Techneau, 07. JUNE Generic Framework and Methods for Integrated Risk Management in Water Safety Plans

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Generic Framework

and Methods for

Integrated Risk

Management in Water

Safety Plans

Techneau, 07. JUNE 2007

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TECHNEAU is an Integrated Project Funded by the European Commission under the Sixth Framework Programme, Sustainable Development, Global Change and Ecosystems Thematic Priority Area

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TECHNEAU

Generic Framework and Methods for

Integrated Risk Management in Water

Safety Plans

Techneau, 07. JUNE 2007

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This report is:

PU = Public

Colofon

Title

Generic Framework and Methods for Integrated Risk Management in Water Safety Plans

Authors

L. Rosén1_{, P. Hokstad}2_{, A. Lindhe}1_{, S. Sklet}2_, J. Røstum2

1_{Chalmers University of Technology} 2_SINTEF

Quality Assurance

By KIWA and LNEC

Deliverable number

D 4.1.3 D 4.2.1 D 4.2.2 D 4.2.3

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Summary

In the 3rd_{edition of the Guidelines for Drinking-water Quality, the World} Health Organisation (WHO, 2004) emphasis the preparation of risk-based Water Safety Plans (WSPs) to manage risks to drinking water consumers. WHO, among others, emphasise that the entire supply system, from source to tap, should be considered when managing risks. The WSP framework

facilitates a much needed increase in awareness and understanding of risk issues for providing safe drinking water. However, an analysis of the WSP framework indicates that there are opportunities for further development, primarily regarding risks to water quantity and methods for risk

identification, risk estimation and risk evaluation.

The main objective of Work Area 4 (WA4) – Risk Assessment and Risk Management in TECHNEAU (TECHNEAU, 2005) is: to integrate risk

assessments of the separate parts in drinking water supplies into a comprehensive decision support framework for cost-efficient risk management in safe and sustainable drinking water supply. The framework should be regarded as a structure and toolbox for risk assessment and risk management in WSP. It should be

applicable to both groundwater and surface water supply systems, with basic as well as more complex designs. The framework should also be applicable on both the operational and strategic levels.

A generic framework which forms the basis for further development of risk management procedures and methods in TECHNEAU is presented in this report. The main components of the suggested framework are shown in Figure 1. To provide the necessary basis for integrated risk management for both basic and complex systems on the operational as well as strategic levels, the framework includes all major steps in the risk management process, as defined in established standards, e.g. IEC (1995).

To be efficient and functional, the framework must also include a set of reliable and well-established tools, adapted to specific decisions to be made and considering type of water supply system, level of complexity, and level of decisions, i.e. operational or strategic. Principal levels of sophistication of risk assessment tools are:

- Qualitative, e.g. based on checklists and classification of risk levels, providing relative ranking of lists and identification of critical points for risk reduction.

- Quantitative, e.g. based on models for combining and structuring events and chains of events, and estimations of quantitative risk levels. This level of sophistication facilitates quantitative comparison of estimated risk levels with established risk tolerability levels.

- Quantitative including decision analysis methods, facilitating strategic analysis of risk reduction measures, e.g. estimations of the risk

reduction – investment trade-offs in prioritisation of risk reduction options.

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Risk Analysis

Define Scope Identify and Estimate

Risks

Qualitative Quantitative

Risk Evaluation

Define tolerability criteria

Water quality Water quantity

Analyse risk reduction options Ranking Cost-efficiency Cost-benefit Risk Reduction/ Control Report risks Make decisions Treat risks Report residual risks

Monitor Get new information Update Develop supporting programmes training, hygiene practices, upgrade and improvement, research and development Document – assure quality Communi-cate Review, approve and audit

Figure 1. The main components of the TECHNEAU generic framework for integrated risk management in WSP.

The suggested framework cannot provide one single risk management method applicable to all types of water utilities for decisions at both strategic and operational levels. Instead, the framework when fully developed will provide:

- Principles for good risk management practice

- The relevant set of tools necessary for performing the risk assessment and management

- Description of these tools, e.g.:

o TECHNEAU Hazard database, THDB o Risk analysis methods description

o TECHNEAU Risk reduction options database, TRDB o Decision support tool

- Clear examples of risk assessment applications and testing of these tools.

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1 Introduction

In the 3rd_{edition of the Guidelines for Drinking-water Quality, the World} Health Organisation (WHO, 2004) concludes that analyses of water quality in treatment and distribution systems are not sufficient to guarantee safe

drinking water to consumers. Such analyses are often completed after the water was consumed and they may not provide correct information

regarding the health effects of the water. Instead, WHO (2004) recommends preparation of risk-based Water Safety Plans (WSPs) that consider conditions in source waters, treatment systems and distribution networks. WSP is currently being implemented in several countries and is expected to become an increasingly important framework for water management in both

developed and developing countries.

The WSP guidelines describe risk assessment on a principal level, based on the Hazard Analysis and Critical Control Point (HACCP) approach. HACCP was originally developed for the food industry (Havelaar, 1994). Because of its origin in HACCP, current WSP practice puts more focus on risk

assessments concerning quality and human health than on water quantity, including water security and water supply.

The WSP framework facilitates a much needed increase in awareness and understanding of risk issues for providing safe drinking water. The WSP framework, however, offers opportunities for further development regarding considerations of water quantity issues, as well as other stakeholder values. There are also opportunities to further develop WSP regarding more specific methods for risk identification, estimation and evaluation in order to provide cost-effective and sustainable prioritisation of safety measures. The main objective of Work Area 4 (WA4) – Risk Assessment and Risk Management in TECHNEAU (TECHNEAU, 2005) is: to integrate risk assessments of the separate parts in drinking water supplies into a comprehensive decision support framework for cost-efficient risk management in safe and sustainable drinking water supply, see Figure 2. Source water systems Treatment systems Distribution and plumbing networks

Integrated Risk Assessment and Risk Management

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The framework should be regarded as a structure and toolbox for risk assessment and risk management in WSP. It should be applicable to both groundwater and surface water supply systems, with basic as well as more complex designs. The framework should be developed in full concordance with the Bonn Charter strategy (IWA, 2004), which supports and further specifies the use of WSP in water safety assessment. The risk management framework should also be applicable on both the operational and strategic levels, see Figure 3. Here the strategic decisions could relate e.g. to

modifications or formulation of maintenance strategy.

