Whither Regulation Risk and Water Safety Plans Cas

STOTEN-142868; No of Pages 16
Science of the Total Environment xxx (xxxx) xxx
Contents lists available at ScienceDirect
Science of the Total Environment
journal homepage: www.elsevier.com/locate/scitotenv
Whither regulation, risk and water safety plans? Case studies from
Malaysia and from England and Wales
Hafizah Hasan a,b, Alison Parker a, Simon J.T. Pollard a,⁎
a
Cranfield University, Cranfield Water Science Institute, School of Water, Energy and Environment, College Road, Cranfield, Bedfordshire, MK43 0AL, United Kingdom
b
Ministry of Health Malaysia, Engineering Services Division, Federal Government Administrative Centre, 62590 Putrajaya, Malaysia
H I G H L I G H T S G R A P H I C A L A B S T R A C T
• We explore regulatory transitions for The regulatory ladder of interventions, risk management strategies and issues for transition between
implementing water safety plans. compliance-led and risk-based regulation (adapted from Leinster, 2001).
• Case study research revealed inherent
tensions and success factors.
• Findings are contextualised by reference
to a ‘regulatory ladder’ of interventions.
• Regulatory failure can occur if naïve
compliance policies are applied to
WSPs.
a r t i c l e i n f o a b s t r a c t
Article history: We explore the interplay between preventative risk management and regulatory style for the implementation of
Received 26 August 2020 water safety plans in Malaysia and in England and Wales, two jurisdictions with distinct philosophies of ap-
Received in revised form 30 September 2020 proach. Semi-structured interviews were conducted with 32 water safety professionals in Malaysia, 23 in En-
Accepted 3 October 2020
gland and Wales, supported by 6 Focus Group Discussions (n = 53 participants). A grounded theory approach
Available online xxxx
produced insights on the transition from drinking water quality surveillance to preventative risk management.
Editor: Damia Barcelo Themes familiar to this type of regulatory transition emerged, including concerns about compliance policy; over-
seeing the risk management controls of regulatees with varied competencies and funds available to drive change;
Keywords: and the portfolio of interventions suited to a more facilitative regulatory style. Because the potential harm from
Drinking water safety waterborne illness is high where pathogen exposures occur, the transition to risk-informed regulation demands
Regulation mature organisational cultures among water utilities and regulators, and a laser-like focus on ensuring risk man-
Risk agement controls are delivered within water supply systems.
Malaysia © 2020 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license (http://
England
creativecommons.org/licenses/by/4.0/).
Wales
Case studies
1. Introduction
⁎ Corresponding author. The United Nations (UN, 2018) reports a rapid rise in the number of
E-mail address: s.pollard@cranfield.ac.uk (S.J.T. Pollard). people living in urban areas, from 751 million globally in 1950 to 4.2
https://doi.org/10.1016/j.scitotenv.2020.142868
0048-9697/© 2020 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Please cite this article as: H. Hasan, A. Parker and S.J.T. Pollard, Whither regulation, risk and water safety plans? Case studies from Malaysia and
from England and Wal..., Science of the Total Environment, https://doi.org/10.1016/j.scitotenv.2020.142868
H. Hasan, A. Parker and S.J.T. Pollard Science of the Total Environment xxx (xxxx) xxx
billion in 2018. By 2050, 68% of the world's population is expected to (Jalba et al., 2010; Summerill et al., 2010a; Summerill et al., 2010b;
live in urban settings. While cities have developed, urban services Summerill et al., 2011; Summerill et al., 2012; Jalba et al., 2014; Omar
have not always kept pace, especially with respect to the supply of et al., 2017). Our studies support others' findings and address issues be-
safe drinking water (Bakker, 2010). One estimate suggests 2.1 billion yond WSP design, focussing on conditions that support effective imple-
people lack safely managed drinking water, including 600 million mentation such as capacity building and training (Gottwalt et al., 2018;
urban inhabitants (WHO and UNICEF, 2017). The UN Sustainable Devel- Ferrero et al., 2019); promotion and adoption of WSPs (Baum and
opment Goals (SDGs) seek to deliver clean water and sanitation (SDG Bartram, 2018; Gunnarsdottir et al., 2020; Jaravani et al., 2019); costs
6) and are aligned to the water safety plan (WSP) framework intro- analysis (Chang et al., 2013); human dimension of WSPs (Kot et al.,
duced in 2004, codified through the systematic assessment and preven- 2014; Parker and Summerill, 2013; Ferrero et al., 2018); inequality
tative management of risks at points of critical control (CCPs) between (Yang et al., 2013); the effectiveness of WSPs (Mudaliar, 2013; Gelting
catchments and the consumer (WHO, 2004; IWA, 2004; UN, 2015). et al., 2012; Kumpel et al., 2018; Tsoukalas and Tsitsifli, 2018; Schmidt
Worldwide, we are witnessing a significant shift from drinking et al., 2019); organisational design and institutional frameworks
water quality surveillance as a vital sentinel for drinking water quality, (Rahman et al., 2011; Kayaga et al., 2018).
to the additional inclusion of proactive, preventative risk management Here, we examine the interplay between preventative risk manage-
through the adoption of WSPs (WHO, 1976, 2017). Ninety-three coun- ment and regulatory style for water safety planning, given the shift in-
tries have implemented WSPs with 76 having scaled-up initial pilot troduced above. This relationship is of research interest because of the
studies to urban and rural settings (WHO and IWA, 2017). The WHO modifications in accountability for risk management associated with
