International Journal of Production Research

ISSN: 0020-7543 (Print) 1366-588X (Online) Journal homepage: www.tandfonline.com/journals/tprs20

Incorporating links to ISO 9001 into manufacturing

process models using IDEF 9000

J. Gingele, S. J. Childe & M. E. Miles

To cite this article: J. Gingele, S. J. Childe & M. E. Miles (2003) Incorporating links to ISO 9001
into manufacturing process models using IDEF 9000, International Journal of Production
Research, 41:13, 3091-3118, DOI: 10.1080/0020754031000101312

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int. j. prod. res., 2003, vol. 41, no. 13, 3091–3118

Incorporating links to ISO 9001 into manufacturing process models

using IDEF9000

J. GINGELE{, S. J. CHILDE{* and M. E. MILES{

This paper looks at how the requirements of the ISO 9001 standard for quality
management systems are implemented in manufacturing. It supports manufactur-
ing companies when modelling a Fulfil Order Process by identifying the links to
the ISO 9001 quality standard and highlighting potential impacts from any
changes in the process or the standard during a redesign project. Case studies
revealed that simply documenting what an organization does in order to satisfy
the various elements of ISO 9001 is still a common approach. This results in a
process-oriented character only at the documentation stage, and is the result of
limited guidance on how to integrate the requirements of ISO 9001 with business
processes. This work includes the identification of links between ISO 9001
requirements and a holistic Fulfil Order Process and leads to the development
of criteria for modelling a manufacturing business process showing its links to
ISO 9001. A modelling technique, named IDEF9000, has been developed which
will enable companies to take a systemic perspective of a Fulfil Order Process
identifying all relevant links to ISO 9001. The evaluation of this technique focuses
on IDEF9000 as a tool that fulfils a common need not fulfilled by existing schemes.
IDEF9000 is based in systems theory and has been validated by review and in
practice.

1. Introduction

As manufacturing organizations are increasingly focusing on flexibility, innova-

tion and processes there appears to be a need to assess current approaches to the
implementation of the ISO 9000 requirements. The ISO 9000 series is an interna-
tional standard that can be used by organizations to develop and document their
quality management systems. An effective quality management system allows an
organization to ensure that its products and services consistently conform to custo-
mer’s requirements. The actual requirements for a quality management system are
described in the standard ISO 9001:2000 (Quality management systems –
Requirements) (International Standards Organization 2000a) and organizations
can be audited against these requirements to become ISO 9001 registered.
With over 500 000 certificates granted by the end of December 2001
(International Standards Organization 2002) even its keenest supporters were sur-
prised how quickly this standard achieved world-wide acceptance. However,
ISO 9000 has had some very bad press. Much of the work undertaken in the field
of ISO 9000 quality management has focused on complying with ISO 9000 require-
ments to get or maintain a certified quality management system which, in many

Revision received October 2002.

{ University of Plymouth, Plymouth, Devon PL4 8AA, UK.
* To whom correspondence should be addressed. e-mail: [email protected]

International Journal of Production Research ISSN 0020–7543 print/ISSN 1366–588X online # 2003 Taylor & Francis Ltd
http://www.tandf.co.uk/journals
DOI: 10.1080/0020754031000101312
3092 J. Gingele et al.

cases, has resulted in very high levels of record-keeping and form-filling. Critics such
as Seddon (1998) reported it as being an expensive and in many cases, an irrelevant
and inappropriate system for many businesses. The commonest criticism is excessive
bureaucracy and the inflexibility it generates (Karapetrovic and Willborn 1998b).
Jonker and Klaver (1998) further argue that, due to the lack of a proper methodol-
ogy, the integration of such models remains difficult.
Much of the development in the field of quality management has tended to focus
on the design and documentation of quality management systems without taking the
business processes of an organization into account. A business process can be
described as a chain of events or activities, independent of departmental structures
of an organization, which provide the desired output of its customers.
Harrington and Marthers (1997), Renfrew (1997) and others have emphasized
the need for quality management systems to be built around the business processes to
keep the system efficient and lean. Hoyle (1998a) and Karapetrovic and Willborn
(l998a) have also stressed the importance of understanding ISO 9001 quality man-
agement systems from a systems viewpoint. The domain of business process design/
redesign has recognized the need for process-based quality management systems and
it was argued that during the design of business processes, greater consideration of
the requirements of the ISO 9001 standard was needed (Mertins and Jochem 1999).
This would result in quality management systems becoming more of an integral part
of the business. Therefore, despite the thorough understanding of business processes,
the authors contend that work needs to be carried out to help organizations to
design/redesign their business processes with an emphasis on the requirements of
ISO 9001.
The research is restricted to an investigation of the design of business processes
that support the product and/or service cycle. It does not consider the implementa-
tion stage or the documentation of a quality management system except where the
quality of the design can only be properly evaluated after the implementation stage.
This limitation will allow the authors to focus on an improved method to design and
redesign business processes.

2. Aims
The aim of this research is to support manufacturing companies in modelling a
Fulfil Order Process showing the links to the ISO 9001 quality standard. The links
should highlight any potential impact from changes in the process or the standard
and should be given special attention during a redesign. With the focus on develop-
ing the current theory of the design of business processes, taking into account the
requirements of ISO 9001, the following research question has been raised:

How can a process model be best drawn to establish links between business
processes and ISO 9001?

This research was firmly embedded in the management of production activities that
transform inputs into products to fulfil customer orders and which are concentrated
on an operating business process. To answer the research question, the following
also need to be addressed:

. to define a business process, in particular a Fulfil Order Process, and describe it

from a systems viewpoint;
 Incorporating links to ISO 9001 3093

. to identify and characterize the requirements of the quality standard

ISO 9001:2000;
. to develop a set of criteria that must be addressed by an appropriate modelling
technique to model a business process to show the links to ISO 9001:2000.

3. Implementation of ISO 9001

With the publication of a completely revised ISO 9000/1:2000 (International
Standards Organization 2000a, 2000b) it is an opportune moment for management
to update or restructure the company’s quality management system. The new 2000
version of ISO 9001 is a major structural and strategic revision of the standards and
recognizes the customers and other relevant stakeholders in playing a significant role
during the process of defining the input requirements. ISO 9001:2000 encourages
organizations in the adoption of a process-based approach for a quality management
system. The ‘Process Model’ is, however, not intended to reflect processes at the
detailed level (International Standards Organization 2000a) and pays no attention to
any architecture model for enterprise modelling or, more importantly, for process
modelling.
The implementor of a quality management system needs to decide how to design
an ISO system according to the aims and objectives for the project. Hoyle (1998)
summarises the various approaches to ISO 9001 implementation in the following
four ways.
(1) Simply following what the standard dictates
This method documents the activities and documentation that are required
by the standard. From there it usually generates a quality manual that
addresses each section of the ISO 9001 in the sequence in which the standard
is presented, regardless of the relevance to the business. The quality manual
becomes an adaptation of the original standard document not reflecting the
unique structure of the business.
(2) Documenting what you do in response to the requirements of ISO 9001
The usual approach to documenting quality management systems is to write
procedures. In many cases procedures are in text form but, more recently,
flowcharts have been used to map what happens in an organization.
Documenting what an organization does will, however, not necessarily
create a system but may only describe its components (Hoyle 1998a,
Karapetrovic and Willborn 1999). Aberer and Hardegger (1997) suggest
that many companies demonstrate the first signs of being process-based by
presenting their procedures in the form of flowcharts. Many of them do this
without changing any of the existing functional organizational structure.
(3) Limited documentation of the business processes to meet the requirements of
ISO 9001
This method focuses on the processes that convert customer input into
customer output and maps the requirements of the standard onto the
process model (Hoyle 1998a). Renfrew (1997) argues that a good starting
point to design a process-oriented quality management system is to split the
processes into the following three distinct types: core processes, which reflect
the sequences of events that cause customers to value the product or services;
supporting processes, which are tasks ensuring the core processes work effec-
3094 J. Gingele et al.

