2/17/00 Production Tester
MateriaI HandIer
Engineering
Production Tester
2/15 2/1 2/21 2/24
eb
39
Step 4: Contain !roblem
- Team Activity
Goals
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
40
Step 4: Contain !roblem - Checklist
ave potential containment actions been identified?
2 ave containment actions been identified?
3 ave containment actions been implemented?
4 Are the containment actions effective at protecting the customer
from defects?
5 ave containment actions been verified?
6 Do we have the right team members to proceed to the next step?
7 ave we communicated our Containment plan to our customer?
re we on target?
41
D !rocess Step 5
mmediate
Actions
Contain the
!roblem
nitial
Analysis
Establish the
Team
Define concern
5
Diagnose
Root Cause
8D
42
D !roblem Solving orm 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




43
Step 5: Diagnose True Root Cause
- Objectives
1. dentify the probable cause (s) of the problem
2. Select the root cause
3. dentify and clarify potential corrective actions
44
Identify Probable auses
A Review customer requirements
B Brainstorm and organize possible causes
(eg, cause and effect diagram)
C Identify probable causes
D Rank causes by correlation to effect: Strong, Moderate or eak
2 Analyze Probable auses
A Select probable causes for data collection
B Determine collection method (eg, Checksheet)
C Collect / analyze / display data to identify root causes preventing
the "desired state" from being reached
Step 5: Diagnose True Root Causes
- General !rocess
45
Step 5: Diagnose True Root Causes
- General !rocess
Select Root auses 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)
46
ause 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
Step 5: Diagnose True Root Causes
- Cause and Effect Analysis
47
Most common cause categories (6-M's)
Manpower
Machine
Materials
Methods
Milieu (environment)
Measurement
Step 5: Diagnose True Root Causes
- Cause and Effect Analysis
48
Step 5: Diagnose True Root Causes
- Cause and Effect Analysis
ame: Date:
(-M's) Time-frame:
Causes Causes
Material Method Milieu (Environment)
Unavailable
Didn't Order Effect Effect
ot on bill (Current State)
Missing
Parts
Training Set Up
Manpower Machine Measurement
49
Step 5: Diagnose True Root Causes
- Cause and Effect Analysis
ame: Date:
(-M's) Time-frame:
Causes Causes
Material Method Milieu (Environment)
Unavailable
Didn't Order Effect Effect
ot on bill (Current State)
Missing
Parts
Training Set Up
Manpower Machine Measurement
ReIationship to Effect
A= Strong
B = Moderate
C = Weak
A
B
C
50
Step 5: Diagnose True Root Causes
- Team Activity
Goals
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
51
as the problem statement been reviewed?
2 ave probable causes been identified?
3 as data been collected on the probable causes?
4 ave true root causes been prioritized and selected?
5 ave potential corrective actions / solutions been identified and
clarified?
6 Do we have the right team members to proceed to the next step?
Step 5: Diagnose True Root Causes
- Checklist
re we on target?
52
TRUE ROOT AUSE VERIFIATIO QUESTIOS
Or How to tell if you have designated the "True" Root ause
Can you ask 'hy" 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?
Step 5: Diagnose True Root Causes
- Checklist
re we on target?
53
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
54
Step 5: Diagnose True Root Causes
- Develop Corrective Action !lan
- 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
55
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
Step 5: Diagnose True Root Causes
- Develop Corrective Action !lan
- General !rocess
56
Step 5: Diagnose True Root Causes
- Develop Corrective Action !lan
- General !rocess
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)
57
Step 5: Diagnose True Root Causes
- Develop Corrective Action !lan
- Team Activity
Goals
Brainstorm a list of corrective action ideas
2 Decide the best potential corrective action(s)
3 Develop a corrective action plan
58
ave potential corrective actions / solutions
been filtered and combined?
2 ave criteria for selection been identified?
3 as a corrective action plan been developed?
4 as 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?
Step 5: Diagnose True Root Causes
- Develop Corrective Action !lan
- Checklist
re we on target?
59
D !rocess Step 6
mmediate
Actions
Contain the
!roblem
nitial Analysis
Establish the
Team
Define concern
Diagnose
True Root
Cause(s)
6
Permanent
Action(s)
8D
60
D !roblem Solving orm 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