and IWA (2017) report that 46 countries have incorporated WSPs into the shift, the organisational competencies required to assess and man-
policy or regulatory instruments, with 23 other countries having formal age system improvements and the changes to the portfolio of regulatory
tools under development (Fig. 1). instruments (Graphical abstract) required for continued public health
There are existing studies exploring the relationship between WSPs protection. Monitoring a compliance point for drinking water quality
and their enacting policies, regulations and guidance (Viljoen, 2010; parameters is a significantly different task from completing a forensic
Vieira, 2011; Reid et al., 2014; Sinclair et al., 2015; Baum et al., 2016; risk analysis for a supply system with the subsequent maintenance of
Gunnarsdottir et al., 2016; Peletz et al., 2016; Zarkin, 2016; Lomboy controls at critical control points (CCPs) by a risk-mature utility sup-
et al., 2017; Sutherland and Payden, 2017; Bereskie et al., 2018; ported by intelligent regulatory oversight. We were interested in ex-
Roeger and Tavares, 2018; Tsitsifli and Tsoukalas, 2019; Roeger and ploring the antecedents of the regulatory shift above, as illuminated
Tavares, 2020). Mixed results are reported but even with national legis- by practices in two case study jurisdictions and the views of informed
lation in place, periodic contamination events and outbreaks of water- water utility staff, regulatory staff and professional advisors at the
borne disease continue to occur, reminding us that safe drinking heart of water safety planning.
water is never guaranteed through policy and regulation alone
(Fewtrell and Bartram, 2001; Hrudey and Hrudey, 2004; Hrudey and 2. Materials and methods
Hrudey, 2019). In their comprehensive review, Roeger and Tavares
(2018) highlight the essential components of political commitment, We devised an approach that (i) examined the interactions of differ-
technical knowledge, good governance and stakeholder collaboration ent regulatory tools and strategies; (ii) explored the behaviours, atti-
for successful WSP implementation. tudes and cultures of various actors adopting WSPs; (iii) investigated
The authors have a research interest in the practical implementation the responsiveness of regulatory systems to change; allowing us to
of WSPs and the organisational changes required to secure traction for (iv) assemble a model to demonstrate the relationships between risk,
these initiatives within water utilities and among their stakeholders regulation and water safety for the shift described above.
Fig. 1. WSP policy and regulatory status (WHO and IWA, 2017; reproduced under Licence: CC BY-NC-SA 3.0 IGO).
2
2.1. Case study-grounded theory 2.2. Case study protocol
A case study grounded theory approach was deployed with the Case study protocols, procedures and rules guided the principal re-
manual coding of data (Yin, 2014; Corbin and Strauss, 2015; Fig. 2). searcher (HH) during the interviews. These were formalised within
Case study research allows the exploration of real-life phenomena. (i) a letter of introduction; (ii) an information sheet; (iii) a consent
Not without its critics (Gomm et al., 2009), Yin (2014) contends it can form; (iv) an interview guide; and (v) a contact list. The interview and
lead to theory building that is applicable worldwide. Similarly, FGD guides included leading questions, follow-ups, probes and they
grounded theory investigates the real world, uncovering concepts targeted regulators, water operators and professional advisors
grounded in qualitative data and applying them to theories of change. possessing a deep understanding of WSP adoption. All methods were
A combination of methods was used (Stake, 1998; Yin, 1984) for two approved by Cranfield University's ethics committee and pilot inter-
cases: (i) Malaysia; and (ii) England and Wales. Case study selection views tested the feasibility of the interview guide. Participants were
was based on the different regulatory systems in each jurisdiction: reminded that participation was voluntary, with a right to withdraw
England and Wales, with its independent, risk-based regulatory model at any time without penalty. Anonymity was secured using abbreviated
for mandatory WSP implementation; and Malaysia with a compliance- code names (Table 2). For example, participant “FRM1” referred to “a
dominated but transitionary system in place, with commitments to male federal regulator number 1”; while PWOF3, “a female private
further reform (Brown et al., 2006). These two jurisdictions, each at a water operator number 3”.
different stage of their evolution with respect to water safety planning,
allowed a potential exposé of issues related to regulatory style and 2.3. Theoretical sampling
organisational maturity. Extensive data was secured through semi-
structured interviews, focus group discussions (FGDs) and document The number of interviews required in a grounded theory study can-
reviews as the principal survey instruments. Table 1 summarises the not be firmly established during the study design and is referred to as
units of analysis deployed, the relationship between the levels of ‘theoretical’ in the first instance. In practice, code saturation can be
investigation and the baseline data of relevance to the study (Halaweh achieved at 9 interviews when the researcher has reportedly ‘heard it
et al., 2008). all’, though meaningful saturation is typically accomplished between
Fig. 2. Schema of the case study grounded theory approach used (after Halaweh et al., 2008).
3
Table 1 Table 3
Unit of analysis developed for this research. Malaysian interview participants.
Level of investigation Unit of analysis 32 interviews 32 participants
Country Malaysia England and Wales • 2 trial/mock-up • 2 trial/mock-up participants

