Self-Assessment for Improving Safety Performance in the Nuclear Industry

Transcription

1 Self-Assessment for Improving Safety Performance in the Nuclear Industry I.A. Beckmerhagen 1, *, H.P. Berg 1, S.V. Karapetrovic 2 and W.O. Willborn 3 1 Bundesamt für Strahlenschutz, Willy Brandt Str. 5, Salzgitter, Germany 2 5-8B Department of Mechanical Engineering, University of Alberta, Edmonton, Alberta, Canada T6G 2GB 3 Faculty of Management, University of Manitoba, Winnipeg, Manitoba, Canada R3T 2N2 Summary Due to the possibility of catastrophic accidents when operating a nuclear plant, ensuring the highest level of safety and continuously improving safety-related performance are imperative in the nuclear industry. One of the prerequisites for such assurance and improvement is a structured program for the assessment of safety performance, consisting of both internal and external evaluation of existing systems and achieved results. This paper discusses a comprehensive program for the self-assessment of safety performance enablers and safety performance outcomes. The main self-assessment concepts are presented, including the framework, objectives, and scope of a self-assessment, a set of main principles and prerequisites for conducting it, and the resulting benefits. An illustration of a self-assessment program currently under development in the International Atomic Energy Agency is also provided. Copyright 2003 John Wiley & Sons, Ltd. Key Words self-assessment; audit; safety management; quality Introduction When facing a risk situation with known or unknown hazards, we caution ourselves *Correspondence to: I. A. Beckmerhagen, Bundesamt für Strahlenschutz, Willy Brandt Str. 5, Salzgitter, Germany ibeckmerhagen@bfs.de with a reminder to be careful. This is the most rudimentary form of safety assurance. In our advanced technological age, however, personal safety has become a complex phenomenon due to dangers that require rigorous control and that must be minimized by appropriate design and preventive measures. This is particularly true in the nuclear industry. Here, proper safety management in conjunction with risk management is a major corporate and managerial responsibility. Verifying compliance with relevant public safety standards and internal procedures cannot be left solely to the individual workers in the nuclear industry, nor can it be limited to the supervisors in charge of operations. External auditors, regulators and other specialized control groups play an important role in the field of nuclear safety. Nevertheless, they do not suffice either. Employees close to potential danger must be equipped, trained, assisted and supervised to maintain personal and general safety. In some industries (e.g. nuclear, aviation, mining), assessment and management of safety performance has the benefit of an extensive framework of regulatory requirements that evolved over a long time period. Other industries and services, which have not been subjected to such a prescriptive regulatory regime, must rely on more rigorous internal procedures to satisfy the less prescriptive and more goal-oriented objectives of their regulators. In the latter situation, it is necessary to create new mechanisms that support the delivery of higher quality. For example, in health care, methods that already exist in other areas can be adapted: one method to improve work or safety performance is the audit loop [1], i.e. an audit and consecutive re-audit process to assure DOI: /qaj.205

2 12 I. A. Beckmerhagen detection and correction of non-compliance with required standards. In the case of the nuclear industry, part of management practice to improve plant safety performance is embodied in the process of quality management using self-assessment techniques. Self-assessments are also undertaken in other industries that have the potential for significant environmental effects in the event of accidents, for example the petrochemical and offshore sectors. The primary requirement for a self-assessment program is to develop a systematic and continuing process that evaluates the status of the plant, systems, equipment, personnel, procedures, policies and practices. Such a self-assessment process should be proactive in nature, with motivation and support at all levels of plant management and personnel. A self-assessment program must also ensure that it is effective in monitoring operational safety performance and that corrective and preventive actions are taken to improve performance in an acceptable time frame. Thus, potential weaknesses can be detected and often resolved, long before they degrade any margin of safe operation. Self-assessments also help to identify and overcome process weaknesses and obstacles, and they help to achieve safety performance objectives. An effective self-assessment program should strive for selfimprovement, not simply the demonstration of minimum compliance with codes and regulations. Experience has shown that integrating feedback on operational experience within the self-assessment process