ISO DIS 10009 (En) - Quality Management - Guidance For Quality Tools and Their Application

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DRAFT INTERNATIONAL STANDARD

ISO/DIS 10009
ISO/TC 176/SC 3 Secretariat: SA

Voting begins on: Voting terminates on:
2023-02-13 2023-05-08
Quality management — Guidance for quality tools and

their application
Management de la qualité — Lignes directrices pour des instruments et techniques qualités pour l'ISO
9001
ICS: 03.120.10
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ISO/DIS 10009:2022(E)
Contents Page
Foreword...........................................................................................................................................................................................................................................v
Introduction............................................................................................................................................................................................................................... vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 Quality tools............................................................................................................................................................................................................... 2
4.1 General............................................................................................................................................................................................................ 2
4.2 Review............................................................................................................................................................................................................. 2
5 Strategy........................................................................................................................................................................................................................... 3
5.1 Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis................................................ 3
5.2 Political, Economic, Social, Technological, Legal and Environmental (PESTLE)
Analysis.......................................................................................................................................................................................................... 3
5.3 Porter’s Five or Six Forces............................................................................................................................................................. 4
5.4 Vision and Mission Statements................................................................................................................................................. 4
5.5 Other relevant resources................................................................................................................................................................ 5
6 Process Approach and Planning........................................................................................................................................................... 5
6.1 SIPOC / COPIS (useful for identifying processes)..................................................................................................... 5
6.2 Turtle diagrams...................................................................................................................................................................................... 6
6.3 Control plans............................................................................................................................................................................................. 7
6.4 Flow Charts / Swim Lane Diagrams / Cross-functional Flow Chart...................................................... 7
6.5 Authority Matrix / RACI / Matrix Diagram................................................................................................................... 8
6.6 Other relevant resources................................................................................................................................................................ 8
7 Risk and opportunity....................................................................................................................................................................................... 9
7.1 Structured What If Technique (SWIFT)............................................................................................................................ 9
7.2 Risk Register / Risk Assessment............................................................................................................................................. 9
7.3 Failure Mode and Effects Analysis (FMEA)................................................................................................................... 9
7.4 Traffic Light / Heat Maps............................................................................................................................................................. 10
7.5 Other relevant resources............................................................................................................................................................. 11
8 Objectives and Objective Management...................................................................................................................................... 11
8.1 Kaizen........................................................................................................................................................................................................... 11
8.2 Hoshin Kanri (also known as the X-Matrix)............................................................................................................... 11
8.3 Management by Objectives (MBO)...................................................................................................................................... 13
9 Customer Focus / Perception............................................................................................................................................................... 13
9.1 Quality Function Deployment (QFD)................................................................................................................................. 13
9.2 Net Promoter Score (NPS)......................................................................................................................................................... 14
9.3 Kano Model.............................................................................................................................................................................................. 15
9.4 Pugh Matrix............................................................................................................................................................................................. 16
10 Process Performance.................................................................................................................................................................................... 17
10.1 Theory of Constraints (ToC).................................................................................................................................................... 17
10.2 Value Stream Mapping (VSM)................................................................................................................................................. 17
10.3 Deadly Wastes / MUDA................................................................................................................................................................. 19
10.4 Work Breakdown Structure..................................................................................................................................................... 19
10.5 Spaghetti Diagram............................................................................................................................................................................ 19
10.6 Five S.............................................................................................................................................................................................................. 20
10.7 Overall Equipment Effectiveness (OEE)......................................................................................................................... 21
10.8 HeiJunka / Production Levelling.......................................................................................................................................... 22
11 Inventory Management / Preservation..................................................................................................................................... 22
11.1 Kanban......................................................................................................................................................................................................... 22
© ISO 2022 – All rights reserved iii

ISO/DIS 10009:2022(E)
11.2 JIT Just-In-Time (JIT)....................................................................................................................................................................... 23

11.3 Other Relevant Resources.......................................................................................................................................................... 23
12 Detection and Prevention........................................................................................................................................................................24
12.1 Error Proofing / Poka Yoke....................................................................................................................................................... 24
12.2 Visual Aids................................................................................................................................................................................................ 24
12.3 Cost of Poor Quality (COPQ)..................................................................................................................................................... 24
13 Statistical Process Control...................................................................................................................................................................... 25
13.1 Box plots..................................................................................................................................................................................................... 25
13.2 Pie diagram.............................................................................................................................................................................................. 26
13.3 Radar Chart / Spider Web........................................................................................................................................................... 26
13.4 Pre-Control.............................................................................................................................................................................................. 27
13.5 Critical to Quality (CTQ) Trees............................................................................................................................................... 28
13.6 Pareto Chart............................................................................................................................................................................................ 28
13.7 Gage Repeatability & Reproducibility (GR&R)......................................................................................................... 29
14 Corrective Action / Problem Analysis........................................................................................................................................ 30
14.1 Root Cause Analysis (RCA)........................................................................................................................................................ 30
14.2 Decision Tree.......................................................................................................................................................................................... 30
14.3 Fault Tree Analysis (FTA)........................................................................................................................................................... 31
14.4 Five Why Analysis............................................................................................................................................................................. 32
14.5 Ishikawa / Fishbone / Cause and Effect Diagrams.............................................................................................. 32
14.6 Is / Is Not Analysis............................................................................................................................................................................ 33
15 Improvement / Benchmarking...........................................................................................................................................................34
15.1 Benchmarking....................................................................................................................................................................................... 34
15.2 Affinity Diagram................................................................................................................................................................................. 35
15.3 Quality Circles....................................................................................................................................................................................... 35
15.4 Brainstorming....................................................................................................................................................................................... 36
15.5 Six Thinking Hats – Lateral Thinking.............................................................................................................................. 36
16 Families of Management Tools............................................................................................................................................................ 37
16.1 Six Sigma Programme.................................................................................................................................................................... 37
16.2 Toyota Production System (TPS)......................................................................................................................................... 38
16.3 Total Quality Management (TQM)...................................................................................................................................... 39
16.4 Dynamic Working Design (non-manufacturing processes)......................................................................... 40
Annex A (informative) PDCA – Techniques overview...................................................................................................................... 41
Annex B (informative) Review of the attributes of Quality Tools.......................................................................................43
Annex C (informative) Storyboard examples for Quality Tool Application.............................................................46
Bibliography.............................................................................................................................................................................................................................. 47
iv © ISO 2022 – All rights reserved

ISO/DIS 10009:2022(E)
Foreword
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© ISO 2022 – All rights reserved v

ISO/DIS 10009:2022(E)
Introduction
Organisations that maintain a quality management system want it to deliver value and implementing a
quality management system should be a strategic decision for an organization.
Depending on the organisation’s area of activity, value can be measured in metrics such as:
— Reduction in complaints
— Reduction in waste
— Improved turn-around times
— Improved delivery times
— Improved responsiveness
— Better staff retention
— Greater confidence in regulatory compliance
— Increase in sales and profitability
It is therefore important to any organisation not only to have an effective quality management system
but one that may be seen through internal and external metrics to be a system with associated
improving and stable metrics.
Most organisations are already using quality tools. Many areas of manufacturing already use statistical
quality tools for process control and early warnings of when these processes become less stable. This
standard is intended to be a companion standard to ISO 10017: Quality Systems: Use of Statistics.
However, ISO 10009 also covers some simple statistical techniques that are not covered in detail in
10017.
In this document, the term quality tool is defined and it is essentially synonymous with a quality
technique. The simplest quality tools are encountered at school so many are well known before
completing formal education. Other quality tools are used by certain industries, the public sector or in
specific cultural contexts. This standard aims to catalogue quality tools in general use somewhere in
the world.
No proprietary quality tools have been included and all tools are used by more than one organisation.
This standard is not promoting any novel quality tools which have not been accepted by the wider
quality community.
The standard aims to familiarise quality practitioners with what could be called “the tool-box” of
quality tools. It is intended as a reference on quality tools which may be used in a number of contexts.
Some quality tools are the subject of commercially available training and certification. The aim of this
standard is not to explain in detail how each quality tool works; this knowledge may be gained from
various publications and training courses (references at the end of the standard may assist). One of
the key concepts is the appropriate use of quality tools; this standard aims to enable users to better
select quality tools that are suited for the task that they have in mind. Some of these tools may also be
appropriate for use in other contexts and the reader is encouraged to consider their wider application.
vi © ISO 2022 – All rights reserved

DRAFT INTERNATIONAL STANDARD ISO/DIS 10009:2022(E)
Quality management — Guidance for quality tools and

their application
1 Scope
This document identifies tools that may be used in a quality management system to:
a) Characterize a process or a variable
b) Facilitate problem solving
c) Highlight areas for improvement
d) Improve effectiveness
Guidance on their selection and application is provided with the aim of providing a resource to
practitioners and promoting the appropriate use of quality tools.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 9001, Quality management systems — Requirements
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000, Quality Management
Systems – Fundamentals and vocabulary and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://w ww.iso.org/obp
— IEC Electropedia: available at https://w ww.electropedia.org/
3.1
quality tool
method or procedure (3.2) to perform an operation to achieve a quality objective (3.3)
3.2
procedure
specified way to carry out an activity or a process (3.4)
[SOURCE: ISO 9000:2015, 3.4.5]
3.3
quality objective
objective (3.5) related to quality (3.6)
[SOURCE: ISO 9000:2015, 3.7.2]
© ISO 2022 – All rights reserved 1

ISO/DIS 10009:2022(E)
3.4
process
set of interrelated or interacting activities that use inputs to deliver an intended result
[SOURCE: ISO 9000:2015, 3.4.1]
3.5
objective
result to be achieved
[SOURCE: ISO 9000:2015, 3.7.1]
3.6
quality
degree to which a set of inherent characteristics (3.7) of an object (3.8) fulfils requirements (3.9)
[SOURCE: ISO 9000:2015, 3.6.2]
3.7
characteristic
distinguishing feature
[SOURCE: ISO 9000:2015, 3.10.1]
3.8
object
anything perceivable or conceivable
[SOURCE: ISO 9000:2015, 3.6.1]
3.9
requirement
need or expectation that is stated, generally implied or obligatory
[SOURCE: ISO 9000:2015, 3.6.4]
4 Quality tools
4.1 General
The quality tools given in this standard have been arranged in approximate alignment with the
sequence of the quality system requirements of ISO 9001. This structure is intended to assist user
access and does not imply priority. A listing of the tools in relation to the PDCA (Plan-Do-Check-Act)
approach is provided in Annex A.
Annex B provides a quick reference tool for guiding appropriate application
Annex C gives examples of how quality tools are used in combination as storyboards
4.2 Review
Each quality tool is reviewed as follows:
— Short explanation of the tool and its context in its use within a quality system.
— How the quality tools are normally used.
— Reasons to use the quality tool and guidance on effective use..
2 © ISO 2022 – All rights reserved

ISO/DIS 10009:2022(E)
5 Strategy
5.1 Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis

SWOT analysis is a tool designed to help develop strong business strategy by consideration of key
strengths, weaknesses, opportunities and threats faced when implementing the intended strategy.
SWOT is used:
— To review the impact of external and internal factors;
— To prioritize action;
— To help identify strategic options: risks and problems to solve;
— To determine the positive points that need to be maintained. The opportunities that should be
exploited and the internal and external issues that present challenges.
— To identify areas and actions to eliminate weakness
SWOT analysis is used to:
— Explore new solutions to problems;
— Identify barriers that will limit achieving objectives;
— Decide on the direction that will be most effective;
— Reveal possibilities and limitations for change; and
— To prioritize actions.
BENEFITS POINTS TO NOTE

Focuses on actions that are most beneficial to Should be reviewed frequently enough to
achieve strategic objectives and sustainabil- recognise and react to changes.
ity
Responds to new influences such as technolo- Output needs to be used as basis of future
gy, legislation, market demand etc. actions
External review includes interested parties Needs to recognise any limitations in data
such as competitors, customers etc. quality to avoid misrepresentation .
SWOT analyses benefits from the diversity of Must be carried out by the leadership team
perspectives. Management alone will not have with external inputs as appropriate (not a
visibility of all interested parties’ perspec- single person).
tives.
5.2 Political, Economic, Social, Technological, Legal and Environmental (PESTLE)

Analysis
PESTLE analysis, is a tool used by organizations to determine and track the environment in which it
operates. PESTLE is an acronym for Political, Economic, Social, Technological, Legal and Environmental
factors. It is often used in strategic planning (possibly with SWOT and Porter’s 6 Forces).
PESTLE Analysis is used:
— When developing, reviewing and updating an organisation’s strategic business plan;
— As a precursor to determining an organization’s strategic and risks and opportunities.
— To capture relevant external issues that impact on the organisation’s strategy.

