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Case Study: Quality Management System at Coca Cola Company

Coca Cola’s history can be traced back to a man called Asa Candler, who bought a specific formula from a pharmacist named Smith Pemberton. Two years later, Asa founded his business and started production of soft drinks based on the formula he had bought. From then, the company grew to become the biggest producers of soft drinks with more than five hundred brands sold and consumed in more than two hundred nations worldwide.

Although the company is said to be the biggest bottler of soft drinks, they do not bottle much. Instead, Coca Cola Company manufactures a syrup concentrate, which is bought by bottlers all over the world. This distribution system ensures the soft drink is bottled by these smaller firms according to the company’s standards and guidelines. Although this franchised method of distribution is the primary method of distribution, the mother company has a key bottler in America, Coca Cola Refreshments.

In addition to soft drinks, which are Coca Cola’s main products, the company also produces diet soft drinks. These are variations of the original soft drinks with improvements in nutritional value, and reductions in sugar content. Saccharin replaced industrial sugar in 1963 so that the drinks could appeal to health-conscious consumers. A major cause for concern was the inter product competition which saw some sales dwindle in some products in favor of others.

Coca Cola started diversifying its products during the First World War when ‘Fanta’ was introduced. During World War 1, the heads of Coca Cola in Nazi Germany decided to establish a new soft drink into the market. During the ongoing war, America’s promotion in Germany was not acceptable. Therefore, he decided to use a new name and ‘Fanta’ was born. The creation was successful and production continued even after the war. ‘Sprite’ followed soon after.

In the 1990’s, health concerns among consumers of soft drinks forced their manufactures to consider altering the energy content of these products. ‘Minute Maid’ Juices, ‘PowerAde’ sports drinks, and a few flavored teas variants were Coca Cola’s initial reactions to this new interest. Although most of these new products were well received, some did not perform as well. An example of such was Coca Cola classic, dubbed C2.

Coca Cola Company has been a successful company for more than a century. This can be attributed partly to the nature of its products since soft drinks will always appeal to people. In addition to this, Coca Cola has one of the best commercial and public relations programs in the world. The company’s products can be found on adverts in virtually every corner of the globe. This success has led to its support for a wide range of sporting activities. Soccer, baseball, ice hockey, athletics and basketball are some of these sports, where Coca Cola is involved

The Quality Management System at Coca Cola

It is very important that each product that Coca Cola produces is of a high quality standard to ensure that each product is exactly the same. This is important as the company wants to meet with customer requirements and expectations. With the brand having such a global presence, it is vital that these checks are continually consistent. The standardized bottle of Coca Cola has elements that need to be checked whilst on the production line to make sure that a high quality is being met. The most common checks include ingredients, packaging and distribution. Much of the testing being taken place is during the production process, as machines and a small team of employees monitor progress. It is the responsibility of all of Coca Colas staff to check quality from hygiene operators to product and packaging quality. This shows that these constant checks require staff to be on the lookout for problems and take responsibility for this, to ensure maintained quality.

Coca-cola uses inspection throughout its production process, especially in the testing of the Coca-Cola formula to ensure that each product meets specific requirements. Inspection is normally referred to as the sampling of a product after production in order to take corrective action to maintain the quality of products. Coca-Cola has incorporated this method into their organisational structure as it has the ability of eliminating mistakes and maintaining high quality standards, thus reducing the chance of product recall. It is also easy to implement and is cost effective.

Coca-cola uses both Quality Control (QC) and Quality Assurance (QA) throughout its production process. QC mainly focuses on the production line itself, whereas QA focuses on its entire operations process and related functions, addressing potential problems very quickly. In QC and QA, state of the art computers check all aspects of the production process, maintaining consistency and quality by checking the consistency of the formula, the creation of the bottle (blowing), fill levels of each bottle, labeling of each bottle, overall increasing the speed of production and quality checks, which ensures that product demands are met. QC and QA helps reduce the risk of defective products reaching a customer; problems are found and resolved in the production process, for example, bottles that are considered to be defective are placed in a waiting area for inspection. QA also focuses on the quality of supplied goods to Coca-cola, for example sugar, which is supplied by Tate and Lyle. Coca-cola informs that they have never had a problem with their suppliers. QA can also involve the training of staff ensuring that employees understand how to operate machinery. Coca-Cola ensures that all members of staff receive training prior to their employment, so that employees can operate machinery efficiently. Machinery is also under constant maintenance, which requires highly skilled engineers to fix problems, and help Coca-cola maintain high outputs.

Every bottle is also checked that it is at the correct fill level and has the correct label. This is done by a computer which every bottle passes through during the production process. Any faulty products are taken off the main production line. Should the quality control measures find any errors, the production line is frozen up to the last good check that was made. The Coca Cola bottling plant also checks the utilization level of each production line using a scorecard system. This shows the percentage of the line that is being utilized and allows managers to increase the production levels of a line if necessary.

Coca-Cola also uses Total Quality Management (TQM) , which involves the management of quality at every level of the organisation , including; suppliers, production, customers etc. This allows Coca-cola to retain/regain competitiveness to achieve increased customer satisfaction . Coca-cola uses this method to continuously improve the quality of their products. Teamwork is very important and Coca-cola ensures that every member of staff is involved in the production process, meaning that each employee understands their job/roles, thus improving morale and motivation , overall increasing productivity. TQM practices can also increase customer involvement as many organisations, including Coca-Cola relish the opportunity to receive feedback and information from their consumers. Overall, reducing waste and costs, provides Coca-cola with a competitive advantage .

The Production Process

Before production starts on the line cleaning quality tasks are performed to rinse internal pipelines, machines and equipment. This is often performed during a switch over of lines for example, changing Coke to Diet Coke to ensure that the taste is the same. This quality check is performed for both hygiene purposes and product quality. When these checks are performed the production process can begin.

Coca Cola uses a database system called Questar which enables them to perform checks on the line. For example, all materials are coded and each line is issued with a bill of materials before the process starts. This ensures that the correct materials are put on the line. This is a check that is designed to eliminate problems on the production line and is audited regularly. Without this system, product quality wouldn’t be assessed at this high level. Other quality checks on the line include packaging and carbonation which is monitored by an operator who notes down the values to ensure they are meeting standards.

To test product quality further lab technicians carry out over 2000 spot checks a day to ensure quality and consistency. This process can be prior to production or during production which can involve taking a sample of bottles off the production line. Quality tests include, the CO2 and sugar values, micro testing, packaging quality and cap tightness. These tests are designed so that total quality management ideas can be put forward. For example, one way in which Coca Cola has improved their production process is during the wrapping stage at the end of the line. The machine performed revolutions around the products wrapping it in plastic until the contents were secure. One initiative they adopted meant that one less revolution was needed. This idea however, did not impact on the quality of the packaging or the actual product therefore saving large amounts of money on packaging costs. This change has been beneficial to the organisation. Continuous improvement can also be used to adhere to environmental and social principles which the company has the responsibility to abide by. Continuous Improvement methods are sometimes easy to identify but could lead to a big changes within the organisation. The idea of continuous improvement is to reveal opportunities which could change the way something is performed. Any sources of waste, scrap or rework are potential projects which can be improved.

The successfulness of this system can be measured by assessing the consistency of the product quality. Coca Cola say that ‘Our Company’s Global Product Quality Index rating has consistently reached averages near 94 since 2007, with a 94.3 in 2010, while our Company Global Package Quality Index has steadily increased since 2007 to a 92.6 rating in 2010, our highest value to date’. This is an obvious indication this quality system is working well throughout the organisation. This increase of the index shows that the consistency of the products is being recognized by consumers.

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Total quality management: three case studies from around the world

With organisations to run and big orders to fill, it’s easy to see how some ceos inadvertently sacrifice quality for quantity. by integrating a system of total quality management it’s possible to have both.

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There are few boardrooms in the world whose inhabitants don’t salivate at the thought of engaging in a little aggressive expansion. After all, there’s little room in a contemporary, fast-paced business environment for any firm whose leaders don’t subscribe to ambitions of bigger factories, healthier accounts and stronger turnarounds. Yet too often such tales of excess go hand-in-hand with complaints of a severe drop in quality.

