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Quality
assurance and
audit systems
Stanislav Karapetrovic
Walter Willborn
679
Received September 1999
Revised December 1999
Introduction
Quality audits have gained prominence in the last 20 years as a tool for
assessing the effectiveness of quality assurance efforts and, more recently, for
the evaluation of compliance with applicable quality standards, such as
ISO 9000. Quality auditors examine, in several stages, whether or not quality
processes, resources and objectives are what they should be. First, they assess
compliance of quality assurance procedures and related documentation with
applicable standards and guidelines (also called ``audit criteria''). Then they
typically evaluate whether actual quality assurance activities conform to the
documented procedures, and are effectively implemented and suitable to
achieve quality objectives. The evaluation of the system effectiveness can be a
powerful management tool for quality improvement. In fact, many authors
argue that one of the primary purposes of audits is continuous improvement
(Burr, 1997; Hunt, 1997; Willborn and Cheng, 1994; Russell, 1997; Russell and
Regel, 1996; Walker, 1998).
In performing auditing activities, quality auditors must objectively and
independently collect and verify audit evidence, evaluate it against audit
criteria, and report their findings. Objectivity and independence are two
separate, yet interrelated, fundamental principles of auditing. Objectivity
relates to the consistency of the auditing process and results, materiality of
evidence, the use of appropriate methodology (e.g. statistical sampling,
flowcharts, and checklists), the application of a systematic approach to
auditing, as well as being free from bias. Consistency, for instance, means that
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two auditors auditing the same system against identical criteria should come
up with similar conclusions. On the other hand, independence refers to both the
auditor's organizational position and his/her state of mind. In order to conduct
effective and efficient audits, and do this objectively, auditors must not be
directly responsible to the function or organization being audited. Here lies the
fundamental difference between an auditor and a consultant. While consultants
assist an organization in establishing a quality system, they cannot objectively
and independently assess whether the system is implemented effectively and in
compliance with applicable standards. However, consulting and auditing have
one common characteristic: both are, in essence, services rendered to
management. As such, both are subject to quality assurance.
The issue of quality assurance and reliability of audits bears a particularly
important impact on the fundamental principles of objectivity, independence
and continuous improvement. For instance, how does an auditor ensure a
reliable and objective collection and evaluation of evidence against audit
criteria? Due to time, organizational, financial and other constraints, these
processes normally involve only a selected sample of activities and
documentation. Thus, an auditor must collect a representative sample of
evidence from the population, and evaluate it against set criteria. Inherent in
sampling procedures is a risk of accepting a wrong finding, or rejecting a
correct one. This concept, called an audit risk, must be taken into account when
assuring the audit client of the reliability of findings and audit results with
some degree of confidence. Naturally, audit errors and inconsistencies do
happen, and audits do fail (Druckman, 1997; Stratton, 1995). For instance, if
audit objectives are deemed unattainable, an audit is terminated (Willborn,
1993). In such a case, how can clients be assured that audits will be restored to
the operational mode and ultimately achieve audit policy and objectives of
continuous improvement? Audit maintainability deals with related questions.
Another related and important issue is the suitability of audits and audit
systems to adapt to changing environments, audit requirements and criteria in
achieving set goals.
The whole notion of quality assurance and quality of auditing activities has
been relatively unexplored in the realm of quality audits (Willborn, 1993).
While earlier national auditing guidelines, such as the Canadian CSA Q395
(1981) and American ANSI/ASQC Q1 (1986), contained provisions for quality
assurance of audits, the contemporary international standard on quality audits,
namely ISO 10011 (1990), does not discuss this issue. In the same vein, the
current work on the revision of quality and environmental audit guidelines,
under the auspices of the International Organization for Standardization, does
not point specifically to addressing audit quality assurance. Unfortunately, this
has created a situation where implied quality assurance of auditing activities
rests solely with the adequate qualification and competence of auditors, and
conformance of the auditing process to the existing audit guidelines. It has also
left a serious gap in the available guidance for quality assurance and control of
auditing programs and systems. In the wake of increased concerns about the
effectiveness of quality audits to achieve stated ``continuous improvement''
objectives, questions about the overall usefulness of sporadic quality system
registration audits, as well as difficulties in achieving and improving the
consistency of both external and internal audits, quality assurance of auditing
services must be seriously examined and implemented.