ISO/DIS 10009:2022(E)

Uses a structured approach. Users may wish to adjust the names of some of the
PESTLE factors and/or add other factors that are
particularly relevant to its context.
Forces Organisations to address factors Users must update periodically to reflect incidents
they might not otherwise consider. such as pandemic, epidemic, military situations
etc.
5.3 Porter’s Five or Six Forces

Harvard Professor Michael Porter developed a strategic analysis tool and also a method to understand
the competing forces that organisations are facing.
These were originally the five competing forces but a sixth has been added as follows:
1. Threat of new entrants
2. Rivalry among existing firms
3. Bargaining power of Buyers
4. Threat of substitute product or services
5. Bargaining power of Suppliers
6. Complementors
Porter says “the collective strength of these forces determines the ultimate profit potential in the
industry where profit potential is measured in terms of long run return on invested capital”.
A useful consideration is that in performing the strategic analysis and understanding these competing
forces is that the organisation needs to obtain the support, resources, technologies and infrastructure
to be able to support such strategic activities. The importance of some competing forces may restrict
opportunities such as growth or increased margins.
Porters Five (or six) forces model is used for analysing context to support developing strategic
objectives.

The six competing forces can provide both risk and Actions need to be determined based on data gathered
opportunity considerations. from reliable sources.
Often provides a fresh approach to strategy Can be used to assess the attractiveness of the indus-
try or sector.
5.4 Vision and Mission Statements

Definitions:
Vision: A vision is the aspiration of what an organisation would like to become as expressed by top
management. It describes in words or perhaps visually, how the organization wants to be perceived by
the world. It can also communicate the message to the people working within it and those wanting to
join it.
A Vision Statement should be underpinned by management team agreement on three key things:
a. The Strategic Goal of satisfying customers and other stakeholders - i.e., what are the planned
products, now and in the future and how they will be delivered.
b. The unique market it wants to secure

ISO/DIS 10009:2022(E)
c. The future Horizon – e.g., the future state or end point

Mission: A Mission is a reason for the organization’s being or existence as expressed by top management
– it’s what it does, its core competence, what it’s known for. It is sometimes called a purpose.
A Mission Statement:
Clearly demonstrates ownership, credibility and sensible, achievable wording.;
a. Gives unanimity of purpose to the organization;
b. Provides a basis to derive Goals and Objectives;
c. Provides answers to the question: “Does this activity contribute to the organisations purpose?”
Vision and Mission are used to communicate effectively at the highest level with customers, employees
and other stakeholders.
Benefits Points to note

Provides common goals to guide all planning and
direction activities
Frames the values, beliefs, principles and govern-
ance disciplines and behaviours
Provides a basis for distilling a complex strategy to
a “Plan-on-a-Page”
5.5 Other relevant resources

— Context of the Organisation (COTO) Diagram / Matrix / Log
— Context of the Organisation (COSO) Diagram / Matrix
6 Process Approach and Planning
6.1 SIPOC / COPIS (useful for identifying processes).

SIPOC (Supplier, Input, Process, Output, Customer) is a process mapping tool that is useful in high-level
identification of main elements of any process. COPIS is the process in reverse and useful for identifying
“Customer Facing Processes”. It may be used to obtain high-level information about any process and
to identify inputs and outputs between suppliers, process owners and customers. It is a tool used for
understanding the bounds of a process and the linked processes, related controls and how effectiveness
is managed.

ISO/DIS 10009:2022(E)
SIPOC is used for:

— Mapping of an existing or a new process
— Providing basic information regarding a process in a simple and short format
— Defining the scope of an improvement activity or project

Simple to use and understand Avoid going into too much detail (4 – 5 key
steps of the process should be identified)
Delivers results quickly Best completed by a team, so there is a com-
mon agreement on the start and the end of
the process being analysed
Provides an overview a whole process from Suppliers and customers can be internal
the beginning to the end on one page
SIPOC can be hierarchical
6.2 Turtle diagrams

A turtle diagram is a tool for visualizing the components or characteristics of a process. The use of
a turtle diagram provides the opportunity to more closely examine a process to enable its better
understanding, more effective process execution and the identification of areas for improvement. The
diagram looks like a turtle, with the process components as the body, legs, head, and tail.
A turtle diagram is used:
— To describe the basic elements of a process for communication and understanding;
— To develop more detailed procedures and process flow diagrams (flowcharts);
— To help quality auditors to understand and effectively interrogate processes and

Uses visual and standardised methods which The turtle diagram does not necessarily
are easy to understand. document all of the information necessary to
fully describe a process, but provides a good
starting point.
Provides a complete view of the most impor-
tant elements of a process on a single page
Aligns process performance to higher level
business strategy and objective(s)

ISO/DIS 10009:2022(E)
6.3 Control plans

A control plan provides a structured approach to determining the controls applied to a processes. Each
process is listed in sequential order, typically aided by the use of a process flow diagram. Product and
process criteria to be controlled are identified at each stage including special characteristics, typically
using a process Failure Mode Effect Analysis (FMEA) as an input. Controls are identified with methods
of measurement, frequency, method of recording results and the reaction plan to be invoked in the
event that the product or process criteria do not conform with requirements.
The objective of a control plan is to provide concise and useable information to users and minimize
process and product variation.
Control plans are used:
— Within manufacturing and service industries;
— Where there are processes where the conformity of the resultant output cannot be verified through
inspection and testing and defects would only become apparent at a later time.;
— Where needed for process approval on the pre-launch and production phase, with linkage and
information from the design risk analysis (as necessary)
— Where process/product monitoring is required to determine process capability or to assess
conformity to requirements.

Provides a clear and structured approach to Product and process characteristics must be
product and process control unambiguously defined.
Assists in effective auditing. Process flows, FMEA and control plans should
be reviewed and updated when non-conform-
ities occur
Helps drive conformity in “special processes” The control plan does not replace work in-
structions which provide greater detail of the
manufacturing process
6.4 Flow Charts / Swim Lane Diagrams / Cross-functional Flow Chart

Flowcharts provide a quick, visual way to show how a series of activities, tasks or processes are
sequenced. Swim lane diagrams add the responsibilities for activities shown on a simple flow chart.
ISO 5807:1985 clause 3.3 defines a flowchart as a graphical representation of the definition, analysis,
or method of solution of a problem in which symbols are used to represent operations, data, flow,
equipment, etc.
In practice, they comprise symbols, text and connecting lines.
How to use
— As a starting point in documenting activities
— To communicate how activities are carried out
— To identify inefficiencies, and allow for analysis and improvement

Visual The direction of flow is mainly left to right,
and top to bottom
Can be quick to develop (depends on the com- Arrows indicating the flow should be used
plexity of the activities under consideration) whenever increased clarity will result

ISO/DIS 10009:2022(E)

Easy for non-experts to interpret Put oneself in the position of the reader
Assists in the automation and or digitalisa- Try to anticipate the reader’s problems in
tion of processes. understanding the chart
Swim Lane Diagrams are a type of flowchart
which use lines (or other methods, such as
shaded rectangles) to separate activities
done by different departments, or persons.
The names come from the appearance which
looks like the lanes in a swimming pool used
for competition
Not to be confused with block diagrams
which use only one shape (a “block”, or rec-
tangle)
Not to be confused with Process Charting
(e.g., Graham Process Charting) which uses
different symbols.
6.5 Authority Matrix / RACI / Matrix Diagram

The term “authority matrix” covers a range of uses for a basic matrix that has persons (or functions)
on one axis and responsibilities on the other. It shows who is the authority, accountable, consulted and
informed for various actions.
When used for financial compliance, it is usually referred to as a Delegated Authority Matrix.
It shows the level of engagement or decision-making authority resides in an organization. May be used
for identifying and communicating changes in roles.
RACI is used to clearly show responsibilities:
— Responsible
— Accountable
— Consulted
— Informed

Focuses on effective collaboration and deci-
sion-making by removing ambiguity
Uses a graphical format
Shows relationships between persons (or
functions) in, or across, processes
Supports team-building
Can be used to map current-state to fu-
ture-state for authorities, etc.

— IDEF0 - IDEF0 Functional Modelling method was designed to model the decisions, actions, and
activities of an organization or system.[2] It was derived from the established graphic modelling
language Structured Analysis and Design Technique (SADT) developed by Douglas T. Ross and
SofTech, ICAM Architecture Part II-Volume IV - Function Modeling Manual (IDEF0), AFWAL-
TR-81-4023, Materials Laboratory, Air Force Wright Aeronautical Laboratories, Air Force Systems
Command, Wright-Patterson Air Force Base, Ohio 45433, June 1981

ISO/DIS 10009:2022(E)
— Quality Plans (ISO 10005:2018)

— APQP – Advanced Process and Quality Plan - "Advanced Product Quality Planning and Control Plan
(APQP)". aiag.org. 2012. Archived from the original on September 26, 2012. Retrieved September 24,
2012.
7 Risk and opportunity
7.1 Structured What If Technique (SWIFT)

The Structured What-If Technique (SWIFT) is a flexible, high-level risk identification technique that
may be used on a standalone basis, or as part of a staged approach to make more efficient use of bottom-
up methods like Failure Mode and Effects Analysis (FMEA).
How to use
SWIFT is used in risk assessment where a series of brainstorming prompts are used for each step of the
process or component of the system being assessed. Each prompt helps to consider different types of
hazards that might be present in the system.

Structured. SWIFT may overcome the self-cen- Best to map out the process or system using no
sorship that occurs in the brainstorming in an more than 10 steps or components.
unstructured group, allowing members of the
group to think the unthinkable.
Simplicity. It does not go into the same level of SWIFT may be used by itself, or as part of a
detail as FMEA does on the process steps to be staged approach.
risk assessed.
7.2 Risk Register / Risk Assessment

A risk register is used to identify, prioritize, record and monitor the actions to be taken on the
identified risks.. A risk register is displayed in tabular format describing each risk, its nature or type,
the probability of occurrence, its impact on the organization, the risk owner, mitigation measure(s),
contingency action(s) and the residual risk after mitigation.
Inputs to the risk register may come from SWOT, PESTLE or FMEA. Outputs may inform improvements,
objectives, human resources development etc.

Displays information on current risks in a It needs to be regularly monitored and kept
single document which is easy to navigate up to date.
and understand.
Defining risks may also present opportunities The use of Risk Priority Numbers (RPN)
for the organization. to evaluate risks may be used as a tool to
prioritize risk impact. Sometimes a cost is as-
sociated with risks and linked to insurances,
contingencies or liabilities.
It is often structured by category such as
Financial / Human Resources / Regulatory /
Customer / etc
7.3 Failure Mode and Effects Analysis (FMEA)

Failure Modes and Effects Analysis (FMEA) is a risk-based methodology for ensuring that potential
problems are identified, analysed and prioritised during product or process development, and during
subsequent production or service delivery and product lifecycle.

