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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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Fixing Health Care from the Inside, Today

• Steven J. Spear
• September 01, 2005

Creating a Culture of Quality

• Ashwin Srinivasan
• Bryan Kurey
• From the April 2014 Issue

Framing the Big Picture

• Scott D. Anthony
• March 31, 2011

Reign of Zero Tolerance (HBR Case Study)

• Janet Parker
• Eugene Volokh
• Jean Halloran
• Michael G. Cherkasky
• October 31, 2006

Manage Your Human Sigma

• John H. Fleming
• Curt Coffman
• James K. Harter
• From the July–August 2005 Issue

Strategies for Learning from Failure

• Amy C. Edmondson
• From the April 2011 Issue

Made in U.S.A.: A Renaissance in Quality

• Joseph M. Juran
• July 01, 1993

The Contradictions That Drive Toyota's Success

• Hirotaka Takeuchi
• Norihiko Shimizu
• From the June 2008 Issue

Making Mass Customization Work

• B. Joseph Pine II
• Bart Victor
• Andrew C. Boynton
• From the September–October 1993 Issue

Power of Internal Guarantees

• Christopher W.L. Hart
• From the January–February 1995 Issue

Why (and How) to Take a Plant Tour

• David M. Upton
• Stephen E. MacAdam
• From the May–June 1997 Issue

U.S. Health Care Reform Can't Wait for Quality Measures to Be Perfect

• Brian J Marcotte
• Annette Guarisco Fildes
• Michael Thompson
• Leah Binder
• October 04, 2017

Organizational Grit

• Thomas H. Lee
• Angela L. Duckworth
• From the September–October 2018 Issue

Selection Bias and the Perils of Benchmarking

• Jerker Denrell
• From the April 2005 Issue

4 Actions to Reduce Medical Errors in U.S. Hospitals

• John S. Toussaint
• Kenneth T Segel
• April 20, 2022

Teaching Smart People How to Learn

• Chris Argyris
• From the May–June 1991 Issue

Beyond Toyota: How to Root Out Waste and Pursue Perfection

• James P. Womack
• Daniel T. Jones
• From the September–October 1996 Issue

A Better Way to Onboard AI

• Boris Babic
• Daniel L. Chen
• Theodoros Evgeniou
• Anne-Laure Fayard
• From the July–August 2020 Issue

The CEO of Canada Goose on Creating a Homegrown Luxury Brand

• From the September–October 2019 Issue

Coming Commoditization of Processes

• Thomas H. Davenport
• From the June 2005 Issue

Solid as Steel: Production Planning at thyssenkrupp

• Karl Schmedders
• Markus Schulze
• February 11, 2016

Texas Instruments: Cost of Quality (A)

• Robert S. Kaplan
• Christopher D. Ittner
• August 18, 1988

Era of Quality at the Akshaya Patra Foundation

• Srujana H M
• Haritha Saranga
• Dinesh Kumar Unnikrishnan
• January 30, 2015

Pumping Iron at Cliffs & Associates: The Circored Iron Ore Reduction Plant in Trinidad

• Christoph H. Loch
• Christian Terwiesch
• December 06, 2002

Cost System Analysis

• December 01, 1994

Sky Deutschland (B): How Supply Chain Management Enabled a Dramatic Company Turnaround

• Ralf W. Seifert
• Katrin Siebenburger Hacki
• January 12, 2016

NEA Baptist Health System (A): Building a Management System One Experiment at a Time

• Sylvain Landry
• Valerie Belanger
• Martin Beaulieu
• Jean-Marc Legentil
• December 20, 2019

Lean as a Universal Model of Excellence: It Is Not Just a Manufacturing Tool!

• Elliott N. Weiss
• Donald Stevenson
• Austin English
• December 14, 2016

BPO, Incorporated

• Scott M. Shafer
• January 15, 2006

Eurasia International: Total Quality Management in the Shipping Industry

• Ali Farhoomand
• Amir Hoosain
• July 23, 2004

NEA Baptist Health System (B): Deployment of the Toyota Kata Practice and the Role of the Shepherding Group

• June Marques Fernandes

NovaStar Financial: A Short Seller's Battle

• Suraj Srinivasan
• March 13, 2013

Spin Master Toys (A): Finding a Manufacturer for E-Chargers

• John S. Haywood-Farmer
• January 19, 2001

John Smithers at Sigtek

• Todd D. Jick
• October 05, 1990

Philips: Redefining Telehealth

• Regina E. Herzlinger
• Alec Petersen
• Natalie Kindred
• Sara M McKinley
• March 24, 2021

Creating and Spreading New Knowledge at Hewlett-Packard

• Robert Cole
• Gwendolyn Lee
• August 01, 2004

Product Innovation at Aguas Danone

• Javier Jorge Silva
• Femando Zerboni
• Andres Chehtman
• Maria Alonso
• December 01, 2012

The Challenge Facing the U.S. Healthcare Delivery System

• Richard Bohmer
• Carin-Isabel Knoop
• June 06, 2006

Maestro Pizza (H): Making the Best of the Situation

• Ramon Casadesus-Masanell
• Fares Khrais
• May 26, 2022

Mastering the Dynamics of Innovation

• James M. Utterback
• August 16, 1996

Solid as Steel: Production Planning at thyssenkrupp, Teaching Note

• March 09, 2016

Solid as Steel: Production Planning at thyssenkrupp, Student Spreadsheet

• January 28, 2016

Managing Service Operations: The Managerial Research Design Process

• Frances X. Frei
• Dennis Campbell
• April 04, 2008

How to Prevent Your Customers from Failing

• Stephen S. Tax
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• April 01, 2006

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Case Study: Quality System Optimization

• March 4, 2020

At QualityHub, we have experience in quality systems for several types of companies and situations. Here are nine examples of quality system case studies to give you some background on that experience.

CAPA System Overhaul

When QualityHub is brought on to do CAPA system revisions, it is often more reactive than proactive. However, one particular client — a major international pharmaceutical and medical device company — noticed shortcomings and wanted to take a more proactive approach to their CAPA system. 

Discover how QualityHub worked alongside one client to transform their CAPA system into what the FDA called “one of the best systems they had ever seen.”   Read the full case study here .