All this is happening while the cutting edge of quality auditing seems to lie
in the use of new information and computer technologies, the systems approach
to auditing, and the harmonization and integration with other auditing
activities and systems, such as environmental, safety, ergonomic, maintenance
and financial audits. The last area mentioned, namely integration with
financial audits, bears a particularly interesting impact on quality auditing.
The financial (also known as ``internal'' or ``accounting'') audit has evolved as an
established element of the accounting profession. Thus, the concepts of audit
risk, uncertainty, materiality, statistical sampling, reliability of findings, and
audit errors are well known and continuously researched in the accounting
literature (e.g. Colbert, 1996; Friedlob and Schleifer, 1999; Shailer et al., 1998;
Busta and Weiberg, 1998; Woodhead, 1997; Karim and Siegel, 1998). These
concepts are crucial for proper understanding and application of audits,
regardless of the particular discipline (e.g. finances, quality, environment or
safety) addressed. However, they are not given appropriate recognition in the
quality auditing literature. For example, the body of knowledge for certified
quality auditors by the American Society for Quality (ASQ), does not even
mention audit risk, materiality, reliability, maintainability, or for that matter,
quality assurance of auditing activities (ASQ, 1999).
This paper attempts to present a systematic view of quality assurance in
auditing. The systems approach to auditing is briefly presented, followed by a
discussion on quality assurance and control of the various elements of the audit
system. A model for evaluating audit effectiveness is presented, and reliability,
maintainability and availability of the audit system are addressed.
Systems approach to auditing
Quality audits are documented systems for independent and objective
collection and verification of audit evidence, and evaluation of the evidence
against audit criteria. Audit evidence relates to all information and material
gathered for the purpose of achieving audit objectives. Audit criteria includes
identified and agreed on procedures, guidelines, and standards, such as
ISO 9001 or QS 9000, that serve as a benchmark for an individual audit.
Under the systems approach (Karapetrovic and Willborn, 1998), an audit is
viewed as a set of interdependent processes (or activities), using human,
material, infrastructural, financial, information and technical resources to
achieve objectives related to the continuous improvement of performance
(Figure 1: top). In other words, an audit is a system (Hirzel, 1998; Bishara and
Wyrick, 1994).
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Figure 1.
Audit system
Audit programs are subsystems of the overall generic audit system (for
example, an organization can have several audit programs forming an
audit system, including environmental, safety, financial and quality, as
well as special external, internal or supplier audit programs).
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at all three levels: individual audits, audit programs and the generic audit
system. The conceptualization of QA at the individual audit level is depicted in
Figure 1, and will be discussed later in the paper, with the presentation of
proper audit methodologies, as well as the discussion of audit effectiveness and
auditor competence. The ISO 9000 scheme, although undoubtedly having an
impact on individual audits, is primarily aimed at the audit program/system
levels. This is because the value of a series of interrelated audits directed at
performance improvement by far outweighs the benefits of a single audit
performed for compliance purposes only (Willborn and Cheng, 1994).
Organizations that utilize their audits in a kaizen-like manner, focusing on
small, but steady improvements, will greatly benefit from a structured QA
approach that ISO 9000 brings. They will manage the audit system by
concentrating first on the global auditing policy and objectives, and
transforming them into a meaningful framework of quality, environmental,
safety, financial, ergonomic, maintenance, and other audit programs, which
will be brought to fruition by conducting individual audits.