Surface water

Ground water

Basic systems Complex systems Operational

Strategic

Figure 3. Schematic description of the applicability of the integrated framework for risk management in Water Safety Plans (WSPs).

In the initial step of the development, stakeholder values will be limited to water safety, or even only to compliance with regulated limit values. Further values, e.g. ecological and socio-cultural values, will be added in a second step in order to more fully consider sustainability issues.

To provide the necessary basis for integrated risk management for both basic and complex systems on the operational as well as strategic levels, the framework must include all major steps in the risk management process, as defined in established standards, e.g. IEC (1995), see Chapter 2. The current WSP guidelines are primarily directed at risk identification and qualitative risk assessment for ranking of risks, whereas quantitative risk estimation, risk evaluation, decision-making and risk communication are not described extensively.

To be efficient and functional, the framework must also include a set of reliable and well-established tools, adapted to specific decisions to be made and considering type of water supply system, level of complexity, and level of decisions, i.e. operational or strategic. The current WSP guidelines provide general descriptions of risk identification approaches and qualitative (or semi-quantitative) approaches to risk estimations, but do not give detailed

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guidance on specific methods nor quality criteria for risk management. Principal levels of sophistication of risk assessment tools are:

- Qualitative, e.g. based on checklists and classification of risk levels, providing relative ranking of lists and identification of critical points for risk reduction.

- Quantitative, e.g. based on models for combining and structuring events and chains of events, and estimations of quantitative risk levels. This level of sophistication facilitates quantitative comparison of estimated risk levels with established risk tolerability levels.

- Quantitative including decision analysis methods, facilitating strategic analysis of risk reduction measures, e.g. estimations of the risk

reduction – investment trade-offs in prioritisation of risk reduction options.

This document provides reviews and descriptions of WSP, other frameworks and specific methods for risk assessment and risk management in water supply. The overall aim of this report is to identify possibilities for further development regarding the structure and specific tools for more

comprehensive risk management in WSP. Specific objectives of this document are:

1. To describe a generic framework for integrated risk management in Water Safety Plans (WSPs).

2. To describe specific risk analysis methods suitable for use in integrated risk management of water supplies.

To meet these objectives this report includes the following main sections: - A description of the general risk management process.

- A review of existing frameworks and national guidelines for risk management in water supply.

- An outline of a proposed generic framework for integrated risk management in WSP.

- A review of specific risk analysis methods.

- Suggestions of possible risk analysis methods for integrated risk management.

Note that in this report the term water safety comprises both water quality and water quantity. The notation is further discussed in Section 2.6.

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2 The risk management process

2.1 Introduction

Although some differences can be found in the literature regarding presentation and outline of the risk management process, there is a rather strong consensus regarding the major contents of the process. The outline shown in Figure 4 is commonly used and is often referred to. According to IEC (1995) the objective of the overall process called risk management is to control, prevent or reduce loss of life, illness, injury, damage to property and consequential loss, and environmental impact. It should be emphasized that an efficient risk management not only protects us from hazards, it also creates opportunities. If a risk is unknown this might restrain us from performing a specific project. However, if the risk is analysed and understood, and it is possible to reduce or control the risk, then the project can be performed. The risk management process includes the entire process from the initial description of the scope and purpose of risk management, the identification of hazards, and the estimation of risks, through the evaluation of risk tolerability and identification of potential risk reduction options, to the selection and implementation of appropriate risk reduction measures. Risk management also includes risk monitoring and follow up during operation. So it should be emphasized that risk management is an iterative process of continuous updating as new information becomes available and as the preconditions change. Successful risk management also requires careful communication of risks between the various involved stakeholders.

Figure 4. The risk management process (IEC, 1995).

Risk analysis • Scope definition

• Hazard identification

• Risk estimation

Risk evaluation

• Risk tolerability decisions

• Analysis of options Risk reduction/control • Decision making • Implementation • Monitoring Risk assessment Risk management

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As stated in Vatn (2004), there is no universally agreed definition of risk. A definition of risk presented by Kaplan (1997) is valuable both when

communicating and assessing the risk situation. Kaplan states that the question “What is the risk?” is really three questions; “What can happen?”, “How likely is that to happen?”, and “What are the consequences?”. Risk may then be expressed as a (complete) set of triplets (Si, Li, Xi), where Si denotes

scenario i, Li denotes the likelihood, and Xi the consequences.

Similarly, according to IEC (1995), risk analysis attempts to answer three fundamental questions:

- What can go wrong? (identification of hazardous events) - How likely is this to happen?

- What are the consequences?

This view is in line with Kaplan’s definition of risk. A common description of risk is that it is a combination of the probability and the consequence of a hazardous event, see e.g. ISO (2002), European Commission (2000a) and IEC (1995).

2.2 Risk analysis

Risk analysis is a major part of risk management. As seen in Figure 4 the first tasks of a risk analysis are scope definition and identification of

hazards/hazardous events. The next step is the estimation of the level of risk resulting from possible hazardous events. This includes both causal

analyses/tools to identify the causes and frequencies of these undesired events, and analyses/techniques to investigate their consequences. In Figure 5 a more detailed description of the risk analysis process is presented. The purpose of risk analysis is to obtain information and knowledge about the risk. This information and knowledge are later used when evaluating the risk and in the end, if it is considered necessary, performing risk reduction measures. The risk analysis varies depending on the system that is being analysed and what kind of risk is considered. A risk analysis can be either qualitative or quantitative, depending on its purpose and the risk. The analysis may also be semi-quantitative, which is something between a quantitative and qualitative analysis. When performing a risk analysis it is important to choose which endpoints or consequences to include and also to decide which measures to use. Slovic (2001) emphasize that the choice of one measure or another can make a technology look either more or less risky.

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Figure 5. The risk analysis process (after IEC, 1995).

2.3 Risk evaluation

The purpose of the risk evaluations is to decide whether or not a risk is tolerable. If the risk is decided to be acceptable it may be enough to control the risk instead of reducing it. However, if the risk is decided to be

unacceptable different risk reduction options has to be analysed and compared so that the best risk reduction option can be identified.