Compliance Master Plan

Qualityhub assisted an international device company with its existing compliance master plan. working with the project manager and qa director we were able to develop a newer version of the document that was more understandable and more detailed. using our ex-fda expertise we determined more emphasis was needed on accountability and responsibilities. we were able to improve the document to more closely hold persons responsible..

We also guided the company to use measurable data for the milestones, thus focusing on the metrics that were needed to demonstrate the success of the milestones via objective evidence. Since numerous project teams were involved in implementation, we worked with the project manager, who held the project team leaders responsible for providing key details in the document.

Based on our guidance and requirements, the teams provided us with improved responsibilities information and information on the objective evidence they would use to demonstrate the accomplishment of the milestones.

Investigation Analysis and Training

QualityHub worked with a major international drug/device corporation to help improve its internal investigation processes and skills. Internal reviews and FDA inspections pointed out weaknesses in that area. We performed a gap analysis by reviewing samples of investigations from divisions across the organization.

Working with company representatives, QualityHub developed a full-day training program on conducting investigations. The course materials were licensed to several thousand users, who became the corporation’s trainers worldwide (using “train-the-trainers”).

QualityHub participated in training the first two levels of trainers and certified the initial cadre. The company trainers presented the training to sites worldwide and initiated other improvements in their investigation programs.

To determine if the program was successful, we performed a second gap analysis of their investigations about six months later and at one-year post-deployment. These gap analyses showed great improvements.

Warning Letter Intervention

QualityHub was contacted by a strategic consulting partner to assist with a drug manufacturer who had recently received an FDA warning letter. Working with the partner company, we assisted in developing the overall compliance plan and writing the FDA update submissions.

The compliance plan included major improvements in the validation program, investigations/CAPA, change control and management controls. Utilizing several specialized contractor consultants and company personnel, we were able to implement a new quality system—and work on culture change initiatives—to ready the company for the inevitable FDA inspection.

CAPA Program Development

QualityHub was contacted by a drug company to assist in the development of a new CAPA program. Working with the company we reviewed their current program and guided them in the development of a new CAPA program. QualityHub also briefed local management and provided training to all applicable personnel on the new system. We also provided some guidance on the role of automation systems for their CAPA information.

Corporate Survey/Gap Analysis – Complaint Handling

QualityHub was contacted by a drug/device company to provide the main office with an analysis of practices company-wide. We visited numerous sites in Europe and the U.S. and provided a report of our findings. Process maps were developed and information was gathered on the strengths and weaknesses of the program. This information will be used for future process improvements as well as organizational analysis.

Corporate Survey/Gap Analysis – MDR and Complaint Handling

QualityHub was contacted by a major international device company to perform an analysis of complaint handling practices company-wide and worldwide. We visited over 20 sites to gather information about their complaint handling and MDR practices. The analysis included an extensive sampling of complaints—both non-MDR reported and MDR reported.

The project included an extensive data-gathering activity using pre-planned sampling plans, questions and analysis tools. Reports were prepared, which the company used to improve its complaint and MDR practices worldwide. We also consulted on their new and improved complaint and MDR procedures.

FDA Preparation Training

QualityHub helped numerous medical device companies in the U.S., Asia and Europe, prepare and handle FDA inspections. Overwhelmingly, the clients reported that our assistance was very helpful in handling the FDA inspections, and also in minimizing the number of FDA 483s the sites received at the conclusion of the inspections. The reduction of FDA 483s resulted in no warning letters for nearly all of these companies.

FDA Inspection Preparation and Back-Room support

We helped a European company plan for handling an FDA inspection. This included pre-inspection gap assessments, SME interviews and SME training, as well as management training and site preparation for the inspection.

During the actual inspection, we helped the back room in orchestrating the documents and SMEs that presented during the inspection.  The company passed the inspection with flying colors .

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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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Home » Management Case Studies » Case Study: Quality Management System at Coca Cola Company

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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Please note you do not have access to teaching notes, a case study of a quality system implementation in a small manufacturing firm.

International Journal of Productivity and Performance Management

ISSN : 1741-0401

Article publication date: 1 April 2005

This paper aims to present the findings of a case study conducted at ABC Structures (pseudonym), which is a small North American manufacturing company that has spent close to one year working on implementing the ISO 9000 standard. The main obstacles faced by ABC during implementation are highlighted. Although the company was not actually seeking registration, it was motivated by an internal need to improve operations, and by a vision of expanding business globally, in which case it expected that registration would be mandatory.

Design/methodology/approach

The case study method was used to achieve the objectives. Information obtained from the case study was collected from various data sources including interviews and informal conversations with the president, sales manager, engineering manager, operations manager, purchasing manager, manufacturing manager and technical personnel, attendance at project meetings, company documents, plant tours, and observations of the manufacturing process and product samples. These sources provided information that was useful in developing and implementing a quality system.

The case study conducted at ABC revealed a number of issues related to the implementation of a quality management system in a small company. While studies have shown that the ISO standard may not be applicable to small businesses, this study shows that the implementation of the standard's requirements benefited the company significantly. However, it should be noted that, while the company did not invest in all of the costs associated with ISO registration, it did invest in implementing as much as it could.

Practical implications

This study will be useful to quality managers, quality assurance and/or quality control practitioners, as well as researchers seeking to further understand quality practices and issues surrounding them. The study will also be beneficial to organizations that are planning to implement ISO 9000, are in the implementation phase, or already practising or registered with ISO 9000. While some of the findings presented in this paper are not new, they confirm the results of prior research on the organizational barriers that companies face in the process of implementing a quality management system.

Originality/value

The paper provides a description of steps taken by a small manufacturing company prior to implementing ISO 9000. It shows the hurdles it faced, and proposes how they could be overcome.

• Quality management
• International standards
• Quality standards

Bhuiyan, N. and Alam, N. (2005), "A case study of a quality system implementation in a small manufacturing firm", International Journal of Productivity and Performance Management , Vol. 54 No. 3, pp. 172-186. https://doi.org/10.1108/17410400510584893

Emerald Group Publishing Limited

Copyright © 2005, Emerald Group Publishing Limited

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Case Study: Nestle Nordic Quality management system audits

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Posted: 6 November 2020 | Intertek | No comments yet

Nestlé is the world’s leading nutrition, health, and wellness company, with over 280,000 employees and over 450 factories globally.