When such a system of interrelated audits is established, an ISO 9000
standard could be applied to further strengthen the system efficiency and
effectiveness. Gardner (1997) illustrates the benefits of an ISO 9000-based audit
administration in terms of increased accuracy and confidence of audit results,
organizational measurements, as well as greater confidence in corrective
actions resulting from an audit. The implementation on the basis of the current
ISO 9001 (1994) standard and its revised year 2000 version is presented in
Figure 2. The illustrated framework is structured around the main system
elements: audit objectives, processes and resources. Overall audit system policy
and objectives are determined and reviewed first. For instance, the policy of a
manufacturing organization could be to manage audits that will consistently
provide opportunities for a measurable improvement of quality, environmental,
health and safety, ergonomic and financial performance. Identified policy and
objectives will determine the types of audits to be conducted, as well as the
suitable audit requirements. In the case of the above-mentioned policy, separate
quality, environmental, safety, ergonomic and financial (accounting) audit
programs may be designed, and corresponding standards, guidelines,
regulations and statutes are used as audit requirements. The ISO 9001
standard is an example of a requirement in auditing quality management
systems, while ISO 14001 and related environmental standards can be used for
the assessment of environmental performance. A smaller organization may
require only a single audit program, which can relate to a particular discipline
(say quality), or an integrated approach with quality, environmental and safety
audits done simultaneously.
The next stage involves audit system planning and design, in which audit
programs are prepared and reviewed for effectiveness to meet stated objectives,
and specific quality assurance procedures for conducting individual audits are
designed. These procedures need not be complicated and detailed. For instance,
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Figure 2.
ISO 9000 application in
auditing
they can simply state that audits are planned and conducted in compliance
with the existing audit guidelines, such as ISO 10011 (1990) and ISO 14010/11/
12 (1996). Audit methodologies, such as discovery, acceptance and estimation
sampling (Hill et al., 1962), computer-aided audit tools, risk or procedure-driven
auditing, flowcharts and checklists are also prepared at this time. The choice of
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System element
Objectives
Policy
688
Objectives
Scope
Feasibility
Criteria
Resources
Auditor
Methods
Table I.
Material
Sample quality
Information
assurance questions for
audit system elements
System element
Processes
Management
Planning
Execution
Improvement
The point is just the opposite: audits are supposed to find something. No
system is perfect, and there is always room for improvement. A system of
interdependent audits should be established in order to identify areas of
non-conformance to audit criteria and areas for improvement. In some cases,
the auditor might even find that the audit criteria, such as prescribed
calibration procedures, might have to be improved (Willborn, 1990).
``Interdependent'' means that the outputs of an audit (audit findings and
conclusions) are directly related to the input of a subsequent audit, and that
individual audits are aligned to achieve the same ``global'' objective. For
example, a quality audit has found that a particular type of service receives
very low ratings in repeated customer surveys. A corrective action identified
problems in the service delivery area as the primary cause, and these were
corrected. These findings were used in the subsequent audit, which again
examined the service. Although some improvement in the ratings was
accomplished, they were still mediocre. The following action was directed at a
better understanding of the customers' needs for the service, and an improved
communication within the company. The ratings were further improved, but
the audit also recognized problems in the methodology of conducting the
survey. In this situation, all audits were directed toward the achievement of the
``global'' continuous improvement objective.
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Table I.
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Effectiveness
Providing confidence to the audit customers that their requirements for the
audit quality are met is a necessary, but not the only sufficient condition to
ensure a good audit. The audit system must be able continuously to meet everchanging audit policy and objectives. In other words, it has to be effective.
Naturally, system effectiveness must be measured somehow in order to be
improved. A particularly useful way of expressing effectiveness is in terms of
probability that a system will fulfill a set objective within a given time frame,
when it is functioning under specified conditions and scope (Vujanovic, 1990;
Zelenovic and Todorovic, 1990). Several models from the systems theory are
available to measure effectiveness defined in such probabilistic terms
(Vujanovic, 1990). For the purposes of illustrating the effectiveness of the audit
system, we have selected the model which expresses it as a product of system
reliability, availability and suitability (Figure 3).
