Chapter 1 Return to ISO9000:2000
A Brief History of ISO 9000
Where
did we go wrong?
During World
War 2 we had a problem - bombs were going off in the factories. To
solve the problem the UK’s Ministry of Defence based inspectors in
factories that supplied munitions. If you wanted to be a supplier,
you had to write down the procedures for making your product, you
had to ensure that your workers worked to these procedures by
inspecting their work and finally you had to have this whole method
of working inspected by a Government inspector. From this seed, a
whole forest of control and inspection has grown in the name of
quality.
This was a
way of working which ensured that production met specifications. It
was a method of control that was designed to ensure consistency of
output. The inherent logic was quite straightforward and remains
appealing – you control how you do the work and hence you make what
you say you are going to make.
These
ideas solved a problem of the time – bombs stopped going off in
factories (1). Whether they went off when
they should, whether they were better quality bombs, was another
matter. “Quality”
became associated with “conformance” rather than “improvement” and
“quality assurance” implied that “conformance had been assured”
through inspection.
The
development of quality standards reflected the desire to shift the
burden of work from inspection by Government inspectors (second
party inspection) to “quality assurance” guaranteed by the supplier
through third party inspection. In 1959 the United States developed
Mil-Q-9858a (“Quality Program Requirements”), their first quality
standard for military procurement. It laid down what suppliers had
to do to achieve conformance. By 1962 the NASA space programme had
also developed its “quality system requirements” for
suppliers.
All of this effort reflected a genuine and
serious concern. Many of our new technologies were causing us
unfortunate problems. In 1962, Vice Admiral Rickover of the US Navy
summarised the situation (2).
He spoke openly about what was happening in the nuclear industry.
Things were going wrong; there had been a series of problems and as
the US Naval Reactors Programme grew in scope, things were getting
worse rather than better. To quote his opening
remarks:
“Progress – like freedom – is
desired by nearly all men, but not all understand that both come at
a cost. Whenever society advances…there is a rise in the
requirements man must meet to function
successfully.”
In short, he
was concerned that the new nuclear technology was insufficiently
understood and thus there were associated risks. To quote two later
passages of his speech:
“Unfortunately decisions
affecting this field are sometimes made by people who have little
knowledge of nuclear engineering and of science. There is a danger
this will lead to errors highly damaging to the position of the
United States or to the health and safety of the American
people.”
“Too often management is
satisfied to sit in plush offices, far removed physically and
mentally from the design and manufacturing areas, relying on paper
reports for information about the status of design and production in
the plant itself – the real centre of the enterprise. This lack of
first-hand evaluation results in poorly designed and manufactured
equipment, late delivery, or both. During the past few years,
hundreds of major conventional components, such as pressure vessels
and steam generators, have been procured for naval nuclear
propulsion plants. Less than ten percent have been delivered on
time. Thirty percent were delivered six months to a year or more
later than promised. Even so, re-inspection of these components
after delivery showed that over fifty percent of them had to be
further re-worked in order to meet contractual specification
requirements.”
These
problems were not unique to the US military. In the UK, during the
1950s and 1960s, we were experiencing similar problems in all of the
new industries. For example in the power industry we had failures of
turbine blades and boilers. Our nuclear industry was experiencing
similar problems to those in America. These were problems associated
with progress. Something had to be done and quality assurance
seemed, to many, to be the answer. In 1968 NATO adopted the AQAP
(Allied Quality Assurance Procedures) specifications – standards for
the procurement of NATO equipment. The UK Government was, naturally,
a signatory.
By this time,
the idea of quality assurance had spread beyond the military. In
1969 the UK’s Central Electricity Generating Board and Ontario Hydro
in Canada developed quality assurance standards for suppliers.
Earlier, in 1966, the UK Government led the first national campaign
for quality and reliability with the slogan “quality is everybody’s
business”. In the report of the year (3), the
following observations were made:
“The vital role of large
purchasers – and the beneficial ‘ripple effect’ they can stimulate
among their suppliers; their influences, through vendor rating and
supplier quality assurance schemes, can help greatly to raise the
level of quality procedures throughout industry. Consideration,
however, could well be given to a more co-ordinated system of vendor
rating to avoid the multiplicity of assessments made by each
customer.”
