Question

Identify two approaches to quality in healthcare (e.g., LEAN, Six Sigma, TQM, The Checklist Manifesto) in healthcare. How is the same or different than the application in other industries, e.g., manufacturing or commercial aviation? How are the metrics the same or different?

Answer 1

1. Six Sigma is a disciplined, statistical-based, data-driven approach and continuous improvement methodology for eliminating defects in a product, process or service. It was developed by Motorola and Bill Smith in the early 1980’s based on quality management fundamentals, then became a popular management approach at General Electric (GE) with Jack Welch in the early 1990’s. The approach was based on the methods taught by W. Edwards Deming, Walter Shewhart and Ronald Fisher among many others. Hundreds of companies around the world have adopted Six Sigma as a way of doing business.

   Sigma represents the population standard deviation, which is a measure of the variation in a data set collected about the process. If a defect is defined by specification limits separating good from bad outcomes of a process, then a six sigma process has a process mean (average) that is six standard deviations from the nearest specification limit. This provides enough buffer between the process natural variation and the specification limits.

   For example, if a product must have a thickness between 10.32 and 10.38 inches to meet customer requirements, then the process mean should be around 10.35, with a standard deviation less than 0.005 (10.38 would be 6 standard deviations away from 10.35), assuming a normal distribution.

   Six Sigma can also be thought of as a measure of process performance, with Six Sigma being the goal, based on the defects per million. Once the current performance of the process is measured, the goal is to continually improve the sigma level striving towards 6 sigma. Even if the improvements do not reach 6 sigma, the improvements made from 3 sigma to 4 sigma to 5 sigma will still reduce costs and increase customer satisfaction   

   However, not all levels are consistent and equal to each other, so it is important to ask questions about the topics covered and requirements needed to complete each belt level.

   Formal certification is recognized at the Green Belt, Black Belt and Master Black Belt level based on one or more of the following criteria:

2. Completion of training covering the body of knowledge
3. Years of work experience with the body of knowledge
4. Passing an exam covering the body of knowledge

5. Certification is typically authorized by consulting firms or industry organizations and membership groups.

   A combined Lean Six Sigma belt typically is an expanded or modified version of Six Sigma training with the addition of Lean principles and tools.

6. Completion of one or more Six Sigma projects

  

  

Total quality management (TQM) is the continual process of detecting and reducing or eliminating errors in manufacturing, streamlining supply chain management, improving the customer experience, and ensuring that employees are up to speed with training. Total quality management aims to hold all parties involved in the production process accountable for the overall quality of the final product or service.

TQM was developed by William Deming, a management consultant whose work had a great impact on Japanese manufacturing. While TQM shares much in common with the Six Sigma improvement process, it is not the same as Six Sigma. TQM focuses on ensuring that internal guidelines and process standards reduce errors, while Six Sigma looks to reduce defects.

KEY TAKEAWAYS

• Total quality management (TQM) is an ongoing process of detecting and reducing or eliminating errors.
• It is used to manufacture to streamline supply chain management, improve customer service, and ensure that employees are trained.
• The focus is to improve the quality of an organization's outputs, including goods and services, through continual improvement of internal practices.
• Total quality management aims to hold all parties involved in the production process accountable for the overall quality of the final product or service.   

  Understanding Total Quality Management

  Total quality management (TQM) is a structured approach to overall organizational management. The focus of the process is to improve the quality of an organization's outputs, including goods and services, through continual improvement of internal practices. The standards set as part of the TQM approach can reflect both internal priorities and any industry standards currently in place.

  Industry standards can be defined at multiple levels and may include adherence to various laws and regulations governing the operation of the particular business. Industry standards can also include the production of items to an understood norm, even if the norm is not backed by official regulations.

  Primary Principles of Total Quality Management

  TQM is considered a customer-focused process and aims for continual improvement of business operations. It strives to ensure all associated employees work toward the common goals of improving product or service quality, as well as improving the procedures that are in place for production.

2 .

