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Quality
Management
System
LEARNING OUTCOMES
By the end of this topic, you should be able to:
1. Explain how the quality management system is developed;
2. Distinguish how value analysis is used to develop an effective quality
management system;
3. Define what the ISO 9001:2000 quality standard is;
4. Identify the elements of the ISO 9001:2000 quality standard and how
they should be applied to ensure an effective quality management
system; and
5. Describe the roles of the quality management system through the ISO
9001:2000 standard in assuring the quality of your products and
services, and then maintaining that quality standard.
INTRODUCTION
What comes to mind when you hear the word ISO? In this topic, we will
discuss two aspects the development of management systems and the
international quality standard ISO 9001:2000.
The Malaysian Standard MS 9001:2000 used as a reference is, in fact, a direct copy
of the ISO 9001:2000 standard. This topic will discuss the relevant elements of the
standard in some detail to allow you to have a good grasp of the meanings and
intentions of each of these elements.
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A little cautionary note is probably appropriate here so that you would not be too
surprised or even disappointed when you read the elements of the standard. Like
any other standards that you may have read or come into contact with, the ISO
9001:2000 is no exception in terms of the dryness of the language of the standard
and the rather monotonous coverage of the various elements.
The reason for the dryness of language in standards is simply because standards
are supposed to be unequivocal, unambiguous and not ambivalent. In other
words, standards should be clear, cannot be misinterpreted by the reader and do
not give more than one meaning in their statements.
The other reason for the dryness is because since standards have to meet the three
basic requirements alluded to above, the language has to be in the simplest form.
Now that we have warned ourselves about this, it is hoped that going through
the standard would not be tortuous.
2.1
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2.1.1
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The list goes on and they are obviously difficult to identify and detect directly but
their effects are not difficult to see. Figure 2.2 shows some of the effects.
This list grows as well. It is easy to see how anything new being introduced into a
system with these sorts of problems can only fail. Hence, we need to flush the
system of these problems and wastages. How do we do that?
Naturally, we need to uncover these wastages first. Looking at the second list
above, it may not be too difficult to do that. In fact, some of them perhaps have
been looking us in the face. These are symptoms of something amiss and if we
can see them, it simply means that our departmental or section managers have
not been doing their jobs right.
SELF-CHECK 2.1
What are the common forms of wastages?
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ACTIVITY 2.1
Can you identify with any of the wastages mentioned in Figure 2.1?
What are the forms of wastages which occur at your workplace? As an
individual, what can you do to reduce or eliminate them altogether?
Discuss and share this with your classmates.
2.1.2
A very simple method which you might have used in the past, perhaps
unconsciously, is to ask the question, Why, for example, Why are sales going
down? A logical and acceptable answer could be put forward. In this case, the
answer could be ineffective marketing or advertising. Your marketing
department may come back and strongly claim that it has worked particularly
hard that particular year to market the organisations products/services. Other
managers may come back with all sorts of data to show that their departments
had not been responsible for the problems. You will then continue to ask the
question WHY until the real reason is uncovered. Quite often, the real reason is a
long way away from areas that are directly linked to the problem. In this
example, perhaps it is possible that the problem was actually in the after sales
area.
It is therefore important to look at and seek areas not closely related to the
problems being faced in order to get to the crux of the problem.
This technique of asking WHY is so powerful and simple that top management
and managers appear suspicious of its efficacy. Those who have used it, however,
need no prompting.
2.1.3
Having discussed how wastages manifest themselves and a very simple method
of seeking the reason why they happen, it is also very important that we
eliminate the worst wastage first, the next worst second and so on. Why? In many
cases, it has been shown that 80% of problems arose from only 20% of the items.
This phenomenon is popularly known as the 80-20 rule. So, 80% of the costs come
from 20% of the problems; 80% of the profits come from 20% of the products and
so on. Therefore, we need to be able to identify which 20% it is in order to
eliminate 80% of the problems, get 80% of the profits or get rid of 80% of the costs
and so on.
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The illustration in Figure 2.3 is also known as the Pareto Analysis or Pareto
Curve. It is named after Italian economist Vilfredo Pareto who found this 80-20
relationship by observing that in any economy, 80% of the wealth is held by 20%
of the people. (For more information on the Pareto Curve, go to:
http://management.about.com/cs/generalmanagement/a/Pareto081202.htm)
From Figure 2.3, it is obvious that wastage A has to be the first resolved, B the
second, C the third and so on simply because by eliminating wastage A, you
eliminate a big chunk of the costs, wastage B the second and so on. While this is
logical, we still have to be very careful in making that decision. Any action, in this
case eliminating wastage, will normally require resources, be it money or people.