At this time,
suppliers were being assessed by any and all of their customers. It
was widely recognised that this was very wasteful, duplicating
effort and consuming resources unnecessarily. In 1969 Colonel G W
Raby chaired a committee whose task was to report on the inspection
and assessment of the UK’s military quality systems. His committee
report reinforced the idea that suppliers should take responsibility
for quality assurance and recommended that their methods should be
assessed against generic standards of quality assurance. This was to
open the door to third party inspection; it would lead to the
establishment of assessing organisations. It would also lead to the
wholesale redundancy of many Government (second party) assessors
during the early 1970s. These people were to populate the new
assessing and consulting organisations, which were to grow
rapidly.
These first standards for quality assurance were
thought of as contractually binding obligations. During the 1970s
the debate moved to how best to inspect and assure. Some
commentators favoured a national body that would have responsibility
for assessment of suppliers; industry was not so keen on the idea
(4).
Meanwhile, in 1971 the British Standards Institute (BSI) published
the first UK standard for quality assurance – BS 9000, which was
developed for the electronics industry in response to the many
problems that were occurring in this, another new industry. In 1974
BSI published BS 5179, “Guidelines for Quality Assurance”; the BSI
was the natural home for the quality assurance debate and its
leaders at the time were fully involved in the developing assurance
industry.
The UK
Government was also very involved. Beyond the sponsorship of the
“Quality and Reliability Year” in 1966, the Government had
management responsibility for many of the new industries. Half the
UK workforce was employed in Government owned or Government
subsidised industry. Power generation and distribution, extraction
of natural resources, telecommunications and even automotive
manufacturing were in Government’s hands. It was in the Government’s
interest to do something to improve things. The Government also
employed some 17,000 inspectors. The solution, when it came, must
have appeared very attractive – at the same time as releasing
thousands of people, Government could claim to be promoting the
improvement of British industry.
During the 1970s BSI orchestrated meetings of
the many interested parties in order to agree a common British
standard. The result was the publication of BS 5750 in 1979. Key
industry bodies, that had developed contractual documents for
suppliers, agreed to drop their own standards and reference BS 5750
instead. In keeping with the historical perspective, the purpose of
BS 5750 was to provide a common contractual document, demonstrating
that production was controlled. This standard had nothing to do with
methods for performance improvement. This shift in emphasis and the
problems it spawned were to come later.
What were the key elements of BS
5750?
They can be summarised as follows:
Management
responsibility: Management
should define and document a quality policy, an organisation
structure, including responsibility and authority. Management should make available
verification resources (inspectors), appoint a management
representative and carry out management reviews.
Quality
system: The quality system must be documented,
including a manual, procedures and work instructions.
Contract
review: A procedure for performing contract review –
documenting what was agreed with the customer – should be written
stating clearly the criteria for contractual obligations to be
met.
Design
control: Procedures should define how the organisation
designs its product and controls any design changes.
Document
control: Procedures and work instructions must be
approved before issue and on subsequent changes. Control of
documents should encompass availability, distribution, issue level,
revision and obsolescence.
Purchasing: Suppliers should be assessed and monitored,
incoming goods should be verified.
Customer
supplied stock: Customer supplied stock should be subject to
procedures for identification, inspection, storage and periodic
maintenance. There should also be a procedure for reporting and
recording lost or damaged stock.
Product
identification and traceability: A company-wide procedure should detail how
items and equipment are to be identified at all stages from receipt
to despatch. Where traceability is required, a unique identification
should be used and recorded.
Process
control: Work instructions defining what is done should
be documented and made available.
Inspection
and test: Inspection should be performed on receipt of
goods. Documented procedures should define the appropriate tests.
Tests should be performed for repair or service to demonstrate
restoration of operative condition. Records should provide evidence
to demonstrate the equipment or device meets the necessary
inspection or test criteria.
Inspection,
measuring and test equipment: These must be controlled, calibrated and
maintained.
Inspection
and test status: This must be identified by using markings,
stamps, labels, routing documents, inspection/test record sheets,
physical location or other suitable means.