tively; and assurance processes, which ensure that an organization is meeting

its operational objectives.
(4) Creating an integrated management system that covers all processes and,
where relevant, addresses the requirements of ISO 9001
There is some confusion in the literature as to what precisely constitutes an
‘integrated management system’. To some it is a combination or linkage of
various standards such as ISO 9000, the environmental standard ISO 14000
and OHAS 18001 (occupational health and safety management systems) into
one single management system such as the QUENSH approach (Quality,
Environment, Safety and Health) (Renfrew 1997). Others (including Bleicher
1992 and Seghezzi 1997) present integrated management concepts that are
not designed around standards and argue that the discussion needs a holistic
approach in which quality or any other requirement can or must be
embedded.

3.1. Business process design incorporating ISO 9001

Instead of emphasizing the structure of an organization, business process design
attempts to plan and optimize the output of an organization according to the
requirements of the market (Mertins and Jochem 1999). Outputs to customers are
delivered by chains of activities which may be seen as business processes. Authors
such as Harrington and Marthers (1997), Hoyle (1998a) and Mertins and Jochem
(1999) suggest that quality management systems should be aligned with business
processes. Companies that are ISO 9000 registered describe their operations in
many ways, typically some mixture of text and diagrams published in a quality
manual. However, not every organization recognises that it operates processes,
even if its functions and responsibilities are well understood (Ould 1995).
Harrington and Marthers (1997) argue that a quality management system needs to
be built around different levels of processes. The process hierarchy should include
processes, activities and tasks and Hoyle (1998b) suggests that a business process
approach cannot start with the standard or by documenting what to do. It must start
with a model of the business – indicating business processes and their dependencies.
Generally, process-oriented quality management system approaches limit their
defined business processes to those processes needed to comply with ISO 9000.
These processes, often referred to as quality processes, do not show the ‘entire
picture’ of how an order is processed.

3.1.1. ARIS and ISO 9001

The Architecture of Integrated Information Systems (ARIS) by Scheer (1998) is a
general methodology that facilitates the specification and implementation of infor-
mation systems (IS) to support business processes. ARIS provides a comprehensive
framework for process engineering and management with integrated IS-support for
designing, managing, controlling and executing business processes (Scheer and
Allweyer 1999). When incorporating the ISO 9001 quality standard during the
modelling of the business processes at the process design stage of the methodology,
one facility of the software solution, the ARIS Toolset, is to support the quality
management system and generate a quality manual. ARIS might offer a process-
oriented solution for the design of an ISO 9001 quality management system. There
is, however, little evidence in the literature that organizations have applied the
 Incorporating links to ISO 9001 3095

comprehensive ARIS methodology with the sole intention of becoming ISO 9001
registered.

3.1.2. GRAI methodology and ISO 9001

The GRAI (Graphe à Resultats et Activités Interliés) methodology is considered
as an enterprise modelling technique and has been developed to model decision-flow
processes predominantly in the domain of production management systems
(O’Sullivan 1994). GRAI Quality, which is currently under development
(Doumeingts, private communication, July 2001), will complement the ten other
methods in the GRAI methodology tree. This particular approach will offer a facility
to deploy quality procedures and link them to the relevant business processes
(Doumeingts and Ducq 2001).

3.1.3. IEM and ISO 9001

Mertins and Jochem (1999) developed a modelling method based on integrated
enterprise modelling (IEM). It is related to the 20 sections of the ISO 9001:1994
quality standard and allows companies to analyse, improve and redesign their
business processes. This object-oriented approach models business processes using
product, order and resource as the three main modelling elements of an enterprise
(Mertins and Jochem 2001). The enterprise model uses predefined models of pro-
cesses that are based on the requirements of the 20 sections of the ISO 9001:1994 to
support the development of a quality management system.
From a practitioner’s viewpoint, Mertins and Jochem (1999) suggest application
of the predefined models as inexperienced users might find it difficult to apply this
comprehensive and complex approach for the first time. There are potential
problems while trying to integrate individual predefined models into suitable posi-
tions in the enterprise model. This is likely to happen if the users are not familiar
with the modelling approach of integrated enterprise modelling (IEM). Case study
findings report that the main benefit of this approach is an improved understanding
of the enterprise through the modelling process (Mertins and Jochem 2001).

3.1.4. Implications and current issues

The literature review and the findings of case studies revealed the following key
weaknesses.

. Responding to the requirements of the ISO 9001, by simply documenting what

a company does, is still one of the most common approaches. Such an
approach can lead to increased bureaucracy and the associated additional
work due to the minimal consideration of the existing organizational structure.
. The design of quality management systems often achieves the process-oriented
character at the documentation stage but fails to create the corresponding
organizational structure.
. The usefulness of business process-oriented organizational structures has been
widely recognized. In the field of quality, the focus remains on the design of a
certifiable quality management system, not on an overall systemic view of the
entire business.
. When modelling with enterprise architectures it is possible to generate auto-
matically a documented quality manual if the requirements of the ISO 9001
standard have been considered during the business modelling. Companies that
3096 J. Gingele et al.

redesign their organizational structures and apply such frameworks usually

have a different set of business objectives and consider that an ISO 9001
certification is not one of the main drivers.

The conclusion is that a process-oriented approach would provide a system that

benefits the business rather than merely conforming to the requirements of a
standard. The majority of activity- or process-based quality management systems
only define required quality processes and set tight boundaries around the quality
management system. Not taking a systemic view of an organization could lead to the
possibility that improvements made to one part of a business process may result in
problems in other parts of the organization. This also applies if the standard
changes.
What seems to be missing is a modelling approach that does not necessarily
document procedures and instructions but supports the modelling of business
processes and establishes the links to the requirements of the standard. Before dis-
cussing how this can be achieved, a brief overview summarizes the main character-
istics of a business process.

4. Understanding business processes

The business process view has concentrated attention on flows of products and
information through the business. A review of some of the principal writers in the
field leads to the principles that, a business process:

. transforms inputs into useful and effective outputs (Davenport and Short 1990,
Johansson et at. 1993, Hammer and Stanton 1995);
. starts and ends with the customer (Harrington 1991, Hammer and Champy
1993);
. focuses on goals (Harrington 1991, Hammer and Champy 1993);
. can be measured to allow feedback and process improvements (Davenport and
Short 1990, Harrington 1991, Hammer and Champy 1993);
. flows horizontally using a hierarchical structure (Davenport and Short 1990,
Harrington 1991);
. crosses organizational (functional) boundaries (Davenport and Short 1990,
Harrington 1991, Johansson et at. 1993);
. requires resources to transform inputs into outputs (Armistead 1990, Rummler
and Brache 1990, Slack et al. 1995).

