Quality Management

STEP NOTES
Quality Management
2 015 E D I T I O N
ACKNOWLEDGEMENT
RRC acknowledge the contributions of the following authors:
Colin Bentley, Diploma in Management Studies (UMIST)
Peter McGuire, MSc, BSc, MIQA
Frank Southall, BTech (Mech Eng), Dip EM
Every effort has been made to trace copyright material and obtain permission to reproduce it. If
there are any errors or omissions, RRC would welcome notification so that corrections may be
incorporated in future reprints or editions of this material.
RRC Ref. SNQUA
© RRC International
All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form, or by any means, electronic, electrostatic, mechanical, photocopied or otherwise, without the
express permission in writing from RRC International.
QUALITY MANAGEMENT
STEP NOTES
CONTENTS
LIST OF TOPICS PAGE
INTRODUCTION .................................................................................... 1
ABBREVIATIONS ................................................................................... 1
GLOSSARY OF TERMS ............................................................................ 2
QUALITY DEFINED ................................................................................ 5
SPECIFYING QUALITY ............................................................................ 6
CERTIFYING QUALITY............................................................................ 9
PROJECT MANAGEMENT AND QUALITY ................................................. 13
DESIGNING FOR QUALITY.................................................................... 15
QUALITY REVIEW TECHNIQUE ............................................................. 19
DESIGN CONTROL ............................................................................... 21
SUPPLIER QUALITY ............................................................................. 23
STATISTICAL PROCESS CONTROL (SPC) ............................................... 24
MANAGING QUALITY ........................................................................... 25
STANDARDS........................................................................................ 27
QUALITY REVIEW ................................................................................ 32
ISO 9000 AND ISO 14000 IN PLAIN LANGUAGE ..................................... 37
THE ISO 9000 SERIES .......................................................................... 39
ISO 14000 .......................................................................................... 41
QUALITY COSTS .................................................................................. 43
THE QUALITY ‘GURUS’ ......................................................................... 46
TOTAL QUALITY MANAGEMENT (TQM).................................................. 51
REPORTS ............................................................................................ 52
CONFIGURATION MANAGEMENT .......................................................... 53
QUALITY AWARDS ............................................................................... 55
SIX SIGMA .......................................................................................... 59
QUALITY AND INFORMATION TECHNOLOGY ......................................... 60
QUALITY TOOLS AND TECHNIQUES ...................................................... 61
STEP NOTES Quality Management
INTRODUCTION
 How do you define quality?
 What is Total Quality Management?
 What is Excellence?
 How can Zero Defects be achieved?
 How does a quality circle work?
Questions like these will often come up in quality matters and as a quality
practitioner or manager, you need to have a good understanding of the
fundamentals of quality and quality procedures.
ABBREVIATIONS
Allied Quality Assurance Publications (AQAP).
British Standard (BS).
British Standards Institution (BSI).
Chief Executive Officer (CEO).
European Foundation for Quality Management (EFQM).
Failure Mode and Effects Analysis (FMEA).
Fault Tree Analysis (FTA).
International Organisation for Standardisation (ISO).
Just in Time (JIT).
Managing Director (MD).
Project Initiation Document (PID).
Quality Assurance Management System (QAMS) (synonymous with QMS).
Quality Function Deployment (QFD).
Quality Management System (QMS).
Statistical Process Control (SPC).
Total Quality Management (TQM).
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Quality Management STEP NOTES
GLOSSARY OF TERMS
Failure Mode and Effects Analysis (FMEA) - the study of potential failures to
determine their effects. If the criticality factors are included, the objective is then
to determine which features of the product design, production and operation are
critical to the modes of failure.
Fault Tree Analysis (FTA) - a method of studying potential failures of a system or
product. It differs from FMEA in three respects:
 Studies the negative outcomes, which are serious enough to warrant further
analysis.
 Analyses situations in which a negative event will not occur unless several
prior events take place.
 Shows more explicitly the relationship between events which interact.
It is a useful tool for investigating safety issues.
International Organisation for Standardisation 9000 Series (ISO 9000) - a standard
equivalent to BS 5750 which it supersedes. It is the model for most QMS standards
and describes what should be done within a given quality system, but not how it
should be done.
Just in Time (JIT) - producing only what is wanted, when it is needed, and in the
quantity that is required.
PRINCE 2 - a structured project management method widely used in both the
public and private sectors (acronym of PRojects IN Controlled Environments).
Project Assurance - part of the responsibilities of each project board member,
which may be delegated.
Project Initiation Document (PID) - the working document which defines the
project: what, why, who, how and when. It contains the Project Quality Plan and is
raised in the first instance from the Project Brief.
Quality - “degree to which a set of inherent characteristics fulfils requirements”
(ISO 9000:2005). A “characteristic” is defined as a “distinguishing feature” and
“requirement” is defined as a “need or expectation that is stated, generally implied
or obligatory” (ISO 9000:2005).
Quality Assurance – “part of quality management focused on providing confidence
that quality requirements will be fulfilled” (ISO 9000:2005). It is the regular
planned actions which satisfy quality requirements, actioned by a quality
assurance group or department.
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Quality Assurance - quality assurance is the establishment of standards and

procedures to ensure quality, and the audit of all work to ensure that quality
checks are being planned and carried out. Quality assurance is the responsibility of
bodies external to any single project (PRINCE).
Quality Assurance Management System (QAMS) – a model which can be used by
organisations to provide direction for quality assurance controls. A set of
standards covering all aspects of the production of tangible or intangible products.
Note: Quality assurance is not the same as project assurance. Quality assurance is
site- or company-wide. It may be given a role as part of project assurance, but this
is a choice made per project. Project assurance is part of the responsibilities of
each project board member and may be delegated.
Quality Control - “part of quality management focused on fulfilling quality
requirements” (ISO 9000:2005). It is the operational techniques and activities
which sustain the product or service quality to the specific requirements.
Quality Function Deployment (QFD) - provides a method of determining and
focusing on the important customer requirements. It provides the maximum effort
in planning, documentation and communication during the design of the product
or process.
Quality Management System (QMS) - a set of standards which covers all normal
work done by a company or organisation. Each standard will cover the techniques,
tools, required expertise and steps to be used in the creation of a specific type of
product.
Quality Manual - “document specifying the quality management system of an
organisation” (ISO 9000:2005).
Quality Plan - “document specifying which procedures and associated resources
shall be applied by whom and when to a specific project, product, process or
contract” (ISO 9000:2005).
Quality Policy - a general statement of intent with regard to corporate quality. The
policy should be known and understood by all employees and show senior
management’s commitment to the QMS, for which it is the precursor.
Quality Records - record of compliance with QMS.
Six Sigma - a methodology which provides businesses with the tools to improve
the capability of their business processes.
Specification - documented description of product or service.
Statistical Process Control (SPC) - developed by W. Shewhart, the principle is
based on using control charts built on statistical laws. It provides quantitative
evidence of the determination of variation due to common or special causes.
Total Quality Control - Feigenbaum’s term for what is now QMS (QAMS).
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Total Quality Management - a set of objectives requiring a structured approach to

implementation. It requires organisation, planning and programming and
repeated improvement by all personnel and of all aspects of the organisation.
Validation - ratification or confirmation.
Verification - establishment of correctness.
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QUALITY DEFINED
Factors Defining Quality
 Performance and description meeting the published specification.
 Cost economy.
 Availability of advice and information.
 Adherence to delivery date.
 Post-sales service.
 Reliability.
 Safety.
 Compliance with legal requirements.
Some factors are tangible and relate to a product; others are to do with the service
from the supplier in providing or supporting that product. The same principles are
true of service organisations, such as cleaning contractors.
Comparative Quality
Quality Grade: “category or rank given to different quality requirements for
products, processes or systems having the same functional use” (ISO 9000:2005),
e.g. grade of hotel in a hotel guide.
Quality Level: “Any relative quality measure obtained by comparing observed
values with relevant requirements” (BS 4778-2:1991). Usually this would be a
numerical value based on the degree of conformity/non-conformity.
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SPECIFYING QUALITY
Other Definitions of Quality
We have already seen the official definition as per ISO 9000, but how else can we
define quality?
“Quality is conformance to requirements.” (Phil Crosby, businessman and
author).
Quality is fitness for use.
Quality is giving the customer what he or she expects.
All of these definitions of quality are perfectly valid, but a question we should be
asking is:
Who Defines the Quality?
Customers may be competent to specify a unique product - a construction or
engineering project, for example - but more often it is a marketing function to
understand the customer’s needs, both expressed and implied, and develop
products and services which satisfy them.
Thus the origin of specifications may be:
 The customer.
 The supplier (by offering a standard range of products).
 The supplier as a result of market research into the customer’s needs.
Elements of an Effective Specification

