The development of healthcare quality is associated with the profession of medicine as a craft, with quality based almost solely on the skill of the ‘craftspeople’. As outlined by Leggat in Chapter 2, this craft-based approach to professional practice vested the control of quality with individual clinicians more at an implicit level, within the overall scope of their professional practice. Consequently, the competence of individual practitioners is a major contributor to the delivery of high-quality care, something that has traditionally been regulated through controlling entry into the profession and upholding standards of professional education.

The influence of the craft-based model is apparent in some of the early approaches to quality evaluation in medical practice. For example, in outcome-related morbidity and mortality studies, clinical case conferences and the early introduction of medical audit, the emphasis was on closed discussions about quality and standards, typically through applying peer review methods (Harvey 1996). As quality became a more prominent feature in healthcare policy, so too more formal requirements for doctors to engage in quality and audit emerged, for example through the mandatory introduction of medical audit in the UK in the late 1980s (Department of Health 1989). For some doctors, these changes were seen as a threat to the traditional craft-based organisation of medical work, resulting in resistance to medical audit and distinctions being drawn between audit as an internal, peer review activity and audit as an external, regulatory mechanism (Shaw 1980).

Throughout these developments, a number of prominent clinicians have challenged traditional ways of thinking and pioneered developments in medical quality evaluation and improvement. As early as 1916, Ernest Codman, a US surgeon, used and published the ‘ends results’ system of auditing surgical care (Codman 1916). In the 1960s and 1970s, Avedis Donabedian went further, presenting quality as a multidimensional concept, influenced not just by the technical quality of care, but also by features of the interpersonal relationship between doctor and patient and by the physical amenities of care (Donabedian 1966). He is perhaps best known for his structure–process–outcome model of quality.

More recently, influential figures such as Don Berwick have led the way in calling for a move beyond medical audit towards more improvement-based approaches to quality (Berwick 1992) largely because of perceived failures to act on the results of audit to achieve meaningful change. In refocusing efforts towards the action phase of audit, the medical profession needs to look beyond its immediate sphere of knowledge and experience defining and measuring standards and criteria, towards more general theories of organisational change and industrially based approaches to quality improvement. As such, the narrow evaluation of practitioner performance needs to be widened to a more patient/client-focused view of quality, with clinicians taking on a so called new set of ‘clinical skills’, including skills in teamworking, process analysis, guideline development and collaborative working with patients, managers and other professional colleagues (Berwick et al 1992).

Other professional groups in healthcare have been less influenced by the craft-based model of practice, largely as a result of their position in the professional hierarchy relative to medicine. The nursing profession, for example, had their own pioneer of quality and standards in the early work of Florence Nightingale. However, early developments in nursing quality evaluation were largely focused on methods of external monitoring, through the development and application of quality indicators and measurement instruments (Harvey 1996). Such developments were superseded by more practitioner-based methods that typically involved local teams of practitioners working together to identify and work on topics for improvement. These approaches had more in common with industrially based approaches such as quality circles, although sometimes failed to become integrated within overall organisational systems for quality management (Morrell et al 1997). More recent clinically focused initiatives such as practice development in nursing that aim to transform the context and culture of care (McCormack et al 2004) may have the same effect.

More recently, developments emanating from the evidence-based medicine movement and from public inquiries into major healthcare failures have introduced a number of new concepts to the field of clinical quality, which may have the potential to create better integration with organisational quality. The evidence-based practice agenda, with its focus on synthesising existing research through systematic review methods, has contributed to the development of clinical guidelines, described as ‘systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances’ (Institute of Medicine 1992, cited in Duff et al 1996:888). A key defining attribute of clinical guidelines is that they should be based on available research evidence (Duff et al 1996) and the focus on distilling evidence of clinical and cost effectiveness into recommendations for clinical practice is an attempt to standardise care, within the operations management methods outlined by Leggat in Chapter 2. However, despite the extent of investment in guideline development, evidence to date suggests that their impact on actual practice and patient outcomes is variable (Grimshaw et al 2004), highlighting the challenges and complexities involved in translating evidence into practice.