While this list may not be complete, it incorporates the fundamental issues discussed
in business process literature. In this paper a business process is defined as:

A structured, measured set of activities and flows which are independent of

departmental structures and that use necessary resources of the organization to
provide specified output for a particular customer.

The CIM-OSA standard (Computer Integrated Manufacturing Open Systems

Architecture) (CIM-OSA/AMICE 1989) defines the three fundamental types of
business processes as Manage-, Operate- and Support-type business processes.
Their relationships are shown in figure 1.
Management processes are concerned with planning strategy and operations and
monitoring performance, and are used to manage and control other processes.
 Incorporating links to ISO 9001 3097

Figure 1. Typical operate business processes in the CIM-OSA process model.

Operational processes are to develop product, make product and market product.
Support processes are mainly concerned with the maintenance and assistance of the
operational and management processes (providing, maintaining and assisting enter-
prise resources) (CIM-OSA/AMICE 1987, Childe et al. 1994).
This paper is concerned with management of the production activities that trans-
form inputs into products to fulfil a customer’s order. This transformation can be
viewed as being an operate type of process because it is directly related to satisfying
an external customer’s requirements by producing direct value. Four types of oper-
ate processes are defined and described in Childe et al. (1995) and Maull et al.
(1995a): they are Get Order, Develop Product, Fulfil Order and Support Product.
A Fulfil Order Process turns an order into a finished product or service and delivers
it to the customer by activities that are performed by employees and machines.
Enquiries are turned into specifications, and product orders into products. This
will include a flow of materials and information that result in the fulfilment of an
external customer’s order or enquiry. The concept of the order fulfilment process is
widely accepted in the literature (Meyer 1993, Jackson 1996, Chen 1999) and the
following definition by Childe et al. (1995) of a Fulfil Order Process is adopted here:

The Fulfil Order Process contains activities performed by humans and machines.
Its principal transformations are product orders into products and enquiries into
specifications. It includes the flow of both the material and the information that
results in the fulfilment of the external customer order or enquiry. The process
3098 J. Gingele et al.

constantly seeks to fulfil customer requirements whilst balancing stakeholder

requirements.

Maull et al. (1995a) state that a number of important ideas associated with the
concept of a business process are not made explicit enough. They believe that the
use of a business process can be grounded in the discipline of systems. This view is
also shared by other authors such as Rummler and Brache (1990) and McHugh et al.
(1995).

4.1. Fulfil Order Process and systems theory

A pragmatic definition for a system is an organized collection of men, machines
and material required to complete a set objective. Modelling such a system as a
business process requires an understanding of the elements involved. To clarify the
criteria for a typical Fulfil Order Process the following systems parameters, as shown
in figure 2, are described following Churchman (1971) and Checkland (1981) as
source, input, processes and transformation, output, receiver and feedback.
A source is an origin outside the boundaries of a system that provides inputs.
There are often alternative sources for each input. For a Fulfil Order Process, inputs
usually originate from various suppliers, customers and other stakeholders.
Inputs are those things needed by the process to fulfil its purpose that come from
outside the defined system’s boundary. Typical inputs for a Fulfil Order Process are
information about a product or about a business strategy, preliminary design,
product order or supplied items.
Transformation is the actual conversion of matter and adding value to the input
to achieve a desired output. In a Fulfil Order Process a conversion can be explained
as the change in shape of incoming materials, the content or location of information
or the satisfaction of customers.
The parameter for processes deals with the conversion and the adding of values to
inputs in order to generate desired outputs. Processes can be explained as chains of
events that are performed to achieve transformation. By studying processes it is
possible to show what needs to happen but also what might be able to happen
when carrying out the process in a certain manner. Processes can be altered to
achieve the same transformation of inputs. This is the basis of re-engineering,
where the transformation is kept but the process to achieve it will be changed.
Plan order fulfilment, Obtain required items, Manufacture, or Dispatch a customer
order are typical activities within a Fulfil Order Process.
An output can be anything that will cross the system’s boundary into its
surrounding environment. Outputs may take the form of objects or information.
The former can be a product as ordered while information might leave the system in

Figure 2. Systems parameters from the viewpoint of the process (after Churchman 1971).
 Incorporating links to ISO 9001 3099

the form of customer or supplier communication or a request for product develop-

ment.
Any party outside the system’s boundary that is interested in the output of the
system is called a receiver. Outputs should be useful and of value to a particular
receiver such as customers and suppliers. Information from earlier events will be fed
back to influence future choices about sources, inputs, processes and outputs.
Generally, feedback can be thought of as a kind of input that comes from a receiver.
In terms of a Fulfil Order Process internal feedback might deal with process or
product control while external feedback loops might be confronted with customer
issues and concerns.

4.2. Systems views of a Fulfil Order Process

As any kind of system in an organization can be very complex it becomes appar-
ent that models should be used that are capable of dealing with multiple views and
addressing all aspects, such as events, conditions and users of each element of a
process. To deal with the complexity of systems, models are often divided into
individual views that represent different aspects and can be handled independently
(Scheer 1998). The following four views are widely discussed in the literature and
also used within process models such as CIM-OSA (Computer Integrated
Manufacturing Open Systems Architecture) (Jorysz and Vernadat 1990) or ARIS
(Architecture of Integrated Information Systems) (Scheer 1998). The logical struc-
ture of data to be used and produced by activities is described by a data view. Events
such as ‘order received’ are information and are represented by data. The function
view contains the description of the activity itself, addressing enterprise functionality
(i.e. what has to be done) and the relationship between activities, sub-activities and
the system’s boundaries. The organization view represents the organizational struc-
ture of the company and the interrelationship between users and the organizational
units they are assigned to. In the resource view resources such as information tech-
nology, materials, tooling and other equipment are shown that might be both con-
sumed and/or produced by activities.
The design and redesign of a Fulfil Order Process require an analysis of the
activities the organization must perform, the flows of information and material
that these activities generate or require, and the performance requirements of each
activity. By taking a function view of the process, all required activities and the flows
can be shown. While the function view primarily concentrates on activities and tasks,
information and the flow of it can also be incorporated when being understood in the
context of the description of activities. This is stated by Kueng et al. (1996) explain-
ing activity-oriented modelling approaches that primarily concentrate on activities, as
the name implies. The function view associated with activity modelling shows infor-
mation as inputs and outputs of activities on a basic level without showing the actual
information structures (Wang et al. 1993). An information view represents the con-
ditions and events that exist when data is updated (Gulledge et al. 1999). This paper
concentrates on showing information, data flow and resources only on the level of
graphical labels and in the context of activities. Focusing on activities also allows the
modeller to analyse them in terms of being value-adding or non-value-adding to the
overall business, an essential principle in the streamlining process (Harrington 1991).
It is therefore proposed that the Fulfil Order Process under the discussed limitations
can be modelled using a function view.
3100 J. Gingele et al.