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Keywords: Medical error, patient safety, patients

Comparisons have often been made between safety management in aviation and healthcare. This emulation is in the context of major achievements in the field of aviation – despite the number of worldwide flight hours doubling over the past 20 years (from approximately 25 million in 1993 to 54 million in 2013), the number of fatalities has fallen from approximately 450 to 250 per year. This stands in comparison to healthcare, where in the USA alone there are an estimated 200,000 preventable medical deaths every year, which amounts to the equivalent of almost three fatal airline crashes per day. As the renowned airline pilot Chesley Sullenberger noted,if such a level of fatalities was to happen in aviation, airlines would stop flying, airports would close, there would be congressional hearings and there would be a presidential commission. No one would be allowed to fly until the problem had been solved.

In this article, we present a comprehensive review of similarities and differences between aviation and healthcare and the application to healthcare of lessons learned in aviation.

Go to:

Aviation versus healthcare: how comparable?

Table 1 summarises how aviation compares with healthcare. Some authors have expressed reservations about the analogies between aviation and healthcare,and others have noted that industries such as mining and metal manufacturemay provide just as valuable safety lessons as aviation. Amalberti et al.have pointed to some inbuilt features of healthcare which may mean that it can never be as ultrasafe as industries such as aviation. In contrast to aviation, Reason has referred to the close personal contact in healthcare and to the ‘lethal convergence of benevolence’, which may result in the bypassing of protocols, barriers and safeguards, often with patients’ best interests at heart.   

3 .

Distinctive features of aviation and healthcare.

  The need for checklists is based on the premise that in the execution of procedures the human brain may be subject to three key cognitive limitations: we may forget to retrieve one of a number of steps in a procedure; we may retrieve a step but for one reason or another (e.g. distraction, fatigue) may not remember to carry it out; or we may retrieve the step, remember to carry it out, but execute the action incorrectly. In aviation, there is usually much more in terms of procedural documentation of immediate relevance, such as in Airline Operations Manuals or Quick Reference Handbooks, and Toff28 has proposed the availability of similar systems in healthcare. In aviation, there appear to be three forms of checklists, one for simple, routine operations; one for more complex operations; and one for emergency procedures (where the checklist may be ‘do-verify later’ rather than ‘read-verify’). Checklists also vary between types of aircraft. Checklists have traditionally been a more integral part of aviation workflow, whereas in medical disciplines such as surgery, they have been a more recent innovation.

Training in aviation and training in fields such as surgery have been compared, with aviation training and competency assessment generally considered to be more rigorous and more regimented.41–43 Initial pilot training normally takes around three years, and becoming a captain will usually take around a further 10 years. Training to become a doctor usually takes around five years, with generally a further 10 years before becoming a consultant. Keeping up with the explosion of knowledge in healthcare is daunting but necessary, even for experienced consultants, but this is not so much the case in aviation. Pilot training is in a variety of settings, on the ground, in an aircraft and always in a simulator. Simulation has also been extended to teamwork and debriefing. Simulators are overall less used in medical training – or they are used less systematically. Pilots have to undergo proficiency checks, usually in a simulator, every six months. Doctors in the UK now undergo re-validation every five years. Pilot training is broken down into core competency skills, and this form of behavioural analysis of the skill training needs is becoming more common in healthcare. Non-technical skills, such as leadership, team working, decision making, situational awareness, managing stress and coping with fatigue, are extensively taught in pilot training, with well-established protocols for behavioural measurements of crew while in flight.44 It is only in recent years that behavioural marker systems that capture the non-technical skills of healthcare professionals have been developed in medicine, with some areas such as anaesthesia and surgery particularly embracing their value

There are many opportunities for safety measures and concepts in high-risk industries such as aviation to be considered for adoption in healthcare, with a need for actions to be proactive and generative, rather than solely reactive to adverse events.81 A focus on systems rather than individuals, and an examination of ‘latent risk factors’ that may result in adverse events, are other lessons that we can learn from aviation.82,83 Naturally, adopting measures from aviation without adapting them for the unique healthcare environment would be unwise, but where this has been done in a systematic but flexible way, clear benefits have been found.84 Issues such as privacy and patient confidentiality are particularly important in healthcare. In the finance-driven world of healthcare, any safety improvements should ideally have a good economic argument to accompany them, but – as Lewis et al.51 have argued – making such a case should be relatively easy to do, especially bearing in mind the huge litigation costs of clinical negligence claims.