ProblemSolvingProcess PDF

Corrective
Action
Process
A Problem Solving Process
Contents
Foreword
Step 1: Identify Team Members, Roles & Responsibilities
Overview.................................................................................................................................... 1-1
Procedures.................................................................................................................................. 1-2
Checklist .................................................................................................................................... 1-4
Step 2: Define the Problem
Overview.................................................................................................................................... 2-1
Procedures.................................................................................................................................. 2-2
Checklist .................................................................................................................................... 2-5
Step 3: Implement & Verify Interim Containment Action(s)
Overview.................................................................................................................................... 3-1
Procedures.................................................................................................................................. 3-2
Checklist .................................................................................................................................... 3-5
Step 4: Analyze Current Process & Define Desired Outcomes
Overview.................................................................................................................................... 4-1
Procedures.................................................................................................................................. 4-2
Checklist .................................................................................................................................... 4-4
Step 5: Define & Verify Root Cause(s)
Overview.................................................................................................................................... 5-1
Procedures.................................................................................................................................. 5-2
Checklist .................................................................................................................................... 5-5
Step 6: Identify & Verify Proposed Permanent Corrective Action(s)
Overview.................................................................................................................................... 6-1
Procedures.................................................................................................................................. 6-2
Checklist .................................................................................................................................... 6-5
Step 7: Implement Permanent Corrective Action(s)
Overview.................................................................................................................................... 7-1
Procedures.................................................................................................................................. 7-2
Checklist .................................................................................................................................... 7-4
Step 8: Action(s) To Prevent Re-Occurrence
Overview.................................................................................................................................... 8-1
Procedures.................................................................................................................................. 8-2
Checklist .................................................................................................................................... 8-4
Step 9: Communicate Results & Recognize The Team
Overview.................................................................................................................................... 9-1
Procedures.................................................................................................................................. 9-2
Checklist .................................................................................................................................... 9-4
Toolkit Index
Appendix A: Toolkit
1. Meeting Facilitation............................................................................................................... A-1
2. Project/Team Chartering........................................................................................................ A-3
3. Horizontal Five-Why Analysis .............................................................................................. A-5
4. Is/Is Not Analysis .................................................................................................................. A-7
5. Customer Requirements Matrix............................................................................................. A-8
6. Supplier Requirements........................................................................................................... A-10
7. Pareto Analysis ...................................................................................................................... A-11
8. Manufacturing Dynamic Control Plan - DCP ....................................................................... A-12
9. Process Map........................................................................................................................... A-14
10. Customer↔Process Matrix................................................................................................... A-15
11. Histogram .............................................................................................................................. A-17
12. Measurement Systems Analysis ............................................................................................ A-18
13. Differences & Changes.......................................................................................................... A-20
14. Potential to Probable Filter .................................................................................................... A-21
15. Process ↔=Input Matrix........................................................................................................ A-23
16. Cause & Effect Diagram........................................................................................................ A-24
17. Design Failure Modes & Effects Analysis (DFMEA)........................................................... A-25
18. Force Field Analysis .............................................................................................................. A-27
19. Choose & Verify Corrective Actions .................................................................................... A-28
20. Test Planner ........................................................................................................................... A-30
21. Implementation Plan.............................................................................................................. A-31
22. Reaction Plan ......................................................................................................................... A-32
23. Poka-Yoke (Mistake Proofing).............................................................................................. A-33
24. Problem Prevention ............................................................................................................... A-34
25. Control Chart ......................................................................................................................... A-35
Appendix B: Examples
1. Meeting Facilitation............................................................................................................... B-1
2. Project/Team Chartering........................................................................................................ B-2
3. Horizontal Five-Why Analysis .............................................................................................. B-3
4. Is/Is Not Analysis .................................................................................................................. B-4
5. Customer Requirements Matrix............................................................................................. B-5
6. Supplier Requirements Matrix............................................................................................... B-6
7. Pareto Chart ........................................................................................................................... B-7
8. Manufacturing Dynamic Control Plan................................................................................... B-8
9. Process Map........................................................................................................................... B-9
10. Customer ↔=Process Matrix ................................................................................................ B-10
11. Histogram .............................................................................................................................. B-11
12. Measurement Systems Analysis ............................................................................................ B-12
13. Differences & Changes.......................................................................................................... B-14
14. Potential to Probable Filter .................................................................................................... B-15
15. Process↔Input Matrix.......................................................................................................... B-16
16. Cause & Effect Diagram (Fishbone) ..................................................................................... B-17
17. Design Failure Modes & Effects Analysis - DFMEA ........................................................... B-18
18. Force Field Analysis .............................................................................................................. B-19
19. Choose & Verify Corrective Action Worksheet 1................................................................. B-20
19. Choose & Verify Corrective Action Worksheet 2................................................................. B-21
20. Test Planner ........................................................................................................................... B-22
21. Implementation Plan.............................................................................................................. B-23
22. Reaction Plan ......................................................................................................................... B-24
23. Poka-Yoke (Mistake Proofing).............................................................................................. B-25
24. Problem Prevention ............................................................................................................... B-26
25. Control Chart (Chart)............................................................................................................. B-27
25. Control Chart (Flow Charts).................................................................................................. B-28
25. Control Chart (Constants Table)............................................................................................ B-29
25. Control Chart (Data Tables) .................................................................................................. B-30
Form Index
Appendix C: Forms
Form 1: CAP Report.................................................................................................................. C-1
Form 4: Is/Is Not Analysis ........................................................................................................ C-2
Form 5: Customer Requirements Matrix................................................................................... C-3
Form 6: Supplier Requirements Matrix..................................................................................... C-4
Form 10: Customer Input Matrix ................................................................................................ C-5
Form 12: Measurement Systems Analysis 1 ............................................................................... C-6
Form 13: Differences & Changes Analysis................................................................................. C-8
Form 14: Potential to Probable Filter Worksheet........................................................................ C-9
Form 15: Process Input Matrix.................................................................................................... C-10
Form 19: Choose & Verify Corrective Action Worksheet 1....................................................... C-11
Form 19: Choose & Verify Corrective Action Worksheet 2....................................................... C-12
Form 20: Test Plan ...................................................................................................................... C-13
Form 21: Implementation Plan.................................................................................................... C-14
Form 23: Poka Yoke (Mistake Proofing) Worksheet.................................................................. C-15
Form 24: Problem Prevention Worksheet ................................................................................... C-16
Foreword
How to Use This Handbook

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Page down now to see the remainder of this Foreword, about the contents of this handbook and a
brief description of the Corrective Action Process.
This handbook defines a problem-solving methodology otherwise known as a Corrective Action
Process or CAP.
One Global Corrective Action Process
A process that provides a logical step by step approach to solving relatively

complex problems.
A process based on a proven methodology.
A process to help identify the true root cause of a problem.
A process that eliminates and prevents the re-occurrence of a problem.
A process that can be used at all levels of an organization that is easy to follow.
The material in each step is presented on three levels:
A process flow chart, which shows an overview of the steps covered in each section. As
Teams become familiar with the process this can be used as a guideline.
A step-by-step detailed explanation of the process steps, which also includes references
to the tools required to facilitate each step of the process.
A checklist at the end of each step states the objective and a list of questions to ensure
that the objective has been adequately met.
At the back of the handbook is a collection of tools which facilitate the problem-solving process. The
tools have been designed so that they may be used independently for other applications if desired.
All tools contain the following information:
How to use the tool
Results you can expect
Step-by-step guidelines on how to use the tool
Next steps
Tips
Examples
The final section contains a collection of forms that can be used as worksheets to assist you in the
problem solving process.
Identify Team Members, Roles & Responsibilities
Overview
IDENTIFY TEAM MEMBERS, ROLES & RESPONSIBILITIES

Tools Forms
DEFINE Identify Team Members, Determine if the problem

what's important Roles & Responsibilities needs a team approach
D 1
Define the Problem Identify a team champion

2
Select team & team leader

Implement & Verify Interim
establish roles & 01 - Meeting Facilitation
Containment Action(s)
3 responsibilities
MEASURE Analyse current process & Charter team and clarify

02 - Project/Team Chartering
how we're doing Define desired outcomes team goals
M 4
Review the problem

ANALYSE Define & Verify Root
solving process & assess
what's wrong Cause(s)
A 5 need for training
Identify & Verify Proposed

IMPROVE Complete section 1 of
Permanent Corrective CAP - 001
by fixing what's wrong CAP Report
I 6 Action(s)
Implement Permanent
Corrective Action(s)
7
CONTROL Action(s) to Prevent Re-

to sustain gains occurrence
C 8
Communicate results &

Recognise team
9
Corrective Action Process - Overview 1-1

Procedures
When an individual cannot solve a problem quickly, it is necessary to form a team. The team will
engage in the investigation and resolution of the problem. Many factors are critical to establish a
group and to ensure that the group can work effectively together. Using a team approach is not just
a step in the problem solving process, but an overriding framework for decision-making. It is neces-
sary to re-evaluate team membership continually. However, all steps within the process must be
given attention if the team is going to be successful in truly eliminating the problem.
1.1 Determine if the problem needs a Team Approach

Depending on the complexity, scope, and significance of the problem, management will make the
recommendation that there be a team assigned to find the root cause, eliminate the problem, and
prevent it from recurring. If the management group does not agree that the problem is significant or
important enough to have an impact on the business, they should not charter a team. Otherwise,
the team will not receive the support it will require to be successful.
1.2 Identify a Team Champion

The team Champion is the person who legitimizes the need for the team to solve the problem. The
Champion must have a strong and decisive commitment to the project.
The role and responsibilities of the Champion include: -
Developing the team charter

Formally launching the team by reviewing the charter with the team
Providing leadership and encouragement when required
Addressing any concerns the team may have
Providing resources at the necessary steps to support the corrective action process
Monitoring the team’s progress
Supporting the final decision
Having the authority to implement the corrective actions and system repair
1.3 Select Team & Team Leader, establish roles and responsibilities
The team should be a small group of people with the process and product knowledge, the allocated
time and authority, and the skill in the required disciplines to solve the problem and implement cor-
rective action.
Typically, a good team size is approx. 5 to 7 people. Consider using some people as resources
rather than as team members.
The Team Leader will either be appointed by the Champion or elected by the team. The role &
responsibilities of a Team Leader include: -
Managing and focusing the team on achieving the objectives

Keeping the team focused on the CAP problem solving process
Determining a regular meeting place and time and setting a meeting agenda
Identifying resource requirements
Providing feedback to the Champion and sponsors
Corrective Action Process — Procedures 1-2

Resolving conflicts within the team

Holding team members accountable
Helping and supporting all team members
Maintaining the project schedule and budget
To ensure meetings are effective and efficient it is recommended that meetings be structured using
the meeting facilitation TQ tool.
01 – Meeting Facilitation

As soon as possible after each meeting, an agenda for the next meeting should be constructed,
based on the action plan. This should be distributed to all team members with the minutes of the
previous meeting. Be aware that team membership can change. As more information about the
problem is gathered, or needs change for information and expertise as you go through the problem
solving stages, the membership of the team may need to change. Make sure the team takes time to
assimilate new members into full participation in the group. If anyone leaves the team, make sure
they are recognized and appreciated for their contribution.
1.4 Charter Team and clarify team goals
The Champion should complete a Team Charter using the team chartering TQ tool, to make sure
members understand the background, scope, and effects of the problem and clarify the team goals.
The team members need to know the problem’s significance to the business, why it needs to be
solved, and why a team has been assembled. The team charter is a document that clearly identifies
the project scope, customer requirements, stakeholders, objectives, deliverables, constraints,
assumptions and concerns/risks to provide the basis for detailed planning. In addition the charter
helps to communicate the project definition and provide understanding and commitment from all
stakeholders. Each team member should receive a copy of it.
02 – Team Chartering

1.5 Review the Problem Solving process
Make sure each member has access to this handbook. Explain that the handbook will lead the team
through the problem solving process step by step.
Discuss the value of following the process and using the handbook as a guide. Review the materials
provided, including the worksheets and the checklists of questions at the end of each stage of the
process.
This handbook assumes that members have had some basic training in teamwork and problem
solving. However, depending on the level of the group’s training and experience in working on prob-
lem solving teams, a facilitator may be needed to monitor and guide the communication, decision-
making, and problem solving processes. Additional training in teamwork and problem solving may
also be advisable. If so, the Team Leader or Champion should arrange for that training.
1.6 Complete Section 1 of the CAP Report

Fill in Section 1 of the CAP report (Form #CAP-001). Identify Team Champion, Leader and mem-
bers together with their title and location.
Proceed to Checklist
Checklist
CHECKLIST
OBJECTIVE
The main objective is to establish a Team with the relevant skills,

knowledge and experience to solve the problem.
The following checklist should be used to ensure the Teaming YES/NO

process is relevant and effective for the problem at hand:
Are the people affected by the problem represented on the team?

Have team members been given sufficient time & authority to work on the
problem?

Have team member’s roles & responsibilities been clearly identified, communicated
& understood?

Does the team membership have the relevant knowledge and expertise to solve
the problem?

Does the team membership have sufficient training in the Corrective Action Pro-
cess (CAP)?

Does the team have a scheduled time & place to meet?

Has a project charter been developed?

Does the team have sufficient decision making authority to accomplish the goals &
objectives of the project?

Have you filled in the team membership, roles & responsibilities in Section 1 of the
CAP Report?

Corrective Action Process — Checklist 1-4

Define the Problem
Overview
DEFINE THE PROBLEM

Tools Forms
05 - Customer Requirements Matrix
DEFINE Identify Team Members, Prepare a preliminary CAP - 005
06 - Supplier Requirements Matrix
what's important Roles & Responsibilities description of the problem CAP - 006
D 1 09 - Process Map
Draft a preliminary problem

Define the Problem 03 - 5 Why Analysis
statement
2
Implement & Verify Interim Explore the problem using
04 - IS / IS NOT Analysis CAP - 004
Containment Action(s) IS / IS-NOT analysis
3
Determine whether the

MEASURE Analyse current process &
problem needs
how we're doing Define desired outcomes
M 4 sub-dividing
ANALYSE Define & Verify Root Review and update

02 - Project/Team Chartering
what's wrong Cause(s) team/project charter
A 5

IMPROVE Re-draft the
Permanent Corrective
by fixing what's wrong problem statement
I 6 Action(s)
Implement Permanent Complete section 2 of the

CAP - 001
Corrective Action(s) CAP Report
7

C 8
Communicate Results &

Recognise team
9

Procedures
DEFINE THE PROBLEM
Having a good description of the problem is important for several reasons. It will guarantee that the
team is focusing on the problem, and not on its symptoms. It will assure that you are working on the
right problem. It will put boundaries around the problem. And it will provide a direction for searching
for the root cause.
2.1 Prepare a preliminary description of the problem

A problem is a situation that needs to be corrected, adjusted, or changed. More specifically:
A problem is a situation in which an expected level of performance or a norm is not being

reached, or maintained; and
The cause of that unacceptable performance is not known.
Many problem-solving teams unintentionally head off in the wrong direction by inaccurately
describing the problem. A problem statement should not imply either a cause or a solution. Those
implied causes and solutions may be the wrong ones.
A preliminary problem description should simply state the situation, as it currently exists. It is usually
a description of the symptom.
Examples of good and bad problem descriptions:
[No]: Our order forms need to be redesigned. (Implied solution)

[No]: Department members need more training in how to fill out order forms. (Implied cause).
[Yes]: 21% of the order forms processed in this department last month contained errors.
(Problem).
Here are several more typical preliminary (generic) problem descriptions:
Parts are labeled incorrectly.

There is a high rate of engineering change notices.
Parts are damaged on delivery to the customer.
Delivery dates are tracking 50 days past due.
We are experiencing a high rate of shortages in production.
The best approach to describing a problem is to first develop a process map to clarify the work pro-
cess or manufacturing process where the problem exists. In addition this will ensure all team mem-
bers are familiar with the process in question. Make sure it adequately reflects the status of the
current process.
09 – Process Map

To help describe the problem it may be necessary to obtain input from our customers. This will help
to define process performance against the true customer requirements. The preferred and most
effective approach is to have a customer representative on the team. Whether the customer is
represented or not, input is best accomplished by using the Customer requirements matrix. This is a
very powerful tool, which not only defines customer requirements, but in addition it will define and
prioritize possible process improvements and provide the basis for discussing improvement
opportunities with customers.

DEFINE THE PROBLEM
05 – Customer Requirements Matrix

Additionally it may be necessary to understand the supplier’s inputs to the process. By using the
Supplier requirements matrix, we are able to understand supplier’s performance against
requirements, define and prioritize possible process improvements and provide the basis for
discussing improvement opportunities with suppliers.
06 – Supplier Requirements Matrix

2.2 Draft a preliminary Problem Statement
To develop a preliminary draft of the problem statement use the Why? Why? Why? Why? Why?
Approach. The “Why” Technique is frequently used as a tool for finding the root cause. In complex
problems, however, it is more effectively used to make sure you are looking at the true problem.
For example; this problem statement: the production line is experiencing too much downtime. This
is actually a statement of a symptom. Asking “Why?” should lead to a real problem: Part numbers
are incorrect when they reach the production line.
03 – 5 Why Analysis

It is helpful to note that problem statements:
Are not questions, but declarative statements

Contain a specific situation that can be measured
Focus on the gap between what is and what should be
Never contains phrases like “lack of” or “too much” which implies a situation.
2.3 Explore the Problem using IS/IS-NOT analysis

The Is/Is-Not analysis is an essential part of the problem solving process, because it asks you to list
all the “knowns” about the problem. This gives you valuable information that allows you to see all
the boundaries of the problem. This means the team won’t waste time exploring areas of the work
process that do not affect the problem.
Don’t skimp on time with the IS/IS-NOT analysis. You will come back to the information generated
by this analysis time after time. If this analysis is done effectively it will save your team a lot of time
later on in the problem solving process. The analysis helps in reducing the number of potential root
causes to just one: the root cause.
Using the IS/IS-NOT analysis tool, take a flip chart and begin by writing down the problem statement
that the team has arrived at.
The team should then ask the following questions in the four general categories of What? Where?
When? And How Big? To facilitate this part of the process use a flip chart to record the IS and
IS-NOT answers to these questions. Typically begin with a sheet for each with a line down the
middle. The IS answers on the Left hand side and the IS-NOT answers on the right hand side. Avoid
putting down assumptions, use only fact based information. Document the analysis on the
IS/IS-NOT Form. This will help with distribution, communication and record retention.

