Designing a Quality Management System for the NHS

At a recent webinar convened on behalf of the Quality Management System Special Interest Group, myself and Q colleagues explored how an NHS organisation could design a quality management system (QMS) to manage the quality of its outputs.

I put forth that a QMS begins with designing a product or service realisation system that meets your customer’s requirements. The next step is to manage the processes that form your product or service realisation system. This allows you to ensure that work activities are compliant and the quality of your outputs is assured.

For an organisation to claim that it has a QMS in place, it needs to have systematically documented and recorded results within a specific time frame that demonstrate how the product or service realisation system meets the customer’s requirements.

It must also show that the work activities are compliant to the requirements of this system. The records must include any examples of non-conformance and be able to show, via an audit trail, any corrective and preventative action taken. Organisations must also document their structure, and provide information on key responsibilities and organisational policies.

The success of your QMS is down to how you manage the design and process of your organisation. To do this methodically is not a simple task. Quality management is not a new activity and over the years ISO9001 has evolved to become a widely used standard for a QMS in the UK and Internationally.

An organisation’s compliance to ISO9001 can be a ​‘work in progress’ project, and an organisation may take some number of years to achieve full compliance.

During the webinar, a number of participants pointed to the variation in how language is used in the NHS as compared to QMS, and the challenges that this presented. 

Quality management is a mature profession. The Chartered Quality Institute has existed for over 100 years in the UK and quality management terminology is very well defined. If they are to demonstrate quality assurance to their stakeholders, most of whom are not employees of the NHS, the NHS could consider adopting existing QMS terminology. 

In my view, discussion about language should not dominate or delay progress towards quality management in the NHS.

In the literature of QMS, W. Edwards Deming is well known for the development of the Plan Do Study Act (PDSA) cycle and his work on product or service design and realisation processes. The work of Deming and Joseph M. Juran form the basic building blocks around which standards for quality management systems have evolved. Within Deming’s body of work, my favourite is the Red Bead experiment. 

The video clips are worth watching. Juran further developed the PDSA cycle and it became known as the Plan Do Check Act (PDCA) cycle and is the most widely used version in quality management. My favourite is his Trilogy, Quality Planning, Quality Control and Quality Improvement.

Please note that in this context, the term ​‘quality improvement’ has a different meaning to NHS quality improvement. I’ve produced some notes on this.

Please note that in this context, the term ​‘quality improvement’ has a different meaning to NHS quality improvement. I’ve produced some notes on this.

With reference to my notes on Juran’s Trilogy, we need to consider Juran’s two types of beneficial change. The first relates to changes to the product/​​service offered or the design of their realisation system. This compares most to what the NHS call QI. 

The second relates to improvements to processes within the product or service realisation system to reduce non-conformance and error and increase effectiveness and efficiency. 

It is important to differentiate between these two types of change, as they require different techniques and should be undertaken by different work teams. It is also important to note that quality management is a technical activity.

The requirements (clauses) of an ISO9001 can be approached from both the top and bottom. The clauses highlighted in red are more relevant to the top team and those in blue to front line staff. Help will be required from an experienced quality professional in undertaking this activity. Establishing a design team and a quality management team may be a necessary starting point. Information technology, patient safety and maybe audit departments will already exist. 

Not included in the webinar index diagram is finance, which should be included as part of the project. A starting baseline should be established using some recognised maturity matrix tools and progress measured periodically.

For me this is one of the key outcomes from implementing a QMS. First ​‘error’ or non-conformance needs to be defined for the NHS. A process management system, designed to be part of a QMS, will address the problem of error. 

Process management has two key aims, first to reduce the number of steps in a process (simplify), and second to eliminate error or non-conformance in its application (error proofing). 

The process management system can be designed as a learning system as illustrated below.