The Challenge

Prior to obtaining ISO 9001 certification with Intertek, Nestlé used their own proprietary quality management system, However, in 2017, Nestlé’s global operations made the decision that the entire company would be converting to ISO standards. Being accredited to an international standard looked better from the perspective of customers. Since then, they have been audited to ISO 9001, ISO 14001, and ISO 45001 integrated into one management system.

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A Case Study of a Whole System Approach to Improvement in an Acute Hospital Setting

Marie e. ward.

1 Centre for Innovative Human Systems, School of Psychology, Trinity College, The University of Dublin, D02 PN40 Dublin, Ireland; [email protected]

Ailish Daly

2 Beacon Hospital, Sandyford, D18 AK68 Dublin, Ireland; [email protected]

Martin McNamara

3 UCD Centre for Interdisciplinary Research, Education & Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, UCD Health Sciences Centre, University College Dublin, D04 V1W8 Dublin, Ireland; [email protected] (M.M.); [email protected] (S.P.T.)

Suzanne Garvey

Sean paul teeling.

4 Centre for Person-Centred Practice Research Division of Nursing, School of Health Sciences, Queen Margaret University, Queen Margaret University Drive, Musselburgh EH21 6UU, UK

Associated Data

Not applicable.

Changes in healthcare tend to be project-based with whole system change, which acknowledges the interconnectedness of socio-technical factors, not the norm. This paper attempts to address the question of whole system change posed by the special issue and brings together other research presented in this special issue. A case study approach was adopted to understand the deployment of a whole system change in the acute hospital setting along four dimensions of a socio-technical systems framework: culture, system functioning, action, and sense-making. The case study demonstrates evidence of whole system improvement. The approach to change was co-designed by staff and management, projects involving staff from all specialities and levels of seniority were linked to each other and to the strategic objectives of the organisation, and learnings from first-generation projects have been passed to second and third-generation process improvements. The socio-technical systems framework was used retrospectively to assess the system change but could also be used prospectively to help healthcare organisations develop approaches to whole system improvement.

1. Introduction

The Patient Safety and Quality Improvement (QI) movements in healthcare have been slow to achieve momentum in improving outcomes [ 1 ]. Braithwaite et al. (2018) estimate that in healthcare organisations, nearly two-thirds of initiatives experience implementation failure [ 2 ]. Changes in healthcare tend to be project-based with whole system change, which acknowledges the interconnectedness of socio-technical factors, not the norm. In addition, it can be difficult both to sustain change beyond the project lifecycle as well as to generalise change to a broader level [ 3 ].

Lean Six Sigma is a powerful methodology that reduces waste and variation in an organisation and ultimately minimises operating costs, optimises productivity, and maximises customer satisfaction [ 4 ]. LSS is the merger of two methods used in process improvements. Lean originated in Toyota car production factories and focuses on refining and improving processes as well as eliminating non-value-added (NVA) activities [ 5 ]. Six Sigma was introduced by Motorola to optimise its manufacturing processes by reducing their variability through the rigorous application of process metrics collection and statistical analysis [ 6 , 7 ]. Since the early 2000s, LSS thinking has been adapted into healthcare with the goal of improving patient safety, quality of care, efficiency, patient satisfaction, and performance [ 8 ].

Healthcare providers worldwide, both publicly and privately funded, are faced with similar challenges of caring for an ageing population with a limited pool of financial and personnel resources. Consequently, the need to seek improved efficiencies while continuing to provide safe and high-quality services has become more and more acute [ 9 ]. LSS has been implemented in many healthcare organisations, with impacts achieved across many clinical and administrative pathways and processes [ 10 , 11 ]. While there are positive associations between LSS adoption and performance indicators in individual case studies [ 12 , 13 , 14 , 15 ], overall evidence on the success of LSS is mixed. Considerable time and effort need to be spent on implementation for LSS to be associated with gains in hospital performance. The degree to which this investment is made depends on the system maturity, leadership commitment, daily management system use, and training [ 16 , 17 ]. There is also increasing recognition of the importance of improving both patient and staff experience of healthcare [ 18 , 19 ] and moving to person-centred approaches in healthcare [ 20 ]. Political and policy stakeholders have widely advocated that person-centred care should be at the heart of the health system [ 21 , 22 , 23 , 24 ]. Person-centredness refers to embedded practices within a specific type of culture that enable and facilitate the delivery of person-centred care [ 25 , 26 ]. Person-centred cultures are deemed necessary for the delivery of person-centred care [ 26 ]. Person-centred care has an explicit focus on ensuring that the client or patient is at the centre of care delivery [ 25 , 27 ] and is concerned with every person involved in the patient’s care, including staff members and patients and their families/carers [ 20 , 27 ].

Implementation science as a field aims to help understand the factors surrounding the uptake of evidence-based practice into healthcare [ 28 ]. A central tenet of implementation science is that implementation strategies will be most successful when they align with healthcare systems’ existing culture, infrastructure, and practices [ 29 ]. Context has thus emerged as a key construct in understanding challenges to healthcare improvement [ 30 ]. Inconsistencies exist, however, in defining context [ 31 ] and in understanding the complexity of context in healthcare [ 32 ].

When talking about the healthcare system as a whole system, it is important to refer to a method for describing such a system that addresses its complexity and provides an analysis that gives leverage over the mechanisms of system change. McDonald et al.’s 2021 [ 33 ] work presented in this special issue makes a cogent argument for the importance of taking a socio-technical systems (STS) approach to whole system understanding and change. STS analysis involves studying the dynamic interconnectedness of elements of the system at different levels, such as team, processes, and information and knowledge. They propose a model called the CUBE for STS analysis that focuses on four domains:

1.1. Culture

Culture represents the pattern of shared basic assumptions and (what is often) a partial shared understanding of the STS and incorporates Schein’s [ 34 , 35 ] and Pigeon and O’Leary’s [ 36 , 37 ] work on culture.

1.2. System Functioning

System functioning represents how the system actually works and incorporates both formal elements (work-as-imagined), i.e., Policies, Procedures, Protocols, and Guidelines (PPPGs) as well as informal elements (work-as-done or the sequence of activities that normally takes place) [ 38 ] and incorporates Perrow’s functional focus on complexity and coupling [ 34 ].