DEFINE THE PROBLEM
04 – IS/IS NOT Analysis

As the team goes through the process of answering these questions and filling in the IS/IS-NOT
form, you may discover that you need more information. Note this need, and identify who will get
that information. It may be necessary to do some preliminary or additional testing or complete a
further detailed investigation to provide the information required.
2.4 Determine whether the problem needs sub-dividing

After you complete the IS/IS-NOT analysis, determine whether the problem situation actually
contains more than one problem. If so determine whether it, should be subdivided.
The team should consider whether to use separate and parallel corrective action processes for each
subdivision.
2.5 Review & Update Team/Project Charter

At this point within the process it is important to review and update the team/project charter. Based
on the work completed to this point the project scope, objectives, deliverables etc. may have
changed.
02 – Project/Team Chartering

2.6 Re-Draft the Problem Statement
Compare your problem statement with the information revealed in the IS/IS-NOT form.
Revise the problem statement to reflect the additional information.
Make sure your customer is in full agreement with the team’s description of the problem and the
problem statement.

Fill in Section 2 of the CAP report (Form # CAP-001). Document the problem statement and problem
description.

Checklist
CHECKLIST
OBJECTIVE
The main objective is to establish a good description of the problem identifying

project boundaries to ensure that the team maintains a focus on the problem and
not the symptoms of the problem. A clearly defined problem statement will pro-
vide direction to establishing root cause.
The following checklist should be used to ensure that a clear, YES/NO

well-defined Problem Statement is established:
Have the customer specific requirements been established?

Has Supplier input and /or involvement been requested?

Has current and historical data been collected to quantify the problem and assess
its severity?

Has an IS /IS-NOT analysis been completed asking What, Where, When and How
Big to help define/describe the problem statement?

Is further data and/or information required and if so, are arrangements in place to
get it?

Has a 5-Why Analysis been used to eliminate symptoms and reach the true prob-
lem?

Does the problem need sub-dividing?

Does the customer agree with the problem statement?

Have you filled in the problem statement and problem description in Section 2 of
the CAP Report?


Implement & Verify Interim Containment Action(s)
Overview
IMPLEMENT & VERIFY INTERIM CONTAINMENT ACTIONS

Tools Forms
Identify, Retrieve & Isolate
DEFINE Identify Team Members,
all defective & suspect 09 - Process Map
what's important Roles & Responsibilities
D 1 product
Identify any differences or

13 - Differences & Changes
Define the Problem changes to the product, CAP - 013
Analysis
2 process, service etc.
Evaluate any control gaps

Implement & Verify Interim 08 - Manufacturing DCP
in current DCP &
Containment Action(s) 22 - Reaction Plan
3 Reaction Plan
Implement agreed
containment actions &
M 4 verify their effectivness
Review IS / IS-NOT and

create new containment 04 - IS / IS NOT Analysis CAP - 004
A 5 ideas
Identify & Verify Proposed Communicate actions to all

IMPROVE
Permanent Corrective relevant internal & external
by fixing what's wrong
I 6 Action(s) customers
Implement Permanent Complete section 3 of

CAP - 001
Corrective Action(s) the CAP Report
7

C 8
Communicate results &

Recognise team
9

Procedures
If the problem your team is investigating is complex, it is likely to take some time before the team
identifies the root cause and implements permanent corrective action. In order to contain the effects
of the problem from any internal or external customer in the meantime, you will need to select and
implement some interim containment action(s).
Containment action is a temporary holding action to contain the problem until you can fix it perma-
nently. The danger of many interim actions is that they are considered to be a permanent solution to
a problem. But in reality, they are “band-aids”. Many temporary “fixes” are easily forgotten because
they are looked upon by many, as permanent solutions to problems.
It is a mistake to ever treat containment actions as the solution to the problem. They typically
address the effect not the root cause, and should be considered only the immediate “first aid”, a
quick fix to contain or manage the defect or problem temporarily. It will quite likely add cost to the
product. So don’t be tempted to employ the containment action as a “solution”. It needs to be
reviewed quickly and ultimately removed.
These containment action steps are relevant and necessary for all problems, manufacturing and
non-manufacturing. You should go through the same containment process whether you are dealing
with incorrect invoices, safety problems, errors in warranty claims, or defective manufactured parts
and so on.
3.1 Identify, Retrieve & Isolate all defective & suspect product
As rapidly as possible, internal and external customers must be isolated immediately from the
effects of any defective product or output. Often this is a scramble, with many actions going on at
the same time. Some of them may have already been implemented before your team was con-
vened. The following actions should be taken (including any related measures for non-manufactur-
ing problems):
Identify and place a hold on all suspect product in inventory, in warehouses, or in transit.
The containment action normally involves finding every bad product or output and hold-
ing it — keeping it away from the customer. You will need a Process Flow Diagram to
map the processes affected by the containment action, to determine which internal/
external customers may be affected.
09 – Process Map

Any suspect product that has reached the customer should be isolated or returned.
Determine what level of inspection, sorting, rework, etc is required for product in
progress. This means that instead of the normal detection process you may have
installed in the process — for instance, to look at every fifth part — now you will increase
the scrutiny and look at every part.
Determine what level of inspection, sorting, rework, etc is necessary for finished parts.
As part of this increased detection, you need to establish what your pass/fail criteria are.
What will be accepted and what will be rejected? You may want to obtain input from the
customer to agree these criteria?

3.2 Identify any Differences or Changes to the Process, Product, Service etc.
Reviewing the changes or differences within a process, product or service can often help identify the
root cause. Often the cause of a problem is that something has changed. For example; new opera-
tor, tooling change, change in process parameters, new equipment etc. This analysis will help iden-
tify where the containment action(s) need to be deployed. Using a flip chart, brainstorm the changes
and differences. Be sure to document all these and their effective date on Form CAP – 013. This will
help you later on in the problem solving process as you work towards determining root cause.
13 – Differences & Changes Analysis
3.3 Evaluate any control gaps in the current manufacturing DCP & reaction plans
A breakdown in process control, whether it is process control within a manufacturing process or a
business process, will often result in a problem. Therefore during this phase of the problem solving
process it is important to conduct an audit of the “AS IS” process controls & reaction plans against
those documented and approved in the manufacturing Dynamic Control Plan (DCP).
In addition this review may identify any gaps in the current DCP, which should be evaluated and
addressed immediately.
08 – Manufacturing DCP
22 – Reaction Plan
3.4 Implement agreed containment actions & verify their effectiveness

Based on the investigation and analysis to date, identify and implement the containment actions
agreed upon by the team.
To make sure that any unwanted effects are eliminated, and no additional problems occur, identify
controls to monitor and measure the effectiveness of the containment actions and document them in
the relevant Manufacturing DCP. You will need to monitor the containment action until the perma-
nent corrective action is in place.
Review the Containment action checklist to ensure the Containment action implemented will protect
the internal/external customer from the problem.
3.5 Review IS/IS-NOT analysis and create new containment ideas

There is a lot that you will have learned in Step 2 of the problem solving process as you completed
the Is/Is-Not form. Your new and expanded description of the problem could tell you that you need to
make a change or modification in the containment action.
Compare your documented containment actions and results with each item on the Is/Is-Not form.
Ask :

04 – IS/IS-NOT Analysis
3.6 Communicate actions to all relevant internal & external customers

It is very important that all containment actions are communicated to the internal & external cus-
tomer. Suggested forms of effective communication are as follows: -
External customer
Fax
Telephone call
E-mail
Communication Bulletin
The communication should contain details of the problem, containment

action(s), and target date for preventative action.
Internal Customer
Communications meeting
Training
Communications notice/Bulletin
Effective communication internally is essential for effective deployment of a containment action.

Fill in Section 3 of the CAP report (Form # CAP - 001). Identify containment action(s), the date they
were effective and state whether they have been verified.

Checklist
CHECKLIST
OBJECTIVE
The main objective of implementing a containment action or

actions is to isolate the effects of a problem from any internal or
external Customer until permanent corrective action is imple-
mented. Put in another way, what can we do immediately to prevent
the Customer from receiving any more poor quality product or ser-
vice?
The following checklist should be used to ensure the actions YES/NO

you have identified are true effective containment actions:
Have the actions identified prevented the customer from receiving any more defec-
tive units or parts?

Have you evaluated the effectiveness of the containment action(s), proving you can
no longer pass this defect on to the next operation or customer?

Have you implemented controls to ensure the containment action remains in

place?

Have you communicated to all relevant employees the customer dissatisfaction and
the specific issues experienced?

Have you communicated the containment action(s) to all relevant employees?

Have you checked to ensure the containment actions implemented do not create
any other quality or safety issues?

Have you reviewed & updated the IS/IS-NOT and Differences & Changes analysis?

Have you discussed with the Quality department whether this containment
action(s) should be communicated to the customer?

Have you filled in the interim containment action(s), implementation date & verifica-
tion in Section 3 of the CAP Report?


Analyze Current Process & Define Desired Outcomes
Overview
ANALYZE CURRENT PROCESS & DEFINE DESIRED OUTCOMES

Tools Forms
Review what measures are
DEFINE Identify Team members, 10 - Customer Input Matrix
important to our customers
what's important Roles & Responsibilities 17 - Design FMEA
D 1 (VOC)
Map the current 'As Is'

Define the Problem process, identify key Input 09 - Process Map
2 & Output variables
12 - Measurement System
Implement & Verify Interim Analyze Measurement
Analysis
Containment Action(s) System(s)
3
07- Pareto Analysis

MEASURE Analyse current process & Review & analyse process 08 - Manufacturing DCP
how we're doing Define desired outcomes controls & measures 11 - Histogram
M 4 25 - Control Chart
ANALYSE Define & Verify Root Review & update the

04 - IS / IS-NOT Analysis CAP - 004
what's wrong Cause(s) IS / IS-NOT analysis
A 5
Identify & Verify Proposed Review & update the

IMPROVE 13 - Differences & Changes
Permanent Corrective Differences & Changes CAP - 013
by fixing what's wrong Analysis
I 6 Action(s) analysis
Review and update

Implement Permanent
problem statement. and 02 - Project/Team Chartering
7 Project/Team Charter
Identify additional
CONTROL Action(s) to Prevent Re- measures and/or controls 08 - Mfg. DCP
to sustain gains occurrence are required to monitor & 25 - Control Chart
C 8 control the process
Communicate results & Complete section 4 of the

CAP - 001
Recognise team CAP Report
9

Procedures
This analysis step is used to organize data and look for process problems and opportunities. This
very important step helps to identify gaps between current and desired performance, prioritize
opportunities for improvement, identify sources of variations and root causes of problems within
the process.
4.1 Review what measures are important to our customers

(voice of the customer - VOC)
One very important step that is often overlooked when completing any problem analysis is the step
to review and interpret customer requirements and expectations. We often assume what the
customer wants.
Taking the Customer requirements analysis in Step 2, we will now need to conduct an analysis to
understand how our processes and process inputs relate to these customer requirements.
10 – Customer Input Matrix

15 – Process Input Matrix
At this point it is important to review and update the design FMEA so that it reflects the current
product design and performance as reported by our customer(s).
17 – Design FMEA

4.2 Map the current “AS IS” process, identify key input & output variables
One of the key and essential steps to analyzing any problem is to map the “AS IS” process includ-
ing sub-processes. It is important to ensure that sufficient time is given for completing this step. A
well-drafted process map can prove to be an invaluable platform for how much success you will
have in the later stages of the Corrective Action Process.
09 – Process Map

4.3 Analyze measurement system(s)
A study needs to be performed to investigate the amount of variation added to the total process by
the measurement system or gage. Variation needs to be analyzed in terms of Reproducibility,
variation added by the operator, and Repeatability, variation introduced by the gage or
measurement precision. This is known as GR&R.
Measurement system studies are essential to problem solving. In many cases, the measurement
system may be a large contributor to the problem.
12 – Measurement Systems Analysis

4.4 Review & analyze process controls and measures
Take an up to date copy of the Manufacturing Dynamic Control Plans (DCP) for the processes
involved. Conduct an audit of the process to assess compliance to the specified controls. Document
any discrepancies. Communicate these discrepancies to the person responsible for the area and
ensure controls identified on the DCP are followed from this point onwards.

Conduct an analysis of the data sets for each of the controls/measures identified on the DCP. The
data sets should be analyzed using the most appropriate analytical tool.

07– Pareto Analysis
11 – Histogram
25– Control Chart
4.5 Review & update the IS / IS-NOT analysis
Having completed a detailed process map, an evaluation of relevant measurement systems and a
review of all known measures and controls and corresponding data, review and update the IS /
IS-NOT analysis.
04 – IS / IS-NOT Analysis

4.6 Review & update the Differences & Changes Analysis
Having completed a detailed process map, an evaluation of relevant measurement systems and a
review of all known measures and controls and corresponding data, review and update the differ-
ences and changes analysis.

4.7 Review and Update Problem Statement & Project/Team Charter
If you don’t have an accurate problem statement then you will find it very difficult to establish a true
root cause. Therefore based on the analysis completed to date it is now important to review and
update the problem statement and project charter for one last time.
02 – Project/Team Chartering

4.8 Identify additional measures and/or controls required to monitor & control the
process
You will have reviewed the current “AS IS” DCP earlier on in the analysis process. At this stage it is
now necessary to re-evaluate the current process controls and, where required, introduce additional
controls to monitor and control the process. Be sure to document these controls on the relevant
DCP’s. Re-evaluate and update the risk priority numbers (RPN) reflecting the new controls.

4.9 Complete section 4 of the CAP Report
Fill in Section 4 of the CAP report (Form #CAP - 001). Summarize the results of the analysis and
document the desired outcomes. Finally revise section 2 of the CAP report, updating the problem
statement.
Checklist
CHECKLIST
OBJECTIVE
The main objective is to complete a comprehensive analysis of all

information and data associated with the problem. Based on the
analysis define the desired outcome of this problem solving project.
The following checklist should be used to ensure this step is YES/NO

executed effectively:
Are the people affected by the problem represented on the team?

Has a map of the “AS IS” process been completed with all input & output variables
clearly identified?

Has GR&R studies been completed to ensure the current measurement system is
capable?

Has all data from process controls, measures etc. been collected and thoroughly
analyzed?

Has the IS/IS-NOT analysis been reviewed and updated?

Has the differences and changes analysis been reviewed and updated?

Establish targets for reduction in variation?

Have additional measures/controls been established to monitor & control the pro-
cess?

Have you filled in Section 4 of the CAP Report summarizing the results of the pro-
cess analysis and the desired outcomes, which have been defined?


Define & Verify Root Cause(s)
Overview
DEFINE & VERIFY ROOT CAUSES(S)

Tools Forms
09 - Process Map
13 - Differences & Changes
DEFINE Identify Team Members, CAP - 013
Identify all potential causes Analysis
what's important Roles & Responsibilities 15 - Process Input Matrix
D 1 16 - Cause & Effect Diagram
Scope the project & 04 - IS / IS-NOT Analysis CAP - 004

Identify probable causes
Describe the problem 14 - Potential to Probable Filter CAP - 014
2
Implement & Verify Interim Verify probable root cause

20 - Test Planner CAP - 020
Containment Action(s) using supporting data
3
MEASURE Analyse current process & Prepare root cause

how we're doing Define desired outcomes statement
M 4
ANALYSE Define & Verify Root Complete section 5 of the

CAP - 001
what's wrong Cause(s) CAP Report
A 5
Identify & Verify proposed
IMPROVE
I 6 Action(s)
Implement Permanent
7

C 8

Recognise team
9

Procedures
DEFINE & VERIFY ROOT CAUSES
As anyone who has ever been involved in trying to solve a complex problem knows, this stage is the
heart of the matter. If we don’t find the true root cause, the problem will eventually reappear. In order
to“kill” the problem for all time, we know we have to find, be absolutely sure of, and then eliminate
the root cause — the one cause or combination of causes that explain 100% of the problem.
And yet this is the part of the process we typically do most poorly. All too often we apply brainstorm-
ing to generate a list of possible causes, decide on one we like, and go off to eliminate it. That’s if
we’ve even got this far. More often or not, we don’t get beyond the symptoms of the problem to a
true description, and then we spend most of our time in containment. That’s why we end up with root
cause statements like “operator error” — which could never be a true root cause because it doesn’t
explain 100% of the problem.
The steps in this stage – assuming you have done your work well up to this point – will lead your
team to discover all the potential causes there could be for the problem, to narrow that list to the
ones that are the probable causes, and – through careful data analysis – to verify the true root
cause.
5.1 Identify all potential causes

Making sure you capture all the potential causes of the problem requires creative, non-judgemental
thinking by the whole team. It is so important at this stage not to criticize or question any of the
potential causes suggested. This will stifle participation in the brainstorming process. Another
important requirement at this stage is to ensure that the team does not jump straight to a few favor-
ite causes or best guesses. Allow the process to do the work. If you don’t capture all potential
causes then you might miss the true root cause.
The following steps are required to identify all potential causes.

Review the problem statement, “AS IS” process map and differences & changes analysis
completed in Step 4.
Generate a Process Flow Cause & Effect Diagram by reviewing the input variables iden-
tified in the process map.
Next generate a Categories Cause & Effect Diagram by looking for potential causes
under the six main categories: — Man, Method, Machine, Material, Measurement &
Mother Nature. By completing this C&E diagram in addition to the process flow C&E dia-
gram we will be able to generate a greater number of potential causes.
Reviewing the changes and differences analysis identify any additional potential causes.
09 – Process Map

16 – Cause & Effect Diagram
5.2 Identify probable causes
In Step 5.1 the team will have established a broad list of potential causes. This broad list will contain
many potential causes that have nothing to do with the root cause.

The next step is to filter each of these potential causes against the IS/IS-NOT information reviewed
and updated in Step 4.
Using the Potential to Probable Filter establish a prioritized list of probable causes.
If you end up with a long list of probable causes then you may need to re-check the problem state-
ment or re-evaluate the IS/IS-NOT information for accuracy. The IS/IS-NOT information may contain
assumptions, which can sometimes be misleading. Be sure to investigate the validity of any
assumptions that are made.
04 – IS/IS-NOT Analysis

14 – Potential to Probable Filter
5.3 Verify probable root cause(s) using supporting data
In this step, the team will investigate the probable causes and gather data to prove conclusively
which one (or combination) is the root cause of the problem. Ask the following questions about each
probable cause of the problem:
If the root cause is...

1. How could this cause have resulted in the described problem?
2. What type of data must be collected to prove or disprove that this is the root cause?
3. Can the problem be turned off and on by controlling the variables associated with this
cause? In other words, can the problem be re-created?
4. Does this cause explain the problem 100%
5. Is the supporting data quantifiable?
1. Try to investigate all probable causes simultaneously to save time. Other-

wise, you could lose a lot of time if what you think is the most likely cause
turns out not to be the root cause.
\ 2. Look for simple, low cost, quick and effective ways to make the problem
turn on and turn off before trying more elaborate means of verification.
3. You may need to investigate some combination of probable causes to
determine the root cause. To verify it, remember to test the combination.
Data-Gathering process
In order to investigate or verify a probable cause, you should:
Establish what type of data should be gathered.
Develop a plan on how the study will be conducted (Test Planner).
Identify the steps on an action plan.
Organize and prepare the required materials and resources to conduct the study.
Conduct the study and/or process the data.
Use appropriate statistical tools. (If possible, illustrate the data graphically. See toolkit
index for appropriate tools).
Outline the conclusions from the study. Does the data establish the probable cause as
being 100% of the root cause?
20 – Test Planner

5.4 Prepare root cause statement

Using the results of your investigating/verifying work, determine the true root cause of the problem.
Develop a root cause statement.