Care pathways are another tool that has been applied in healthcare in an attempt to standardise processes of care delivery (see Claridge & Cook, Chapter 4). Pathways have been used in different ways, for example as a way of translating national guidelines into local practice or as a way of mapping ideal processes for specific care groups. Typically they are presented as structured, multidisciplinary plans of care designed to support the implementation of clinical guidelines and protocols, providing guidance about each stage of the management of a patient with a particular condition, including details of both process and outcome. They aim to improve continuity and coordination of care and enable more effective resource planning, as well as providing comparative data on many aspects of quality of care. Claims made are that they reduce variation and improve outcomes (Middleton et al 2001).

Clinical governance, defined as the ‘action, the system or the manner of governing clinical affairs’ (Lugon & Secker-Walker 1999:1), developed as an overall strategy within a policy on quality in the UK’s National Health Service (NHS) (Department of Health 1989). After a high-profile failure of care in a hospital providing paediatric cardiac surgery services that highlighted organisational shortcomings (Kennedy 2001), statutory changes were introduced to impose a legal duty of quality on the chief executives and boards of NHS organisations, for the first time creating a corporate responsibility for the quality of clinical care. The significance of this is apparent in cases where poor clinical quality is observed and the boards of healthcare organisations are held to account for this, as opposed to individual clinicians or clinical teams, as illustrated by the case study in Box 10.1 later in the chapter.

In summary, developments in clinical quality have been professionally led and reflect the different traditions and ways of working within the profession. As a consequence, a range of healthcare definitions and ‘dimensions of quality’ have developed (see Table 10.1). Over time, there has been a move away from uniprofessional, clinical quality initiatives towards more multiprofessional, patient-centred models that are integrated within wider organisational structures and processes. This, in turn, has led to increasing awareness and application of some of the industrially based approaches and techniques that are described in the next section.

The concept of ‘quality’ in industry can again be argued to have developed from early models of production management (see Leggat, Chapter 2) but was formalised through Shewhart’s work on statistical process control (SPC) in the 1920s (Shewhart 1931) with the result that ‘the management of quality acquired a scientific and statistical foundation’ (Kolesar 1993:319). Many of the concepts of SPC are now being applied in healthcare with evidence that ‘SPC is a versatile tool which can help diverse stakeholders to manage changes in healthcare and improve patients’ health’ (Thor et al 2007:387).

The concepts of quality then were developed by a number of key figures (‘gurus’). Four in particular stand out:

Until the 1980s most of the emphasis on quality improvement, and most of the empirical utilisation of the associated techniques, was within the manufacturing industry. However, the field of ‘service quality’ developed initially from a marketing focus (Groonroos 1984) but relatively little attention is paid explicitly to the ‘service’ aspects of healthcare quality. This is despite the fact that many of the philosophies that underpin industrial quality improvement and the techniques that are associated with it are increasingly being applied in the healthcare sector in both the US and Europe.

During the same period there was also an increasing emphasis on overall organisational approaches to quality improvement, such as total quality management (TQM): a ‘set of powerful interventions wrapped in a highly attractive package’ (Hackman & Wageman 1995:339). Its attractiveness may have been its apparent simplicity; it offers ‘a unified set of principles which can guide managers through the numerous choices [open to them] or might even make choosing unnecessary’ (Huczynski 1993:289). Similar claims have been made for other packages of improvement such as business process re-engineering (BPR) (McNulty & Ferlie 2002).

Other techniques that are also described as approaches to quality improvement include six sigma, an improvement approach initially developed by Motorola in 1987. A sigma score represents the amount of variation in a process, and the term ‘six sigma’ refers to a process that has at least six standard deviations (6σ) between the process mean and the nearest specification limit, that is, a defect rate of 3.4 parts per million. Many argue that six sigma is both a set of improvement tools and an overall philosophy, with the tools ‘strikingly similar to prior quality management approaches’, although the way in which six sigma is implemented is claimed to ‘represent a new organisation structural approach to improvement’ (Schroeder et al 2007). The evidence for applying six sigma in healthcare is limited (Sehwail & DeYong 2003) and often methodologically weak with studies based on the assumption that six sigma can be applied in healthcare, rather than whether it is appropriate.

The concepts from lean thinking based on the Toyota Production System (Womack & Jones 1996) have become popular recently in healthcare. Although there are now reviews of its implementation in the public sector (Radnor et al 2006), including health (Kollberg et al 2007), there is as yet little systematic evaluation of its impact.