We therefore need to do one more thing before embarking on the elimination of
these wastages.
By knowing the costs of the wastages, we have one side of the equation sorted
out. The other side of the equation is, how much it will cost to eliminate this
wastage. Obviously, if the cost of eliminating the wastage is more than the
savings to be gained, then there is no point carrying out that action. Figure 2.4
clearly shows that:
(a)
(b)
By the time we get to wastage D, the potential savings has been negated by
the costs of eliminating the wastage; and
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(c)
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From wastage E onwards, the costs of eliminating the wastages are bigger
than the potential savings and therefore, it is pointless to eliminate.
Of course, you could say that the costs for each of the different wastages should also
be different and perhaps smaller for the smaller wastages. This may be true in some
cases. In any case, there will be a minimum cost to eliminate wastages that you
cannot reduce. The effect of this on smaller wastages may be depicted in wastages
from D onwards, as shown in Figure 2.4.
Based on Figure 2.4, it is clear that there is no point in doing anything about
wastages from D onwards; the biggest returns would lie in eliminating wastages
A and B (2 out of 10 items shown or 20% of the wastages) as predicted by the
Pareto analysis.
However, that is not the end of the story.
In many organisations where wastages such as those shown in Figure 2.3 exist,
we will also find that the idea of saving money is probably foreign to many, if not
all, the staff. This may have been due to past attempts which were not based on
any methodological approaches. Perhaps, the past attempts were for wastage D
onwards (see Figure 2.3) this will, of course, not give them any savings. The
staff will therefore be skeptical and even cynical about any further attempts to
reduce wastage and save money. This attitude is seldom easy to address. They
want assurance that your attempt will work. That is, your attempt has to be 100%
successful. Yes, 100% successful. What you promise has to be delivered 100%.
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In practice, this means we should not tackle the obvious, that is, we should not
just concentrate on wastages A or B despite their potential savings. This is
because there are usually pitfalls that will prevent you from getting 100% success
rates, especially since such efforts usually involve many people or different
departments with their respective priorities which may not coincide with yours.
If you think it is important to get a 100% success rate so that future projects to
eliminate wastage will be received positively, then tackle something that involves
the least number of people and departments first. This can be done more easily
although the potential savings are minimal, maybe something like wastage C
(Figure 2.3 or 2.4).
As an example, a RM30,000 potential savings as a starting point in a mining
company but with a 100% success rate to the most skeptical of its staff, ended up
with $10.5 million savings in three years. This is with minimal implementation
costs and about 90% of the wastage elimination projects originating on the shop
floor and suggested by the shop floor people.
A similar consideration will still be prudent to use for subsequent wastage
elimination projects, wherever they come from. A successful second project will
build on the first, a successful third will build on the second and so on. As we
know, changing a culture or belief takes a long time and will need a high level of
continuous success to sustain it.
2.1.4
If you can reduce costs without reducing quality, do it, because any extra costs
for the same quality simply means a waste. Why do you spend more money on
something that you can achieve with less money? The qualification, that of not
reducing quality, is extremely important and is non-negotiable. You must never
compromise on quality.
Figure 2.5 shows graphically the optimum cost for the quality required and the
cost that may be incurred if value analysis is not used. The shaded area is then
the resulting amount of unnecessary costs or wastage. The dotted line above the
uncontrolled cost line and above the shaded area could very well be the real
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uncontrolled costs as time goes on. This shows that uncontrolled costs do not
accumulate in a linear fashion.
The point here is that once you are not in control of costs or wastages, the
outcome can be negative. For example, when you let them go beyond what is
required to produce quality (of products and services), they will grow unheeded
and unseen until they do so in some exponential way, at which time it will be too
late.
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Table 2.1 shows the types of wastages and their effects. Does your workplace face
a similar situation?
Table 2.1: Types of Wastages and Their Effects
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What is clear from the examples mentioned is that all those wastages are directly
related to costs. Most of the time, those responsible for these wastages are just not
aware that they are creating wastages. Awareness, plus some procedural policy
or practice, could help eliminate those wastages without having to spend any
money on it. For example, all lecturers will only be supplied with one ream of
paper over an agreed period, beyond which they will have to purchase their own.
This will make them more conservative in paper usage without compromising
the quality of their work.
Due to the direct relationship between costs and wastages, costs, or more to
the point, excessive costs, are a good identifier of wastages.