Fill in Section 5 of the CAP report (Form #CAP - 001). Identify root cause(s) and state whether they
have been verified.

Checklist
CHECKLIST
OBJECTIVE
To systematically identify & verify root cause(s) that explain the

problem 100%.

Have all input variables that have a significant effect on the process output perfor-
mance been considered?

Have you established the effects of the of the problem on the internal/external cus-
tomer?

Have you generated a list of potential root causes relating to the effects of the prob-
lem on the customer?

Have you used all supporting data & the IS/IS-NOT analysis to narrow your list of
potential causes to establish the most probable root cause(s)?

Have you been able to verify root cause by re-creating the defect?

Have you prepared a statement describing the root cause?

Have you quantifiable test data to verify the true root cause?

Have you identified/measured what percentage of the problem the root causes
relate to?

Have you filled in the root causes in Section 5 of the CAP Report?


Identify & Verify Proposed Permanent Corrective Action(s)
Overview
IDENTIFY & VERIFY PROPOSED PERMANENT CORRECTIVE ACTIONS(S)

Tools Forms
Develop list of possible
DEFINE Identify Team members ,
permanent corrective
D 1 actions
Prioritise & filter list

Scope the project & 18 - Force Field Analysis CAP - 019
establishing proposed
Describe the problem 19 - Choose & Verify CA
2 solutions
08 - Manufacturing DCP
Implement & Verify Interim 17 - Design FMEA
Identify proposed solutions
Containment Action(s) 23 - Poka - Yoke (Mistake
3 Proofing)
MEASURE Analyse current process & Gain approval for tests

20 - Test Planner CAP - 020
how we're doing Define desired outcomes &/or proposed actions
M 4
Commit to agreed choice

of permanent corrective
A 5 actions
Identify & Verify proposed

IMPROVE Complete section 6 of the
Permanet Corrective CAP - 001
I 6 Action(s)
Implement Permanent
7

C 8

Recognise team
9

Procedures
Sometimes a team is tempted to rush through the process of choosing a permanent corrective
action. When they have found the root cause of the problem, they grab a corrective action, which
they think will solve the problem. It is implemented, and the team expects to see the problem go
away. If it doesn’t the team is often thrown back to square one.
It is much more efficient to determine, through paper testing and real-world verification, that you
have the best permanent corrective action from the available options.
This stage of the problem-solving process will show you — through a series of filters — how to
determine ahead of time that the choice you make is the right one.
Before proceeding with Step 6 it is worth reviewing the make-up of the team. As you are now look-
ing at permanent corrective actions and solutions you may wish to add new members with expertise
in developing, designing and implementing solutions. If you decide to bring on new members,
remember to assimilate them adequately into the team.
6.1 Develop list of possible permanent corrective actions

Develop a list of all the possible permanent corrective actions you might consider. Don’t worry about
evaluating the corrective action here: that will be done in the next step. At this point, you want to cre-
atively name as many potential solutions to the problem as possible. Here are some of the
approaches you can use:
Brainstorming
Benchmarking other locations with similar problems
Expert and team member input (Experts could be a supplier, a consultant etc.)
6.2 Prioritize & filter list establishing proposed solutions

As you go through this step, use the Filter I worksheet outlined in the Choose & Verify Corrective
Actions Tool. At this stage it is recommended that you use the Force Field Analysis tool to rationally
evaluate any proposed solutions.
18 – Force Field Analysis

19 – Choose & Verify Corrective Action
The first filter requires the team to develop a list of MUSTS that any permanent corrective action
must satisfy. These are the criteria that are mandatory. They should also be measurable. Your first
MUST will probably be “Kill the root cause”. If you are not sure of others, consider common criteria
categories such as:
Cost
Time to Implement
Materials
Manpower
Company procedures
Process impact
Customer impact

Some of these categories may be more appropriate when you develop a list
of “wants” in the next step.
Also in Filter I the team will need to generate a list of WANTS that the Permanent Corrective Action
should satisfy. Use the list of common criteria categories you used above, and include any others
that are relevant to your situation.
The team will need to decide on the relative importance of the WANTS. This helps to minimize con-
flicts over the final decision. One way to do that is to give the most important WANT a 10. Give the
others a value that reflects their relative importance to the 10. Finally, list the WANTS from High to
Low value on the worksheet.
Rank the choices. Give each choice of permanent corrective action at the top of the worksheet a +
or — in the +/- column by evaluating it against your list of MUSTS and WANTS.
Eliminate any choices that do not meet the mandatory MUSTS. Rank the remaining choices accord-
ing to how they perform to the weighted WANTS. This should narrow your list of possible permanent
corrective actions to between one and three that are preferable to the group. List them at the bottom
of the worksheet.
6.3 Identify proposed solutions

Use Filter II worksheet outlined in the Choose & Verify Corrective Actions Tool.
19 – Choose & Verify Corrective Action

For each of your preferable choices of permanent corrective action, evaluate the risk of implementa-
tion.
Weight each risk according to its Seriousness and Probability by giving each one a High, Medium,
or Low under each category.
Choose the best possible Permanent Corrective Action based on your risk analysis. Write it in the
space provided at the bottom of the worksheet.
In addition to using Filter II, the risks should also be assessed using a design FMEA and/or Manu-
facturing DCP where applicable.
17 – Design FMEA

If the proposed solutions do not improve the RPN numbers then re-evaluate the MUSTS and
WANTS together with all the possible corrective actions identified in step 6.1. With any proposed
solutions, it is vital to take advantage at all times to mistake-proof or fool-proof the solution. This can
be done by designing/using poka-yoke device. These can truly kill-off defects/errors re-curring and
are often worth their weight in gold.
23 – Poka-Yoke (Mistake proofing)

6.4 Gain approval for tests and proposed solutions

Up until this point, all the analysis has been “paper based”. Before committing to the final choice for
permanent corrective action, the team needs to be sure it will eliminate 100% of the problem.
Decide what testing is necessary to verify that the permanent corrective will eliminate the problem
completely. This could be called the “Turn-on/Turn-off” test. Consider using Process Flow Diagrams,
Control charts and other appropriate validation test tools. In addition, plan contingency actions to
protect against any unwanted effects of the permanent corrective action.
Assess whether to temporarily remove the interim containment action while you conduct the tests.
Prior to testing, it is good practice to seek approval from the team Champion. Testing can some-
times be expensive and/or can have an impact on day-to-day operations.
20 – Test Planner

6.5 Commit to agreed choice of permanent corrective actions
After all the validation testing is complete, the team should make the final choice of permanent cor-
rective action.
At this point, before you proceed to implement the permanent corrective

action, it may be advisable to re-evaluate the interim containment action that
was installed earlier — in terms of life expectancy, cost, coverage, etc. Rede-
sign the interim containment action if required.

Fill in Section 6 of the CAP report (Form # CAP - 001). Identify proposed permanent corrective
actions and state whether they have been verified.

Checklist
CHECKLIST
OBJECTIVE
The main objective is to utilize the relevant skills, knowledge and

experience of the team in following a methodical approach which
can find the most appropriate permanent corrective action(s).

Do you need additional team members to identify & select the best permanent cor-
rective actions?

Have you identified possible poka-yoke devices and mistake-proofed solutions?

Have you developed a list of possible permanent corrective actions?

Have you developed a list of criteria to identify the solution Musts & Wants?

Have you analyzed & assessed the risks of each proposed solution?

Have you developed and performed tests to verify the effectiveness of the pro-
posed solutions? (Note: Ensure you have approval to perform the tests)

Have the team agreed and committed to the choice of permanent corrective
actions?

Have you filled in & listed all proposed permanent corrective actions in Section 6 of
the CAP Report?


Implement Permanent Corrective Action(s)
Overview
IMPLEMENT PERMANENT CORRECTIVE ACTION(S)
Tools Forms
Develop & troubleshoot
detailed implementation 21 - Implementation Plan CAP - 021
D 1 plan
Scope the project & Implement and

Describe the problem communicate actions
2
Monitor effectiveness of
Implement & Verify Interim
actions, ensuring
3 elimination of defects
MEASURE Analyse current process & Remove interim

how we're doing Define desired outcomes containment action(s)
M 4
ANALYSE Define & Verify Root Complete section 7 of the

what's wrong Cause(s) CAP - 001
CAP Report
A 5
IMPROVE Identify & Verify Proposed

by fixing what's wrong Permanet Corrective
I 6 Action(s)
Implement Permanent
7
to sustain gains occurence
C 8

Recognise team
9

Procedures
You may need to change the team membership to allow input from or assign responsibilities to
departments or functions that will be involved in implementing the permanent corrective action.
Evaluate the necessity of this in your case.
7.1 Develop and troubleshoot detailed implementation plan

The team should develop a practical and comprehensive plan to implement the permanent correc-
tive action. The plan will cover documenting any changes to the process that will be needed, verify-
ing that the permanent corrective action is effective, installing controls to monitor it, and removing
the interim containment action.
There is an Implementation Plan Form #CAP – 21 in this handbook (see below) for your team to use
to develop the implementation plan.
Wherever they apply, the plan should also address these or related issues:
Disposing of defective parts already produced

Changing product or processes
Revising ineffective operating systems
Updating documents
Coordinating with suppliers
Providing employee training
Identify potential problems
To anticipate any unwanted effects that could occur after the permanent corrective action is imple-
mented, the planning team should ask the following questions, and include the answers on your
action plan:
What could go wrong with our plan?

1. What could go wrong at each step of the plan?
2. What could cause this to go wrong?
3. How will we be able to tell if this occurs?
4. How can we prevent these potential problems?
After you answer these troubleshooting questions, go back and make any necessary changes to
your plan.
21– Implementation Plan

7.2 Implement and communicate action(s)
Follow your plan to implement the permanent corrective action.
7.3 Monitor effectiveness of action(s), ensuring elimination of defects

Set up monitoring controls to measure the effectiveness of the permanent corrective action in elimi-
nating the problem. Make sure your controls will quantifiably measure the process.

7.4 Remove interim containment action(s)

Part of your interim containment action most likely included a close inspection of all suspect prod-
uct/output. That inspection should reveal no suspect product since the permanent corrective action
was implemented. If this is true, and/or if your monitoring controls are also showing that the root
cause has been eliminated, you should now remove the interim containment action.

Fill in Section 7 of the CAP report (Form # CAP - 001). Implement proposed permanent corrective
actions and state whether they have been verified.

Checklist
CHECKLIST
OBJECTIVE
The main objective is to ensure permanent corrective actions are

successfully implemented and verified.

Do you need to change the Team membership to implement the permanent correc-
tive action(s)?

Have you developed a detailed implementation plan?

Have you identified potential problems with the implementation and developed pre-
ventative actions?

Have you updated the relevant documentation to reflect these permanent correc-
tive actions?

Have you fully implemented the permanent corrective actions identified?

Have you quantifiably verified that the permanent corrective action(s) have com-
pletely eliminated the root cause of the problem?

Have you removed the interim containment action(s) and set-up controls to monitor
the permanent corrective action(s)?

Have you filled in and listed all permanent actions and the dates implemented in
Section 7 of the CAP Report?


Action(s) To Prevent Re-Occurrence
Overview
ACTION(S) TO PREVENT RE-OCCURRENCE

Tools Forms
Review process controls 08 - Manufacturing DCP
& measures, and identify 11 - Histogram
D 1 any new problems 25 - Control Chart
Identify the processes that

Scope the project & 24 - Problem Prevention
allowed the problem to CAP - 024
Describe the problem Worksheet
2 occur
Establish whether this

Implement & Verify Interim 24 - Problem Prevention
process affects any other CAP - 024
Containment Action(s) Worksheet
3 areas
MEASURE Analyse current process & Recommend or implement 24 - Problem Prevention

CAP - 024
how we're doing Define desired outcomes process changes Worksheet
M 4
ANALYSE Define & Verify Root Calculate actual business

what's wrong Cause(s) impact/savings
A 5

IMPROVE Complete section 8 of
Permanet Corrective CAP - 001
I 6 Action(s)
Implement Permanent
7

C 8
Recognise team
9

Procedures
Up to now your work has been reactive. This stage requires you to do preventative work which has
broader benefits. You will widen your focus to include not only the process that allowed this problem
to occur, but also any systems that may need to be changed.
Many teams end their work at Step 7, as soon as the permanent corrective action is implemented.
They miss an important opportunity to prevent similar problems from occurring elsewhere in the
future.
The responsibilities of teams will vary at this stage. Some teams will be asked to simply compile a
list of recommended changes. Some teams may be empowered to make the recommended
changes. Still others may identify opportunities for a process improvement team to take on.
The problem prevention worksheet should be used to effectively execute the following steps:
8.1 Review process controls & measures and identify any new problems
Review all process controls and measures, especially the ones set up to monitor the effectiveness
of the permanent corrective actions. Identify whether any new problems have arisen.
8.2 Identify the processes that allowed the problem to occur

In this step your team will identify the process breakdowns, deviations or obsolete methods that led
to the problem. As you review the history of the problem, ask the first five questions on the Problem
Prevention Worksheet.
24 – Problem Prevention Worksheet

8.3 Establish whether this process affects any other areas
Now take an even broader view. Look beyond the specific process in which this problem occurred.
Try to discover where else the problem could crop up - and even what systems might need to be
changed in order to prevent similar problems from occurring in the future.
To do that, answer Questions 6 - 10 on the Problem Prevention Worksheet.

8.4 Recommend or Implement process changes
Based on your analysis, the team should develop a list of recommended changes to prevent re-
occurrence. This list will include reinforcements, or improvements that should be made to the pro-
cesses or systems that gave rise to the problem.
Use your answers from the Problem Prevention Worksheet to develop the team’s recommendation
actions to present to your team Champion and/or management.
The Champion or management will need to respond to the recommendations and determine who
will be responsible for implementing them, and the target date for implementation.
Complete the problem prevention worksheet identifying responsibility and timing for agreed actions.

8.5 Calculate actual business impact/savings

As for any improvement initiative or project it is important to measure the actual impact on the busi-
ness and capture the actual savings. Here are some suggestions of items to consider when fulfilling
this task.
Safety
Quality
Cost
Delivery
Productivity
Labor
Capacity

Fill in Section 8 of the CAP report (Form #CAP - 001). Identify the actions to prevent re-occurrence,
their date of implementation and state whether they have been verified.

Checklist
CHECKLIST
OBJECTIVE
The main objective is to establish actions to prevent re-occurrence

of this problem anywhere within the organization.

Have you completed the problem prevention worksheet?

Have you reviewed process controls & measures to identify any new problems that
may have arisen?

Have you identified whether this process affects any other areas?

Have you developed a list of recommended process or system changes or
improvements needed in any affected areas?

Have you communicated these changes to management?

Have management determined who will implement these recommended improve-
ments?

Have you calculated the actual business impact savings from this CAP?

Have you filled in and listed all actions to prevent re-occurrence of the problem in
Section 8 of the CAP Report?


Communicate Results & Recognize The Team
Overview
COMMUNICATE RESULTS & RECOGNIZE THE TEAM

Tools Forms
DEFINE Identify Team Members, Communicate the team's

what's important Roles & Responsibilities work & results
D 1
Scope the project & Recognise the team's

Describe the problem efforts & results
2
Complete section 9 of
Implement & verify Interim
CAP Report & submit to CAP - 001
3 the Quality department

M 4

A 5

IMPROVE
I 6 Action(s)
Implement Permanent
7

C 8

Recognise team
9

Procedures
COMMUNICATE RESULTS & RECOGNIZE THE TEAM
This is the final and yet very important stage of the process. Here is where the team’s results are
publicized, and management congratulates the team.
The Champion has a major responsibility for seeing that the efforts of the team are communicated
and recognized. This recognition is important for several reasons:
It provides an opportunity to document the team’s work and share it with others who can
benefit from it.
It shows the team members that their work is appreciated.
It recognizes the unique contributions of individuals.
It communicates the value of teamwork in solving difficult problems.
It demonstrates - through the elimination of the problem and process improvement rec-
ommendations - the value of this teams efforts as a whole.
9.1 Communicate the team’s work and results

The work the team has done will be very helpful to others who face similar problems. It will also be
valuable in future planning, The company can save time and money by applying what you have
learned wherever similar conditions exist. Therefore, the team Champion should make every effort
to see that the work gets the widest possible publicity.
Publicity can take several forms. Here are just a few ideas:
Article in a company and/or employee publication

Video
Published paper (perhaps submitted to professional journal)
Organizational learning
Project summaries/overviews posted on notice boards within information areas
Project presentations made available on intranet
Case study
Memo to management
If the work of the team warrants it, an application could be made for a patent on design or process
improvements that the team, or its members, have made.
9.2 Recognize the team’s efforts and results

Management - particularly the team Champion - has a large responsibility for seeing that the team is
properly congratulated. After all, team problem solving means improved quality, increased produc-
tivity and improved customer satisfaction for the company.
Make sure that the whole team receives recognition and credit - not just the team Leader. Also
make sure that all members of the team, past and present, are recognized, as well as all the people
who served as resources. Don’t forget suppliers, administrative support, etc.
There are many means of recognition available to the team or to management. Here are only a few
suggestions.

Management luncheon and presentation

Appropriate publicity
Recognition letters from Management
Gifts
Corporate Quality Award
9.3 Complete Section 9 of the CAP Report and Submit to Quality Department
Fill in Section 9 of the CAP report (Form #CAP - 001). Document how the team’s results were commu-
nicated and how the team was recognized.
Submit the final completed report to the Quality Manager for review and approval. This document
will then be filed per document control and retention requirements.

Checklist
CHECKLIST
OBJECTIVE
The main objective is to effectively communicate and recognize the

teams work & results.

Have you appropriately publicized the problem and solutions throughout the orga-
nization?

Have all team members involved throughout the process been appropriately recog-
nized for their efforts?

Have you filled in the actions to communicate and recognize the team in Section 9
of the CAP Report?

Have you submitted the final report to the Quality Department?