interviews • 4 professional advisors / independent professionals
Sector Urban public water supplies Urban public water supplies
• 30 interviews • 14 federal regulators
- Government - Private
• 2 state regulators
- Private
• 2 government water operators
Individual Regulators Regulators
• 8 private water operators
- Federal
- State
Water operators Water and sewerage operators
- Senior management Water operators
- Executives Table 4
- WSP champions Summary of Malaysian FGD participants.
Professional advisors / Professional advisors /
6 FGDs 53 participants
Independent professionals Independent professionals
• FGD 1 (n=11) • 2 professional advisors / independent professionals
• FGD 2 (n=10) • 12 federal regulators
• FGD 3 (n=7) • 13 state regulators
16 and 24 interviews when the researcher ‘understands it all’ (Charmaz, • FGD 4 (n=5) • 2 government water operators
2014; Aldiabat and Le Navenec, 2018). Initially, participants were sam- • FGD 5 (n=16) • 24 private water operators
• FGD 6 (n=4)
pled through snowballing (Sbaraini et al., 2011). Comprehensive, semi-
structured interviews were conducted with 32 participants for the
Malaysian case (Table 3). In addition, 6 sequential FGDs (n = 53 2.4. Document review
participants, in total) were held to acquire the desired depth of informa-
tion (Table 4). For England and Wales, 20 comprehensive, semi- Documents can strengthen or contravene the rigour of findings se-
structured interviews were conducted with 23 participants (Table 5). cured through methodological triangulation (Leech and Onwuegbuzie,
All sessions were recorded and transcribed verbatim. Malaysian tran- 2007). Documents were selected using Caulley's (1983) rules; the
scripts were translated into English because conversations were con- most relevant being those close to the events described, including stat-
ducted bilingually. utory instruments (copies of laws, regulations, guidelines and legal
interpretations), programme documents (annual reports, policy docu-
ments and newsletters) and primary documents on the constitutional
affairs of WSP programmes, such as the minutes of meetings,
Table 2
Code names for interviews and FGDs.
organisational structures and memos.
Malaysia
2.5. Coding data, constant comparison and writing memos
Abbreviation Full Form Example
TM Trial/Mock-up Male TM1: Trial/Mock-up Male No. 1 Coding fragments interview data into smaller conceptual compo-
TF Trial/Mock-up Female TF1: Trial/Mock-up Female No. 1
nents (Bernard et al., 2017; Table 6) from which ideas, themes and
SRF State Regulator Female SRF1: State Regulator Female No. 1
FRM Federal Regulator Male FRM1: Federal Regulator Male No. 1 storylines can be generated (Fig. 2). Open, axial and selective coding
FRF Federal Regulator Female FRF1: Federal Regulator Female No. 1 can be applied to grounded theory. HH started with a small mass of
IPM Professional Advisor / IPM1: Professional Advisor / text and codes, line by line. Useful concepts were identified. The process
Independent Professional Independent Professional Male No. 1
was repeated, through “open coding” (Corbin and Strauss, 2015). “Axial
Male
IPF Professional Advisor / IPF1: Professional Advisor /
coding” (Corbin and Strauss, 2015) then involved a selection of central
Independent Professional Independent Professional Female codes connecting categories to subcategories. “Selective coding” refined
Female No. 1 the final categories and related them to one another (excerpt in
GWOF1 Government Water GWOF1: Government Water Operate Table 6). To support coding and maintain methodological rigour,
Operator Female Female No. 1
memos captured analytic thoughts, especially for significant or unex-
PWOM1 Private Water Operator PWOM1: Private Water Operator Male
Male No. 1 pected codes, for comparison in upcoming interviews. A set of supple-
PWOF1 Private Water Operator PWOF1: Private Water Operator mentary data illustrates the approach for readers from one transcript
Female Female No. 1 alone, for which there were 694 open codes, 59 axial codes; and 10 se-
S1 State or Federal Territory X S1: State or Federal Territory No. 1
lective codes.
Water Utility 1 Water Utility X Water Utility 1: Water Utility No. 1
England and Wales