Control of
non-conforming product: Procedures must define the controls used to
prevent the use of non-conforming product. Items should be
identified, segregated and the authority for disposition made
clear.
Corrective
action: A corrective action procedure must be
documented defining what is to be analysed, how corrective actions
are to be initiated and obtained to prevent re-occurrence.
Corrective action procedures should be documented for dealing with
customer complaints.
Handling,
storage, packaging and delivery: There must be procedures for all of these.
Additionally, inventory must be controlled and procedures for
warranty must be written and communicated to customers.
Quality
records: Procedures for identification, collection,
indexing, filing, storage and maintenance must be written and
records must be kept.
Internal
quality audits: These must be planned and scheduled to verify
the effectiveness of the quality system. Audits must be performed by
staff independent of the authority responsible for the area being
audited. The procedures for audits, follow-up actions and reporting
must be documented.
Training:
Procedures should be established to identify
training needs. Training must be conducted on a formal basis and
records kept.
Servicing:
If there is a requirement to service equipment,
the servicing procedures should be documented and
maintained.
Statistical
techniques: Statistical
techniques should be used where appropriate.
BS 5750 was,
in its essential content, no different from the methods used to stop
bombs going off in factories. It was a method for the control of
output. In response to the obvious problems we were having with our
new technologies, this way of working was assumed to be a solution.
At the end of the Seventies the standards movement had gained
momentum. But its underlying theory was not good theory. While Vice
Admiral Rickover – and many commentators since – lamented the state
of management, this solution was to promote a theory of control, not
a better theory of management. Perhaps we now have the benefit of
hindsight, but would it not have been better to promote
understanding rather than control? Admiral Rickover, discussing
nuclear technology, saw management understanding as the
priority:
“More effective management
and engineering attention should be given to the routine and
conventional aspects of our technology. Nothing must ever be taken
for granted. Management must get into the details of problems…
analyse the cause of trouble by personal investigation, and take
prompt action to prevent recurrence… Management and engineers must
not conclude their job is over once drawings have been completed and
the first component successfully built and tested to these
drawings.”
It is ironic
that ISO 9000, what we would describe as the “control solution” to
our problems, separated “design” from “process” (see page 137),
making the understanding of this important issue less likely. It
also served to maintain the tradition that management could and
should be separated from work (see page 62), something Admiral
Rickover, rightly in our view, saw as the nub of the
problem.
He went
on:
“It should be of concern to
us that specifications are normally written by manufacturers and
therefore usually represent the lowest standard of engineering to
which all manufacturers are willing to agree. This should be
changed.”
However, ISO
9000 ensured that it was not. ISO 9000 ensured that the manufacturer
could determine its own quality system, provided it also satisfied
the requirements of an inspector.
And he
concluded:
“Quality control must be
recognised as an essential tool to enable management to meet today’s
technological imperatives.”
But he did
not say by what method. Admiral Rickover’s address was probably the
most open account of our failures with new technologies. The
undisputed truth and alarming nature of the problems he described
fuelled the urgency to “do something”.
The same
sense of urgency was being felt in British Government. In 1982 the
Department of Trade and Industry published a white paper entitled
“Standards, Quality and International Competitiveness" (5). It was to
give a strong fillip to the emerging standards industry. Not only
did it repeat many of the assertions of the leaders of the standards
movement; it gave power to the BSI through a memorandum of
agreement. The BSI now had Government backing to promulgate the
adoption of the quality standard as quickly as possible and was
authorised to represent the UK’s approach on the world stage. The
white paper also set out the arrangements for “certification
schemes” and hence created the inspection industry we know
today.
Again, with
hindsight, one is bound to wonder what influenced ministers and
officials. Clearly the idea of international standards as means of
entry to world markets appealed, but one wonders whether this was
important for defensive reasons. The cynic might say it was
important for control of those markets, and the evidence would bear
him out. No doubt Government ministers were aware of the “Japanese
miracle” (see below) and it is conceivable that they believed this
quality management standard would deliver the
same.
The British
Government sought to “enhance the status of standards as an
instrument of improving efficiency and the international
competitiveness of British firms” by ensuring four
things:
1.
