Skip to main content
English Cymraeg
Good Practice Regulatory Change

Good Practice Regulatory Change: Appendix

Bibliography and discussion guide

Bibliography

Almond, P. and Ebester, M. (2018) ‘Regulatory inspection and the changing legitimacy of health and safety’, Regulation and Governance,12 (1).
https://doi.org/10.1111/rego.12155

Armenakis, A. and Harris, S.G. (2009) ‘Reflections: our Journey in Organizational Change Research and Practice’, Journal of Change Management, 9(2), pp. 127-142.
https://doi.org/10.1080/14697010902879079

Baldwin, R. and Black, J. (2016) ‘Driving Priorities in Risk-based Regulation: What's the Problem?’, Journal of Law and Society, 43(4), pp. 565-595.
https://doi.org/10.1111/jols.12003

Baxter, J. and Clarke, J. (2013) ‘Farewell to the tick box inspector? Ofsted and the changing regime of school inspection in England’, Oxford Review of Education, 39, pp. 702-718.
https://doi.org/10.1080/03054985.2013.846852

Beaussier, AL., Demeritt, D., Griffiths, A. and Rothstein, H. (2015) ‘Why Risk-based Regulation of Healthcare Quality in the NHS Cannot Succeed’, King College London. 

Beaussier, AL., Demeritt, D., Griffiths, A. and Rothstein, H. (2016) ‘Accounting for failure: risk-based regulation and the problems of ensuring healthcare quality in the
https://doi.org/10.1080/13698575.2016.1192585

BEIS (2020) ‘Agile Nations Charter’. Available at:  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/942312/Agile_Nations_Charter.pdf. (Accessed: 15th July 2022).

BEIS (2019) Regulating for the Fourth Industrial Revolution White Paper. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/807792/regulation-fourth-industrial-strategy-white-paper-web.pdf (Accessed 15th July 2022).

Benson, D. and Jordan, A. (2011) ‘What Have We Learned from Policy Transfer Research? Dolowitz and Marsh Revisited’, Political Studies Review, 9(3), pp. 366-378.
https://doi.org/10.1111/j.1478-9302.2011.00240.x

Carroll, P. (2008). Rethinking Regulation, 73-88. In Carroll, P., Deighton-Smith, R., Silver, H. and Walker, C. Minding the Gap: Appraising the promise and performance of regulatory reform in Australia.
https://doi.org/10.26530/oapen_459375

Competition & Markets Authority and Ofcom (2022) Policy Paper: Online safety and competition in digital markets: a joint statement between the CMA and Ofcom. Available at: https://www.gov.uk/government/publications/cma-ofcom-joint-statement-on-online-safety-and-competition/online-safety-and-competition-in-digital-markets-a-joint-statement-between-the-cma-and-ofcom (Accessed: 14th July 2022).

De Bruca, G. and Scott, J. (2006) Law and New Governance in the EU and US. Oxford: Hart publishing.  

Demeritt, D., Rothstein, H. and Beaussier, AL. (2015) ‘Mobilizing risk: explaining policy transfer in food and occupational safety regulation in the UK’, Environment and Planning, 47, pp. 373-391.
https://doi.org/10.1068/a140085p

Dolowitz, D. P. and Marsh, D. (1996) ‘Who Learns What from Whom? A Review of the Policy Transfer Literature’, Political studies, 44(2), pp. 343-357.
https://doi.org/10.1111/j.1467-9248.1996.tb00334.x

Dolowitz, D. P. and Marsh, D. (2000) ‘Learning from Abroad: The Role of Policy Transfer in Contemporary Policy Making’, Governance, 13 (1), pp. 5–24
https://doi.org/10.1111/0952-1895.00121

Etienne, J. (2015) ‘The politics of detection in business regulation’, Journal of Public Administration Research and Theory, 25(1), pp. 257-284.
https://doi.org/10.1093/jopart/muu018

Everett, C. (2019) How can the public sector successfully manage change? Available at:  https://www.govtechleaders.com/2019/02/04/how-can-the-public-sector-successfully-manage-change/ (Accessed: 15th July 2022).

GDS (2021) 5 benefits of making blueprints when you build or improve a service. Available at:  https://services.blog.gov.uk/2021/03/17/5-benefits-of-making-blueprints-when-you-build-or-improve-a-service/ (Accessed: 15th July 2022).