3. Results and discussion
Abbreviation Full Form Example
TM Trial/Mock-up Male TM1: Trial/Mock-up Male No. 1 We discuss the key themes from this study: (a) the journey in regu-
RM Regulator Male RM1: Regulator Male No. 1 latory style from compliance- to risk-based regulation; (b) compliance
RF Regulator Female RF1: Regulator Female No. 1
RF3a & RF3b: Regulator Female No. 3
Session a & Regulator Female No. 3
Session b Table 5
IM Professional Advisor / IM1: Professional Advisor / A summary of the England and Wales interview participants.
Independent Professional Independent Professional Male No. 1
20 interviews 23 participants
Male
WOM1 Water Operator Male WOM1: Water Operator Male No. 1 • 1 trial/mock-up • 1 trial/mock-up participant
WOF1 Water Operator Female WOF1: Water Operator Female No. 1 interview • 5 professional advisors / independent professionals
WSU1 Water and Sewerage WSU1: Water and Sewerage Utility • 2 group interviews • 7 regulators
Utility No. 1 • 17 interviews • 9 private water and sewerage operators
WU1 Water Utility WU: Water Utility No. 1 • 1 private water operator
4
Table 6
Excerpt of coding for the RF3b transcript (Supplementary data for detail).
Raw data from interview Open coding Axial coding Selective coding
“Because our regulations, don’t forget, are written in a way • Regulatory instruments
that we have a catch-all standard as well. So, as well as having
the parameters for PCV in these schedules, we have a
regulation that says there shouldn’t be anything in the water at • Regulatory instruments
any concentration that might cause a risk to health. So, that
catches everything and we consider that sufficiency is also a • Regulatory instruments
risk to health because if you don’t have water coming out of
your tap, you have no drinking water which is a risk to health.
So, anything that affects pressure supply…any of those things • The comprehensiveness
are included in our risk assessments.” PCV, prescribed of the risk assessment
concentration or values.
“Yeah, they go from catchment to tap, yeah, so.” • From catchment to tap • Comprehensiveness • The comprehensiveness of
the risk assessment
“So, they will have their own specific risk assessments, but again it • Specific risk assessments that • Risk assessment for buildings • The comprehensiveness of
will be generic for the area. So, all hospitals and all schools will be is generic for the area the risk assessment
risk assessing roughly the same way, unless they have other
information that tells them otherwise, which they can do because
they will go and inspect and take samples from public buildings,
hospitals, not just hospitals, and schools.”
policy; (c) regulating the risk management activities of utilities; MOH, as the most competent health agency in the country, regulates
(d) cooperation between regulators; (e) the role of various instruments drinking water quality surveillance outside the national context-
within the ‘regulatory ladder’ for water safety planning; and (f) practical specific regulations, relying on directives from the WHO. A Malaysian
issues that influenced (a) to (e) above; Sections 3.1 to 3.6 below. These state regulator, FRM2, proclaimed, “We have monitoring, sampling, anal-
themes, which included the portfolio of regulatory instruments, the ysis, all the sanitary surveys…all that”. A Federal regulator, FRF9, quoted
comprehensiveness of risk assessments and how they are overseen by “[…] since then I think all are accepted the drinking water quality stan-
regulators (Table 6), are familiar to debates on the transition to risk- dards which we were produced although it is administrative, right?
based regulation (Black, 2005; Black and Baldwin, 2012; Collins et al., [chuckles] So, people accept it”. There is a limit on MOH's powers how-
2012; Leinster, 2001; Leinster and Pollard, 2019; Hughes, 2020; ever, FRF9, “[…] definitely we are not so clear what will be happened in
Venitsianov et al., 2020). They reflect a cautiousness in the move from the future, with the Act [Drinking Water Quality Act] in place? Except, per-
‘command and control’ to risk-informed regulation and the associated haps from the compliance when there is a violation, we have the basis that
issues of institutional competence, organisational cultures and the per- we can refer to for any action, right?” In terms of skill sets, the majority of
ceived transfer of power from regulator to regulatee. The governance ar- personnel on the ground are samplers and compliance staff (Fig. 4a),
rangements and regulatory instruments that contextualise the findings FRF9, “Our officers at the State level have a variety of experience. Well ex-
for Malaysia and England and Wales are presented in Figs. 3, 4a, b and perienced and new ones,” but, “The Health Inspectors, they tend to turn
5a, b. A glossary is provided as an endnote. over”. These are skilled personnel with their competences reinforced
by task repetition. A State regulator, SRM4, offered a mixed view on
3.1. The journey from compliance- to risk-based regulation the range of interventions available to the regulator, suggesting a rather
uniform approach, “I believe enforcement is the last step we do. We are
Drinking water quality surveillance has historically been ready for the last. But, the [interim] approaches...steps...we are not
compliance-based by reference to accepted drinking water guidelines, ready,” inferring a limit to expertise on risk-based approaches.
with sanitary surveys and enforcement actions in place to correct sup- Enforcement in Malaysia has become an essential means for the reg-
ply system failures (Horton, 1898; Pillay et al., 1994). These tenets of ulator to exercise authority over the water sector, rather than as a last
water quality control (WHO, 1976) remain essential sentinels of public resort on a ladder of regulatory mechanisms (Graphical abstract), not-
health protection. They are now (WHO, 2017) augmented with the ex- withstanding reforms signalling a more facilitative regulatory style.
pectation of a preventative, risk- and systems-based interventions from Command and control regulation, though costly, is viewed as culturally
catchment to tap to protect public health. When potential harms are more straightforward to discharge. One danger is that transition to-
high, a transition to the middle and upper rungs of the regulatory ladder wards risk-based regulation, with operators supplying risk assessments
(Graphical abstract) can be hotly debated (Gunningham and Sinclair, to the regulator for review, is seen as conceding regulatory power. Re-
1999; Collins et al., 2012; Hughes, 2020; Venitsianov et al., 2020) and sistance to a more mature approach, or perhaps a lack of regulatory con-
might be anticipated here, given the potential disease burden associated fidence or resources, might find expression in the ‘tick box’ inspection of
with the supply of poor quality of drinking water. Transition is documentary requirements, such as risk assessments, rather than a fo-
smoothest among mature, high-performing utilities that understand rensic analysis of risk management controls at CCPs.
their supply and organisational systems well and can identify CCPs England and Wales have achieved a successful journey to risk-based
and specify measures to mitigate risk to acceptable levels; that is poten- regulation through a collaborative approach with the water sector. The
tial harms are understood and preventative measures are in place to Drinking Water Inspectorate (DWI) is an independent water quality
prevent their realisation. Practical competency in the controls that regulator for England and Wales, part of the ministerial Department of
maintain potable drinking water quality is essential for functional oper- Environment, Food and Rural Affairs (Defra; Fig. 5a). Since 2007,
ations (Hrudey et al., 2006; Jayaratne, 2008; WHO and IWA, 2018). water utilities have progressed towards a mandatory risk-based ap-
In Malaysia, compliance with drinking water quality is enacted proach to water safety planning (Fig. 5b, c). Reform has been smooth
through a three-tiered hierarchy (Fig. 3) and regulated by the Ministry and “[…] progress has been very good because there is a regulatory re-
of Health (MOH), requiring compliance from water suppliers through quirement” as one independent professional, IM5 said, adding “before
a system of rules and laws: “[…] we want the water quality to comply Water Safety Plans became required by the regulator, the water companies
with the standards,” one private supplier, PWOF2, expressed. The were looking at Water Safety Plans”. IM5 had led a project for UK Water
5
risk-based compliance monitoring […]” using the Compliance Risk