Toolkit Index
Description Use This Tool
Meeting Facilitation To review at start of meeting to establish

facilitation guidelines.
Project/Team Chartering To clearly define the content, requirements

and other key attributes of a project.
Five Why Analysis To clarify the true problem definition and

better identify potential root cause.
IS/IS-NOT Analysis To clarify the problem being addressed in

order to determine root cause.
Customer Requirements To document our understanding of our

Matrix customers and their requirements.
Supplier Requirements To document our understanding of sup-

Matrix plier inputs to our processes.
Pareto Analysis To graphically compare importance of

defects or potential causes.
Mfg. Dynamic Control To identify and evaluate potential failure

Plan (DCP) modes within a process. Identify corre-
sponding controls and improvement plan.
Process Map To define and highlight key input and out-

put variables within a process.
Customer Input Matrix To understand the relationship of major

process steps to customer requirements.
Histogram To graphically display the distribution of

data.
Measurement System To verify the capability of a measurement

Analysis system in terms of repeatability and repro-
ducibility.
Differences & Changes To identify potential root causes by identi-

Analysis fying changes and differences to a proc-
ess, product or system etc.
Corrective Action Process — Toolkit Index

Potential to Probable To identify the most probable root cause
Filter from a list of potential causes.
Process Input Matrix To understand the relationship between

process inputs and customer require-
ments.
Cause & Effect Diagram To illustrate visually and identify the

potential causes of a specific problem or
condition.
Design FMEA/Process To identify and evaluate the potential fail-

FMEA ure modes of a product design /manufac-
turing process & to identify & prioritize
actions to eliminate or reduce the risk of
failure.
Force Field Analysis To identify the forces & factors that sup-
port or work against the solution of a prob-
lem and to strategically analyze a change
event.
Choose & Verify To determine the most effective permanent

Corrective Actions corrective action from a list of possible
solutions.
Test Planner To create a plan for collecting data to test

the effect of a process or product change.
Implementation Plan To establish a plan to implement a perma-

nent corrective action.
Reaction Plan To assure a systematic approach to trou-

ble shooting of issues/concerns.
Poka - Yoke (Mistake To develop a Poka - Yoke device to error

Proofing) proof an operation to attain zero defects.
Problem Prevention To identify the process breakdowns, devi-

Worksheet ations or obsolete methods that led to a
problem in order to prevent re-occurrence
of this or like problems.
Control Chart To monitor, control and improve process

performance over time by studying varia-
tion and its source.
Corrective Action Process — Toolkit Index-2

Appendix A: Toolkit
Meeting Facilitation
APPENDIX A: TOOLKIT MEETING FACILITATION
When To Use This Tool: How To Use This Tool: 4. AGENDA – Review the items to be cov-
To be reviewed at the start of a meeting 1. At the beginning of a the meeting review ered and establish a schedule. It is good
to establish facilitation guidelines. each element of the SPACER practice to develop and communicate an
2. SAFETY – identify emergency exit route, agenda prior to the meeting; this allows
Results You Can Expect: location of rest rooms and any other participants to prepare materials, presen-
Focused, orderly and effective safety considerations. tations, etc.
meetings. 3. PURPOSE – discuss and establish the 5. CODE OF CONDUCT – Have all meeting
purpose for the meeting. attendees introduce themselves. Estab-
lish rules for the meeting, some examples
being:
a. 3 – Knock rule, when a meeting
becomes disorderly or there are side
discussions or too many people talk-
ing then knock the table 3 times and
re-establish order and focus.
b. Establish the rule whereby you are
only allowed to criticize ideas not peo-
ple.
c. If focus is lost, call ‘Time-out’ –
Review purpose and expectations of
meeting to re-establish focus.
d. Car park – write any issues which
may arise which may not be on the
agenda or detracts the focus, during
the meeting on a flip chart and review
at the end.
6. EXPECTATIONS – Clarify the expecta-
tions and desired outcomes from the
meeting.
Corrective Action Process - Toolkit A-1

7. ROLES & RESPONSIBILITIES -
Establish the following roles an NEXT STEPS: Update meeting minutes
and distribute to all meet-
responsibilities: - ing attendees, team
Facilitator – Leads the meetings. members, team cham-
Participants – Contributes to the pion and sponsors.
meeting.
Scribe – Takes meeting minutes or
makes notes on flip chart.
Timekeeper – Keeps the meeting
on schedule.
1. Usually actions generated

from a previous meeting
should form part of the
agenda.
2. Meetings are a business
necessity and if faciliated
effectively they can become
value added.
3. Another important require-
\ ment for good effective
meetings is the environment
in which the meeting is held.
Room lighting and temper-
tature should be consid-
ered.
4. Make sure facilities are
available for required form
of communication and pre-
sentation: Flip charts, wipe
boards, markers, projects
etc.

Project/Team Chartering
APPENDIX A: TOOLKIT PROJECT/TEAM CHARTERING
When To Use This Tool: Results You Can Expect: 5. Project Scope - Define the Project
To clearly define the content, Identifies and documents project scope, Scope. Give a brief description of the end
requirements and other key attributes of customer requirements, objectives, key product; identify major project compo-
a project. stakeholders, constraints, assumptions nents, deliverables and project phases. At
and concerns to provide the basis for this point it is important to identify any
detailed planning. specific exclusions from the scope.
To initiate active participa- 6. Objectives - Identify the project objec-
tion and gain commitment tives preferably expressed as measurable/
from project stakeholders. quantifiable goals:
• Primary Objectives – The overrid-
How to Use This Tool:
ing reasons/goals, without which the
1. Team Champion - Begin project probably would not be under-
by establishing a Team taken.
Champion, team leader
• Secondary Objectives – Additional
and team members.
intended/expected benefits.
2. Project Name - Establish a
7. Project Stakeholders – Identify all any
name for the project.
person/organization that can significantly
3. Revision Number and impact or be impacted by the results of
Date - Identify on the doc- the project. Stakeholders include; the cus-
ument the revision number tomer both internal & external, project
and date. champion, project manager or team
4. Background - Establish leader, team members.
and document the project 8. Completion Date(s) – Target or con-
background including a straint
description of the customer
9. Identify Total Cost – Identify expected
requirements.
target or constraint.
10. Project Timing - Estimate savings for
compressing project timing.

11. Identify Contraints - Document any con-
straints, assumptions, concerns and/or NEXT STEPS: Obtain sign-off and
approval from all Project
risks.
Stakeholders.
• Constraint – Any limitation on allowa-
ble project planning alternatives or
acceptable project outcomes.
• Assumption – Any unverified supposi-
tion on which the project plan is based.
• Concern/Risk – Any identifiable and
significant potential problem associ-
ated with the performance of a project.
Provides basis for contingency
planning.
1. Ensure all objectives are

achievable. Do not set or
stretch unachievable objec-
tives.
2. The charter must be
developed by consensus.
\ 3. When developing the charter,
be clear and concise.
4. Do not make the mistake of
confusing Project Deliver-
ables, which specify what the
team must produce, with
Objectives, which state the
reasons why the organiza-
tion is motivated to perform
the project.

Horizontal Five-Why Analysis
APPENDIX A: TOOLKIT HORIZONTAL FIVE-WHY ANALYSIS
When To Use This Tool: How To Use This Tool: 4. Repeat Steps 2 & 3 until it is felt that you
To better clarify what the true problem 1. Identify the initial problem statement you have reached a logical conclusion for
definition is, or to help better identify wish to analyze, and state it to the left- each of the element(s) of the reasons
potential root causes. most side of the page. behind the problem.
2. Working across the page, horizontally 5. You will now be seeing a progression of
Results You Can Expect: from left-to-right, ask what are the imme- the problem: across the page (as the
A clear path showing the increasing diate reasons believed to be causing this problem element is shown in more and
level of detailed analysis of a problem, problem. more detail), and down the page (as each
enabling the team to make sure it is 3. Having agreed on this reason(s), state step sub-divides into multiple reasons).
focusing on the true/correct elements of them underneath the next nearest Why?
a problem. Column heading. You can do more or less iterations
than five.
6. The problem statements remaining to the

right-most side of the page are the identi-
fied true/correct elements of the problem/
cause that need to be addressed.
NEXT STEPS: • Complete the list of

potential root causes
by combining this
analysis with other
tools such as a Cause
& Effect (Fishbone),
and a Differences &
Changes method.
• Apply filter to identify
most probable root
causes.

1. Once you have completed
an initial draft analysis,
review it to see where there
are common links or unnec-
essary repetition, and re-
draft.
2. If the analysis keeps
\ spreading too far down or
across the page, you may
need to sub-divide the
problem and do a separate
Horizontal Five-Why
Analysis on each of these
sub-divided elements.
3. Use factually based infor-
mation wherever possible.
4. For unsubstantiated infor-
mation decide if further
investigation is required.

Is/Is Not Analysis
APPENDIX A: TOOLKIT IS/IS-NOT ANALYSIS
When To Use This Tool: Results You Can Expect: NEXT STEPS: • You will now have a
To better clarify the problem being More specific identification of the much better specified
addressed in order to get to root cause. boundaries of the problem, hence problem.
helping significantly to pinpoint potential • You can use this analy-
root causes. Ensures you do sis to help find probable
not explore areas or work root causes by a process
processes that do not affect of elimination based on:
the problem. a. Past experience or
familiarity with the
How To Use This Tool: operation
1. When using this approach, a b. Finding the unusual
problem/defect is when there is differences identified
a deviation/difference between in the analysis, and
what was expected to happen by…
and what actually occurred. c. Determining what
2. Verify that the above condition changes are associ-
is met, and that the cause of ated with each of the
the deviation is currently not unusual differences.
known. • The most probable
3. Fill in the problem statement at cause of the defect/prob-
the top of the IS / IS-NOT anal- lem is the one which
ysis form. explains all of the IS / IS-
4. Use the IS / IS-NOT question- NOT facts, with the
naire (shown below left) to fewest reasonable
complete the IS IS-NOT analy- assumptions.
sis, by asking the questions in
the four categories of 'what',
1. Don't skimp on time with this
'where', and 'Extent.'
\ tool. It can save a lot of time
later.

Customer Requirements Matrix
APPENDIX A: TOOLKIT CUSTOMER REQUIREMENTS MATRIX
When To Use This Tool: Results You Can Expect: How To Use This Tool:
To document our understanding of our Definition of process outputs. 1. Get direct customer requirements from
customers and their requirements. Understanding of our performance direct interviews, surveys, etc.
against customer requirements. 2. Identify direct customers (who use our
products or services).
Priorities of possible areas to improve.
3. Create one 'Customer Requirement'
Basis for discussing opportunities inter- sheet for each customer.
nally and with customers. Enter Customer Name.
4. Describe the output or outputs.
5. Enter customer requirements (Quality,
Cost, Delivery, Dependability, Respon-
siveness, Accessibility, etc.).
6. Record our customer's measure of our
performance.
7. Rate the importance of this item.
8. Enter estimate of customer satisfaction.
9. Calculate priority number by multiplying
the ratings for 'importance to customer'
by 'customer satisfaction'.
10. What has this customer complained
about, and what do we believe they would
ask us to fix.
\ 1. Always verify your

perceptions with your
customer.

NEXT STEPS: • Focus on those
requirements with the
highest 'priority rating
number'
• See this as the first
step of improvement,
typically leading to
efforts towards:
a. Ensuring our man-
ufacturing specifi-
cations and
acceptance stand-
ards are in line with
customer require-
ments
b. Complete 'Cus-
tomer Input Matrix'
c. Complete 'Proc-
ess Input Matrix'
d. Complete 'Proc-
ess Map'
e. Assess & Clarify
'Supplier Require-
ments'

Supplier Requirements
APPENDIX A: TOOLKIT SUPPLIER REQUIREMENTS
When To Use This Tool: Priority of possible process 3. Enter our required standard, including
To document our understanding of (supplier) improvements. quantitative measures or specification.
inputs to our processes. Basis for improvement opportunities 4. Document the suppliers actual perfor-
with suppliers. mance in meeting our required standard.
Results You Can Expect: 5. Brainstorm issues with input from the
Identification of process inputs from How To Use This Tool: suppliers. Prioritize based on the impact
suppliers. 1. Identify supplier by name. to the customer, business or team
2. Identify inputs which trigger our activity, requirements.
Ensure we have a full, factual
understanding of our performance what product, service or information do
requirements for suppliers. we need?
NEXT STEPS: • Arrange to discuss

issues with suppliers
• Working with the sup-
pliers, use process
mapping, followed by
the principles of Fail-
ure Mode & Effects
Analysis (FMEA) to
brainstorm and priori-
tize failure modes,
their effects and how
to get to root cause
and reduce variation.
1. Always verify with suppliers

that they have the same
\ understanding of our
requirements and their per-
formance against those
requirements.

Pareto Analysis
APPENDIX A: TOOLKIT PARETO ANALYSIS
NEXT STEPS: • Use the priorities which

When To Use This Tool: How To Use This Tool: the chart shows you to
To graphically compare importance of 1. Agree on the defects/reasons (potential continue on to the next
defects or potential causes. causes) to study. stages of problem reso-
2. Gather data on frequency of occurrence lution, e.g. verify poten-
Results You Can Expect: of each of the defects/reasons. tial and ultimately find
Separate and identify the most common 3. Show total frequency/occurrence. root cause.
(and hence most critical) reasons from 4. Establish a convenient scale.
the more incidental many 5. Show reasons/potential causes in 1. Don't forget you can use a
pareto chart to help better
Focus team and resources on verifying
the most likely and most critical causes
descending order from left to right.
6. Graphically show columns, illustrating the
\ identify and clarify priorities
frequency for each defect/reason. on any range of issues, not
of defects.
just quality/defect related
ones.
Defect Reason/Potential Cause

Manufacturing Dynamic Control Plan - DCP
APPENDIX A: TOOLKIT MANUFACTURING DYNAMIC CONTROL PLAN
The Manufacturing Dynamic Control Prioritized action plan to prevent the 1. Complete Process FMEA section per
Plan is a combined Process FMEA and occurrence of failures or reduce the AGIG Potential Failure Modes Effects
control plan. The DCP should be used severity of a failure mode. Analysis Manual. (QS9000)
to evaluate potential failure modes of a Documented Knowledge of a 2. In the control plan section identify the
process and identify corresponding manufacturing process. control factor for each failure mode:
controls and improvement actions. • O - Operator
Ensures customer expectations in terms
Used in the development of new manu- • P - Process,
of product design requirements are
facturing processes & optimization of • M - Material,
understood, deployed & controlled in
current processes. • E - Equipment,
the mfg. & assembly processes.
• Me - Measurement, and
• Ev - Environment.
3. For each failure mode identify the method
of Control, i.e. Statistical process control
(SPC), inspection, attribute data, poka-
yoke, sampling plans.
4. Ultimately the method of control is depen-
dant on the type of process.
5. List the size and frequency of any sam-
pling plan.
6. Determine the current capability indices
Cpk for the process.
7. Describe the type of gage or poka-yoke
device. e.g. micrometer, no go gauge etc.
8. Complete and record the results of the
gage capability study (GR&R) performed
on the gage used.
9. In the reaction plan column make refer-
ence to the specific reaction plan which
specifies the corrective action(s) neces-
sary to avoid producing non-conforming
product. (See Reaction Plan tool #22.)

NEXT STEPS: • Obtain approval of con-
trols identified in the
Manufacturing DCP
from the Quality depart-
ment.
1. Cross-functional approach is
essential to ensure all
\ process knowledge is
captured, documented &
shared.
2. ReferenceThe AGIG
Advanced Product Quality
Planning and Control Plan
Manual for completing the
Control Plan Section of the
DCP. (QS9000)

Process Map
APPENDIX A: TOOLKIT PROCESS MAP
When To Use This Tool: How To Use This Tool: 10. Identify process input variables (controls,
To provide a step-by-step picture of the 1. Name the process. settings, procedures, noise/environment
'as-is' operation. To define and highlight 2. Identify the end product. variables etc).
key input and output variables within the 3. Identify customers & their requirements
process. 4. Identify last step (setting boundary) NEXT STEPS: • Discuss which inputs
5. Identify inputs from suppliers. drive key outputs.
Results You Can Expect: •Select critical inputs for
6. Identify first step (setting boundary)
Shows opportunities for improvement to 7. Identify intermediate process steps. further study/analysis.
reduce variation & waste in process. 8. Identify tasks or standard operating pro- •Plan tests to prove (sta-
Reveals sources of scrap, rework, cedure for each process steps. tistically) that these
waste, HS&E issues. 9. List process output variables (results inputs have a significant
Can be used as direct input to develop from the product or process) for each impact on the outputs’
Manufacturing DCP. step. variability.
•You will find this is an
immediate lead in to
many of the most
important tools, such as
Manufacturing Dynamic
Control Plans (DCP's).
1. A well-drafted process map

can prove to be an invaluable
\ platform for how much
success you will have in the
later stages of the Corrective
Action Process.
Click on sample to view full screen.

Customer↔Process Matrix
APPENDIX A: TOOLKIT CUSTOMER ↔=PROCESS MATRIX
To understand the relationship of major Prioritise process steps based on Get direct customer requirements from 'Cus-
process steps to customer customer requirements. tomer Requirements Matrix', and Business &
requirements. Focused improvement efforts on highest Regulatory requirements from interviews/sur-
priority process steps. veys, etc.
1. Write Customer Requirements (Key Out-
Provide a basis for discussing
put Variables) across the top of the
improvement projects with customers.
matrix.
2. Enter the priority for each requirement:
(see Customer Requirements, Tool).
Priority = Importance x Satisfaction
1=Nice to have1=Very satisfied
2=Important 2=OK-could be better
3=Critical 3=Unhappy, improve
3. Write major process steps in the boxes
along the left side of the matrix.
Estimate Relationship between Step &
Requirement:
5=Very strong 3=Medium
1=Very Weak 0=None
4. Multiply Relationship x Priority
5. Add sub-totals across the rows to give
Total.
\ 1. Always verify your percep-

tions with your customer.

NEXT STEPS: • Focus on those process
steps with the highest
total.
• See this as the logical
step of improvement,
typically continuing on to
efforts towards:
a. Refer back to 'Cus-
tomer Requirements
Matrix';
b. Ensuring our manu-
facturing specifica-
tions and acceptance
standards are in line
with customer
requirements;
c. Complete 'Process
Input Matrix';
d. Complete 'Process
Maps'; and
e. Assess & Clarify
'Supplier Require-
ments'.

Histogram
APPENDIX A: TOOLKIT HISTOGRAM
When To Use This Tool: How To Use This Tool:

To graphically display the distribution of 1. Set up a convenient scale to plot the
NEXT STEPS: • Interpret charts, for
example, as shown
data. data. below.
2. Plot data onto the chart to show actual
result. Target
Results You Can Expect: 3. Calculate the average for the data. Lower Spec Limit Upper Spec Limit
Process is centered
Visually display the process's centre, its 4. Ensure that you have lines that clearly and capable of
meeting customer
spread, and its shape. indicate the Lower and Upper Spec Lim- requirements.
Indicates the capability of the process in its, and the Target which exactly meets
meeting customer requirements the customer requirement. Variation is OK, but
process is off centre.
(specifications) and therefore our Change & adjust
process to drive
business needs. centre to meet
customer
requirements.
Target Variation is high.