4.3. Criteria for selecting a process modelling technique for a Fulfil Order Process
To understand a business process for design or redesign, a process modelling
technique must fulfil the following requirements developed by considering the work
of Jorysz and Vernadat (1990), Harrington (1991), Franks (1993) and Maull et al.
(1995b).

. Easy to use, common language for communication

An important criterion for the technique must be to present and communicate
the view of the modeller clearly so that anyone not involved in the modelling
process can easily understand and discuss the process at any later stage.
. Simple syntax and semantics
Syntax in general describes and represents the format and the rules and reg-
ulations set for a modelling technique. Syntax also includes how the concept of
a process is presented, such as by showing graphics, drawn symbols and
various other pictorial elements. Rules must provide a description of what
each individual symbol represents (activities, data entries or resources) as
well as the connections and relationships to others. Semantics is concerned
with the meaning of symbols and pictorial elements defined within the syntax.
Semantic rules should support the interpretation of each type of symbol by
means of precise labelling and identification.
. The identification of a systems hierarchy for activities and information
The process model must be able to show the process at detailed levels.
Harrington (1991) proposed a hierarchy of macro-processes, sub-processes,
activities and tasks similar to the systems concept in which systems are com-
posed of sub-systems. This requires a process model where each component of
a process is identified in the same way so it can be seen in its proper context
relative to the other elements.
. A means to define the whole system, including its boundaries and the overall goals
The model must have the ability to present the consensus of the modellers
regarding the system boundaries within which the modelling takes place. It is
important to distinguish between the system under study and the surrounding
environment.
. The description of a process in terms of systems parameters
The modelling technique must be able to represent and distinguish between a
number of systems parameters including sources, inputs, processes, transfor-
mation, outputs, receivers and feedback as defined above.

5. ISO 9001 in a Fulfil Order Process

Figure 3 gives an overview showing that ISO 9001 addresses the entire business
model and how, when broken down into greater detail, individual requirements of
ISO 9001 can be linked to the different parts (operating and non-operating) of the
business. In some areas, the standard’s requirements are more directly relevant to
manage or support processes than to an operate process.

5.1. Review of the requirements of ISO 9001:2000 in a fulfil order context

To understand the relevance of ISO 9001 in a process context, each section of the
standard was reviewed to describe the characteristics a Fulfil Order Process must
provide. The review assessed each section of the standard against whether the
 Incorporating links to ISO 9001 3101

Figure 3. Systems model of ISO 9001 and a Fulfil Order Process.

requirements can be classified as data, information, resources, objects, activities or

others.
The systems parameters described for a Fulfil Order Process formed the basis for
review of each requirement of ISO 9001 and its role within this process. Each section
of ISO 9001 has been assessed by taking a systemic view of the Fulfil Order Process
addressing the following questions.

. What kind of inputs and outputs are needed to address each of the ISO 9001
requirements for the Fulfil Order Process?
. What activities and/or processes are needed by each ISO 9001 requirement?
. Whether other parts of the quality management system outside the boundaries
of a Fulfil Order Process are relevant as either a source or a receiver?

Finally, the general requirements of ISO 9001 were assessed. Considering the
requirements of a Fulfil Order Process from a modelling technique viewpoint,
emphasis has been placed on process identification, process sequence and the depen-
dence between processes and activities. Process identification addresses the need to
label all components of the modelling technique consistently. Furthermore the
process sequence and the dependence of processes focus on the provision of a
sound structure and hierarchy for the process model. These characteristics are rele-
vant for validation and control purposes of the standard and also for its continuous
improvement elements.
This reviewing process was completed by classifying each link between an
ISO 9001 requirement and the Fulfil Order Process. A detailed description is given
below.
3102 J. Gingele et al.

5.1.1. ISO 9001 requirements – directly relevant

Requirements that are considered to be directly relevant to a Fulfil Order Process
are those such as ‘Planning of product realisation’ (ISO 9001 Section 7.1 c) which
require activities such as verifying, validating, monitoring, inspecting and testing etc.
that are specific to the product. An example would be ‘Identification and traceability’
(ISO 9001 Section 7.5.3) which requires activities to identify the product throughout
its production.

5.1.2. ISO 9001 requirements – indirectly relevant

Requirements of the standard that are considered to be indirectly relevant to a
Fulfil Order Process are usually dealt with in the non-operating/non-fulfil-order part
of the quality management system. However, this part of the quality management
system often requires data and information from the Fulfil Order Process. For
example, an activity in the Fulfil Order Process which uses forms (documents)
and records data may be indirectly linked to ISO 9001 Section 4.2.3 ‘Control of
documents’ and to ISO 9001 Section 4.2.4 ‘Control of records’ if the forms and
records are required by the quality management system. ISO 9001 Section 4.2.3
controls aspects such as the approval of documents for adequacy, ensuring the use
of documents with current revision status only and preventing the use of obsolete
documents. In ISO 9001 Section 4.2.4 the standard requires the user to be specific
about the identification, storage and protection of records. ISO 9001 Section 8.5
‘Improvement’, which deals with continual improvement of the quality management
system is another example of being only indirectly linked to fulfil order activities.
Information and data in the form of records or other documents provided by the
fulfil order activities are often required by processes in the non-operating/non-order
part of the quality management system to introduce improvements.

5.1.3. ISO 9001 requirements – not relevant

Sections of ISO 9001 considered to be not relevant to fulfil order activities are, for
example, ‘Management commitment’ (ISO 9001 Section 5.1) and ‘Design and devel-
opment’ (ISO 9001 Section 7.3). The former includes the establishment of a quality
policy that is appropriate and is communicated company wide. This ISO section
would apply to the group manage processes rather than operate processes as defined
in the CIM-OSA standard (CIM-OSA/AMICE 1989). ISO 9001 Section 7.3 deals
with the design and development of products, including relevant inputs and outputs to
the design process, design review and the control of design changes. This ISO section
would apply to another of the four operating type processes described as Develop
Product (Maull et al. 1995a, Childe et al. 1995).

5.2. Criteria for selecting a process modelling technique that can link ISO 9001 to
a Fulfil Order Process
ISO 9001 affects a Fulfil Order Process in many different ways. This includes the
requirements to perform certain activities, using controlled documents and equip-
ment and to provide the quality management system with specific data and informa-
tion in the form of records and reports etc. In terms of controlling documents and
equipment and identifying them to prevent unintended use of any kind, the standard
requires, throughout, a unique identification convention. Among other sections of
the standard, ‘Control of documents’ (ISO 9001 Section 4.2.3), ‘Control of records’
(ISO 9001 Section 4.2.4), and ‘Control of monitoring and measuring devices’
 Incorporating links to ISO 9001 3103

(ISO 9001 Section 7.6) specify in detail what needs to be controlled. A modelling
technique must show the identification of referred documents or equipment.
As the Fulfil Order Process has been described from a systems viewpoint, the
relevant requirements of ISO 9001 will also be discussed in terms of the systems
parameters: source, input, process, transformation, output, resource and feedback. The
systems parameters will be used to explain the overall system of a Fulfil Order
Process as well as the elements at all levels within this process.

