Title: Avoiding disaster Engineering, Technology and the Law
1Avoiding disasterEngineering, Technology and the
Law
- M. G. Lay
- What should reasonably be expected
2The unwitting witness
- The lecture will describe how normal producing
organisations could be expected to operate, - pre-disaster, and therefore,
- what could be expected of them,
- during a disaster,
- immediately after a disaster, and
- much later.
- and, hence, what could be expected of your
witness a normal but unwitting participant in a
disaster.
3Organisational structure
- What is a normal, producing, organisation? From
a structural viewpoint - A producing organisation is a complex, operating,
value-adding system - comprised of a set of interlinked but
self-contained processes (defined in Note to
clause 4.1 of ISO 9000). - A process is the transformation of an input into
an output - adding value during the transformation.
- The output from one process is usually the input
to another process. However, for the final
process, the output is the organisations product.
4Organisational attitudes
- What is a normal, producing, organisation? From
an attitudinal viewpoint, and despite the media
and your particular clients, most organisations
are - competent and well-run,
- effectively managed with good systems,
- ethical law-abiding,
- as a first priority, focussed on their
continuance, - driven by strategies and required outcomes,
- continually learning and improving,
- risk adverse.
5On the deck of the Titanic(disasters are not the
organisational norm)
- Thus, this lecture will
- focus on the simple elemental processes that are
the building blocks of complex organisations, - assume that people in such organisations will
normally behave rationally and legally, - discuss strategies rather than outputs,
- all in the context of a disaster about to happen.
6Process expectations, 1(Organisations are
comprised of interacting processes)
- The expectations held for the output of each
elemental process are developed from - customer requirements
- the producer will have given the consumer advance
assurances about the product to be supplied - 1A. requirements not specified by the customer,
but necessary for the use of the product
(9001/Clause 7.2.1a) - company policy and objectives
- the shareholders/owners wishes will be known
- and will usually relate to long term return on
investment - (continued)
7Process expectations, 2(most organisations are
ethical and law-abiding)
- external requirements, which will include
- company law and related laws regulations
- OHS regulations
- accounting regulations
- environmental protection regulations
- the triple bottom line
- economic performance
- environmental performance
- social performance
- industry practice
- benchmarking
8Managing processes(a producing organisation is a
complex system of processes)
- Three world-wide trends are that organisations
are - prepared to enter long-term partnerships, beyond
conventional contracts. - increasingly self-regulated
- despite the war stories, the alternative of
regulation by government is too horrendous to
even contemplate, let alone revisit - the independent reviewer provides a middle ground
- qms makes self-regulation feasible
- committed to quality management systems (qms).
9Quality management systems, 1
- Quality management systems (qms) are now the norm
throughout Australian industry - qms is a worldwide approach, with much
international consistency and success, - an organisation without qms must be suspected of
major deficiencies. It should be asked - why does it not use qms?
- which of its current problems could have been
avoided by the proper use of qms?
10- Mr A is an employee of Organisation B, where a
disaster has occurred. - Mr A, does Organisation B have a qms?
11Quality management systems, 2
- In Australia, qms is governed by Standard
- AS/NZS ISO 90012000
- ISO is the International Standards Organisation
and - the Australian Standard is, properly, a direct
copy of the ISO standard. - The first Australian version was issued in 1987.
- The current version is the third edition.
- External formal certification via JASANZ
accreditation is normal rigorous.
12- Mr A is an employee of Organisation B, where a
disaster has occurred. - Mr A, a. does Organisation B have a qms? b. has
it been certified? - Is it in accordance with ISO 9001?
- In terms of clause 4.1 of ISO 9001, in which
process did the disaster occur? (Answer process
C) - In the context of clause 4.1 of ISO 9001, please
describe process C. - In the context of clause 4.1c of ISO 9001,
please describe the criteria and methods being
used to ensure effective operation of process C.
13Quality management systems, 3
- In an organisation, qms operates at both
strategic and operational levels - The core methodology is plandocheckact
- qms does not imply
- uniformity
- voluminous documentation
- qms does imply
- a focus on process management
- understanding requirements
- self-regulation
14- Is the qms in accordance with ISO 9001?
- In terms of ISO 9001, in which process did the
disaster occur? (Answer process C) - In the context of clause 4.1 of ISO 9001, please
describe C. - In the context of clause 4.1c of ISO 9001,
please describe the criteria and control methods
being used to ensure effective operation of
process C. - a. In the context of clause 4.1e of ISO 9001,
were you monitoring, measuring and analysing
process C? b. Was the associated documentation
controlled in accordance with Clause 4.2.2?