Reduce variation to
Average (40) meet customer
(39) requirements.
Lower Spec Limit Lower Spec Limit

(15) (65)
Change & adjust
process to drive to
centre and reduce
variation to meet
customer
requirements.
• Ensure when attempting to

get a process back within its
\ spec limits or when shifting to
re-centre a process that you
follow a designated reaction
Click on sample to view full screen.
plan.
10 20 30 40 50 60 70

Measurement Systems Analysis
APPENDIX A: TOOLKIT MEASUREMENT SYSTEMS ANALYSIS
When To Use This Tool: Results You Can Expect: How to use this tool:
To investigate the amount of variation A percentage value for Gage 1. Identify three Appraisers (Operators).
added to a process by the operator Reproducibility & Repeatablility Since the purpose is to evaluate the total
(Reproducibility) and the gage/ (GR&R). measurement system, the Appraisers
measurement system precision Determines whether the measurement should be selected from those that nor-
(Repeatability). system is acceptable for its intended mally operate the instrument.
application. 2. Select 10 sample parts from the process
that represent the actual or expected
range of process variation.
Measurement Unit Analysis % Total Variation (TV)
Repeatability – Equipment Variation ( EV ) Trial s K1
Standard Average and Range Method
Gage Repeatability & Reproducibility Data Sheet
Date:
3. Number each part for identification ensur-
= R xK 2 4.56
EV
=
1
x . 3 3.05
% EV
Gage Name:
= 100 x [EV / TV]
= 100 x [ / ] Part Name:
ing the number is not visible to the
= . Gage Number:=
Gage Type:
% Part No.
Characteristics:
Appraisers.
Reproducibility
AV
– Appraiser Variation (
= ( X DIFF x K 2 ) - ( EV
AV )
2
/ nr )
Manufacturer:
Calibration
% AV date:
= 100 x [AV / TV]
Specifications:
Performed by:
4. Calibrate the gage or instrument if this is
= ( x )2 - (
2
/ x ) = 100 x [ / ]
Part
part of the normal gaging/measurement
= .
Appraisers K2 Trial #
=
Appraiser/ %1 2 3 4 5 6 7 8 9 10
Avera ge procedures.
n = number of parts
r = number of trials
2
3
3.65
2.70
1.
2.
A
A
1
2
5. Following the defined measurement pro-
Repeatability & Reproduc
= ( EV
ibility (R&R)
2
+ AV 2
)
3. A 3 cedure, let Appraiser A measure 10 parts
R&R = 100 x [R&R / TV]
4. % R&R Average X =
= ( + ) 5. = 100 x [
Range / ]
A
RA =
in a random order. The observer enters
= .
6. B 1
= %
the readings in the appropriate row. Let
7. B 2
Part Variation (PV)
PV =R p xK 3
Parts
2
K3
3.65
8. B
% PV
3 = 100 x [PV / TV]
Appraisers B & C measure the same 10
9. Average
=
= .
x . 3
4
2.70
2.30 10.
= 100 x [
=
Range %
/ ] X B
RB =
=
parts without seeing each other’s results.
5
6
2.08
1.93
11. C 1 6. The Appraisers should be unaware of
12. C 2
7
8
1.82
1.74 13. C 3
which part is being measured. However,
9
10
1.67
1.62
14. Average XC = the person conducting the study should
15. Range RC =
Total Variation (TV)
= (R & R 2
+ PV 2
)
16. Part Average X =
know which numbered part is being
TV
(X P )
= ( + )
17.
R P=
checked and record the data accordingly
([ R A = ]+[ RB = ]+[ RC= ]) / [ # of Appraisers = ]= R =
= .
18. [Max X = ] – [Min X = ]= X DIFF
on the Measurement Systems Analysis
All calculations are based upon predicting 5.15 sigma (99.0% of the area under the normal distribution curve).
19.
K 1 is 5.15 /d 2 where d 2 is dependent on the number of trials (m) and the number of parts times the number of appraisers
greater than 15. d 2 valves are can be found in the MSA Manual by AGIG in table 2, page 29 and tool 12 of CAP.
[ R(g)= which is ]assumed
x [D to4be
= ] = UCL R worksheet.
20.
AV – if negative value is calculated under the square root sign, the appraiser (AV) d efaults to Zero (0).
[ R =
K 2 is 5.15 /d 2 where d 2 is dependent on the number of appraisers/operators (m) and (g) is 1, since there is only one range calculation
K 3 is 5.15 /d 2 where d 2 is dependent on the number of parts (m) and (g) is 1, since there is only one range calculation
] x [D 3 = ] = LCL R
*D 4 = 3.27 for 2 trials and 2.58 for 3 trials. D3 = 0 for up to 7 trials; UCL R represents the limit of individual R’s. Circle those that are beyond this
7. Repeat this cycle until each appraiser
limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and
compute R and the limiting value from the remaining observations. has measured each part 3 times. For
Notes/Observations:
each measurement cycle, vary the order
of the parts being measured.

8. Having completed the measurements and 17. Perform the calculations in the column enti-
1. A measurement systems
entered the readings on the worksheet, tled % Total Variation also on page 2 of
analysis should be observed
begin the numercial calculations. the worksheet.
by a person who recognizes
9. For each appraiser, calculate the range R 18. Check all results and calculations to ensure
the importance of caution
for each pat and the average range R . no mistakes have been made.
required in conducting a
19. Evaluate the results of the percent total
10. Calculate the R and Upper Control Limit reliable study.
variation to determine if the measurement
UCLR and Lower Control Limit LCLR.
11. Repeat any readings that produced a
system is acceptable for its intended use. \ 2. The instrument must have a
discrimination that allows for
Please note that the sum of the percent of
range greater than the calculated UCLR at least one-tenth of the
consumed by each factor will not Equal
using the same part and Appraiser. expected process variation of
100%.
12. Calculate the average reading of each trail the characteristic to be read
20. Guidelines for acceptance of Gage
for each Appraiser. Enter the average in directly. For example, if the
Repeatability And Reproducibility
the Average Column. Finally, calculate the characterististic’s variation is
(%R&R) are:
average of these entries giving XA for 0.001, the instrument should
Under 10% Error be able to read a change of
appraiser A, XB for appraiser B and XC for
The measurement system is acceptable. 0.0001.
appraiser C.
13. Calculate XDIFF by subtracting the maxi- 10% to 30% Error
May be acceptable based upon impor-
mum and minimum averages from rows 4,
9 and 14 (in the end column).
tance of application, cost of gage, cost of
repairs, etc.
For complete details, please
refer to the AGIG (QS9000)
14. Sum the measurements for each trial, for
each part, and divide the total by the num- Over 30% Error manual Measurement Sys-
ber of measurements (# of trials x # of Measurement system needs improvement. tems Analysis (MSA).
Appraisers) this will give you the part Aver- Make every effort to identify the problems.
age X. and have them corrected.
15. Subtract the smallest part average from the NEXT STEPS: • Complete the list of
largest part average to calculate the range potential root causes
of part averages RP. by completing a cause
16. Perform the calculations in the column enti- and effect diagram.
tled Measurement Unit Analysis on page
2 of the worksheet.

Differences & Changes
APPENDIX A: TOOLKIT DIFFERENCES & CHANGES
When To Use This Tool: For the Differences For all statements in the differences
To identify potential root causes by What is: column.
identifying changes and differences to • Different 2. For each change identify when it
the process, product or system etc. • Distinct occurred this will help to eliminate any
• Unique that occurred after the problem first
Results You Can Expect: • Peculiar appeared.
A chronological list of events identifying • Special 3. Next create a timeline of events.
a list of potential root causes. • True 4. For each event ask "how could this
For the Changes change have caused the problem". If the
How To Use This Tool: What has changed: answers suggest potential root causes
1. For each pair of statements on the IS/IS- • In add the to the list of potential root causes.
NOT statement forms, ask the following • On
questions: • Around NEXT STEPS: • Complete the list of
• About potential root causes by
completing a cause and
effect diagram.
• Apply filter to identify
most probable root
causes.
5. Use factual information.

\ 6. For unsubstantiated infor-
mation decide if further
investigation is required.

Potential to Probable Filter
APPENDIX A: TOOLKIT POTENTIAL TO PROBABLE FILTER
When To Use This Tool: How To Use This Tool: 3. Using the Potential to Probable form label
To identify the most Probable Root 1. Take the Potential to Probable form with each potential cause in the list with a ,
Cause from a list of Potential Root the listing of Potential Root Causes. û or ?
Causes. 2. For each of the Potential Root Causes =if both the IS and IS-NOT are satisfied;
ask the following Filter Question: û if neither the IS or IS-NOT are satis-
Results You Can Expect: “If potential cause # is the root cause, fied; and
A list of prioritized Probable Root does it satisfy or explain the IS and ? If more information is needed to draw
Causes agreed by the team. IS-NOT information shown on the Is/Is- a conclusion.
Identification of the most Probable Root Not Form?” 4. Look at the causes that received the most
Cause. 's and form a list of Probable Root
Causes.
NEXT STEPS: • Investigate probable

root cause(s) to
determine true root
cause.
•To determine root
cause you may need
to investigate a com-
bination of probable
causes.
•Identify and imple-
ment corrective and
preventative actions.

1. If you end up with a long list
of probable root causes then
you may need to re-check
the definition of the problem
or re-evaluate the Is/Is-not
information for accuracy.
2. If no factual data/information
\ is available and assumptions
are made, be sure to investi-
gate the validity of that
assumption.
3. The most probable root
cause is the one that
satisfies all of the Is/Is-not
facts with the fewest most
reasonable assumptions.

Process ↔=Input Matrix
APPENDIX A: TOOLKIT PROCESS ↔=INPUT MATRIX
When To Use This Tool: Prioritise inputs to be analysed with 1=Nice to have 1=Very satisfied
To understand the relationship between “Cause & Effect” tool to drive 2=Important 2=OK-could be better
process inputs and customer require- improvement. 3=Critical 3=Unhappy, improve
ments. 3. By taking the highest priority Major Pro-
How To Use This Tool: cess Steps (as identified in the
Results You Can Expect: Lead into this analysis by firstly reviewing the “Customer↔Process Matrix”) enter the
Sharpen the focus for improvement from 'Customer Requirements Matrix' and more process inputs (tasks, controls, noise).
the highest priority steps (identified on specifically using the “Customer↔Process 4. Estimate Relationship between Step &
the “Customer↔Process Matrix”) to Matrix”. Requirement:
what the most important inputs are 1. Write Customer Requirements (Key Out- 5=Very strong 3=Medium
within those steps. put Variables) across the top of the 1=Very Weak 0=None
matrix. 5. Multiply Relationship x Priority.
Understand the effects and relationship
2. Enter the priority for each requirement: 6. Add sub-totals across the rows to give
of process inputs to the customer.
(See Customer Requirements, Tool) Total.
NEXT STEPS: • Focus on those inputs

with the highest total.
•Use the principles of
Failure Mode &
Effects Analysis
(FMEA) to brain-
storm and prioritise
failure modes, their
effects and how to get
to root cause and
reduce variation.
\ 1. Always verify your percep-

tions with your customer.

Cause & Effect Diagram
APPENDIX A: TOOLKIT CAUSE & EFFECT DIAGRAM
When To Use This Tool: Creates a snapshot of the collective

To illustrate visually and explore the knowledge and consensus of a team
around a problem. This creates support
potential root causes of a specific prob-
for the resulting solution(s). NEXT STEPS: • Apply filter using
lem or condition using specific catego- Potential to Probable
ries of a work process.
How To Use This Tool: Filter to identify most
probable root causes.
Results You Can Expect: 1. Write the description or definition of the
problem in the Problem Statement box •Investigate probable
Enables a team to focus on the content root cause(s) to iden-
of a problem not the history or differing (Effect).
2. Label each of the major bones as one of tify true root cause.
personal interests.
the following major categories. Method,
Focuses the team on causes not
Man, Machine, Measurement Material
symptoms.
and Mother nature. 6. Ensure every one in the
3. Under each category team agrees the problem
Method Machine Man 'Brainstorm' the potential statement.
Why?
Causes of the stated prob- 7. It is ok to repeat causes
lem. under different major cate-
Why?
4. For each cause ask Why, gories.
\
Why? Why?
Why?
Why? Why? Why, Why as far back as 8. If a cause does appear
Why? possible to identify all the under different categories
Why? potential causes. List each then interpret or test for root
Problem of these off each of the cause.
Statement causes. 9. When brainstorming for
5. Another form of Cause & potential causes, set-up to
Why?
Effect diagram that is ask every one in rotation
Why? used in an identical way, is (clockwise) until all causes
Why? Why?
the Process Classification have been exhausted.
Why?
Why?
Why? Cause & Effect where all
process steps are sequen-
tially listed as the major
Measurement Material Mother Nature categories.

Design Failure Modes & Effects Analysis (DFMEA)
APPENDIX A: TOOLKIT DESIGN FAILURE MODES & EFFECTS ANALYSIS (DFMEA)
To identify and evaluate the potential Prioritized action plan to prevent the 1. Determine the customer and manufactur-
failure modes of a product or process occurrence of failures or reduce the ing requirements so that the design intent
and its effects. severity of a failure mode or cause. of the product is fully understood & char-
To identify & prioritize actions to elimi- Documented Knowledge of a product/ acterized.
nate or reduce the risk of failure. process. 2. Break the product design down into criti-
cal subsystems or components
3. Enter the subsystem/component in the
Example: item column and briefly describe its func-
Action Results
tion.
Item or Potential Failure Potential S Potential Causes O Current Process D R Recommended Resp’y & Actions Implemented S O D R 4. For each item, brainstorm and list all the
Function Mode Effects of E of Failure or C Controls E P improvement Actions date & date E C E P
Failure V Sources of C T N V C T N potential failure modes.
variation
5. For each of the failure modes brainstorm
the effects of failure.
6. Assess the seriousness off these effects
Ranking Effect Severity E ffect Occurrence Effect Detection of the potential failure mode on the next
10 Hazardous without unsafe operation or non-compliance with Very High, failure ≥ 1 in 2 Absolute No Known Control(s) available to detect
warning government regs without warning almost inevitable Uncertainty failure mode component, subsystem, system, process
9 Hazardous with unsafe operation or non-compliance with 1 in 3 Very remote Very remote likelihood current controls will
warning government regs with warning detect failure mode or customer. Determine the Severity of
8 Very High Major disruption to production. Unit inoperable High Repeated failures 1 in 8 remote Remote likelihood current controls will detect
loss of primary function failure mode the effect and rank between 1 and 10
7 High Minor disruption to production line, Unit
operable, reduced level of performance,
1 in 20 Very Low Very low likelihood current controls will
detect failure mode
(See table).
6 Moderate
Customer dissatisfied
Minor disruption to production line Operable. Moderate Occasional 1 in 80 Low Low likelihood the Dsgn control will detect
7. Determine the potential causes for failure
Convenience inoperable, customer
inconvenienced
failures potential cause/ failure mode for each failure mode.
5 Low Minor disruption to production line Operable,
Convenience operable customer experiences
1 in 400 Moderate Moderate likelihood current controls will
detect failure mode
8. Determine the likelihood that the specific
some dissatisf’n cause of failure could occur. Review the
4 Very low Minor disruption to production line Fit/finish/ 1 in 2000 Moderately high Moderately high likelihood current controls
rattle & squeak, noticed by most customers will detect failure mode table and determine a ranking for Occur-
3 Minor Minor disruption to production line Fit/finish/ Low, relatively few 1 in 15K High High likelihood current controls will detect
rattle & squeak, noticed by average customers failures failure mode rence again between 1 and 10.
2 Very Minor Minor disruption to production line Fit/finish/ 1 in 150K Very High Very high likelihood current controls will
rattle & squeak, noticed by discriminating detect failure mode 9. List the design validation and verification
customers
1 None No Effect Remote, failures 1 in 1,500K Almost certain Current controls almost certain to detect
tests or activities which are used to evalu-
unlikely failure mode
ate the design integrity. (Current controls)

10. Evaluate the design control(s) for they
ability to Detect the potential cause or NEXT STEPS: • Design responsible
Engineer to ensure all
For complete details please
reference the AGIG Potential
subsequent failure mode before the com-
actions recommended Failure Mode and Effects
ponent/subsystem/or system is released
have been imple- Analysis Manual. (QS 9000)
to production. For each control, rank its
mented or adequately
ability to detect the potential cause or fail-
addressed.
ure (see table) between 1 and 10
•The Design FMEA is a
11. Determine the Risk priority number by
living document and
multiplying the Severity, Occurrence and
should reflect the latest
Detection rankings.
design level.
Risk priority No. RPN = Sev x Occ x
• Complete Process
Det
FMEA for the manufac-
12. When each failure mode has been
ture of the product,
ranked, priority for improvement actions
component/system/
can be determined through the highest
subsystem.
RPN.
13. For each action identify a champion
responsible for that action and identify a
target date for completion. 1. When determining the
potential failure modes
14. Once the action has been completed,
enter a brief description on the DFMEA. \ review previous design
15. Next, review and record the impact of FMEA's, warranty, service
each action on the Severity, Occurrence reports, dealer reports and
and Detection of the cause or failure customer reports etc.
mode.
16. Choose the best possible Permanent
Corrective Action based on this risk anal-
ysis.

Force Field Analysis
APPENDIX A: TOOLKIT FORCE FIELD ANALYSIS
To identify the forces & factors that sup- Forces team members to analyze all 1. Draw a large table on a flipchart.
port or work against the solution of an facets of a solution or change. 2. State the problem/issue/change to be
issue or problem so that positives can Encourages people to agree about the analyzed.
be reinforced and/or the negatives elim- relative priority of factors on each side 3. Describe the ideal solution you would like
inated or reduced. of the table. to achieve.
To strategically analyze change event. 4. Brainstorm the forces (positives) that
Provides a starting point for
are driving towards the idea solution.
improvement actions.
These may be internal and external.
5. Brainstorm the forces (negative) that
present a barrier to achieving the ideal
solution.
6. Prioritize the positives that can be
strengthened or identify the negatives
that allow for the most improvement
toward reaching the solution or ideal
state.
NEXT STEPS: • Develop improvement

actions to realize the
solution/change.
1. When choosing a problem

for resolution, remember
that simply pushing the
\ positive factors can have the
opposite effect. It is often
more helpful to remove
barriers. This tends to break
the change bottleneck.