Scope definition

• Describe concerns • Define system • Define circumstances • State assumptions • Identify analysis decisions

Documentation

• Risk analysis plan

Hazard identification and initial consequence evaluation • Identify hazards • Analyse consequences Start Stop Analysis update when appropriate Risk estimation • Analyse frequencies and/or probabilities • Analyse consequences • Calculate risk Risk estimation required? Documentation

• Risk analysis report

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Different categories of stakeholders are in different ways and to different extents involved in the risk management process. It is important to realize that stakeholders exposed to the specific risks may not always be those benefiting from the risk generating activities. For example, industries in a catchment area of a water supply will benefit from their production, but they will also contribute to water safety risks to consumers which have no benefit from the industrial activities. Grimvall (1998) described the principal types of stakeholders affected by decision-making involving risks, see Figure 6.

Those exposed to risks Those benefiting from risk generating activities Decision-makers

Figure 6. Main categories of stakeholders affected by decisions on risk (Grimvall, 1998). Due to the multi-dimensional character of decision-making regarding risk issues, it is of primary importance that the evaluation of risks and the decision-making are made with respect to criteria and principles that are agreed upon among the affected stakeholders. There are different principles described in the literature for evaluation of risks and it is important that the used principle is openly communicated and accepted by the involved stakeholders. The evaluation principles form the basis for defining risk tolerability. An example of a principle currently much referred to is the ALARP (As Low As Reasonably Practicable), seeFigure 7. According to this principle, risks that are clearly unacceptable must be reduced or eliminated under any circumstances. Risks that are clearly acceptable can be left without further actions. In between the acceptable and unacceptable risks there are risks that may be accepted if it is economically and/or technically

unreasonable to reduce them. A principle closely related to ALARP, and with the same meaning, is ALARA (As Low As Reasonably Achievable)

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Acceptable Risk ALARP Region

The risk can be accepted if it is economically and technically unreasonable to reduce it Unacceptable Risk

The risk cannot be accepted under any circumstances

Figure 7. The ALARP (As Low As Reasonably Practicable) Principle (Melchers, 2001). Risk tolerability criteria, based e.g. on the ALARP principle, can be showed in risk matrices, where estimated probability and consequences are graphically displayed in relation to the defined risk tolerability levels, see Figure 8.

Probability

Consequences

Figure 8. Risk matrix with ALARP zones.

Also other principles exist and Davidsson et al. (2002) present the following four general approaches that can be used when evaluating risk:

- Principle of reasonableness – If it is reasonable with respect to economical and technical means, the risk shall be reduced regardless the level of risk.

- Principle of proportionality – The overall risk resulting from an activity should not be unreasonably large compared to the benefits. - Principle of allocation – The allocation of risk in society should be

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- Principle of avoidance of disasters – Risks with disastrous consequences should be avoided so that the consequences can be managed with accessible resources.

The principle of reasonableness is closely related to the ALARP principle. Risk evaluation is further discussed in Section 7.2.

The risk tolerability levels must be defined taking peoples perception and aversion of risks into consideration. The public perception has for example been found to have an important affect on the priorities and legislative agendas of regulatory bodies (Slovic, 2001). Examples on factors affecting peoples risk aversion are:

- Catastrophic potential - Familiarity - Uncertainty - Individual or societal - Controllability - Voluntariness

Renn (1998) mention that technical analyses of risk have drawn much criticism from the social science. One reason to this is that the technical analyses not are considered to include people’s perception of risk and social constructions. Klinke and Renn (2002) present nine criteria to be used for evaluating risk. These criteria are meant to include more than just the extent of damage and probability of occurrence when evaluating risks. The nine criteria are: - Extent of damage - Probability of occurrence - Incertitude - Ubiquity - Persistency - Reversibility - Delay effect - Violation of equity - Potential of mobilization 2.4 Risk reduction/control

If the risk evaluation has the result that risk is not acceptable, it is required to carry out risk reduction, also called risk treatment. If the risk is decided to be acceptable it may be enough to control the risk instead of reducing it. When risk reducing measures are carried out the action plans for risk

prevention/mitigation should, according to the Australian-New Zeeland risk management standard (AS/NZS 4360:2004), include:

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2. the existing/required resources; 3. the involved responsibilities; 4. their duration; and

5. action tracking and controlling measures.

Suggestions for risk reducing measures should be an outcome of the risk assessment. When reducing the risk different approaches can be used. Based on the description of risk as a combination of the probability and the

consequence of a hazardous event, three different approaches can be identified. Two of the approaches are based on reducing one of the

parameters, i.e. the consequence or probability. The third approach is based on reducing both parameters at the same time.

One risk reduction measure is denotedrisk avoidance; i.e. an activity or process being a source of risk is not started or is discontinued. Sometimes we are looking for risk optimization; i.e. implementation of actions to minimize negative consequences/maximize the positive ones, possibly reducing the probability of the occurrence of undesirable events.

2.5 Risk communication

According to the Swedish Rescue Services Agency (SRA, 2003) the purpose of risk communication is to increase the public’s knowledge about risk related questions and make them participate in the risk management. Owen et al. (1999) point out that communication of risks related to drinking water between laypeople and experts are complicated due to the difference in knowledge. To be efficient the risk communication has to be a two-way process enabling both parts to contribute. When managing risks to drinking water systems it is important to communicate with all three stakeholders presented in Figure 6.

One important part of risk communication is how to present the risk. Slovic (2001) point out that different ways of presenting the same risk information can lead to different evaluations and decisions, even though they are logically equivalent. The fact that peoples perception of risk differs is one of the

reasons why risk communication is complicated.

2.6 Notation

Integration of risk management requires careful coordination with respect to harmonisation of terminology, commonality in approach, and measurement of risk in comparable units. Terms commonly used in risk management are defined differently by different actors. The following notation and definitions of terms are based on IEC (1995) and are applied in the TECHNEAU project:

- Risk is a combination of the frequency, or probability, of occurrence and the consequence of a specified hazardous event.

- Hazard is a source of potential harm or a situation with a potential of harm.

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- Hazardous agent is for example a biological, chemical, physical or radiological agent that has the potential to cause harm.

- Hazardous event is an event which can cause harm.

- Hazard identification is the process of recognizing that a hazard exists and defining its characteristics.

- Risk estimation is the process used to produce a measure of the level of risk being analysed. Risk estimation consists of the following steps; frequency analysis, consequence analysis, and their integration. - Risk analysis is the systematic use of available information to identify

hazards and to estimate the risk to individuals or populations, property or the environment.