ISO/DIS 10009:2022(E)
Variants of the tool may be seen in:

— Design (dFMEA);
— Manufacturing Process (pFMEA);
— DRBFM – Design review based on failure mode;
— Tooling;
— Software;
— Service design;
— Service delivery; and
— Monitoring Systems

Enables early identification and mitigation of FMEA is a team-based activity
problems
Reduces risk of late design or process changes The FMEA is a living document and should be
updated when there are unexpected issues
Reduces risk of field failures and warranty There should be no incentive to score low to
costs avoid high RPNs and any need for action.
Reduces risk of problems during production The scoring criteria should use a scale where
or service delivery there are clear criteria for each point on the
scale
Focuses on actions which address the most The methodology considers only single fail-
significant risks with a priority on occurrence ure modes and is not suitable for compound
reduction, and where possible elimination of failure modes
high severity failure modes (the severity of a
failure mode cannot be reduced but it may be
possible to design it out).
Preparation is vital. Documented process
flows or system schematics should be availa-
ble or created at the start of the process.
Sufficient time and resources need to be allo-
cated to the team
Facilitator competence in FMEA and team
selection are critical to effectiveness
The team should represent all functions in-
volved (and could include the customer).
7.4 Traffic Light / Heat Maps

The use of the colours red, amber and green to illustrate whether a situation or risk is satisfactory/
unsatisfactory or high/low. Sometimes referred to as “RAG” – for red, amber, green.
It is used in situations such as:
— Reports referencing Key Process Indicators (KPI);
— Risk analysis / registers;
— Warning signs;
— Dial gauges;
— Safety signals; and

ISO/DIS 10009:2022(E)
— Andon lights.

Simple to use Care should be used with heat maps which
are symmetrical as risk may need to be han-
dled in a precautionary manner.
Easy to understand The colours are to attract attention but an
indicator may change colour with a small
change in data
Supported by programmes such as Microsoft Will not be effective if a person is col-
Excel (conditional formatting) our-blind.

— Voice of Customer
8 Objectives and Objective Management
8.1 Kaizen
Kaizen means continual improvement. When applied to the workplace, Kaizen means continual
improvement for all human resources: managers and workers alike. Kaizen is a systematic and long-
term action aimed at accumulating improvements and savings by achieving performance improvement
through changes or small incremental improvements in the processes.
Kaizen may be used for any improvement project.

Standardisation Kaizen should always be an ongoing process
and should not be practiced in ad-hoc basis as
its philosophy is based on continual improve-
ment.
Waste elimination Changes may come from any employee any-
time and do not have to happen slowly.
Cost reduction
Performance improvement
8.2 Hoshin Kanri (also known as the X-Matrix)

Translated from Japanese as “Compass Management”, Hoshin Kanri, is a 7-step process to assist
organisations to chart a course and realise their strategic objectives.
Hoshin Kanri sets out to operationalize organisation strategy. It achieves this by breaking out the
strategic plan into a structured set of achievable objectives. Key Performance Indicators (KPIs) are
used to ensure the organisation is moving towards the delivery of its strategic vision.
There are 7 steps as follows:
1. Identification of the organisation’s vision, mission and values;
2. Definition of breakthrough objectives;
3. Breakdown of the breakthrough objectives according to the organisation’s structure and
development of annual improvement plans;
4. Roll out the annual objectives
5. Monitor results

ISO/DIS 10009:2022(E)
6. Problem solve any missed objectives

7. Reflection and learning
Hoshin Kanri may help organisations to;
— Operationalize their vision;
— Engage in forward thinking strategies;
— Simplify planning output delivery;
— Focus on the strategically important KPI’s;
— Promote an inclusive “work” environment;
— Celebrate achievements;
— Ensure strategic planning does not stagnate; and
— Make strategic planning sustainable.

Takes conceptual and aspirational objectives It is vital that all members of the Top Manage-
and turns them into a set of deliverables. ment Team are fully committed.
It is a structured approach. Hoshin Kanri may become a rigid framework
that discourages deviation. This may lead to:
— Stifling innovation.
— Focusing on the wrong things.
— Loss of agility and ability to quickly change.
— Reduction in the ability to adapt to

customer / market conditions.
It is a top-down approach, ensuring every mem- It is vitally important that the employees are
ber of staff is fully engaged in the plan. presented with tangible benefits that make it
worthwhile for them to buy into and deliver the
organisation’s Vision.
Allows objectives which are not met, may be Customers are a key component of the Vision.
refined and carried into the next year. KPI’s should be aligned to (and match) customer
requirements.
Engages management in forward thinking
strategies (e.g., next 3 – 5 years rather than
next quarter)

ISO/DIS 10009:2022(E)
8.3 Management by Objectives (MBO)

Setting objectives and achieving them is the goal of Managing by Objectives (MBO). SMART (Specific,
Measurable, Attainable, Relevant and Time-bound) is the acronym for the five key attributes of
successful objectives. This is the basis of Clause 6.2 of ISO 9001.
MBO is a formal approach to realising the strategy and can be an important part of any successful
management system. Objectives can be linked with elements of performance of processes and,
ultimately, the performance of the organisation
Once objectives are determined, SMART can be applied. Alignment with the strategy and KPIs is
important and should be cascaded throughout the organisation so that any individual is aware of how
they may contribute to the relevant objectives.
Also used with a Balanced Scorecard (BSC).

Direct relationship with business results and Objectives are not KPI (Key performance Indi-
success. cators) although appropriate KPIs provide an
additional measurement.
Improves empowerment and self-worth when Objectives are not “at any cost”, they must
linked to positive feedback be achieved within the normal operating
environment of the organisation and to their
normal code of ethics etc
Minimizes information overload Plans which exist should be updated to align
with the objectives.
Energise an organisation
9 Customer Focus / Perception
9.1 Quality Function Deployment (QFD)

Quality function deployment is an approach for ensuring quality throughout, but not necessarily at each
stage of, the product development process, starting with the initial product concept.

ISO/DIS 10009:2022(E)
Quality function deployment is a method to assure customer or stakeholder satisfaction and value
with new and existing products by designing in, from different levels and different perspectives, the
requirements that are most important to the customer or stakeholder. These requirements should be
well understood using quantitative and non-quantitative tools and methods to improve confidence of
the design and development phases that they are working on the right things. In addition to satisfaction
with the product, QFD improves the process by which new products are developed.
QFD is used in the planning and development of products / services.

Improves customer satisfaction with prod- Needs time and significant resources
ucts at time of launch
Improves cross-functional communication Keep the customer voice in mind
Promotes systematic and traceable design Also known as the House of Quality because
decisions and efficient use of resources of the shape of the diagram usually associated
with this tool.
Reduces rework
Reduces time-to-market, lower life cycle cost
Improves reputation of the organization
among its customers or stakeholders
9.2 Net Promoter Score (NPS)

NPS is a customer loyalty and satisfaction measurement taken by asking customers how likely they
are to recommend an organization's product or service to others. Customers select a number from 0
(extremely unlikely to recommend) to 10 (extremely likely to recommend). Customers who are given
scores of 6 or less are considered ‘detractors’, scores of 7 or 8 are considered ‘passives’, and a score of 9
or 10 are considered ‘promoters’. The NPS is simply the percentage of promoters minus the percentage
of detractors.
Used as a proxy for gauging the customer's overall satisfaction with an organization's product or service
and the customer's loyalty to the brand.
NPS may be used to:
— investigate consumers' willingness to buy;
— evaluate the degree of customer loyalty/brand cognition/brand favourite;
— measure customer experience;
— identify the causes of defect/complaints;

ISO/DIS 10009:2022(E)
— predict business growth/sustained profitability;

— prioritize improvement efforts that will be most impactful;
— evaluate the organization's value; and
— create internal benchmarks.

Simplicity. The surveys may use just one The sampling plan, relevance and sample size
question but typically requires two or three should be as large as possible
questions.
Ease of use. The surveys may be conducted by Follow up questions need to be added if wish-
phone, e-mail or Web—whichever generates ing to discover why the score (particularly if
the best response rates and the most useful less than 6) is being given.
data.
Quick follow-up. Customer feedback is shared It’s not equivalent to customer loyalty calcu-
very quickly after it is received. lated by a composite index
A growing body of experience. Thousands of
organizations in many different industries
have begun to measure their NPS.
Adaptability. No high-priced vendors or
‘black box’ statisticians required.
9.3 Kano Model

The objective of the Kano Model is to improve customer satisfaction by understanding, qualifying and
quantifying the drivers of satisfaction. The model aids the identification of certain qualities that need
to be in place to ensure customer satisfaction. It also proposes that, over time, product perception will
evolve and what was previously a “delighter” may become an “expected” quality. Understanding these
nuances allows product and service designers to future proof against possible market complacency
while also keeping the customer requirement front and centre. For new product or service, it helps gain
insights into the attributes which are perceived to be important for the customer.
The Kano Model utilizes customer preference information to :
— Aid with the development of new products;
— Help gain a competitive advantage;
— Include “Must have” design features.;
— Help define customer delights;
— Discover unknown needs;
— Future proof design; and
— Identify design risks & sources of waste.

Simple to use It is important that the relevant customers be
surveyed.
Focuses on product features not just custom- The objective is to discover the minimum
er requirements level of product attributes a customer expects
and build from there.

ISO/DIS 10009:2022(E)

Quickly identifies known and unknown qual- Positive outcomes are achieved when the
ities. defined product qualities are those the cus-
tomer is not aware they needed in the first
place (excite quality)
9.4 Pugh Matrix

The Pugh Matrix is used to compare a number of alternatives and find the best solution by testing
against key criteria. The Pugh Matrix uses scoring to help evaluate the best approach.
Having established the key criteria that are desired in the design, each is given a weighting score with
the higher number for the more important criteria. The tool can be used by an individual but is best
used by a team. It is normally used at the initial stages of design development to guide on the options
that are best suited to fulfil the design brief.
The Pugh Matrix is used:
— To evaluate alternative design approaches;
— To select vendors;
— To hire staff

It is a structured method allowing easy com- The score awarded for each category needs to
parison. be well assessed and, if possible, justified
Best used in a team-based approach
Allows an optimal solution to be developed
which is a hybrid of other alternatives.
Is a quick method which can be used repet-
itively if other alternatives are developed
later.

— Lost Business Analysis
— Mystery Shopper
— Customer surveys
— Potential Gain in Customer Value (PGCV) Index

ISO/DIS 10009:2022(E)
— Focus Groups - Odimegwu, C. O. (2000). Methodological Issues in the Use of Focus Group Discussions
as a Data Collection Tool. CSAT (Customer Satisfaction Score)
— CRM (Customer Relationship Management).
— ISO 10004:2018 Quality management — Customer satisfaction — Guidelines for monitoring and
measuring
— TRIZ It was developed by the Soviet inventor and science-fiction author Genrich Altshuller (1926-
1998) and his colleagues, beginning in 1946. In English the name is typically rendered as the theory
of inventive problem solving, Altshuller, Genrich (1999). The Innovation Algorithm: TRIZ, systematic
innovation, and technical creativity. Worcester, MA: Technical Innovation Center. ISBN 978-0-9640740-
4-0.
10 Process Performance
10.1 Theory of Constraints (ToC)

The Theory of Constraints is a methodology for identifying the most important limiting factor (i.e.,
constraint) that stands in the way of achieving a goal and then systematically improving that process
until the constraint is no longer the limiting factor. It includes five steps,
1. Identify the system constraint,
2. Decide how to exploit the constraint,
3. Subordinate everything else,
4. Elevate the constraint,
5. Return to step 1.
It is a scientific and logical way to analyse the problems of throughput and provide a solution.
Theory of Constraints is used:
— in project management in conjunction with the critical path in PERT (Project Management and
Review Technique)/CPM (Critical Path Method).
— To discover what activity determines the maximum output of linked processes. This process may be
applied to the supply chain as well as a production or design process.
— To develop new operational indicators (KPI).