Index (CRI; Great Britain. DWI, 2018a) and Event Risk Index (ERI;
Great Britain. DWI, 2018b). CRI is structured to assign a numerical
value to the risk, allocating a figure to the significance of the failing pa-
rameter, the proportion of consumers potentially affected and the effi-
ciency of the water utilities' response; while ERI is used to generate a
practical measure to quantify risk to the public when an incident occurs.
On the basis of this experience, the incorporation of WSPs into law has
resulted in improved compliance and informs the prioritisation and
Fig. 3. Drinking water quality surveillance arrangements for Malaysia delivered through a targeting of surveillance activities, with WSP outcomes used to justify
three-tiered administrative hierarchy. investment needs (Hackett, 2019; Great Britain. DWI, 2020; Great
Britain. OFWAT, 2020).
Industry Research (UKWIR, a water industry research body) before (b) “Tick box” compliance. As noted in 3.1 above, there may still be a
2004, producing manuals to support the implementation of the risk- tendency towards a “tick box” compliance of risk-based requirements
based approach in advance of changes to regulation. As IM5 concluded, (i.e. Non-Conformance Report (NCR), Quality Assurance Programme
the regulator is the primary driver, but “there was recognition in parts of (QAP) and Drinking Water Quality Index (DWQI)), so effort is required
the industry,” […] “WSU7 [a specific water utility] was very good on their to instil an intelligence-led approach to the oversight of risk manage-
treatment works, and the way that they did that. WU1 [another utility], as ment actions on the ground. FRF9 explained for WSP implementation
they became, had a very good system for their distribution systems. WSU8 in Malaysia, “[…] in the regulations we won't dictate what we will penalise
was very, very good on their catchment protection. So they all learned from from their implementation […] Perhaps when there is a violation we would
each other”. Regulator RF1 acknowledged this success “Well the DWI, like to see, ‘Eh! Do they actually have a WSP? So, what have they commit-
they're not a very big organisation, but they're quite powerful in terms of ted in their WSP?’ So based on that reason, when we have to penalise them
the water companies and what's required of them. It's a legislative require- [apply sanctions] based on the violation, we would take a look at such re-
ment; water companies have to do them. So, they don't have to write a cords”. As inferred, in Malaysia a regulatory intervention can be initiated
water safety plan; they have to use a water safety planning approach, following a violation of reporting requirements, rather than an absence
which is more around the risk assessment. So what they will require is of valid control measures, say at CCPs. Sparrow (2011) suggests a lack of
risk assessments. They will require the water companies to make sure agility can lead to regulatory failure. This appears to be recognised in
that they are managing the risks from source to tap. So, I think it's pretty part, FRM2 “the WSP is actually tying everything together,” […] “We
well established, but I think that it's enshrined in legislation. So, I don't have monitoring, sampling, analysis, all the sanitary surveys…all that.
think that there's a huge risk of them not doing it. And I think, the impres- But if you put everything together actually, it is quite something like
sion I get is that it's a useful tool that the water companies have found ben- WSPs. But all those elements, the five elements [FRM2 referring to the Na-
eficial…but it was a case of not making it into a document that sits on a tional Drinking Water Quality Surveillance Programme of monitoring;
shelf that nobody uses. Making it into a tool that is actually dynamic, and sanitary surveys; data processing and evaluation; remedial action; and
that is actually flexible to adjust according to new information and new institutional examination (MOH, 2004)] were done separately, individu-
challenges”. ally without relating one another. You do a sanitary survey, you do a sani-
The DWI has benefited from regulating a mature set of high- tary survey. You do monitoring, you do monitoring. The result, you look at
performing utilities that adopt risk management as part of their the result of the monitoring”. Regulators need to recognise WSPs as a syn-
organisational cultures and that have used risk assessments for many thesised assembly of the water supply system from catchment to tap,
years to inform their asset management plans (MacGillivray et al., with risk-informed interventions to manage the likelihood of system
2006; WHO and IWA, 2009: Alegre and Coelho, 2012; NALAS, 2014). failures at CCPs where, if failure were to occur, they would pose the
Building on a philosophy of risk-informed regulation, informed by most significant potential for harm.
pre-competitive research, the ‘roll-out’ of WSPs in England and Wales
has been smooth and broadly welcomed. 3.3. Regulating the risk management activities of water utilities
3.2. Compliance policy How then should the risk management efforts of regulatees be over-
seen? Allan et al. (2013) recognised a regulatory model for one country
Compliance is how regulators assess whether regulatees meet their does not necessarily fit another's arrangements. The water sector has
legislative obligations, or not. Notwithstanding the continued value of demonstrated how each country uses its regulatory model for the pro-
drinking water quality surveillance, for WSPs compliance also relates vision of water services (OECD, 2015).
to a utility's ability to assess their system, identify CCPs and design inter- (a) Risk-based regulatory frameworks. In England and Wales, the
ventions to manage risk. Sparrow (2011), in his description of the regu- Hampton Review (Great Britain. Hampton, 2005) advocated risk-
latory craft, expresses the agility required of a transformation to risk- based regulatory frameworks that informed amendments to the
based regulation. Risk-based regulators deploy a variety of mechanisms Water Supply (Water Quality) Regulations 2000 (Amendment) Regula-
across the regulatory ladder (Graphical abstract) to secure public health tions 2007 (Great Britain. The Water Supply (Water Quality)
and environmental protection (Pollard et al., 2004; Rothstein et al., Regulations 2000 (Amendment) Regulations, 2007). The notable
2006; Sparrow, 2011). changes concerning WSPs were for Regulations 27 and 28 on the
(a) Drinking water quality indices. Besides developing audit protocols conducting and reporting of risk assessments. The key instrument se-
to validate the completeness, effective implementation and efficacy of curing the comparability of risk management actions offered to the reg-
WSPs (WHO and UNECE, 2019), the DWI in England and Wales also ulator by water utilities is a DWI evaluation of risk categories and
has procedures for verification monitoring to assess whether the drink- descriptors (Table 7). This is a high-level means of standardising risk
ing water provided by the utilities is wholesome, as evidenced by 100% management actions, whereby each prioritised risk is compared to the
compliance with the 2016 Water Supply (Water Quality) Regulations DWI's risk category (A to H) by reference to the implementation of con-
(Great Britain. The Water Supply (Water Quality) Regulations, 2016). trol measures.
Regulator RF3b emphasised that “[…]mean zonal compliance, which is A water utility operator, WOM1 explained, “It's just how our regula-
just a calculation based on compliance results […]” was “[…] a reactive tors want to interpret our risks”. The regulator conducts an audit pro-
way […]” employed by the DWI before their shift to proactive “[…] gramme, RF3b “We are required to do that by the regulation because any
6
Fig. 4. (a, b). Compliance-based instruments and associated strategies for water services in Malaysia (see Glossary for abbreviations).
7
Fig. 5. (a, b). Risk-based instruments and strategies within the context of water services in England and Wales (see Glossary for abbreviations).
of all of our activities have to be carried out by a risk-based approach”. ranking of all of the assets of each company. […] and we pick the top ones of