Gerbec, M. (2016) ‘Safety change management – A new method for integrated management of organizational and technical changes’, Safety Science, (100), pp. 225-234.
https://doi.org/10.1016/j.ssci.2016.07.006

Gunnigham, N. and Sinclair, D. (2017) Smart regulation in Drahos, P. Regulatory Theory: Foundations and applications, pp. 133-148.

Ham, C. (1999) Improving NHS performance: human behaviour and health policy. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1117210/. (Accessed: 15th July 2022).

Hampton, P. (2005) Reducing administrative burdens: effective inspection and enforcement. Available at: https://www.regulation.org.uk/library/2005_hampton_report.pdf (Accessed: 14th July 2022).

Haughey, D. (2021) RAID Log. Available at: https://www.projectsmart.co.uk/tools/raid-log.php (Accessed: 17th August 2022).

HM Treasury (2018) Guide to Developing the Programme Business Case. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/749085/Programme_Business_Case_2018.pdf (Accessed: 14th July 2022).

Hooper, N. (2019) Can you achieve transformation without change management? Available at: https://www.govtechleaders.com/2019/05/22/can-you-achieve-transformatio… (Accessed: 15th July 2022).

Lercel, D. (2019) ‘Gaining Perspective of an Industry's Readiness for Regulatory Change: A Case Study From the Aviation Industry’, Journal of Management and Strategy 10, (3), pp. 15-26.
https://doi.org/10.5430/jms.v10n3p15

Lodge, M. and James, O. (2003). ‘The limitations of ‘Policy Transfer’ and ‘Lesson Drawing’ for public policy research’, Political Studies Review, (1), pp. 179-193.
https://doi.org/10.1111/1478-9299.t01-1-00003

Martinez, M., Verbruggen, P., and Fearne, A. (2013) ‘Risk-based approaches to food safety regulation: what role for co-regulation', Journal of Risk Research, 16(9), pp. 1101-1121.
https://doi.org/10.1080/13669877.2012.743157

May, P. (2007). ‘Regulatory regimes and accountability’, Regulation & Governance, 1, pp. 8-26.

Moore, VL. (2020) ‘Leaving hospital: a step too far for risk-based regulation?’, Medical Law Review, 28(4), pp. 675-695.
https://doi.org/10.1093/medlaw/fwaa015

Mustchin, S. and Martinez Lucio, M. (2020) ‘The evolving nature of labour inspection, enforcement of employment rights and the regulatory reach of the state in Britain’, Journal of Industrial Relations, 62(5), pp. 735-757.
https://doi.org/10.1177/0022185620908909

Mustchin, S. and Martinez Lucio, M. (2022) ‘The fragmenting occupation of labour inspection and the degradation of regulatory and enforcement work inside the British state’, Economic and Industrial Democracy, pp. 1-21.
https://doi.org/10.1177/0143831x221078337

National Audit Office (2021) Principles of effective regulation. Available at : https://www.nao.org.uk/wp-content/uploads/2021/05/Principles-of-effecti…. (Accessed: 15th July 2022).

National Audit Office (2022) Departmental Overview 2020-21 Regulation. Available at : https://www.nao.org.uk/wp-content/uploads/2022/03/Departmental-Overview…. (Accessed: 15th July 2022).

National Audit Office (2019) Regulation Overview 2019. Available at: https://www.nao.org.uk/wp-content/uploads/2020/03/Overview-Regulation-2…. (Accessed: 15th July 2022). 

National Audit Office (2017) A short guide to regulation. Available at: https://www.nao.org.uk/wp-content/uploads/2017/09/A-Short-Guide-to-Regu… (Accessed: 15th July 2022).

National Audit Office (2016) Performance measurement by regulators. Available at: https://www.nao.org.uk/wp-content/uploads/2016/11/Performance-measureme… (Accessed: 15th July 2022).

Neves, P. (2009) ‘Readiness for Change: Contributions for employee’s level of individual change and turnover intentions’, Journal of Change Management, 9(2), pp. 215-231.
https://doi.org/10.1080/14697010902879178

OECD (2021) Regulatory Policy Outlook 2021. Available at: https://www.oecd-ilibrary.org/sites/38b0fdb1-en/1/3/1/index.html?itemId…. (Accessed: 15th July 2022).

