Avoiding disaster Engineering, Technology and the Law

1. Avoiding disasterEngineering, Technology and the Law M. G. Lay What should reasonably be expected MGLay presentation

2. The 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. MGLay presentation

3. Organisational 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 organisation’s product. MGLay presentation

4. Organisational 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. MGLay presentation

5. On 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. MGLay presentation

6. Process 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) MGLay presentation

7. Process expectations, 2(most organisations are ethical and law-abiding) • external requirements, which will include: • company law and related laws & regulations • OH&S regulations • accounting regulations • environmental protection regulations • the “triple bottom line”: * economic performance * environmental performance * social performance • industry practice • benchmarking MGLay presentation

8. Managing 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). MGLay presentation

9. Quality 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? MGLay presentation

10. Mr A is an employee of Organisation B, where a disaster has occurred. • Mr A, does Organisation B have a qms? MGLay presentation

11. Quality management systems, 2 In Australia, qms is governed by Standard AS/NZS ISO 9001:2000 • 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. MGLay presentation

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. MGLay presentation

13. Quality management systems, 3 • In an organisation, qms operates at both strategic and operational levels • The core methodology is plan—do—check—act • qms does not imply: • uniformity • voluminous documentation • qms does imply • a focus on process management • understanding requirements • self-regulation MGLay presentation

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? MGLay presentation

15. Quality 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 MGLay presentation

16. Quality management systems, 4(external process expectations and requirements were discussed earlier) Qms requires the relevant portions of an organisation’s process expectations and requirements to be explicitly: • established, • determined & given local relevance, and • adopted, by the Organisation. ISO 9001/clause 7.2.2 MGLay presentation

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? MGLay presentation

18. Quality 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. MGLay presentation

19. Quality 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 MGLay presentation

20. Quality 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 MGLay presentation

21. Organisations 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. MGLay presentation

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 4.2.1d&e 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? MGLay presentation

23. How do requirements E compare (benchmark) with those in use by similar organisations? • In the context of clauses 4.2.1d&e 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 Company’s approach to non-conformances? b. Do you self-regulate? c. Is it effective? MGLay presentation

24. Organisations 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 MGLay presentation

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 Company’s 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 Company’s 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? MGLay presentation

26. Organisations 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 5.6.1&2 MGLay presentation

27. a. Is your Company committed to qms? b. Is it being properly applied? c. How is the Company’s 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 Company’s 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? MGLay presentation

28. (Poor) alternatives to qms • qmsor crisis management • process control or tinkering • safety plans or insurance/litigation MGLay presentation

29. a. How would you describe your Company’s 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 Company’s commitment to qms, is there a tendency to put it aside in times of crisis? MGLay presentation

30. Production 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: MGLay presentation

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 Company’s 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? MGLay presentation

32. What is an audit?(audits have proved to be invaluable tools) • A qmsaudit 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. MGLay presentation

33. Production 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. MGLay presentation

34. Quality 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. MGLay presentation

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? MGLay presentation

36. OH&S management systems, 1(Occupational health and safety - the human obligation) OH&S is one component of an organisation’s operation. It is covered by AS/NZS 4810:2001 which: • provides a systematic approach to OH&S • has a special emphasis on hazards and risks. • is based on qms • and thus requires an OH&S policy (continued) MGLay presentation

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 OH&S 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? MGLay presentation

38. The disaster that occurred in Process C had OH&S 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 Company’s OH&S policy? MGLay presentation

39. OH&S management systems, 2 (continued) • requires management commitment to OH&S, • has demonstrable OH&S conformance, • is able to be independently certified, • provides for • monitoring, • independent audits, & • continuous improvement. MGLay presentation

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 Company’s OH&S policy? • Describe your management’s commitment to OH&S. • a. What OH&S non-conformances have you had recently? b. How many are relevant to Process C? MGLay presentation

41. What is your Company’s OH&S policy? • Describe your management’s commitment to OH&S. • a. What OH&S 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 OH&S practices? • Describe how you monitored, audited and continuously improved OH&S for Process C. MGLay presentation

42. Hazards & risks, 1(in an OH&S context) Hazards and unacceptable risks must be: • identified, • assessed, stating their • potential • consequences • past experience • controlled, and • the controls evaluated • emergency responses defined. MGLay presentation

43. Have you had independent certification of your OH&S practices? • Describe how you monitored, audited and continuously improved OH&S 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? MGLay presentation

44. Hazards & 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. MGLay presentation

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? MGLay presentation

46. Best 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. MGLay presentation

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? MGLay presentation

48. Best 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-assessor’s risk assessment. MGLay presentation

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? MGLay presentation

50. Best 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 won’t it? - preventing • But what if it did? - mitigating Two other questions are: • How wide is the coverage? – for whom? • Is anything exempted? – for what? MGLay presentation