- Risk evaluation is the process in which judgements are made on the tolerability of the risk on the basis of risk analysis and taking into account factors such as socio-economic and environmental aspects. - Risk assessment is the overall process of risk analysis and risk

evaluation.

- Risk management is the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating,

controlling risk.

Note that WHO defines hazard and risk in the following way (WHO, 2004): - A hazard is a biological, chemical, physical or radiological agent that

has the potential to cause harm.

- Risk is the likelihood of identified hazards causing harm in exposed populations in a specified frame, including the magnitude of that harm and/or the consequences.

The definition of hazard given by WHO is not used in TECHNEAU because it only considers health related hazards. The WHO definition of hazard is similar to how a hazardous agent is defined above. A hazard does not have to be an agent in the water, since other sources of harm exist. The definition of risk given above is similar to the WHO definition; both definitions include probability/likelihood and consequence. However, the WHO definition indicates that only health related risks are considered.

2.7 Generic guides for risk management

There are various standards and guidelines for risk management. Some examples are:

- AS/NZS standard 4360:2004. Risk management. ISBN 0733759041 - Standards Australia / Standards New Zealand.

- CEI/IEC (1995). 300-3-9 Dependability management - Part 3:

Application guide - Section 9: Risk analysis of technological systems. - ISO/IEC (1999). Guide 51 Safety aspects - Guidelines for their

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- ISO/IEC (2002). Guide 73 Risk management - Vocabulary - Guidelines for use in standards.

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3 Existing frameworks and national

guidelines

3.1 Review of existing frameworks for drinking water management There exist various strategies and frameworks relevant for water

management and some of these are described and discussed below. The frameworks and the more general risk management process have been compared and similarities as well as differences have been identified and are presented.

3.1.1 The Bonn Charter

The Bonn Charter for Safe Drinking Water (IWA, 2004) is a high level framework consisting of key principles that are basic requirements for managing water supplies from catchment to consumer. It also provides guidance to the institutional roles and responsibilities. The principles presented in the Bonn Charter are supposed to be applicable from source to tap and the goal is good safe drinking water that has the trust of consumers. According to the document, safe drinking water is fundamental to a healthy community and to its economic development. Drinking water should, according to the Bonn Charter, not just be safe to drink but also have an aesthetic good quality. It is emphasized that risks should be assessed at all points throughout the system and this requires a close co-operation between all stakeholders. The Bonn Charter is a complementary document to the Guidelines for Drinking-water Quality of the World Health Organisation (WHO, 2004) and the use of Water Safety Plans (WSPs) is emphasized. To shortly summarize the Bonn Charter it can be described as a document that clearly states the importance of drinking water to humans and advocates that the entire drinking water system is considered when managing risks.

3.1.2 Hazard Analysis and Critical Control Point

The Hazard Analysis and Critical Control Point (HACCP) system was originally conceived by the Pillsbury Company in 1960 to assure food safety when delivering food to the NASA space program, and it has later been used by the food industry to assure safe food production (Dewettinck et al., 2001). The HACCP principles are described by the Codex Alimentarius Commission (Codex, 2003) and Havelaar (1994) describes the application of HACCP to drinking water supply with main emphasis on microbial contamination. According to Havelaar (1994) HACCP had not formally been applied to the drinking water supply before 1994.

According to the Codex Alimentarius Commission (2003) HACCP is a science-based and systematic system that identifies specific hazards and measures for their control to ensure safety. Dewettinck et al. (2001) describes HACCP as a preventive system that helps to assure that all products reaching

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the consumer are safe for consumption. The system is supposed to be compatible with the ISO 9000 series and other quality management systems (Codex, 2003).

The key steps when applying the HACCP approach are presented in Figure 9. The first step is to assemble a team, when doing this it is important to make sure that all necessary knowledge and expertise are available within the team. In this step the scope of the application of HACCP should also be identified. Describing the product and identifying intended use are not as important when applying the HACCP approach to drinking water systems as if it is applied in the food industry. Nevertheless some attention should be paid to the drinking water consumption of the local population (Havelaar, 1994). The next steps are constructing a flow diagram and confirm it against the real system. All the five first steps can be described as preparatory to the following work with hazards.

For each step in the drinking water system the HACCP team should list all hazards that may be reasonably expected to occur. The hazard analysis aims at identify which hazards that yields such a risk that they need to be

eliminated or reduced to acceptable levels. The Codex Alimentarius

Commission (2003) defines a hazard as a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. For each hazard control measures must be identified and critical control points (CCPs) determined. In the food industry a CCP is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. More than one control measure may be required to control a specific hazard and more than one hazard may be controlled by a specified control measure. If no control measure can be identified for a hazard, the system has to be modified in a way that makes a control measure arise.

For each CCP critical limits must be established, which are supposed to indicate when something is wrong. A monitoring system including scheduled measurements or observations should be established for each CCP and is supposed to detect loss of control in time to make adjustments. Corrective actions must be specified and documented to make sure the CCP can be brought under control. To make sure the entire HACCP system is working correctly, verification procedures need to be established. Also the

documentation and record keeping is important to a successful application of HACCP.

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Figure 9. Steps in the HACCP approach (Codex, 2003).

An extract from a generalized HACCP analysis of drinking water production is shown in Table 1.

Table 1. Extract from a generalized HACCP analysis of drinking water production (Havelaar, 1994).

Process step Hazards Preventive _measures CCP? CCP _parameters Monitoring _procedures Corrective _actions

Groundwater abstraction Storage of surface water in reserviors Transport of pathogens to well-head Short circuiting Define protection zone and restrict land-use Build reservoirs in series Yes No Travelling time - Tracer injection studies Specific pathogens Tracer studies Conservative parameters Fecal index bacteria Remove sources of pollution Increase treatment

Even though the HACCP system most commonly is applied by the food industry it may also be applied for water safety. One important question to

Assemble HACCP team

Describe product

Identify intended use

Construct flow diagram

On-site confirmation of flow diagram

List all potential hazards, conduct a hazard analysis and consider control measures

Determine CCPs

Establish a monitoring system for each CCP

Establish corrective actions

Establish verification procedures

Establish documentation and record keeping Establish critical limits for each CCP

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ask is what range of application the HACCP system has in the drinking water system? According to the Australian Drinking Water Guidelines

(NHMRC/NRMMC, 2004) HACCP is aligned quite readily on the treatment component of drinking water supply and may not as easily be applied to the important areas of catchment and distribution system. Havelaar (1994) points out that several steps in the system are important to assure the quality of the final water, but cannot be considered as CCPs under the responsibility of the water producer because of a lack of a direct control.