Ostroff, F. (2006) ‘Change management in government’, Harvard Business Review, 84(5), pp. 141-7, 158. 

Ozga, J., Baxter, J., Clarke, J., Grek, S. and Lawn, M. (2013) ‘The Politics of Educational Change: Governance and School Inspection in England and Scotland’, Swiss Journal of Sociology, 39(2), pp. 205-224.

Patterson, L. (2011). ‘Regulation of the NHS – is it working?’, Clinical Medicine, 11(6), pp. 517-18.

Price, T., Tredinnick-Rowe, J., Walshe, K., Tazzyman, A., Ferguson, J., Boyd, A., Archer, J. and Bryce, M. (2020) ‘Reviving clinical governance? A qualitative study of the impact of professional regulatory reform on clinical governance in healthcare organisations in England’, Health Policy, 124(4), pp. 446-453.
https://doi.org/10.1016/j.healthpol.2020.01.004

Regulatory Policy Committee (2014) Regulatory Policy Committee: recommendations used when scrutinising impact assessments. Available at:  https://www.gov.uk/government/publications/how-the-regulatory-policy-co… (Accessed: 15th July 2022). 

Richardson, E., Walshe, K., Boyd, A., Roberts, J., Wenzel, L., Robertson, R. and Smithson, R. (2019) ‘User involvement in regulation: A qualitative study of service user involvement in Care Quality Commission inspections of health and social care providers in England’, Health Expectations, 22(2), pp. 245-253.
https://doi.org/10.1111/hex.12849

Shea, C., Jacobs, S. R., Esserman, D. A., Bruce, K. and Weiner, B. J. (2014) ‘Organizational readiness for implementing change: a psychometric assessment of a new measure’, Implementation Science, 9(7).
https://doi.org/10.1186/1748-5908-9-7

Vickers, I. (2008) ‘Better regulation and enterprise: the case of environmental health risk regulation in Britain’, Policy Studies, 29(2), pp. 215-232.
https://doi.org/10.1080/01442870802033514

Discussion guide

Background for moderators 

The FSA has commissioned Ipsos UK to conduct research to better understand how other industries and regulatory bodies have introduced their own regulatory change programmes, and how the FSA can use some of these ideas for their own future programme.

These interviews will involve engaging with key stakeholders from different regulatory bodies and highlighting the different approaches they have taken in actioning their own regulatory change programme. We are speaking with representatives from different regulatory bodies, who witnessed and were involved in change processes. 

The interviews will help inform our key findings and identify case studies to illustrate the different aspects that emerge in regulatory change programmes and how different organisations approached related challenges. 

The focus of discussions should be on what challenges regulatory bodies faced while introducing programmes, and how they overcame them. There should also be a focus on how effectively the regulatory body operates now that it has gone through this period of change, and how they have managed relationships with key stakeholders, of different sizes and influence, before and after the regulatory change.  

This interview discussion guide is designed to deepen our understanding and build on what we learnt during the desk-based research. The guide first introduces the purpose of the discussion and confirms consent. It then goes on to capture contextual background about the participant’s current role and the service their organisation provides. The guide then asks about how the organisation initially approached planning and implementing their regulatory change programmes. It will then consider how relationships with different stakeholders were affected by the regulatory change programme, before considering how successful the programme has been and what advice they could offer to someone who is planning to introduce their own regulatory change programme.

1.    Introduction and consent (5 minutes)

    Thank you very much for agreeing to take part in this interview. My name is [xxx], and I will be conducting the interview with you. 

    To begin with I’ll tell you a bit about who I am, what the purpose of this interview is, and what to expect. After that you can ask me any questions before we make a start. 

    I work for an independent research organisation called Ipsos UK, and the Food Standards Agency (FSA) have commissioned us to speak with a number of stakeholders across different industries and regulatory bodies. The Food Standards Agency regulates food in England, Wales, and Northern Ireland to ensure that the food we eat is safe and what it says it is. Achieving Business Compliance (ABC) is one of the FSA’s flagship programmes, aiming to make sure that consumers continue to have food that they can trust but in the rapidly evolving sector, acknowledges a need to regulate in smarter way. The food landscape has changed dramatically in the three decades since the current regulatory system was introduced. Although regulation has continued to evolve, our assurance model has not kept pace with the significant changes in the food industry. ABC endeavours to design new, responsive, regulatory approaches which are innovative and make best use of technology, data, and relationships. 