Increased effectiveness of resources (the pri- It may be most effective when combined with
mary goal of TOC for most organisations) other methods such as Lean Thinking.
Focussed improvement
Improved capacity
Reduced lead times (see Just-in-Time)
Reduced inventory
10.2 Value Stream Mapping (VSM)

Value Stream Mapping (VSM) is a method of understanding a process in terms of value activities (as
against “no-value” activities such as waiting to process, movement around the facility, set-up time,
rework, sorting etc.). It may be linked to “right first time”, Just in Time, Kanban, Theory of Constraints

ISO/DIS 10009:2022(E)
A “value stream” is the sequence of activities that an organization carries out in order to deliver
a specific product or service requested by a customer. A value stream includes both material and
information flows. The term value stream mapping is a lean management tool that helps visualize at a
macro or strategic level, the material and information flows across different functional areas in order
to deliver on a customer request. The technique was first used by the Toyota Motor Corporation and
referred to as “material and information flow”.
Value Stream Mapping is used:
— To show graphically the material and information flows for a product or service to a customer in
order to understand and improve its operations;
— To find and eliminate waste and costly delays in its operations or add value to the products and
services it provides to customers;
— To design new manufacturing or service processes.

It is visual tool, with pictures and friendly It is not a process map. It is not as detailed
symbols which makes it a simple tool to un- and does not show all of the possible paths
derstand and develop. that a process may take. VSM tracks only one
part, service or transaction or a single family
of parts, services or transactions through the
process.
Templates for creating VSMs are available on A Value Stream Map can be constructed
the internet. either by using self-adhesive notes on paper
or by drawing the boxes directly onto a white
board. The symbols, accompanying arrows
and timelines are added to the mapping paper
or whiteboard.
Commercial software is available for creating The customer box is usually placed in the top
VSMs centre position on the map. Where the value
stream involves outside suppliers the custom-
er box is placed at the upper right of the map
and the supplier at the upper left.
A summary table showing the key summary
metrics for the current state is shown. The
same applies to the future state.
It the VSM includes pre-production or
pre-service activities, a second timeline is
often added.

ISO/DIS 10009:2022(E)
10.3 Deadly Wastes / MUDA

The aim is to identify waste in the organisation’s processes and to work to minimise or eliminate these
wastes. This results in an increase profitability (via process efficiency) by eliminating anything that is
wasteful and does not add value to the product and/or service intended for the customer.
The 8 deadly wastes (in Japanese, muda) consist of:
1. Transportation
2. Inventory
3. Motion
4. Waiting
5. Overproduction
6. Over-processing
7. Defects
8. Skills
This was developed as part of the Toyota Production System between 1948 and 1975. In the 1990s an
8th waste (unused skills) was added. Often referenced by the acronym TIMWOODS

Improves process performance: reduced cycle Requires “hands-on” data collection
time, on-time delivery, reduced waste, etc.
Uses cross-functional teams to make sure
that value-added aspects are not eliminated
Part of the Toyota Production System; used in
conjunction with 5S and kaizen.
10.4 Work Breakdown Structure

A work breakdown structure (WBS) is typically used in project management or product/ service
development to decompose the high-level deliverables into smaller elements through two or more
hierarchical layers.
Work Breakdown Structure is used in:
— Project management
— Product and service development

Enables detailed project planning and re- All necessary tasks should be identified to
source allocation achieve the deliverables
Identifies any missing work elements and Tasks are broken down to a level where they
establishes boundaries. can be delivered within one review cycle or
by one discipline
Focuses on planning outcomes rather than
actions
10.5 Spaghetti Diagram

A spaghetti diagram is a visual lean tool to show the journey of a product or person in the workplace
with the aim of rearranging the work to reduce crossovers and reduce the distance of travel.

ISO/DIS 10009:2022(E)
A spaghetti diagram in used in:

— Evaluating flows as part of lean
— Designing work places
— Reducing accidents

Simple visual tool
Inefficient workplaces are readily identified
Can be used in any workplace
10.6 Five S
The Five S quality tool is derived from five Japanese terms beginning with the letter "S" used to create
a workplace suited for visual control and lean production. An additional “S” – Safety is often added.
The aim is to have a workplace that is clean, uncluttered, safe, and well organized to help reduce waste
and optimize productivity. It's designed to help build a quality work environment, both physically and
mentally
The pillars of Five S are simple to learn and important to implement:
— Seiri (Organization): To separate needed tools, parts, and instructions from unneeded materials
and to remove the unneeded ones;
— Seiton (Orderliness): To neatly arrange and identify parts and tools for ease of use;
— Seiso (Cleanliness): To conduct a clean-up campaign;
— Seiketsu (Standardized clean-up): To conduct seiri, seiton, and seiso daily to maintain a workplace
in perfect condition;
— Shitsuke (Sustain): To form the habit of always following the first four S’s; and
Five S philosophy applies in any work area suited for visual control and lean production. The Five S
condition of a work area is critical to employees and is the basis of customers' first impressions.
The Five S methodology is applied to all kinds of work environments

Improves safety, by reducing work accidents It is essential to implement using a rigorous
and disciplined methodology.
Increases equipment availability and better Depends on the ability of personnel to re-
asset utilization spond to process change.

ISO/DIS 10009:2022(E)

Lowers defect rates Remember shitsuke, the fifth S, which essen-
tially calls for performing the first four S on
an ongoing basis
Reduces costs through removing waste in the It requires effort and perseverance to main-
work place tain
Increases production agility and flexibility Can be implemented gradually and only one
at a time, after having successfully imple-
mented one of them, the next one is continued
until reaching all of them
Improves employee morale and enhanced Tendency to see it as a minor tool focused on
image to interested parties. order and cleanliness, given its simplicity.
Suitable for use in any environment (even at Reinforced by audits and scoring.
home)
10.7 Overall Equipment Effectiveness (OEE)

The overall equipment effectiveness (OEE) is a metric that takes 3 factors (Availability, Performance
and Quality) to monitor the effectiveness of an equipment or manufacturing process as a percentage,
which support the identification of gaps to be eliminated by improving quality, and reducing downtime
and cycle time.
It is used to monitor potential for improvement of a process and as a productivity metric.
OEE is used to support the identification of potential causes and losses that affect downtime, speed, and
quality such as:
— Unplanned Stops;
— Planned Stops;
— Small Stops;
— Slow Cycles;
— Production Rejects; and
— Start-up Rejects

Supports improvement Avoid using OEE as organisation-wide calcu-
lation, by keeping the calculation on the top
sources of losses
Provides a better focus on where improve- The data used in the calculation should be
ment may be made. (Availability, Performance representative of the equipment or manu-
and Quality) facturing process running for a significant
period.
Uses a single Key Process Indicators (KPI) Can also be an indicator for effective energy
which sums up efficiency. management
Supports equipment or manufacturing pro- A single KPI does not show the impact of
cesses maintenance, such as Total Productive Availability, Performance or Quality
Maintenance (TPM)
Can be used as benchmark, by increasing
visibility of equipment or manufacturing
processes performance.

ISO/DIS 10009:2022(E)
10.8 HeiJunka / Production Levelling

Heijunka means “levelling” in Japanese and refers to the methodology used to reduce unevenness in a
continual production process and, therefore, minimises overload as well as spare capacity.
The aim is to stop producing in batches and to produce in tune with the natural demand. This will
reduce inventories (of raw materials and finished goods) which reduces the vulnerability of fluctuating
demand.
Hiejunka is used in any continual production process and is a cornerstone of Lean.

Less inventory The effectiveness is the ability of the line to
adapt to producing different products on
demand and efficiently
Less stress on the workforce
Reduces waste in the supply chain being
demand driven

— SMED (Single Minute Exchange of Dies, Attributed to Shigeo Shingo in the 1950s’s
— Total Productive Maintenance - • "Seiichi Nakajima - The Principles and Practice of TPM". www
.cetpm.de. Archived from the original on 2019-06-05. Retrieved 2016-03-09.
— Kraljic Model, Peter Kraljic, a director in the Düsseldorf office of McKinsey, wrote an article in the
Harvard Business Review (1983) entitled "Purchasing Must Become Supply Management".
— MRP (Materials Requirements Planning) - Joseph Orlicky, Materials Requirement Planning, McGraw-
Hill 1975
— ERP (Enterprise Resource Planning) - "B. Bond, Y. Genovese, D. Miklovic, N. Wood, B. Zrimsek, N.
Rayner, ERP Is Dead — Long Live ERP II; Gartner Group RAS Services, SPA-12-0420 4 October 2000"
Allows the reader to look previously or towards the next 20 years
— Agile / SCRUM – Sutherland, “Scrum” (2014) Random House ISBN 9781847941084, Good coverage
of early history
— Robotic Process Automation (RPA) - DeBrusk, Chris. "Five Robotic Process Automation Risks to Avoid".
MIT Sloan Management Review. MIT Sloan Management Review. Retrieved 28 June 2018.
11 Inventory Management / Preservation
11.1 Kanban
Kanban is a system for preventing over-supply or over-production. It was originally a system of cards
which were sent up-stream from the point of consumption to signal that re-supply was required. This
may be used throughout a supply chain.
It is based on a study of supermarkets which allocated shelf-space based on customer demand. This
allowed predictable re-stocking.
The card system has now largely been replaced by electronic systems which manage inventory and
supply in a similar manner.
Kanban is used in a lean environment and is linked to visual production control.

ISO/DIS 10009:2022(E)

Simple to use The amount to be supplied with each Kanban
cycle needs to be tuned with the rate of use
of parts and, for the supplier, with supplier
production lead times and minimum order
quantities.
Prioritises supply Often results in the use of a buffer warehouse
close to the point of consumption
Reduces inventory and Work in Progress Needs to be carefully managed over time to
(WIP) ensure the system remains correctly bal-
anced.
The basis of Kanban is that all parts are de-
fect-free
11.2 JIT Just-In-Time (JIT)

"Just-in-Time" means making "only what is needed, when it is needed, and in the amount needed"
(Toyota). It has been referred to as an inventory-management strategy, and is now used to cover the
philosophy of producing with minimum waste.
The aim is to meet customer demand with the minimum of waste. The product must meet requirements
for quality, quantity and on-time delivery.
Elements of JIT include:
— Continual improvement;
— Eliminating waste;
— Good housekeeping;
— Set-up time reduction;
— Levelled / mixed production;
— Kanbans;
— Jidoka (Autonomation); and
— Andon (trouble lights).
JIT is used to:
— Prioritise manufacturing;
— Reduce waste in systems; and
— Ensure customer requirements are met.

Reduces waste Associated with other practices such as 5S
and kaizen.
Improves quality and on-time delivery A stable supply chain is required.
Reduces cost
11.3 Other Relevant Resources

— First-In First-Out (FIFO) and Last in First Out (LIFO) US Only - Used in computer engineering and –
especially - in the food industry

ISO/DIS 10009:2022(E)
— Cycle Counts - Gumrukcu, Seda; Rossetti, Manuel D.; Buyurgan, Nebil (December 2008). "Quantifying
the costs of cycle counting in a two-echelon supply chain with multiple items". International Journal of
Production Economics. 116 (2): 263–274. doi:10.1016/j.ijpe.2008.09.006.
— Inventory turns - Weygandt, J. J., Kieso, D. E., & Kell, W. G. (1996). Accounting Principles (4th ed.). New
York, Chichester, Brisbane, Toronto, Singapore: John Wiley & Sons, Inc. p. 802.
12 Detection and Prevention
12.1 Error Proofing / Poka Yoke

Error proofing (Japanese: Poka Yoke) is stopping incorrect application through physical or electronic
controls.
Poka Yoke is used in the design of product or process (including tools and fixtures) to prevent the
occurrence of a failure mode. Used where safety or function is very important and incorrect positioning
could impact on function or use.