Excessive costs may be defined in a number of ways. We could compare our costs
against those of similar sized organisations and if we cannot find specific reasons
for our bigger amount, then we should be able to reduce these costs. You can take
the steps shown in Figure 2.6:
The following is a very simple method that has been proved, in a number of
cases, to have saved millions of dollars. For every aspect, there are examples of
appropriate questions you should ask in order to help you initiate a value
analysis. The method involves asking the questions listed, and then following up
with whatever you think needs to be done. The second part, finding out how to
address the issue, is as important as answering the questions posed.
As value analysis originates from the manufacturing industry, some of the
questions need to be rewritten for other industries. The manufacturing industry
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questions refer to a part forming a final product. The items in other organisations
may be processes, procedures or rules, generated by the organisations or
imposed by stakeholders such as the government, with its rules and acts.
Table 2.2: Practical Value Analysis Method
No.
1
Original
Can you eliminate it?
[Therefore eliminate the potential for
problems.]
Comments
Do
you
really
need
that
process/procedure or method for the
purpose? If not, eliminate it and redesign
your procedures or processes.
If you still need that process/procedure,
can you combine it with another or others
to avoid potential unnecessary errors?
If you still need that process/procedure,
can you simplify it so that its parts will
ensure fewer errors?
See (4)
See (4)
See (4)
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No.
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Original
Comments
10
11
Information
and
communication
technology give us a great opportunity to
waste less and less material. Even within
the new technology itself, reduced waste
is possible. For example, saving your
documents in HTML format rather than
document format can easily save 60% to
70% of your hard disk.
There are many ways of buying more
cheaply; you just have to think and
discuss with your suppliers. Bulk buying
is good but you have to make sure that
you do not end up having to build
storage rooms and, in the process, take
the risk of ending up with damaged
goods and expired supplies.
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No.
12
Original
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Comments
13
14
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2.1.5
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As most of the process information is held by staff, it is only logical that the
management should consult them when planning any changes in the
organisation.
Communication between management and this constituency needs to be fluid and
supportive in order to invite favourable inputs from them. In turn, information
should be pervasively distributed and made as inclusive as possible. Everyone, at all
levels, should be able to access the information even if it is not directly sent to them.
In todays knowledge society, information is not only power but essential, more so in
organisations such as higher education institutions.
Information that is feedback to inputs already given is even more critical. This
feedback provides a closed-looping of communication between stakeholders and
management. Not only is this good management, it would also encourage the
constituents to provide more inputs in future knowing that their inputs will be
considered by the management.
Buy-in by staff in most cases occurs when they are given the opportunity to air their
ideas and be evaluated through discussions by their peers as well as by the
management. Depending on the number of staff, such discussions can either be done
over a short or long period. A large organisation, for example, would not be able to
have its entire staff together at one time and in one place to discuss management
plans.
The management should, therefore, be prepared to re-run these discussions several
times at different times of the day and sometimes at different venues as well. These
should have been calculated into the planning horizon.
2.1.6
Unlearning is not exactly a good English word. But the point it conveys is potent.
It is meant to underline the need to rid ourselves of practices, habits and cultures
that debilitate against quality. Figure 2.7 shows the normally accepted steps of
unlearning.
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Deliberate awareness is called for in this case and the operative word is
pervasive. This means the unlearning process should be applied to all corners
of the organisation without exception. Even the janitor must be involved in this
exercise, because only through such coverage can the whole organisation
improve. As an example, a wastepaper basket overlooked from being emptied by
the janitor can cause irritation to the staff concerned all day and impact
negatively on his work. This reduced quality or standard of work from the staff
will negatively impact other staff. Before you know it, the whole organisation is
affected, one way or another. So everyone, without exception, is involved. This is
the meaning of pervasive.
ACTIVITY 2.2
You have probably heard of the saying, old habits die hard. In
relation to this, if you are the manager of a company, how do you
ensure that your staff rid themselves of practices, habits and cultures
which detract from quality?
2.1.7
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ACTIVITY 2.3
1. Use the value analysis technique to identify and reduce
unnecessary costs in your organisation. In doing so, estimate the
savings that you think you would create through this exercise.
2. Diagrammatically show how the initial actions advocated in the
above sections contribute to the achievement of quality objectives.
3. Using your organisation as an example, prove the hypothesis put
forward in the above sections that without the pre-introductory
actions shown above, the success of introducing a new concept
such as quality assurance would be limited.
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ISO 9001 was the most comprehensive among the three standards mentioned.
Various comments were received during the years of their use. Typically, many
lamented its buraucratic nature which insisted on a thorough documentation
system. Others strongly criticised it for its lack of human resource considerations.
And yet others insisted that the standard was too parochial and would only be
applicable to the manufacturing industry.
As a result, a revision was published in 1994 which had, to a large extent,
addressed a lot if not most of the criticisms, comments and observations.