1.3. Action

Action represents how we act within the system, incorporates Turner and Pidgeon’s work on the flows of information, knowledge and understanding, and anything that happens in the system that is recordable or measurable [ 37 ]; this can be analysed at different levels, such as individual actions, team performance against a standard, activity sequences, or key outcome, process, and balancing measures in relation to system performance [ 35 ].

1.4. Sense-Making

Sense-making represents how we understand and make sense of our world and incorporates Weick’s work on how individuals operating within the system make sense of it, often through practical action [ 39 ].

These dimensions of the CUBE are further broken down in terms of four types of relation: Goals (linked to objectives and outcomes), Process (sequential relations), Social Relations (reciprocal relations of working with and reporting to), and Information and Knowledge (exchanges of meaning that link people and processes). Figure 1 represents the CUBE.

Pictorial representation of the CUBE.

This case study reports on the system-wide implementation of LSS in conjunction with person-centred care principles in a large acute private hospital setting. The organisation’s mission is to provide exceptional patient care in an environment where quality, respect, caring, and compassion are central. This mission is based on organisational values of dignity, excellence, collegiality, and communication. In 2014, the organisation set out on a journey of expansion and growth. It was recognised that if this was to be achieved while holding the highest standards in quality and safety of patient care all staff would need to be involved and play a role. At that time, the organisation had achieved accreditation by the Joint Commission International and to maintain this was a key organisational goal [ 40 ].

This case study sets out to address the question ‘Was the deployment of LSS and person-centred care in this hospital a change on a whole system level?’. The CUBE will be employed as a descriptive and analytic framework to help answer this question.

The CUBE framework is firstly used here to outline some of the important considerations prior to the commencement of the change programme.

1.5. Culture

There was a recognition of the importance of culture from the outset. Retention and development of a highly-skilled staff body with significant organisational knowledge would be crucial to the journey of expansion. A key organisational priority became adopting a person-centred approach with the principles of collaboration, inclusiveness, and participation (CIP) underpinning process improvement in the hospital [ 20 ].

1.6. System

The following strategic objectives were set in 2014: to ensure excellence in quality and safety of patient care through compliance with the six International Patient Safety Goals as outlined by Joint Commission International [ 35 ]; to use Information Technology to enhance Safer Patient Care; to improve Patient Flow, and to improve Care of the High-Risk Patient. With the setting of these strategic objectives, it was recognised that all improvement work needed to come under one approach and be aligned to these strategic objectives as set out in the Hospital Leadership Goals 2014 [ 41 ]. This has been a criticism of QI in healthcare with the term ‘projectitis’ referring to an excessive focus on small projects that are not aligned to the strategic goals of the organisation or each other [ 42 ].

1.7. Action

Not all action in healthcare is suitable for easy measurement. A key focus of the hospital’s efforts, however, would be the ability to measure current performance and to know when a change is an improvement [ 43 , 44 ]. Another priority would be to give healthcare teams information and knowledge on how they were performing so that they would make sense of their own processes and improvement [ 38 , 45 ].

1.8. Sense-Making

Providing staff with excellent educational and developmental opportunities would be essential to support sense-making. The desired “future state” was a better patient and staff experience supported by a culture where all staff members, from Board and Executive Management Team (EMT) to frontline staff, had a shared vision of the goals and adopted a system-wide approach to process improvement, avoiding working in silos [ 46 ]. The organisation had a strong history of supporting staff in the completion of post-graduate education and training; however, before this project, education and training opportunities had been considered based on the individual’s or possibly the department’s needs. Outputs were delivered at the individual or departmental level. A system-wide consideration of education and training needs and outputs had not previously been attempted. It would be essential that staff were educated together to achieve a system-wide approach to change and improvement.

2. Materials and Methods

2.1. case study.

A case study approach [ 47 , 48 ] was adopted here to understand the deployment of a whole system change in the acute hospital along the four dimensions of STS outlined above. A case study is an approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context [ 49 ]. This case study sets out to address the question ‘Was the deployment of LSS and person-centred care in this hospital a change on a whole system level?’. The case study analysis was informed by a number of different sources of evidence [ 47 ].

2.2. Evidence

2.2.1. internal hospital documentation.

Hospital Leadership Goals (2014)

Education and Training Working Group; agendas and minutes (2015–2021)

Education and Training Working Group; gap analysis (2015)

Lean Academy presentation to the Hospital Board of Directors (2016)

LSS projects; meeting notes, project progress tracking (2017–2021)

2.2.2. Seven Research Studies Presented in This Special Issue

Operation Note Transformation: The Application of Lean Six Sigma to Improve the Process of Documenting the Operation Note in a Private Hospital Setting [ 50 ].

Releasing Operating Room Nursing Time to Care through the Reduction of Surgical Case Preparation Time: A Lean Six Sigma Pilot Study [ 51 ].

Redesigning the Process for Scheduling Elective Orthopaedic Surgery: A Combined Lean Six Sigma and Person-Centred Approach [ 52 ].

Lean Six Sigma Redesign of a Process for Healthcare Mandatory Education in Basic Life Support—A Pilot Study [ 53 ].

The Use of Lean Six Sigma for Improving Availability of and Access to Emergency Department Data to Facilitate Patient Flow [ 54 ].

Using Lean Six Sigma to Redesign the Supply Chain to the Operating Room Department of a Private Hospital to Reduce Associated Costs and Release Nursing Time to Care [ 55 ].

The Use of Lean Six Sigma Methodology in Reducing Length of Stay and Improving Patient Pathway in Anterior Cruciate Ligament Reconstruction Surgery (submitted) [ 56 ].

2.2.3. Participant Observation

One of the authors (AD) is the Director of Education, Innovation, and Rehabilitation at the hospital and has been on this whole system change journey since 2014. She has observed most of the processes concerning the deployment of LSS and person-centred care across the hospital. Another author participated in the Education and Training Working Group (SG). Another author (SPT) is one of the staff members from the Lean Academy who has also been involved since the beginning of the deployment from an academic provision perspective and has observed the system change unfold through this lens since 2017.