Choose & Verify Corrective Actions
APPENDIX A: TOOLKIT CHOOSE & VERIFY CORRECTIVE ACTIONS
When To Use This Tool: How To Use This Tool: 3. Generate a list of Wants that the perma-
To determine the most effective perma- 1. Develop a list of all possible permanent nent corrective actions must satisfy.
nent corrective action from a list of pos- corrective actions and list them on the Consider the same criteria categories.
sible solutions. Filter I worksheet. 4. Agree within the team the relative impor-
2. Develop a list of Musts that the perma- tance of the Wants (the most important a
Results You Can Expect: nent corrective action must satisfy. These value of 10 & the least a value of 1).
Identifies the best permanent corrective criteria are essential. Consider the crite- 5. Rank all possible solutions against the
action to implement with lowest risk of ria categories identified on the work- Musts & Wants using a + or -.
failure. sheet. 6. Eliminate any solutions that do not meet
the mandatory Musts and rank the
remaining solutions to how they per-
formed against the ranked Wants. This
should result in a very shortlist of proba-
ble solutions.
7. Using the Filter II worksheet choose the
best permanent corrective action by
assessing the risk.
8. Risk assess each solution using the
Questions on the worksheet. List under
each solution any risks associated with it.
9. Weigh each risk according to its Serious-
ness & Probability by giving each one a
High, Medium or Low.
10. Choose the best possible Permanent
Corrective Action based on this risk
analysis.
NEXT STEPS: • Develop test plan to

verify the perma-
nent corrective
action.

1. Ensure the team has the
required expertise or
\ knowledge to identify
solutions and determine the
best possible corrective
action
2. Benchmark other locations
with similar processes.

Test Planner
APPENDIX A: TOOLKIT TEST PLANNER
When To Use This Tool: Results You Can Expect: 7. Not all inputs can ever be controlled,
To create a plan for collecting data to Ensures the purpose of the test is detail how & when these will be mea-
test the effect of a process or product clearly understood. sured:
change. • Before conducting studies of controlla-
Identifies the measurements required
ble variables, study the impact of these
and the method(s) for measurement.
'noise' variables.
How To Use This Tool: • Try to minimize the number of uncon-
1. Define the purpose of the test. Gen- trolled variables.
erally this will be stated in terms of 8. Define all elements which could cause
the effect of the change of input on variation in the input measurement:
customer requirements. • Equipment, procedures, calculations.
2. List the outputs to be studied (most • Experience and training of data collec-
important to customers). tors.
3. Define how and when the output will • Sampling methods.
be measured. Assign responsibility 1. Ensure whatever measure-
for that measurement. \ ment system or equipment
4. Consider all elements which could used has a suitable
create variation in the output mea- GR&R.
surement:
• Equipment, procedures, calcu-
lations. NEXT STEPS: • Schedule and per-
• Experience and training of data form test.
collectors. • Use statistical tools
• Sampling methods. (Define to analyze data.
these so all involved follow the
same procedures.)
5. For each change of input, define the
levels to be tested.
6. Define how and when each input
will be measured.

Implementation Plan
APPENDIX A: TOOLKIT IMPLEMENTATION PLAN
When To Use This Tool: Results You Can Expect: • Are there any time constraints?
To establish a plan to implement a per- Assures every member of the team • Are there any barriers that needs to be
manent corrective action. understands and focuses on the critical overcome?
actions, responsibilities and milestones. • What could cause this to go wrong?
• What indicators do we have to tell if
Documents the improvement/change.
something is going wrong?
How To Use This Tool: • How can we prevent any potential
1. Re-evaluate the team composition problem from occurring?
to ensure you have the desired 5. If any issues have been identified, review
functions and resources required to and revise the plan.
implement the Permanent Correc- 6. Follow the plan and implement the per-
tive Action. manent corrective action(s).
2. Describe the Permanent Corrective 7. Implement the necessary controls to
Action(s) to reconfirm to the team monitor and verify the effectiveness of the
membership the objective and permanent corrective action(s).
focus.
3. Using the implementation plan form
NEXT STEPS: • Once the effectiveness
of the permanent cor-
shown begin to evaluate the list of rective action has been
actions/tasks required. For each verified, remove any
action identify responsibility and interim containment
timing. action.
4. Once the implementation plan has
been drafted review and identify any
potential issues which could arise.
Ask the following questions: 1. The people identified to
• For each step of the plan what \ implement and develop the
can go wrong? plan should be the same.
• Are there sufficient resources
identified?

Reaction Plan
APPENDIX A: TOOLKIT REACTION PLAN
When To Use This Tool: Documents important sources of 3. For each out of control condition, identify
To assure a systematic (efficient and variation. the probable cause(s).
consistent) approach to trouble shoot- Provides common understanding of 4. Develop a list of checks which will help to
ing of issues/concerns. critical input variables and standards. identify the root cause.
5. Identify the corrective actions required to
Results You Can Expect: How To Use This Tool: eliminate or compensate for the root
Provides a trouble shooting resource 1. First complete a manufacturing Dynamic cause.
which: Control plan (DCP) for the manufacturing/ 6. Identify the reaction plan number on the
• defines conditions which require assembly process. Manufacturing DCP.
actions; and 2. For each control identify the out of control 7. To make the reaction plan user friendly,
• provides guidelines for action. condition. use a flow chart. The flow chart will
always begin with the out of control con-
Example: dition. The chart will then identify the
sequence of checks and decisions
Out of Reaction Plans
control required to identify root cause and imple-
Condition
ment corrective action.
Check No Process/action Check No Process/action NEXT STEPS: • Reaction plans should

be posted at the
Yes Yes
relevant work station,
accessible to the
operator.
Process/action Process/action
• Reactions plans should be

Reaction Out of Probable What Action(s) to \ updated as new corrective
Plan No. Control Cause to Eliminate actions have been
Condition check and/or com- implemented per
Click on sample to view full screen. Manufacturing DCP.
pensate for
cause

Poka-Yoke (Mistake Proofing)
APPENDIX A: TOOLKIT POKA-YOKE (MISTAKE PROOFING)

When To Use This Tool: Results You Can Expect: as it is being made. Type 3 detects the
To develop a Poka-Yoke device to error A systematic team approach to defect before it reaches the next
proof an operation to attain Zero identifying the root cause of defects. operation.
Defects. 8. Develop and build a Poka-Yoke device,
Development of a Type 1, Type 2 or
test and verify it satisfies requirements
Type 3 Poke device.
and prevents or detects the error or
How To Use This Tool: defect.
1. As a team describe in detail the
defect. NEXT STEPS: • For each Poka-Yoke
2. Review defect date and plot on device develop
chart provided. boundary samples to
3. Identify the location, i.e., operation verify/calibrate the
or process step where the defect is device at required
discovered and the operation/pro- intervals.
cess step where it is made. • Ensure the device is
4. Map the process step/operation in entered into the
detail per current work instructions/ gauge calibration and
standard procedures where the preventative mainte-
defect is made. nance systems.
5. Identify any errors or deviations
from the standard procedures
where the defect is made. 1. Work instructions for the
6. Investigate and analyze the Poka-Yoke device must be
causes for each error/deviation. posted at the workstation
Ask WHY?, WHY?, WHY?, WHY?, visible to the operator.
WHY? the error /deviation occurs \ 2. The most effective Poka-
until the root cause of the error is Yoke device are inexpen-
identified. sive, simple & easy to
7. Identify the Type of Poka-Yoke implement, specifically
devices required to prevent or focused and developed by
detect the error or defect: Type 1 all affected employees.
which eliminates the cause of error
at source. Type 2 detects the error
Corrective Action Process — Examples B-33

Problem Prevention
APPENDIX A: TOOLKIT PROBLEM PREVENTION
When To Use This Tool: Results You Can Expect: .

To identify the process breakdowns, A list of improvement actions/changes
deviations or obsolete methods that led to prevent re-occurrence of this NEXT STEPS: • Implement and commu-
to the problem in order to understand problem. nicate recommended
how to prevent re-occurrence of this or Helps to identify where else this process actions.
like problems. could appear; i.e., other processes,
systems or locations.
How To Use This Tool: 1. Problem prevention is more
1. Begin by asking questions 1 than just solving the
through 4 on the worksheet, \ problem. The process or
these will help identify the pro- system which allowed the
cess breakdowns, process/pro- problem to occur must be
cedure deviations or obsolete improved.
methods that led to the problem.
2. Record the responses.
3. Expand the focus by asking
questions 5 through 10. These
help to identify where else this
problem could appear.
4. Again record the responses.
5. Based on all the responses, the
team should develop a list of rec-
ommended changes or actions to
prevent re-occurrence. This list
should include reinforcements or
improvements that could be
made to the processes or sys-
tems which led to the problem

Control Chart
APPENDIX A: TOOLKIT CONTROL CHART
When To Use This Tool: To determine whether the process is Results You Can Expect:
To monitor, control and improve process stable & capable of meeting customer Serves as a tool for ongoing process
performance over time by studying requirements. control.
variation. To determine whether process improve-
Identifies special and common causes
ments are consistently implemented.
of variation.
Helps to improve a process to perform
Control Chart consistently & predictably.
Plant
Mach. No.
Dublin
XXXX
Dept. XXX
Operation Bend Clip
Part No. XXXX-YYY
Part Name Clip
Characteristic GAP dimension A
Engineering Specification .50 to .90 mm
Chart No. A200
Sample Size/Frequency 5/hour
Comparison of process variation
Key to Actions:
X = .715 R = .178 UCLX = .813 LCLX = .617 UCLR = .619 LCLR = 0 against customer specification.
.85
How To Use This Tool:
.80
1. There are many types of control charts.
.75
The type of chart will depend on the type
of data available. Reference the flow dia-
.70
gram to determine the type of control

.65
chart which will best fit your situation.
.60
2. Identify the key characteristic(s) (vari-
.55 ables) within the process to be controlled
3. Determine the sample size and fre-
quency.
0.04
• The frequency will depend on whether
0.03
you are able to discern patterns in the
0.02 data. Consider hourly, daily shifts, lots,
0.01 etc.
• The sample size will depend on lot
6/10 9 10 11 12 13 14 15 7/10 9 10 11 12 13 14
Date/Time
1
8.00
.65 .60 .80 .85 .70 .65 .90 .75
8.00
.75 .75 .65 .60 .50 .60 .80
size, defect levels etc. refer to the flow
2 .80
.85
.70
.60
.75
.90
.75
.85
.70
.75
.70
.85
.80
.80
.80
.75
.70
.85
.70
.60
.65
.85
.60
.65
.55
.65
.80
.65
.65
.75
diagram for the suggested sample size.
3
4 .85 .80 .50 .65 .75 .75 .75 .80 .70 .70 .65 .60 .80 .65 .65
5 .75 .65 .80 .70 .70 .60 .85 .65 .80 .60 .70 .65 .80 .75 .65
Sum ∑ 3.9 3.35 3.75 3.8 3.6 3.55 4.1 3.75 3.8 3.35 3.5 3.1 3.3 3.45 3.5
.78 .67 .75 .76 .72 .71 .82 .75 .76 .67 .70 .62 .66 .69 .70
X-bar X
Range R .20 .20 .40 .20 .05 .25 .15 .15 .15 .15 .20 .05 .30 .20 .15

4. Initiate data collection. Be sure to capture defects per unit. For variable construct • Variable charts identifies/measures
any unusual events that may occur two charts. On the top chart plot each variation between sub-groups and
5. Calculate required statistics and control subgroup's mean, median or individuals. within sub-groups.
limits( see table of constants and attribute On the bottom chart plot the range or • Determine whether the process mean
& variable data tables). standard deviation of each subgroup. is consistent with the customer specifi-
6. Construct the appropriate control chart. 7. Interpret the control chart. cations or process requirements If the
For attribute, construct one chart, plot- • Attribute charts identifies/measures mean is not where it should be then it
ting each subgroup's proportion or num- variability between samples. indicates that the process may have
ber defective , number of defects or changed.
• Analyze the data relative to the
control limits. Variation within
Choose the Appropriate Control Chart the control limits is from varia-
Flow Diagram tion inherent within the pro-
cess (Common Cause). (For
Choose an example, design, choice of
Appropriate
Control Chart machine, preventative mainte-
nance and can only be affected
by changing the system.)
Variable Data • Points outside the control limits
Attribute Data
Measured & plotted on a continuous scale
Counted & plotted as discreet events
Measures variation between subgroups and
within subgroups over time
Measures variation between samples or significant patterns within
the limits come from special
causes. (For example, opera-
Defect data Defective data
Sample size = 1
Sample size is small, Sample size is large Sample size is small (failure to meet one of the acceptance (An entire unit fails to meet acceptance
tor errors, unplanned events,
Median value ≥ 10 3 to 5 criteria) unit may have multiple criteria,regardless of the number of
defects defects on the unit) freak occurrences, which are
not part of the way the process
normally operates.) Special
X and Rm X bar -R X bar - s X bar - R Constant sample size
Variable sample size
Constant sample size Variable sample size causes must be removed
c >=5 usually ≥ 50 usually ≥=50
before the control chart can be
used as a monitoring/control
tool.
c chart u chart np chart p chart

• The presence of significant patterns or a) A run of 7 points above or below
trends within the control limits can be the average line whether it be for NEXT STEPS: • Collect data over time
and determine proc-
evidence of non-control or process shift. X or R.
ess capability index
These conditions must be reacted to and b) A run of 7 points continuously
Cpk.
corrected. Each of the following are increasing or decreasing.
• Based upon data col-
signs that the process is not in control or c) Any other non-random distinct
lected over time, peri-
the process has shifted: pattern.
odically evaluate and
re-calculate the control
limits.
Table of Constants
~
Sample X and R chart X and s chart X and R chart X and Rm chart
Size
n A2 D3 D4 A3 B3 B4 c4
~ D3 D4 E2 D3 D4 d2
A2
2 1.880 0 3.267 2.659 0 3.267 0.7979 - 0 3.267 2.659 0 3.267 1.128
3 1.023 0 2.574 1.954 0 2.568 0.8862 1.187 0 2.574 1.772 0 2.574 1.693
4 0.729 0 2.282 1.628 0 2.266 0.9213 - 0 2.282 1.457 0 2.282 2.059
5 0.577 0 2.114 1.427 0 2.089 0.9400 0.691 0 2.114 1.290 0 2.114 2.326
6 0.483 0 2.004 1.287 0.030 1.970 0.9515 - 0 2.004 1.184 0 2.004 2.534
7 0.419 0.076 1.924 1.182 0.118 1.882 0.9594 0.509 0.076 1.924 1.109 0.076 1.924 2.704
8 0.373 0.136 1.864 1.099 0.185 1.815 0.9650 - 0.136 1.864 1.054 0.136 1.864 2.847
9 0.337 0.184 1.816 1.032 0.239 1.761 0.9693 0.412 0.184 1.816 1.010 0.184 1.816 2.970
10 0.308 0.223 1.777 0.975 0.284 1.716 0.9727 - 0.223 1.777 0.975 0.223 1.777 3.078
11 0.285 0.283 1.744 0.927 0.321 1.679 0.9754
12 0.266 0.307 1.717 0.886 0.354 1.646 0.9776

1. Control doesn't necessarily
mean that the product or
service will meet your needs.
It only means that that the
process is consistent.
2. Don't mistake control limits
with specification limits.
Specification limits are
related to customer require-
\ ments while control limits are
related to process variation.
3. A process is within statistical
Attribute Data Table Variable Data Table
control if the process is not
Control Sample Center line Control limits Control Sample Center line Control limits being affected by special
Chart
Fraction
Size
Variable for each sub-group:
Chart
Average &
Size
< 10
causes. All points must be
(X1 X2 ... X k )
Defective usually
p np / n UCLp p 3
p (1 p) Range but X
k
UCL
x
X A
2
R
within the control limits and
n usually
3 to 5 LCL X A
2
R dispersed randomly about
x
p - chart for all subgroups:
p (1 p) X and R ( R1 R2 .... R k ) UCL R D4 R LCL R D3 R the mean.
LCLp p 3 R
p np / n
n k 4. For detailed information refer
Number
defective
Constant
usually
For each subgroup:
np # defectives
UCLnp np 3 n p (1 p)
Average &
Standard
Usually
X
(X1 X2 ... X k ) UCL X A s
3
to the AGIG Statistical
Deviation x
k
Process Control Manual
LCL X A s
np - chart
x 3
SPC (QS9000).
For all subgroups: X and s ( s1 s2 ....s k ) UCL R B4 s LCL R B3 s
LCLnp np 3 n p (1 p)
s
np np / k k
Number of Constant For each subgroup: Median & < 10, but
defects UCLc c 3 c Range (X1 X2 ... X k ) UCL X A R
c >5 usually X x 2
c defects
k
3 or 5
LCL X A R
x 2
c - chart For all subgroups:
LCLc c 3 c X and R ( R1 R2 .... R k ) UCL R D4 R LCL R D3 R
c c/k R
k
Number of Variable For each subgroup: Individuals
u ( X1 X2 ... X k ) UCL X E Rm
defects per & moving 1 X 2
unit u c/n UCLu u 3 Range
x
n k
LCL X E Rm
x 2
u - chart For all subgroups X and
u Rm (Xi 1 Xi ) UCL Rm D4 R m
u c/n LCLu u 3 Rm
n ( R1 R2 ... R k 1 ) LCL Rm D3 R m
Rm
k 1
Key: np = # of defectives c = # of defects n = sample size within each subgroup k = # of subgroups

Appendix B:
Examples
Meeting Facilita-
tion
APPENDIX B: EXAMPLES MEETING FACILITATION
Safety Review exit routes and any other considerations.
Purpose Establish purpose for the meeting.
Agenda Identified items to be covered including “Any Other Business”.
Code-Of-Conduct People introductions

One meeting (3-knock rule)
Criticise ideas, not people
Stay focused (time-out!) and stay on agenda and
Have fun!
Expectations Clarify expectations and required outcomes from the meeting.
Roles & Facilitator (including materials)

Responsibilities Participants
Time-Keeper
Scribe and
Car Park

Project/Team Chartering
APPENDIX B: EXAMPLES PROJECT/TEAM CHARTERING
Project Name
Revision Number & Date
Background:
Scope:
Primary Objectives:
Secondary Objectives:
Stakeholders/Key Reporting Relationships:
Project Completion/Deliverable dates:
Project Cost/Compression Cost Rate:
Constraints/Assumptions/Concerns:
Approval Signatures:
Date
Name
Name
Name

Horizontal Five-Why Analysis
APPENDIX B: EXAMPLES HORIZONTAL FIVE-WHY ANALYSIS
Why? - 1 Why? - 2 Why? - 3 Why? - 4 Why? - 5
Engineer
Safety
Unaware of Insufficient Poor training doesn't Lack of mgt
Problem training is
risks training process follow-up on commitment to
Unsafe Act low priority
needs safety
Following
Aware but Safe behaviour
supervisor
took risk is a low priority
priority
Ignores
supervisor
priority

Is/Is Not Analysis
APPENDIX B: EXAMPLES IS/IS-NOT ANALYSIS
ý PROBLEM STATEMENT
[Insert statement here]
Problem Is IS NOT
Object What is the object with the What could be, but is not, the
defect or problem? object with the defect?
WHAT Defect What is the actual defect, what’s What could be, but is not the
wrong with it? defect?
Observed Where is this object with the Where could this object with
defect observed? the defect be observed, but is
not?
WHERE
Seen on Object Where is the defect on the Where could the defect on the
object? object, but is not?
First Observed When was the object with the When could the object with
defect first observed? the defect first have been
observed, but was not?
WHEN
Observed Since When has the object with the When could the object with
defect been observed since? the defect have been
observed since then, but was
not?
In Life Cycle When is the defect first When could the defect first
observed in the life cycle of the have been observed in the life
object? cycle of the object, but is not?
How Many How many of the units of the How many of the units of the
Units? object have the defect? object could have the defect,
but do not?
HOW
BIG How Much of How much of each unit is How much of each unit could
the Unit? affected? be affected, but is not?
How Much How many defects are on each How many defects could be
Defect? unit? on each unit, but are not?
Trend What is the trend? What could be, but is not the
trend?