During the years between 1994 and 2000, and with increasing understanding of
quality and increasing use of the standard itself, practitioners began to query the
conformance aspect that underpinned the standard. Should it be conformance to
the standard or to some other achievement targets set by the organisation? Could
the standard be a misleading target as it is a minimum requirement for
conformance? What if the requirements are indeed higher than the minimum?
In the meantime, the existence of the three standards for each of the three
different purposes, though related, gave a sense of unnecessary competition
between organisations that obtained certification.
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The latest revision of the quality standard, known as ISO 9001:2000, was
published in 2000. There is no ISO 9002 or ISO 9003 as all aspects have been
incorporated within ISO 9001:2000 and exclusions of certain clauses in the
standard are allowed, for example, to exclude clauses on design aspects when the
organisation does no design.
ISO 9001:2000 incorporates the people aspect and the roles of customers. You are
encouraged to have a look at a copy of the standard in order to have a feel of it.
ISO 9001:2000 is made up of clauses and sub-clauses written in the manner of
requirements, i.e. for example:
Clause 4.1 General Requirements
The organisation shall establish, document, implement and maintain a
quality management system and continually improve its effectiveness in
accordance with the requirements of this International Standard.
This means that the ISO 9001:2000 standard provides guidelines and directions
on how a quality standard is developed, maintained and improved. It does not
dictate the levels of quality required nor the detailed rules that must be followed
to achieve the quality standard. It is therefore essential that the organisation
develops a quality manual that does all those in accordance with the guidelines
given by the ISO 9001:2000 standard.
2.2.1
The clauses contained in the ISO 9001:2000 quality standard are collectively called
elements. There is a total of just over 20 major elements that form this quality
standard and more than 80 detailed requirements. These are shown in Table 2.3
(refer to Appendix A). The table has been arranged to show ISO 9001:2000
clauses, the respective standard requirements, the people responsible (according
to this author) and additional comments as required. These are covered under
Clauses 4 to 8 in the standard.
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2.2.2
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The flow chart in Figure 2.9 shows a recommended process in preparing for an
external audit such as ISO 9001:2000 that auditees may wish to follow.
You will notice that the flow chart is a closed-loop system indicating the need for
continual and perpetual improvement of the system in line with expectations of a
good quality management.
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2.2.3
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There are eight major principles of quality contained within ISO 9001:2000 and
they are given in Table 2.3. The last column is given in anticipation of the future
beyond ISO 9001.
Table 2.3: QM Principles in ISO 9001:2000
Principle
1.
2.
3.
4.
CustomerFocused
Organisation
Leadership
Involvement
of People
Process
Approach
ISO 9001
Assure conformance to
defined customer
requirements.
Measure customer
satisfaction and act on it.
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5.
System
Approach to
Management
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Understand their
interdependencies.
6.
Continual
Improvement
Through management
x
review, internal/external
audits and
corrective/preventive
actions, continually improve
the quality management
system.
8.
Factual
Approach to
Decision
Making
The managements
decisions and actions on the
quality management system
are based on the analysis of
factual data and
information gained from
reports on audits, corrective
action, nonconforming
products, customer
complaints and other
resources.
8.
Mutually
Beneficial
Supplier
Relationships
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ACTIVITY 2.4
1. Study the flowchart in Figure 2.8 and identify action items that you
consider are not as yet done or available in your organisation.
2. Referring to the elements of ISO 9001:2000 in Table 2.3, describe
what and how you would rectify the situation so that your
organisation complies with ISO 9001:2000 requirements.
3. Using the eight quality principles shown in Table 2.4, assess your
own organisation as to its commitment to quality and describe
how you would improve the situation.
Improvement in a system, especially the infusion of a new idea or subsystem, can only be successful if all the contamination existing in the system
is flushed out first. The failure of anything newly introduced to an existing
system is not necessarily caused by the new idea. In fact, most often,
failures are due to existing inefficiencies in the system. It does not matter
what one introduces to that system, because everything will fail.
Value analysis is the reduction of costs without reducing quality. If you can
reduce costs without reducing quality, then you should do it, as any extra
costs for the same quality simply means a waste.
Most wastages are directly related to costs. Most of the time, those
responsible for these wastages are not aware that they are creating
wastages. Awareness plus some procedural policy or practice could
eliminate the wastages without having to spend any money on it.
ISO 9001:2000 is the latest in a series of ISO 9000 quality standards first
published in 1987. It is made up of clauses and sub-clauses written in the
manner of requirements, for example:
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This means the ISO 9001:2000 standard provides guidelines and directions
on how a quality standard is developed, maintained and improved.
Value analysis
Pareto analysis
Wastages