5.2.1. Source related to an ISO 9001 oriented Fulfil Order Process

The boundaries for the system are set around the operate type process Fulfil
Order. ISO 9001 affects all parts of an organization and information from anywhere
about ISO relevant inputs that cross the system’s boundaries must be shown.
Suppliers are one of the main sources of these inputs through the provision of
required material and information.
Documents in the form of procedures, instructions or blank forms and labels are
developed and controlled in the non-operating part of the quality management
system. Therefore, this part of the quality management system can be seen as
another source. Both suppliers and document production are outside the Fulfil
Order Process system boundaries and therefore need to be acknowledged by the
modelling technique as sources.

5.2.2. Inputs of an ISO 9001 oriented Fulfil Order Process

In ISO 9001, material, equipment, personnel and information are considered to
be inputs for processes and activities. Activities of a Fulfil Order Process affected by
the standard are constrained by inputs in the form of data and information and
resources. Data and information are either processed in electronic form by compu-
ters, or come as different types of documents. The documents, which are mostly
paper based, convey data and information and can be divided into four classes:
policies, practices, derived documents and reference documents (Hoyle 1998b).

Policies
Policies are documents that define the organization’s approach to achieving set
objectives. For the Fulfil Order Process policies are not relevant as they are dealt
with within the non-operating part of the quality management system outside the
system’s boundaries.

Practices
Practices are statements that define the details of an operation such as What,
When, Where, How and Who and need to be shown by the modelling technique. In
ISO 9001, practices can be in the shape of procedures, forms, labels or notices. The
standard specifies the requirements for different practices mainly in ‘Control of
documents’ (ISO 9001 Section 4.2.3), ‘Control of records’ (ISO 9001 Section
4.2.4), ‘Corrective action’ and ‘Preventive action’ (ISO 9001 Section 8.5.2 and
8.5.3). Sub-categories of procedures, forms or records may also be required for
the ‘Purchasing process’ (ISO 9001 Section 7.4.1), the ‘Monitoring and measuring
of products’ (ISO 9001 Section 8.2.4), ‘Planning of product realisation’ (ISO 9001
Section 7.1) and ‘Identification and traceability’ (ISO 9001 Section 7.5.3).
3104 J. Gingele et al.

Derived documents
Derived documents are the result of implementing policies and practices and can
be further divided into prescriptive and descriptive documents. Prescriptive documents
are, for example, plans (business plan, quality plan), instructions, or product
specifications and need to be shown as control inputs by a modelling technique as
they contain requirements (‘Planning of product realisation’, ISO 9001 Section 7.1).
Descriptive documents are discussed in Section 5.2.4 where they are classified as
outputs.

Reference documents
Hoyle (1998b) describes the fourth type of document as a reference document.
Documents of this nature often only include information without giving instructions.
A list of approved suppliers, including names and addresses or other data is an
example. Where reference documents must be used by an activity they can affect
the way it is done. A procedure or other type of practice often refers to the reference
documents necessary to complete an activity. Engineering drawings, purchase orders
or government regulations may be among the requirements of ‘Planning of product
realisation’ (ISO 9001 Section 7.1) which belong to this category. ISO 9001 would
usually require such documents to be identified and controlled. In some instances,
reference documents can also be classed as resource inputs (which includes physical
requirements or human resources) where they give guidance and support an activity.

5.2.3. Processes and transformation in an ISO 9001 oriented Fulfil Order Process
As discussed, the systems parameter transformation itself is the actual conversion
of material to achieve the desired output. Processes are needed to achieve this
transformation. ISO 9001 is concerned with tasks and activities that achieve the
transformation. The remainder of this section therefore focuses on the systems para-
meter processes.
Besides ISO 9001 controlling activities by the use of procedures, it also asks for
additional activities to be considered during the product production phase in a Fulfil
Order Process. Additional to making product, which is a key activity within a Fulfil
Order Process, ISO 9001 requires many different activities, such as validating, verify-
ing, monitoring, identifying, testing, inspecting, handling, packing and storing.
‘Planning of product realisation’ (ISO 9001 Section 7.1), ‘Purchasing’ (ISO 9001
Section 7.4), ‘Production and service provision’ (ISO 9001 Section 7.5) and
‘Control of non conforming products’ (ISO 9001 Section 8.3) are among those
which directly specify particular activities to be performed. Activities such as record-
ing data and information and the filing of documents are required by sections such as
‘Monitoring and measurement of product’ (ISO 9001 Section 8.2.4), ‘Control of
nonconforming product’ (ISO 9001 Section 8.3) and ‘Analysis of data’ (ISO 9001
Section 8.4).
Each of these activities may incorporate various sub-activities to complete a job.
The sequence and flow of these activities and sub-activities are critical to the per-
formance of the Fulfil Order Process. A modelling technique needs to address this
requirement by showing the hierarchy of activities and their decomposition.

5.2.4. Outputs of activities in an ISO 9001 oriented Fulfil Order Process

Outputs in general can be described as processed information or objects and
often act as input for subsequent activities. Processed information that derives
 Incorporating links to ISO 9001 3105

from measurements or assessments is documented as records and may be written up

in reports. It can therefore be classified as being descriptive. A descriptive document
can be defined, in general, as containing results and information on any kind of
achievement, e.g. forms and labels once completed may become records and are
transformed from being inputs to outputs. Depending on the type of information
included, prescriptive documents might be used as inputs in the form of a specifica-
tion or a procedure. The use of a checksheet for an activity to set up a machine is an
example of a form transforming from an object input to an output. As the original
checksheet might need to have certain machine parameter settings recorded or given
specifications checked, it changes is status and acts as a control input for a subsequent
activity such as start producing parts.
The quality management system with its need for continual improvement
requires reliable data and information to ensure the suitability and effectiveness of
the overall system. Therefore, the organization needs to determine, collect and ana-
lyse appropriate data (‘Analysis of data’, ISO 9001 Section 8.4). This requires activ-
ities in the Fulfil Order Process to provide data and information that can be used to
achieve continual improvement. The requirements are only indirectly relevant to the
Fulfil Order Process. ‘General requirements’ (ISO 9001 Section 4.1) of the ‘Quality
management system’, ‘Planning’ (ISO 9001 Section 5.4) and ‘Management Review’
(ISO 9001 Section 5.6) as part of ‘Management responsibility’ and ‘Competence,
awareness and training’ (ISO 9001 Section 6.2.2) of ‘Resource management’ all
indirectly rely on such data. It also impacts on ‘Planning of product realisation’
(ISO 9001 Section 7.1), ‘Measurement, analysis and improvement’ (ISO 9001
Section 8) as well as on ‘Improvement’ (ISO 9001 Section 8.5). Regardless of
where the improvements and the redesign will be implemented, be it within the
Fulfil Order Process system boundaries or outside, relevant data from activities
within the Fulfil Order Process need to be provided to make improvements
happen in the first place.