Reliability
Audit system reliability can be defined as a probability that the system will
adequately function within a given time frame when it is functioning under
specified conditions and scope. For example, an organization can prepare a
three-year audit plan, with a number of individual audits to be conducted in
Figure 3.
Audit system
effectiveness measures
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this time period. Reliability refers to the characteristic of such a series of audits
that their intended function is performed continuously over the stated period of
time. Implied in this definition is that an audit (or a series of audits) can fail,
meaning (in simple terms) that it does not do what it is supposed to.
Unfortunately, audits can and do indeed fail in myriad different ways. At the
individual audit level, failures (also called ``errors'') may be indicated by:
.
In fact, much like any physical system, audit systems are prone to failure when
any of their constitutive elements fail. For instance, audit objectives, processes
and resources are connected in a series-like fashion, and when an element fails,
it is likely that the whole system will be damaged. Possible audit failure modes,
representing different mechanisms or ways an audit could fail, can be analyzed
using several techniques, including the fault tree analysis (FTA) and failure
mode, effect and criticality analysis (FMECA). An example of a fault tree,
corresponding to the three main audit system elements, is presented in
Figure 4. These techniques help us identify possible causes of errors, and focus
the effort of improving the system reliability by eliminating the root causes.
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Figure 4.
Fault tree diagram for
an audit (example)
Interestingly, due to the analogy between physical and audit systems, many
proven techniques in reliability and maintenance engineering can be
conceptualized in improving the reliability of audits. For instance, physical
systems are continuously monitored in order to detect any changes that could
negatively affect reliability, i.e. cause the system to fail. This technique is called
``condition-based monitoring''. An analogous method in monitoring audit
systems would be an internal audit of the audit system and related programs.
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Figure 5.
The bathtub curve in
auditing
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the auditor and the audit to achieve set audit objectives. Audit suitability
refers to the ability of the audit system to adapt itself to changes in audit
scope, requirements, criteria, or suggested practices, and still achieve the
overall audit policy. For instance, if the audit criteria have changed from the
ISO 9001 standard to the automotive counterpart of QS-9000, does the
auditor have the ability to audit against this newly introduced standard in
his/her company? Or if an audit program was designed to assess a quality
system, its effectiveness in doing the same for an environmental
management system, i.e. after a change in the scope, could be questioned.
Such changes in scope and criteria may even involve the addition of new
concepts that were previously thought to be outside the auditor's realm. For
example, Hunt (1997) suggests the inclusion of the examination of corporate
culture in the auditing process. ``Organizational culture'' is a fairly evasive
term, especially for a technically oriented auditor. While an auditor must be
familiar with the prevailing language, customs, attitudes, and other aspects
of the manner in which an audited organization operates, if for no other
reason than to establish and maintain proper communication with the
auditee, it is unclear how such ``cultural analysis'' would be incorporated in
the set of relatively straight forward audit criteria (such as an ISO 9001
standard). For instance, what would be the objective evidence the auditor
should look for, and how would such evidence be analyzed against audit
criteria to form audit findings? The emergence of new management system
standards, which for an auditor means a new set of audit criteria, in such
areas as social responsibility (SA 8000) and occupational health and safety,
is bound to further complicate these matters.
As we can see from these examples, although audit suitability depends on
many audit elements, the onus is usually on the auditor (or the audit team) and
his/her qualifications and competence. The auditor must assess his/her
qualifications and competence, for instance whether he/she is competent to
conduct both quality and environmental management system audits, in order
to achieve adequate suitability. The evaluation of auditor qualifications and
competence follows the chain of concepts performance qualification/
competence auditor (Figure 6). Competence may be defined as the
demonstrated and recognized ability of a qualified auditor to consistently
achieve audit objectives to the satisfaction of client and auditee, while
qualifications refer to the auditor's education, training and experience. This
implies qualification as a pre-condition for competence. Relevant principles and
methods for the competence evaluation, demonstration, recognition and
development are illustrated in Table II, representing a possible framework for
quantifying audit suitability.