BS 7373-1:2001 Guide to the preparation of specifications: Guide to preparation
suggests that the following factors should be considered for their relevance to the
specification of users’ needs (see Table 2 of the standard).
Performance
Performance concerns the required ability of the process, product or service being
defined in the specification. It is subdivided into the requirements concerning:
 Function: factors such as strength, velocity, capacity, shape, size, scope and
range of performance the product must fulfil.
 Material: properties such as hardness, texture, colour, appearance, density,
purities that the product must exhibit.
 Dependability: in terms of reliability and maintainability that the product
must achieve.
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Location
The product will be used, or the device provided, in a particular environment
determined by its physical location. Considerations which must be established
include:
 Environment: factors such as the temperature, altitude/depth, relative
humidity, precipitation, radiation, or pressure the product will have to
withstand.
 Ergonomics and aesthetics: factors such as the accessibility, noise, shock and
illumination levels which are available or can be tolerated.
 Interface: these considerations take account of requirements for the product
to work successfully with other products; this includes compatibility (e.g.
electromagnetic compatibility), size, shape and interchangeability.
Acquisition and Operation

These factors relate to successful operation of the product:
 Training: such as available skills and experience, staff selection, language,
education, custom and culture.
 Safety: such as health, tools and equipment, protective clothing.
 Cost and timing: such as range and scope of actions, marketing and sales
factors, life-cycle costs.
Specification Format
A suggested format and contents for the specification is found in Table 1 of the
standard:
 Identification: title, date, designation, reference and numbers, authority.
 Circulation: distribution list.
 Contents list: guide to layout (clauses, illustrations, annexes, etc.).
 Foreword: the reason for writing the specification.
 Introduction: describes content in general and technical aspects of objectives.
 Scope: range of objectives/contents.
 References: statement of policy about reference documents.
 Definitions: terms used with meanings special to the text.
 Main body of the specification: requirements, guidance and methods.
 Annexes: examples, etc.
 Index: alphabetical index.
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 Bibliography: internal and external publications referred to in the

specification.
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CERTIFYING QUALITY
Certification is intended to bring “standardisation” so that customers can have
confidence in the physical interchangeability and similarity of performance of
items purchased at different times and/or from different suppliers.
Standardising agents can be national, international, industry associations, or simply
large and influential customers. The objectives of these bodies can be to establish
safety standards, interchangeability of products, higher product quality standards,
or better management practices.
Purchasers
Large customers can exercise great influence on their suppliers through their
purchasing power and desire for uniformity, e.g. the ISO/TS 16949:2009 standard
which describes the application of the ISO 9000 QMS to automotive production
and associated service part organisations.
Other standards, such as TL 9000, have been designed specifically for use in the
telecommunications industry. TL 9000 is based on ISO 9000 and incorporates
performance metrics and measurements.
Industrial Standardising Bodies
Multiple Assessment
This would occur where a company supplies to a range of customers, each with
their own certification standard for assessment. It is wasteful of resources for both
parties and could lead to widely differing results. This can be avoided by the use of
regulatory “third-party” assessment schemes.
First-, Second- and Third-Party Assessment
 If a company evaluates itself according to an established standard (i.e. if it
does an “internal audit”), it is a first-party audit or assessment.
 If a customer evaluates a (potential or actual) supplier against the standard, it
is performing a second-party assessment. From the evaluator’s (customer)
point of view this is sometimes described as an “external” audit. From the
recipient’s (supplier) point of view it is sometimes referred to as an “extrinsic”
assessment.
 If the assessment is conducted by an independent specialist, such as a
consultant or a certification body, it is referred to as a third-party assessment.
There are obvious economic advantages all round if a number of second-party
assessments by different purchasers can be replaced by a single, regulatory, third-
party assessment in which all potential customers have confidence.
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National Standardising Bodies

Most developed nations have established a national standards organisation, either
as a government department or an autonomous body. Within the UK this is the
British Standards Institution, established by Royal Charter. In the USA it is ANSI
(American National Standards Institute), in France AFNOR (Association Française
de Normalisation) and so on.
The BSI establishes written standards for a wide variety of products and services of
commercial significance. British Standards are drawn up by all those who have a
particular interest and believe they will benefit by establishing a standard for the
subject concerned. They can include manufacturers, users, research organisations,
government departments and consumers. A typical BSI technical committee
working on such a project could include representatives from all these groups. All
Standards are also made available for public comment before they are issued.
Each year, BSI withdraws obsolete Standards and adds new ones.
As the British national standards organisation, BSI is a member of numerous other
bodies, both European and fully international; for example the International
Organisation for Standardisation (ISO) whose name explains its function, and the
International Electro-technical Commission (IEC) which has a very wide scope.
Through its membership of bodies such as the ISO, BSI is represented on their
policy and technical committees and so plays a part in formulating worldwide
policies and practices, as well as contributing to the development and definition of
new standards.
Types of National Standard
Industry standards agreed on a national basis are often adopted as national
standards, or negotiated in the first place as national standards. Thus it may be
difficult in some circumstances to differentiate between the two; there are
numerous examples in the UK of national standards which are only used by a
particular industry. There are, for example, whole blocks of British Standards on
automotive, marine and aerospace topics, whereas other Standards are sufficiently
general in scope to apply to many or all industries.
Several different types of document may be given the status of national standards
and used for different purposes, for instance:
 Product specifications: e.g. BS 64, Specification for normal and high strength
steel bolts and nuts for railway rail fishplates.
 Services specifications: e.g. BS 7269, Drycleanability of leather garments.
 Materials specifications: e.g. BS 506-1, Methanol for industrial use.
Specification for methanol.
 Management standards: e.g. BS 8210, Guide to facilities maintenance
management.
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 Codes of practice: e.g. BS 8000, Workmanship on construction sites.

 Design guides: e.g. BS 5385-1, Wall and floor tiling. Design and installation of
ceramic, natural stone and mosaic wall tiling in normal internal conditions.
Code of practice.
 Test methods: e.g. BS 1016, Methods for analysis and testing of coal and
coke.
 Inspection criteria: e.g. BS 8461, Football goals. Code of practice for their
procurement, installation, maintenance, storage and inspection.
 Tables of data: e.g. BS 7231-1, Body measurements of boys and girls from
birth up to 16.9 years. Information in the form of tables.
 Definitions of terms, standard symbols and abbreviations: e.g. BS 499-1,
Welding terms and symbols. Glossary for welding, brazing and thermal
cutting.
 Guides: e.g. BS 1916-1, Limits and fits for engineering. Guide to limits and
tolerances.
Product Certification Procedures

Ideally, a customer would like the choice of being able to purchase from a variety
of suppliers, knowing the product will meet a defined grade and quality level, and
be interchangeable or substitutable for a similarly identified certified product from
any other source. Such a scheme demands:
 Consultation between all suppliers and customers contributing to the scheme.
 A source of funding.
 An independent inspectorate and testing laboratory.
 Assessment of suppliers’ quality management systems.
Defined Specifications
With regard to defined specifications of performance and other factors affecting
interchangeability, many product approvals are handled by defined test methods.
Examples are car windscreens and motor-cycle helmets. In all such cases the
supplier has to fulfil two criteria:
 Approval of the product by passing defined tests conducted by BSI or an
independent test laboratory, or by self-certification subject to periodic
independent audit.
 Approval of his quality management system under BS EN ISO 9000.
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The rationale behind the requirement for approval of the quality management
system is that only through effective quality assurance can confidence in the
consistency of product be obtained; in other words, that all batches of helmets, for
example, will withstand impact as well as the batch tested independently.
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PROJECT MANAGEMENT AND QUALITY

Project Initiation Document (PID)
The purpose of this is to define the project, form the basis of its management and
allow an assessment of the successful outcome.
Project Quality Plan