Food and entertainment markets are riddled with cautionary tales, but service sectors such as health and education aren’t immune to the disappointing by-products of unsustainable growth either. As always, the first steps in avoiding a catastrophic forsaking of quality begins with good management.

There are plenty of methods and models geared at managing the quality of a particular company’s goods or services. Yet very few of those models take into consideration the widely held belief that any company is only as strong as its weakest link. With that in mind, management consultant William Deming developed an entirely new set of methods with which to address quality.

Deming, whose managerial work revolutionised the titanic Japanese manufacturing industry, perceived quality management to be more of a philosophy than anything else. Top-to-bottom improvement, he reckoned, required uninterrupted participation of all key employees and stakeholders. Thus, the total quality management (TQM) approach was born.

All in Similar to the Six Sigma improvement process, TQM ensures long-term success by enforcing all-encompassing internal guidelines and process standards to reduce errors. By way of serious, in-depth auditing – as well as some well-orchestrated soul-searching – TQM ensures firms meet stakeholder needs and expectations efficiently and effectively, without forsaking ethical values.

By opting to reframe the way employees think about the company’s goals and processes, TQM allows CEOs to make sure certain things are done right from day one. According to Teresa Whitacre, of international consulting firm ASQ , proper quality management also boosts a company’s profitability.

“Total quality management allows the company to look at their management system as a whole entity — not just an output of the quality department,” she says. “Total quality means the organisation looks at all inputs, human resources, engineering, production, service, distribution, sales, finance, all functions, and their impact on the quality of all products or services of the organisation. TQM can improve a company’s processes and bottom line.”

Embracing the entire process sees companies strive to improve in several core areas, including: customer focus, total employee involvement, process-centred thinking, systematic approaches, good communication and leadership and integrated systems. Yet Whitacre is quick to point out that companies stand to gain very little from TQM unless they’re willing to go all-in.

“Companies need to consider the inputs of each department and determine which inputs relate to its governance system. Then, the company needs to look at the same inputs and determine if those inputs are yielding the desired results,” she says. “For example, ISO 9001 requires management reviews occur at least annually. Aside from minimum standard requirements, the company is free to review what they feel is best for them. While implementing TQM, they can add to their management review the most critical metrics for their business, such as customer complaints, returns, cost of products, and more.”

The customer knows best: AtlantiCare TQM isn’t an easy management strategy to introduce into a business; in fact, many attempts tend to fall flat. More often than not, it’s because firms maintain natural barriers to full involvement. Middle managers, for example, tend to complain their authority is being challenged when boots on the ground are encouraged to speak up in the early stages of TQM. Yet in a culture of constant quality enhancement, the views of any given workforce are invaluable.

AtlantiCare in numbers

5,000 Employees

$280m Profits before quality improvement strategy was implemented

$650m Profits after quality improvement strategy

One firm that’s proven the merit of TQM is New Jersey-based healthcare provider AtlantiCare . Managing 5,000 employees at 25 locations, AtlantiCare is a serious business that’s boasted a respectable turnaround for nearly two decades. Yet in order to increase that margin further still, managers wanted to implement improvements across the board. Because patient satisfaction is the single-most important aspect of the healthcare industry, engaging in a renewed campaign of TQM proved a natural fit. The firm chose to adopt a ‘plan-do-check-act’ cycle, revealing gaps in staff communication – which subsequently meant longer patient waiting times and more complaints. To tackle this, managers explored a sideways method of internal communications. Instead of information trickling down from top-to-bottom, all of the company’s employees were given freedom to provide vital feedback at each and every level.

AtlantiCare decided to ensure all new employees understood this quality culture from the onset. At orientation, staff now receive a crash course in the company’s performance excellence framework – a management system that organises the firm’s processes into five key areas: quality, customer service, people and workplace, growth and financial performance. As employees rise through the ranks, this emphasis on improvement follows, so managers can operate within the company’s tight-loose-tight process management style.

After creating benchmark goals for employees to achieve at all levels – including better engagement at the point of delivery, increasing clinical communication and identifying and prioritising service opportunities – AtlantiCare was able to thrive. The number of repeat customers at the firm tripled, and its market share hit a six-year high. Profits unsurprisingly followed. The firm’s revenues shot up from $280m to $650m after implementing the quality improvement strategies, and the number of patients being serviced dwarfed state numbers.

Hitting the right notes: Santa Cruz Guitar Co For companies further removed from the long-term satisfaction of customers, it’s easier to let quality control slide. Yet there are plenty of ways in which growing manufacturers can pursue both quality and sales volumes simultaneously. Artisan instrument makers the Santa Cruz Guitar Co (SCGC) prove a salient example. Although the California-based company is still a small-scale manufacturing operation, SCGC has grown in recent years from a basement operation to a serious business.

SCGC in numbers

14 Craftsmen employed by SCGC

800 Custom guitars produced each year

Owner Dan Roberts now employs 14 expert craftsmen, who create over 800 custom guitars each year. In order to ensure the continued quality of his instruments, Roberts has created an environment that improves with each sale. To keep things efficient (as TQM must), the shop floor is divided into six workstations in which guitars are partially assembled and then moved to the next station. Each bench is manned by a senior craftsman, and no guitar leaves that builder’s station until he is 100 percent happy with its quality. This product quality is akin to a traditional assembly line; however, unlike a traditional, top-to-bottom factory, Roberts is intimately involved in all phases of instrument construction.

Utilising this doting method of quality management, it’s difficult to see how customers wouldn’t be satisfied with the artists’ work. Yet even if there were issues, Roberts and other senior management also spend much of their days personally answering web queries about the instruments. According to the managers, customers tend to be pleasantly surprised to find the company’s senior leaders are the ones answering their technical questions and concerns. While Roberts has no intentions of taking his manufacturing company to industrial heights, the quality of his instruments and high levels of customer satisfaction speak for themselves; the company currently boasts one lengthy backlog of orders.

A quality education: Ramaiah Institute of Management Studies Although it may appear easier to find success with TQM at a boutique-sized endeavour, the philosophy’s principles hold true in virtually every sector. Educational institutions, for example, have utilised quality management in much the same way – albeit to tackle decidedly different problems.

The global financial crisis hit higher education harder than many might have expected, and nowhere have the odds stacked higher than in India. The nation plays home to one of the world’s fastest-growing markets for business education. Yet over recent years, the relevance of business education in India has come into question. A report by one recruiter recently asserted just one in four Indian MBAs were adequately prepared for the business world.

RIMS in numbers

9% Increase in test scores post total quality management strategy

22% Increase in number of recruiters hiring from the school

20,000 Increase in the salary offered to graduates

50,000 Rise in placement revenue

At the Ramaiah Institute of Management Studies (RIMS) in Bangalore, recruiters and accreditation bodies specifically called into question the quality of students’ educations. Although the relatively small school has always struggled to compete with India’s renowned Xavier Labour Research Institute, the faculty finally began to notice clear hindrances in the success of graduates. The RIMS board decided it was time for a serious reassessment of quality management.

The school nominated Chief Academic Advisor Dr Krishnamurthy to head a volunteer team that would audit, analyse and implement process changes that would improve quality throughout (all in a particularly academic fashion). The team was tasked with looking at three key dimensions: assurance of learning, research and productivity, and quality of placements. Each member underwent extensive training to learn about action plans, quality auditing skills and continuous improvement tools – such as the ‘plan-do-study-act’ cycle.

Once faculty members were trained, the team’s first task was to identify the school’s key stakeholders, processes and their importance at the institute. Unsurprisingly, the most vital processes were identified as student intake, research, knowledge dissemination, outcomes evaluation and recruiter acceptance. From there, Krishnamurthy’s team used a fishbone diagram to help identify potential root causes of the issues plaguing these vital processes. To illustrate just how bad things were at the school, the team selected control groups and administered domain-based knowledge tests.

The deficits were disappointing. A RIMS students’ knowledge base was rated at just 36 percent, while students at Harvard rated 95 percent. Likewise, students’ critical thinking abilities rated nine percent, versus 93 percent at MIT. Worse yet, the mean salaries of graduating students averaged $36,000, versus $150,000 for students from Kellogg. Krishnamurthy’s team had their work cut out.