15Quality management systems, 5(a documented
process control regime)
- Control mechanisms are required for document
- approval,
- availability,
- legibility and identification,
- distribution, storage and retrievability,
- review and up-dating,
- change management and status definition,
- obsolescence disposition.
- Clause 4.2.4
16Quality management systems, 4 (external process
expectations and requirements were discussed
earlier)
- Qms requires the relevant portions of an
organisations process expectations and
requirements to be explicitly - established,
- determined given local relevance, and
- adopted,
- by the Organisation.
- ISO 9001/clause 7.2.2
17- a. In the context of clause 4.1e of ISO 9001,
were you monitoring, measuring and analysing
process C? b. Was the associated documentation
controlled in accordance with Clause 4.2.2? - In the context of clause 7.1 of ISO 9001, what
product was being produced at the time? Answer
product D. - In the context of clause 7.2.1 of ISO 9001, which
requirements was product D meeting? Answer
requirements E. - In the context of clause 7.2.2 of ISO 9001, had
requirements E been reviewed? - How do requirements E compare (benchmark) with
those in use by similar organisations?
18Quality processes, 1(an organisation is a set of
independent but interlinked processes)
- With qms understood, we return to our core
discussion of the processes occurring within an
organisation. Reiterating - the processes used must all be
- identified,
- their method of operation defined, and
- their interactions determined.
- qms is about the control of
- the individual processes, and
- their interaction.
- the control method and associated criteria must
be defined.
19Quality processes, 2(the two classic
performance measures)
- Process control requires objectively measuring
and analysing process performance with respect to
process - effectiveness
- outputs compared with expectations,
- an external measure
- efficiency
- outputs compared with inputs
- an internal measure
20Quality processes, 3(the expectations held for
each process are developed from external, company
and customer requirements)
- Effectiveness measures will include feedback on
how each of the above three sets of expectations
- external, company, customer
- are met.
- Efficiency measures relate to
- profitability
- sustainability
21Organisations using qms, 1
- As well as having a process control regime, an
organisation purporting to operate under qms must
have documented, implemented and maintained a - quality policy and set of quality objectives,
- quality manual for operating the qms,
- set of quality procedures, and
- record of events and actions.
- particularly with respect to conformity with
procedures and defined processes.
22- In the context of clause 7.2.1 of ISO 9001, which
requirements was product D meeting? Answer
requirements E. - In the context of clause 7.2.2 of ISO 9001, had
requirements E been reviewed? - How do requirements E compare (benchmark) with
those in use by similar organisations? - In the context of clauses 4.2.1de of ISO 9001,
what documents records exist concerning the
operation and control of Process C? - In the context of clause 8.2.4 of ISO 9001, what
do the records say about the conformity of
process C product D?
23- How do requirements E compare (benchmark) with
those in use by similar organisations? - In the context of clauses 4.2.1de of ISO 9001,
what documents records exist concerning the
operation and control of Process C? - In the context of clause 8.2.4 of ISO 9001, what
do the records say about the conformity of
process C product D? - a. Is your Company committed to qms? b. Is it
being properly applied? - a. How would you describe your Companys approach
to non-conformances? b. Do you self-regulate?
c. Is it effective?
24Organisations using qms, 2(top management
commitment)
- Top management shall provide evidence of its
commitment to - the development and implementation of a qms, and
- continually improving the effectiveness of the
qms, - by
- communicating to the organisation the importance
of meeting customer, shareholder and regulatory
requirements, - establishing a quality policy,
- ensuring that quality objectives are established,
- conducting management reviews,
- ensuring the necessary resources are available.
- ISO 9001, Clause 5.1
25- In the context of clause 8.2.4 of ISO 9001, what
do the records say about the conformity of
process C product D? - a. Is your Company committed to qms? b. Is it
being properly applied? c. How is the Companys
support demonstrated? d. When was the last
management review? e. Are you adequately
resourced? f. How do your comments specifically
apply to Process C? - a. How would you describe your Companys approach
to non-conformances? b. Do you self-regulate?
c. Is it effective? - a. What is your position in the Company? b. What
are you responsible for? c. Who do you report
to? d. Do they support your qms activities? - What quality improvements were made in qms in the
year before the disaster?