This is part of the PID. Its purpose is to define how the supplier intends to deliver
products which meet the customer’s quality requirements and the supplier’s
quality standards.
Composition
 Quality responsibilities.
 Reference to standards to be used.
 Key product quality criteria.
 Quality control and audit process.
 Change management procedures.
 Configuration management plan.
 Tools to be used to ensure quality.
Derivation
 Customer’s quality expectations.
 Corporate or programme Quality Management System (QMS).
 Produced as an output from Planning Quality.
Quality Criteria
 Is it clear how the customer’s quality expectations are to be met?
 Are the defined ways sufficient to achieve the required quality?
 Are responsibilities for quality defined up to a level which is independent of
project and project manager?
 Does the plan conform to the corporate quality policy?
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Quality Log
This is the record of all the quality checking done in the project. It is updated by
the team manager or individual team member charged with the development and
testing of a product. It forms an audit trail of the quality work done in the project.
The quality log is created during “Initiating a Project” (IP):
 To issue a unique reference for each quality check planned.
 To act as a pointer to the quality check documentation for a product.
 To act as a summary of the number and type of quality checks held.
Log Composition
 Reference number.
 Product.
 Planned date.
 Actual date.
 Result.
 Number of action items.
 Target sign-off date.
 Actual sign-off date.
Derivation
 The first entries are made when a quality check or test is entered on a stage
plan.
 The remaining information comes from the actual performance of the check.
 The sign-off date is when all corrective action items have been signed off.
Quality Criteria
 Is there a procedure in place which will ensure that every quality check is
entered into the log?
 Has the responsibility for the log been allocated?
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DESIGNING FOR QUALITY

Design of any product or project is fundamental to the ultimate quality. Any
following process of manufacture, installation or documentation will not correct or
improve faults in the design process. Programme Evaluation and Review
Technique (PERT) and PRINCE 2 are techniques which ensure that design is given
the high priority essential to a good quality product, be it tangible or intangible.
The PRINCE 2 quality path outlined below is a typical methodology which can be
used.
Customer's Quality ISO 9001

Expectations
Project Approach
Project Quality Plan Quality Policy
Stage Quality Plan QMS
Product Description Quality Assurance
Project Issues
Quality Review
Quality Log
The Quality Path
Customer’s Quality Expectations

This is essentially an agreement between customer and supplier as to the quality
requirements of the customer in terms of cost, quality and time and is a pre-
project action during the start-up of a project. From this the project mandate is
produced and subsequently the project brief.
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International Organisation for Standardisation (ISO 9000)

ISO 9000 is part of an international standard for quality systems, issued under the
authority of the ISO. It applies to quality assurance in the design/development,
production, installation and servicing of a product.
Earlier, we referred to the ISO 9000 definition of quality. Informal interpretations
of this definition are:
 The quality of a product is its suitability for the purpose for which it is
intended. Within this definition both tangible and non-tangible products are
included.
 The quality of the process is its ability to deliver the product in a trouble-free
way.
Quality applies to two areas of production, the product and the process by which it
is produced.
It is more cost-effective to design quality into a product or process than to fix the
problem later. For example, to recall 50,000 cars to replace a £1.50 seal on a faulty
brake system is an expensive option in comparison to the identification of the
correct specification in the design stage.
Quality Policy
A company and its suppliers may have a quality policy which can be a simple
statement of intent based on some recognised standard, e.g. ISO 9001. If both use
the same standard for their respective policies, the harmonisation makes quality
assurance easier to apply. Some large companies specify that a certain standard is
followed by the supplier when projects are put out to tender.
A company’s approach to quality should stem from a mission statement from its
senior management about the quality expected from its workers, e.g. “If it’s not
excellent, it’s not good enough”. The company quality policy should be backed up
by the allocation of quality responsibilities, defined in the company’s QMS if it has
one. To have any teeth, these responsibilities should reach high enough in the
organisation to ensure that quality concerns are not overridden by cost or time
constraints.
Quality Management System
With a policy in place, a QMS can be established which defines the company set of
standards for each of the activities, whether production techniques or procedures.
Quality Assurance
A group responsible for setting and monitoring the standards defined in the QMS
should be set up as a separate department. The ultimate person responsible
should be at the highest level in the company - the CEO or MD.
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Where an organisation has a quality assurance group, it requires a place in the

project organisation structure. The quality assurance group will have set the
standards which will be used in the project and part of their job is to monitor the
implementation of those standards. A role as part of the project assurance is the
ideal way to establish a formal position in the project for quality assurance.
Both the customer and supplier may have a quality assurance group. Both may
require a project assurance role. They may report either to members of the
project board, for example, senior user and senior supplier, or to whoever in the
organisation has overall quality responsibility, such as the MD.
Product Quality Plan

This defines the desired quality of the project products. It will contain general
criteria and specific quality standards including documentation. Agreement
between those who develop and those who use and operate the product is
essential and once agreed is fixed. The topics in the agreement are:
 The quality standard to be used.
 The quality control methods, tests and quality review method.
 Major products of the project subject to quality review and formal test.
Stage Quality Plan

This should identify:
 Specific quality reviews to be held.
 Planned dates for review.
 Members and chairperson of the review board.
 Product descriptions for every stage product.
 Review checklists for each product.
 Product tests contained in the stage, and test methods used.
 Timing and resources for the above activities plus allowance for error
correction.
Product Description
Written product descriptions are part of the planning process. The product should
be described in terms of its purpose, composition, derivation, format, quality
requirements, methods of checking quality and the agreement of the user and
developer of the product as to the description. This ensures that all concerned
have a clear idea of what is to be produced and that at quality review there is a
benchmark against which comparison can be made. Products should be described
under the headings shown below and include department, project, national and
international standards and review checklists:
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 Title.
 Purpose.
 Composition.
 Derivation.
 Format.
 Quality criteria.
 Quality method.
Product Quality Criteria

 Functional requirements.
 Performance.
 Practicability.
 Security.
 Compatibility.
 Reliability.
 Maintainability.
 Clarity.
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QUALITY REVIEW TECHNIQUE

Purpose
Quality review is basically a structured review of a document by a group of people
in a planned, documented and organised fashion. The people involved have been
nominated at creation of the stage plan. The technique links with the
configuration management part of the project organisation, which will be
responsible for releasing copies of the document to be reviewed, freezing the
original copy and updating the status of the product. There is also a link with the
project support office, which might undertake the organisation of the review and
the dissemination of the documentation.
Quality Log
The results of each quality review should be entered on the quality log, which is
used as a quality audit trail by the project manager. If planned participants and
dates are in the log as well as actual results, the project manager can spot any
slippage or quality problems.
The maintenance of a quality log is also part of the requirements of standards such
as ISO 9000.
Stage Quality Plan
This is not a separate document, but part of the stage plan. It defines how, when
and by whom a product is to be tested. The stage quality plan is a lower and more
detailed level of part of the project quality plan. The two should therefore be in
harmony. No test methods should be used at stage level which were not identified
in the project quality plan.
Project Assurance
Quality reviews are a key point at which project assurance can check the quality of
the products. They may either attend personally or identify experienced personnel
who should attend on their behalf. For example, if the senior user in a small
project was carrying out his or her own assurance, they might examine the draft
stage plan, identify products of key importance to them, but delegate inspection of
the product to people with more detailed experience.
Note: Quality assurance is not the same as project assurance. Quality assurance is
site- or company-wide. It may be given a role as part of project assurance, but this
is a choice made per project. Project assurance is part of the responsibilities of
each project board member and may be delegated.
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Project Issues
These have many potential impacts on quality. A project issue may be reporting a
quality problem with a product. It might be thought that such problems would be
handled on an action list as part of a quality review or some other test. However, a
quality problem may be found in a product which has already been approved, or a
review might discover a problem in a product which is not the one being inspected.
There is also the possibility that an action item from a quality review may be found
to require a lot of time. It may even be decided, because of time constraints, to
approve a product which contains an error. In both these latter cases the error can
be transferred to a project issue, so that a record exists and the error will not be
overlooked.
If a project issue requires changes to one or more products, the relevant Product
Descriptions should be checked to see if they also need changing.
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DESIGN CONTROL
The supplier should establish and maintain procedures to control and verify the
design of the product in order to ensure that the specified requirements are met.
He or she should draw up plans to identify the responsibility for each design and
development activity. Plans are updated as the design develops.
Activity Assignment
The design and verification activities should be planned and assigned to qualified
personnel equipped with adequate resources. The work package identifies the
responsibility for the work and the stage and team plans show the assignment of
personnel to activities and the facilities and equipment required.
Organisational and Technical Interfaces
Such interfaces between groups should be identified and the necessary
information documented, transmitted and regularly reviewed:
 Project Initiation.
 Stage Assessments.
 Project Closure.
Design Input
Requirements relating to the product should be identified and reviewed by the
supplier. Incomplete, ambiguous or conflicting requirements should be resolved
with those responsible for them.
Design Output
This should be documented and expressed in terms of requirements, calculations
and analyses and should:
 Meet the design input requirements.
 Contain or reference acceptance criteria.
 Conform to appropriate regulatory requirements.
 Identify those characteristics of the design which are crucial to the safe and
proper functioning of the product.
Design Verification
The supplier should plan, establish, document and assign to competent personnel
functions for the design. Design verification should establish that design output
meets the design input by means of appropriate control measures.
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Design Changes
The supplier should establish and maintain procedures for the identification,
documentation and appropriate review and approval of all changes and
modifications.
Design and Development Planning