Closer
co-operation between the Government and BSI to develop British
Standards which are of the required quality, command respect in
world markets and are suitable for regulatory purposes and/or for
public purchasing;
2.
Commitment
from the Government to make greater use of standards where
appropriate in its regulatory functions and to explore new ways of
recognising standards;
3.
A much
greater emphasis in public purchasing on linking requirements to
existing standards rather than technical specifications particular
to the purchasers;
4.
The
encouragement of certification schemes
In doing this,
the British Government set up the market and primed the pump. This
white paper also began the confusion of “quality assurance” with
“quality improvement”. During the 1970s UK industrialists had visited
Japan to learn about the “Japanese miracle” (6). While they
began to copy some Japanese practices, for example quality circles
and suggestion schemes, they failed to “see” what was behind these
practices – a fundamentally different way of thinking about the
design and management of work. Unaware of this crucial
distinction, the Department of Trade and Industry funded “road
shows” on the benefits of BS 5750 registration and provided funding
to encourage organisations to use consultants in its
implementation.
The
recommended method of implementation was (and is) as
follows:
1.
Look
at your current organisation to see how it compares with the
requirements of the Standard.
The Standard would ask you to consider such things as whether you
had a formal way to review your contracts with your customers;
whether your methods of working were documented and whether your
manuals and procedures were kept up-to-date.
2.
What
corrective action is needed to conform to the
Standard?
This is to ask “How should we close the gap?” What actions need to be
taken to ensure we comply with the Standard?
3.
Prepare
a programme of work.
It becomes important to establish by when all necessary actions can
expect to be achieved. The focus of the work becomes achievement of
the plan, in order to achieve registration.
4.
Define,
document and implement new management systems and
procedures.
Documentation is always central to the plan, it is the means by
which the inspectors can do their work.
5.
Prepare
a quality manual.
This ties together all of the above. It is the starting-place for
inspection.
6.
Pre-assessment
meeting.
The chosen inspector will often get involved in a pre-assessment
meeting to help the client establish their suitability for going
forward to assessment and thus registration. The interpretation of
the Standard’s requirements for the particular circumstances is the
focus for discussion.
7.
Assessment.
The inspector determines whether the organisation conforms to its
documentation. ‘Do you
do as you say you do?’
8.
Registration.
Consultants
and assessors provided much of the interpretation and guidance on
the Standard’s requirements. A correspondent whose career spanned
the introduction of quality standards talked of his experience of
the early period of BS 5750:
“The
greatest fear we all had was where the ‘assessors’ would come from.
We knew in our hearts that it would be from the redundant Government
inspectors and ‘surplus’ industry ‘quality’ managers. This has
turned out to be the most disastrous part of the whole scheme. There
are many ISO 9000 consultants I knew from their old industry days
that frankly I wouldn’t have around, and now I find them
pontificating on how to run a business!”
The emergence
of doubts about the value of the Standard and the quality of advice
on offer resulted in managers shopping around for assessors, perhaps
wanting to find the assessor that will do the least damage; perhaps
trying to find an assessor who would add value. As long ago as the
mid 1980s assessing organisations were hearing their customers
express serious discontent with assessment and registration. These
organisations responded by changing the role definition of their
“visiting professionals” from “assessing” to “auditing”. They argued
that the latter suggested they were in the business of providing
advice and guidance — it was driven by a recognition that they
needed to create value for their customers.
Yet this was
to cross a boundary; an assessor should not be an advisor for that
would open the possibility of undue influence. The original role, that of
inspection, was the reason for the Standard’s origins. The assessor
was just that, someone who could relieve the customer of the need to
check on suppliers (it was assumed that checking could not be
entrusted to the supplier). Now the role of the assessor began to be
being blurred: the auditor became both poacher and gamekeeper. This
of course could lead to advice being tailored to meet the needs of
the paymaster. Does this shift of emphasis get us any closer to
improving quality and competitive position, or does it run the risk
of taking us further away? There is, quite naturally (because the
system encourages it), evidence of abuse of the power of the
auditor’s role. For example, one assessing organisation sets targets
for assessors to sell “value-added” services. Inevitably this will
lead to malpractice.