The purpose of this research is to better understand how other regulatory bodies have approached their own regulatory change programmes. It also seeks to understand if there any lessons that the FSA could learn from when introducing their own change programme. 

Please be reassured that the purpose of this interview is not to scrutinise you or [ORGANISATION]. By participating in this interview, you will help the FSA better understand regulatory change programmes across different sectors and identify ways to work alongside their various stakeholders. 

Information shared during interviews will be published externally in an anonymised report. This report will not identify any individuals who have been involved in the research. We will also produce a report with case studies of different organisations. If we would like to include your organisation as a case study in the report, we will provide you with an opportunity to review your contribution and suggest amendments before publication. This is because there is a chance that participants could be identifiable based on the case study write-up. You will also be able to request that the case study is not published and only used internally by the FSA. 

Any quotes that we use will be completely anonymous, with any identifying details omitted from the quote. Only the Ipsos project team will have access to your information, and this will be securely stored and deleted once the research has been completed. 

I do have a set of questions to guide us through this conversation, but we are mostly interested in your views and experience of working within [ORGANISATION] and approaching your own regulatory change programme, so we will let this conversation be led by you and what you have to say. 

This interview is completely voluntary, and so you are free to pause or end the interview at any point if you wish to. You can also decline to answer any question if you wish to or ask to come back to it later in the interview. 

If it is okay with you, I’d like to audio record the interview so that I can listen back to make sure that my notes accurately reflect what you have said. The recording will be saved securely in an encrypted folder, only accessible by the Ipsos project team, and will also be deleted once we have completed our report. 

    Are you happy for me to make this recording?  TURN ON RECORDING
    Can I confirm that you are happy to proceed with the interview?
    Now that I have talked through the approach, do you have any questions? 

▪    If you don’t right now, please do feel free to ask me any that come to your mind as we go through the discussion. 
    Are you currently in a comfortable and quiet space to start the discussion? 
    If not, I am happy to call back in 5 minutes once you are.

    2. Background (10 minutes)

Would you be able to introduce yourself for the recording and tell me a bit about your role? 
    How long have you worked at [REGULATOR]? 
    What areas does your agency/ department regulate?
    What was/is your role within the change programme?
I’ve got a number of questions designed to understand more about specific elements of [PROGRAMME]. First, it would be great to have a summary of the programme and the wider context for regulatory change. 

Would you be able to summarise what the programme was trying to achieve? 
    When did the change programme begin and finish [if relevant]?
    What timescales were involved? Was this phased at all? 
    What was the scale of change involved in the programme? 
    How many organisations were affected? 
    Probe if relevant: What different approaches were taken to inspection:
    Changes to inspection frequency?
    Virtual or in person inspections?
    Changes to unannounced inspections?

What was the key problem(s) the programme was trying to solve? 
    What did the evidence base look like? How did you go about building this evidence base? 
    Were there any wider contextual factors that influenced the design or delivery of the programme at the time? 
    Probe if relevant: Did COVID-19, and any changes you were forced to make as a result of the pandemic, influence the intentions of the regulatory change programme?

    3. Planning and implementation (15 minutes)

Thank you, that’s really helpful to understand. I’m now going to ask some questions about how [ORGANISATION] went about planning for the new regulatory change programme, and how [ORGANISATION] implemented it. 
Moderators to adapt based on the type of organisation e.g. international. 
How did you approach designing the change programme? 
•    How did you engage with internal stakeholders during the design phase?
o    Probe if relevant: Did you encounter any major challenges/ pushback from internal stakeholders? 
•    Did you commission any research? 
o    Probe: with industry? Experts? Public?

Did you identify any risks or challenges at the outset? 
    How did you approach mitigating them?
    Probe: Information, infrastructure, technology, legislative changes, behaviour change  
What influenced the decision to implement the programme when you did? 
    Why was it the right time for this kind of change? 
    Had this change been considered previously/ have there been any previous attempts to introduce the change programme?