The supplier should produce plans to identify the responsibility for each design and
development activity. Plans should be updated as the design develops.
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SUPPLIER QUALITY
Quality Policy
The supplier’s management should define and document its policy with respect to
quality.
Quality System
The supplier should establish and maintain a documented quality system as a
means of ensuring that products conform to specified requirements. It should
include:
 The preparation of documented quality system procedures and instructions.
 The effective implementation of the documented procedures and
instructions.
Quality Controls
The supplier should have clearly defined technical and management procedures:
 Product-based planning.
 Product descriptions defining the product quality criteria.
 Supplier audit.
Where the supplier company is ISO 9000 registered (or the appropriate standard
dependent upon the type of company) then a cursory audit would suffice.
Where the company is not registered, the quality system in use is examined
against the requirements of ISO 9000 or some other agreed standard of quality.
© RRC 23
STATISTICAL PROCESS CONTROL (SPC)

Developed by W. Shewhart, the principle is based on using control charts with a
foundation in statistical laws. It provides quantitative evidence of the
determination of variation due to common or special causes. It is, however, a
preventative or retrospective measure in that it fixes problems after they have
occurred. QFD addresses the problem much earlier and to greater effect in that
the customer’s requirements are influential at the start and at each stage of the
product or process.
24 © RRC
MANAGING QUALITY
Project Manager
The project manager has the authority to run the project on a day-to-day basis for
and on behalf of the project board within the constraints it has laid down.
Dependent upon the project, the project manager can be appointed from either
the customer or supplier company. In either case his or her responsibility is to
ensure the production of the product within cost, to time and to the required
quality standard.
In detail the specific responsibilities are:
 Manage the production.
 Direct the team.
 Plan and monitor the project.
 Produce the Project Initiation Document.
 Delegate any project assurance roles.
 Prepare project, stage and exception plans with team leaders and the Board.
 Liaise with and report to the Project Board via Highlight Reports and Stage
Assessments.
 Manage business and project risks.
 Liaise with programme management if the project is part of a greater whole.
 Responsible for overall progress and use of resources.
 Responsible for change control and Configuration Management.
 Agree technical and quality strategy with Board appointee.
 Prepare Lessons Learned Report.
 Prepare End Project Report.
 Prepare Follow-On action.
 Responsible for project administration.
 Liaise with suppliers.
Configuration Management
Configuration items to be considered:
 Sum of all products.
 Quality documentation optional.
 Management documentation optional.
© RRC 25
Configuration management plays several roles in ensuring the management of

project quality. Use of the correct version of a product is clearly a quality
requirement. Identifying all products affected by a requested change is a quality
matter, because failure to spot such a product will give rise to a failure or quality
problem later on. An example would be failure to update documentation in line
with the change to a product.
Configuration management provides the ability to trace the origin of work which
causes a later fault. It can also tell the project manager of the status of a product;
for example, any product which has not yet been quality checked.
A configuration audit identifies any disparity between the actual and recorded
version numbers, thus providing the information to prevent people from using the
wrong version. Imagine producing a bill of materials to tell a car assembly line
what is required to produce thousands of a particular model. It would be essential
to state the correct version numbers of all the parts or the whole thing would not
fit together or would not work properly when built.
26 © RRC
STANDARDS
Company Quality Policy
See Quality Policy under DESIGNING FOR QUALITY.
ISO 9000
This is one example of a set of national or international standards (or quality
requirements) which might form the basis for a customer’s quality expectations or
the way in which those requirements might be met. For instance, a customer
might look for a supplier whose work is certificated as meeting the requirements
of that standard, e.g. a heating engineer who is a registered gas installer. This
means the company’s work has been independently inspected and meets a certain
standard.
Quality Management System (QMS)
The set of standards, work steps and responsibilities to be used for a particular
type of work should be recorded in a company’s QMS. This will certainly be so if
the company is registered or certificated under any national or international
standard, such as ISO 9000.
Customer
The customer may have a QMS which it requires its own people to use. If so, it
may wish to have this used on the project.
Supplier
The supplier may have a QMS which it wishes to use for the work. The supplier’s
staff may be more familiar with the requirements of their own QMS and be more
efficient using this than having to change to new standards. One thing to consider
here is whether the customer’s staff will be responsible for the maintenance and
enhancement of the product after it is delivered. If so, will they be able to deal
with a product built to standards which are different from their own?
There must be agreement during the initiation stage on which set of standards or
what amalgamation of the two sets will be used for the project.
Quality Assurance
A QMS is normally created by and would be monitored by an independent quality
assurance group, thus creating the reason why this group might want
representation on the project through the project assurance role.
© RRC 27
When designing the assurance part of the team, it is necessary to consider the
possibility of both the customer and supplier having quality assurance functions
which require representation.
Project Brief
The project manager has to ensure that the project brief contains a statement of
the customer’s quality expectations. This is done as part of the pre-project process
“Starting Up a Project” (SU). It will go forward and become part of the project
quality plan in the Project Initiation Document, created during the process
“Initiating a Project” (IP).
Project Mandate
This is the original request to carry out a project. It may be formal and contain all
the information required, or it may need expansion before the project can begin.
It should contain the customer’s quality expectations. If not, it is the project
manager’s job to ascertain what those expectations are. The information goes
forward to the project board as part of the project brief.
Customer’s Quality Expectations
The customer should give a lot of thought to the required quality of the end
product. The construction, testing and customer verification of quality all take
time and money. The customer must balance the desired quality with these
considerations. The quality expectations should consider such things as the
potential impact of the product’s failure, for how long it is to be used and the
added value of its use. This implies that the senior user should discuss the quality
expectations and their financial implications with the executive.
Project Approach
How a solution is to be provided will affect how its quality can be tested. This is a
chicken-and-egg situation, because the required quality may influence the choice
of project approach. For example, should a company create its own statistical
analysis software package or buy one off-the-shelf? The bespoke version would
provide a complete fit with some special requirements, but the cost and time
taken compared to buying an off-the-shelf product would be very difficult to
justify. This is the kind of question which a feasibility study would be asked to
resolve prior to the project.
Stage Quality Plan
This is where the detail of how, when and by whom quality will be checked is
planned. The stage quality plan is part of the stage plan and will be reflected in its
Gantt or bar chart and text. It is created as part of the stage plan in the sub-
process “Planning a Stage” (SB1).
28 © RRC
For each product delivered by the stage the plan should show when quality is to be
tested and the resources to be used. The Product Descriptions will show the
method to be used.
Work Packages
Part of a work package authorisation is agreement on how the product(s) will be
tested. This links across to the need of project assurance to see the team
manager’s plans, agree with the quality checking method to be used, and add any
relevant checkers of their own. This may mean that the agreement and the team
plan go through a negotiation until project manager, team manager and project
assurance are agreed.
Quality Log
See Quality Log under QUALITY REVIEW TECHNIQUE.
The quality log is the audit trail of quality work. The customer (or project
assurance) can inspect it at any time to verify that quality work is being carried out.
It is therefore another check on quality for project assurance apart from
appointing resources to attend the quality checks.
It is also a way in which the project manager can check on what is happening in
regard to quality checking and check back on who was involved if a later quality
problem appears.
As part of the reporting arrangements of a work package authorisation, the team
manager is required to complete entries in the quality log, giving dates and details
of each quality inspection or test. The details would include who was involved,
reference to any test products used and what the results were.
Project Assurance
The Project Board is accountable for project assurance and may delegate to third
parties independent of the Project Manager. The number of appointees and scope
will depend on the size and type of project.
Project assurance has the responsibility to satisfy itself that draft stage and team
plans contain adequate details of when, how and by whom products in the plan
are to be inspected. It also has the task of ensuring that the supplier is able to
deliver to the required quality standard.
See also Project Assurance under QUALITY REVIEW TECHNIQUE.
External Supplier
It is dangerous for the project manager to rely completely on an external supplier
to deliver products of the required quality. Finding out that quality is inadequate
after product delivery is going to be expensive in terms of time and cost to correct.
© RRC 29
There are many facets to obtaining “the expected quality” from external suppliers:
 Is there a clear definition of “expected quality” or was it assumed?
 Has the manager put in place the necessary monitoring of the quality of the
external supplier’s work during development, rather than leaving it until the
supplier delivers? At these times is quality being checked by people who
represent the customer, rather than relying on the supplier’s staff? This is
part of quality assurance, checking that the supplier’s plans contain sufficient
quality checks and that the right people are to be involved in them.
Contractual Terms
When dealing with external contractors it may be necessary to insert into the
contract the right of project assurance to examine team plans and insist on the
inclusion of identified resources in quality checking. Otherwise there may be
difficulties in getting the contractors to accept this modification of their plans.
Product Descriptions
A product description is written for each major product of a plan.
Writing the product description tells the planner whether he or she knows enough
about the product to estimate the work needed, and can often trigger realisation
of another required product. Descriptions can improve the quality of the plan.
See also Product Description under DESIGNING FOR QUALITY.
Quality Criteria
An essential part of ensuring quality is the definition before a product is built of the
quality criteria required from that product. This is given to the developer as part of
the work package. Those reviewing the completed product also use the quality
criteria as a measure of its quality. It is therefore important that a lot of thought is
given to appropriate, measurable and meaningful criteria, otherwise they do not
act as a yardstick of whether the product is of the required quality or not.
Writing good quality criteria is not a trivial job and requires experience. As an
example, a list of general quality criteria for any document is given below:
 Clear and concise.
 Accurate.
 Comprehensive.
 The composition matches that stated in the Product Description.
 The grammar and spelling are correct.
 The product meets the defined standard.
 The product is on the required form.
30 © RRC
 Reflects accurately the information contained in/required by the derivation