To tackle these issues, Krishnamurthy created an employability team, developed strategic architecture and designed pilot studies to improve the school’s curriculum and make it more competitive. In order to do so, he needed absolutely every employee and student on board – and there was some resistance at the onset. Yet the educator asserted it didn’t actually take long to convince the school’s stakeholders the changes were extremely beneficial.

“Once students started seeing the results, buy-in became complete and unconditional,” he says. Acceptance was also achieved by maintaining clearer levels of communication with stakeholders. The school actually started to provide shareholders with detailed plans and projections. Then, it proceeded with a variety of new methods, such as incorporating case studies into the curriculum, which increased general test scores by almost 10 percent. Administrators also introduced a mandate saying students must be certified in English by the British Council – increasing scores from 42 percent to 51 percent.

By improving those test scores, the perceived quality of RIMS skyrocketed. The number of top 100 businesses recruiting from the school shot up by 22 percent, while the average salary offers graduates were receiving increased by $20,000. Placement revenue rose by an impressive $50,000, and RIMS has since skyrocketed up domestic and international education tables.

No matter the business, total quality management can and will work. Yet this philosophical take on quality control will only impact firms that are in it for the long haul. Every employee must be in tune with the company’s ideologies and desires to improve, and customer satisfaction must reign supreme.

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Making quality assurance smart

For decades, outside forces have dictated how pharmaceutical and medtech companies approach quality assurance. The most influential force remains regulatory requirements. Both individual interpretations of regulations and feedback received during regulatory inspections have shaped quality assurance systems and processes. At the same time, mergers and acquisitions, along with the proliferation of different IT solutions and quality software, have resulted in a diverse and complicated quality management system (QMS) landscape. Historically, the cost of consolidating and upgrading legacy IT systems has been prohibitively expensive. Further challenged by a scarcity of IT support, many quality teams have learned to rely on the processes and workflows provided by off-the-shelf software without questioning whether they actually fit their company’s needs and evolving regulatory requirements.

In recent years, however, several developments have enabled a better way. New digital and analytics technologies make it easier for quality teams to access data from different sources and in various formats, without replacing existing systems. Companies can now build dynamic user experiences in web applications at a fraction of the cost of traditional, enterprise desktop software; this development raises the prospect of more customized, user-friendly solutions. Moreover, regulators, such as the FDA, are increasingly focused on quality systems and process maturity. 1 MDIC Case for Quality program. The FDA also identified the enablement of innovative technologies as a strategic priority, thereby opening the door for constructive dialogue about potential changes. 2 Technology Modernization Action Plan, FDA.

Smart quality at a glance

“Smart quality” is a framework that pharma and medtech companies can apply to redesign key quality assurance processes and create value for the organization.

Smart quality has explicit objectives:

• to perceive and deliver on multifaceted and ever-changing customer needs
• to deploy user-friendly processes built organically into business workflows, reimagined with leading-edge technologies
• to leapfrog existing quality management systems with breakthrough innovation, naturally fulfilling the spirit—not just the letter—of the regulations

The new ways in which smart quality achieves its objectives can be categorized in five building blocks (exhibit).

To learn more about smart quality and how leading companies are reimagining the quality function, please see “ Smart quality: Reimagining the way quality works .”

The time has arrived for pharmaceutical and medtech companies to act boldly and reimagine the quality function. Through our work on large-scale quality transformation projects and our conversations with executives, we have developed a new approach we call “smart quality” (see sidebar, “Smart quality at a glance”). With this approach, companies can redesign key quality processes and enable design-thinking methodology (to make processes more efficient and user-friendly), automation and digitization (to deliver speed and transparency), and advanced analytics (to provide deep insights into process capability and product performance).

The quality assurance function thereby becomes a driver of value in the organization and a source of competitive advantage—improving patient safety and health outcomes while operating efficiently, effectively, and fully aligned with regulatory expectations. In our experience, companies applying smart quality principles to quality assurance can quickly generate returns that outweigh investments in new systems, including line-of-sight impact on profit; a 30 percent improvement in time to market; and a significant increase in manufacturing and supply chain reliability. Equally significant are improvements in customer satisfaction and employee engagement, along with reductions in compliance risk.

Revolutionizing quality assurance processes

The following four use cases illustrate how pharmaceutical and medtech companies can apply smart quality to transform core quality assurance processes—including complaints management, quality management review, deviations investigations, and supplier risk management, among others.

1. Complaint management

Responding swiftly and effectively to complaints is not only a compliance requirement but also a business necessity. Assessing and reacting to feedback from the market can have an immediate impact on patient safety and product performance. Today, a pharmaceutical or medtech company may believe it is handling complaints well if it has a single software deployed around the globe for complaint management, with some elements of automation (for example, flagging reportable malfunctions in medical devices) and several processing steps happening offshore (such as intake, triage, and regulatory reporting).

Yet, for most quality teams, the average investigation and closure cycle time hovers around 60 days—a few adverse events are reported late every month, and negative trends are addressed two or more months after the signals come in. It can take quality assurance teams even longer to identify complaints that collectively point to negative trends for a particular product or device. At the same time, less than 5 percent of incoming complaints are truly new events that have never been seen before. The remainder of complaints can usually be categorized into well-known issues, within expected limits; or previously investigated issues, in which root causes have been identified and are already being addressed.

The smart quality approach improves customer engagement and speed

By applying smart quality principles and the latest technologies, companies can reduce turnaround times and improve the customer experience. They can create an automated complaint management process that reduces costs yet applies the highest standards:

• For every complaint, the information required for a precise assessment is captured at intake, and the event is automatically categorized.
• High-risk issues are immediately escalated by the system, with autogenerated reports ready for submission.
• New types of complaints and out-of-trend problems are escalated and investigated quickly.
• Low-risk, known issues are automatically trended and closed if they are within expected limits or already being addressed.
• Customer responses and updates are automatically available.
• Trending reports are available in real time for any insights or analyses.

To transform the complaint management process, companies should start by defining a new process and ensuring it meets regulatory requirements. The foundation for the new process can lie in a structured event assessment that allows automated issue categorization based on the risk level defined in the company’s risk management documentation. A critical technological component is the automation of customer complaint intake; a dynamic front-end application can guide a customer through a series of questions (Exhibit 1). The application captures only information relevant to a specific complaint evaluation, investigation, and—if necessary—regulatory report. Real-time trending can quickly identify signals that indicate issues exceeding expected limits. In addition, companies can use machine learning to scan text and identify potential high-risk complaints. Finally, risk-tailored investigation pathways, automated reporting, and customer response solutions complete the smart quality process. Successful companies maintain robust procedures and documentation that clearly explain how the new process reliably meets specific regulatory requirements. Usually, a minimal viable product (MVP) for the new process can be built within two to four months for the first high-volume product family.

In our experience, companies that redesign the complaint management process can respond more swiftly—often within a few hours—to reduce patient risk and minimize the scale and impact of potential issues in the field. For example, one medtech company that adopted the new complaint management approach can now automatically assess all complaints and close more than 55 percent of them in 24 hours without human intervention. And few, if any, reportable events missed deadlines for submission. Now, subject matter experts are free to focus on investigating new or high-risk issues, understanding root causes, and developing the most effective corrective and preventive actions. The company also reports that its customers prefer digital interfaces to paper forms and are pleased to be updated promptly on their status and resolution of their complaints.

2. Quality management review

Real-time performance monitoring is crucial to executive decision making at pharmaceutical and medtech companies. During a 2019 McKinsey roundtable discussion, 62 percent of quality assurance executives rated it as a high priority for the company, exceeding all other options.

For many companies today, the quality review process involves significant manual data collection and chart creation. Often, performance metrics focus on quality compliance outcomes and quality systems—such as deviation cycle times—at the expense of leading indicators and connection to culture and cost. Managers and executives frequently find themselves engaged in lengthy discussions, trying to interpret individual metrics and often missing the big picture.

Although many existing QMS solutions offer automated data-pull and visualization features, the interpretation of complex metric systems and trends remains largely a manual process. A team may quickly address one performance metric or trend, only to learn several months later that the change negatively affected another metric.