5.2.5. Receiver of an ISO 9001 oriented Fulfil Order Process

Similarly to the source, a receiver is outside the defined boundaries of a Fulfil
Order Process. The product as ordered crosses the boundaries of the Fulfil Order
Process to the external customer and will include all required information, such as
inspection records, quality reports and process capabilities. In terms of supplier
communication there will be an exchange of documents relevant to the
‘Purchasing process’ (ISO 9001 Section 7.4.1), which includes requests for quotes
(RFQs) or purchase orders etc. Suppliers and any other stakeholders who have an
interest in the outcome of the Fulfil Order Process can therefore also be seen as
receivers. The Fulfil Order Process also provides the quality management system
with data and information to ensure compliance with the ISO 9001 standard. This
includes the provision of reliable data for continual improvement efforts (ISO 9001
Section 4.1 or 8.5). Therefore, that part of the quality management system outside
the boundaries of the Fulfil Order Process can generally be classed as a receiver.

5.2.6. Feedback in an ISO 9001 oriented Fulfil Order Process

Feedback can be thought of as a kind of input that comes from a receiver. The
plans for improvements established in the non-operating part of the quality manage-
ment system can be seen as an input based on feedback from within the organization
and information from the customer to improve future activities. Requirements for
3106 J. Gingele et al.

such improvements are stated in sections ‘Quality management system’ (ISO 9001
Section 4), ‘Management responsibility’ (ISO 9001 Section 5) and ‘Measurement,
analysis and improvement’ (ISO 9001 Section 8).

5.3. Criteria for modelling ISO 9001 in a Fulfil Order Process

The previous sections have discussed the criteria which, in addition to those
necessary to model the basic Fulfil Order Process, are required to demonstrate its
links with ISO 9001. The specific requirements of a modelling technique to incor-
porate ISO 9001 are as follows.

Criterion 1
To show activities and clearly identify the ones that are controlled by the
ISO 9001 quality standard. A function view of the Fulfil Order Process is required
which will allow it to show activities, an activity’s dependence on other activities and
its flow. The modelling technique needs to identify and distinguish between activities
that are constrained by the standard and those that are not, either graphically or by
some other means of identification.

Criterion 2
To identify and distinguish information and objects that are linked to a require-
ment of ISO 9001 from those that are not. Where data and information are classed as
different types of documents such as practices, derived documents, or reference
documents, the modelling technique must be able to label them accordingly. This
may also include referring to sources within the quality management system that
originate documents. This applies similarly to objects such as goods (material or
consumables) which must be identified.

Criterion 3
To show information and the flow of information. As with the hierarchy of
processes, the modelling technique needs also to decompose information to the
different levels of detail. The focus of this research lies in showing information
and its flow to allow the activities within the Fulfil Order Process to be redesigned.
Consequently, information will only need to be shown as graphical labels, not
including the content and structure of information. Therefore the modelling techni-
que does not need to show a separate information view.

Criterion 4
Any form of information, be it electronically or paper document based, must be
shown as different types of input to an activity. The different types of inputs have
been identified as control inputs, object inputs or resource inputs. This requirement
also applies to feedback. Documents that are transformed from inputs to outputs
and include the processed information that is required by the standard must be
identified.

Criterion 5
To decompose activities and information to the level of detail necessary to link
them to individual requirements of ISO 9001. The modelling technique must describe
a hierarchy that composes systems from subsystems.
 Incorporating links to ISO 9001 3107

Criterion 6
To set system boundaries in order to identify any source or receiver within the
quality management system or with external stakeholders affected by ISO 9001:2000
inputs or outputs.

Criterion 7
To show resources that are required by the activity and to identify the ones that
are linked to the standard. The different types of resources required to be shown by
the modelling technique have been defined as human resources and equipment.

Criterion 8
All relevant elements such as inputs, outputs and resources within a quality
management system must be controlled and identification is usually achieved by a
document numbering convention or other forms of unique labelling systems. The
modelling technique needs to refer to the various conventions of identification and
show individual identity codes.

6. Selection of an appropriate modelling technique

A variety of methods are used for process modelling within business process re-
engineering. The literature search identified a number of studies, among them
surveys carried out by O’Sullivan (1994), Kettinger et al. (1997), Kota et al. (1998)
and Kokolakis et al. (2000). They all use similar categories grouping the techniques
into either functional, data (information), dynamic, simulation, flow or decision
(process logic) modelling. This list may not be exhaustive but covers the most
widely used, well documented and referenced modelling techniques in the process
modelling of manufacturing systems. It is also representative of the various different
approaches.
The modelling process in general can produce different kinds of models and there
is a concern that modelling can become an end in itself (Wilson 1984). It is therefore
important to select an appropriate modelling technique and develop a suitable model
that shows the relevant aspects. From the variety of methods, an initial selection was
performed excluding all techniques that do not focus on the two main criteria to
(1) model activities and (2) to show the flow of activities and information. The
following modelling techniques, which were reviewed in this research are Action
Workflow, Petri Nets, Role Activity Diagrams (RAD), Flowcharts (Block diagrams,
ANSI Flowcharts, Functional Flowcharts, HIPO – Hierarchy plus Input Process
Output), Data Flow Diagrams (DFD), Object Oriented Modelling (OOM/Use Case)
and IDEF suite (IDEF0, IDEF1X, IDEF1-IDEF4).
It is not the intention of this paper to explain each modelling technique under
investigation, for that the reader is referred to other literature. In the first instance of
this review the techniques were assessed for their applicability to model a Fulfil
Order Process. This resulted in an exclusion of all those where syntactical limitations
did not support the modelling of systems parameters. This is because a Fulfil Order
Process has been described from a systems viewpoint and a systemic presentation of
it has been seen as a vital criterion for selecting a modelling technique.
The techniques that supported these criteria were further investigated in respect
of their appropriateness to highlight ISO 9001 criteria. None of the modelling tech-
niques completely supported this second set of criteria. Each of the selected model-
ling techniques was therefore reviewed with regards to how easily its syntax and
3108 J. Gingele et al.

semantics could be adapted. IDEF0 was selected to be the most appropriate model-
ling technique. The remainder of this paper discusses an adapted version of IDEF0,
named IDEF9000, which identifies ISO 9000 constraints in the design of a business
process model.