Quality
assurance, according to the Standard, is a way of managing
that prevents non-conformance and thus “assures quality”. This is
what makes ISO 9000 different from other standards: it is a
management standard, not a product standard. It goes beyond
product standardisation: it is standardising not what is made
but how it is made. To use standards to dictate and control
how organisations work was to extend the role of standards to new
territory. To take such a step we might have firstly established
that any such requirements worked — that they resulted in ways of
working which improved performance.
Yet the
plausibility of this Standard, and the fact that those who had an
interest in maintaining it were (and still are) leading opinion,
prevented such enquiries. In simple terms the Standard asks managers
to say what they do, do what they say and prove it to a third
party.
ISO
9000 (1994) paragraph 1: “The requirements specified are aimed
primarily at achieving customer satisfaction by preventing
non-conformity at all stages from design through
servicing.”
To put it
another way, the Standard asserts that preventing non-conformance
achieves customer satisfaction. But does it? Of course it matters to
customers that a product works. But there is no guarantee that the
Standard will ensure even that. Furthermore, customers take a total
view of an organisation — how easy it is to do business with — in
respect of all things of importance to each and every customer.
ISO
9000 requires managers to “establish and maintain a documented
quality system as a means of ensuring that product conforms to
specified requirements”. Loosely translated this is “say what
you do”. Management is supposed to “define and document its
policy for quality . . . including its commitment to quality”.
What
management would not declare its commitment to quality? But would
they know what it means? Would they argue (as they should) that
quality management is a different and better way to do business, or
would they believe that ISO 9000 will take care of quality? The
Standard encourages managers to think of “quality” and “business as
usual” as separate and distinct. It helps managers avoid the
revelation that quality means a wholly different view of management.
Instead, the organisation “shall appoint a management
representative who, irrespective of other responsibilities, shall
have defined authority and responsibility” [for ISO 9000]. At a
practical level this means only one executive might decide he or she
had better learn a thing or two about quality. However, would being
responsible for ISO 9000 lead to learning about quality or simply
enforcing the ISO 9000 regime in an
organisation?
Key
to the regime is auditing. The Standard requires organisations to
conduct internal quality audits to “verify whether quality
activities comply with planned arrangements”. This can be
loosely translated as “do you do as you say?” and the purpose of the
audit is to see that you do. It was not until the 1994 review that
the words were changed to “quality activities and related
results”. It was a Standard which was rooted in the
philosophy of inspection: fifteen years after its initial
promulgation the promoters sought to extend the focus to results.
But results or improvements assessed by what means? Inspection. By
the time the Standard was adopted world-wide, quality thinking had
moved a long way from the philosophy of inspection. It is now
understood, at least by a few, that quality is achieved through
managing the organisation as a system and using measures which
enable managers to improve flow and reduce variation (which we
explore in chapters 5 and 7). The defenders argue that there is
nothing stopping a company having ISO 9000 and implementing methods
for managing flow and reducing variation, but where are such
companies? Few of the companies we researched, formally and
informally, knew anything about this thinking. The Standard does not
talk about it; moreover, the Standard effectively discourages
managers from learning about it by representing quality in a
different way.
“The
totality of features and characteristics of a product or service
that bear on its ability to satisfy stated or implied
needs.”
Everything we
have learned about ISO 9000 suggests that the people who created
this definition were thinking about the things which need to be
controlled, those things which “bear on its ability . . .”. The
builders of the Standard assumed that customer needs would be listed
in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic
— procedures for “how you do what you do” — and a “control” logic —
check to see that it is done. It is a relic of the era when
contractual agreements were perceived to be an important device for
regulating the behaviour of suppliers. In these ways, ISO 9000
encouraged “planning for quality”.
Planning
for quality sounds plausible, but it assumes many things: that the
plan is the right plan, that it is feasible, that people will “do
it”, that performance will improve. It is an approach which,
paradoxically, leads to poor decisions. Planners of quality systems,
guided by ISO 9000, start with a view of how the world should be as
framed by the Standard. Understanding how an organisation is
working, rather than how someone thinks it should, is a far better
place from which to start change of any kind.
