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Operational Transformation Programme – an Inspectorate view

Posted by: , Posted on: - Categories: Inside the Inspectorate, Wider MHRA

You may have already heard about the MHRA Operational Transformation Programme (OTP) through taking part in a customer survey, attended MHRA symposia, participated in a stakeholder meeting or engagement workshop with the Medicines Industry Liaison Group (MILG). But for those of you who haven’t, this blog will provide some background to the aims of the OTP and how the Inspectorate is rising to the challenge.

The case for change

We are currently facing a period of unprecedented change at the Agency linked to Brexit, relocation of our head office to Canary Wharf, and a major upgrade to our IT and operating systems. The OTP is designed to ensure we retain our position as a leading Agency at a time of considerable change and are best placed to meet developing customer needs. The aim of OTP is to revolutionise the way we work by redesigning, realigning and improving our functions and operations to maximise public health impact and to optimise our role in the health system. The objective is to ensure services are delivered in a way that demonstrates best value for money, in terms of cost, service quality and ultimate impact on public health, based on a broad external understanding of the opportunities, challenges and capabilities on which to base the Agency’s future direction.

Wow, that’s almost a full house on the business buzzword bingo, but what does this mean in practical terms and how is it impacting on the work of the Inspectorate?

Strategy into action

Light bulb with a number of thought clouds coming out of it. Starting at the top, the Agency has a business strategy and goals that are formulated into a Business Plan. The core objectives are then “translated “into Divisional Business Plans and cascaded down into manager and individual objectives. This helps staff visualise how what they do relates to the overall strategy and goals of the Agency. There are five strategic aims identified in the business plan, and whilst you may automatically associate the work of the Inspectorate with themes such as ‘enabling innovation’ and ‘secure global supply chains’, we also have a significant role to play on the ‘organisational excellence’ front, given that the OTP is identified as one of the top priorities in the MHRA business plan for 2017-2018 and beyond.

The Agency’s approach to OTP has been to involve colleagues in different roles, at different levels in all areas of the programme, and so the Inspectorate management team took the decision to assign dedicated resource to lead the Inspectorate inputs to the OTP going forward. Having joined the Inspectorate in 2005, I have worked across the GXP teams as an Inspector, Senior Inspector and Operations Manager. I therefore have both a current and historical understanding of the work we do, and so was asked to take on the role. I jumped at the chance, as I believed it would provide me with the time to refresh the knowledge I had gained from completing a Masters Degree in Quality Management and Business Process Improvement from my time in industry, as well as the opportunity to learn new skills, try new approaches and be creative.

Whilst there are specific activities and deliverables required by the OTP, the Inspectorate are using the programme as an opportunity to identify and review all key Inspectorate business processes with the aim of harmonising the way the Inspectorate works and to implement best practice across all areas of GXP.

Mapping our processes

Electrical circuit with connectionsThe Inspectorate is currently made up of five teams covering all areas of GXP. To date many of the Inspectorate’s key business processes have been aligned with specific Inspectorate groups and consequently have evolved independently of each other. We therefore wanted to use OTP as an opportunity to map all key business processes across the Inspectorate with the aim of identifying novel approaches, best practices and harmonising activities where practicable. As the project starts to identify and implement changes to business processes, the existing quality system will need to be reviewed and amended to ensure it is risk-based and appropriately focused. Finally, as new or revised business processes are implemented, we will need to establish metrics to allow the Inspectorate and divisional management teams to assess key performance indicators.

Progress so far

It’s still early days given the magnitude of the overall programme, but a few key achievements so far include:

  • completing a ‘Current Operating Model’ for the Inspectorate and wider division. This involved compiling information on volumes of services provided and financial details; external factors affecting the division; strengths, weaknesses, opportunities and threats; relevant legislation; key stakeholders and channels used to communicate; services, capabilities and processes; how people and teams are organised; and technology. This information will feed in to the development of a ‘Target Operating Model’ for how the Agency will work in the future.
  •  developing user requirements for a new inspection and licensing case management system to replace Sentinel. This involved mapping the ‘as is’ Inspectorate processes, identifying ‘pain points’, and establishing core requirements for the replacement system. This information will be used to develop a solution to transform the way IT supports the work of the Agency.
  •  supporting the introduction of new tools and equipment designed to make it easier to manage and access Agency and team information. This has involved the roll out of new laptops equipped with Office 365 and the introduction of SharePoint as a document management repository. This technology is being used together with the output from the Inspectorate business process improvement project to develop the Inspectorate SharePoint Team Site, to enable Inspectorate staff to connect with information and applications they rely on to perform their day to day roles.

 Next steps

So, depending on your personal view and appetite for change, it’s either exciting or daunting times ahead, and I hope to keep you posted on our progress in future blog posts. The OTP is a major and ambitious programme of work for the Agency, involving lots of change. In the Inspectorate, we embrace change and seek to improve.  After all, in the words of Winston Churchill:

“To improve is to change; to be perfect is to change often”.

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1 comment

  1. Comment by John Turner posted on

    Fascinating and confusing, very different to when I joined the Inspectorate of a dozen people forty-four years ago! But I guess the fundamentals don't change, probing, challenging and assessing what is actually happening in a facility to assure the quality of the product, always. I do enjoy your blogs in peaceful retirement.