Stops misuse Will impact on the design of a component,
product or fixture.
Avoids incorrect assembly
Provides visual warning when misuse is
expected
12.2 Visual Aids

A visual aid is a reference to assist the standardisation of operations.
Visual aids are used to:
— Classify defects
— Define acceptance criteria
— Grade ability (e.g., eyesight tests)
— Grading natural products

Simple to use The quality of visual material may have to be
reviewed when better images are obtained or
when new defects are found.
No language used (suitable for foreign work- Sight tests and minimum lighting levels may
ers or low skilled) have to be specified.
Easier than trying to explain a visual issue in
text.
12.3 Cost of Poor Quality (COPQ)

Cost of Poor Quality (COPQ) is the systematic identification and measurement of the cost of work not
going according to plan. It is an adaptation of the Cost of Quality (Failure, Appraisal and Prevention
Costs) This is followed up by action to address the issues.
The aim is to eliminate or reduce wasted time, labour and materials (and cost).
COPQ is used for systematic improvement of processes and increased customer satisfaction. Often
linked to Six Sigma™ “Lean” and “pareto analysis” and corrective action techniques.

ISO/DIS 10009:2022(E)

Focuses on cost (which is appealing to man- All organisations have to decide what quality
agement and provides commercial informa- product their customer expects and tune the
tion which helps select the most beneficial Cost of Poor Quality to that level.
actions)
Considers cost in a holistic manner Generally used to reduce evident scrap or
waste but may be used to review such areas
as preventive versus corrective measures.
Improves customer perception through Having reviewed the contributory costs, it is
competitive pricing and products that meet best to set standardised figures (e.g., labour
customer expectations cost for repair $200/hr
Applies to services as well as product

— Checklist - Higgins, W. Y., and D. J. Boorman. "An analysis of the effectiveness of checklists when
combined with other processes, methods and tools to reduce risk in high hazard activities." Boeing
Tech J (2016).
— Shainin Lot Plot Method – See WORLD CLASS QUALITY: Using Design of Experiments to Make it Happen.
By Keki R. Bhote and Adi K. Bhote, ISBN 0-8144-0427-8
13 Statistical Process Control
13.1 Box plots

Box plots (or Box and Whisker plots) visually show the range of numerical data and are constructed
from five values: the minimum value, the first quartile, the median, the third quartile, and the
maximum value. They are used to show the differences between samples taken (possibly over time or
by competing suppliers). Box plots provide a lot of statistical information including medians, ranges,
and outliers.
Box plots give more information than the mean.

Simple to use
Easy to present in graphical format
Simple mathematics
Many computer applications can handle the
arithmetic and presentation.
Particularly useful for comparing distribu-
tions across groups.

ISO/DIS 10009:2022(E)
13.2 Pie diagram

A pie diagram (or chart) is a simple visual tool used to show the relative proportions of a population
(contributing factors) within a group through its “slices”.
A Pie Diagram is used to show the relative proportions of, for example:
— Sales (e.g., by region, product);
— Costs;
— Customer satisfaction scores (e.g., 1 to 5);
— Causes of complaints;
— Defect types; and
— Customers

Simple to use Zero values should not be included,
Easy to present in graphical format Multiple pie charts may be used to show
trends, however the changes in relative pro-
portions may not be easily visible,
The area of the pie chart (diameter) may be Works best with few categories; too many
used to represent the total number of samples small “slices” may be difficult to interpret, or
not add value,
May be difficult to distinguish actual values
when “slices” are similar in size; data labels
may be used in these cases,
Data may not be accurately interpreted as
people tend to underestimate the size of acute
angles (<90°), and overestimate the size of
obtuse ones (>90°); data labels may be used
in these cases.
13.3 Radar Chart / Spider Web

The Radar Chart, also known as the Spider Chart or the Spider Web Diagram because of its shape, is a
two-dimensional chart used to show measurements where several variables contribute or are being
compared. Measurements are on a polar grid with the axes (spokes) starting at the centre point. Axes

ISO/DIS 10009:2022(E)
(spokes) are arranged radially with equal distances between them whilst maintaining the same scale
on each axis. Each variable is plotted along its own axis (spoke) and all the variables in a dataset are
connected by straight lines to form a polygon. Grid lines are placed on each axis (spoke) and used as
guidelines to make the chart more easily readable. Usually at least three variables are compared and all
variables are considered equally important.
Radar charts are best used for determining which variable in a data set is doing better than the rest.
Hence, they are mostly used for performance analysis. The chart may be used to compare the properties
of a single component or compare the properties of three or more variables together. The filled radar
chart is better for demonstrating comparison by using different fill colours, however filling the polygons
may obscure information on the chart.
Radar charts may be used where:
— Tracking or reporting performance or progress
— Several variables are measured to assess overall performance
— It is not necessary to weight the importance of the variables

A visual tool Having multiple polygons in one Radar Chart
makes it difficult to read, confusing and too
cluttered
Simple mathematics required It is good practice to keep Radar Charts sim-
ple and limit the number of variables used
Visually aesthetic and compact in presenta- When planning the spoke, group together
tion variables that are related
A wide variety of software applications are If the criteria used mixes scales so that high
available for the construction of radar charts is good for some variables and bad for others,
(e.g., popular spreadsheet programs and either re-word the criteria so that all of the
stand-alone software programs) scales are directionally consistent or group
together spokes whose scales run from high
at the centre to low at the outside
13.4 Pre-Control
Pre-control is a statistical technique that seeks to prevent the production of units whose dimensions lie
outside specifications.
A sample of 5 consecutive units from production must lie within the central half (50 %) of the range
between upper and lower specifications.
When that condition is met, production can proceed with periodic sampling inspection of 2 units;
the inspection results determine whether production can continue as-is or if the process needs to be
adjusted. There is a cumulative scoring system applied to the three bands either side of the mean and
to points outside specification.

ISO/DIS 10009:2022(E)
It aims to maintain product quality through a sampling inspection procedure that governs whether
production can continue or if process intervention is required.
Pre-control is used as a low-cost alternative to SPC or where SPC is not viable. The technique lends itself
more to the production of products (than services). It is also used for monitoring a machining process
which may be prone to drift because of tool-wear.

Requires minimal training. Pre-control offers limited insight into the
process and is not advocated as a tool for
improvement. It can be useful in operations
where defect levels of “1-3 % are permissi-
ble”..
Simple methodology that allows the use of Because the maths is simple, it can be used
“go/no-go” gauges. with PLCs with low memory capability.
13.5 Critical to Quality (CTQ) Trees

This Six Sigma tool is useful when needing to define quality in a product or service. Critical to Quality
Trees (CTQ Trees) can be used at the inception phase of a project to focus development on areas that
really matter, or to drive an improvement initiative in existing products or services.
To use CTQ Trees:
a) Define each critical ‘need’ that the service or product must satisfy.
b) Define the quality ‘drivers’ for each need that must be in place for the customer to receive high
quality.
c) Determine the performance criteria needed to satisfy the quality drivers.
d) Start a new tree for each need
13.6 Pareto Chart

Pareto analysis is used to prioritize action based on the Pareto Principle (also called the 80:20 Rule).
This principle states that the majority (80 %) of effects are produced by a few (20 %) key factors. Pareto
Analysis is used prioritize the factors with the greatest influence on a result.
A Pareto Chart is used for analyses of factors such as:
— Costs;
— Defect types;
— Resources;
— Risks;
— Sources of waste;
— Market segments;
— Customers by category; and
— Equipment downtime.

ISO/DIS 10009:2022(E)

Simple to use The data needs to be able to be categorized
into discrete factors
Easy to present in graphical format Only analyses two variables at a time (e.g.,
may not analyse frequency, cause and cost at
one time)
Simple mathematics Missing data limits the validity of the results
Focus on actions which deliver maximum It works best if the variability of the factors to
results (the ‘vital few’). be analysed is significant
13.7 Gage Repeatability & Reproducibility (GR&R)

Gage Repeatability and Reproducibility (GR&R) assesses the capability of a measurement system. It is a
common method of Measurement System Analysis.
It is used to establish how much reliability may be placed in the outputs of the measurement process
Gage R&R is used where reliable measurements are vital to ensure conformity and normally where
there are several persons (appraisers) responsible for measurement. Repeatability is typically due to
equipment variation and reproducibility typically due to appraiser variation.

Identifies the capability of the entire meas- The instruments need to be suitable for the
urement system measurement being undertaken.
Separates the proportion of variability in The instruments need to be recently and suc-
measurement contributed by the appraiser, cessfully calibrated.
equipment and part variability
Validates the effectiveness of training The measurements need to be undertaken in
the environment in which they would normal-
ly be taken (e.g., laboratory, production line
etc.)
Can identify where differences of technique It is important to understand the system in
influence the result (e.g., parallax, lighting, detail prior to commencement – e.g., is there
instrument deployment etc.) any ‘in part variation’ e.g., ovality; equipment
or part hysteresis etc and design the study
accordingly
Alternative methodologies using statistical
tools such as ‘Cohen’s Kappa’ exist for attrib-
ute gauges/ gages.

ISO/DIS 10009:2022(E)

— ISO 10017:2021 Quality management — Guidance on statistical techniques for ISO 9001:2015
— Analytic Hierarchy Process (AHP) - Bhushan, Navneet; Kanwal Rai (January 2004). Strategic
Decision Making: Applying the Analytic Hierarchy Process. London: Springer-Verlag. ISBN 978-1-
85233-756-8.
— Control Charts (Attributes and Variables) – ISO 7870-1:2019 Control charts — Part 1: General
guidelines; ISO 3951-1:2022 Sampling procedures for inspection by variables — Part 1: Specification
for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a
single quality characteristic and a single AQL
14 Corrective Action / Problem Analysis
14.1 Root Cause Analysis (RCA)

Root cause analysis (RCA) refers to a series of methodologies to understand the fundamental reason(s)
why a problem or failure occurred or could potentially occur, with a view to preventing its recurrence
or from it occurring in the first place. More advanced techniques may seek to identify multiple causes
e.g., occurrence (why it happened), non-detection (why the controls in place failed to identify or
escalate the problem) and systemic (why the problem or the failure of controls was not anticipated
and/ or mitigated).
Root Cause Analysis is the principal tool for problem solving.
— Wherever a problem occurs and the fundamental cause(s) need to be identified and addressed
— When assessing risks and identifying potential problems (e.g., FMEA)

Focus is on addressing fundamental causes The root cause must be defined within the
of problems rather than, or in parallel with, control of the organisation (e.g., cannot be
dealing with the symptoms or correcting the weather, human error etc.)
immediate problem.
When root causes are addressed, problems It is important to use logical techniques and
are less likely to occur or recur. processes avoid jumping to conclusions
Improves customer confidence. A clearly defined problem statement is essen-
tial.
In addition to personnel with appropriate
expertise, it can be useful to include person-
nel without experience of the problem area,
as they may challenge embedded ways of
thinking
The root cause cannot include anything that
is not within the organisation’s control (e.g.,
weather, human error, otherwise the correc-
tive action must be to remove the weather or
the humans).
Often recorded in an 8D of A3.
14.2 Decision Tree

Decision tree is a decision support tool that uses a tree-like model of decisions and their possible
consequences, including chance event outcomes, resource costs, and utility. Each branch of the decision
tree represents a possible decision, outcome, or reaction.

ISO/DIS 10009:2022(E)
It is used to evaluate the best decision or the solution to a problem through asking a series of defined
questions
Decision Tree analysis is used:
— When there is a need for recurrent decision-making or the problem-solving.
— When the decision-making may be broken down into a series of questions for standardisation
— Typical applications of decision tree include dispute resolution and emergency handling.

Application of decision tree allows personnel Usually, some questions are given higher
without a high level of knowledge to make priority. If there is no apparent sequence, the
appropriate decision under specific scenarios most frequently encountered events should
be prioritized.
The decision tree should include all possible
solutions and sequences.
14.3 Fault Tree Analysis (FTA)

Fault tree analysis was developed as a tool to investigate failures or malfunctions of a system. It is
usually applied in reliability analysis or safety engineering.
Constructed by laying out the components and systems (or events) in a hierarchy with the failure
identified at the top of the tree. In this visually depicted structure, symbols are used to display types of
dependencies – this in turn can identify vulnerabilities and their locations.
Best used when a system (or sub-system) comprises multiple elements; these could include human
elements, software, etc. that are interlinked and together contribute to the totality of the function of
the upper-level system.