Water utilities provide the regulator with “a general risk-based database, that list,” which means, “the most risky ones” (RF3b). The audit pro-
which takes lots of different bits of information and data, and gives us a risk gramme adopts a series of techniques and can “can branch [off] from a
8
water quality event” (FR3b). RF3b categorised audits as “technical audits Table 7
and they're driven by a number of different things,” whereby the regulator DWI risk categories and descriptions used for risk assessment reporting arrangement by
the water companies (after Great Britain. DWI, 2015).
will “go and proactively do a technical audit on those particular sites, or on
that particular subject because it might be something to do with, like, emer- Category Description
gency planning”. In parallel, the regulator conducts “themed audits, which A Target risk mitigation achieved, verified, and maintained.
take place and themes come from […] where we find there's a common B Additional control measures which will materially reduce risk are being
weakness,” which they “find something more than a couple of times,” validated.
C Additional control measures which will materially reduce risk are being
and “actually touch on all companies – most companies”. For example,
delivered.
the regulator has started themed audits on disinfection processes and D Additional control measures are required to materially reduce risk.
chemicals, which the regulator disseminates the findings from, so the E Mitigation under investigation.
sector takes note and makes improvements. A vertical audit is another F Partial mitigation.
technique “where we follow a sampler from the point when, you know, G No mitigation in place: control point downstream.
H No mitigation in place and none required.
they go out to take the samples, and then, follow the sample through to
the laboratory until it gets put on a public record” (RF3b). Since samplers
are audited by UKAS (the national accreditation body assessing organi-
sations that provide certification, testing, inspection and calibration ser- 3.4. Cooperation between regulators
vices), this type of vertical audit is less of the regulators core business, as
said by RF3b, “We don't do that as much as we use to because of UKAS's The regulatory landscape within the water sector in England and
programme, […] I think pretty much covers that. So we do a bit of it, but Wales is somewhat complex. The DWI (drinking water quality) is joined
that's not one of our core”. Thus, for a country transitioning from by OFWAT (financial, customer value) and the Environment Agency (EA;
compliance- to risk-based regulation, a vertical audit is useful to confirm environmental quality) who also have significant loci on the activities of
the competency of samplers, especially if they are outsourced and re- water utilities (Great Britain. Defra, 2018; Great Britain. OFWAT, 2019;
quire accreditation. Great Britain. EA, 2020). Defra (Great Britain. Defra, 2012) sets out a
(b) Risk matrices. Turning to the assessment of supply system risks, ‘Statement of Obligations’, the Government's understanding of the
DWI works with a variety of risk matrices from each utility, RF3b, major environmental statutory obligations applied to water utilities
“Whatever gives them visibility of where their risks are and where they over a five-year price review period. A joint letter from Defra, OFWAT,
need to concentrate their effort. Then, that is fine by us, as long as we get DWI and the EA sets out the future ambition of building resilient water
the end outcome, you know, in submissions that they give to us. How supplies (Great Britain. Defra, 2018) and the co-ordinated leadership
they break up their risk assessments is up to them. So, I mean that's why across the Government and its regulatory bodies to support this aim
we never prescribed a particular risk assessment methodology,” this (Great Britain. DWI, 2018c). RF3a, a DWI regulator, described the mutual
being a UK philosophy to regulatory risk assessment. Risk matrices are support on the “outputs of all the risk assessments and the inputs to the busi-
not without their critics (Levine, 2012) and differences exist between ness planning process”. For the water industry “they saw the process of risk
countries that prescribe a template matrix and those that allow assessment for water quality as a useful way of actually stacking up their
flexibility. water quality risks against all the other risks that they have to manage as a
In England and Wales, the regulator provides the freedom to water business, […] because all of those have to be put into their business plans
suppliers to deploy their risk matrices. A senior utility operator, for OFWAT to get approved, so they can get their funding”. The Business
WOM3 confirmed, “So it's up to you how you do that, and DWI let you Plan is a vehicle for utilities to evidence their financial requests for risk
do that”. To accommodate the DWI risk categories (Table 7), another op- management concerning drinking water quality and environmental im-
erator, WOM5 summarised their risks on three separate semi- provement. The DWI is involved directly in the financial review led by
quantitative risk matrices for public health, compliance and serviceabil- OFWAT (Great Britain. DWI, 2020). A similar understanding exists with
ity, “[…] the reason being is that serviceability, in a very simplistic sense is the EA, RF1 explaining, “[…] we're just going into an Asset Management
[an assessment of whether] the asset available to run or not? All right. So, Plan. Ummm…new period where water companies want to bid for money
we risk assessed that. Compliance is not just compliance with Drinking so that they go to our water regulator, OFWAT, and put their Business Plan
Water Regulations, whether it's compliance with DWI, compliance with forward to say what they want to spend money on in the coming, sort of…
any form of regulation that has a compliance value, and there are numer- 2019 to 2024. […] So we provide all the guidance from the EA on the catch-
ous – hundreds out there, and therefore, we develop three matrices, ment work that we would be supportive of, to protect water quality for drink-
which sit in the same application, and they sit alongside each other. So, ing waters. And DWI, they provide guidance on what they would expect from
you have this extra level of detail, such that you can have a public health water companies, to ensure compliance with either legal instrument that
risk, which is not a compliance risk. Not very often, but it – and then you they've got in place”. RF3a emphasised that “[…] it's very well embedded
can relate it to serviceability”. IM3 added, “There must be a challenge ses- and we are now in a process whereby we are in a risk management zone,
sion of these assessments,” because otherwise they “can be misunderstood you know, we are now about improving all of the risk management processes
and can be out of the context of what I mean is, I won't say accurate, but it that we have in place, rather than being in a stage where we're doing initial
may not reflect the true risk, may have not reflected true risk of that partic- risk assessment and finding out where the gaps of information and data are.
ular item. So, that's a concern about – there's a risk to that risk assessment”. We're sort of in that stage where we're in the proper cycle”.
The consequence (or severity) and likelihood (or frequency) must The cycle referred to by RF3a is a programme to improve drinking
be clearly defined in these matrices, as indicated for the Malaysian risk water quality established by the DWI (Great Britain. DWI, 2013) that
matrix (Fig. 6a, b). IM3 explained by providing an excellent example captures 1) enforcement for violations of drinking water standards;
in juggling between the consequence, likelihood and a conscientious 2) enforcement for issues arising out of DWI's investigations of drinking
judgment, “If you are near like Labuan [in Malaysia], the treatment plant water quality incidents or through regulatory audits; and 3) identifica-
is very close to the airport. So, what's the chance of a plane crashing into tion of critical health risks through a risk assessment of a water supply