2.3. Synthesis

The synthesis of the evidence was facilitated by two authors (MEW and MMcN). MEW was involved in the development of the STS CUBE framework [ 33 , 57 ] and MMcN developed the university-accredited LSS curriculum to overcome system blindness [ 58 ], which was used within the hospital. MEW and MMcN supported the synthesis of the evidence by using questions from the CUBE framework combined with reflective questions from Oshry’s Organic Systems Framework (OSF) [ 59 , 60 ]. Because of the participatory nature of the involvement, it was felt important to add this reflective dimension. Oshry’s OSF provides a framework and vocabulary for describing human systems as organic wholes and allows us to understand and, potentially, influence a range of system phenomena. Oshry’s concepts enable us to see the whole as a pattern of systemic relationships (what the whole is) and as a pattern of systemic processes (what the whole does). He addresses how, as system members, we experience ourselves, our relationships with others, the systems we are a part of, other systems, and the relationships among systems, and it allows us to make more informed decisions and to take more informed actions based on these experiences. A set of questions based on the CUBE and Oshry’s OSF can be found in Table 1 and Table 2 . These questions were posed by MEW and MMcN to the other authors and answered through a process of iteratively writing up this case study. The synthesis set out to generate an answer to the question of whether or not this change could be described as being at a whole system level.

High-level questions are derived from the STSA CUBE [ 46 ].

Reflective questions derived from Oshry’s Organic Systems Framework [ 48 , 49 ].

2.4. Approach to Change

The approach to change at the time of commencement is now outlined under the domains of the CUBE.

2.4.1. Culture

Simpson et al. (2019) describe the importance of healthcare organisational culture when considering quality and patient safety in healthcare [ 49 ]. In 2014, the organisation culture was evolving from a “Power Culture” where the key to the organisation sits in the centre surrounded by widening circles of intimates and influence [ 61 ] (Handy 1999 p. 86). While such a command-and-control culture supported the successful initial drive to build and open the hospital, there was an acknowledgement that a challenge to sustaining and developing an organisation based on a “Power Culture” can be high staff turnover and staff dissatisfaction. There was a need to evolve to a culture of collaboration, inclusion, and participation, allowing the right staff power and influence to contribute to service progression and ultimately organisational development and expansion [ 20 ].

2.4.2. System

The strategic goals that the change was to support are outlined in Table 3 . These are aligned to the JCI accreditation program chapters. JCI accreditation had been achieved by the organisation and a key strategic goal was to maintain this accreditation.

The organisation’s strategic goals.

2.4.3. Action

Each part of the change process would address a strategic goal and would need to achieve certain pre-defined outcomes as outlined in Table 4 below.

System and action table.

2.4.4. Sense-Making

With support from the Board of Directors and the EMT, an Education and Training Working Group (ETWG) was created to identify the needs of the organisation and recommend relevant education and training programmes for implementation. The ETWG comprised a diverse set of stakeholders, all with a crucial role in developing a strategic direction for the organisation. The ETWG agreed on the importance of including all staff in opportunities to input into the design of the education programme; however, they also identified the challenge in accessing and meeting with a wide number of staff productively and effectively. Therefore, an open platform for suggestions was created through town hall meetings, departmental meetings, and performance reviews, including training needs analysis. Each ETWG member took responsibility for a staff/departmental grouping to gain their thoughts on education and training requirements as outlined in Table 5 .

Education and Training Working Group.

Engagement sessions were structured as focus groups with one-to-one sessions also facilitated when requested. The results of the stakeholder engagement sessions helped to inform the desired outcome of education and training solutions as outlined in Table 6 .

Outputs from stakeholder engagement sessions.

Participants were asked to consider focus group themes in the context of the wider organisation rather than discipline or department-specific and the context of the deliverables outlined by the hospital Board of Directors and EMT. To ensure inclusion, a representative from all departments was invited to contribute. When choosing a representative, departments were encouraged to consider staff from all grades/groupings—not specifically managers.

Based on feedback from stakeholders, the ETWG proceeded to scope potential education and training solutions with some key outcomes required in the following areas:

• the culture of quality and patient safety as a priority goal for the organisation would need to be endorsed in any education and training programme;
• to continue to deliver the best patient care, the organisation would need to constantly evolve and improve, working to best international evidence-based practice; and
• the programme would need to take account of the strategic direction of the organisation, including the use of technology to enhance patient care, optimise patient flow, and optimise care of the high-risk patient.

The ETWG identified that the gap in organisational knowledge lay not in the theory of what care to provide but the project management and process improvement skills to bring those theories to fruition. Rather than middle management/senior clinicians passing an idea to EMT to realise, the goal was to achieve a system-wide change in how projects are delivered—co-creating and realising strategies with senior and middle management and frontline staff working together [ 62 ]. Thus, education and training would need to be accessible to team members from all disciplines and all levels of seniority. To support future goals of improved inter-professional collaborative and shared decision-making, education and training that was accessible to the wider healthcare team across levels of seniority, from EMT to department managers as well as staff directly involved in the patients’ journey through the organisation, was deemed a priority [ 62 ].

To add accountability to students and the organisation, a formal academic qualification was deemed a requirement. This was to ensure that students would receive official recognition of knowledge gained and the organisation would be able to formally identify deliverables from investment in training that could be expected.

With education requirements defined ( Table 6 ), the ETWG completed a scoping review of literature of Cinahl and PUBMED databases using keywords including Process Improvement, Healthcare, and Person-Centredness. Emerging evidence of the role of LSS in wider healthcare settings was identified. Of particular note was the variation in LSS work completed in healthcare settings, including administration/patient scheduling, Emergency Department patient flow, Theatre flow, and laboratory turnaround times [ 11 , 63 , 64 , 65 , 66 ], as well as the impact of LSS in improving quality, patient safety, and employee engagement in healthcare [ 27 ]. The ETWG identified LSS as an evidence-based approach to process improvement. Its background in business and then healthcare aligned with the logistics of merging clinical and business process improvements in a private healthcare setting. The principles of LSS include recognising the complexity of healthcare, avoiding silo working, always being open to change and improvement, gathering data to create knowledge, cutting waste not care and focusing on improving the process rather than seeking person-specific improvements that matched the ethos of the organisation.