Identifies components and subsystems for a Need to know the architecture of the system
system (its elements and their relationships)
Displays relationships and their nature Four common types of symbols used to
denote relationships: And, Or, Exclusive OR,
Prioritized And.
Computes overall system reliability metrics Reliability metrics of each event (component,
or sub-system must be known to arrive at the
overall reliability metric for the system)
Identifies vulnerabilities and their location Weak spots / high failure events are identifi-
able via computations that rollup reliability
based on nature of component / event rela-
tionships.

ISO/DIS 10009:2022(E)
14.4 Five Why Analysis

The Five Why analysis is a systematic, structured approach of identifying actual and potential cause(s)
of a problem by repeatedly asking why until a root cause is reached. It is possible at each stage that
there may be more than one answer to the question ‘why’ and multiple actual and potential causal
pathways may emerge which can be tested with facts, data and evidence to determine which ones are
most likely to cause the problem.
The objective of using the 5-why methodology is to identify actual and potential root cause(s) of a
problem, going beyond the immediate and obvious causes. There needs to be a clear logical flow through
each causal pathway; often “therefore” is used in reverse to ensure that the why cascade is valid.
The 5-Why analysis is used:
— To analyse complex problems;
— Where systemic problems occur;
— Where additional potential causes of a problem need to be identified;
— When conducting an FMEA.

Straightforward activity Despite its name, the number of times ‘why’ is
asked may vary
Readily facilitates a comprehensive analysis There needs to be a clear and logical flow
through each causal pathway.
Easy to present findings graphically Parallel 5-Whys may be conducted separately
to address causes of occurrence and non-de-
tection. When doing so it is important for the
team to remember whether they are looking
at occurrence or non-detection at each stage.
The tool does not prioritise the likelihood of
different causal pathways – it is important
that appropriate testing of findings be carried
out.
The causes must be under the control of the
entity.
14.5 Ishikawa / Fishbone / Cause and Effect Diagrams

There can be many causes of an event or the outcome from a process where the quality of a product or
service is dispersed.

ISO/DIS 10009:2022(E)
“A cause-and-effect diagram is useful in sorting out the causes of dispersion and organising mutual
relationships.” K Ishikawa, University of Tokyo, 1943
The possible cause of deviation from a standard (dispersion) in a quality characteristic can be
determined by the use of Ishikawa Cause and Effect Diagram that help see where ideas on possible
cause can be captured. Dr Ishikawa developed three types of Cause-and-Effect Diagrams:
a) Event Problems:
1. Dispersion analysis type
2. Cause enumeration type
b) Process-based Problems
c) Production process classification type
Ishikawa diagrams are used to validate root cause analysis.
14.6 Is / Is Not Analysis

A methodology to clearly define what is and is not the problem, non-conformity, concern or issue that
individuals and teams perceive they have identified.
It is commonly used in Flow Process Charts that are the input charts for capturing the activities for the
Process Failure Mode an Effects Analysis.
The methodology supports the first step in problem solving that if done correctly will go some way to
solving that problem by having the problem well stated.
Is / Is Not Analysis contributes to continual improvement methods as quality circles, problem
solving teams, Kaizen continual improvement teams, process improvement teams, business process
reengineering, Six Sigma™ and Lean project teams.
It may reduce any wasted time in defining the extent of the problem. It requires a data collection plan
and basic skills in sampling techniques and then data graphical analysis to better enable the final
efforts to define the problem.

Helps determine if a problem contributes to There may be confusion with “5-Whys” (what,
an event. The Affinity Diagram, Relationship when, who, why, where, and how)
Diagram or Mind Maps may be helpful for
such event analysis.

ISO/DIS 10009:2022(E)

Once the areas of likely causality are selected, The Process Flow Chart, Flow Diagrams,
an Ishikawa diagram may be drawn including Swim Lanes, or Procedures may help struc-
the ranking the most likely causes. ture the process.
Is / Is Not helps better understand and define Helps narrow down the problem area(s) and
the problem. What IS NOT wrong is as impor- focus on a set of activities in a process.
tant as what IS wrong.

— Solution Effect - A reverse way of using the Cause and Effect Diagram. See also Ishikawa, Kaoru (1968).
Guide to Quality Control. Tokyo: JUSE
— Lewin’s Force Field Analysis - Lewin Kurt. (1951) 'Field Theory in Social Science', Harper and Row, New
York
— 8D and A3 charts - Laurie Rambaud (2011), 8D Structured Problem Solving: A Guide to Creating
High Quality 8D Reports, PHRED Solutions, Second Edition 978-0979055317
— Relationship Diagram – Entity Relationship Diagrams
— Mind Mapping - Buzan, Tony (1974). Use Your Head. London: BBC Books
15 Improvement / Benchmarking
15.1 Benchmarking
Benchmarking is the process of comparing products, services, operations or processes within an
organization against best practices in similar or related operations or processes internally within
the organization, or externally against competitors or world class organizations with similar or
related operations or processes. The aim is to stimulate improvement. Benchmarking is an important
component of continual improvement initiatives including Six Sigma.
There are a number of different types of benchmarking, which are driven by different motivating
factors and thus involve different comparisons. Some of the major types of benchmarking are:
a) Metric benchmarking which is the use of quantitative measures as reference points for comparisons
and improvement in performance;
b) Best-practice benchmarking is focused on identifying outstanding practices and techniques of
organizations and incorporating them with appropriate modifications into the organization’s
operations; and
c) Strategic benchmarking includes skills assessment, information technology strategy, business-
technology alignment, and delineation of roles and responsibilities.
Benchmarking is used:
— When it is recognized that a process needs to be improved based on identified gaps in performance;
— When an organization wishes to compare itself to its competitors to identify opportunities for
improvement to gain a competitive edge; and
— When an organization is interested in comparing its performance with what is deemed to be world-
class performance in order to become best-in-class.

ISO/DIS 10009:2022(E)

Tangible and significant performance im- Organizations should be wary of placing too
provements by an organization are possible much emphasis on internal benchmarking
in a relatively short time period alone. An organization that is preoccupied
with itself easily loses track of competitors
and broader-world innovations and the
changing demands of customers.
Benchmarking statistics are readily available Looking outside of the organization’s own
as many industry-related and consumer-re- industry for the best-in-class performance
lated organizations publish comparative data of particular processes or functions is an
which is useful to the benchmarking process excellent way to challenge the organization
to rethink longstanding assumptions and
practice
Performance indicators for thousands of Care should be taken to define benchmarking
different organisations and assistance in initiatives deliberately and scientifically, or
conducting benchmarking studies are acces- the results could be misleading
sible through membership in organizations
providing such services such as the non-profit
American Productivity and Quality Centre
15.2 Affinity Diagram

The affinity diagram is a tool used to organize a large number of ideas and order them into relationships
groups.
It is used to order lot of ideas and they seem to be in disorder.

Organizes a lot of ideas in one place The results depend in the information that
the participants give
It is a simple tool It only organizes ideas but does not prioritize.
It is a visual tool and helps to achieve a con- It is useful only for complicated problems that
sensus have a lot of ideas
15.3 Quality Circles

Quality circles are quality improvement or self-improvement study groups composed of a small number
of employees (10 or fewer) and their supervisor. Quality circles originated in Japan, where they are
called quality control circles
The aim is to identify improvements or solve problems through the participation of the members of a
group directly related to the activity being studied and seek the cooperation of the members by making
use of their collective capacities.
Quality circles are used in any group work environment.

Effective problem solving Being a voluntary act, the organisation will
not always find people who want to engage
Promotes of teamwork Difficult to maintain. Consider rotating circle
membership, thereby continually introducing
new members into groups that may be run-
ning out of ideas.
Improves motivation Difficult to maintain without strong manage-
ment support

ISO/DIS 10009:2022(E)

Improves employee communication at all There may be cultural obstacles and formal
levels of the organization organization. There is a need to define suita-
ble behaviours of members.
Improves the relationship between managers Staff need to be trained in the objectives of
and the work force Quality Circles and there should be guidelines
on meeting etiquette.
Improved productivity and quality The leadership need to motivate.
15.4 Brainstorming
In the western world, Brainstorming has been attributed to Alex F Osborne who started using the tool
around 1940. Variations over the years, notably by Yale University, have resulted in the term now being
used to describe a range of methods. What they all have in common is the goal of finding new ideas,
concepts or solutions to a problem at hand.
Brainstorming is used:
— To resolve a new issue;
— To provide insights where there are no effective solutions to a pre-existing problem;
— To identify potential / new products, markets, etc.; and
— To identify potential root causes for nonconformities.

No judgement of ideas leads to people's natu- Too many persons in a group may result in
ral inhibitions being reduced persons not contributing
A greater quantity of ideas is generated Online technology may significantly affect
(positively or negatively) the way in which
the original rules are applied
The greater quantity of ideas usually results Modifications to the original method may
in better quality ideas result in poor output of ideas
Research of any existing evidence-based The group should have varying amounts of
practice. experience in the problem / task at hand.
Note that Osborne discouraged mixing par-
ticipants from various levels in the organ-
isation’s hierarchy within a brainstorming
group, but this may be culture-specific
Train members before the session on rules &
method
Inform members about the problem / issue
before the brainstorming session to allow
them to come with ideas
Facilitator plays a critical role in the process
Later techniques assist in brainstorming, like
Six Thinking Hats (Edward de Bono, 1970)
and Mind Mapping (Tony Buzan, 1996).
15.5 Six Thinking Hats – Lateral Thinking

Edward de Bono made a step change and contribution to the popularity of lateral and creative thinking.
Six Thinking Hats is valuable to use in engaging people in various qualitative Quality that need to
generate ideas, lateral thinking and broaden perspectives for a topic. In so many of the Quality Tools,
they rely on effective and well managed brainstorming sessions to respect everyone’s inputs, ideas and
contribution to the process used in that quality tool or technique.

ISO/DIS 10009:2022(E)
The basis for many qualitative tools relies on and aspect commonly attributed to the Toyota Lean
Production Policy being “Respect for People”. That is where Edward de Bono’s “Six Thinking Hats®”
can help people understand people’s thinking styles.
The technique is based on role play where thinking role is identified with a coloured symbolic
“thinking hat.” By mentally wearing and switching “hats,” one can easily focus or redirect thoughts, the
conversation, or the meeting.
WHITE HAT: calls for information known or needed. “The facts, just the facts.”
YELLOW HAT: symbolizes brightness and optimism; explores the positives through value and benefit.
BLACK HAT: Risks, difficulties, The risk management hat.
RED HAT: Signifies feelings, hunches and intuition; expresses emotions, feelings, fears, likes, dislikes,
loves, and hates.
GREEN HAT: focuses on creativity; the possibilities, alternatives, and new ideas.
BLUE HAT: used to manage the thinking process; the Six Thinking Hats® monitor.

Six Thinking Hats supports awareness of different If people feel their ideas are not respected and re-
approaches to issues. corded effectively, their creativity, contribution and
on-going participation, may be diminished.
Disciplined Brainstorming sessions and a Code of Con- Disciplined Brainstorming sessions and a Code of Con-
duct helps develop mutual respect. duct helps develop mutual respect.