What was needed to deliver the programme? What were the critical components and dependencies?
    Probe: information needs, infrastructure, technological changes, behaviour changes (businesses/ public)
    Was legislative change required? How did this affect delivery? 

Overall, what key challenges did you face in implementing the changes?
    In practice, what were the key issues for delivery? How similar/different were these to the risks and challenges you identified?
    PROBE: resourcing, external stakeholders, internal organisational change, perceptions of certain businesses/ groups (for example, SMEs), public sector organisations (e.g. schools/ hospitals etc) being disadvantaged by the changes 

What would you do differently if asked to deliver the programme again? 
    What would you not change?

    4. Relationships (15 minutes)

Thank you, that’s very useful. The next area I’d like to explore further, is how you managed relationships as part of the change programme. 

Can you provide a brief overview of the different stakeholders connected with [PROGRAMME]?
•    Who were the key stakeholders involved? 
o    Probe if relevant: Businesses (small, medium, large), Government Departments, Local Authorities, Public Services, Public 
o    Did any have more power or interest than others? 
•    What type of relationship did they have with [REGULATOR]?

How did you manage the relationship with industry/regulated organisations during the changes?
    [If not covered above]: how were they engaged in the design stages of the programme? 
    How were they engaged during the early stages of implementing the programme? 

What kind of relationship did you want to develop between regulators and industry? 
    Probe: Did the changes require industry/regulated organisations to take greater responsibility, ownership, accountability? 
    If so, how did you encourage behaviour change? 
    Were there shared objectives, or did industry and regulated organisations have different priorities? How/to what extent was this overcome?
    Probe if relevant: How do you maintain clarity about your role as a regulator/enforcer while building partnerships and encouraging cooperation?
How successful were you in managing these relationships?
    What kinds of challenges did you face? How did you overcome these? 
    Probe if relevant: Were there any challenges that could not be overcome and how did this impact the change programme?
    How did your relationships with stakeholders change during the implementation of the programme? 
    What, if any, challenges remain?
How did you communicate the changes in regulation to the public? 
    Are the public aware of the changing relationship? Why/why not? Does this matter?
    What level of public interest was there before introducing the changes?
▪    Probe if relevant: If you did not communicate with the public, what factors influenced this decision?
    What challenges did this raise and how did you overcome them?
    Probe if relevant: How did you make sure the public were clear that you still have a role as the regulator (for example, not self-regulation)?

    5. Outcomes (10 minutes)

To what extent did the programme achieve the intended outcomes?
    Probe: High level view of the impact of change on the industry, regulator, and other key stakeholders.
    Did any risks arise that you had not anticipated? 

How did you measure the final benefits and value of the programme? 
    Qualitative/ quantitative methods? Another method?

What (if any) unforeseen / unintended consequences resulted from the changes?
    How were these overcome? 
    If the consequences were positive, how did you get the maximum potential out of this?
What advice would you give to someone involved in implementing a regulatory change programme? 

    6. Wrap up (5 minutes)

Thank you so much. We are nearly at the end of our conversation. Reflecting on what we have spoken about:
    Has your regulatory change programme worked as intended?
    What was the biggest challenge to introducing regulatory change?
    If you were to have the time again, is there anything you would do differently?
    Are there any other regulatory bodies and regulatory change programmes, either national or international, that you are aware of and think we should be speaking to?
Before we finish, is there anything else is there anything you feel is important that we haven’t covered today that you’d like to share? 

Explain next steps of research and recontact:
    We are producing a report to share with the FSA that describes how other bodies have approached their own regulatory change programmes. 
    .
    We would like to know if we can contact you again if there is anything further we’d like to ask you or to get your feedback on findings to ensure it reflects all of the relevant detail. For example, we would like to get back in touch if we are considering using your organisation or change programme as a case study, to check you are happy for us to do so as this could be identifiable in the report. Are you happy for us to contact you in the future, either via phone or email?
    The FSA is interested in building relationships with other regulators who have been through similar change programmes to act as ‘critical friends’. Would you be happy for us to pass on your contact details to the FSA team? This will not change the anonymity of your contributions today as we will not be sharing any identifiable details from the interview with the FSA.  
    Thank You.