26Organisations using qms, 3(top management
commitment)
- Top management must also ensure that the qms
- covers all functions and levels in the
organisation, - Clause 5.4.1
- has defined responsibilities and authorities,
- Clause 5.5.1
- has a manager with the right responsibility,
authority and reporting channels, Clause
5.5.2 - has regular reviews (particularly with respect to
preventative and corrective actions). - Clauses 5.6.12
27- a. Is your Company committed to qms? b. Is it
being properly applied? c. How is the Companys
support demonstrated? d. When was the last
management review? e. Are you adequately
resourced? f. How do your comments specifically
apply to Process C? - a. How would you describe your Companys approach
to non-conformances? b. Do you self-regulate?
c. Is it effective? - a. What is your position in the Company? b. What
are you responsible for? c. Who do you report
to? Do they support your qms activities? - What quality improvements were made via qms in
your area the year before the disaster? - a. Who is responsible for Process C? b. When was
it last reviewed, particularly with respect to
preventative and corrective actions?
28(Poor) alternatives to qms
- qms or crisis management
- process control or tinkering
- safety plans or insurance/litigation
29- a. How would you describe your Companys approach
to non-conformances? b. Do you self-regulate?
c. Is it effective? - a. What is your position in the Company? b. What
are you responsible for? c. Who do you report
to? Do they support your qms activities? - What quality improvements were made in qms in the
year before the disaster? - a. Who is responsible for Process C? b. When was
it last reviewed, particularly with respect to
preventative and corrective actions? - Despite your Companys commitment to qms, is
there a tendency to put it aside in times of
crisis?
30Production and service, 1
- Processes under qms must
- be carried out under controlled conditions, which
include - work instructions
- suitable equipment
- monitoring devices
- include objective and impartial audits of the
qms, - which in turn must be formally reported
- include verification that actions required by an
audit are undertaken
31- a. What is your position in the Company? b. What
are you responsible for? c. Who do you report
to? Do they support your qms activities? - What quality improvements were made in qms in the
year before the disaster? - Despite your Companys commitment to qms, is
there a tendency to put it aside in times of
crisis? - a. Who was responsible for Process C? b. When
was it last reviewed, particularly with respect
to preventative and corrective actions? - Did Process C have adequate work instructions,
equipment and monitoring devices? - a. How many quality audits were done on Process
C? b. Please table the records. c. How many
non-conformances were listed?
32What is an audit?(audits have proved to be
invaluable tools)
- A qms audit is a systematic examination against
defined criteria to determine - whether activities and related results conform to
planned processes, - whether the processes are
- implemented effectively, and
- able to achieve the defined output expectations.
- A qms audit is analogous to a financial audit.
33Production and service, 2(nonconfomances can
arise form operators or auditors)
- Within qms, process nonconformities must have
- been noted recorded,
- had their causes determined,
- had corrective actions determined and
implemented, - had the results of any closure action assessed,
- been reviewed for possible closure.
34Quality processes, 4(diligence it is not enough
to observe a problem)
- Thus, the next qms steps - after measuring and
analysing a process - involve - noting each conformity or non-conformity,
- taking appropriate action,
- recording all relevant information,
- making continual improvements based on these
measurements and actions.
35- a. Who was responsible for Process C? b. When
was it last reviewed, particularly with respect
to preventative and corrective actions? - Did Process C have adequate work instructions,
equipment and monitoring devices? - a. How many quality audits were done on Process
C? b. Please table the records. c. How many
new non-conformances were listed. - For each non-conformance related to Process C, a.
describe the cause ascribed to the
non-conformance, b. list the corrective action
taken to correct it, c. estimate how effective
the correction was, and d. describe the current
status of the non-conformance. - Did any continual improvements result from each
Process C non-conformance?
36OHS management systems, 1(Occupational health
and safety - the human obligation)
- OHS is one component of an organisations
operation. It is covered by AS/NZS 48102001
which - provides a systematic approach to OHS
- has a special emphasis on hazards and risks.
- is based on qms
- and thus requires an OHS policy
- (continued)
37- For each non-conformance related to Process C, a.
describe the cause ascribed to the
non-conformance, b. list the corrective action
taken to correct it, c. estimate how effective
the correction was, and d. describe the current
status of the non-conformance. - Did any continual improvements result from each
Process C non-conformance? - The disaster that occurred in Process C had OHS
implications. To what extent were these foreseen
or foreshadowed in a. the qms work instructions
for Process C, b. the pre-disaster
non-conformances for Process C and c. the
pre-disaster audits of Process C?