the treatment plant and affecting it? It will be catastrophic, right? So, system. DWI retains powers to ensure these actions are implemented
what's the chance of it crashing to your treatment plant? Oh, once in a life- (Great Britain. DWI, 2013). In terms of the role of WSPs in the Business
time! There's no risk; frequency is very low. One in ten years? No!!! To me, Plans, WOM1 who represented a WSP team in his utility explained, “[…]
the probability is very high! Because you are close. You are in the flight for starters, having an active safety plan that is always being reviewed and
path. So, there's a very high risk there! You cannot say it may happen manipulated – ‘manipulated’ is a bad word – but you know our change,
once in a lifetime, then it is low, no! To me it is very high”. we've always got a resource of data and interpretation of the data. So,
9
we've got easy access to information if another part of the business requires forms, including on voluntary initiatives for pesticide controls, for ex-
it. So, we can inform the Business Plan a bit more effectively, but it's more to ample, as IM3 commented, “[A] sort of national initiative to work with
do with strategy. The strategy team are more into developing that because farmers and with the manufacturers of pesticides”. These initiatives in-
they need it to fit in with the company's strategy. They will define how volve substantive capacity-building, often taking years; WOF4 “[…]
much money we have and how we are going to spend it, and where it speaking to them and trying to get an understanding of risks in the catch-
needs to be spent. Then it's our asset integration. We're the ones that ments that they're seeing, and thinking about how I can apply that to the
prioritise that and make sure that's channelled in the correct way”. water safety plan. Some of this stuff doesn't need to be reported to the
DWI, they don't require that, but for us, I think it's useful to know and to
3.5. Regulatory instruments and the regulatory ladder have that contact, and to maintain that level of knowledge”. From the
regulator's viewpoint, RF3b explained it is necessary for water utilities
The insights from this study are summarised in Fig. 7, the ladder of to “actually defines the catchment […] and that actually tell us, you
interventions available to regulators, with generic examples mapped know, what the catchment is represented by. And then, in that catchment,
across to the WSP context. Also depicted is a mapping to accepted strat- they identify who are the stakeholders that they need to be involved with
egies for risk management (Pollard et al., 2004) and factors associated […] either the holders of information, or the groups that have an impact
with the regulatory transition (Fig. 7; arrows) discussed above. on source water quality in that catchment area.” Hence, in this case,
FRF9 (Malaysia) recognised the need for risk maturity and financial RF3b concluded, “the water company is responsible for identifying who
capacity where the risk-based approach is deemed mandatory, “So this those people are and getting the information that they need from those
is the same with WSP. If you want to make it mandatory, you've got to pre- groups and those people in order to form their risk assessment”.
pare them, so no surprise. We have to consider those poor suppliers, be- (b) Customer awareness. WOF2 declared “the safety plan responsibil-
cause we have poor and rich suppliers. So we have to balance. The poor ity is up to the kitchen tap actually,” […] “the first draw-off point, so that's
ones, they couldn't afford if we make it mandatory on the spot. That's where our sampling takes place, and some of that will be risk-based.”
why like Water Utility 5B asked us to increase the minimum standard. WOF2 pointed out that “It's probably one of the areas for development
We said, “We can't. You are rich, you are able to do it. What about State in safety planning that – where looking after customers in their homes –
1 and State 9? They are so poor that even the minimum standard they can- quite a lot of risks get introduced by plumbing that we can't control and
not comply? So we have to be balanced. We have to strike the balance, so whatnot.” As a result, “Education in water quality is one of our – it's on
what is the comfortable level everybody can comply”. our sort of radar's growth areas for drinking water safety plan thinking re-
ally, which we, as an industry, don't really do a lot of – because we advise
3.6. Practical issues for water safety plans people a lot on efficiency, but we haven't really done so on quality.” As
stated by regulator RF3b, “For the customer side, so, beyond the boundary
WHO (2017) emphasises the need for a comprehensive preventive of the – ummm, property and the tap, it is possible to do some site-specific,
risk management framework for public health protection from catch- or zone-specific risk assessments.” However, it is “very difficult because for
ment to the consumer; one that includes policy formulation and the most part, water quality zones are made up of varying types of prop-
standard-setting, risk-based approaches and surveillance. erty”, adding “it would be very rare to find a water quality zone where
(a) Stakeholder issues. A sophisticated and mature set of arrange- all the properties suffer from the same problems”. As a result, “you tend
ments is inferred that can address both point and diffuse sources of pol- to have a generic risk assessment for a water quality zone, which will
lution in catchments. The management of diffuse pollution in supply cover all eventualities. And then, what water companies will do is they
catchments is a good indicator of organisational maturity because it re- will obviously alter the likelihood of certain issues depending on what
quires high degrees of behavioural change and multiagency engage- their compliance and operational monitoring tell them about that zone”.
ment. Engagement with catchment stakeholders takes place in many She admits that compared to the catchment area, “There aren't really
Fig. 6. a. Malaysian uniform semi-quantitative risk matrix and the risk rating (Malaysia. MOH, 2012). b. Malaysian uniform semi-quantitative risk matrix – the description of consequence
or severity as well as the likelihood or frequency (Malaysia. MOH, 2012).
10
Fig. 6 (continued).
11
Fig. 7. The regulator ladder contextualised for WSPs.
that many other stakeholders in the customer's side, although from a com- all treatment plants will have the WSP. WSP will be part and parcel of the
munication point of view, there are certainly stakeholders because depend- water business in the country”.
ing on the water quality issues that might be faced in a zone”. However, (e) Affordability. Since the majority of the water suppliers in Malaysia
proactive communication is one of many means to engage with the are State-owned, it is also appropriate to consider the States' relative ac-
targeted groups, RF3b, “with, say, local health authorities, or with certain cess to funds to drive change. States such as State 3, State 4, State 5 and
vulnerable groups, such as pregnant mothers […] because if you do have a State 8 are considered affluent, while State 1 and State 9 are regarded as
zone, which is say, more prone to lead issues because there might be very poorer in comparison (Box 1). Compared to slow track and significant
old housing stock”. RF3b concluded, “You will find that the risk assess- scrutiny utilities, fast track water utilities in more prosperous States
ments are more generic. They're not just for a household, they'll be for are fairly ahead in implementing WSPs.
more likely a water quality zone”. FRF6, referring to asset ownership, “Like State 3 and State 4, although
(c) Organisational maturity. Organisational maturity among water they already migrated to licence, but […] some of their treatment plants,
utilities and their regulators emerges as a critical requirement to sup- are not handed over to WAHCO since the treatment plants are free from
port the shift to risk-based regulation. Capacity-building and training debt. That's why we have to issue them facility licence since they own the
is essential to build competency and confidence. WSPs in Malaysia asset”. Contrarily for poorer States like State 9, FRF6 noted the capability