provides significant benefits to overall plant safety [2, 3]. A comprehensive program for safety evaluations in the nuclear industry normally includes modules for both self-assessment and independent-assessment of performance. This paper specifically discusses the former module, namely, the selfassessment. It refers to the evaluations performed by process owners (i.e. nuclear plant operators), ranging from individuals through organizational units to the whole plant. This module also covers internal safety audits. The independent-assessment module refers to external audits performed by professional auditors and regulators. We also provide an outline of the International Atomic Energy Agency (IAEA) guidelines on self-assessment which are currently under development. Although this paper is focused on safety performance and safety management in the nuclear industry, the self-assessment concepts and their underlying principles and issues can be adapted to other industries and services, particularly those which are not governed by a strict regulatory system and therefore need more rigorous internal means of managing quality. Industries

3 Self-Assessment for Improving Safety Performance in the Nuclear Industry 13 involved in medical care, for example, are also observed by a critical and deeply involved public, and therefore could benefit from a self-assessment program. The application of common principles and the specific concepts of self-assessment described below, and the management systems or, better yet, an integrated management system as recommended in [4, 5] that evolve from consideration of the principles and issues, will always depend on the following factors: Nature of the business of a particular industry. Type of regulatory system that supervises and governs the industry, for example International Organization for Standardization (ISO), Safety Certificate Contractors (SCC) and Occupational Health and Safety Assessment Systems (OHSAS). Style of regulation adopted by the regulatory authority, for example how they work together with the licensees. Possibility of reliance on international organizations accepted by experts, regulatory bodies and the public. Senior management perceptions of findings and motivation of personnel to rectify problems. Self-assessment Concepts Evaluation of work is an integral part of the work itself. Because work is a goal-oriented activity, its results (also known as performance ) are always compared with planned objectives. A typical evaluation includes the measurement of effectiveness and efficiency of the work process and subsequent comparison of process performance with expected goals. The two components of performance, namely effectiveness and efficiency, are defined in the ISO 9000 (2000) standard [6] as the extent to which planned activities are realized and planned results achieved and the relationship between the result achieved and the resources used, respectively. When goals are presented in the form of a documented policy, standards or model, the evaluation process is referred to as audit or assessment against criteria (or desired safety goals ). For example, a nuclear plant can perform an audit against the OHSAS [7] standard, which represents the criteria for an occupational health and safety management system. Other defined performance expectations could be described by safety indicators, which enable the assessment of the plant safety level, as well as comparisons with other plants. Examples of such safety indicators are [3]: Number of corrective work orders issued for a safety system in a time period. Number of hours that key safety equipment is out of service. Plant availability factors. Number of unplanned reactor shutdowns. Personnel radiation exposure. Environmental releases (i.e. radiation, waste water, waste gas), even if they are below limits set by the authorities. What is self-assessment? Zink and Schmidt define self-assessment as a tool to systematically monitor and control a company s continuous improvement process [8]. The main notion of self-assessment is that the person or the organizational unit in charge of the process (in other words the process owner ) performs the assessment, at the process location. Other people or organizational units directly involved with the process may participate in the assessment, but only under the leadership of the owner. The primary objective of self-assessment is to evaluate and improve performance, by examining both the performance drivers and accomplished results. Performance drivers can be grouped into three categories: goals (including strategy, policy and objectives), resources (people, material, information, money and infrastructure) and processes (including leadership and realization of the outputs). These drivers are evaluated for their suitability to achieve set performance levels (effectiveness), and the ability to achieve them with minimum effort (efficiency). The results, which may include specific safety indicators, are measured and compared with target levels.