material.
 The information is at the correct level for the readership.
 Free from jargon which is unknown or unexplained to the readership.
 Information is provided under every expected heading.
 The information provided under each heading is appropriate to that heading.
 Input has been provided from all the relevant parties.
 The document’s summary/conclusions are consistent with the body of the
report.
 The product fulfils its stated purpose.
 Delivered on time.
 The contents match the contents page.
 The product’s author is clearly indicated.
 The distribution list is provided and correct.
 The version number is clearly indicated and correct.
 The header and footer information matches the required standard.
Quality Method
Each Product Description should identify the method, tool or technique to be used
to check the product quality. It can also state who should carry out the quality
inspection or approval.
User/Project Assurance Involvement

It is important to involve the user and project assurance in the writing of Product
Descriptions. They are the best people to define the information required,
especially the quality criteria.
© RRC 31
QUALITY REVIEW
An inspection which sets out to check that the document in question matches the
quality criteria in the Product Description. It has a specific structure and defined
roles and procedures.
Stage Quality Plan

See Stage Quality Plan under QUALITY REVIEW TECHNIQUE.
Change Control and Quality

If close control is not kept over changes, quality is likely to suffer in one or more
ways:
 If uncontrolled changes are made, the financial quality of the project may
suffer. Changes incur cost. If there has been no agreement between
customer and supplier to add to the project’s budget, it is likely that the
project will overrun its budget.
 For the same reasons uncontrolled changes may also affect the ability of the
project to complete on time.
 If changes are made without project board approval, the final product may
not be what the project board expects, thus representing a quality problem.
 If a change is made which is not properly tested and contains errors, this is
another quality problem. If all associated products, such as documentation,
are not updated at the same time as the change, there is yet another quality
problem.
Reports
Those listed below are essential to the project manager and the Project Board and
are noted in the Quality Log.
Quality Log Report
See Quality Log under STANDARDS.
Checkpoint Report
This is a time-driven progress report from a team to the project manager. To make
consolidation easier, it will normally have the same three sections as the highlight
report: products delivered in the current period, products to be delivered in the
next period and problems. The last section is where a team manager would report
on any quality problems, possibly to back up with more detail an entry in the
quality log. This report can be either written or verbal, according to the wishes of
the project manager. Its frequency is defined as part of the work package
authorisation.
32 © RRC
Highlight Report
This is a time-driven report from the project manager to the project board. The
latter defines the frequency in the PID. It is usually a summary of a number of
checkpoint reports. It gives the project manager the first formal avenue to tell the
project board of any quality problems. Remember, quality may refer to products,
time or cost. It can be used to get project board pressure brought to bear on the
source of the quality problem. Examples might be:
 The users are too busy to identify their requirements properly or assist in
writing Product Descriptions.
 Supplier staff are delivering products of poor quality or obstructing project
assurance staff in quality inspections.
End Stage Report

Part of each end stage report should cover the quality work of the stage; how
many checks of each type were carried out, confirmation that the quality of all
products has been checked in some way, any quality problems (e.g. inadequate
tools) and confirmation of the project assurance work.
Exception Report
If there is a serious quality problem, this should be entered on a project exception
report and presented to the project board.
Quality Manual
ISO 9000 requires a formal quality manual, which we defined earlier.
Project Quality Plans

The plan is created during the process of Initiating a Project and defines how the
project will meet the customer’s quality expectations. The project quality plan
identifies the standards to be used, and quality responsibilities for the project in
terms of who has the quality assurance for it.
Responsibilities
The identification of responsibilities for quality is part of the project plan.
Depending on the project, this will cover any specific responsibilities for, for
example, the project manager, team managers, project assurance, and any quality
assurance or internal audit from customer and/or supplier.
© RRC 33
Senior Supplier
The senior supplier is responsible for the quality of the products to be delivered by
those he or she represents. This means that the other members of the project
board can press the senior supplier on matters which affect the quality of the
products to be delivered. This is a very effective way of bringing pressure to bear
on the relevant team managers from their own management. One useful check
during the design of the project management team is to ensure that the senior
supplier has sufficient authority for this task.
Senior User
The senior user has a dual quality role. Firstly, the role is responsible for the
quality of the requirements specification, its completeness and clarity. Secondly,
the senior user must check regularly that a product is being designed and
developed which will satisfy those requirements. Where the project is large or
complex the senior user may wish to delegate the assurance of these two things:
 What internal documents are invoked.
 What additional documents have been created for the specific contract.
The one certain common factor between the plan and the purely internal system
will be the existing Quality Manual.
Purpose of the Quality Plan
This is to specify how the quality system described in the quality manual will be
applied to a particular project or contract and to give details of the specific
practices, resources and activities which either have been or will be developed for
this purpose.
Quality plans are used to demonstrate how the quality requirements of a particular
contract will be met, and to monitor and assess adherence to those requirements.
While a quality plan usually refers to the appropriate parts of the quality manual, it
can be used in conjunction with a quality system or as a stand-alone document.
Quality plans can also provide a mechanism by which to tie specific requirements
of the service/product or contract to existing procedures. They do not require a
separate set of procedures or instructions in addition to those which already exist.
34 © RRC
Guidelines for Quality Plans

Earlier, we described a “quality plan” according to the ISO 9000 series definition.
These plans are generally one of the outputs of the quality planning process.
The ISO 9001 QMS model requires suppliers to plan and develop processes for
“Product Realisation”. This latter term sounds mysterious but it is simply
everything you do to bring a product/service to market (so, designing,
manufacturing, delivering the finished product/service to the customer). This
needs a bit of quality planning and, in relation to the requirements for specific
products, projects or contracts, the main document outlining processes and
resources needed is usually referred to as a “quality plan”.
There is a specific guideline on quality plans (ISO 10005:2005). The contents of
plans are not prescriptive and they may be documented in a variety of formats,
e.g. tabular, flowcharts, descriptive text. The standard suggests that the following
activities are addressed in the plan (as appropriate):
 Scope.
 Quality objectives (e.g. on-time delivery).
 Management responsibilities (who is responsible for what).
 Documentation (e.g. contract retention times).
 Records (to provide evidence of activities).
 Resources.
 Requirements review/customer specifications (e.g. review customer
requirements prior to acceptance to make sure that you can meet them).
 Customer communication (e.g. how do you collect customer feedback?).
 Design and development (this may be required for a customer requirement
which is outside your standard product range).
 Purchasing (do you inspect incoming raw materials to make sure that they
meet quality standards?).
 Production (usually, this is standard operating systems).
 Identification and traceability (again, standard operating procedures).
 Customer property (ensuring confidentiality of disclosed information and any
specially supplied materials supplied by the customer, such as packaging).
 Storage and handling (security of, and also care to avoid damage).
 Non-conforming products (how do you treat product that falls outside the
agreed specification?).
 Monitoring and measurement (sampling/testing).
© RRC 35
 Inspection and test equipment (calibrations, etc.).