The smart quality approach speeds up decision making and action

By applying smart quality principles and the latest digital technologies, companies can get a comprehensive view of quality management in real time. This approach to performance monitoring allows companies to do the following:

• automatically collect, analyze, and visualize relevant leading indicators and outcomes on a simple and intuitive dashboard
• quickly identify areas of potential risk and emerging trends, as well as review their underlying metrics and connections to different areas
• rapidly make decisions to address existing or emerging issues and monitor the results
• adjust metrics and targets to further improve performance as goals are achieved
• view the entire value chain and create transparency for all functions, not just quality

To transform the process, companies should start by reimagining the design of the process and settling on a set of metrics that balances leading and lagging indicators. A key technical enabler of the system is establishing an interconnected metrics structure that automates data pull and visualization and digitizes analysis and interpretation (Exhibit 2). Key business processes, such as regular quality management reviews, may require changes to include a wider range of functional stakeholders and to streamline the review cascade.

Healthcare companies can use smart quality to redesign the quality management review process and see results quickly. At one pharmaceutical and medtech company, smart visualization of connected, cross-functional metrics significantly improved the effectiveness and efficiency of quality management review at all levels. Functions throughout the organization reported feeling better positioned to ascertain the quality situation quickly, support decision making, and take necessary actions. Because of connected metrics, management can not only see alarming trends but also link them to other metrics and quickly align on targeted improvement actions. For example, during a quarterly quality management review, the executive team linked late regulatory reporting challenges to an increase in delayed complaint submissions in some geographic regions. Following the review, commercial leaders raised attention to this issue in their respective regions, and in less than three months, late regulatory reporting was reduced to zero. Although the company is still in the process of fully automating data collection, it has already noticed a significant shift in its work. The quality team no longer spends the majority of its time on data processing but has pivoted to understanding, interpreting, and addressing complex and interrelated trends to reduce risks associated with quality and compliance.

Healthcare companies can use smart quality to redesign the quality management review process and see results quickly.

3. Deviation or nonconformance investigations

Deviation or nonconformance management is a critical topic for companies today because unaddressed issues can lead to product recalls and reputational damage. More often, deviations or nonconformances can affect a company’s product-release process, capacity, and lead times. As many quality teams can attest, the most challenging and time-consuming part of a deviation or nonconformance investigation is often the root cause analysis. In the best of circumstances, investigators use a tracking and trending system to identify similar occurrences. However, more often than not, these systems lack good classification of root causes and similarities. The systems search can become another hurdle for quality teams, resulting in longer lead times and ineffective root cause assessment. Not meeting the standards defined by regulators regarding deviation or nonconformance categorization and root cause analysis is one of the main causes of warning letters or consent decrees.

The smart quality approach improves effectiveness and reduces lead times

Our research shows companies that use smart quality principles to revamp the investigation process may reap these benefits:

• all pertinent information related to processes and equipment is easily accessible in a continuously updated data lake
• self-learning algorithms predict the most likely root cause of new deviations, thereby automating the review of process data and statements

In our experience, advanced analytics is the linchpin of transforming the investigation process. The most successful companies start by building a real-time data model from local and global systems that continuously refreshes and improves the model over time. Natural language processing can generate additional classifications of deviations or nonconformances to improve the quality and accuracy of insights. Digitization ensures investigators can easily access graphical interfaces that are linked to all data sources. With these tools in place, companies can readily identify the most probable root cause for deviation or nonconformance and provide a fact base for the decision. Automation also frees quality assurance professionals to focus on corrective and preventive action (Exhibit 3).

Pharmaceutical and medtech companies that apply these innovative technologies and smart quality principles can see significant results. Our work with several companies shows that identifying, explaining, and eliminating the root causes of recurring deviations and nonconformances can reduce the overall volume of issues by 65 percent. Companies that use the data and models to determine which unexpected factors in processes and products influence the end quality are able to control for them, thereby achieving product and process mastery. What’s more, by predicting the most likely root causes and their underlying drivers, these companies can reduce the investigation cycle time for deviations and nonconformances by 90 percent.

4. Supplier quality risk management

Drug and medical device supply chains have become increasingly global, complex, and opaque as more pharmaceutical and medtech companies outsource major parts of production to suppliers and contract manufacturing organizations (CMOs). More recently, the introduction of new, complex modalities, such as cell therapy and gene editing, has further increased pressure to ensure the quality of supplier products. Against this backdrop, it is critical to have a robust supplier quality program that can proactively identify and mitigate supplier risks or vulnerabilities before they become material issues.

Today, many companies conduct supplier risk management manually and at one specific point in time, such as at the beginning of a contract or annually. Typically, risk assessments are done in silos across the organization; every function completes individual reports and rarely looks at supplier risk as a whole. Because the results are often rolled up and individual risk signals can become diluted, companies focus more on increasing controls than addressing underlying challenges.

The smart quality approach reduces quality issues and optimizes resources

Companies that break down silos and apply a more holistic risk lens across the organization have a better chance of proactively identifying supplier quality risks. With smart quality assurance, companies can do the following:

• identify vulnerabilities by utilizing advanced analytics on a holistic set of internal and external supplier and product data
• ensure real-time updates and reviews to signal improvements in supplier quality and any changes that may pose an additional risk
• optimize resource allocation and urgency of action, based on the importance and risk level of the supplier or CMO

Current technologies make it simpler than ever to automatically collect meaningful data. They also make it possible to analyze the data, identify risk signals, and present information in an actionable format. Internal and supplier data can include financials, productivity, and compliance metrics. Such information can be further enhanced by publicly available external sources—such as regulatory reporting, financial statements, and press releases—that provide additional insights into supplier quality risks. For example, using natural language processing to search the web for negative press releases is a simple yet powerful method to identify risks.

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Once a company has identified quality risks, it must establish a robust process for managing these risks. Mitigation actions can include additional monitoring with digital tools, supporting the supplier to address the sources of issues, or deciding to switch to a different supplier. In our experience, companies that have a deep understanding of the level of quality risk, as well as the financial exposure, have an easier time identifying the appropriate mitigation action. Companies that identify risks and proactively mitigate them are less likely to experience potentially large supply disruptions or compliance findings.

Many pharmaceutical and medtech companies have taken steps to improve visibility into supplier quality risks by using smart quality principles. For example, a large pharmaceutical company that implemented this data-driven approach eliminated in less than two years major CMO and supplier findings that were identified during audits. In addition, during the COVID-19 pandemic, a global medtech company was able to proactively prevent supply chain disruptions by drawing on insights derived from smart quality supplier risk management.

Getting started

Pharmaceutical and medtech companies can approach quality assurance redesign in multiple ways. In our experience, starting with two or three processes, codifying the approach, and then rolling it out to more quality systems accelerates the overall transformation and time to value.

Smart quality assurance starts with clean-sheet design. By deploying modern design techniques, organizations can better understand user needs and overcome constraints. To define the solution space, we encourage companies to draw upon a range of potential process, IT, and analytics solutions from numerous industries. In cases where the new process is substantially different from the legacy process, we find it beneficial to engage regulators in an open dialogue and solicit their early feedback to support the future-state design.

Once we arrive at an MVP that includes digital and automation elements, companies can test and refine new solutions in targeted pilots. Throughout the process, we encourage companies to remain mindful of training and transition planning. Plans should include details on ensuring uninterrupted operations and maintaining compliance during the transition period.

The examples in this article are not exceptions. We believe that any quality assurance process can be significantly improved by applying a smart quality approach and the latest technologies. Pharmaceutical and medtech companies that are willing to make the organizational commitment to rethink quality assurance can significantly reduce quality risks, improve their speed and effectiveness in handling issues, and see long-term financial benefits.

Note: The insights and concepts presented here have not been validated or independently verified, and future results may differ materially from any statements of expectation, forecasts, or projections. Recipients are solely responsible for all of their decisions, use of these materials, and compliance with applicable laws, rules, and regulations. Consider seeking advice of legal and other relevant certified/licensed experts prior to taking any specific steps.