— Plan – Do - Check – Act (PDCA) - Deming, W. Edwards (1986). Out of the crisis. Cambridge, MA:
Massachusetts Institute of Technology, Center for Advanced Engineering Study. p. 88 . ISBN 978-
0911379013. OCLC 13126265
— Capability Maturity Model (CMM) - Humphrey, W. S. (March 1988). "Characterizing the software
process: a maturity framework". IEEE Software. 5 (2): 73–79. doi:10.1109/52.2014. ISSN 0740-7459.
S2CID 1008347
— Suggestion Schemes - Martin, Charles. Employee Suggestion Systems: Boosting Productivity and
Profits. Crisp Publications, 1997.
— PICK chart - Michael.L.George (2003) Lean Six Sigma for Service: How to Use Lean Speed and Six Sigma
Quality to Improve Services and Transactions. ISBN 0-07-143635-9
— Crawford Slip method / Use of self-adhesive notes – See also SCRUM techniques - C. C. Crawford,
John W. Demidovich School of Public Administration, University of Southern California, 1983
— Boston Consulting Group Chart (BCG)
— Waterfall Chart - Ethan M. Rasiel. The McKinsey Way. McGraw–Hill, 1999.
16 Families of Management Tools
16.1 Six Sigma Programme

“Six-Sigma” is a statistical concept of process capability, such that the process spread is well contained
within specifications. Given this condition, the resulting defect level will be near-zero even with shifts
in the process average.

ISO/DIS 10009:2022(E)
Six-Sigma is an organizational program to achieve ambitious business goals, and even serve as a
vehicle for business transformation. The Six-Sigma program is supported by a management framework
designed to facilitate the achievement of stated objectives. The program typically employs DMAIC
(Define, Measure, Analyse, Improve, Control) and calls for investment in training in relevant statistical
(& other) techniques.
Six-Sigma programs have yielded quantum improvements in quality and productivity; and the expertise
gained in training and application is found to yield continuing benefits.
Six-Sigma methodology is adapted to serve the business need to serve applications such as:
— problem solving;
— quality or performance improvement;
— cycle time reduction;
— cost reduction; and
— aligning the organisation’s focus and resources to achieve strategic business goals

Quantum improvement in quality and perfor- Six-Sigma program requires executive com-
mance of processes, products and services mitment and engagement at the highest level
The cost of implementing Six-Sigma is typical- The program typically requires financial
ly offset by significant reduction in cost and/ investment in training in:
or increases in productivity and profitability. — management framework for
implementation
— statistical tools and other quality

techniques
Improved customer satisfaction and in- It is a disciplined approach with clearly de-
creased market share fined targets and measures of success
Applicable to all sectors: manufacturing,
software and services
16.2 Toyota Production System (TPS)

The Toyota Production System — also known as TPS — is an organizational culture that engages people
to continually make improvements.
The objective of TPS is to create a culture which is sustained by three integrated elements:
— Toyota’s Philosophy (Values):
— Customer First: Provide customers with what they want, when they want it and in the amount,
they want it.
— People are the Most Valuable Resource: Deeply respect, engage and develop people.
— Continual Improvement: Engage everyone, each and every day.
— Shop Floor Focus: Go to where the work is done to find and solve problems.
— Appropriate use of TPS Tools & Practices (Technical) to achieve:
— Just-in-Time production practices.

ISO/DIS 10009:2022(E)
— Built-in Quality (Jidoka) and to expose roadblocks to improving safety, quality, cost and lead
time.
— Managerial Role (Leadership):
— Leaders inspire and develop people to surface and solve problems to improve performance.
The Toyota Production System is a culture of problem solving at every level of the organization from
top management to the shop floor or area of need, such as:
— General Industry;
— Construction;
— Agricultural;
— Service;
— Government; and
— Non-profit.

Personal development, Leadership must understand key differences
between TPS and traditional management
Increased productivity. Leadership must understand top manage-
ment's role in the TPS transformation
Improved safety and quality Leadership must support empowering em-
ployees to identify and solve problems
Reduced costs (do more with less)
16.3 Total Quality Management (TQM)

Total Quality Management (TQM) involves the top management and all personnel to achieve customer
satisfaction and continual improvement, through effective leadership, teamwork, communications, use
of indicators and feedback.
TQM issued for analyses of factors such as:
— Costs;
— Defect types;
— Resources;
— Risks;
— Sources of waste;
— Market segments;
— Customers by category; and
— Equipment downtime.

Improved customer focus and satisfaction It requires adequate and expensive resources
Improved employees’ contribution It requires a cultural change in the organiza-
tion

ISO/DIS 10009:2022(E)

Commitment and leadership of top manage- It does not offer concrete guidelines for de-
ment ployment and action
Comprehensive vision of the organisation
Strengthened competitive position
Reduced costs
16.4 Dynamic Working Design (non-manufacturing processes)

Dynamic Work Design (DWD) is a set of principles and structures that guide human behaviour as work
moves through an organization, including finding and fixing issues and making improvements all in
real time.
DWD provides a framework to evaluate and improve both task based and studio/creative based work
and how to best design a set of triggers and checks to move between different work modes.
DWD is a principle-based assessment tool that guides the user to the most elegant solutions that improve
quality, cycle time, throughput, and customer satisfaction. It leads to more efficient operations, better
organizational alignment and deeper employee engagement. In its ideal application, it facilitates quick
effective change and encourages innovation while establishing a culture of continual improvement.
The practical tools and methods of DWD may be adapted to any type of work of any scale and at any level
within an organization. It has been effectively used in manufacturing plants, service organizations,
genetics labs and various types of office/knowledge work, from the top management to the front line
on activities such as:
— Product Development;
— Strategy Deployment;
— Marketing;
— Strategic Procurement;
— Purchase to Pay; or
— Risk Management.

The principle-based approach, adds speed Principle based vs a set of rules
and agility to improvement efforts
Creates alignment from senior leadership to Visual Management techniques are par-
the front line ticularly useful as it puts a physical face to
knowledge work
Improves organizational efficiency Compatible with other improvement method-
ologies, Lean, Agile, 6 Sigma, as it is principle,
not tools based.
Simplifies the view of how work is flowing
through an organization
Establishes an effective management system
Enables effective process/people loading
Develops inquiry and evidence-based prob-
lem-solving

ISO/DIS 10009:2022(E)
Annex A
(informative)
PDCA – Techniques overview
A.1 Overview
— a) Strategy and Business Planning Storyboard
Plan Do Check Act

5.2 PESTLE 5.4 Vision and Mission 8.1 Structure what if 15.7 Lewin’s Force Field
Analysis
5.3 Porters 6 Forces 8.4 Heat Maps 9.3 Balanced Scorecard
6.2 RACI
5.1 SWOT 9.2 Management by Objec- 9.2 Management by Objec-
tives tives 18.5 Dynamic Work De-
16.1 Benchmarking
sign
10.3 Kano Model 10.2 Net Promoter Score
16.2 Affinity Diagrams
8.2 Risk Register
10.4 Mystery Shopper 11.1 Theory of Constraints
16.5 Brainstorming
9.3 Balanced Scorecard
13.3 Cost of Quality
17.1 BCG Matrix
10.5 Potential Gain in Cus-
14.1 to 14.5 Tools
tomer Value
15.2 Decision Tree
13.2 Visual Aids
15.4 Solution Effect
5.2 PESTLE
16.5 Brainstorming
5.3 Porters 6 Forces
17.4 De Bono’s 6 Thinking
5.1 SWOT
Hats
16.1 Benchmarking
17.2 RADAR Chart
b] Process Improvement Storyboard

ISO/DIS 10009:2022(E)
Plan Do Check Act

16.5 Brainstorming 6.1 SIPOC 11.1 Theory of Constraints 8.2 Risk Register
16.1 Benchmarking 6.2 Turtle Diagrams 18.1 Six Sigma 15.7 Lewin’s Force Field
Analysis
17.1 BCG Matrix 8.2 Risk Register 11.1 Theory of Constraints
11.9 Heijunka
16.2 Affinity Diagrams 10.1 House of Quality 13.3 Cost of Quality
9.3 Balanced Scorecard
10.2 Net Promoter Score 10.3 Kano Model 14.1 to 14.5 Tools
9.2 Management by Objec-
9.2 Management by Objec- 15.6 Ishikawa Diagrams 15.2 Decision Tree
tives
tives
15.5 5-Why Analysis 16.4 Solution Effect
10.1 House of Quality
11.8 OEE
16.5 Deadly Wastes 16.5 Brainstorming
10.5 Potential Gain in Cus-
13.2 Visual Aids
17.4 De Bono’s 6 Thinking tomer Value
15.8 Structure What Is /Is Hats
13.3 Visual Aids
Not Analysis
9.2 Management by Objec-
14.9 Analytical Hierarchy tives
Process (AHP)
11.4 Deadly wastes
11.5 Work Breakdown
Structure
11.7 Robotic Process Auto-
mation
c] Problem Solving Storyboard- Kaizen, Quality Circles, TQM, Six Sigma™
Plan Do Check Act

16.5 Kaizen 11.2 Value Stream Map- 8.3 FMEA 15.7 Lewin’s Force Field
ping Analysis
18.4 Total Quality Manage- 18.1 Six Sigma
ment 6.1 SIPOC 11.9 Heijunka
11.1 Theory of Constraints
18.1 Six Sigma 6.2 Turtle Diagrams 15.4 Solution Effect
13.3 Cost of Quality
16.6 Brainstorming 12.2 Cycle counting 10.1 House of Quality
14.1 to 14.7 Tools
15.8 Structure What Is /Is 12.3 Inventory Turns 17.2 RADAR Chart
15.2 Decision Tree
Not Analysis
13.3 Cost of Poor Quality 9.3 Balanced Scorecard
15.2 Decision tree
18.1 Six Sigma 9.2 Management by Objec-
16.5 Brainstorming
16.2 Affinity Diagrams tives
15.6 Ishikawa Diagrams
17.4 De Bono’s 6 Thinking
14.9 Analytical Hierarchy 10.5 Potential Gain in Cus-
15.5 5-Why Analysis Hats
Process (AHP) tomer Value
16.5 Deadly Wastes 11.4 Deadly wastes
13.2 Visual Aids 13.4 Visual Aids
12.1 Kanban
11.5 Work Breakdown
Structure

ISO/DIS 10009:2022(E)
Annex B
(informative)
Review of the attributes of Quality Tools
B.1 Overview table

Clause Quality Tool Area of Use Product / Ser- Team / In- Data Level of Effort to
Ref. vice / Both dividual Quantity Expertise apply
5.1 SWOT Strategy Both Team Small • Easy
5.2 PESTLE Strategy Both Team Small • Easy
5.3 Porter’s 5 Strategy Both Team Small • Easy
Forces
5.4 Mission / Vision Strategy Both Individual or Small • Easy
Team
6.1 SIPOC / COPIS Process Both Individual or Small • Easy
Team
6.2 Turtle Diagrams Process Both Individual or Small • Easy
Team
6.3 Control Plans Process Control Both Individual Medium •• Easy
6.4 Flow Charts Planning Both Individual or Small • Easy
team
6.5 RACI Strategy Both Individual or Small • Easy
Team
7.1 SWIFT Risk assess- Both Individual Medium • Easy
ment and team
7.2 Risk Register Risk assess- Both Team Medium • Easy
ment
7.3 FMEA Risk assess- Both Tam Medium •• Medium
ment
7.4 Heat Maps Risk Assess- Both Individual Small • Easy
ment
8.1 Kaizen Change man- Both Team Medium •• Easy
agement
8.2 Hoshin Kanri Objectives Both Team Small • Easy
8.3 Management by Objective set- Both Individual / Small •• Easy
Objective ting team
9.1 Quality Func- Planning Both Team Medium •• Medium
tion Deploy-
ment (QFD)
9.2 Net Promoter Voice of cus- Both Individual Medium •• Easy
Score tomer
9.3 Kano Model Voice of cus- Both Individual Small •• Easy
tomer
9.4 Pugh Matrix Prioritization Both Team Small • Easy
10.1 Theory of Con- Effectiveness Both Individual / Medium •• Easy
straints team
10.2 Value Stream Productivity Both Individual / Medium •• Easy
Mapping team