have been in place since 2010 for rural water supplies and since 2011 of the water supplier to pay for operational expenditure, “Water Utility
for urban public water utilities, starting with demonstration projects 9, they even don't have money to pay for the staff salary. The State needs to
(MOH, 2012). FRM2, one of the senior federal regulators commented inject recently for 50 millions or something. They even have no sufficient
openly, “Only last five years when we come in, when we recognise the im- fund to pay for salary”.
portance of WSPs, we started by attending the international training in
Singapore, for example. And then, with more assistance initially from 4. Conclusions
WHO, we have training in Ipoh way back in 2010. And from there on we
gained more experience, and I think by now, we should be able to go on We have considered the interplay between risk management and
our own”. FRF9 believed implementation is not yet comprehensive regulatory styles for WSPs in Malaysia and in England and Wales, as
from source to tap, “This is my personal opinion. I think it seems okay the philosophy of regulation shifts from a compliance-led to a risk-
when we asked the water companies to do it; they do it. But, in terms of informed approach. The analysis has revealed the tensions that accom-
full implementation, I don't think – we don't achieve that yet. We are not pany this transition and expose the antecedents of a successful shift. To
there yet. Because, how we want to see, we claimed this company had im- an extent, the analysis reasserts generalised observations elsewhere on
plemented WSPs? If they didn't have anything to show that they did it,” and which we have commented (Leinster and Pollard, 2019), but here for
as she adds that progress is just moderate: “They are progressing, the water safety plan context. Nevertheless, there are important points
progressing. But to say it is speeding, I don't think so”. for water safety regulation that is in transition. The transition is easier
(d) Comprehensive coverage. Coverage is also an issue. In Malaysia, for risk-mature utilities and regulators that have confidence in the iden-
not all systems are equipped with WSPs (FRM2), “In Malaysia, more tification (water utilities) and oversight (regulators) of system controls
than 450 treatment water systems in Malaysia. And, we suppose to equip that mitigate risk at CCPs in their WSPs. This transition is not a binary
all those numbers of the treatment plant or system with WSP. We start switch from drinking water quality surveillance to ‘arm's length’ risk-
from almost zero last three years. But I think now we are achieving a num- based regulation. A ladder of regulatory mechanisms is available and
ber of about 50, 60 or 70…numbers. So I think it is very good progress, but the upper rungs of it help grow competency and confidence among util-
of course, we have to look into the quality of the plan. […] So in general, it is ities through best practice, audit, guidance and training (Fig. 7).
improving, expanding, getting better and then there are more efforts in the Regulatory failure, the absence of control over intended regulatory
pipeline to ensure that this achievement will be attained within the shortest outcomes, can occur if naïve compliance policies are applied to risk as-
timeframe hopefully, I hope within the next five years, the whole country, sessments and WSPs submitted for regulatory review. The actual test
12
Box 1 permission to publish; the DWI for their prior review; the multiple par-
Discourse of the ability to pay for WSP implementation among ticipants and organisations that took part; and the PhD panel support of
Malaysian utilities. Prof. Peter Jarvis and Prof. Ian Jennions (Cranfield). The opinions
expressed herein are the authors' alone with no conflicts of interest.
“[…] there are States which already done it, for example State 5.
And State 4 too, they do it just by themselves. That were for the
Acknowledgements
demonstration projects earlier, but after that, they continue
doing it. Then they do it again, they continue to add, add, add
HH was supported by a Ministry of Health Malaysia's Federal Train-
[interruption by third party] continue back, that the states. Like
ing Award; SJTP by an EPSRC consortium award (EP/K012347/1), the In-
State 4, of course they were parts of the demonstration projects,
ternational Centre for Infrastructure Futures. The authors thank the
they took their own initiative to expand them. We don't in fact,
Director-General of Health Malaysia for permission to publish; the
saying, ‘Okay, after this it is not a demonstration project
DWI for their prior review; multiple participants and organisations that
anymore.’ Like I feel, those states which continue, it is
took part; and the PhD panel support of Prof. Peter Jarvis and Prof. Ian
voluntary. Their own effort. Like State 4, right? Most of their
Jennions (Cranfield). The opinions expressed herein are the authors'
plants now are started to implement. They have started
alone with no conflicts of interest. The underlying materials for this
documenting their WSPs.” - FRF9
study can be accessed via the Cranfield University repository at 10.
“[…] the State 8 case – is actually because State 8 they have been
17862/cranfield.rd.13026533.
implemented – the earliest, one of the earliest many years ago,
so they can see the benefits and they have made decisions
Appendix A. Supplementary data
based on WSP document.” - FRM2
“For the demonstration projects, there are a few which continue.
Supplementary data to this article can be found online at https://doi.
But, there are states like in State 1, they definitely not working,
org/10.1016/j.scitotenv.2020.142868.
it is not working. We try to help. Just focus on them. […] But,
like in State 1, they said they can't. They don't have the capacity
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Inquiry. Sage Publications, Thousand Oaks, California, pp. 86–109. sand Oaks, California.
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15
Glossary Kementerian Tenaga, Sains, Teknologi, Alam Sekitar dan Perubahan Iklim) and subse-
quently to the Ministry of Science, Technology and Innovation (MOSTI, or Kementerian
CCP: Critical Control Point Sains, Teknologi dan Inovasi) in 2020 under the Eighth Prime Minister Cabinet
CRI: Compliance Risk Index MOH: Ministry of Health
Defra: Department for Environment Food and Rural Affairs NCR: Non-Conformance Report
DWI: Drinking Water Inspectorate OFWAT: Water Services Regulation Authority
DWQI: Drinking Water Quality Index QAP: Quality Assurance Programme
EA: Environment Agency SDGs: Sustainable Development Goals
ERI: Event Risk Index SPAN: Suruhanjaya Perkhidmatan Air Negara or National Water Services Commission
FGD: Focus Group Discussion UKAS: UK's National Accreditation body
IWA: International Water Association UN: United Nations
JAS: Jabatan Alam Sekitar or Department of Environment UNICEF: The United Nations Children's Fund
JBA, KeTTHA: Jabatan Bekalan Air or Water Supply Department under KeTTHA WAHCO: Water Asset Holding Company
JBA WP Labuan: Labuan Federal Territory Water Supply Department WHO: World Health Organisation
KeTTHA: Kementerian Tenaga, Teknologi Hijau dan Air or the Ministry of Energy, Green WQS: Water Quality Surveillance System
Technology and Water, with the water component transfers to the restructured Ministry WSPs: Water Safety Plans
of Water, Land and Natural Resources (Kementerian Air, Tanah dan Sumber Asli) during
the Seventh Prime Minister Cabinet in 2018 and the rest of the components to the Ministry
of Energy, Science, Technology, Environment and Climate Change (MESTECC, or
16

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STOTEN-142868; No of Pages 16

Science of the Total Environment xxx (xxxx) xxx

Contents lists available at ScienceDirect

Science of the Total Environment

journal homepage: www.elsevier.com/locate/scitotenv

2.1. Case study-grounded theory 2.2. Case study protocol

Level of investigation Unit of analysis 32 interviews 32 participants

Country Malaysia England and Wales • 2 trial/mock-up • 2 trial/mock-up participants

England and Wales

risk-based compliance monitoring […]” using the Compliance Risk

Fig. 7. The regulator ladder contextualised for WSPs.

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