7. Development of the modelling approach IDEF9000

To support its Integrated Computer Aided Manufacturing programme (ICAM)
the US Air Force developed a system definition method known as the ICAM
Definition (IDEF) methodology (US Air Force 1981, Le Clair 1982). IDEF0 is a
function-based modelling technique for designing and analysing a system as a set of
interrelated functions and may be one of the most influential techniques for function
modelling of manufacturing systems and its processes, as the method is widely
understood and well documented (Marca and McGowan 1988, Mayer 1990,
Colquhoun and Baines 1991, Colquhoun et al. 1996). It is a process mapping tech-
nique based on combining graphics and text to gain an understanding of how
process functions operate and interrelate.
From a taxonomy point of view, the domain of enterprise modelling distin-
guishes between action, function and activity. Within the Generic Activity Model
(GAM) of the object-oriented IEM (Spur et al. 1996) an action describes an activity
without an established relationship to objects within the model. Such an action is
described as a function if it is related to inputs that are transformed into outputs. An
activity represents a function to which control and executing inputs were assigned.
The IDEF0 methodology traditionally uses the term function to describe systems
functions such as activities, actions, processes and operations. As the work presented
in this paper is based on the IDEF0 methodology it will follow this terminology.
The structure of an IDEF0 model consists of the following main parts: a node
index, the context diagram and a set of function diagrams. The node index is a listing
of all functions or nodes used in an IDEF0 model in an outline format similar to an
ordinary table of contents. The list presents a hierarchical structure of the processes
and any subordinate functions including diagram titles and/or function names. The
context diagram establishes the scope and purpose of the model as well as the
particular viewpoint. It defines the boundaries with the outside world. Everything
in the model comes from a decomposition of the context diagram. The function
diagrams of the model define the process. The diagram is the basic unit of the
model and contains boxes and arrows. The boxes represent functions in the process
being modelled. Box labels are named using imperative verbs. Imperative verbs can
be explained as active verbs that describe the function.
Arrows connect boxes together and represent interfaces or interconnections
between the boxes. Arrows may be split (branched) or may be joined together
(bundled). This indicates that the kind of data or object represented by the arrow
may be used or produced by more than one function.
In IDEF0, there is a meaning associated with each side of the box where an arrow
enters it or leaves it (see figure 4). The left side is reserved for inputs, things trans-
formed into outputs by the function. The right side is reserved for outputs, the
transformed inputs. The top is reserved for controls, inputs such as constraints or
rules that dictate the conditions of the transformation. The bottom is reserved for
mechanisms, tools, people and systems used during the transformation. These four
types of arrows, inputs, controls, outputs and mechanisms are sometimes referred to
 Incorporating links to ISO 9001 3109

Figure 4. Function box and ICOMs.

as ICOMs. Whereas functions are always labelled with verbs or verb phrases, nouns
are used for labelling arrows.
The adapted IDEF9000 modelling technique must address the eight criteria devel-
oped to show the links and controls of the ISO 9001 quality standard. The following
sections will now discuss the extensions in the semantics of IDEF9000 together with
the adapted syntax for each ISO 9001 criterion. The key issues discussed below
should be seen as a specific set of guidelines in addition to the IDEF0 methodology
published as a Federal Information Processing Standards Publication (National
Institute of Standards and Technology 1993) and by Mayer (1992).
The IDEF0 methodology starts with drawing a context (A-0) diagram (figure 5)
which includes the context, purpose and viewpoint of the process model. A Fulfil
Order Process contains all functions that transform product orders into products. Its
key focus is to show the material and information flow essential to satisfy customer
requirements. The system boundaries set by the context diagram also must identify
all links relevant to ISO 9001 that enter the operative part of the organization.
IDEF0 allows the design of systemic process models, a criterion that was imperative
for its selection (criterion 6).
There are only two reasons why a function box needs to be formatted differently.
The first rule is to show when functions are constrained by an ISO 9001 control input
(entering the box from the top). The second is when a higher level function must
indicate if any of its subordinate functions are controlled by ISO 9001 in order to
maintain consistency when decomposing the process model.
The following sections will now discuss the extensions in the semantics of
IDEF9000 together with the adapted syntax for each ISO 9001 criterion.
The enhanced modelling technique for ISO 9001 links identifies and distinguishes
graphically between functions that are controlled by the ISO standard and those that
are not. A transparent box with a normal black font style represents ordinary
functions. Using a black box with the font style white, italics, bold and underlined
(criterion 1), indicates that either this box or any subordinate box (or boxes) is
controlled by ISO 9001 (see figures 5 and 6).
It is mandatory that this rule is applied when controls governed by ISO 9001 are
present. Typical controls that rule and constrain how an function needs to be per-
formed are ISO 9001’s control or operating procedures. However, this extension in
3110 J. Gingele et al.

Figure 5. Identification of IDEF9000 functions controlled by ISO 9001 (decomposed).

Figure 6. Identification of an IDEF9000 function controlled by ISO 9001.

 Incorporating links to ISO 9001 3111

Figure 7. Identification of activities controlled by ISO 9001.

the syntax and semantics of IDEF9000 does not apply to inputs (object inputs),
outputs or mechanisms (resource inputs) related to ISO 9001, as shown in figure
7. Such object inputs may be controlled forms, identified goods or inspected com-
ponents that do not constrain the nature of the function itself. They only need to be
transformed by a particular function by using certain mechanisms to produce a
specific output. With the graphically different layout of a ISO 9001 controlled,
black function box, the attention of the designer is drawn to the ISO 9001 control
that constrains the function first before starting the redesign.
To identify and distinguish information and objects that are linked to a
requirement of ISO 9001 from those that are not, the modelling technique will
need to label them differently (criterion 2). It may also be necessary to refer to
sources within the quality management system from where documents originate.
The syntax proposed for identifying ISO 9001 links is to draw arrows using a heavier
or thicker line. For the labelling of arrows controlled by ISO 9001 the font style is
changed to italics, bold and underlined as seen in figure 6.
Some typical inputs, controls, outputs and mechanisms for a Fulfil Order Process
from an ISO 9001 viewpoint are shown in figure 8. Inputs (object inputs) can usually
be classified as being either controlled documents (information and data) or objects.
Similarly to the traditional IDEF0 rules, inputs can also become controls. A function
always has to have a control arrow regardless of whether it is controlled by ISO 9001
or not, although it need not always have other inputs. Typical ISO 9001 related
outputs are completed documents in the form of reports and charts or objects, such
as inspected and identified goods. Mechanisms that are identified with the new
syntax could be, for example, customer-owned equipment, any measuring and test-
ing equipment or qualified personnel (criterion 4, 7).
To decompose functions into sub-functions to the level of detail necessary to link
them to documents or objects controlled by ISO 9001, the modelling technique will
use the ability of IDEF0 to describe a hierarchy that composes systems from sub-
systems. IDEF0’s original facility for decomposing functions is combined with the
identification of functions controlled by ISO 9001 in figure 5 (criterion 5).
Similarly to the hierarchy of processes, the decomposition of information down
to the different levels of detail needs to consider the extended syntax to identify
information controlled by ISO 9001 at all levels. As there is always concern about
overloading the diagrams, the arrows should only be branched at the required level
3112 J. Gingele et al.

Figure 8. Typical ISO 9001 arrows in a Fulfil Order Process.

Figure 9. Decomposing activities and information controlled by ISO 9001.

 Incorporating links to ISO 9001 3113

of detail. For example, instead of drawing all individual work and test instructions
(control inputs), entering the more general function make product they can be
bundled into one arrow labelled as ‘Work instruction (ISO 9001 Procedure Folder
PF-Ru)’ and decomposed at the next lower level of the more detailed diagram (see
figure 9). This example also shows the source or location of documents and other
information on each arrow label. This is required because many ISO 9001 documents
have their origin outside the boundaries of a Fulfil Order Process. They must be
shown on the context diagram entering the system at a high level (bundled) and
should be identified as, for example, ISO 9001 documentation (criterion 3, 8).