4 14 I. A. Beckmerhagen Naturally, performance levels are also periodically examined for purpose and feasibility [9]. Self-assessment comprises the measurement and comparison of actual versus required levels of performance through a negative feedback loop. It can be performed by an individual worker comparing her/his performance with set standards, identified strengths, weaknesses, opportunities and threats, and the work of best-in-class people. Moreover, the whole organization can conduct such a self-assessment, by using safety standards and benchmarks for reference. Such evaluations of performance must be coordinated so that individual self-assessment results are utilized at the unit level, as well as in organizational assessments. Assessment criteria must be communicated throughout the organization and must be inter-linked, making each person aware of how her/his individual assessment criteria correspond to unit or company-level criteria [9]. Typical steps to conduct a self-assessment, along with the related objectives, are described in Table I. Well-planned and well-performed self-assessments for safety, conducted by supervisors and operators, are an important extension of regular internal and external audits. Unlike audits, which are limited to the evaluation of effectiveness (whether the organization is going in the right direction), self-assessments are able to measure both the effectiveness and efficiency (how fast it is going in a chosen direction of improvement and what resources it is using to go there). The following are three most important differences between audits and self-assessments [10]: Audits foster quality assurance and conformance to specified requirements, wherea selfassessments facilitate continuous improvement. Audits normally follow strict guidelines and generate compliance or non-compliance findings from audit evidence. Self-assessments are planned and directed towards achieving a specific, dynamic level of performance reflected by criteria or safety indicators. Audits are not particularly effective in linking their results with business planning and/or management review. Self-assessments facilitate the use of results in the planning process, which may lead to changes in technical equipment or in operational procedures. Table I. Steps and associated objectives of a self-assessment process Step Objective 1. Define the areas to be covered by the Define the scope and objectives to be included in an overall self-assessment self-assessment program or to be applied to a specific self-assessment activity 2. Define the performance expectations Define the expected level of performance to fully accomplish the desired safety goals. 3. Identify assessment process and schedule Provide plans, resources and schedules for completing the self-assessment. 4. Conduct performance comparison Compare the actual performance to the established performance expectations in order to identify differences. 5. Conduct performance assessment Determine the significance of observed differences between performance and expectations necessary to identify the extent and priority of needed corrective actions. 6. Implement corrective actions Implement actions to correct significant identified deficiencies. 7. Monitor effectiveness of corrective actions Monitor performance indicators to verify that the actions are effective in resolving noted discrepancies.

5 Self-Assessment for Improving Safety Performance in the Nuclear Industry 15 Table II provides a more detailed comparison of the features of internal and external audits, and self-assessments. Several terms that are commonly used in this area, such as audit, inspection, review and assessment are also commented on in Table III. Procedures for conducting audits and self-assessments are similar with respect to the sequence and content of required activities. However, unlike self-assessments, audits must be planned and conducted independently of the function being audited. What are the principles of selfassessment? Some principles necessary to conduct effective self-assessments are: The goal and purpose of the self-assessment project must be determined, documented, and approved by senior management. Safety standards, regulations and procedures, including the goals and targets set by the management, are the basic criteria for performing the assessment. Such criteria may exist as qualitative policy statements made by top management, as well as quantitative performance measures, Self-assessment involves people at all levels and units in assuring effective and efficient safety procedures and compliance. All participants must be properly trained, prepared, and provided with guidelines, working papers, and adequate supervision. Results of a self-assessment