ISO/DIS 10009:2022(E)
10.3 MUDA Productivity Both Individual / Small • Easy
Team
10.4 Work Break- Clarity of Re- Both Team Small • Easy
down Structure sponsibility
10.5 Spaghetti Dia- Productivity Both Individual / Small • Easy
gram team
10.6 5S/ 6S Housekeeping Both Team Small • Easy
10.7 Overall Equip- Efficiency Manufacturing Individual Medium • Easy
ment Effective-
ness
10.8 Heijunka Efficiency Manufacturing Individual Medium • Easy
11.1 Kanban Inventory Both Individual / Small • Easy
Team
11.2 Just in Time Lean Both Team Medium • Easy
12.1 Error Proofing Defect reduc- Both Individual Small • Easy
tion
12.2 Visual Aids Quality control Both Individual Small • Easy
12.3 Cost of Poor Waste reduc- Both Team Medium •• Medium
Quality tion
13.1 Box Plots Visual SPC Both Individual Any size • Easy
13.2 Pie Diagram Visual SPC Both Individual Any size • Easy
13.3 Radar Chart* SPC Both Individual / Medium •• Medium
Team
13.4 Pre-Control SPC Both Individual / Small •• Easy
Team
13.5 Critical To
Quality
13.6 Pareto Analysis Visual SPC Both Individual Any size • Easy
13.7 Gage R&R Metrology Manufacturing Team Medium •• Medium
14.1 Root Cause Problem solv- Both Team Small •• Easy
Analysis ing
14.2 Decision Tree Problem solv- Both Team Small •• Medium
ing
14.3 Fault Tree Problem solv- Both Team Small •• Easy
ing
14.4 5 Whys Problem solv- Both Team Any size • Easy
ing
14.5 Iskikawa Dia- Problem solv- Both Team Small •• Easy
gram ing
14.6 Is / Is Not Anal- Problem solv- Both Individual / Small • Easy
ysis ing Team
15.1 Benchmaking Improvement Both Individual / Any size •• Medium
Team
15.2 Affinity Dia- Improvement Both Individual/ Small • Easy
gram Team
15.3 Quality Circles Improvement Both Team Small • Easy
15.4 Brainstorming Improvement Both Team Small • Easy
15.5 6 Thinking Hats Improvement Both Team Small •• Medium
16.1 Six Sigma Reducing vari- Both Team Large ••• Difficult
ation

ISO/DIS 10009:2022(E)
16.2 Toyota Produc- Reducing vari- Both Team Large ••• Difficult
tion System ation
16.3 Total Quality Reducing vari- Both Team Large ••• Difficult
Management ation
16.4 Dynamic Work- Reducing vari- Both Team Large ••• Difficult
ing Design ation

ISO/DIS 10009:2022(E)
Annex C
(informative)
Storyboard examples for Quality Tool Application

ISO/DIS 10009:2022(E)
Bibliography
ISO Standards
[1] ISO 5807:1985, Information processing — Documentation symbols and conventions for data,
program and system flowcharts, program network charts and system resources charts
[2] ISO 9004:2018, Quality Management – Quality of an Organization – Guidance to achieve sustained
success
[3] ISO 10001:2018, Quality Management – Customer satisfaction – Guidelines for codes of conduct of
organisations
[4] ISO 10002:2018, Quality Management – Customer satisfaction – Guidelines for complaints handling
in organisations
[5] ISO 10003:2018, Quality Management – Customer satisfaction – Guidelines for dispute resolution
external to organisations
[6] ISO 10004:2018, Quality management — Customer satisfaction — Guidelines for monitoring and
measuring
[7] ISO 10005:2018, Quality management – Guidelines for quality plans
[8] ISO 10006:2017, Quality management – Guidelines for quality management in projects
[9] ISO 10007:2017, Quality management – Guidelines for configuration management
[10] ISO 10008:2013, Quality management – Guidelines for business-to-consumer electronic commerce
[11] ISO 10012, Measurement management systems – Requirement for measurement processes and
measuring equipment
[12] ISO 10013:2021, Guidelines for documented information
[13] ISO 10014:2021, Quality management systems -Managing an organisation for quality results –
Guidance for realising financial and economic benefit
[14] ISO 10015:2019, Quality management – Guidelines for competence management and people
development
[15] ISO 10017:2021, Quality management – Guidance for the use of statistical techniques for
ISO 9001:2015
[16] ISO 10018:2020, Quality management – Guidance for people engagement
[17] ISO 10019:2005, Guidelines for the selection of quality management system consultants and the use
of their services
[18] ISO 13053-1, Quantitative methods in process improvement – Six Sigma— Part 1: DMAIC
methodology
[19] ISO 13053-2, Quantitative methods in process improvement – Six Sigma— Part 2: Tools and
techniques
[20] ISO 14971:2019, Medical Devices – Application of risk management to medical devices
[21] ISO 16355-1:2015, Application of statistical and related methods to new technology and product
development process — Part 1: General principles and perspectives of Quality Function Deployment
(QFD)

ISO/DIS 10009:2022(E)
[22] ISO 31000:2018, Risk management – Principles and guidelines

[23] ISO 31010:2019, Risk management – Risk assessment techniques
Published references
[24] Strategy Competitive, Techniques for analysing industries and competitors. Michael Porter.
The Free Press. 1998. ISBN: 0029253608
[25] The Execution Premium, Kaplan and Norton,
[26] Strategy Blue Ocean, Kim and Mauborgne,
[27] What really works, Joyce, Nohira, Roberson.
[28] The Mind of the Strategist, Ansoff, Corporate Strategy; Ohmae.
[29] Kanri Hoshin, Deployment Quality Function, Akao,
[30] Business Excellence Models – EFQM, MBNQA, ABEF; Shingo Prize - Operational Excellence
[31] IATF 16949:2016 – Annex A ; AIAG Advanced Product Quality Planning and Control Plan 2nd
Edition
[32] European Computer Manufacturers Association Standard ECMA-4 Flow Charts, (Nov 1964)
[33] IBM Data Processing Techniques Flowcharting Techniques, GC20-8152-1 (1969)
[34] Charting D.P., Speaking the Language of Process, http://w ww.detail-process-charting.com/
chapter1.htm, accessed 2020-07-09
[35] AIAG FMEA Manual Fourth Edition
[36] AIQG Measurement System Analysis (MSA) Handbook (for IATF 16949)
[37] SAE J 1739
[38] Harvard Business Review, The Balanced Scorecard—Measures that Drive Performance by Robert
S. Kaplan and David P. Norton, January–February 1992
[39] Harvard Business School Conceptual Foundations of the Balanced Scorecard by Robert S.
Kaplan, Working Paper 10-074 (201)
[40] The Practice of Management, Drucker, P., Harper, New York, 1954; Heinemann, London, 1955;
revised edn, Butterworth-Heinemann, 2007
[41] Doran G. T., 1981).
[42] The Quality Toolbox, Nancy R Tague, ASQ Quality Press
[43] What Is This Thing Called Theory of Constraints, Eliyahu M Goldratt ( Author). 1999
[44] Learning to See: Value Stream Mapping to Add Value and Eliminate Mudaby Mike Rother and
John Shook | 1 December 1999
[45] Taiichi Ohnos Workplace Management, Special 100th Birthday Edition, Taiichi Ohno 27
November 2012
[46] Work Breakdown Structure NASA, (WBS) Handbook NASA SP-2016-3404 Rev.1 . NASA | 2
February 2019
[47] 5 Pillars of the Visual Workplace: Volume 1. Hiroyuki Hirano | 1 January 1995

ISO/DIS 10009:2022(E)
[48] Understanding Measuring, Improving Overall Equipment Effectiveness, How to Use OEE to
Drive Significant Process Improvement. Ross Kenneth Kennedy | 23 August 2017
[49] Production levelling in the scope of Bosch Production System: Produktionsnivellierung Bosch
Produktions System BPS (Heijunka). Johannes Köck | 10 November 2017
[50] Quality is Free, Philip Crosby (ISBN: 9780451621290)
[51] Cost Poor-Quality, Implementing, Understanding, and Using the Cost of Poor Quality, H. James
Harrington: (ISBN: 9780824777432).
[52] Cost-Benefit Analysis of Quality Practices, Robert T McCann | 9 March 2012
[53] Cost of poor quality Standard Requirements. Gerardus Blokdyk | 25 August 2021
[54] Planning Quality, and Analysis, J.M. Juran and Frank L. Gryna:, McGraw Gill, 1980#
[55] Guide to Quality Control, Kaoru Ishikawa | 1 December 1986
[56] The Conceptual Representation and the Measurement of Psychological Forces, Kurt Lewin | 6
November 2013
[57] Performance improvement of management systems - Guidelines for procedures and methodology
for continual improvement (JIS Q 9024:2003)
[58] Quality Control Handbook J., M Juran
[59] Kepner-Tregoe Decision Analysis as a Tool to Aid Route Selection. Part 1. Parker, JS and Moseley,
JD. American Chemical Society. Organisation Process Research and Development. 2008.
[60] Benchmarking: The Search for Industry Best Practices that Lead to Superior Performance.
Robert C. Camp | 31 August 2006
[61] The Certified Six Sigma Black Belt Handbook TM Kubuaz and Donald W. Benbow
[62] Improvement Continuous, Volume 19: Quality Control Circles in Japanese Industry. Paul
Lillrank and Noriaki Kano | 1 January 1989
[63] Quality tools A to Z, ASQ, The Six Sigma black belt handbook
[64] Quality Circles - After the Fad by Edward E. Lawler III and Susan A. Mohrman
[65] Euskalit. 25 años de ideas, modelos y herramientas para la mejora en la gestión: pasado, presente
y futuro
[66] Father of the Brainstorm, Alex F. Osborn.
[67] Six-Sigma Mikel Harry, Schroeder Richard, Doubleday/Random House Inc., 2000
[68] Six-Sigma Implementing, Forrest W Breyfogle III, John Wiley & Sons, Inc. 2003
[69] Mapping Mind, Buzan Tony, 1996.
[70] Hats Six Thinking, de Bono Edward, 1970.

ISO DIS 10009 (En) - Quality Management - Guidance For Quality Tools and Their Application

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Quality management — Guidance for quality tools and

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DRAFT INTERNATIONAL STANDARD ISO/DIS 10009:2022(E)

Quality management — Guidance for quality tools and

3 Terms and definitions

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5.1 Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis

BENEFITS POINTS TO NOTE

5.2 Political, Economic, Social, Technological, Legal and Environmental (PESTLE)

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BENEFITS POINTS TO NOTE

5.3 Porter’s Five or Six Forces

BENEFITS POINTS TO NOTE

5.4 Vision and Mission Statements

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c. The future Horizon – e.g., the future state or end point

Benefits Points to note

5.5 Other relevant resources

6 Process Approach and Planning

6.1 SIPOC / COPIS (useful for identifying processes).

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SIPOC is used for:

BENEFITS POINTS TO NOTE

6.2 Turtle diagrams

BENEFITS POINTS TO NOTE

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6.3 Control plans

BENEFITS POINTS TO NOTE

6.4 Flow Charts / Swim Lane Diagrams / Cross-functional Flow Chart

BENEFITS POINTS TO NOTE

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BENEFITS POINTS TO NOTE

6.5 Authority Matrix / RACI / Matrix Diagram

BENEFITS POINTS TO NOTE

6.6 Other relevant resources

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— Quality Plans (ISO 10005:2018)

7 Risk and opportunity

7.1 Structured What If Technique (SWIFT)

BENEFITS POINTS TO NOTE

7.2 Risk Register / Risk Assessment

BENEFITS POINTS TO NOTE

7.3 Failure Mode and Effects Analysis (FMEA)

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Variants of the tool may be seen in:

BENEFITS POINTS TO NOTE

7.4 Traffic Light / Heat Maps

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BENEFITS POINTS TO NOTE

7.5 Other relevant resources

8 Objectives and Objective Management

BENEFITS POINTS TO NOTE

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