The ETWG took the evidence from the literature and sought further information regarding the impact of LSS in healthcare through visiting sites that had successfully implemented LSS to examine the “lived experience” of the organisation and their team. This took the form of a site visit to an acute hospital as well as attendance at a White Belt: “Fundamentals of Process Improvement for Healthcare” provided by the Mater Lean Academy. On assessing the literature and reflecting on the site visit, the ETWG reflected on the potential for LSS in healthcare as an education and training resource for process improvement in the organisation. The specific advantages related to accessibility. The structured delivery of LSS from White Belt: “Fundamentals of Process Improvement for Healthcare” to Green Belt: “Professional Certificate Process Improvement in Health Systems” to Black Belt: “Graduate Diploma Process Improvement in Health Systems” would enable staff at all levels to access LSS training—from a 1-day training course to a 1-year diploma.

The ETWG agreed to recommend LSS as an education programme to support process improvement in the organisation. The hospital Board of Directors supported the recommendation and an implementation plan was agreed upon. The support of the Board and EMT was a key requirement before the implementation plan and was based on the following principles:

• LSS training would be made available to all staff. Training would not be discipline or grade-specific. This was important in developing staff who ‘can’, contextualising the change across the organisation, and recognising the role of all employees [ 62 ].
• The method of delivery would be the same for all staff—thus, there was no specific delivery methodology for the EMT.
• The organisation would fully support participation in LSS education events. This included the provision of study leave and financial support for attendance at LSS training events. Thus, the improvement approach was resourced from the outset.
• Members of the EMT were committed to attending training events and acting as executive sponsors as projects emerged. This confirmed leadership commitment through walking the walk, getting involved, and supporting the project [ 50 , 51 , 52 , 53 , 54 , 55 , 56 ].

3.1. How Change Was Achieved in the Organisation

The details for how each individual project achieved its goals are written up in the accompanying papers to this case study [ 50 , 51 , 52 , 53 , 54 , 55 , 56 ]. Some examples of quality and patient safety improvement include: a reduction in the length of stay for surgeries, leading to less likelihood of acquiring a healthcare-associated infection; an increase in capacity to deliver Basic Life Support across the organisation; surgical notes transferred to electronic platforms to improve legibility and accessibility; and releasing nursing and healthcare assistants time to care for patients. Please see Table 7 for a full list of outcomes.

LSS projects delivered through collaborative, inclusive, and participative working.

The mechanisms for change at a system level are presented here using the four domains of the CUBE.

3.1.1. Culture

As can be seen in Table 7 , it is evident that the teams involved in the process improvement projects were from a wide range of backgrounds and seniority, some directly involved in the process, some giving an external perspective. Working from a common framework of the LSS methodology underpinned by a person-centred approach has allowed voices across disciplines and seniority to take an active role in project delivery. It has allowed for devolved responsibility for project delivery from the EMT level. The organisational culture shifted from a power-based culture to a task-based culture [ 61 ].

3.1.2. System

All projects supported organisational strategic goals as well as quality and patient safety priorities. Table 7 demonstrates the system-wide impact of process improvement projects delivered to date. Learnings from first-generation projects have been passed to second and third-generation process improvements ( Figure 2 ). Rather than being completed in isolation, projects are linked and outcomes are used to inform further process improvement.

Interconnection of projects supporting multiple strategic targets.

3.1.3. Action

Each of the projects described in Table 7 has resulted in concrete tangible outcomes for the organisation. For example, the Emergency Department data are circulated daily to the Emergency Department and EMT [ 54 ]. The use of LSS to redesign the delivery of Basic Life Support (BLS) training has resulted in a 50% increase in the capacity to deliver BLS [ 53 ]. Key to this was the academic qualification attached to the LSS training. The requirement to present a completed project that was nominated and supported by the hospital Board of Directors and EMT gave influence and a voice to the project groups.

3.1.4. Sense-Making

The deployment of LSS in conjunction with person-centred care commenced in the hospital in 2017. The following practical aspects of deployment were also put in place to support the above principles. All staff members were included in invites to attend training events. LSS training events were advertised through hospital-wide newsletters, email groups, team meetings, etc. Every staff member was invited to attend White Belt training. Staff from all disciplines and grades attended White Belt training together; there was no specific training for members of the EMT. This supported the hospital’s values of removing barriers between senior managers and staff directly involved in patient care as well as encouraging collaboration across teams/moving from a siloed approach to process improvement. White Belt training had to be completed before moving on to Green Belt training. Academic institution requirements were also noted. Once a staff member was assigned a place at a training event, they agreed to participate actively in the training event. To encourage collaboration, training events were arranged with team members from different departments and at different levels of seniority.

To ensure a whole system approach to improvement, each staff member applying for Green or Black Belt training was asked to submit a project charter as part of their application. Members of the EMT and quality and patient safety staff committed time to potential students to co-design project suggestions and project charters. This ensured that projects were aligned to the strategic goals and direction of the organisation. From a staff perspective, this also demonstrated the EMT and senior management commitment to their improvement project. This commitment was also demonstrated in practice. To assist with staff being released for improvement work, each application required approval from the staff member’s line manager—to ensure cover was in place for the staff member’s improvement leave as required. The first White Belt course was delivered in May 2017. Attendees included the CEO, a nurse specialist, a procurement operative, a physiotherapist, a healthcare assistant, and a patient services administrator. The ETWG had achieved a very important goal—the training event was accessible to all and had served to show that hierarchy was not going to be a barrier to improvement [ 67 ].

Following the implementation of White Belt training events, the organisation was ready to submit applications for Green Belt training commencing September 2017. For the candidates proceeding to Green Belt training, the organisation and candidates hoped that this would empower “middles” to lead process improvement by giving them the skills to integrate the needs and requirements of management with the potential and skills of the frontline staff [ 60 ]. The first Black Belt training programme was completed in November 2020, delivering advanced knowledge on LSS in healthcare. This also delivered the very significant milestone of the hospital being able to deliver White Belt training internally.