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International Journal of Quality & Reliability Management

ISSN : 0265-671X

Article publication date: 1 May 1993

Most quality professionals recommend a core set of attributes as the nucleus of any quality improvement process. These attributes include: (1) clarifying job expectations; (2) setting quality standards; (3) measuring quality improvement; (4) effective super‐vision; (5) listening by management; (6) feedback by management; and (7) effective training. Based on a survey of employees at a medium‐sized manufacturing firm in the United States, it was found that management philosophy and actions can undermine even a proven total quality management (TQM) programme. For the many firms which hire outside consultants to set up a TQM programme, makes recommendations to management to ensure its successful implementation.

• MANAGEMENT PHILOSOPHY
• QUALITY ASSURANCE
• QUALITY MANAGEMENT

Longenecker, C.O. and Scazzero, J.A. (1993), "Total Quality Management from Theory to Practice: A Case Study", International Journal of Quality & Reliability Management , Vol. 10 No. 5. https://doi.org/10.1108/02656719310040114

Copyright © 1993, MCB UP Limited

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Healthcare Quality Management: A Case Study Approach 1st Edition

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Healthcare Quality Management: A Case Study Approach is the first comprehensive case-based text combining essential quality management knowledge with real-world scenarios. With in-depth healthcare quality management case studies, tools, activities, and discussion questions, the text helps build the competencies needed to succeed in quality management.

Written in an easy-to-read style, Part One of the textbook introduces students to the fundamentals of quality management, including history, culture, and different quality management philosophies, such as Lean and Six Sigma. Part One additionally explains the A3 problem-solving template used to follow the Plan-Do-Study-Act (PDSA) or Define, Measure, Analyze, Improve, and Control (DMAIC) cycles, that guides your completion of the problem-solving exercises found in Part Two. The bulk of the textbook includes realistic and engaging case studies featuring common quality management problems encountered in a variety of healthcare settings. The case studies feature engaging scenarios, descriptions, opinions, charts, and data, covering such contemporary topics as provider burnout, artificial intelligence, the opioid overdose epidemic, among many more.

Serving as a powerful replacement to more theory-based quality management textbooks, Healthcare Quality Management provides context to challenging situations encountered by any healthcare manager, including the health administrator, nurse, physician, social worker, or allied health professional.

• 25 Realistic Case Studies–Explore challenging Process Improvement, Patient Experience, Patient Safety, and Performance Improvement quality management scenarios set in various healthcare settings
• Diverse Author Team–Combines the expertise and knowledge of a health management educator, a Chief Nursing Officer at a large regional hospital, and a health system-based Certified Lean Expert
• Podcasts–Listen to quality management experts share stories and secrets on how to succeed, work in teams, and apply tools to solve problems
• Quality Management Tools–Grow your quality management skill set with 25 separate quality management tools and approaches tied to the real-world case studies
• Competency-Based Education Support–Match case studies to professional competencies, such as analytical skills, community collaboration, and interpersonal relations, using case-to-competency crosswalks for health administration, nursing, medicine, and the interprofessional team
• eBook Access–Included with print purchase so you can continue your studies on the go on mobile devices and computers
• Comprehensive Instructor’s Packet–Includes PPTs, extensive Excel data files, an Instructor’s Manual with completed A3 problem-solving solutions for each Case Application Exercise, and more!
• Student ancillaries–Includes data files and A3 template
• ISBN-10 0826145132
• ISBN-13 978-0826145130
• Edition 1st
• Publisher Springer Publishing Company
• Publication date February 21, 2020
• Language English
• Dimensions 7.2 x 0.8 x 9.9 inches
• Print length 404 pages
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Zachary Pruitt, PhD, MHA, CPH, is assistant professor and director of community practice at the University of South Florida College of Public Health.

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Eddie Pérez-Ruberté, MS, is senior Lean project manager at BayCare Health Systems who leads the deployment of the Lean management system and culture. Eddie is a certified Lean expert and a certified Six Sigma Black Belt from the American Society for Quality. He also helps organizations implement Lean programs through his consulting company, Areito Group. Eddie is an instructor for the Institute of Industrial and Systems Engineers where he teaches Lean and Six Sigma and certifies students in these methodologies at multiple universities and healthcare organizations across the United States.

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Organizational approach to Total Quality Management: a case study

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Afizan Amer

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This study came to examine the impact of Total Quality management (TQM) as instrument in achieving on the organisational performance. TQM is defined as a policy that essentially aimed at establish and deliver high quality products and services that cover all their client's demands and achieve a high level of customer satisfaction. Total Quality Management (TQM) is a management is an administrative approach for firms focused on quality, in light of the cooperation and every individuals and aims at long haul accomplishment through consumer's loyalty and advantages to all individuals from the associations and society. The impact of many organisations failure to properly implement TQM by all administration level, challenges the organisation ability to organise frequent employee training have been a big problem. This research work attempt to find out the effect of TQM execution in the board inclusion, challenges disturbing the usages, impact of employee training and TQM standard application to the accomplishment of organisational goal. The key discoveries demonstrated that rehearsing TQM but it is yet to implement it to the highest level of subscribing to a quality reward system. The implementation of TQM is at the quality assurance level. It was discovered that administration inactions undermined initiative promise to quality and rendered TQM rehearsal insufficient. It is through questionnaires method and oral interview that data are collected from the aforementioned organisations. References were made to journals, related books, internet the aforementioned organization concurred that TQM have in hierarchical execution.

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In the current market economy, companies are constantly struggling to achieve a sustained competitive advantage that will enable them to improve performance, which results in increased competitiveness, and of course, profit. Among the few competitive advantages that can become sustainable competitive advantages, quality plays a crucial role. Recent research shows that about 90% of buyers in the international market, consider quality as having at least equal importance with price in making the decision to purchase. In the opinion of some specialists in economic theory and practice, total quality refers to the holistic approach of quality, which actually means, addressing all aspects of economic and social development and technical of quality. Thus, the holistic approach of quality at organisation-wide involves procedural approach of quality, in this respect, the study focuses on this type of quality approach, i.e. the procedural approach, taking into account the strategic aspects of the continuous improvement of quality, which means in fact, the quality management. Total Quality Management is seen as a way to transform the economies of some countries to be more competitive than others. However, Total Quality Management brings not and will not produce results overnight, it is not a panacea for all the problems facing the organization. Total Quality Management requires a change in organizational culture, which must focus on meeting customer expectations and increasing the involvement of all employees to meet this objective, as an expression of the ethics of continuous improvement. In general, research on quality aiming identify why an organization should adopt the principles of total quality management, but attempts to identify the failing companies' attempts to implement total quality management principles are not so visible. Concerns companies to introduce quality management systems are becoming more pronounced, therefore, in this study we try to identify and present the main reasons that prevent achieving quality and implementation of total quality management system, in other words, we are interested in identify barriers to implementation and development of a quality management system.

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A case study evolving quality management in Indian civil engineering projects using AI techniques: a framework for automation and enhancement

• Published: 02 April 2024

Cite this article

• Kaushal Kumar 1 ,
• Saurav Dixit 2 ,
• Umank Mishra 3 &
• Nikolai Ivanovich Vatin 4 , 5  

The present research examines a wide range of civil engineering projects across India, each providing a distinct platform for investigating quality management, automation techniques, and improvement activities using artificial intelligence (AI) techniques. The study covers projects demonstrating the variety of India’s civil engineering undertakings, from the Smart City Mission to the Mumbai Metro Line 3 and the Chennai-Madurai Expressway. The adoption of quality management techniques, including ISO 9001 Certification, Lean Construction, Six Sigma, Building Information Modeling (BIM), and Total Quality Management (TQM), is evaluated in the projects. In this case study, experimental datasets and employed AI techniques such as Artificial Neural Networks (ANN) are used to predict accurate outcomes. It was also observed that more variation in the regression coefficient (R 2 ) and errors (MSE) from 1 to 5 hidden layer nodes. While hidden layer nodes 6 to 10 performed stable outcomes. Out of them, hidden layer node 9 performed best of the best regression coefficient (R 2  = 99.4%) with minimum error (MSE = 0.04). The comple investigation of the outcomes indicating towards the suitability of the existing model as an important one for accurately predicting the UCS. A thorough framework for improving quality management in Indian civil engineering projects is the research’s final product, and it offers insightful information to industry stakeholders.

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Acknowledgements

The authors are thankful to Lovely profession University, Jalandhar, an autonomous organization Punjab, India, for providing basic data set for analysis to carrying out this study.