 Audit (internal, customer and regulatory).
Once prepared, a Quality Plan should be revised and authorised by the supplier
and submitted to the customer either pre or post bid for the work. After being
revised according to the pre-contract negotiations, the plan should be submitted
again to the customer for acceptance before commencing the activity.
Management Review
 Internal Audit.
 Supplier Performance/Quality.
 Customer Complaints.
 Quality Policy.
 Quality Objectives.
 Quality Manual.
Management Responsibility
 Job Descriptions.
 Organisation Chart.
Contract Review
 Review customer enquiries.
 Approve quotations.
 Approve orders.
 Amendment procedure.
36 © RRC
ISO 9000 AND ISO 14000 IN PLAIN LANGUAGE

This section explains briefly what ISO 9000 and ISO 14000 are and what they are
not.
Both "ISO 9000" and "ISO 14000" are actually families of standards which are
referred to under these generic titles for convenience. Both families consist of
standards and guidelines relating to management systems, and related supporting
standards on terminology and specific tools, such as auditing (the process of
checking that the management system conforms to the standard).
 ISO 9000
ISO 9000 is primarily concerned with "quality management". Like "beauty",
everyone may have his or her idea of what "quality" is. In plain language, the
standardised definition of "quality" in ISO 9000 refers to all those features of a
product (or service) which are required by the customer. "Quality
management" means what the organisation does to ensure that its products
conform to the customer's requirements.
 IS0 14000
ISO 14000 is primarily concerned with "environmental management". In plain
language, this means what the organisation does to minimise harmful effects
on the environment caused by its activities.
Both ISO 9000 and ISO 14000 are concerned with the way in which an organisation
goes about its activities and not directly with the result of this work. In other
words, they both concern processes and not products – at least, not directly.
Nevertheless, the way in which an organisation manages its processes is obviously
going to affect its final product. In the case of ISO 9000, it is going to affect
whether or not everything has been done to ensure that the product meets the
customer's requirements. In the case of ISO 14000, it is going to affect whether or
not everything has been done to ensure a product will have the least harmful
impact on the environment, either during production or disposal, in terms of
pollution or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The
management system standards in these families state requirements for what the
organisation must do to manage processes influencing quality (ISO 9000) or the
processes influencing the impact of the organisation’s activities on the
environment (ISO 14000).
In both cases, the philosophy is that these requirements are generic. No matter
what the organisation is or does, if it wants to establish a quality management
system or environmental management system, then such a system has a number
of essential features which are spelled out in ISO 9000 or ISO 14000.
© RRC 37
A process management approach is widely used in the business world, and this led
to the development of a process-based structure for the latest versions of the ISO
9000 series of standards. This process-based structure is compatible with the Plan-
Do-Check-Act improvement cycle used in the ISO 14000 family of standards on
environmental management systems.
38 © RRC
THE ISO 9000 SERIES

The standard is based on eight quality management principles which can be used
by top management in order to lead the organisation towards improved
performance.
Principles (see ISO 9000:2005)

1. Customer focus.
2. Leadership.
3. Involvement of people.
4. Process approach.
5. System approach to management.
6. Continual improvement.
7. Factual approach to decision making.
8. Mutually beneficial supplier relationships.
Standards and Guidelines
ISO 9000:2005, Quality management systems - Fundamentals and
vocabulary
This establishes a starting point for understanding the standards and defines the
fundamental terms and definitions used in the ISO 9000 family which are
necessary to avoid misunderstandings in their use.
ISO 9001:2008, Quality management systems - Requirements

This is the requirement standard used to assess your ability to meet customer and
applicable regulatory requirements and thereby address customer satisfaction.
ISO 9001:2008 is used if you are seeking to establish a management system that
provides confidence in the conformance of your product to established or specified
requirements. It is now the only standard in the ISO 9000 family against the
requirements of which your quality system can be certified by an external agency.
The standard recognises that the word "product" applies to services, processed
material, and software intended for, or required by, your customer.
There are five sections in the standard which specify activities that need to be
considered when you implement your system:
 Quality management system (Section 4).
 Management responsibility (Section 5).
 Resource management (Section 6).
© RRC 39
 Product realisation (Section 7).

 Measurement, analysis and improvement (Section 8).
ISO 9004:2009, Managing for the sustained success of an organisation –
A quality management approach
This standard provides you with guidance for your organisation to achieve
sustained success in a complex, demanding and ever-changing environment, by
using a quality management approach.
40 © RRC
ISO 14000
The general concept of this standard is continual improvement in environmental
performance.
ISO 14001:2004
Environmental Management Systems components:
 Environmental Policy.
 Planning:
− Environmental aspects.
− Legal and other requirements.
− Objectives, targets and programmes.
 Implementation and Operation:
− Resources, roles, responsibility and authority.
− Competence, training and awareness.
− Communication.
− Documentation.
− Control of documents.
− Operational control.
− Emergency preparedness and response.
 Checking:
− Monitoring and measurement.
− Evaluation of compliance.
− Nonconformity, corrective action and preventive action.
− Control of records.
− Internal audit.
 Management Review.
The most difficult aspect of ISO 14001 is the identification of the environmental
aspects for your organisation and that of your suppliers.
© RRC 41
A Possible Approach to ISO 14001

 Decide, commit and make a senior person responsible for the system.
 Form a Task Force and review the need for an EMS adviser.
 Conduct an EMS assessment using ISO 14001 and report.
 Publish Environmental Policy, Objectives, Targets and Action Plan.
 Develop leaders to create and sustain employee awareness.
 Define organisational structure and responsibilities.
 Involve employees in developing and improving their system.
 Decide on the document coding procedure.
 Flowchart key processes showing all interfaces.
 Code all forms in line with agreed coding procedure.
 Correlate all forms to flowcharts.
 Review flowcharts for accuracy.
 Develop and use flowcharts as documented procedures.
 Review, reconcile, approve and issue as-is procedures.
 Prepare new procedures and train staff to implement them.
 Issue new procedures and the environmental management programme.
 Describe the whole system in an EMS manual.
 Launch the system and respond quickly to revision requests.
 Start auditing to continually improve your integrated system.
 Conduct pre-assessment at least four months before any Registrar.
42 © RRC
QUALITY COSTS
These can be seen as non-productive and a financial loss to the organisation.
However, it is well to bear in mind that reduced waste (to Zero Defects) can
directly affect the bottom-line operating costs as can products designed properly
from the outset (QFD) and the elimination of inspection, which can be considered
as merely a process of producing a bad product but avoiding dispatch to a
customer before rework or replacement at significant cost.
These are interdependent and can only result in increased customer satisfaction
which, within the TQM philosophy, results in increased profits.
To achieve company-wide acceptance of the principle that quality sells, reduces
overheads and thus is profit-making, requires a programme on the basis of:
 Company-wide approach.
 Department approach.
 Evaluating the relationship between costs and profits.
The Overall Approach - Prevention, Appraisal, Failure (PAF)

Model
Cost of Quality Reduction Programme
Five stages are identified:
 Sell: establish whether it is viable to examine the cost of quality and justify to
higher management to gain total commitment without which the programme
will fail.
 Information: establish a breakdown of categories that go to make the quality
cost.
 Measurement: assess the cost of each category, frequency of information
gathering and establish resources allocated to data gathering.
 Analysis: decide form of results, how data will be analysed and publication
frequency.
 Action: produce the programme with targets and key dates working towards
a reduction in quality costs.
Quality Cost Categories

 Prevention Cost - examine, avoid, reduce defects or failures (low).
 Appraisal Cost - assessment of quality standard (medium).
 Internal Failure Cost - how much scrap discovered at inspection (medium).
 External Failure Cost - warranty claims discovered by customer (high).
© RRC 43
The highest quality cost is at the customer (i.e. furthest from the design) stage. It
is the most expensive to rectify and has the most effect on profits in that customer
satisfaction (the aim of TQM) is severely jeopardised. A vicious circle can be
envisaged - more inspection with more rejects in efforts to retain customer
satisfaction and thus profit.
Data Collection (Measurement)

Much of the data required will already be held by finance, accountant, purchasing,
rework reports, payroll, design change notes and scrap reports. This may require
changing to a suitable format. Other data required has to be collected and where
necessary estimated.
Investigation (Analysis)
Once quality costs are identified, to be of use they must be analysed. All require
collection of data and statistical manipulation.
 Compare prevention, appraisal and failure costs.
 Compare by time.
 Compare by products.
 Compare by departments.
 Compare man-hours spent on rectification.
 Compare man-hours spent on appraisal.
Analysis Techniques
 Pareto Analysis
Carry this out to establish which of the factors is the main cause of failure.
This method will show non-conformance in order of importance. It generally
shows a small number of causes to be the main contributor in most failures.
This is known as the 80-20 rule.
 Cause and Effect Diagrams
An alternative is to have a team investigate cause and effect and produce
diagrams. This is a team activity in which the team defines the problem and
then considers the most likely causes and places them in order of priority.
The process is repeated until the problem is solved. More complex problems
require a different approach.
44 © RRC
 Taguchi Technique
This is a more sophisticated statistical approach where there is more than one
factor involved. Rather than the go/no-go approach of implementing
tolerances, the Taguchi Technique minimises variation. Using a combination
of QFD, FTA and FMEA the evaluation, improvement and maintenance of
quality cost can be achieved.
© RRC 45
THE QUALITY ‘GURUS’