Each LSS training event resulted in specific deliverables. At the Black Belt/Green Belt level, this was the completion of process improvement projects with a tangible impact on the strategic goals of the organisation. At the White Belt level, a network of staff familiar with LSS tools was developed who could assist Black and Green Belts to achieve project goals. Every staff member in the hospital has a role to play in quality and patient safety. The accessibility of LSS to all staff created an avenue for all staff to learn and become actively involved in patient safety activities. Combining a person-centred approach and stakeholder engagement methodology, a shared purpose approach has emerged in the LSS projects to date. The project teams formed and refined the project goals and took a shared responsibility with key stakeholders to see projects through to completion.

3.2. Case Study Synthesis

The importance of taking a socio-technical systems approach to whole system change that focuses on the four domains of culture, system, action, and sense-making was stressed in the Introduction [ 33 ] as an important approach to move forward the lack of traction on quality and patient safety improvement that has afflicted healthcare over the last 20 years [ 1 , 2 ].

The results of this case study are now discussed with these four domains in mind. At the outset, the organisation required increased knowledge and skills in person-centred process improvement to help staff provide a sustainable workforce that could engage with and support organisation expansion and development. The person-centred implementation of LSS in the organisation has resulted in the emergence of a task-based culture that focuses on involving the right people with the right resources to complete improvements [ 61 ]. The unifying power of the group is in their approach to the project—a commonality in structuring the project utilising LSS tools based on the principles of collaboration, inclusion, and participation [ 27 ]. These principles allow staff who have completed Green and Black Belt training to support process improvement outside of their usual areas of work—moving away from silo-based improvement or ‘projectitis’ and to more of a system-wide approach to change. LSS graduates from one area are supporting improvement in another. This enables sharing of knowledge and skills, the building up of organisational trust, systemic learning at both a tacit [ 63 ] and explicit level, and the provision of support to system-wide improvement. Interdependencies between projects and areas are noted and a systems view emerges. Staff from patient services supported improvement projects in theatre procurement and graduates from physiotherapy supported projects in information technology/education planning. Investing time and energy to allow staff to do this can be a challenge in a busy acute hospital. By employing the principles of stakeholder engagement promoted by LSS—seeking to understand and giving voice, but also ensuring improvement sessions were well structured with identifiable deliverables, staff were happy to dedicate time to achieve the desired outcome and the organisation supported this.

Study leave was approved before Green Belt and Black Belt training and education commenced. A support network for covering staff was agreed upon. The clear message of support from the Board and EMT removed concerns regarding financial and study leave support. More challenging was facilitating stakeholder engagement/data collection sessions. Teams had to be mindful to meet their stakeholders at times and venues that suited. Additionally, hugely important was the need to reassure stakeholders that the teams sought to understand processes and challenges and seek solutions. The purpose of a LSS project was never to examine or find fault with the person—94% of the problems are caused by the system and 6% by the individual [ 68 ].

In terms of the development of a long-term sustainable team that can support hospital development and expansion, the hospital has moved through forming, storming, and norming and is currently progressing to performing [ 69 ]. D’Andrematteo (2015) [ 70 ] called for further investigation into the organisation-wide success and weakness of LSS. In this system-wide implementation of LSS underpinned by a person-centred approach, the hospital has achieved an organisation-wide approach to improvement involving staff from all specialities and levels of seniority.

Benefits and challenges involving roles within the improvement team were noted. The involvement of clinicians in healthcare improvement is central to system change [ 71 ]. There was great support from clinicians throughout—from practical support given by the Orthopaedic Consultants and Anaesthetist in implementing Day Case Anterior Cruciate Ligament surgery to the “external” process view offered by the Speech and Language Therapist to theatre procurement and stock management [ 55 ]. Each LSS project is based on the collaboration of team members from a combination of medical, nursing, HSCP, and management/administrative backgrounds [ 72 ].

Clinicians are trained to make quick decisions to address an evolving presentation in a patient. The temptation to start a process improvement with “I know the solution—we just have to …..” was something that a lot of staff had to learn to avoid. Process owners within teams also had to learn to allow others the authority to examine processes and facilitate stakeholder engagement and data collection—in some cases acknowledging that team members from outside the process were better placed to complete these activities—as they approached them with “fresh eyes”. This supports a culture where all staff members have psychological safety [ 67 ] and feel able to speak up for important issues such as quality and safety of patient care [ 68 ]. Psychological safety is an essential component of achieving JCI accreditation [ 40 ]. It helps healthcare move on a journey towards high reliability [ 1 ] and to building organisational resilience [ 73 ]. The management is also learning to distribute power and knowledge and acknowledge the expertise and insights of others. There is less emphasis on the positional role and traditional authority [ 74 , 75 ].

LSS is now the method of choice used for improving processes. LSS is also used to present improvements as part of JCI accreditation. The organisation completes JCI accreditation every three years. As part of this accreditation, the hospital reports on key performance indicators, including length of stay and readmission rates, and quality improvement projects around these indicators. Please see Table 8 .

Hospital leadership goals and key performance indicators.

From 2019, these projects have been completed using the LSS methodology. The hospital first achieved JCI accreditation in 2007 and has been re-accredited every three years since then—most recently in 2019. Continuing to achieve re-accreditation requires continuing improvement as well as a commitment to quality and safety of care, including the International Patient Safety Goals.

In addition to the projects described above and as a reflection of the maturing of a LSS culture in the organisation, the LSS methodology has now been adopted as the process improvement method of choice in the organisation. Green and Black Belt projects, as mentioned above, have led to legacy projects outside of the academic structure.

As the number of staff familiar with the LSS approach increases in the organisation, the use of various methods, tools, and strategies has become commonplace. For example, when planning a new or changed service, first thoughts are always to align with the strategic objectives of the organisation, followed by using LSS tools such as process mapping to understand how the service currently runs (AS IS mapping) and to identify how the service will run (TO BE mapping). When analysing potential risks associated with changing a process, a Failure Modes Effect Analysis (FMEA) is completed as standard—this is of particular benefit when preparing for JCI accreditation as it is a tool that JCI commonly requests as part of their accreditation of quality and safety improvement in the hospital.