8. Validation of the proposed modelling approach IDEF9000

The modelling approach was developed to highlight where the relevant require-
ments of ISO 9001 interrelate with activities of the Fulfil Order Process to draw
attention to the potential impact of changes in the process or in the standard. As the
research is about the application of the modelling approach IDEF9000 to design
business processes, which allow the process modeller to show/establish the links to
ISO 9001, IDEF9000 has been evaluated as a tool that fulfils a common need not
fulfilled by existing schemes. The principal aim of this phase was to establish whether
the proposed approach met the needs of practitioners (Thomas and Tymon 1982)
(see below) and the specific criteria. To establish the validity of the proposed model-
ling approach a first stage concentrated on the validation by review and the second
stage validating by use.
In order to assess the use of the modelling technique in a fair manner, reviewers
assessed the modelling approach for its usefulness and how easy the approach was to
understand during stage one of the validation process. Academics involved in the
field of POM (Production and Operations Management) along with managers and
practitioners from industry acted as reviewers. Each reviewer was presented with a
draft copy of the manual IDEF9000 – A Standard for Modelling Operating Business
Processes with Links to ISO 9001 (Gingele 2001b) and a questionnaire. The review
was carried out in several steps to allow improvements to be included with each
version of the modelling technique. This allowed the researcher to obtain useful
information and opinions on how the proposed approach met some of the needs
of practitioners before validating its use.
During stage two, the usefulness of the approach was assessed by practitioners
applying the modelling technique and the method of use in manufacturing com-
panies after incorporating suggestions made during stage one. Validity for these case
studies was improved by using multiple sources of evidence and different methods of
data gathering. Various kinds of evidence, such as documents, records, manuals and
interview transcripts, which belong to the category of data triangulation (Easterby-
Smith et al. 1991) have been evaluated, while the application of different methods
such as semi-structured interviews and questionnaires can be referred to as metho-
dological triangulation. The validation criteria for both stages include the reference
framework of Thomas and Tymon (1982). It describes the ‘five needs of practi-
tioners’ in terms of descriptive relevance, goal relevance, operational validity, non-
obviousness and timeliness. Together with the specific set of criteria defined for the
modelling technique, the key needs form the frame for the validation.
To fulfil the key need descriptive relevance, the modelling technique was assessed
against whether the links of ISO 9001 to a Fulfil Order Process were apparent. With
the second key need, goal relevance, it was validated against whether the use of the
3114 J. Gingele et al.

modelling technique allowed the organization to achieve its objectives. Operational

validity evaluated how easy it was for the organization to use the modelling techni-
que in its particular circumstances. Non-obviousness addressed the question of
whether the use of this approach was an improvement on the method that may
otherwise have been used to understand the existing situation of the company.
From the viewpoint of timeliness the validation concentrated on whether the model-
ling approach was available a time when it was needed.
During stage one, both the modelling technique and its intended method of use
were found useful and easy to understand, meeting the five key needs of practi-
tioners. Comments and suggestions from the reviewers were incorporated in an
improved version of the modelling technique. During stage two, IDEF9000 was
used successfully in two manufacturing companies. In a case study at Case C, the
modelling technique was used extensively during the design and redesign stage of a
Fulfil Order Process. The use of the modelling technique allowed Case C to model its
Fulfil Order Process and to identify the links of ISO 9001 within its fulfil order
environment. The established links resulted in an improved understanding of
ISO 9001 in a process context according to the Quality Improvement Manager
and highlighted potential constraints that needed to be addressed with caution
during a redesign in order to maintain compliance with the quality standard. A
second manufacturing company ‘D’, used the IDEF9000 approach during the
design of their ISO 9001 quality management system and regarded IDEF9000 as
beneficial in identifying where ISO 9001 takes effect on their business. It was per-
ceived as a useful tool to improve the consistency of Case D’s actions in terms of
quality control and quality assurance. They decided to model the entire business
using IDEF9000. Further details of the case studies are presented in Gingele (2001a)
and in Gingele et al. (2002).

9. Conclusions
The research problem developed from a detailed literature review and practical
experience in the field of quality management that revealed the difficulties organiza-
tions face when designing quality management systems and implementing the quality
standard ISO 9001. A first conclusion from the quality management systems’ litera-
ture revealed that simply documenting what an organization does in response to
ISO 9001 is still one of the most common approaches adopted. This is the result of
limited guidance on how to integrate the requirements of the standard into the
business processes of the organization. Such systems often lead to extra bureaucracy
in the business and their design often achieves a process-oriented character only at
the documentation stage. The usefulness of a process-oriented view of business is
often recognized but the approaches available to achieve it fail to take a systemic
view of the business and the quality management system. These initial stages of the
research highlighted that business processes can improve through the integration of
ISO 9001 requirements to establish a responsive quality management system. The
knowledge and understanding gained during this part of the research led to the
following conclusion

during the design/redesign of business processes, currents approaches do not

provide for a systemic consideration of process-based quality management
systems and do not establish the links to the requirements of ISO 9001.
 Incorporating links to ISO 9001 3115

This conclusion stimulated further research work which sought to investigate busi-
ness processes, taking into account the requirements of ISO 9001. It led to the
following research question:

How can a process model be best drawn to establish links between business
processes and ISO 9001?

This paper described the principles of an enhanced version of the modelling techni-
que IDEF0 together with its method of use. The version, called IDEF9000, reflects in
its name the emphasis on identifying ISO 9000 constraints in the design of a business
process model. With the extended syntax and semantics of IDEF9000 the modeller
can graphically identify all activities and flows (inputs, controls, outputs and
mechanisms) that are controlled by ISO 9001 at all levels of detail in a process
model. IDEF9000 benefits from the IDEF0 facility to take a systemic view of a
business process. The enhancements in IDEF9000 and its method of use should be
seen as an extension to the existing IDEF0 methodology.
To support the use of IDEF9000, organizations (especially those without expert
knowledge of ISO 9001) can consult a list of common flows controlled by ISO 9001
in a fulfil order environment as shown in figure 8. The use of IDEF9000 during the
detailed case studies has proved successful in two companies. Based on the two-stage
validation approach it was concluded that the modelling approach IDEF9000 can be
applied as proposed. It can be used as part of the design of a quality management
system as it enables the practitioners to establish the links of ISO 9001 in a Fulfil
Order Process and highlights ISO 9001 constraints during the stages of redesign.
The modelling approach has been developed to design/redesign a business pro-
cess and to establish and identify its links to ISO 9001 requirements. The research
community and companies are aware that ‘model reuse’ is not enabled by simply
developing static IDEF models. The issue of process dynamics also needs to be
addressed to gain real benefits of process modelling. However, process dynamics or
change scenario assessment are an extension of static modelling that can only be
developed once the concepts are clear. The work presented shows how a key concept,
the links between IDEF and ISO 9001, can be understood. Future research could be
undertaken to investigate how the established ISO 9001 links behave within dynamic
business scenarios.
This paper has given the new knowledge needed about how to model a Fulfil
Order Process from a systemic perspective and to identify the activities and flows
that are controlled by ISO 9001. The identification of activities and flows controlled
by ISO 9001 indicates where to take special consideration during the design of an
ISO 9001 quality management system or a redesign exercise of a Fulfil Order
Process. This work has developed and tested a modelling technique which brings
this knowledge into action.

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