38- The disaster that occurred in Process C had OHS
implications. To what extent were these foreseen
or foreshadowed in a. the qms work instructions
for Process C, b. the pre-disaster
non-conformances for Process C and c. the
pre-disaster audits of Process C. - More specifically, the disaster that occurred in
Process C highlighted hazards and risks in
Process C. To what extent were these foreseen or
foreshadowed in a. the qms work instructions for
Process C, b. the pre-disaster non-conformances
for Process C and c. the pre-disaster audits of
Process C. - What is your Companys OHS policy?
39OHS management systems, 2
- (continued)
- requires management commitment to OHS,
- has demonstrable OHS conformance,
- is able to be independently certified,
- provides for
- monitoring,
- independent audits,
- continuous improvement.
40- More specifically, the disaster that occurred in
Process C highlighted hazards and risks in
Process C. To what extent were these foreseen or
foreshadowed in a. the qms work instructions for
Process C, b. the pre-disaster non-conformances
for Process C and c. the pre-disaster audits of
Process C. - What is your Companys OHS policy?
- Describe your managements commitment to OHS.
- a. What OHS non-conformances have you had
recently? b. How many are relevant to Process C?
41- What is your Companys OHS policy?
- Describe your managements commitment to OHS.
- a. What OHS non-conformances have you had
recently? b. How many are relevant to Process
C? c. Which were open when the disaster
occurred? - Have you had independent certification of your
OHS practices? - Describe how you monitored, audited and
continuously improved OHS for Process C.
42Hazards risks, 1(in an OHS context)
- Hazards and unacceptable risks must be
- identified,
- assessed, stating their
- potential
- consequences
- past experience
- controlled, and
- the controls evaluated
- emergency responses defined.
43- Have you had independent certification of your
OHS practices? - Describe how you monitored, audited and
continuously improved OHS for Process C. - a. What hazards and unacceptable risks were
identified in the Organisation in the periods
prior to and after the disaster? b. What was
their potential? c. How were they controlled?
d. Were any relevant to the disaster? e. Did
they alter your emergency response policy?
44Hazards risks, 2
- Incidents associated with hazards must be
- investigated specifically
- including operating conditions
- investigated as system failures
- including studying similar past events
- used to initiate and complete corrective actions
to either - eliminate the risk,
- minimise the risk, or
- isolate the risk.
45- a. What hazards and unacceptable risks were
identified in the Organisation in the periods
prior to and after the disaster? b. What was
their potential? c. How were they controlled?
d. Were any relevant to the disaster? e. Did
they alter your emergency response policy? f.
How many indicated system failures? g. Which
were either minimised or isolated?
46Best practice the Safety Case, 1
- A safety case is a documented demonstration of
the way in which the hazards at a facility are
managed to ensure acceptable risk. - Risk Engineering Society, IEAust, Victoria
- It is consistent with
- qms, and
- performance-based management
- and is analogous to a Business Case
- providing assurance, and
- being capable of independent audit.
47- f. How many indicated system failures? g. Which
were either minimised or isolated? - a. Did you have a Safety Case for Process C? b.
If not, why not? - Had your Safety Case been independently audited?
- a. How do you explain the disaster in the
context of your Safety Case? b. How will you
change the Safety Case?
48Best practice the Safety Case, 2
- A safety case must conclude that the system being
considered meets its defined safety criteria and
is therefore sufficiently safe to be - acceptable, and
- allowed to operate in accordance with its defined
objectives and criteria. - The objectives and criteria will already exist
within the qms documentation. - As it draws a conclusion, the safety case goes
beyond a safety-assessors risk assessment.
49- Had your Safety Case been independently audited?
- a. How do you explain the disaster in the
context of your Safety Case? b. Was the disaster
foreseen by it? c. If it had been, why did your
preventative and/or mitigative measures fail? d.
How will you change the Safety Case? - Who produced your Safety Case?
- a. What would have been your pre-event numerical
estimate of the risk of the disaster? b. What
is the risk of its reoccurrence? - Was the disaster foreseeable?
50Best practice the Safety Case, 3
- Once all possible hazard causes are known,
- the next three key questions for a safety case
are (Hawkesley) - What could go wrong? - foreseeing
- Why wont it? - preventing
- But what if it did? - mitigating
- Two other questions are
- How wide is the coverage? for whom?