Customer satisfaction and the development of quality is the aim of all the
practitioners included in this section. The application and techniques of their
methods are in some instances similar. The ‘gurus’ covered are the most often
quoted. Others are such as Masaaki Imai, author of Kaizen, a seminal book which
deals with how to achieve what the customer sees as important, and Akashi
Fukuhara who used Taguchi’s parameter design, FTA and FMEA at Toyota to
improve customer satisfaction.
W. Edwards Deming
He defined 14 points by which quality could be improved by changing the direction
of the organisation and management, and proposed to action the plan in 7 stages.
The 14 Points
1. Create constancy of purpose.
2. Adopt new philosophy.
3. Cease dependence on inspection.
4. Price has no meaning unless quality is in the equation.
5. Improve constantly.
6. Institute on-the-job training.
7. Institute leadership.
8. Drive out fear.
9. Teamwork between departments.
10. Eliminate slogans, posters, numerical goals.
11. Eliminate work standards or quotas.
12. Remove barriers to pride in workmanship.
13. Institute self-improvement and education programmes.
14. Create organisation to implement the above.
46 © RRC
The 7-Stage Action Plan

Management:
 Agrees the meaning of the 14 points.
 Takes pride in the new philosophy and responsibilities.
 Presents to the whole organisation the need for change.
 Recognises that every activity is part of a process contributing to quality.
 Guides the organisation towards the continual improvement of quality.
 Uses the team approach.
 Organises for quality using statistical methods.
A. V. Feigenbaum
Total Quality Control
Feigenbaum was an influential figure as the result of his book, Total Quality
Control, published in 1951. This provided a model of a QAMS (QMS). He widened
the scope of quality to include the whole process behind the manufacture or
production of a product or service, where quality assurance was previously
thought of as a manufacturing function only.
In the production cycle the quality activities are defined as:
 New design:
− Selling quality products.
− Engineering quality products.
− Planning quality processes.
 Incoming material control:
− Buying quality material.
− Receiving and inspecting quality material.
 Product control:
− Manufacturing quality parts and products.
− Inspecting and testing quality products.
− Shipping quality products.
− Installing and servicing quality products.
The basic requirements for implementation are:
 Management must re-emphasise the quality responsibilities and
accountabilities of each employee, regardless of position.
© RRC 47
 Create a Quality Department that will be responsible for the maintenance of

quality.
Joseph M. Juran
Breakthrough and Control
Juran’s approach was partly philosophical and partly statistical. In the first
instance, a managerial breakthrough is required to change the old level of
performance to a new and better level; then it is necessary to control the new level
by statistical methods such as Pareto Analysis.
Five stages to achieving the management breakthrough were proposed by Juran:
 Breakthrough in attitude: sell the company-wide quality planning to
management and workforce.
 Pareto: identify key areas.
 Organisation: analyse the problem, co-ordinate the project, overcome the
resistance to change (breakthrough in philosophy), institute new standards
(breakthrough in performance).
 Control at the new level of performance.
 Repeat the four stages.
K. Ishikawa
Quality Circles
A quality circle is a team of personnel engaged on the same type of work, who
meet on a regular basis in the work situation to discuss, identify and analyse
problems related to the enterprise on which they are engaged. Each circle has a
leader and the circles are co-ordinated by a facilitator. Both circle members and
team leaders require special training at the outset and continually through the life
of the circle. Circles choose the topics for investigation from input by feedback
from quality control, customer complaints, management information, a circle-
identified problem or an individual who discovers a problem which can be
investigated.
 Knowledge Required
− Sampling.
− Checksheets.
− Histograms.
− Scatter diagrams.
− Statistical quality control.
48 © RRC
− Cause and effect diagrams.

− Pareto analysis.
 Team Operation
Once the team is formed, a formal programme of operation (see below) has
to be followed. Also a means of recording the meetings has to be
established, either in the form of meeting minutes or a proforma which
records group name, attendance, date, duration, problem to be solved, and
the activities carried out in the process of solving it.
 Team Programme
− Select the problem.
− Plan the approach.
− Analyse the problem.
− Decide on what measures to take to avoid the problem.
− Confirm that the measures taken were successful.
− Determine the rules to prevent recurrence.
Philip C. Crosby
His concept was that quality came free if things were done correctly from the
outset of the project. When actions or products are repeated, the waste of time or
materials is money lost.
The 4 Absolutes of Quality

Crosby defined these as:
 Definition - conformance to requirements.
 System - the system of quality has to be preventive rather than detection-
based.
 Measurement - the cost of quality is to be measured in terms of failure.
 Performance standard - zero defects is the only standard.
Crosby’s 14 Points to Zero Defects
(Note the coincidence with Deming.)
1. Management Commitment.
2. Quality Improvement Team.
3. Quality Measurement.
4. Cost of Quality.
© RRC 49
5. Quality Awareness.
6. Correction Action.
7. Zero Defect Planning.
8. Supervisor Training.
9. Zero Defect Day.
10. Goal Setting.
11. Error/Cause/Removal.
12. Recognition.
13. Quality Council.
14. Do it again.
G. Taguchi
Taguchi introduced the concept of Quality Loss Function (Experimental Design and
Analysis of Variance). He defined product quality as “the loss imparted to society
from the time a product is shipped”.
It is based on the concept that:
 Quality is built in from the design or concept stage.
 There is optimisation prior to commencing the manufacturing or service
operation.
 Inspection of the product or service is avoided.
The Taguchi Technique - Loss Function

The Taguchi Technique takes the view that tolerances should not be absolute but
aimed at minimum variation. This is achieved by tests and trials which cost time
and money but result in reduction of losses to the producer and customer and a
consequent increase in quality. At minimum variation the losses are also minimum
and the philosophy is that quality has to be designed in, because Quality Control
and SPC can never compensate for bad design.
50 © RRC
TOTAL QUALITY MANAGEMENT (TQM)

This in essence is an ongoing philosophy of ways and means to motivate
employees to predetermined goals, to achieve customer satisfaction and to assess
current performance to improve future targets.
Definition
TQM as defined in the standard BS 7850-1:1992 Total quality management - Guide
to management principles:
“Management philosophy and company practices that aim to harness the
human and material resources of an organisation in the most effective
way to achieve the objectives of the organisation.”
The standard is a guide to concepts, implementation and techniques and the role
of supporting techniques. It also includes two annexes:
 Annex A - Example of a typical process of TQM.
 Annex B - Example of a systematic improvements process.
Concepts
TQM is based on the following fundamental concepts:
 Total commitment (participation from the MD/CEO down).
 Customer satisfaction (this should be a key objective).
 Quality losses (the failure to utilise most effectively and efficiently the
potential of human, material and financial resources in a process, e.g. through
waste and loss of opportunity).
 Participation by all.
 Process measurements.
 Continuous improvements.
 Problem identification and resolution (on a continuous basis).
 Alignment of corporate objectives and individual attitudes.
 Personal accountability, responsibility and authority.
 Personal development, e.g. through appraisal and training.
© RRC 51
REPORTS
Quality Log Report
See Quality Log under STANDARDS.
Checkpoint Report
See Reports (Checkpoint Report) under QUALITY REVIEW.
Highlight Report
See Reports (Highlight Report) under QUALITY REVIEW.
End Stage Report