This research was also funded by the Ministry of Science and Higher Education of the Russian Federation within the framework of the state assignment No. 075-03-2022-010 dated 14 January 2022 and No. 075– 01568-23-04 dated 28 March 2023(Additional agreement 075-03-2022- 010/10 dated 09 November 2022, Additional agreement 075-03-2023- 004/4 dated 22 May 2023), FSEG-2022-0010.

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Kaushal Kumar

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Saurav Dixit

Department of Civil Engineering, Shri Shankaracharya Technical Campus, Bhilai, Chhattisgarh, 490020, India

Umank Mishra

Peter The Great St. Petersburg Polytechnic University, Saint Petersburg, 195251, Russia

Nikolai Ivanovich Vatin

Division of Research and Innovation, Uttaranchal University, Dehradun, India

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Kumar, K., Dixit, S., Mishra, U. et al. A case study evolving quality management in Indian civil engineering projects using AI techniques: a framework for automation and enhancement. Asian J Civ Eng (2024). https://doi.org/10.1007/s42107-024-01029-5

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Six Sigma is an array of methods and resources for enhancing corporate operations. When Bill Smith was an engineer at Motorola, he introduced it in 1986 to find and eliminate mistakes and defects, reduce variance, and improve quality and efficiency. Six Sigma was first used in manufacturing as a quality control tool. When long-term defect levels are less than 3.4 defects per million opportunities (DPMO), Six Sigma quality is reached.

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Have you checked out how 3M tackled pollution with Six Sigma? It's pretty remarkable. 3M leveraged Six Sigma to pioneer pollution prevention, saving $1 billion and averting 2.6 million pounds of pollutants over 31 years. With 55,000 employees trained and 45,000 Lean Six Sigma projects completed, they focused on waste reduction and energy efficiency. Results included a 61% decrease in volatile air emissions and a 64% reduction in EPA Toxic Release Inventory. Surpassing goals, they doubled Pollution Prevention Pays projects and showcased Six Sigma's prowess in cost-saving measures.

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By using Lean Six Sigma case studies, Microsoft increased customer interactions and profitability through waste removal and process optimization. They concentrated on improving the quality of the current process and reducing problems by utilizing the DMAIC technique. Eight areas were the focus of waste elimination: motion, inventory, non-value-added procedures, waiting periods, overproduction, defects, and underutilized staff talent. Microsoft streamlined processes and encouraged innovation, which allowed them to maintain productivity and client satisfaction even as technology changed.

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It is one of the best examples of a Six Sigma case study. Anne Cesarone's Green Belt project successfully reduced router configuration time by 16 minutes, a remarkable 55% improvement. Anne maintained router inventory, made improvements to documentation and configuration files, and started router requests sooner by resolving last-minute requests and setup mistakes. The initiative resulted in less router programming time from 29 to 13 minutes, an increase in router order lead time of 11 days, and a 60% drop in incorrect configurations. These raised customer happiness and increased operational effectiveness while proving the benefits of process improvement initiatives.

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Can a prolonged healing pressure injury be benefited by using an AI mattress? A case study

• Tung Fang Ni 1 ,
• Jyh-Liang Wang 2 ,
• Chih-Kuang Chen 3 , 4 ,
• De Fen Shih 5 &
• Jeng Wang 6 , 7  

BMC Geriatrics volume  24 , Article number:  307 ( 2024 ) Cite this article

Metrics details

Pressure injuries are a common and serious issue for bedridden residents in long-term-care facilities. Areas of bony prominences, such as the scapula, sacrum, and heels, are more likely to develop pressure injuries. The management of pressure injury wounds include dressing changes, repositioning, away from moisture, decreasing the occurrence of friction and shear, and more. Some supportive surfaces are also used for pressure injury cases such as gel pads, alternating pressure air mattresses, and air-fluidized beds. The aim of this case study was to determine whether the use of an artificial intelligent mattress can improve a nursing home resident with prolonged pressure injury.

Case presentation

A retrospective study design was conducted for this case study. A 79-year-old male developed a pressure injury in the sacrum. His pressure injury was initially at stage 4, with a score of 12 by the Braden scale. The PUSH score was 16. During 5.5 months of routine care plus the use of the traditional alternative air mattress, in the nursing home, the wound stayed in stage 3 but the PUSH score increased up to 11. An artificial intelligence mattress utilizing 3D InterSoft was used to detect the bony prominences and redistribute the external pressure of the skin. It implements a color guided schematic of 26 colors to indicate the amount of pressure of the skin.

The wound size was decreased and all eczema on the resident’s back diminished. The PUSH score was down to 6, as the artificial intelligent mattress was added into the routine care. The staff also reported that the resident’s quality of sleep improved and moaning decreased. The hemiplegic side is at greater risk of developing pressure injury.

Conclusions

This novice device appeared to accelerate wound healing in this case. In the future, more cases should be tested, and different care models or mattress can be explored.

Peer Review reports

Pressure injury (PI) is a type of localized skin damage caused by moisture, friction, shear, or prolonged pressure, especially in areas of bony prominences, such as the sacrum, coccyx, and heels [ 1 , 2 ]. There are many different ways to classify PI stages. The most common classification for PI are the four stages and the unstageable classification [ 3 ]. PI stages are defined on the basis of the severity of skin, tissue, and muscle damage. Particularly, once a PI has reached Stage 3, extending through the skin into deeper tissue and fat but do not reach muscle, tendon, or bone, the treatment process becomes protracted [ 4 , 5 ] Interventions for PI prevention and treatments include support surface, regular repositioning, appropriateness of nutritional status, skin moisturization, and others [ 2 , 6 ]. Gel pads, alternating pressure air mattresses (APAMs), and air-fluidized beds (AFBs) are support surfaces frequently used for PI cases [ 7 , 8 ]. The purpose of using support surfaces is to maximize the body surface area where the body contacts a bed, distribute the body weight, lower the pressure, reduce shearing forces, and control the local microclimate [ 7 , 9 ]. However, the selection of appropriate mattresses in clinical practice remains difficult since most support surfaces recommended are either by expert opinion or via low levels of evidence [ 7 , 10 , 11 ]. Normal capillary closure pressure ranges from 20 mmHg to 40mmHg, with 32 mmHg considered the average [ 4 , 5 ]. If constant pressure on capillary arteries is prolonged, and external pressure exceeds the arterial capillary pressure of 32 mm Hg the blood flow can be impeded, so wound healing may be drastically slowed [ 5 ]. Especially for those with PI at Stage 3 or Stage 4, high pressure can prevent blood flow from entering the wound site [ 5 ]. Therefore, in clinical settings, an APAM is often used in many facilities because of its low cost and easy access. An APAM contains a pump and a celled bed with low air pressure inside. Usually, every 2 or 3 cells is a set, and one air cell releases its pressure, the other one (two) remains the pressure, and the redistribution is based on a time schedule, not on skin pressure [ 7 , 11 , 12 ]. In contrast, AFBs are heavy and expensive. AFB uses warm air under pressure to set tiny silica or glass beads, called microspheres, in motion, which emulates the movement of fluid. When the resident is placed in the bed, his body weight is evenly distributed over a large surface area, which creates a sensation of “floating “. Therefore, they tend to be used in burn units in acute hospitals. In this study, a new kind of mattress was used with an artificial intelligence (AI) application, 3D InterSoft [ 13 ], which makes it possible to calculate the pressure on bony prominences in nursing residents or residents and redistribute the pressure automatically. Three major functions are integrated to the AI mattress, which includes the ePad fabric flexible sensor, the air bubble array, and the intelligent control box. The ePad fabric flexible sensor array and the air bubble array are separated into 1080 (20 × 54) cells in the mattress respectively, and they are connected to each other. The dimension of a single-pressure sensor is 2.2 × 2.2 cm2 with a spacing of 3 cm to the neighboring sensor. When the resident lies on the bed the first time, the mattress does a preliminary scan to identify the baseline. The AI in the mattress locates the areas of bony prominences and actively compares the aforementioned data with its’ database. Furthermore, the Intelligent control box drives the air bubble array to adjust the softness of the mattress. The mattress will then alter and relieve the pressure areas. As a result, pressure injuries can be prevented.