- Is anything exempted? for what?
51Best practice the Safety Case, 4
- Question 4, but what if something did go wrong?
is intended to address - consequence management, and
- damage limitation
- but is often distorted to focus on liability
- management (e. g. control of information flows),
and - assessment (e. g. minimisation of cost incurred)
- (recall the qms requirement for top management
sign-off)
52Best practice the Safety Case, 5
- A safety case can become
- if it is divorced from the rest of qms,
- a contract between an operator and a
single-purpose regulator. - although not produced for the purpose,
- an imperfect tool for assigning liability when
things do go wrong.
53Best practice the Safety Case, 6
- Safety case documents in a qms format are
produced by the organisation doing the work. - They cannot be
- produced by other bodies
- imposed by other bodies
- There is a temptation for regulators to try to
impose a safety case on an organisation. - If this is done, the intended safety case becomes
another regulation, and loses all its qms
attributes and benefits.
54Risk and probability, 1
- Risk can be calculated and given numerical values
using probability theory. - So it is easy to forget that risk is still a
subjective concept. For example - Once the dice is thrown, the probability of a
given number showing, changes from 1/6 to 1. - Our decisions on the same 1/6 probability will
change with the size of the wager. - Although each throw of the dice is an independent
event, when we look at the results from a set of
throws, some order emerges. - There will always be insufficient data to
estimate that order accurately.
55Risk and probability, 2(even more subjectively)
- We will never be able to foresee all hazards.
- Some relevant events will be outside our control.
- Once an unlikely event occurs, any earlier
prediction that it was unlikely becomes a
mistake. - On empirical evidence
- Damage is emotionally worse when it
- is caused by events over which the property
owner had no control. - occurs to large groups of people.
- Risk is rarely symmetric (liabilities vs
value-adds). - People do not avoid low risk events.
56- Who produced your Safety Case?
- a. What would have been your pre-event numerical
estimate of the risk of the disaster? b. What
is the risk of its reoccurrence? - Was the disaster foreseeable?
- Could the disaster have been avoided?
- a. Does your organisation adopt best practice
procedures in risk management? b. Have you been
trained in risk management? - a. In retrospect, were there early warning
signals of the imminent disaster? b. Were there
early signs of the disaster which could have led
to actions causing a reduction in its
consequences?
57Risk and probability, 3(even more subjectively)
- However, because of point 6, people do not want
to be associated with a disaster at the least
it damages their promotion prospects. So the low
risk threshold depends on event consequences.
58Risk and probability, 4
- In a more specific context, it is often forgotten
that the consequences of unwanted events
occurring can be modified by - Adopting best practice processes, particularly
in risk management - Staff training and risk profiling sessions
- Responding to the unwanted event rapidly, as
- early warning signals are seen and understood,
and - the event progressively unfolds.
59The road safety example, 1
- Typical accepted risks are (fatalities /
person / year) from Lay, Handbook of Road
Technology, Vol 2 - safe behaviour (public health), 1 in 1 000 000
- pay money to reduce 1 in 10 000
- in a year of car travel 1 in 10 000
- per car per year 1 in 5 000
- publicly unacceptable, 1 in 1 000
- in a lifetime of driving 1 in 200
60Humans intrude
- Human misfits living outside of qms include
- Blind eyes who shoot messengers
- Bureaucrats who bury or compartmentalise
warning messages - Conservatives who oppose change
- Cowboys, who consider themselves immune from
procedures or risks - Other worlds who dont want to know
- Tyrants who cure risks by threats and
punishments - Walking disasters who create hazards
- Wimps who avoid responsibility
61- a. Does your organisation adopt best practice
procedures in risk management? b. Have you been
trained in risk management? - a. In retrospect, were there early warning
signals of the imminent disaster? b. Were there
early signs of the disaster which could have led
to actions causing a reduction in its
consequences? - a. To what extent did in inappropriate human
behaviour contribute to the disaster? b. Did
the right people give and/or receive the right
messages? c. Did some people act
inappropriately?