must be documented and reported to supervisory management. Necessary corrective actions must be implemented and their adequacy confirmed. Improved performance resulting from a self-assessment must be properly acknowledged. Improvement in self-assessments should be identified without negative repercussions to participants. What are the prerequisites for performing a self-assessment? One established goal of self-assessment is maintaining and improving safety, regardless of Table II. Comparison of audits and self-assessment (based on [9]) Elements External audit Internal audit Self-assessment Objective Compliance with a standard Control of product, Identifying strengths and or procedures process, or system improvement opportunities Scope Standard requirements By directive of As determined by (e.g. OHSAS 18001) management (e.g. management, process owner, plant/unit) or staff member Applicability Registration procedure Mainly in large multi-unit Follow-up of audits, special companies concerns and opportunities Client Applicant, customer or Management Management and stakeholders regulator Auditor Certified professional Appointed and trained Trained staff members and employee process owners Auditee Company employees Supervisory management Process owner Auditing process Compliance with the Documented and Documented procedures and criteria published audit standards authorized procedures work instructions (e.g. ISO 19011) Reporting and Formal report and Report to and decision Formal and informal reporting, follow-up follow-up by management by management cooperative follow-up actions

6 16 I. A. Beckmerhagen Table III. Terms and methodologies related to self-assessment (adapted from [9]). Term Definition Source Comment Inspection Conformity evaluation by ISO 9000 Refers to the evaluation of whether observation and judgment [6] a product or service conforms to accompanied as specified requirements. Safety audit is appropriate by measurement, a broader term, since it involves an testing or gauging evaluation of decisions related to safety inspections Assessment Judgment or decision on the Cambridge When assessment is done with quality, importance, amount or Dictionary [11] reference to a management system value of something standard, a system audit is performed. An audit is a special case of assessment. Self-assessment Comprehensive, systematic and EFQM This definition refers to a selfregular review of an organization's [12] assessment where reference criteria activities and results referenced against for assessment are contained in a BEM, a Business Excellence Model (BEM) and the evaluation is performed by an organization itself and the process owner Audit Systematic, independent and ISO 9000 While the audit defined in this manner documented process for obtaining [6] is restricted to the evaluation of audit evidence and evaluating it compliance with audit criteria, a selfobjectively to determine which assessment is not. No personal agreed criteria are fulfilled independence in self-assessment is required but adequate competence. Review Activity undertaken to determine ISO 9000 [6] Self-assessment focuses not only on the the suitability, adequacy and suitability, adequacy and effectiveness, effectiveness of the subject matter but also on efficiency. The results can to achieve established objectives be used as input into management review. whether or not it is performed for the purposes of a safety management program. An important prerequisite, however, is a well-established management system and general managerial competence. Control functions and methods such as internal and external audits and inspections may be used to guide self-assessment activities. In order for a self-assessment to provide an impetus for improvement, the following must be in place [10]. Objective: Does it have improvement as the main goal? Structure: Does it contain adequate processes and resources for improvement? Support: Does it foster competence and intrinsic interest of the process owner to improve? These conditions point out the need for the provision of an environment that not only facilitates the development of process-owner competence through education, training and experience in conducting self-assessments, but also the build-up of confidence and satisfaction through the understanding and recognition of her/his own self-interests. The allocation of sufficient time and other financial, infrastructure, information and material resources to perform the assessment, deployment of the adequate methodology to conduct the self-assessment, ensuring management support and active involvement, and adequate follow-up with respect to the self-assessment results, are additional prerequisites for a successful assessment [9].