Effectiveness revisited
Audit system effectiveness is a complex issue involving the ability of the
auditor to conduct an audit free of errors, ready to operate when required, and
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Figure 6.
Concept diagram related
to auditor competence
suitable to achieve set objectives. If any one of these three elements is missing,
the system effectiveness will plunge. Thus, auditors and audit managers must
design and implement their systems to maximize the reliability, availability
and suitability of all system elements, while still providing adequate confidence
to clients and auditees. In this effort, trade-offs are inevitable. For instance,
regular audits of the audit system will increase reliability, but may in turn
reduce availability of auditors to perform other required audits. Nevertheless,
audit quality and effectiveness are factors that nobody can afford to lose.
Another related point is audit cost-effectiveness. Not only does the audit
have to be functionally effective, it also must justify the cost of performing the
audit activities. Cost-effectiveness relates to the ability of the audit to achieve
objectives while minimizing the associated spending. When an audit is
designed and conducted in a manner that ensures its suitability, availability
and reliability, reduction of cost comes as a natural consequence. For instance,
an auditor can spend a lot of time (and time is money) auditing a trivial issue
that does not contribute in any significant way to the auditee's business,
thereby reducing both the audit functional and cost-effectiveness. A good way
to judge the cost-effectiveness of an audit is to evaluate its contribution to the
improvement of the organization's bottom-line (i.e. profit), and reduction of the
overall costs, such as waste, scrap, the costs related to defective products, and
so on. While the aim of this paper was to discuss the audit functional
effectiveness, it is recognized that the analysis of various methods of
evaluating cost-effectiveness would be a very interesting and useful area of
further research.
Evaluation principles
Application of relevant auditing principles
Competence development and maintenance
Conducted by competent evaluator
Conducted on request of auditor or audit management
Performed periodically for all auditors
Provision of follow-up training as required
Evaluation against relevant and known criteria
Application of proper evaluation methods
Report of the result to the evaluated auditor
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Demonstration
Based on sound principles
In the entire auditing process
For specific audits normally conducted by the auditor
In audit assignments accepted by the auditor
Prior to an audit assignment
During and after training and professional development programs
Methods
Direct observation of auditor's performance during several relevant audits
Application of formal, prepared, and known checklists
Review of audit plans and reports prepared by the auditor
Monitoring specific competence indicators (criteria) under known conditions
Requesting reports from evaluators who are known and accepted by the auditor
Recognition
Auditor personally (self-assessment) based on performance evaluation
Client when being able to monitor the auditor's performance
Auditee when directly participating in the audit by the auditor
Qualified audit team leader supervising the auditor in several relevant audit assignments
Peers of the auditor in several relevant audit assignments
Qualified audit program manager having conducted a proper formal evaluation
Development (evaluation after each stage)
After basic auditor qualification start as auditor-in-training
Join an audit team as an auditor conducting audit assignments with increasing complexity
Conduct several complete audits
Decide future career as an auditor; i.e. generalist or specialist
Conduct audits in the selected area under various relevant conditions
Prepare, qualify for, and conduct audits as the audit team leader
Continue professional development
Table II.
Auditor competence
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can do, however, is attempt to localize the most important factors that
influence audit reliability, availability and suitability, and test their effects
for a variety of settings (e.g. using design of experiments). Subsequently, we
could model the associated probabilities, and finally obtain the aggregate
score for audit effectiveness using the framework presented in this paper.
An empirical study addressing these issues in further detail is suggested,
and would contribute to the research not only in quality auditing, but also in
financial (internal), health and safety, environmental, maintenance and
other areas of auditing practice.
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