62The road safety example, 2
- The primary causes of a road crash are (from Lay,
Handbook of Road Technology, Vol 2) - Drivers alone (e.g. run off straight road), 65
- Drivers and road (e.g. hit roadside post), 25
- Drivers and vehicles (e.g. wheels lock during
braking), 5 - Road factors alone (e.g. slippery surface), 2
- Vehicle factors alone (e.g. brakes fail), 2
63The chain or the mattress?( a matter of
redundancy)
- In the context of failure theory
- Most practical systems are full of redundancies
and inherent checks and balances (as with a
mattress where the failure of one spring need not
cause disaster). - Few practical systems are determinant, where one
event will cause total disaster (as with the
links in a chain).
64The curse of the Yarra(or the waters strike back)
- I have been involved in four major problems
associated with crossing the Yarra, each of which
supports my thesis that disasters, at a
sub-project role, are rarely isolated events. - They are more likely to be the symptoms of a
widespread disease. - The four crossings are Kings Bridge, Westgate
Bridge, Bolte Bridge and the City Link tunnels.
65Kings Bridge
- The designers were focussed on foundation
problems, the steel used was poorly chosen, the
welding methods were unsuitable for the steel,
and the design details were inappropriate for the
steel/welding used. If just one of these had not
occurred, the bridge would not have failed.
66Westgate Bridge
- The design brief tried to avoid welding, the
designers thought worrying about constructablity
beneath their dignity, the builders thought the
bridge could be modified without recourse to the
designers, site communications were non-existent,
major mistakes were made in design details, and
early warnings of failure were ignored. Fixing
just one of these would have avoided bridge
failure.
67Bolte Bridge and City Link Tunnels
- It is not possible for the author to put his
views on these in writing. - Instead, consider any report on any major
failure. Have you read of any that have said
The failure was caused by item F failing. No,
the norm is to be presented with a long catalogue
of problems. The disaster is just the end play
in a sad saga.
68- a. In retrospect, were there early warning
signals of the imminent disaster? b. Were there
early signs of the disaster which could have led
to actions causing a reduction in its
consequences? - a. To what extent did in inappropriate human
behaviour contribute to the disaster? b. Did
the right people give and/or receive the right
messages? c. Did some people act
inappropriately? - Have there been other instances of related minor
or major disasters in the Organisation or
associated-industry in recent times?
69Zero tolerance to disasters
- A strongly developing concept which underlies the
recent strengthening in support for qms, OHS,
etc is the principle that no disasters should be
tolerated, and their risk of occurrence should be
reduced to zero. - This approach should be applied to planning,
designing, operating and assessing. It is an
attempt to change the state of mind from - passive acceptance, to
- active avoidance.
70Back in the real world(real answers to unreal
questions)
- So what answers would we expect to receive from
- a normal employee
- holding a responsible position
- in an Australian,
- normal, producing organisation
- which has just experienced a typical moderate
major disaster - including damage to people and property?
- recognising that at the coal-face poor decisions
are usually driven by time savings rather than
cost cutting.
71- Mr A is an employee of Organisation B, where a
disaster has occurred. - Mr A, a. does Organisation B have a qms? b. has
it been certified? answer Yes yes. - Is it in accordance with ISO 9001? answer We
up-dated it last year. Was that certified? - In terms of clause 4.1 of ISO 9001, in which
process did the disaster occur? answer In
Process C. - In the context of clause 4.1 of ISO 9001, please
describe process C. answer The best
description of process C is given under procedure
F in our Quality Plan. Process C is
72- relatively labour intensive. Quality Plans are
defined in Note 1 to Clause 7.1 of ISO 9001. - In the context of clause 4.1c of ISO 9001,
please describe the criteria and methods being
used to ensure effective operation of process C.
answer The best description of the criteria
and methods is given under procedure F in our
Quality Plan. The need for this content is
discussed in Clause 7.1c of ISO 9001. - a. In the context of clause 4.1e of ISO 9001,
were you monitoring, measuring and analysing
process C? b. Was the associated documentation
controlled in accordance with Clause 4.2.2?
answers Yes Yes.
73- In the context of clause 7.1 of ISO 9001, what
product was being produced at the time? answer
Product D. - In the context of clause 7.2.1 of ISO 9001, which
requirements was product D meeting? answer
Requirements E. - In the context of clause 7.2.2 of ISO 9001, had
requirements E been reviewed? answer Yes. - How do requirements E compare (benchmark) with
those in use by similar organisations? answer I
am not aware of any identical work elsewhere.