APPENDIX B: EXAMPLES CUSTOMER REQUIREMENTS MATRIX
Customer Name Outputs

(one per sheet) Overhauled Units (What products services, information do we provide?)
Measure Importance Customer Priority

Customer Requirement
to Customer Satisfaction
1 = Nice to Have 1 = Very Satisfied (Importance x
2 = Important 2 = OK, could be satisfaction)
3 = Critical, must better
have 3 = Unhappy, must
be improved
Meets Specification/drawing # Unit Rejects
3 1 3
Delivery within 48 hours %On-Time 3 3 9
Reliable Performance # Hours 2 2 4
No Test Failures # Test Failures 3 2 6
Standard Pricing No “extras” 2 2 4
Customers Complaints /Problems:

(What would the customer like us to work on?)
On-line delivery, as every delivery miss causes a truck to be idle for at least 24 hours.
Corrective Action Process — Examples A-5

Supplier Requirements Matrix
APPENDIX B: EXAMPLES SUPPLIER REQUIREMENTS MATRIX
Supplier Input Required Standard Measure/ Current

(Products, services, (What do we require for our Specification Proformance
information provided) process to work correctly.) (What do we (What is the
require for our suppliers actual
process to work performance to our
correctly.) requirement
(standard/
measure).)
Supplier Complaints /Problems:

(What would the Supplier like us to work on?)

Pareto Chart
APPENDIX B: EXAMPLES PARETO CHART
Defect or Reason/Potential Cause Frequency
Configuration 10
Won’t start up 70
Can’t connect to e-mail 25
Printing problems 50
Cable connections 15
Text formatting in PowerPoint 10
Other 20
Total 200
100
80
60
40
20
0
Won’t start up Printing Can’t connect Other Cable Configuration Text formatting
problems to e-mail connections in PowerPoint

Manufacturing Dynamic Control Plan
APPENDIX B: EXAMPLES MANUFACTURING DYNAMIC CONTROL PLAN

Process FMEA
ID Characteristic Potential Potential Potential Causes S O D R
Description Failure Effects of Failure or Sources of E C E P
(product & Process) Mode of Failure variation V C T N
Control Plan
Control Control Sample Gauge GR&R Reaction
factors method Description and date Plan
Size Freq Cpk
Improvement Actions
Recommended improvement Resp’y & Actions Implemented Previous
Actions date & date
S O D R
E C E P
V C T N
Original Issue date: Revised: Date: Products Affected: Process: Page 1 of 1

Originator: Approved: Date: Team Leader: Core Team: DCP001

Process Map
APPENDIX B: EXAMPLES PROCESS MAP
Process Map: Mold Plastic Boards

Process Step Step Step Step Step Step Product:
(Steps)
Mix Heat Press Board
Tasks Tasks Tasks Tasks Tasks Tasks
(Std Opg Proced) (Std Opg Proced) (Std Opg Proced) (Std Opg Proced) (Std Opg Proced) (Std Opg Proced) Customer: MBI
- Load - Ramp up - Load - - - Requirements:

- Stir - Hold - Activate - - - Dielectric
- - - - - - Flat
Low contamination
- - - - - - Safety
- - - - - -
- - - - - -
-
-
-
-
-
-
-
-
-
-
-
-

Outputs Ø Mix weight
(Results from Ø Route ticket Ø Mix RPM Ø Board thickness
product & process) Ø Bill of Materials Ø Surface finish
Ø ISO Procedure Ø Orientation

Inputs Ø Mix RPM Ø Ramp rate Ø Piston pressure
(Controls, Settings, Ø Bill of Materials Ø Work instruct'n
Procedures, Ø ISO Procedure
Noise/Envir., etc)
Supplier Inputs
(Required standards, Company ABC:
Specs, Measures) Ø Resin xy
Ø Weight b3

Customer ↔=Process Matrix
APPENDIX B: EXAMPLES CUSTOMER ↔∫PROCESS MATRIX
Customer Name Outputs (What product services and information provided?)
Direct Customer Requirements Business, Safety or Regulatory

Better, Faster, Cheaper Requirements
1 = Nice to have / very satisfied with performance
Complete Order
Cost Down 10%

Timely Delivery
4 = Important / Performance could improve
Quality Levels
9 = Critical / Performance must improve
Total
Priority Number 4 6 9 9
X =
↑=====↓
Major Process Step
Request for quote 2 8 2 12 3 27 3 27 74

Process purchase order 5 20 5 30 1 9 5 45 104
Ship & Receive 5 20 5 30 1 9 5 45 104
Inspect 1 4 1 6 2 18 3 27 55
Pay Supplier 1 4 1 6 1 9 1 9 28

Histogram
APPENDIX B: EXAMPLES HISTOGRAM

Histogram & Distribution/Capability Chart
Target
Average (40)
(39)
Lower Spec Limit Lower Spec Limit
(15) (65)
10 20 30 40 50 60 70
Interpreting Charts
Target
Lower Spec Limit Upper Spec Limit Process is centered and capable of
meeting customer requirements.
Variation is OK, but process is off

centre. Change & adjust process to
drive centre to meet customer
requirements.
Variation is high. Reduce variation

to meet customer requirements.
Change & adjust process to drive to

centre and reduce variation to meet
customer requirements.

APPENDIX B: EXAMPLES MEASUREMENT SYSTEMS ANALYSIS

Measurement Systems Analysis Forms
Standard Average and Range Method Date:

Gage Name: Part Name:

Gage Number: Part No.
Gage Type: Characteristics:
Manufacturer: Specifications:
Calibration date: Performed by:
Part
Appraiser/ 1 2 3 4 5 6 7 8 9 10
Trial # Avera ge
1. A 1
2. A 2
3. A 3
4. Average X A =
5. Range RA =
6. B 1
7. B 2
8. B 3
9. Average X =
B
10. Range RB =
11. C 1
12. C 2
13. C 3
14. Average XC =
15. Range RC =
16. Part Average X =
(X P ) R P=
17. ([ R A = ]+[ RB = ]+[ RC= ]) / [ # of Appraisers = ]= R =
18. [Max X = ] – [Min X = ]= X DIFF
19.
[R = ] x [D 4= ] = UCL R
20.
[R = ] x [D 3= ] = LCL R
*D 4 = 3.27 for 2 trials and 2.58 for 3 trials. D3 = 0 for up to 7 trials; UCL R represents the limit of individual R’s. Circle those that are beyond this
limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and
compute R and the limiting value from the remaining observations.
Notes/Observations:

APPENDIX B: EXAMPLES MEASUREMENT SYSTEMS ANALYSIS
Measurement Systems Analysis Forms (cont.)

Repeatability – Equipment Variation ( EV ) Trial s K1
EV = R xK 2 4.56 % EV = 100 x [EV / TV]

1
= x . 3 3.05 = 100 x [ / ]
= . = %
Reproducibility – Appraiser Variation ( AV )
AV = ( X DIFF x K 2 ) - ( EV 2
/ nr ) % AV = 100 x [AV / TV]
) -(2 2
= ( x / x ) = 100 x [ / ]
= . = %
Appraisers K2
n = number of parts 2 3.65
r = number of trials 3 2.70
Repeatability & Reproduc ibility (R&R)
R&R = ( EV 2
+ AV 2
) % R&R = 100 x [R&R / TV]
= ( + ) = 100 x [ / ]
= . = %
Part Variation (PV) Parts K3

PV =R p xK 3 2 3.65 % PV = 100 x [PV / TV]
= x . 3 2.70 = 100 x [ / ]
= . 4 2.30 = %
5 2.08
6 1.93
7 1.82
8 1.74
9 1.67
10 1.62
TV = (R & R 2
+ PV 2
)
= ( + )
= .
K 1 is 5.15 /d 2 where d 2 is dependent on the number of trials (m) and the number of parts times the number of appraisers (g) which is assumed to be
greater than 15. d 2 valves are can be found in the MSA Manual by AGIG in table 2, page 29 and tool 12 of CAP.
AV – if negative value is calculated under the square root sign, the appraiser (AV) d efaults to Zero (0).
K 2 is 5.15 /d 2 where d 2 is dependent on the number of appraisers/operators (m) and (g) is 1, since there is only one range calculation
K 3 is 5.15 /d 2 where d 2 is dependent on the number of parts (m) and (g) is 1, since there is only one range calculation

APPENDIX B: EXAMPLES DIFFERENCES & CHANGES

Differences Changes Date

APPENDIX B: EXAMPLES POTENTIAL TO PROBABLE FILTER
What Where When How Big
Potential Root Is Is- Is Is- Is Is- Is Is- û ?

Causes Not Not Not Not
Potential Cause 1 û û ? ? ? ? 2 2 4
Potential Cause 2 û û ? ? 4 2 2
Potential Cause 3 û û û û ? ? ? ? 0 4 4
Potential Cause 4 8 0 0

Process ↔Input Matrix
APPENDIX B: EXAMPLES PROCESS↔INPUT MATRIX

Complete Order
Timely Delivery
Cost Down 10%

Quality Levels
1 = Nice to have / very satisfied with performance
Total
Priority Priority 4 6 9 9
X =
↑=====↓
Major Process Step Input
Check codes 5 5 4 3 11
Process pur- 30 36 27 3
20
chase order
− Check pricing 0 3 0 3 45
0 18 0 27
− Check delivery 1 5 1 2 61
instructions 4 30 9 18
− Call vendor 3 3 0 1 39
12 18 0 9
−
Ship & Receive Call to expedit- 1 5 1 5 88

ing/ 4 30 9 45
shipping
Cause & Effect Diagram (Fishbone)
APPENDIX B: EXAMPLES CAUSE & EFFECT DIAGRAM (FISHBONE)
Method Machine Man
Why?
Why?
Why? Why?
Why? Why?
Why?
Why?
Why?
Problem
Statement
Why?
Why?
Why? Why?
Why?
Why? Why?
Measurement Material Mother Nature

Design Failure Modes & Effects Analysis - DFMEA
APPENDIX B: EXAMPLES DESIGN FAILURE MODES & EFFECTS ANALYSIS - DFMEA
Action
Results
Process Potential Potential S Potential O Current D R Recommended Resp’y Actions S O D R

Function Failure Effects of E Causes of C Process E P improvement & date Implemented E C E P
Req’t Mode Failure V Failure or C Controls T N Actions & date V C T N
Sources of
variation
Ranking Effect Severity Effect Occurrence Effect Detection
10 Hazardous unsafe operation or non- Very High, ≥=1 in 2 Absolute No Known Control(s)
without compliance with government failure almost Uncertainty available to detect failure
warning regs without warning inevitable mode
9 Hazardous unsafe operation or non- 1 in 3 Very remote Very remote likelihood

with warning compliance with government current controls will detect
regs with warning failure mode
8 Very High Major disruption to production. High Repeated 1 in 8 remote Remote likelihood current
Unit inoperable loss of primary failures controls will detect failure
function mode
7 High Minor disruption to production 1 in 20 Very Low Very low likelihood current
line, Unit operable, reduced controls will detect failure
level of performance, mode
Customer dissatisfied
6 Moderate Minor disruption to production Moderate 1 in 80 Low Low likelihood the Dsgn
line Operable. Convenience Occasional control will detect potential
inoperable, customer failures cause/ failure mode
inconvenienced
5 Low Minor disruption to production 1 in 400 Moderate Moderate likelihood current

line Operable, Convenience controls will detect failure
operable customer experiences mode
some dissatisf’n
4 Very low Minor disruption to production 1 in 2000 Moderately Moderately high likelihood
line Fit/finish/rattle & squeak, high current controls will detect
noticed by most customers failure mode
3 Minor Minor disruption to production Low, relatively 1 in 15K High High likelihood current
line Fit/finish/rattle & squeak, few failures controls will detect failure
noticed by average customers mode
2 Very Minor Minor disruption to production 1 in 150K Very High Very high likelihood current
line Fit/finish/rattle & squeak, controls will detect failure
noticed by discriminating mode
customers
1 None No Effect Remote, 1 in 1,500K Almost Current controls almost

failures certain certain to detect failure mode
unlikely

Force Field Analysis
APPENDIX B: EXAMPLES FORCE FIELD ANALYSIS
Problem/Change
to be analyzed:
Ideal State:
+ -
Positives Negatives/Opportunities

Choose & Verify Corrective Action Worksheet 1
APPENDIX B: EXAMPLES CHOOSE & VERIFY CORRECTIVE ACTION
FILTER I Possible Permanent Corrective Action

Note: For “Musts” and “Wants”, consider the
following categories: cost, timing, materials,
manpower, company procedures/polices,
equipment , government regulations, process
impact, customer impact, solution effective-
ness, capacity, cycle time impact, etc.
"Musts" +/-
"Wants" High
(10)
Low
(1)
Rank
Preferable Permanent Corrective Actions

Solution A
Solution B
Solution C

Choose & Verify Corrective Action Worksheet 2
APPENDIX B: EXAMPLES CHOOSE & VERIFY CORRECTIVE ACTION
FILTER II Possible Permanent Corrective Action

Solution A Solution B Solution C
Risks S P S P S P
1. How might the corrective action fail to satisfy the musts?
2. How might the corrective action fail to satisfy the high-value wants?
3. What other risks are associated with the corrective actions?
Best Permanent Corrective Action:
Rank Seriousness (S) and Probability (P) as High, Medium or Low

Test Planner
APPENDIX B: EXAMPLES TEST PLANNER
PURPOSE OF TEST:
Outputs: (customer requirements etc.)
What Characteristic How will it be When will it be Resp’y
will be measured measured measured
Details (Equipment, procedures, calculations, sampling methods):
Controlled Input variables tested:

Uncontrolled variables to be monitored:


Implementation Plan
APPENDIX B: EXAMPLES IMPLEMENTATION PLAN
Action/Task Responsibility Timing Verified

Permanent Corrective Action(s):

Engineering Change Request ECR
Engineering Change Order ECO
Advanced Quality Planning AQP
Supplier VCAR
Changes to Quality System
DFMEA
Manufacturing DCP
Reaction Plans
Work Instructions
Drawings/specifications
Preventative Maintenance
Calibration (Poka-Yoke, Gauge)
Other
Implement Controls per Mfg. DCP
Employee Training
Potential Issues:
1. What could go wrong with our plan?

BOM Revision:
Materials/Stock Room update:
Remove Containment Action(s):

Disposition of non-conforming materials and

components (test & set-up parts, units etc.)

Reaction Plan
APPENDIX B: EXAMPLES REACTION PLAN
Reaction Plans
Out of
control
Condition
Check No Process/action Check No Process/action
Yes Yes
Process/action Process/action
Reaction Out of Control Probable Cause What to check Action(s) to Eliminate and/or
Plan No. Condition compensate for cause
• •
• •
• •

Poka-Yoke (Mistake Proofing)
APPENDIX B: EXAMPLES POKA-YOKE (MISTAKE PROOFING)
1. Describe the defect: 2. Plot Defect Rate:

Defects
3. Identify the location at which the defect is:

Discovered:
Made:
Time
4. Detail the current standard procedures/elements of the operation where the defect is
made.
5. Identify Errors or Deviations from standards where the defect is made.
6. Analyze the causes for each of the Errors/Deviations.