3.1.3 Water Safety Plans

In 2004 the WHO presented the 3rd_{edition of the Guidelines for} Drinking-water Quality (WHO, 2004). The guidelines aim to protect public health and are intended to support the development of risk management strategies. Safe drinking water is defined as such that does not represent any significant risk to health over a lifetime of consumption, including different sensitivities that may occur between life stages. The access to safe dinking water is emphasized as essential to health and a basic human right.

To ensure safe drinking water a holistic risk assessment and risk management approach is emphasized as well as the importance of considering the entire drinking water system, from catchment to consumer. The WHO presents a so called framework for safe drinking water, consisting of the following five key components:

1. Health-based targets based on an evaluation of health concerns;

2. System assessment to determine whether the drinking water supply

(from source through treatment to the point of consumption) as a whole can deliver water that meets the health-based targets;

3. Operational monitoring of the control measures in the drinking water

supply that are of particular importance in securing drinking water safety;

4. Management plans documenting the system assessment and

monitoring plans and describing actions to be taken in normal operation and incident conditions, including upgrade and improvement, documentation and communication; and

5. A system of independent surveillance that verifies that the above are

operating properly.

A key goal of the framework is to make sure that safety of drinking water is not based solely on end product testing. The health-based targets constitute the basis for the rest of the work and they should be established by a high-level authority in collaboration with water suppliers and affected

communities. When the health-based targets are being established a valuation must be done of what is a tolerable risk. In the guidelines four different principal types of health-based targets are presented: health outcome targets, water quality targets, performance targets, and specified technology targets. All four types aim to protect and improve public health. According to the guidelines

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the health-based targets must take account of the importance of ensuring access to water.

The system assessment, operationalmonitoring and management plans constitute what is called Water Safety Plans (WSPs). A WSP is guided by the health-based targets and overseen through surveillance. The relationship is described in Figure 10. Surveillance is supposed to complement the quality control function of the drinking water supplier and should be conducted by an independent agency and include all aspects of safety.

Figure 10. Framework for safe drinking water (WHO, 2005).

The WSPs are described as means of ensuring the safety of a drinking water supply through the use of a comprehensive risk assessment and risk

management approach that encompasses all steps in the water supply from catchment to consumer (WHO, 2004). Principles and concepts from in

particular the multi-barrier approach and the HACCP system have been used when developing the WSP approach.

The system assessment is meant to determine if the system is capable of delivering drinking water that meets the health-based targets. If the assessment finds that the system theoretically is capable of meeting the health-based targets, monitoring is the next step in ensuring that it actually meets the targets. If the system is not able to meet the health-based targets it has to be modified in some way to meet the targets. When the assessment is carried through it is important that all parts of the drinking water system are considered concurrently and that interactions and influences between each part and their overall effect are taken into consideration (WHO, 2004). The operational monitoring aims to assess control measures in order to ensure that the drinking water system is operating properly. A control measure is an action that serves to reduce or eliminate contamination and is identified during the system assessment. The applied control measures in a system should together ensure that the drinking water meets the health-based targets.

Framework for Safe Drinking-Water

Water Safety Plans Independent Surveillance Health Based Targets Operational Monitoring System Assessment Management plans, Documentation and communication

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The purpose of the management plans are to document and communicate all information regarding the management of drinking water quality. A

management plan includes for example information regarding the system assessment and operational monitoring, and it also describes actions in both normal operation and during situations where control of the system is lost. The key steps in developing a WSP are described in Figure 11.

Figure 11. Key steps in developing a Water Safety Plan (WHO, 2004). The definition of a hazard used by WHO, a biological, chemical, physical or radiological agent that has the potential to cause harm, is very similar to the one given in the description of HACCP. Since the principles of HACCP have been used when developing the WSP approach, this is quite natural. To prioritize and distinguish between important and less important hazards or hazardous events WHO propose the use of a risk matrix. In Figure 12 an example of a risk matrix from WHO (2005) is illustrated. Note that this matrix indicates

Assemble the team to prepare the

water safety plan

Document and describe the system

Undertake a hazard assessment and risk characterization to identify and understand how

hazards can enter into the water supply

Assess the existing proposed system (including a description of the system and a flow diagram)

Identify control measures – the means by which risks may be controlled

Define monitoring of control measures – what limits define acceptable performance and

how these are monitored

Establish procedure to verify that the water safety plan is working effectively and will meet

the health-based targets

Develop supporting programmes

(e.g., training, hygiene practices, standard operating procedures, upgrade and improvement, research

and development, etc.)

Prepare management procedures

(including corrective actions) for normal and incident conditions

Establish documentation and

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that comparatively high risk levels may be tolerable, e.g. that cases of morbidity in the exposed population due to water consumption may be tolerable every year.

Severity of consequences

Likelihood Insignificant Minor Moderate Major Catastrophic

Almost certain H H E E E

Likely M H H E E

Moderate L M H E E

Unlikely L L M H E

Rare L L M H H

Note: The number of categories should reflect the need of the study.

E – Extreme risk, immediate action required; H – High risk, management attention needed; M – Moderate risk, management responsibility must be specified; L – Low risk, management by routine procedures.

Examples of definitions of likelihood and severity categories that can be used in risk scoring

Item Definition

Likelihood categories

Almost certain Once a day

Likely Once per week

Moderate Once per month

Unlikely Once per year

Rare Once every 5 years

Severity categories

Catastrophic Mortality expected from consuming water Major Morbidity expected from consuming water Moderate Major aesthetic impact possibly resulting in use of

alternative but unsafe water sources

Minor Minor aesthetic impact causing dissatisfaction but not _{likely to lead to use of alternative less safe sources} Insignificant No detectable impact

Figure 12. Example of a risk matrix and definitions of likelihood and severity categories to be used in risk scoring in WSP (WHO, 2005; AS/NZS, 1999). Classes of relative risk tolerability are shown in grey shades.

