Aspects of total quality management in a fertility clinic setting

Long before Six Sigma and ISO 9000, and even before Relationship Marketing, we had Total Quality Management (TQM). This process-management philosophy was based on tried-and-tested tools and techniques of quality control used in manufacturing production in the 1980s.

Wikipedia states, “TQM consists of organisation wide efforts to install and make permanent a climate where employees continuously improve their ability. This provides on demand products and services that customers will find of particular value.”

In the late 80’s and early 90’s this management fad took hold. It became religious orthodoxy in organisations from the pharmaceutical industry to clinical departments in public health settings.

As a senior manager in the Pharmaceutical industry, I used to travel the UK to host training. These two-day sessions focussed on the art of TQM. My audience were groups of 20-30 senior nurses, so I can verify the popularity of the TQM phenomenon back then. The courses were always oversubscribed and expensive. People travelled long distances to stay in hotels just to get the prized ‘Certificate Of Attendance’ at the end!

TQM, in its entirety may not have stood the test of time. It was superseded by other management fashions, but aspects of it can still be very important.

There are three reasons for this:

  1. TQM is based on proven aspects of quality assurance in production. These had seen immense strides in the quality of all aspects of consumer goods in just one decade. This can be seen in the dramatic improvements in consumer goods from the 1970s to the 1980s. For instance, the improvement in Japanese cars, which saw them overtake and eventually destroy British competition in the car industry.
  2. TQM is flexible. It can it be adapted to all kinds of environments from car manufacturing to the healthcare setting.
  3. TQM is scalable, whereas Six Sigma and later management models suit large scale organisations. For example, corporations with thousands of employees. TQM being more generic is also perfect for small organisations such as fertility clinic.

TQM in a fertility setting

Writing about TQM as it might apply in all its aspects to the fertility setting would be quite a task! Maybe even a whole book, so I’m not going to embark on that task! Instead, let’s take a look at an aspect where TQM can make a real difference to management of a fertility clinic.

When setting up a TQM Quality Management System (QMS) for a fertility clinic, end points that could be considered might be:

  • Designing clinical processes
  • Designing laboratory processes
  • Setting clinical processes
  • Writing standard operating procedures
  • Setting up document control such as record keeping, maintenance and protocols
  • Creating protocols for staff training and competence
  • Joining quality assurance schemes, for instance for semen analysis
  • Internal auditing protocols
  • Procedures and protocols for gaining requisite certification

This is not an exhaustive list by any means. It just gives an idea of the sort of things that need to be in place. The goal is for the QMS to match one of its key TQM requirements – managing risk.

TQM and risk management

In the field of fertility there is a chance of risk to the patient. That is the nature of the service provided. Therefore, one of the most important strategies of any QMS is to reduce the chance of risk. Risks can fall into the following categories:

  • Physical safety such as avoiding ovarian hyperstimulation syndrome
  • Legal safety e.g. ensuring the right gametes are utilised
  • Psychological safety such as duty of care to the patient
  • Moral safety – the use of ART according to acceptable cultural norms.

How can we begin to consider a simple risk-focused approach to TQM in a fertility clinic?

  1. Set the mission statement, goals and key performance indicators (KPIs) for the organisation

In setting the mission statement, a good question to ask is ‘Why does the organisation exist?’

The answers might be multifold, in which case it is a good idea to brainstorm all the phrases and words. Write them down in order to distil the essence into a few succinct and clear sentences. The mission statement should define the stakeholders and prioritise them. For instance, the primary stakeholders will be the patients.

From the mission statement come the goals. These are the what the organisation wishes to achieve for its stakeholders in particular patients. In terms of risk is important that one of the main goals pertains to patient safety.

The idea of key performance indicators (KPIs) is that goals can be quantitatively measured over a viable timeframe. You can do this annually, quarterly or monthly for specific parameters.

In the case of safety goals there will be multiple KPI’s. For example, you may want to log the number of incidents of ovarian hyperstimulation syndrome.

A QMS action could be a KPI dashboard of all the performance indicators is updated monthly and shared with staff.

  1. Incident reporting

Robust systems of incident reporting are an important part of the TQM method. This is for three reasons:

  • Failures of process can be seen in real time and remedied immediately.
  • Solutions to failures of process can be logged so it’s available if there are future failures.
  • Analysis of a number of failures can lead to a system overhaul, which prevents such failures from repeating in future.
  1. Adopting a risk registry approach

A risk registry is simply a list of common risks that the organisation is likely to face. This can be refined from time to time as incident reporting refines it. It should contain all the things that you think could jeopardise the success of the clinic. This could be from IVF related risks such as equipment failure, through to business risks such as interruption of communications. An example of this could be a computer virus attack, or denial of internet service for technical reasons. Risks can be assigned according to likelihood, consequences and severity. The means of dealing with risk should link into the clinic’s SOP’s.

  1. Mitigation of risks

This is QMS refinement of the risk register. Each risk should have one or more ways of reducing its impact if it occurs or its chance of occurring. These means of dealing pro-actively with risks are known as risk mitigation. Many will be generic rather than specific to fertility. For instance, the training of staff to requisite levels of competency would fall in the area of generic risk mitigation. The use of single embryo transfer to prevent the chance of multiple birth falls under specific risk mitigation. It is useful to list risk mitigation as a table in the risk register. At a glance you can see how well a clinic is addressing each risk. This is an important part of risk management in TQM.

  1. Internal auditing process for risk

Like most of TQM, audit is a simple process. In terms of your QMS, it addresses risk. It simply means tests your risk mitigants periodically. This ensures that they are still viable and working as you anticipate.

It is designed, by stress testing every so often. This ensures you find the gaps in your risk management before they cause a problem in a real risk situation.

Listing, dating and signing when the mitigant was tested in the risk register is good practice. This QMS protocol ensures compliance with the TQM safety goals a clinic sets for itself.


Although the jargon of management has moved on from the pre-Internet 1980s, it is clear that TQM is still a gold standard. Its application in the management of smaller organisations such as fertility clinics is still relevant. It covers all the necessary areas without being overly complicated, or requiring huge amounts of staff input. And it can be monitoring it in real time.

Neil Madden, Editor

The Fertility Hub

References and further reading

  1. Hackman, J. R., & Wageman, R. (1995). Total quality management: empirical, conceptual, and practical issues. Administrative Science Quarterly
  2. Powell, T. C. (1995). Total quality management as competitive advantage: a review and empirical study. Strategic Management Journal
  3. Fleming, S.D., & Varghese, A.C. (2016). Organization and management of IVF units. Springer Publishing