61
Step 6: !ermanent Actions
- Objectives
1. Test the intended corrective action(s) and
adjust the plan if required
2. mplement 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
62
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
Step 6: !ermanent Actions
- General !rocess
63
Step 6: !ermanent Actions
- General !rocess
Evaluate the effectiveness of the action
A Collect results data for evaluation of the effectiveness of the
corrective action (s)
ote: Include customer feedback
B Analyze data in comparison with:
Previous analysis
Business objectives
'Desired state"
C Determine if there is still a gap
omplete 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
64
Mistake !roofing
LEVEL I DEVICES (e.g.: Railroad Crossing Signs)
!hysical 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 lashing 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).
65
Step 6: !ermanent Actions
- General !rocess
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
ork Instructions
Standard Operating Procedures
Product / Component Prints and Specifications
ailure Mode & Effects Analysis (MEA's)
66
Step 6: !ermanent Actions
- Class Activity
Goals
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 ( - 2 - 3)
6 ormalize any system changes
67
ave pilot(s) been conducted?
2 as data been collected?
3 as success been achieved based on closing the problem gap
and addressing customer feedback?
4 ave new problems (if any) been identified?
5 as a Validation Plan Timeline been established?
6 Do we have the right team members to proceed to the next
step?
Step 6: !ermanent Actions
- Checklist
re we on target?
68
D !rocess Step 7
mmediate
Actions
Contain the
!roblem
nitial
Analysis
Establish the
Team
Define
Concern
7
Prevent
Recurrence
Diagnose Root
Cause (s)
!ermanent
Action (s)
8D
69
D !roblem Solving orm 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




70
Step 7: !revent 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 !oke-Yoke or Mistake !roofing nitiatives
71
Step 7: !revent Recurrence
- General !rocess
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
72
Step 7: !revent Recurrence
- General !rocess
Look for additional applications of the action
Other products, processes, operations, customers, etc
related to the business may benefit from the same
corrective measures
Review and update Work Instructions, SP harts, and Associated
Forms
5 Review and revise FMEA based on increased occurrence levels and
newly implemented controls
Identify implemented Mistake Proof level ( 2 )
7 alculate a timeline for when expected Validation activities can
occur based on production planning and quantities
73
Mistake !roofing
LOW MED&M
HGH
LEVEL 1
LEVEL 2
LEVEL 3
!HYSCAL DEVCES
WARNNG DEVCES
NSTR&CTONS
M
I
S
T
A
K
E
-
P
R
O
O
F
I
N
G


T
Y
P
E
MISTAKE-PROOFING EFFECTIVENESS
74
Step 7: !revent Recurrence
- Class Activity
Goals
Make sure the corrective action plan and
any system changes are in place
2 Define Mistake Proof level (-2-3) and the potential for
improving Mistake Proof level
3 Develop/Revise MEA
4 Develop/Revise Control Plan
5 Review other products, processes, operations, customers, etc
that may benefit from the same corrective measures
75
as the problem statement been reviewed?
2 as the Corrective Action plan been reviewed and
all the steps implemented?
3 as all the appropriate paperwork been reviewed
and revised to assure prevention?
4 ave new problems (if any) been formally
addressed?
5 as the customer confirmed that the problem has
been resolved to their satisfaction?
Step 7: !revent Recurrence - Checklist
re we on target?
76
D !rocess Step
mmediate
Actions Contain
the !roblem
nitial Analysis
Establish the
Team
Define concern
!revent
Recurrence
8
VaIidation of
SoIutions &
Permanent
ControIs
Diagnose Root
Cause (s)
!ermanent
Actions (s)
8D
77
D !roblem Solving orm Step
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




78
Step : Validation of Solutions &
!ermanent Control Measures
- Objectives
1. Validate all corrective actions and Mistake !roofing
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
79
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
ommunicate the action to those outside of the
organization who may benefit from knowledge of it
Reward and recognize the success of those involved in
the process
Step : Validation of Solutions &
!ermanent Control Measures
- General !rocess
80
Step : Validation of Solutions &
!ermanent Control Measures
- Class Activity (page 1 of 2)
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 if problem reoccurs or if process cannot be
validated as a result of the analyzed data
81
Step : Validation of Solutions &
!ermanent 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
82
ave changes been communicated to the customer as required?
2 ave changes been communicated across the organization as
required?
3 ave the changes been communicated to other sites where the
same process is performed?
4 as the 8D team been recognized?
Step : Validation of Solution
Celebrate & Communicate
Success - Checklist
re we on target?
83
re we on target?
D !roblem Solving
84
D !roblem Solving
The objective of this
8-D Process
is to
PREVENT
REOCCURANCE
85
D !roblem Solving
8D Problem Solving
follows the logic of
the PDCA Cycle
(a.k.a. Shewhart or Deming Cycle)
86
D !roblem Solving
4
Immediate
Actions
- Contain the
ProbIem
3
InitiaI AnaIysis
2
EstabIish the
Team
1
Define Concern
7
Prevent
Recurrence
8
VaIidation of
SoIutions &
Permanent
ControIs
5
Diagnose
Root Cause (s)
6
Permanent
Action (s)
8D
Process
87
D !roblem Solving
II you have any questions please contact: II you have any questions please contact:
Brenda Roos, SQD Brenda Roos, SQD
(252) 246 (252) 246- -8460 8460
Email: brenda.rooshs.utc.com Email: brenda.rooshs.utc.com
88
The 8 Discipline
8D
Problem Solving
Process