Error/ Why? Why? Why? Why? Why? Root
Deviation Cause
7. Recommended Solutions
Root Cause of Type 1: Solution Type 2: Solution Type 3: Solution
Error/Deviation Eliminate Cause Detect Error Detect Defect before
of Error at Source as it is being made the next operation
8. Implementation
Poka-Yoke Device Type Id/ No. Cost Timing Resp’y Comments

Problem Prevention
APPENDIX B: EXAMPLES PROBLEM PREVENTION
Response Recomended Resp’y Timing

Action(s)
1. What process failures, practices, and/or procedures permitted the root cause to occur?
2. Is the process (practices/procedures) outdated or does it need to be revised?
3. Is the process adequate but not being complied with?
4. Could the process as it presently exists generate similar problems in the future?
5. Are there any Quality system (ISO 9000) elements within our documentation that are
inadequate, non-existent or not being followed?
6. Where else within Thermo King is this process being used?
7. Who else could experience this or a similar problem?
8. Are there any other processes that should be analyzed to make sure they can't allow for
similar problems?
9. How can we make sure Thermo King never starts this process up anywhere in the world
with the same potential for this type of problem?
10.Is there a weakness in our management system/process that allowed this problem to
occur?
11.Other. (Please Specify)

Control Chart (Chart)
APPENDIX B: EXAMPLES CONTROL CHART (DATA TABLES)

Chart & Graph Illustration
Plant Dublin Dept. XXX Part No. XXXX-YYY Characteristic GAP dimension A Chart No. A200
Mach. No. XXXX Operation Bend Clip Part Name Clip Engineering Specification .50 to .90 mm Sample Size/Frequency 5/hour
Key to Actions:
X = .715 R = .178 UCLX = .813 LCLX = .617 UCLR = .619 LCLR = 0
.85
.80
.75
.70
.65
.60
.55
0.04
0.03
0.02
0.01
Date/Time 6/10 9 10 11 12 13 14 1 5 7/10 9 10 11 12 13 14

8.00 8.00
1 .65 .60 . 80 . 85 . 70 . 65 . 90 .75 .75 . 75 . 65 . 60 .50 . 60 . 80
2 .80 .70 . 75 . 75 . 70 . 70 . 80 .80 .70 . 70 . 65 . 60 .55 . 80 . 65
3 .85 .60 . 90 . 85 . 75 . 85 . 80 .75 .85 . 60 . 85 . 65 .65 . 65 . 75
4 .85 .80 . 50 . 65 . 75 . 75 . 75 .80 .70 . 70 . 65 . 60 .80 . 65 . 65
5 .75 .65 . 80 . 70 . 70 . 60 . 85 .65 .80 . 60 . 70 . 65 .80 . 75 . 65
Sum 3.9 3.35 3.75 3.8 3.6 3.55 4.1 3.75 3.8 3.35 3.5 3.1 3.3 3.45 3.5
.78 .67 . 75 . 76 . 72 . 71 . 82 .75 .76 . 67 . 70 . 62 .66 . 69 . 70
X-bar X
Range R .20 .20 . 40 . 20 . 05 . 25 . 15 .15 .15 . 15 . 20 . 05 .30 . 20 . 15

Control Chart (Flow Charts)
APPENDIX B: EXAMPLES CONTROL CHART (FLOW CHARTS)

Control Flow Charts
Choose an Appropriate Control Chart
Variable Data
Measured & plotted on a continuous scale
Measures variation between subgroups
and within subgroups over time
Sample size = 1 Sample size is Sample size is Sample size is

small, Median value large ∫ 10 small 3 to 5
X and Rm X bar -R X bar -s X bar -R
Attribute Data
Counted & plotted as descrete events
Measures variation between samples
Defect data Defective data

(failure to meet one of the acceptance (An entire unit fails to meet acceptance
criteria) unit may have multiple defects criteria,regardless of the number of defects
on the unit)
Constant sample Variable sample Constant sample Variable sample

size c > 5 size size usually ∫ 50 size usually ∫ 50
c chart u chart np chart p chart

Control Chart (Constants Table)
APPENDIX B: EXAMPLES CONTROL CHART (CONSTANTS TABLES)

Tables of Constants
Sample Size X and R chart X and s chart

n A2 D3 D4 A3 B3 B4 c4
2 1.880 0 3.267 2.659 0 3.267 0.7979
3 1.023 0 2.574 1.954 0 2.568 0.8862
4 0.729 0 2.282 1.628 0 2.266 0.9213
5 0.577 0 2.114 1.427 0 2.089 0.9400
6 0.483 0 2.004 1.287 0.030 1.970 0.9515
7 0.419 0.076 1.924 1.182 0.118 1.882 0.9594
8 0.373 0.136 1.864 1.099 0.185 1.815 0.9650
9 0.337 0.184 1.816 1.032 0.239 1.761 0.9693
10 0.308 0.223 1.777 0.975 0.284 1.716 0.9727
11 0.285 0.283 1.744 0.927 0.321 1.679 0.9754
12 0.266 0.307 1.717 0.886 0.354 1.646 0.9776
~
Sample Size X and R chart X and Rm chart
n ~ D3 D4 E2 D3 D4 d2
A2
2 - 0 3.267 2.659 0 3.267 1.128
3 1.187 0 2.574 1.772 0 2.574 1.693
4 - 0 2.282 1.457 0 2.282 2.059
5 0.691 0 2.114 1.290 0 2.114 2.326
6 - 0 2.004 1.184 0 2.004 2.534
7 0.509 0.076 1.924 1.109 0.076 1.924 2.704
8 - 0.136 1.864 1.054 0.136 1.864 2.847
9 0.412 0.184 1.816 1.010 0.184 1.816 2.970
10 - 0.223 1.777 0.975 0.223 1.777 3.078

Control Chart (Data Tables)

Attribute Data Table
Attribute Data Table

Control Chart Sample Size Center line Control limits
Fraction Defective Variable usually ≥ 50 For each sub-group:
p (1 − p )
p = np / n UCLp = p + 3
n
p - chart For all subgroups:

p (1 − p )
LCLp = p − 3
p = np / n n
Number defective Constant usually ≥ 50 For each subgroup:

UCLnp = n p + 3 n p (1 − p )
np = # defectives
np - chart For all subgroups:
LCLnp = n p − 3 n p (1 − p )
n p = np / k
Number of defects Constant For each subgroup:

UCLc = c + 3 c
c >5 c = defects
c - chart For all subgroups:

LCLc = c − 3 c
c = c/k
Number of defects per unit Variable For each subgroup:

u
u = c/n UCLu = u + 3
n
u - chart For all subgroups

u
LCLu = u − 3
u = c/n n
Key: np = # of defectives
c = # of defects
n = sample size within each subgroup
k = # of subgroups

Variable Data Table
Control Chart Sample Size Center line Control limits
( X 1 + X 2 + ... X k ) = X + A
Average & Range < 10 but usually 3 to 5
UCL R
X = x 2
k
LCL = X − A R
x 2
X and R ( R1 + R 2 + .... R k ) UCL R = D 4 R LCL R = D3 R

R =
k
Usually ≥=10
( X 1 + X 2 + ... X k ) = X + A s
Average & Standard Deviation
UCL
X = x 3
k
LCL = X − A s
x 3
X and s ( s1 + s 2 + ....s k ) UCL R = B 4 s LCL R = B 3 s

s =
k
( X 1 + X 2 + ... X k ) = X + A
Median & Range < 10, but usually 3 or 5
UCL R
X = x 2
k
LCL = X − A R
x 2
X and R ( R1 + R 2 + .... R k ) UCL R = D 4 R LCL R = D3 R

R =
k
( X 1 + X 2 + ... X k ) UCL = X + E Rm
Individuals & moving Range 1
X = x 2
k
LCL = X − E Rm
x 2
X and R m R m = ( X i +1 − X i )
UCL Rm = D 4 R m LCL Rm = D3 R m
( R1 + R 2 + ... R k −1 )
Rm =
k −1
Key: np = # of defectives
c = # of defects
n = sample size within each subgroup
k = # of subgroups

Form Index
Form Number Description
Corrective Action Process Report
IS/IS-NOT Analysis
Supplier Requirements Matrix
Customer Input Matrix
Differences & Changes Analysis
Form umber Description
Corrective Action Process — Form Index

Form Number Description
Process Input Matrix
Choose & Verify Corrective Actions
Test Planner
Implementation Plan
Poka - Yoke (Mistake Proofing)
Problem Prevention Worksheet
Corrective Action Process — Form Inde x

Appendix C: Forms
From: CAP Report
APPENDIX C: FORMS CAP REPORT
CAP Report
Title: Report Number:
1. Identify team members/Roles & Responsibilities
Champion: Leader:
Team members:
2. Define the problem

Statement:
Description:
3. Implement & Verify Interim Containment Action(s)
Date Implemented Verified Y/N
4. Analyze Current Process & Define Desired Outcome(s)

Analysis:
Desired Outcomes:
5. Define & Verify Root Cause(s)

Verified Y/N
6. Identify & Verify Proposed Permanent Corrective Action(s)

Verified Y/N
7. Implement Permanent Corrective Action(s)

8. Action(s) to Prevent Re-Occurrence

9. Communicate Results & Recognize Team
Date Last Reported by:

Opened: Updated:
Date Reviewed &

Closed: Approved by:
Corrective Action Process — Forms C-1

Form: Is/Is Not Analysis
APPENDIX C: FORMS IS/IS-NOT ANALYSIS
PROBLEM STATEMENT
PROBLEM IS IS NOT
Object What is the object with the What could be, but is not, the
defect or problem? object with the defect?
WHAT Defect What is the actual defect, what’s What could be, but is not the
wrong with it? defect?
Observed Where is this object with the Where could this object with
defect observed? the defect be observed, but is
not?
WHERE
Seen on Object Where is the defect on the Where could the defect on the
object? object, but is not?
First Observed When was the object with the When could the object with
defect first observed? the defect first have been
observed, but was not?
WHEN
Observed Since When has the object with the When could the object with
defect been observed since? the defect have been
observed since then, but was
not?
In Life Cycle When is the defect first When could the defect first
observed in the life cycle of the have been observed in the life
object? cycle of the object, but is not?
How Many How many of the units of the How many of the units of the
Units? object have the defect? object could have the defect,
but do not?
HOW
BIG How Much of How much of each unit is How much of each unit could
the Unit? affected? be affected, but is not?
How Much How many defects are on each How many defects could be
Defect? unit? on each unit, but are not?
Trend What is the trend? What could be, but is not the
trend?

Form: Customer Requirements Matrix
APPENDIX C: FORMS CUSTOMER REQUIREMENTS MATRIX
Customer Name Outputs (What product services and information, do we provide?)
Requirement Measure Importance to Customer Priority

Customer Satisfaction (Importance
1 = Nice to Have 1 = Very Satisfied x-satisfaction)
2 = Important 2 = OK, could be better
3 = Critical, must have 3 = Unhappy, must be
improved
Customers Complaints /Problems: (What would the customer like us to work on?)
Corrective Action Process - Forms A-3

Form: Supplier Requirements Matrix
APPENDIX C: FORMS SUPPLIER REQUIREMENTS MATRIX
Supplier Name Input Required Measure Current

Standard Specification Performance)
(Products, services,
and information, (What is required for the (What is required for the
provided) process to work correctly?) process to work correctly)
Supplier Complaints /Problems:

Form: Customer Input Matrix
APPENDIX C: FORMS CUSTOMER INPUT MATRIX

1 = Nice to have / very satisfied with performance Total
Priority Number
X =
Major Process Step
Customer Contact(s) Team/Other Representative(s)

Form: Measurement Systems Analysis 1
APPENDIX C: FORMS MEASUREMENT SYSTEMS ANALYSIS
Standard Average and Range Method Date:

Gage Name: Part Name:
Gage Number: Part No.
Gage Type: Characteristics:
Manufacturer: Specifications:
Calibration date: Performed by:
Part Average
Appraiser/ Trial # 1 2 3 4 5 6 7 8 9 10
1. A 1
2. A 2
3. A 3
4. Average X =
A
5. Range R =
A
6. B 1
7. B 2
8. B 3
9. Average X =
B
10. Range R =
B
11. C 1
12. C 2
13. C 3
14. Average X =
C
15. Range R =
C
16. Part Average X=

X P
R
P=
17. RA RB RC R=
([ = ]+[ = ]+[ = ]) / [ # of Appraisers = ]=
18. [Max X = ] – [Min X = ] = X DIFF
19.
[R = ] x [D4= ] = UCLR
20.
[R = ] x [D3= ] = LCLR
*D4 = 3.27 for 2 trials and 2.58 for 3 trials. D3 = 0 for up to 7 trials; UCLR represents the limit of individual R’s.
Circle those that are beyond this limit. Identify the cause and correct. Repeat these readings using the same
appraiser and unit as originally used or discard values and re-average and compute R and the limiting value
from the remaining observations.
Notes/Observations:

MEASUREMENT SYSTEM ANALYSIS

Repeatability –
Trials K1
Equipment Variation (EV)
EV 2 4.56 % EV = 100 x [EV / TV]
= R x K1
= x . 3 3.05 = 100 x [ / ]
= . = %
Reproducibility – Appraiser Variation (AV)
AV ( X DIFF x K 2 ) ( EV 2 / nr ) % AV = 100 x [AV / TV]
=
( x )2 ( 2
/ x ) = 100 x [ / ]
=
= . = %
Appraisers K2
n = number of parts 2 3.65
r = number of trials 3 2.70
Repeatability & Reproducibility (R&R)
R&R (EV 2 AV 2 ) % R&R = 100 x [R&R / TV]
=
( ) = 100 x [ / ]
=
= . = %
Part Variation (PV) Parts K3
PV = Rp x K 3 2 3.65 % PV = 100 x [PV / TV]
= x . 3 2.70 = 100 x [ / ]
= . 4 2.30 = %
5 2.08
6 1.93
7 1.82
8 1.74
9 1.67
10 1.62
TV (R & R 2 PV 2 )
=
( )
=
= .
K1 is 5.15 /d2 where d2 is dependent on the number of trials (m) and the number of parts times the number of apprais-
ers (g) which is assumed to be greater than 15. d2 valves are can be found in the MSA Manual by AGIG in table 2, page
29 and tool 12 of CAP. AV – if negative value is calculated under the square root sign, the appraiser (AV) defaults to
Zero (0). K2 is 5.15 /d2 where d2 is dependent on the number of appraisers/operators (m) and (g) is 1, since there is only
one range calculation. K3 is 5.15 /d2 where d2 is dependent on the number of parts (m) and (g) is 1, since there is only
one range calculation.

Form: Differences &
Changes Analysis
APPENDIX C: FORMS DIFFERENCES & CHANGES
DIFFERENCES CHANGES DATE

Form: Potential to Probable Filter Worksheet
APPENDIX C: FORMS POTENTIAL TO PROBABLE
What Where When How Big

Potential Root Is Is-Not Is Is-Not Is Is-Not Is Is-Not
Causes

Form: Process Input Matrix
APPENDIX C: FORMS PROCESS INPUT MATRIX

1 = Nice to have / very satisfied with perfor- Total
mance
Priority Number
X =
Major Process Step
v
Customer Contact(s) Thermo King Representative(s)

Form: Choose & Verify Corrective Action Worksheet 1
APPENDIX C: FORMS CHOOSE & VERIFY CORRECTIVE ACTION
FILTER I Possible Permanent Corrective Action

Note: For “Musts” and “Wants”, consider the
following categories: cost, timing, materials,
manpower, company procedures/polices, equip-
ment , government regulations, process impact,
customer impact, solution effectiveness, capac-
ity, cycle time impact, etc.
"Musts" +/-
"Wants" High (10)
Low (1)
Rank
Preferable Permanent Corrective Actions

Solution A
Solution B
Solution C

APPENDIX C: FORMS CHOOSE & VERIFY CORRECTIVE ACTION
FILTER II Possible Permanent Corrective Action

Solution A Solution B Solution C
RISKS S P S P S P
1. How might the corrective action fail to satisfy the musts?
2. How might the corrective action fail to satisfy the high-value wants?
3. What other risks are associated with the corrective actions?
Best Permanent Corrective Action:
Rank Seriousness (S) and Probability (P) as High, Medium or Low

Form: Test Plan
APPENDIX C: FORMS TEST PLAN
Purpose of Test:
Outputs: (customer requirements etc.)
Controlled Input variables tested:

Uncontrolled variables to be monitored:


Form: Implementation Plan
APPENDIX C: FORMS IMPLEMENTATION PLAN
Action/Task Responsibility Timing Verified

Permanent Corrective Action(s):

Engineering Change Request ECR
Engineering Change Order ECO
Advanced Quality Planning AQP
Supplier VCAR
Changes to Quality System
DFMEA
Manufacturing DCP
Reaction Plans
Work Instructions
Drawings/specifications
Preventative Maintenance
Calibration (Poka-Yoke, Gauge)
Other
Implement Controls per Mfg. DCP
Employee Training
Potential Issues:
1. What could go wrong with our plan?

BOM Revision:
Materials/Stock Room update:
Remove Containment Action(s):

Disposition of non-conforming materials and
components (test & set-up parts, units etc.)

Form: Poka Yoke (Mistake Proofing) Worksheet
APPENDIX C: FORMS POKA-YOKE (MISTAKE PROOFING)
1. Describe the defect: 2. Plot Defect Rate:

Defects
3. Identify the location at which the

defect is:
Discovered:
Made:
Time
4. Detail the current standard procedures/elements of the operation where the

defect is made.
5. Identify Errors or Deviations from standards where the defect is made.
6. Analyze the causes for each of the Errors/Deviations.

Error/Deviation Why? Why? Why? Why? Why? Root
Cause
7. Recommended Solutions
Root Cause of Type 1: Solution Type 2: Solution Type 3: Solution
Error/Deviation Eliminate Cause Detect Error Detect Defect before
of Error at Source as it is being made the next operation
8. Implementation
Poka-Yoke Type Id/ No. Cost Timing Resp’y Comments
Device

Form: Problem Prevention Worksheet
APPENDIX C: FORMS PROBLEM PREVENTION PLAN
Response Recomended Resp’y Timing

Action(s)
1. What process failures, practices, and/or procedures permitted the root cause
to occur?
2. Is the process (practices/procedures) outdated or does it need to be revised?
3. Is the process adequate but not being complied with?
4. Could the process as it presently exists generate similar problems in the

future?
5. Are there any Quality system (ISO 9000) elements within our documentation
that are inadequate, non-existent or not being followed?
6. Where else is this process being used?
7. Who else could experience this or a similar problem?
8. Are there any other processes that should be analyzed to make sure they can't
allow for similar problems?
9. How can we make sure process doesn’t occur anywhere in the world with the
same potential for this type of problem?
10. Is there a weakness in our management system/process that allowed this

problem to occur?
11. Other. (Please Specify)

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Corrective

How to Use This Handbook

Using Links within your document to navigate:

One Global Corrective Action Process

A process that provides a logical step by step approach to solving relatively

IDENTIFY TEAM MEMBERS, ROLES & RESPONSIBILITIES

DEFINE Identify Team Members, Determine if the problem

Define the Problem Identify a team champion

Select team & team leader

MEASURE Analyse current process & Charter team and clarify

Review the problem

Identify & Verify Proposed

CONTROL Action(s) to Prevent Re-

Communicate results &

Corrective Action Process - Overview 1-1

IDENTIFY TEAM MEMBERS, ROLES & RESPONSIBILITIES

1.1 Determine if the problem needs a Team Approach

1.2 Identify a Team Champion

The role and responsibilities of the Champion include: -

Developing the team charter

Managing and focusing the team on achieving the objectives

Corrective Action Process — Procedures 1-2

Resolving conflicts within the team

01 – Meeting Facilitation

02 – Team Chartering

1.6 Complete Section 1 of the CAP Report

The main objective is to establish a Team with the relevant skills,

The following checklist should be used to ensure the Teaming YES/NO

Are the people affected by the problem represented on the team?

Does the team have a scheduled time & place to meet?

Corrective Action Process — Checklist 1-4

DEFINE THE PROBLEM

Draft a preliminary problem

Determine whether the

ANALYSE Define & Verify Root Review and update

Identify & Verify Proposed

Implement Permanent Complete section 2 of the

CONTROL Action(s) to Prevent Re-

Communicate Results &

Corrective Action Process - Overview 2-1

DEFINE THE PROBLEM

2.1 Prepare a preliminary description of the problem

A problem is a situation in which an expected level of performance or a norm is not being

Examples of good and bad problem descriptions:

[No]: Our order forms need to be redesigned. (Implied solution)

Here are several more typical preliminary (generic) problem descriptions:

Parts are labeled incorrectly.

09 – Process Map

Corrective Action Process — Procedures 2-2

05 – Customer Requirements Matrix

06 – Supplier Requirements Matrix

03 – 5 Why Analysis

Are not questions, but declarative statements

2.3 Explore the Problem using IS/IS-NOT analysis

Corrective Action Process — Procedures 2-3

04 – IS/IS NOT Analysis

2.4 Determine whether the problem needs sub-dividing

2.5 Review & Update Team/Project Charter

02 – Project/Team Chartering