The mattress completes a reading with modifications to the cells every 60 min or every time the resident switches position. Each change in the cell provides more than 15% of decreased pressure pertaining to the original area. Moreover, the AI uses a color guided schematic of 26 colors, (Fig.  1 ) each with a representative gradient color to indicate the levels of pressure. According to the data obtained from the pressure sensor after the user lies down, 5% of the highest values are designated as the red portion, and 10% of the lowest values are designated as the white portion. Thus, with a redistribution of pressure the schematic changes accordingly. Nursing staff can monitor the pressure by observing the color scheme on the screen of the intelligent control box. Therefore, the aim of this case study was to determine whether the use of an AI mattress can improve a nursing home resident with PI.

Changes in PUSH scores overtime

This is a retrospectively designed case study. The case was the resident of an independent nursing home in Taiwan. All the data such as PI wound size, skin condition, and staff record were collected anonymously based on the chart review from Nov. 1., 2022 to Nov30, 2022. The pressure on the area of bony prominence was recorded by the AI mattress automatically very second. All the data were coded and analyzed by using the software of SPSS version 25.0. The descriptive statistical analysis and paired-t test was used based on the aim of this study.

Ethical approval

This case study was approved by the Chang Gung Foundation Institution Review Board (approval No: 202201641B0). The Helsinki Declaration was followed throughout the study. The researcher explained the study’s purpose, risk, and benefits prior inclusion. Written consent for data collection and publication was obtained by the surrogate of the subject. The surrogate of the participant has signed the informed consent for publication of identifying information/images. This case study was reported according to CARE case report guidelines.

The case recruited in this study was a 79-year-old male with a history of multiple diseases, including heart disease and myocardial infarction, who experienced long-term bedridden status after a heavy stroke. He was admitted to a nursing home because of left-sided hemiplegia and the need for positional changes. Although he was conscious, he could not express himself verbally, so he sometimes made grunting sounds to notify staff for diaper changes. In nutrition, 2100 kilocalories were given daily. Six bottles of Ensure® and 600 cc-800 cc of high protein drinks were administered through a nasogastric tube with four equal doses per day. His body mass index was 24 kg/m 2 .

On admission, A PI developed on his sacrum with a size of 6.5 × 3.5 × 3 cm 3 , and his PI was classified as Stage 4 according to the NPUAP The Braden scale was used to evaluate the risk of PI concurrently. In the Braden Scale his sensory perception, nutrition, and moisture were all scored 3, but friction and shear, activity, and mobility were scored 1 by the nursing staff. As a result, the total score was 12, indicating a high risk of PIs [ 5 ]. Moreover, the Pressure Ulcer scale for Healing (PUSH) was used to evaluate the healing status of PI [ 14 ]. The sub-score for the length x width was 9, for exudate amount was 3, and for tissue type was 4. The total score of PUSH was 16(Fig.  1 ). In addition, the staff reported several eczemas on the resident’s back and the resident moaned most of the time. Three major strategies were identified as the routine for PI care in this nursing home: first, changing position every 2 h allows for a decrease in pressure caused by being bedridden; second, the diaper and clothes were checked every two hours and changed if needed to ensure a relatively dry condition for the skin. Finally, a wet dressing wound change with antibiotic ointment is done once a day.

Improvement of his PI was one of the major concerns for admitting him to this nursing home, so a traditional APAM was used to relieve the pressure of being bedridden. Five months later, the wound size had decreased to 2.5 × 2 × 3 cm 3 .The PUSH score was down to 11 but no further improvement was observed. Consequently, an air mattress with the AI application was used to replace the traditional APAM; wound dressing and repositioning remained as before. The size of the AI mattress was similar to that of the traditional APAM but had an active pressure sensor array that ensured the accuracy of positioning. The pressure redistricting process is a dynamic process; this AI mattress can be programmed to automatically detect and calculate the pressure every second. The AI device uses the result from the first-time scan as the baseline or compare the aforementioned data to locates the areas of bony prominences and showed in a 26-colored schematic (Fig.  2 ). The red portion indicated the area with highest risk to develop PI. As a result, the pressure would be redistributed by the AI mattress.

Picture of real situation for the case in the Nursing Home ( A ) an AI mattress on bed with a box aside the bed ( B ) a color guided schematic of 26 colors to indicate the levels of pressure ( C ) an colored image of the pressure showing on the screen of the box. As the AI mattress scans the case, all bony prominences are identified

Therefore, Fig.  3 (A) to (C) are demonstrating how different colors were used to highlight the pressure level in different positions, with red indicating high pressure and thus a higher risk of PI development, while white indicated a lower pressure. Figure  3 (D) to (F) are displaying the redistributed pressure once the risk area was identified. Figure  3 (A) shows the body supine, Fig.  3 (B) shows the resident lying on his left side, and 3(C) shows the resident lying on his right side. A sensory array was used to scan and record the pressure data and connected to each cell. AI was set to automatically calculate skin pressure and presented in colored schematic. Figure  3 (C), (D), and (E) show that the AI mattress automatically redistributed pressure as AI compared with the aforementioned data and identified risky areas.

Using the AI device to detect bony prominences and to redistribute the pressure Panel ( A ), ( B ), ( C ) are pressure of lower extremities in different positions, flat, left, and right postures, respectively. The white dotted lines (square)were bony prominences Panel( D ), ( E ) and ( F ) are pressure of lower extremities in different positions, flat, left, and right postures, respectively, after the pressure was redistributed The pressure in white squares decreased once the pressure was redistributed by the AI device

The case used the AI mattress for 4 weeks. Figure  4 shows that repositioning by the nursing home staff occurred every 3.10 ± 0.25 h. In total, the time lying on the bed increased from 5.79 ± 2.95 h per day in the first week to 9.89 ± 2.21 h in the 4th week (Fig.  5 ). Regarding the total time spent on the bed in different positions, the time spent supine or sitting up at 30° was the highest (8.89 ± 2.36 h/day), followed by the left side (8.57 ± 1.79 h/day) and right side (6.50 ± 0.78 h/day). Due to the use of the AI device, no new PIs developed, and the size of the original PI decreased. Interestingly, left-sided pressure in the scapula and hip was significantly higher than right-sided pressure ( p  <.05) during both day and night (Table  1 ). Photographs of the PI wounds were taken and measured weekly. The size of the wound was 2 × 2.5 × 3.2 cm 3 at the start of using the AI mattress. Four weeks later, the size had reduced to 2 × 1 × 1.2 cm 3 (stage 2), and the score of the PUSH was down to 6(Fig.  1 ).

Average hours of lying on bed per time in different positions by the AI mattress overtime

A total hour of lying on bed per day in different positions by the AI mattress overtime

According to the NPUAP, repositioning every 164–240 min, is recommended to prevent PIs [ 2 , 15 , 16 ]. However, the reposition routine in this nursing home and most health institutions in Taiwan still remains with a frequency of every 2 h. In Fig.  4 , the AI data showed that the average time between repositioning was 3.11 h, much longer than the required 2 h in this nursing home. Over these 4 weeks in which the AI mattress was used, the average time for lying supine or sitting on the bed at 30° (with a stuffed pillow behind the resident’s back) was always longer than 3 h; the average time for lying on the right side was approximately 3 h, but lying on the left side was always less than 3 h.