7 Self-Assessment for Improving Safety Performance in the Nuclear Industry 17 What are the benefits of an effective self-assessment? Some general advantages of instituting a selfassessment program are: Regular audits are enhanced, because an organization s strengths and weaknesses are identified. This allows for improvements to be made based on up-to-date factual knowledge and the objectives to be achieved. Comparisons with other facilities in the same field are enabled. Supervisory management at all levels are able to attain closer work relationships and become better informed for rational decision making. Staff awareness of the self-assessment process can result in a better understanding of the performance expectations and can broaden staff knowledge of the objectives to be achieved. Work is enriched, raising staff morale and motivating staff to seek improvements in performance. Public image and trust in the organizational abilities improve, which is especially important for the nuclear industry. Self-assessment and the International Atomic Energy Agency The International Atomic Energy Agency (IAEA) is currently developing a document for selfassessment programs in the nuclear industry [13] incorporating the experience gained in different countries and extracting good practices to provide guidance for those which would like to implement self-assessment in their plant. Figure 1 shows the general features of an operational safety performance program, as conceptualized by the IAEA. Direct information about the plant s performance in terms of safety is derived from three primary in-house sources: operational data, events, and other information that may affect the plant safety such as safety basis as shown in Figure 1. Various external sources are used to expand upon and supplement current in-house information. Such sources include reviews of related experiences at other nuclear facilities, evaluations performed by external organizations and external information that may affect the safety basis. In the self-assessment program, both internal and external sources of information are evaluated in terms of their effect on the plant status and operation. Such evaluations determine whether there has been any deviation from the acceptable safety basis. They also define the scope for proposed improvements to eliminate or reduce adverse trends. Also within the self-assessment process, appropriate corrective actions are identified to improve the level of safety performance. Prioritization and implementation of these measures and actions are part of the operational safety performance program. The self-assessment program is implemented through a set of four following basic elements, illustrated in Figure 1: Operational data assessment: This element includes activities to record, analyze, and act upon information that can be used to detect incipient or developing failures and deviations from desired conditions (e.g. plant operating parameters, equipment performance data, surveillance test results, and maintenance records). Event assessment: This element covers the evaluation of safety-related events and the analysis of their consequences and causes to identify appropriate corrective actions in order to prevent the recurrence of these events. Safety basis assessment: This element involves the review and comparison of operating experience and proposed changes within the context of the analyses, regulations, guidelines, and practices to ensure that the plant design and operating parameters remain consistent with its defined safety basis. Assessment of the related safety experience: This element includes the review and evaluation of experience from similar plants, owners groups, international organizations, and other sources of information to develop broader insights about relevant safety issues.

8 18 I. A. Beckmerhagen PLANT EXTERNAL SOURCES Sources of Data Operational data assessment Events assessment Safety basis assessment Related experience assessment Self assessment elements Evaluation of all self assessment elements Self assessment process Prioritization Implementation Figure 1. General features of the operational safety performance The interested reader is referred to [14] for more details on these elements. In the past, the assessment of operational data and events was a typical approach used in the aviation, space and nuclear industries to learn as much as possible from operational experience and to avoid repetition of failures. For that purpose, the evaluation of all types of events not only the significant ones became increasingly important to make it possible to develop pro-active measures. It has been found [13] that much information can be gained from nearmisses, i.e. events that did not result in any adverse consequences, but that under a slightly different set of circumstances might have caused major problems. In the meantime, this approach of operational experience feedback can also be applied in the medical area by implementing, for example, a medical event reporting system in transfusion medicine [15]. It is important to recognize that in current practice in the nuclear industry events are evaluated using in-depth assessment tools such as deterministic (DSA) and probabilistic safety assessment (PSA) methods. Attempts to apply PSA methods in the medical field have also been undertaken [16] and the integration of risk assessment with medical device design control is discussed in [17] for heart valves and anaesthesia systems. Such data, as provided in [17], supplemented by information from users of the medical devices, could form a basis comparable with the operational data introduced as one element of self-assessment. Analyzing operational data is of increasing importance by applying PSA-based and safety indicator-based methods in order to