See Reports (End Stage Report) under QUALITY REVIEW.
Exception Report
If there is a serious quality problem when costs or time-scales are exceeded for an
approved Stage Plan, the project manager is informed, who will then inform the
project board.
52 © RRC
CONFIGURATION MANAGEMENT
Configuration Management is part of the quality control of a project. It is not
optional. Without it, managers have little or no control over the products being
produced, e.g. what their status is, where they are, whether they can be changed,
what the latest version is.
Definitions
The configuration of a project is the sum total of products which will form part of
the final released system. Each part of that final system is known as a
Configuration Item. The specialist products of a project are all Configuration Items.
Management and quality documentation may optionally be treated as
Configuration Items in order to control the issue of various versions of them.
Therefore every product is a Configuration Item, but a Configuration Item may not
necessarily be a product.
Functions
Configuration Management must specify and identify all components of the final
product. Its task is to provide:
 The mechanisms for managing, tracking and keeping control of all the
project’s specialist products. It keeps files and libraries of all the products of a
project once they have been quality-reviewed, controls access to them and
maintains records of their status.
 The ability to select and package the products which comprise the final
working system. This covers releasing the complete system, or updates to it.
 A system for logging, tracking and filing all project and quality issues.
 Control - ability to prevent any change without authorisation.
 Status accounting - the reporting and recording of all configuration items.
 Verification - reviews and audits to ensure conformity of the project’s
products and those registered in the configuration management records.
Configuration Librarian
A specimen job description for a configuration librarian appears below. All the
listed functions are necessary for successful projects.
The configuration librarian is the custodian and guardian of all master copies of the
project’s specialist products. The librarian also maintains the Issue Log and Quality
Log.
© RRC 53
Role
 To control the receipt, identification, storage and issue of all project products.
 To provide information on the status of all products.
 To number, record, store and distribute project issues.
54 © RRC
QUALITY AWARDS
European Foundation for Quality Management
This is a membership, not-for-profit organisation created in 1989 by 14 leading
European businesses, with a mission to be the driving force for sustainable
excellence in Europe and a vision of a world in which European organisations excel.
Fundamental Concepts of Excellence

 Adding value for customers.
 Creating a sustainable future.
 Developing organisational capability.
 Harnessing creativity and innovation.
 Leading with vision, inspiration and integrity.
 Managing with agility.
 Succeeding through the talent of people.
 Sustaining outstanding results.
Excellence Model
The Model comprises three integrated components:
 Fundamental Concepts – see above.
 The Criteria – see below.
 RADAR - a tool ‘for driving systematic improvement in all areas of the
organisation’.
The Model can be applied to any organisation, regardless of size, sector or
maturity. Although it provides a framework to achieve business excellence, it is
non-prescriptive, which allows flexibility of interpretation and application for
individual organisations.
Each of the nine criteria can be used to assess an organisation's progress towards
excellence.
© RRC 55
EFQM Excellence Model

(Adapted from EFQM original source)
The five enablers on the left-hand side of the Model relate to areas and activities
that an organisation needs to develop to implement and execute its strategic
goals.
On the right-hand side of the Model there are four result areas. These are the
results an organisation achieves in line with its strategic goals.
The arrows in the diagram of the Model emphasise the dynamic nature of the
EFQM framework, whereby a business cycle of continuous improvement is
initiated through investment in learning, creativity and innovation, that helps to
improve enablers, that in turn leads to improved results.
Each of the nine EFQM criteria has a high-level definition that is supported by a
number of sub-criteria that address questions which should be considered in the
pursuit of business excellence.
The Model can be used in two ways:
 as a means of self-assessment to measure the extent to which an organisation
is reaching excellence; and/or
 to make application for the annual award of the British Quality Foundation.
The EFQM Excellence Model can be perceived as a concrete manifestation of Total
Quality Management principles.
56 © RRC
Malcolm Baldrige Quality Award

An American award aimed at improving the awareness and standing of American
organisations with regard to quality, developed by a public-private partnership
administered by the American National Institute of Standards and Technology. The
award was established in 1987 because Congress wanted to stem the eroding
leadership of American products and services as well as assist in the improvement
of the nation’s productivity growth.
Core Values and Concepts
 Visionary Leadership.
 Organisational and Personal Learning.
 Focus on the Future.
 Valuing Workforce Members and Partners.
 Managing for Innovation.
 Management by Fact.
 Focus on Results and Creating Value.
 Agility.
 Societal Responsibility.
 Systems Perspective.
 Customer-Driven Excellence.
The Criteria
The award is based on seven criteria of performance excellence which establish a
framework for integrating total quality principles and practices throughout the
organisation:
 Leadership.
 Strategic Planning.
 Customer Focus.
 Measurement, Analysis and Knowledge Management.
 Workforce Focus.
 Operations Focus.
 Results.
© RRC 57
Other Quality Awards

There are other quality initiatives and quality awards in operation throughout the
world, each having specific aims and goals although some are similar to the EFQM
Excellence Model.
58 © RRC
SIX SIGMA
The goal of Six Sigma is to increase profits by eliminating variability, defects and
waste that undermine customer loyalty.
Six Sigma can be understood/perceived at three levels:
1. Metric: 3.4 Defects Per Million Opportunities. DPMO allows you to take
complexity of product/process into account. Rule of thumb is to consider at
least three opportunities for a physical part/component - one for form, one
for fit and one for function, in the absence of better considerations. Also you
want to be Six Sigma in the critical to quality characteristics and not the whole
unit/characteristics.
2. Methodology: structured problem-solving roadmap and tools.
3. Philosophy: reduce variation in your business and take customer-focused,
data-driven decisions.
Six Sigma is a methodology that provides businesses with the tools to improve the
capability of their business processes. This increase in performance and decrease
in process variation leads to defect reduction and vast improvement in profits,
employee morale and quality of product.
Six Sigma is a rigorous and a systematic methodology that utilises information
(management by facts) and statistical analysis to measure and improve a
company's operational performance, practices and systems by identifying and
preventing 'defects' in manufacturing and service-related processes in order to
anticipate and exceed expectations of all stakeholders to accomplish effectiveness.
© RRC 59
QUALITY AND INFORMATION TECHNOLOGY

TickIT
TickIT is an ISO 9001 certification scheme applied specifically to software
development. An ISO 9001 certificate endorsed with a TickIT logo proves that your
Quality Management System is compliant with best practice for a Software Quality
Management System.
ISO 9000 Applicable to Software Development

ISO/IEC 90003:2014 is a set of guidelines for the application of ISO 9001 to the
acquisition, supply, development, operation and maintenance of computer
software.
60 © RRC
QUALITY TOOLS AND TECHNIQUES

To assist within quality there are various tools and techniques that can be used by
quality managers and engineers; some of these tools and techniques are listed
below.
The 7 Statistical Tools

(The 7 original tools, Ishikawa’s 7 Tools of Quality)
 Data Collection Sheet.
 Histogram.
 Cause and Effect Diagram.
 Pareto Diagram.
 Stratification Analysis.
 Scatter Diagram.
 Control Chart.
The 7 Management Tools
(New Tools of Quality)
 Affinity (KJ) Diagram.
 Relationship Diagram.
 Tree Shaped Diagram.
 Matrix Diagram.
 Decision Tree.
 Arrow Diagram.
 Matrix Data Analysis.
© RRC 61
62 © RRC

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STEP NOTES

RRC Ref. SNQUA

Quality Assurance - quality assurance is the establishment of standards and

Total Quality Management - a set of objectives requiring a structured approach to

Elements of an Effective Specification

Acquisition and Operation

 Bibliography: internal and external publications referred to in the

National Standardising Bodies

 Codes of practice: e.g. BS 8000, Workmanship on construction sites.

Product Certification Procedures

PROJECT MANAGEMENT AND QUALITY

Project Quality Plan

DESIGNING FOR QUALITY

Customer's Quality ISO 9001

Project Quality Plan Quality Policy

Stage Quality Plan QMS

Product Description Quality Assurance

The Quality Path

Customer’s Quality Expectations

International Organisation for Standardisation (ISO 9000)

Where an organisation has a quality assurance group, it requires a place in the

Product Quality Plan

Stage Quality Plan

Product Quality Criteria

QUALITY REVIEW TECHNIQUE

Design and Development Planning

STATISTICAL PROCESS CONTROL (SPC)

Configuration management plays several roles in ensuring the management of

 Reflects accurately the information contained in/required by the derivation

User/Project Assurance Involvement

Stage Quality Plan

Change Control and Quality

End Stage Report

Project Quality Plans

Guidelines for Quality Plans

 Inspection and test equipment (calibrations, etc.).

ISO 9000 AND ISO 14000 IN PLAIN LANGUAGE

THE ISO 9000 SERIES

Principles (see ISO 9000:2005)

ISO 9001:2008, Quality management systems - Requirements

 Product realisation (Section 7).

A Possible Approach to ISO 14001

The Overall Approach - Prevention, Appraisal, Failure (PAF)

Quality Cost Categories

Data Collection (Measurement)

THE QUALITY ‘GURUS’

The 7-Stage Action Plan

 Create a Quality Department that will be responsible for the maintenance of

− Cause and effect diagrams.

The 4 Absolutes of Quality

The Taguchi Technique - Loss Function

TOTAL QUALITY MANAGEMENT (TQM)

End Stage Report

Fundamental Concepts of Excellence

EFQM Excellence Model

Malcolm Baldrige Quality Award

Other Quality Awards

QUALITY AND INFORMATION TECHNOLOGY

ISO 9000 Applicable to Software Development

QUALITY TOOLS AND TECHNIQUES

The 7 Statistical Tools

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