PIs are mainly caused by long-term pressure on weak skin, especially in areas of bony prominence [ 17 ]. According to the Braden scale, sensory perception, moisture, activity, mobility, friction, and shear are the 6 major parameters used to measure the risk of PI [ 6 , 17 , 18 ]. The case presented in this study is still at high risk of developing PI, since in addition to multiple illnesses and issues of immobility due to hemiplegia, the resident suffered from urinary incontinence. Consequently, poor recovery from a PI wound was foreseeable [ 6 , 19 ]. Additionally, in this case, use of passive changing of positions every 2 h and wet dressing wound care with antibiotic ointment may not fully follow the international guideline for prevention and treatment of pressure ulcer of PI [ 6 , 18 ]. Treatments such as negative pressure oxygen therapy or wound debridement are recommended by the guideline. However, those treatments can only be performed in the hospital in Taiwan. It is highlighted that protecting skin away from moisture is of great importance for PI prevention and wound healing. In some instances, the addition of a traditional pressure relief mattress will be suggested, such as a gel pad or APAM. In the case study, routine wound care and an APAM initially improved wound healing. After 5.5 months, however, no further wound improvement was found, an outcome similar to those reported in the literature. Thus, the addition of a traditional mattress for PI may only slightly assist with wound healing. On the other hand, the mechanism of an air-fluidized bed uses flowing sand in the mattress that allows the human body to “float” in such a way that PIs can be prevented and wound healing [ 7 ] can be promote [ 8 ]. For bedridden residents, such beds have been identified as the most useful devices for PI prevention. However, they have the disadvantages of weight and expense. This case study involved a bedridden resident with hemiplegia who was suffering from a Stage 3 PI. Previous research has suggested that a Stage 2 PI wound takes an average of 1 month to heal and that a Stage 3 or 4 PI wound takes up to 4 months. The wound size of the resident decreased after receiving routine wound care and the use of a traditional air mattress for 5.5 months, but the wound depth did not change significantly. The process of wound healing has 4 phases: hemostasis, inflammation, proliferation, and maturation, and the typical period of wound healing is 4 or 5 weeks. The phase of hemostasis or inflammation takes less time, but the phases of proliferation and maturation persist the longest to create a skin scab. The scab may need up to 9 months to fall off from the healed skin. If a wound does not heal for more than 30 days, it is referred to as a chronic wound; most PI wounds at Stage 2 or above are considered chronic wounds [ 19 ]. Factors associated with prolonged wound healing include desiccation, infection, abnormal microbial increase, necrosis, pressure, and trauma. Theoretically, pressure on a part of the human body can inhibit or block blood flow that would provide oxygen or nutrients to the wound, thus prolonging the wound healing time [ 20 ]. With 5.5 months of wound care in the nursing home, the wound size of the resident in this study was reduced to 2 × 2.5 × 3 cm 3 and remained at Stage 3. Since no further improvement was seen, the decision was made to replace the traditional APAM for the AI mattress; the routine care was kept. The AI mattress is programed to complete a reading with modifications to the cells every 60 min or every time the resident switches position. The pressure would be redistributed after identifying the bony prominences at risk. Research showed that with appropriate use of wound care and nutritional support, removing pressure from a wound is critical and effective for wound healing [ 21 ]. Removing pressure from the PI wound can increase blood circulation around the wound, accelerate the elimination of wound waste, increase wound immunity, and provide a better healing environment. Changes in the microclimate of the wound may also be a contributory factor [ 9 ]. The environment of skin under pressure may feature high humidity and heat. Once the pressure has decreased, the microclimate of the wound area may become more amenable to wound healing Microclimate comprises of temperature, humidity, and airflow [ 9 ]. When the resident encountered the use of medical or nursing care procedures, such as dressing, diaper changes, repositioning, wound care and more, his microclimate changes. Microclimate can affect the degree of soft tissue deformation and responses. In turn, the skin condition may change [ 6 , 9 ].

In addition to wound healing, the staff reported that the sleep quality of the resident improved significantly after using the device, the frequency of moans for unknown reasons decreased, and sleep time was prolonged. The increased comfort could be attributed to improvement in the PI wound. Several instances of eczema on the back of the resident was found, which may be related to moisture-associated skin damage (MASD) [ 22 ]. The changing of clothing can lead to friction and shear which can damage the skin. The moisture from sweating may change the microclimate of the skin [ 18 ]. As the pressure is relieved by the AI mattress the microclimate may change, and eczema may improve.

In the examination of pressure on the scapula, sacrum, and hips (Table  1 ) it showed significantly higher pressure on the affected(hemiplegic) side than on the unaffected side of the body. This finding is similar to Chung’s study in 2006. The study was to compare the differences of skin pressure between hemiplegia and healthy persons in different position [ 23 ]. It is possible that muscle in the hemiplegic side is too weak to support body weight. Therefore, the hemiplegic side is at greater risk to develop PI than the unaffected side. Furthermore, even the nursing assistants tended to decrease the time spent by the resident lying on the hemiplegic side (left side), which would explain why this was the lowest average time. However, the finding still indicates that the pressure of the hemiplegic side is still higher than the unaffected side.

On the other hand, the nursing assistants may have tended to settle the resident in the supine position or sitting up in a 30° position [ 23 ]. It is possible that this is the most comfortable and natural posture. The other possibility is that diaper changes, nasogastric tube feeding, and wound changes require lying in the supine position or sitting on the bed at 30°. Because the staff were aware that the AI device was being used, they probably believed that it was removing most of the pressure. This leads to the increased length of time spent by the resident in supine or sitting up in a 30° position in weeks 3 and 4.

There was no deterioration in wound healing or the development of new PI sites. Moreover, the total number of turns to different orientations tended to be similar, which is beneficial for consistent care in nursing homes, suggesting a positive effect of the AI mattress on nursing quality and management.

Unfortunately, the resident was transferred to the hospital because of renal problems. Consequently, it was not possible to determine whether the PI wound had fully healed. However, the depth of the PI wound persisted throughout. Friction and shear are typically identified as the major factors leading to the development of PIs by the NPUAP [ 2 ], and both are regarded as major risk factors by the Braden scale. Friction and shear can be generated by changing diapers, uncovering gauze, and incorrect turning so that the healed wound tears repeatedly. Because these improper care behaviors occur easily, freshly healed tissues can crack, resulting in prolonged proliferation and remodeling delay. Furthermore, residents with multiple illnesses, as in this case, have difficulty following care plans because of frequent visits between hospitals and nursing homes.

This is a case study, though the use of an innovative AI seemed to be able to improve PI healing, a single case can just be a reference for other similar cases. The assumption was that if compressed skin could be not only redistribution(relieved) based on skin pressure automatically, but the pressure can be relieved in the smaller portion than the traditional air mattress. Then, PI could be prevented, and wound healing could be accelerated. Even though the total frequency of repositioning and wound care routine and position change frequency were not changed, the resident’s PI wound showed greater improvement with the use of the AI mattress than with traditional routine care. However, a larger sample size is needed to validate the effectiveness of the device and will be necessary to determine whether the device can be used to reduce the frequency of position changes needed. In the future, comparisons with other types of mattresses such as mattresses designed for changes of pressure to the body, or the mattress with constant low pressure over the whole body should be done. These studies should be done to allow for the correct allocation of mattresses for the residents with PI.

Data availability

The manuscript, including all relevant raw data, will be freely available to any scientist wishing to use them for non-commercial purposes, without breaching participant confidentiality. The data can be obtained through contacting the correspondent author.

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Acknowledgements

all the author are thankful to the participating resident, and all support from the workers at the nursing home of Excelsior Healthcare Group.

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Tung Fang Ni

Department of Electronic Engineering, Ming Chi University of Technology, New Taipei city, Taiwan

Jyh-Liang Wang

Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan

Chih-Kuang Chen

School of Medicine, Chang Gung University, Taoyuan, Taiwan

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De Fen Shih

Geriatric & Long-term Care Research Center, Chang Gung University of Science and Technology, 261 Wen-Hwa 1 Rd, Kwei-Shan, Tao-Yuau, Taoyuan, 333, Taiwan

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the author has contributed to this study. Tung Fung Ni and Jeng Wang conceived and designed the original study protocol. Jyh-Liang Wang and De Fen Shih assisted collection and analysis of the data from the AI mattress. They also were responsible to write-up part of result section, and a table & figures. Chih Kuang Chen was responsible for collecting and analyzing the data of the wound healing process and chart review. Tung Fung Ni was responsible for writing the first draft. Jeng Wang was responsible for revision of the manuscript and the overall content as a guarantor. All authors review and approved the final manuscript.

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Correspondence to Jeng Wang .

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Ni, T.F., Wang, JL., Chen, CK. et al. Can a prolonged healing pressure injury be benefited by using an AI mattress? A case study. BMC Geriatr 24 , 307 (2024). https://doi.org/10.1186/s12877-024-04900-x

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Received : 14 November 2023

Accepted : 18 March 2024

Published : 02 April 2024

DOI : https://doi.org/10.1186/s12877-024-04900-x

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