9 Self-Assessment for Improving Safety Performance in the Nuclear Industry 19 anticipate and avoid significant events. However, the use of safety indicators must be given careful consideration because they must be measurable, objective, transparent, and well-accepted by plant personnel. In contrast to information on operational data and events, external information (which is in practice mostly limited to events and equipment defects) will be provided in many forms with varying levels of detail and accuracy. Each plant needs to examine these potential sources of information, their applicability, degree of usability, and ultimately determine the most effective sources of information to review. However, exchange of information is essential for the identification and correction of safety problems that have not yet occurred in the operating experience of the plant under consideration. Operational data are recorded, reviewed and evaluated, in particular for improving plant availability. Events require special attention because they are important warning signs of possible breakdowns in the normal plant safety practices. Experience has shown that reviews of operational data and assessments of events are not the only source of improvements in safety performance. Therefore, in order to complement the other self-assessment elements, a process of reviewing the conditions that are contained in the safety basis must be developed. The safety basis element includes all of the information describing the plant safety and licensing envelope. Naturally, these conditions change over time. For example, new information, advances in technology, extension of analytical tools and methods, and insights from plant specific risk assessments expand the understanding of the conditions that are relevant to plant safety. Within the safety basis element, the following information must be considered: Long-term safety reviews. Research results. Aging management regarding the deterioration of safety relevant systems and components. Changes in standards, as well as the plant s operating limits and conditions. Special regulatory requirements. Analyses of design and accidents. Final safety analysis reports. The evaluation of the safety basis element allows the plant to verify that it is being operated in conformance with the available design intent and safety basis. This element may also support decisions, focus supervision, and establish priorities for the plant improvement programs, as well as help to identify and implement lessons learned from the results of research and development programs that are directly oriented to resolve generic safety issues. The evaluation of the safety significance of the data in each safety assessment element requires a consistent evaluation process of the data according to agreed criteria. However, the evaluation processes for each element may be done over different time frames. For example, in the case of the event assessment, a timely self-assessment will only gain maximum benefit from the knowledge of those personnel directly involved. Timely implementation of corrective actions may also be necessary to minimize the possible repetition of the events. On the other hand, in the case of the safety basis element, the implications of the results of research, for example, may take time to evaluate for a particular plant and may not need immediate implementation. The evaluation of individual self-assessments elements will ultimately lead to the determination of various corrective actions. The prioritization of these actions will involve consideration of all the corrective actions regarding their various time scales, as well as other factors, in order to arrive at an action plan. Conclusions and Discussion Performing audits to evaluate compliance with predefined audit criteria is a well-accepted tool in quality management in all types of industries and services. For example, audits are now part of clinical practice to allow a critical analysis of the quality of medical care [18]. In addition to

10 20 I. A. Beckmerhagen audits, industries like the nuclear industry have introduced another more comprehensive tool for reliability and safety management self-assessment in order to focus not only on suitability, adequacy and effectiveness, but also on efficiency. Self-assessment is an approach that facilitates continuous improvement by measuring an organization s performance with respect to the stated goals and acting upon the identified differences. The goals or criteria for self-assessment can be standards, authority regulations or targets set by the organization s management. Self-assessment is a valuable tool to evaluate safety performance in the nuclear industry in order to further enhance overall plant safety and reduce possible safety risks. Self-assessment can also be successfully applied in services and might be a useful tool in the pharmaceutical and healthcare area. A first discussion to use the self-assessment approach as explained in this paper may be started on the basis of the proposals described by Jackson [19] examining the similarities of the principles behind clinical governance and the EFQM Excellence Model [12]. The application of the EFQM Excellence Model requires a process of self-assessment (corresponding