3.1.4 The Water Framework Directive

The Water Framework Directive (2000/60/EC) is based on natural river basin districts and the purpose is to protect freshwater resources in order to reach a sustainable water use (European Commission, 2000b). Within each river basin all impact on the water environment shall be controlled with the aim to reach good water status for all European waters by 2015. The directive can be

described as a European strategy on how to manage freshwater resources, the first part of the drinking water system.

3.1.5 Integrated Water Resources Management

Integrated Water Resources Management (IWRM) has according to Agarwal et al. (2000) not been clearly defined but can be described as a process which assists countries in their effort to deal with water issues in a cost-effective and sustainable manner. Al Radif (1999) points out sustainability of water

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resources, water policy and integrated management, and management of the resource as key elements in IWRM. The catchment approach characterises IWRM (Nakamura, 2003) and hence the part of a drinking water system considered in IWRM is the source water.

3.1.5.1 Agenda 21

Agenda 21 were adopted at the United Nations Conference on Environment and Development held in Rio de Janerio, Brazil, 1992. Agenda 21 is a

comprehensive programme dealing with sustainable development and the protection of quality and supply of freshwater resources is just one part of what Agenda 21 considers. A holistic management of water resources is emphasized in order to ensure long-term development (United Nations, 1992). It is also pointed out that water resources development and management should be planned in an integrated manner based on the principle of sustainability and it should prevent and mitigate hazards.

3.2 Examples on national guidelines

3.2.1 EU - The Directive on the Quality of Water (“Drinking water directive”)

The objective of the Council Directive (98/83/EC) on the quality of water intended for human consumption is to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean (European Commission, 1998). Because drinking water is very important for human health, essential quality standards which drinking water must comply with have been compiled. The parametric values, which are based on scientific knowledge and the

precautionary principle, should ensure that drinking water can be consumed safely on a life-long basis, and thus represent a high level of health protection. It is also emphasized that appropriate water-protection measures should be applied to ensure that surface and groundwater is kept clean. The work should safeguard and promote a sustainable use of drinking water.

There is an ongoing project (“Support for the Development of a Framework for the Implementation of Water Safety Plans in the European Region”) funded by the European Commission (EC) related to the planned revision of the Drinking Water Directive (98/83/EC). As a part of this project the status of implementation of WSPs in water services of the EU Member States and other European countries is revealed and the project also gives guidance to the EC on revison of the directive.

3.2.2 Switzerland

The safety of drinking water supply is controlled through food legislation in Switzerland. To develop HACCP in all food industry (including drinking water supply) is obligatory in Switzerland. WSP legal based implementation (based on HACCP principles) started in 1995.

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Main legal acts relevant to drinking water are:

- Federal Act on Water Protection (source protection zones) - Federal Act on Foodstuff

- Ordinance on Drinking Water and Natural Mineral Water - Ordinance on Hygiene

- Cantonal ordinances

Swiss Water and Gas Association (SVGW) produced guidelines for simple quality assurance system for water supplies (the first edition in 1997, the second in 2003).

3.2.3 Germany

The content of this section is taken from Sturm et al. (2006). In Germany, numerous laws and ordinances form the legal basis of the public drinking water supply. They include for instance the Drinking Water Ordinance (Trinkwasser-verordnung), the Infection Protection Act

(Infektionsschutzgesetz) and the Water Management Act

(Wasserhaushaltsgesetz). The Drinking Water Ordinance refers to the

generally acknowledged rules of technology (state-of-the-art technology) and thus to the DVGW (2006) (Technical and Scientific Association for Gas and Water) System of Technical Standards and corresponding European and German standards. It has to be pointed out that in Germany special attention is paid to resource protection. Apart from the relevant DVGW Technical Standards, the state measures and legal regulations regarding water pollution control and groundwater protection have to be mentioned. They altogether serve the protection of the raw water sources.

German water supply has a long-standing tradition in technical self-regulation concerning the field of technical or hygienic safety and quality management based on the principle of precaution. The objectives are often described as multi-barrier approach that combines resource protection with a high standard in technical and hygienic safety in water abstraction, treatment, storage and distribution, see Figure 13.

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Figure 13. Multi-barrier approach in German water supply (Sturm, 2006). The DVGW, as the technical scientific association in the field of water, has already for decades been compiling practical and scientifically based

Technical Standards for all areas of water supply, which are recommended to the water suppliers for implementation. The DVGW System of Technical Standards describes the state-of-the-art technology concerning safety and reliability in water supply. The draft standards (codes of practice, Technical Guidelines and Recommendations) are established by working groups of scientists and experts from industry and public authorities. Draft Standards are published for public comment, and all comments are reviewed before final publication. Published Standards are reviewed regularly for continuing relevance, guaranteeing the integration of latest insights, experience and technical-scientific progress.

The system of Technical Standards published by DVGW includes more than 300 Codes of Practice, Technical Guidelines, and Recommendations. Several of them are incorporated in the German standards set up by the German Institute for Standardization. Besides these standards there are Technical Guidelines and rules published by other national water supply associations like the Association for Drinking Water from Reservoirs (ATT) or the German association for Water, Wastewater and Waste (DWA). However, they are not designed to regulate every aspect in detail, like a treatment step or a

monitoring system, but to provide recommendations and to outline

principles. On this basis the technical and hygienic safety in the entire supply chain can be assured.

The system of Technical Standards is complemented by the so called Technical Safety Management (TSM). TSM is a voluntary management measure to guarantee the correct implementation of the Technical Standards (see Figure 14). The main target of the Technical Safety Management is to support supply companies in legal certainty of its operational processes. To

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guarantee a safe and hygienic water supply the requirements must be fulfilled to the organisational and staff qualifications in the company. The application of the Technical Safety Management in the water supply company is controlled by external consultants. The TSM inspection certificate

documents the success of this process and the fulfilment of requirements of technical safety.

Figure 14. Technical Safety Management and the system of Technical Standards (Sturm et al., 2006)

3.2.4 UK – Yorkshire water

The United Kingdom has in many environmental and health issues stressed the importance of economic valuation as part of the basis for prioritisation of efforts; see e.g. the UK Treasury Green Book (2003). The Yorkshire Water utility, owned by the Kelda Group, is well-recognized in the UK and internationally for performing efficient risk management where explicit economic risk valuation is an integral part. Yorkshire Water has managed to increase water safety and simultaneously decreasing the water tariffs for consumers, by implementing a well-structured risk management framework based on cost-benefit analysis. Decisions regarding water safety issues are made with respect to the costs for implementing actions to reduce risks compared to the changes in risk level, the number of people affected by the risk, and their willingness to pay for reducing or avoiding the risk (Smith, 2005). The approach is similar in scope to the approach suggested by TECHNEAU in WP 4.4 (see TECHNEAU, 2005).