This is a very competitive business. Is he
saying that they all compromise safety? - In the context of clauses 4.2.1de of ISO 9001,
what
74- documents records exist concerning the
operation and control of Process C? answer A
complete set. - In the context of clause 8.2.4 of ISO 9001, what
do the records say about the conformity of
process C product D? answer There were a few
non-conformances but most had been closed when
the disaster occurred. Question 21 returns to
explore the issues raised by this answer. For
the moment, note that a. disasters rarely occur
in splendid isolation and b. it is common for
people to fail to perceive what in retrospect are
the obvious signs of an impending disaster.
75- a. Is your Company committed to qms? b. Is it
being properly applied? c. How is the Companys
support demonstrated? d. When was the last
management review? e. Are you adequately
resourced? f. How do your comments specifically
apply to Process C? answer a. Yes, but they
get upset when it causes delays. b. Yes, but I
wouldnt say it was first priority. c.
Everywhere you look there are signs about quality
but I bet there are none in the Boardroom. d.
Just before the next certification. e. The
quality group always want more staff, but theyre
another overhead. f. Its easy to be wise in
hindsight. These issues are pursued further in
the answers to questions 17-23.
76- a. How would you describe your Companys approach
to non-conformances? b. Do you self-regulate?
c. Is it effective? answer We self-regulate
and we are very honest and also very practical in
our approach. practical we dont let it delay
the job - most jobs carry small compromises. - a. What is your position in the Company? b. What
are you responsible for? c. Who do you report
to? d. Do they support your qms activities?
answer I am a manager and I am responsible for
Process C. I report to the Works Manager.
Everyone supports qms but the bosses get
aggressive when it results in unscheduled
stoppages. most current jobs are highly
programmed with insufficient allowance for
unplanned delays. - What quality improvements were made in qms in the
year before the disaster? answer We reduced
the number of process alarms as the important
ones were being masked. Who determined which
alarms were important?
77- a. Who is responsible for Process C? b. When was
it last reviewed, particularly with respect to
preventative and corrective actions? answer I
am responsible. We reviewed the process about
six months ago and thats when we decided to make
the changes I mentioned in my previous answer.
There is rarely a sense of urgency in these
matters. - Despite your Companys commitment to qms, is
there a tendency to put it aside in times of
crisis? answer Until the disaster, we havent
had a crisis. - Did process C have adequate work instructions,
equipment and monitoring devices? answer Yes.
And still the disaster occurred.
78- a. How many quality audits were done on Process
C? b. Please table the records. c. How many
non-conformances were listed? answer There
were two audits. Here are the records. There
were five non-conformances. There is rarely a
problem having non-conformances raised. - For each non-conformance related to Process C, a.
describe the cause ascribed to the
non-conformance, b. list the corrective action
taken to correct it, c. estimate how effective
the correction was, and d. describe the current
status of the non-conformance. answer Here is
the list - NC12, trivial alarms, alarms decommissioned,
effective, closed.
79- NC3, no test record, record obtained, no link to
product used, still open - NC45, no same-day sign-offs, retrospective
sign-offs, work verified by others, closed. - The closures are not too convincing and might be
rejected by a future audit. - Did any continual improvements result from each
Process C non-conformance? answer We
decommissioned the alarms. ! - The disaster that occurred in Process C had OHS
implications. To what extent were these foreseen
or foreshadowed in a. the qms work instructions
for Process C, b. the pre-disaster
non-conformances for Process C and c. the
pre-disaster audits of Process C?
80- answer a. The OHS link was good at a general
level. b. Perhaps that alarm might not have
been disconnected? c. There hadnt been an
audit since the alarm was disconnected. - We will skip many of the OHS, Safety Map and
Risk Management responses. Of course, the staff
followed the requirements as well as could be
expected and, of course, the plans did not cover
all the eventualities that did arise. The
disaster was, after all, unforeseen. - a. What hazards and unacceptable risks were
identified in the Organisation in the periods
prior to and after the disaster? b. What was
their potential?
81- c. How were they controlled? d. Were any
relevant to the disaster? e. Did they alter
your emergency response policy? f. How many
indicated system failures? g. Which were either
minimised or isolated? - answer a. After the event we did discover that
the disabled alarm, if it had been noted amongst
all the other alarms, would have alerted someone
to the fact that the installation crew had
omitted a key step. Im not sure whether anyone
would have realised the significance of the
omission. b. There would have been no disaster
if the installation had been done as specified,
or, if someone in authority had known of the
omission and its significance and then acted. c.
In retrospect, they werent. d. Yes. e. How
do you protect against humans? f. About 4. g.
None.