to levels 1 and 2 in Figure 2) and provides an objective measure of strengths and areas for improvement. There are four levels of assessment of safety performance (Figure 2): External audit (review), performed by a regulator or an independent organization, such as the IAEA and the World Association of Nuclear Operators (WANO). Internal audit (review), undertaken by independent teams of auditors working for the nuclear plant operator. Management self-assessment, encompassing the evaluation of safety performance of the whole plant. Individual and/or working group assessment involving safety assessments that are limited to the nuclear plant s organizational units and individuals. An important requirement for a self-assessment program is that it should be a fully integrated part of normal operation and safety assessment activities. A successful, safe and reliable operation (e.g. of a nuclear power plant) and maintenance are important tasks of the nuclear industry, reflecting the operators responsibility Independent external review (Regulator, IAEA, WANO ) level 4 Independent internal review (Operators) level 3 Self assessment Management (Plant) level 2 Assessment regarding working groups and individuals (Group, individual) level 1 Figure 2. Example of a four-tier safety assessment program

11 Self-Assessment for Improving Safety Performance in the Nuclear Industry 21 for nuclear safety. A key element to check, if this task is sufficiently fulfilled, is the application of a self-assessment program. Different approaches for self-assessment were described in this paper as they are applied in the nuclear industry. Self-assessment has not only led to technical improvements in nuclear plants, but also to changes in staff attitude recognizing the responsibility for their daily work. However, experience has shown that it is useful to supplement self-assessments with periodic examinations and independent (peer) reviews, for example by the national and/or international licensing and supervisory bodies or by international organizations such as IAEA [20] in the case of nuclear plants. These evaluations result in broader perspectives of mid-term and long-term performance and allow comparison of actual experience with established benchmarks and goals. They also provide an opportunity to examine generic safety issues, update analyses, and evaluate long-term trends that may not be apparent from routine assessments. References 1. Kulkarni R, Sudheer K, Worell J, Strenks GJ. Completing the audit loop: A New Objective and Standardized Method. Qual Assur J 2001; 5 (1): IAEA. Reviewing Operational Experience Feedback: Supplementary Guidance and Reference Material for IAEA Operational Safety Review Teams (OSARTs). IAEA-TECDOC- 596, International Atomic Energy Agency: Vienna, IAEA. Procedures for Self-Assessment of Operational Safety, IAEA-TECDOC-954. International Atomic Energy Agency: Vienna, Beckmerhagen IA, Berg HP, Karapetrovic SV, Willborn WO. Integration of management systems: focus on safety in the nuclear industry. Int J Quality Reliab Manag 2002; 19 (8): in press. 5. Wright T. IMS three into one will go!: the advantages of a single integrated quality, health and safety, and environmental management system. Qual Assur J 2000; 4 (3): ISO Quality Management Systems Fundamentals and Vocabulary. International Organization for Standardization: Geneva, Switzerland, OHSAS. OHSAS 18001: Occupational Health and Safety Management Systems Specification. British Standards Institution: London, UK, Zink KJ, Schmidt A. Practice and implementation of self-assessment. Int J Qual Sci 1998; 3 (3): Karapetrovic S, Willborn W. Self-audit of process performance. Int J Qual Reliab Manag 2002; 19 (1): Karapetrovic S, Willborn W. Audit and self-assessment in quality management: comparison and compatibility. Managerial Auditing J 2001; 16 (6): Cambridge. Cambridge International Dictionary of English. Cambridge University Press: Cambridge, MA, EFQM. Assessing for Excellence: A Practical Guide for Self- Assessment. European Foundation for Quality Management: Brussels, IAEA. Plant Review of Operational Safety Performance, Safety Report Series. International Atomic Energy Agency: Vienna, under preparation. 14. Berg HP, Hashmi JA. A self-assessment programme to enhance safety and reliability of nuclear installations. Proceedings ESREL 2000, Foresight and Precaution, vol. 1. A.A. Balkema: Rotterdam, 2000; Battles JB, Kaplan HS. A medical event reporting system in transfusion medicine: an error management approach. Proceedings of the 4th International Conference on Probabilistic Safety Assessment and Management (PSAM-4), September, New York City, Springer: Berlin, Heidelberg, New York, 1998; Dhillon BS. Medical Device Reliability and Associated Areas. CRC Press; Boca Raton, FL, Dhillon BS. Risk assessment in medical devices. Proceedings of the 6th International Conference on Probabilistic Safety Assessment and Management (PSAM-6), Puerto Rico 2002, Elsevier: Amsterdam, CD-ROM, Burnett AC, Winyard G. Clinical audit at the heart of clinical effectiveness. J Qual Clin Pract 1998; 18 (1): Jackson S. Exploring the suitability of the European foundation for quality management (EFQM) excellence model as a framework for delivering clinical governance in the UK national health service. Qual Assur J 2001; 5 (1): IAEA. PROSPER Guidelines, Guidelines for the Peer Review of the Effectiveness of the Operational Safety Performance Experience Review Process, IAEA-TECDOC. International Atomic Energy Agency, Draft 8, under preparation.