3.2.5 Denmark

The Danish Water and Waste Water Association (DWWA) has developed guidelines for water safety based on the WSP and HACCP principles

(DANVA, 2006). The approach includes the complete drinking water system from source to tap, including private installations.

The guidelines focus on doing things as simple as possible making it practical also for smaller water companies to carry out the analysis. Lately the number of water utilities (municipalities) in Denmark has been reduced from 271 to 98. A threshold for minimum size of the municipality is about 20 000 inhabitants.

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3.2.6 Sweden

The Swedish Water and Wastewater Association (SWWA) have in

collaboration with the National Food Administration prepared a guidance document on how to apply the HACCP principles to drinking water

production and distribution (SWWA, 2005). The purpose of the document is to help the water suppliers to include and make the HACCP approach a part of today’s surveillance work. Even though many water suppliers have not started to apply the HACCP approach yet, it is becoming more frequently used in Sweden.

3.2.7 Norway

In 2003 a national investigation pointed out that the water industry in Norway were lacking guidelines on how to carry out Risk and Vulnerability Analysis (RVA). In 2006 new guidelines were published (Mattilsynet, 2006) that focus on identifying events, to rank the undesired events with respect to risk and to assess need for risk reducing measures. The chosen approach was not based directly on WSP/HACCP principles e.g. identifying critical control points are not included. In Norwegian legislation, systems for internal control (IKmat) are required and these systems include the documentation which is a part of the HACCP approach. The internal control systems are sometimes nationally referred to as HACCP light.

3.2.8 The Netherlands

In the Netherlands, EU regulations for drinking water quality are endorsed, thus forming the basis of the health based targets. Since the new Drinking Water Decree was issued in the Netherlands in 2001, water companies using surface water or groundwater at risk of contamination with pathogens are required to quantitatively assess whether the infection risk of the finished water meets the standard. To guarantee that infrastructure and operation (automated and manual) comply with design criteria, pilot audits are conducted to assess whether systems are implemented to manage these processes. These audits of the quality system are conducted similar to HACCP audits, although the audit is not just focusing on the critical risk control points. Water companies evaluate all risk management systems, as they are striving to maintain a quality level that, at acceptable costs, should even prevent once in a life time contamination events. A special tool has been developed to guarantee a systematic evaluation and documentation of

existing hazards and the risk management systems (control measures). The tool called MaRiskA combines features of HACCP with features of FMEA (Failure Mode and Effect Analysis).

Dutch water companies apply an analysis for the vulnerability of supply (referred to as ‘Leveringsplan’). All elements of the supply chain are checked in order to ensure that if they fail, water is still supplied in sufficient

quantities. Dutch water companies are executing an analysis to check whether distribution mains could cause risks to external objects (dykes, roads,

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2004. In addition to this all water companies perform actions against terrorism.

3.2.9 USA

The main federal law directed at protecting the drinking water quality in United States is the Safe Drinking Water Act (SDWA, 1996). The United States Environmental Protection Agency (US EPA) is authorized by the SDWA to set health-based standards for drinking water quality and to oversee the

implementation by states, localities, and water suppliers. The SDWA is based on a multiple barrier approach including source water protection, treatment, distribution system integrity, and public information. This means that the entire supply system, from source to tap, is considered.

To protect areas serving as public sources of drinking water the states are required to develop Source Water Assessment Programs (SWAP). A SWAP intend to (US EPA, 1997):

- identify the areas that supply public tap water;

- inventory of contaminants and assess water system susceptibility to contamination; and

- inform the public of the results.

The aim is to use the assessment results when implementing Source Water Protection Programs.

Since the September 11, 2001, attacks on World Trade Center in New York, a deliberate contamination intrusion to a water distribution system is now considered one of the most serious threats to public health in the United States (Ostfeld and Salomons, 2005). As a consequence of this the security of United States drinking water and wastewater infrastructures has become a top priority. The Bioterrorism Act (2002) requires that drinking water utilities serving more then 3,300 persons conduct a vulnerability assessment. The assessments should help the water utilities to identify and evaluate potential threats and identify risk reduction options. An emergency response plan describing the actions that a drinking water utility would take in response to a major event also has to be complied.

The description above is based on the federal legislation, the implementation by different states may differ and individual states may have additional, more stringent, rules.

3.2.10 The Canadian Multi-Barrier Approach

To use multiple barriers when managing risks is a common approach and often included in other approaches. However, the Canadian Council of Ministers of the Environment (CCME, 2004) has described how the multi-barrier approach can be applied to drinking water supplies, see Figure 15. The multi barrier-approach is described as an integrated system of procedures, processes and tools that collectively prevent or reduce the contamination of

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drinking water from source to tap, in order to reduce risks to public health. The approach is based on the implementation of multiple barriers throughout the drinking water system, from source to tap. The barriers are supposed to block or control microbiological pathogens and chemical contaminations that may enter the supply system. Since multiple barriers are used the failure of one or more barriers can be compensated by the remaining barriers. The barriers can be physical like a filter or they can be processes or tools linked to the overall management, e.g. training and education.

Clean, safe, reliable drinking water Source water protection Drinking water treatment Drinking water distribution system M a na ge me n t Moni to ri ng Legislative and policy frameworks Guidelines, standards and objectives Public involvment and awareness

Research, sience and technology Clean, safe, reliable drinking water Source water protection Drinking water treatment Drinking water distribution system M a na ge me n t Moni to ri ng Legislative and policy frameworks Guidelines, standards and objectives Public involvment and awareness

Research, sience and technology

Figure 15. The Multi-Barrier Approach (CCME, 2004).

3.2.11 Australian framework

In the Australian Drinking Water Guidelines (ADWG) it is stated that safe drinking water is essential for life and it is therefore of great importance that the safety is assured (NHMRC/NRMMC, 2004). It is also emphasized that a preventive management approach that consider all steps in water production, from catchment to consumer, is the best way to manage the risks to drinking water systems. According to the ADWG drinking water should be safe to drink for people in most stages of normal life, including children over six months of age and the very old. The water is safe to drink when it does not contain any harmful concentrations of chemicals or pathogenic micro-organisms. It is also stated that ideally the drinking water should be aesthetically pleasing in regard to appearance, taste and odour.

