‘You can’t inspect for quality!’ I don’t suppose there are many people who work or study in the world of quality improvement in either industry or healthcare that can’t have heard that phase, or a phrase like it. Quality control is not quality improvement.
Deming said ‘Cease dependence on inspection’ (1984) and Crosby said ‘Make Certain’ (1996) and more recently Berwick has said culture and leadership are key for safety and zero harm, rather than regulation (2013). For certain, for me, getting it right first time rather than finding defects or harm after the fact has got to be better for staff, customers, patients and the bank balance. Crosby indicated that the price of non-conformance (PONC), i.e. not meeting requirements first time, was as much as 40% of costs in service organisations, and widening that out, in healthcare, the costs of poor prevention or lack of preventative care in people’s homes and lifestyles are huge. So it seems inherently sensible to focus on prevention, (of poor health and healthcare), ensuring that requirements are defined (and keep being improved) and teams are trained in delivering them right first time, and that services around them support this to happen and keep improving as the requirements change, making certain of zero defects and zero harm.
So, imagine my slight hesitation when thinking of doing my PhD on the topic of regulation, in healthcare. That slight internal cringe when I think of inspection and quality and the internal voice saying ‘you can’t inspect quality into a product or service’. That brief look of horror that (I feel) flashes across my professional quality improvement peers’ faces when I tell them the topic area for my PhD.
The thing is, despite my enthusiasm for improvement from within organisations and engrained belief that you can’t inspect for quality, I am aware that few start seriously at improvement, even fewer stick at it for long enough to reap the benefits, and many of us are aware it often it ‘fails’, hence sadly other strategies to ensure quality, and safety are needed instead. It is often quoted that as much as 95% of improvement programmes ‘fail’. Why is less clear, reasons include too high expectations, ‘context’, poor implementation – project management, measurement and improvement techniques, lack of resources and time, poor priority setting, unions and others unwillingness to engage through fear and protectionism – sometimes justified, sometimes less so, a focus on cost not the customer or patient, negative environments unwillingness to experiment and take risks, and most of all, lack of leadership commitment throughout the organisation. And yet the potential benefits are huge, for safety and quality as well as a reduced reliance on inspection and its costs, so the $1M dollar question for me is, what can help with all this? Is it just we all need more skills, do we all just need more training and experience, more improvement collaboratives or leadership development, or maybe system wide approaches, such as regulation are too part of the answer.
The evidence states that whilst regulation has problems of its own, such as provider capture, ritualistic and bureaucratic compliance – ‘red tape’ – generated through fear of failure, and standards ossification, which are often the reasons used in arguments against regulation; regulation can also be used to mitigate some of the problems with organisational improvement, helping to reduce some of the problems that are faced. It can be described as ‘rules’ to impose behavioural practices (Brennan, 1998), but it is not just inspection against those rules. It is also about standard setting, credentialing and certification, oversight, third party accountability, sharing best practice between organisations, and helps to provide public assurance (Walshe, 2003, pp19-22; Boyd and Walshe, 2007) and is described often as that ‘third line of defence’ against problems including inadequate and unsafe care, monopolistic provision and exponentially growing costs.
Getting it right first time every time is also the goal, for regulation, but they also have a role of public assurance too. In ‘Out of the Crisis’, (Deming, 1984 , pp261-262) whilst overall suggesting that inspection should be kept to the minimum, he did acknowledge that for some things, like ‘extra high quality’ and to maintain a reputation for safety and accuracy, 100% inspection is still needed, and gives examples, of filling out pharmacy prescriptions and also interestingly for banking calculations!!
So how can regulators, not just inspect where safety is critical but also work to prevent and ‘make certain’ that there is little for them to find and that this keeps reducing and so reducing the need for inspection and this price of non-conformance? How can regulators work too, to prevent errors, defects and harm, so that they don’t exist to be found? How can they work harder to encourage organisational improvement (through teams not just heroic improvement individuals who might leave), and ensure improvement behavioural practices within those they regulate and lead by example through their own improvement work? Do they / Could they ask how improvement is being built into, normalised and embedded in the routines and practices of day job and teams, rather than occasionally highlight the odd great project or individuals that demonstrated special effort and results? How can they help when there is leadership transition and organisational crisis (sometimes resultant of regulatory intervention), when leadership continuity is critical, to ensure that any embryonic or existing improvement continues and the proverbial baby isn’t thrown out with the bathwater? How can they ensure that learning from failure is captured and valued, that ideas and techniques that work in one area are transferred quickly to others and adapted to the new environments, with a role not just looking and sharing the ideas, but also checking if they have been evaluated and adapted for local use and implemented where appropriate quickly, not stuck in endless committees, and helping (not overthrowing) internal teams to apply that little extra pressure where needed, to unstick things and/or increase their priority. Some of this is increasingly within regulatory frameworks for assessing leadership and board governance arrangements and being ‘well-led’, but improvement is more than leadership and/or strategy, it is also culture and technique (West et al., 2014) and whilst these areas are growing in concern for regulators and providers, they are areas where much more development and focus is needed.
So, I am changing my ingrained view, maybe ingrained through quality improvement dogma, about improvement, regulation, and inspection. There does seem to be a place for both, organisationally internally driven improvement and externally driven, system wide improvement, inspection and regulation. The challenge is how they work together, rather than sometimes as adversaries generating a climate of fear. How can organisations and regulators work much more in sync with each other towards common purpose, learning together, encouraging each other and holding each other to account to ensure they meet their ‘customer’ requirements? In healthcare this purpose, is surely about the health of the nation and this includes both the safety of the services provided, prevention and cure, and also the costs of those services and regulation of them, for each £1 spent in healthcare quality control and rectification, and on healthcare regulation, or care for health issues that could have been prevented, is potentially a £1 price of non-conformance, that cannot be spent elsewhere, for example in social care, schools or housing, preventing poor health in the first place.
Berwick, D. (2013) A Promise to Learn – A Commitment to Act. Improving the Safety of Patients in England. National Advisory Group on the Safety of Patients in England.
Boyd, A. & Walshe, K. (2007) Designing regulation: a review. A review for the Healthcare Commission of the systems for regulation and their impact on performance in seven sectors, and a synthesis of the lessons and implications for regulatory design in healthcare. Manchester, UK: Manchester Business School.
Brennan, T. A. (1998) The Role of Regulation in Quality Improvement. The Milbank Quarterly, 76(4), 709-731.
Crosby, P. B. (1996) Quality is still free: Making quality certain in uncertain times. New York: Mc Graw-Hill.
Deming, W. E. (1984) Out of the Crisis (1st MIT Press ed.). Cambridge, Mass.: MIT Press.
Walshe, K. (2003) Regulating Healthcare. A Prescription for Improvement? Maidenhead, UK: Open University Press.
West, M., Steward, K., Eckert, R. & Pasmore, B. (2014) Developing collective leadership for healthcare. London: The Kings Fund.