In the ADWG a framework for management of drinking water qualityis presented. The framework is according to Rizak et al. (2003) supposed to provide a comprehensive and preventive strategy from catchment to

consumer. Some parts of the framework are based on the HACCP system as well as the two management systems ISO 9001 (Quality Management) and AS/NZS 4360 (Risk Management). Figure 16 is adapted from the risk

management standard and is a flowchart illustrating the relation between the activities of the risk assessment process. The flowchart in Figure 16 and the illustration of the risk management process in Figure 4 are very similar.

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Figure 16. Relation between activities of the risk assessment process (AS/NZS 4360:2004). The framework for management of drinking water quality presented in the ADWG consists of four key areas: commitment to drinking water quality management, system analysis and management, supporting requirements, and review. The four areas and the connection between them are described in Figure 17. No Start Hazard Identification and Context definition Is risk acceptable ? Risk Estimation Risk Treatment Risk Evaluation End Yes Risk Criteria Communicate an d consult Monitor and review

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Figure 17. The ADWG framework for management of drinking water quality (NHMRC/NRMMC, 2004).

It is important that senior executives as well as the entire organisation show commitment to drinking water quality management. Organisational support and long-term commitment is described as a basic requirement to reach an effective management system. When analysing and managing the water supply system, hazards as well as preventive measures should be identified. When doing this it is important that the entire system is understood. The assessment of the drinking water supply system is divided into water supply system analysis, assessment of water quality data and hazard identification and risk

assessment. To distinguish between high and low risks the use of a risk matrix is proposed in the ADWG. The proposed risk matrix is similar to the one proposed by WHO (2004), see Figure 12. The importance of using a multi-barrier approach is emphasizes in the ADWG as a part of the preventive measures for drinking water quality management. The protection of source water is considered as the most effective barrier since it is the first part of the system. Another part of the preventive measures is the application of critical control points, based on the HACCP approach.

To make sure the management system is working properly a review

including evaluation and audit processes are suggested. The review should make it easier to continually improve the work. The communication and involvement of the consumers is also pointed out as an important aspect of the management work. The expectations of the community and the

willingness to pay should be used as a basis when making decisions. According to Sinclair and Rizak (2004) compliance monitoring is often used by regulatory structures as a mean to manage drinking water quality.

Compliance monitoring, however, has major limitations and are by it self not an efficient manner to manage drinking water quality. An example is that Escherichia Coli or thermotolerant coliforms that are used as indicator

organisms when assessing microbiological water quality do not give a good measure of the risks from viruses and protozoa (Sinclair and Rizak, 2004). Even though the compliance monitoring has some limitation it is of great

Commitment to Drinking Water Quality Management

System Analysis and Management

Assessment of the drinking water supply system

Preventive measures for drinking water quality management

Operational procedures and process control

Verification of drinking water quality Management of incidents and management

Supporting Requirements

Employee awareness and training Community involvement and awareness Research and development

Documentation and reporting

Review

Evaluation and audit Review and continual improvement

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importance when managing water quality. When applying the framework presented in the ADWG the compliance monitoring is supposed to be viewed in a proper perspective (Sinclair and Rizak, 2004).

3.2.12 New Zealand Public Health Risk Management Plan

In New Zealand compliance criteria for water leaving the treatment plant and the distributions system are presented in the Drinking Water Standards for New Zealand (DWSNZ) by the Ministry of Health (2005a). The DWSNZ can be used to verify the quality of the water delivered to the consumers but is not enough to protect the public health against risks from contaminated drinking water. To be able to do this the use of a Public Health Risk

Management Plan (PHRMP) is emphasized. The PHRMP is described by the Ministry of Health (2005a) as a management tool for suppliers that will aid them to identify, manage and minimise events that could cause water quality to deteriorate. The DWSNZ as well as the PHRMP focus on health related risks and microbial contaminants are considered the most severe.

How to prepare and develop a PHRMP is described by the Ministry of Health (2005b) and a lot of guidance material is available on the Ministry of Health webpage (www.moh.govt.nz). In Figure 18 the main steps when developing a PHRMP are presented and in Figure 19 the main steps when using the

PHRMP are presented. The so called guides mentioned in Figure 18 are documents, specific for different supply elements, describing causes of an event, preventive measures, how to check preventive measures, and corrective actions.

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Figure 18. Main steps when developing a PHRMP (Ministry of Health, 2005b). In Figure 18 the steps that have to be performed and the result that should be added to the PHRMP is illustrated. The work can simplified be described as a process that starts with getting to know the system and identifying barriers as well as hazards, preventive measures and corrective actions. This information is later used to identify necessary improvements and in which order they should be accomplished. The process illustrated in Figure 19 describes how the PHRMP should be used when it has been developed. It is a continuous work that aims to increase the safety.

Produce an overview of your supply and decide which Public Health Risk Management Plan Guides are needed.

Step Add to your PHRMP

Identify the barriers to contamination your supply has.

Use the Guides to identify events that may introduce hazards into the water.

Use the Guides to identify: • possible causes of each event

• preventive measures to avoid each event • corrective actions to use if preventive measures fail.

Decide where improvements in your supply should be made.

Decide on the order in which improvement will be made.

Draw up a timetable for making the improvements.

Note links to other quality assurance systems.

Use the Guides to prepare Contingency Plans.

Use the Guide to prepare instructions for checking that your Plan is working properly

- Performance Assessment

Decide on communication policy and needs.

Flow diagram of your supply

Checklist of barriers present

Risk information Table for your supply

Improvement Schedule listing: • improvements needed • their levels of importance • a time table for their introduction • responsibility

Note of other quality assurance systems and their links with the Plan.

Set of Contingency Plans for each supply element.

Set of instructions for review of the performance of the Plan.

Techneau, 07. JUNE Generic Framework and Methods for Integrated Risk Management in Water Safety Plans

Generic Framework

and Methods for

Integrated Risk

Management in Water

Safety Plans

TECHNEAU

Generic Framework and Methods for

Integrated Risk Management in Water

Safety Plans

Colofon

Summary

Contents

1

Introduction

2

The risk management process

3

Existing frameworks and national

guidelines