The CUBE STS analysis framework as further developed in the Access Risk Knowledge (ARK) Platform addresses questions of value in terms of the projected gain and the actual gain of the change achieved [ 28 , 66 ]. In Table 7 the expected outcome and the actual outcome achieved are presented for each individual project. Improvements also occurred outside of these projected outcomes, for example, improvements related to operation notes also improved patient safety and created a template for the transference of further documents to the patient electronic record—without having to seek external consultancy advice. Value can also be seen by stakeholder satisfaction and improved patient care. Examples of stakeholder satisfaction include:

“The novelty, of actually being able to read the handwriting and understand the detail of the surgery, is brilliant!”

“It’s so easy to use”,

“With the help of the templates, I can complete my Op note in minutes”

“It’s saving me so much time!”

“Love the layout, it’s so easy to read”

Harder to estimate is overall Return on Investment (ROI). Four years into the deployment, ROI can be estimated by savings made related to improvement projects. Each of the seven studies reported on here achieved outcomes that can be quantified separately, e.g., projects involving theatre stock have led to a 91% reduction or EUR 24,769 in the value of out-of-date stock and a 45% reduction in nursing stock preparation time (releasing that nursing time to caring for patients) [ 51 , 55 ]. Projects involving patient flow, such as improving the pathway for patients attending Anterior Cruciate Ligament reconstruction, have resulted in an additional 24.6 bed days annually in the organisation [ 56 ]. This implementation was funded within the existing postgraduate education and training budget. Analysis of staff retention and progression is complicated due to many changing circumstances resulting from the COVID-19 pandemic. Of the 32 staff who have completed Lean Six Sigma practitioner training, 25 (78%) remain and are progressing to new roles in the organisation. Further analysis of the 21% of staff trained who have left the organisation is required to identify motivating factors behind the staff member’s decision to change.

Another ROI was the ability to continue White Belt training with in-house resources, meaning the cost of continuing LSS training in the organisation reduced significantly in 2020. Perhaps a mark of leadership satisfaction with the LSS programme was that rather than allocating those savings to another area, the savings were ploughed back into LSS training and education—supporting further Green Belt and Black Belt training.

4. Discussion

The case study synthesis, using the CUBE domains of culture, action, system functioning, and sense-making combined with Oshry’s OSF, has enabled us to answer the question of whether or not these elements combined to create agency for change at the organisational level of the hospital. The case study demonstrates evidence of whole system improvement; projects involving staff from all specialities and levels of seniority are linked to each other and to the strategic objectives of the organisation, and learnings from first-generation projects have been passed to second and third-generation process improvements.

The question of whole system change is difficult, however. There is little agreement in the literature on what constitutes ‘whole system’ change, which speaks to the origins of this special issue. This case study has taken the approach that the design of an effective agency of complex and socio-technical system change requires both an understanding of socio-technical systems and the engineering of their development [ 28 ] and takes some reflection on our role as actors within the system [ 47 , 48 ].

Flynn et al. (2019) [ 77 ] completed a realist evaluation to identify contexts and mechanisms that enabled and hindered implementation and had an effect on the outcome of sustainability of what was meant to be a whole system Lean intervention in a pediatric healthcare setting (CMOs). This intervention was noted as being the ‘largest Lean transformation in the world’ [ 78 ]. While Flynn et al.’s evaluation focused on the outcome of sustainability, the framework could still be used to assess whether the hospital intervention reported here did have an impact at a systems level. The CMOs from Flynn et al.’s work are thus presented here along with a response from the synthesis of evidence in this case study.

CMO1: The early stages of Lean’s implementation were funded, mandated, and top-down in nature (C), driven by an external consultancy firm that initially focused on training senior leadership (C). Frontline staff did not feel involved in Lean changes, and they felt pressured to adopt Lean (M). The Lean language used did not make sense to staff (M). Training failed to demonstrate a connection between Lean and healthcare.

In this case study, it can be seen that an approach to whole system improvement was co-designed from within the system by a team of staff (ETWG) in conjunction with the Board of Directors and EMT. A partnership approach was developed with the UCD Lean Academy who are a team of former and current healthcare workers who have adopted LSS for healthcare staff. The training used and examples given were based in the Irish healthcare settings. The UCD Lean Academy has committed to supporting healthcare teams publish their research to add to the international evidence base [ 12 , 13 , 14 , 15 , 79 ]. Materials from these cases studies were used to support the training.

CMO2: The complexity and dynamic nature of healthcare (C) were perceived as incongruent with the nature of Lean. The translation of Lean to patient care did not make sense for many staff and Lean efforts felt impersonal. Lean training failed to make the connection between Lean and healthcare clear for staff (M) and the early stages of implementation led by the consultancy company failed to customise Lean to the local context. This triggered pitfalls to the success of Lean, such as feelings of disconnection and negative perceptions of Lean (M), resulting in resistance to and a lack of support for Lean continuation (O).

In this case study, it was seen that LSS process improvements were designed and led by organisational staff from the outset with support from staff from the Lean Academy. Organisation stakeholders met with their colleagues rather than with an external consultant. This enabled a shared approach to understanding the challenges, the joint consideration of solutions, and an acknowledgement of previous efforts at improvement made in the past, rather than a suggestion of “just do it” solutions.

CMO3: Lean was implemented in areas that experience constant change (C), early stages of implementation involved multiple Lean events for training purposes (C), and frontline staff felt overwhelmed from the constant change, they were unsure what changes were due to Lean, and felt that Lean was the latest fad (M). This led to negative perceptions of Lean, resistance, and a lack of support by frontline staff (O).

As a relatively young organisation, staff are accustomed to change and progression with short lead-in times. In this case study, it was evident that rather than change being seen as a challenge, the use of LSS and data-driven solution design allowed team members to participate actively in change and take ownership and credit when solutions were found.

CMO4: The contract of the external consultancy leading Lean’s implementation ended (C), placing the continuation of Lean on internal senior leaders and unit managers (C). This led to a process of customisation of Lean to the local context through a variety of ways. This customisation of Lean and shift in implementation triggered positive and negative responses from frontline staff, unit managers, and senior leaders (M). As a result, only some Lean efforts became embedded. However, there was variation and a discrepancy between senior leaders and unit managers compared with frontline staff on perceptions of how embedded Lean efforts were (O).

In this case study, it was seen that the hospital system was committed to building up in-house expertise from the beginning via the training of White, Green, and Black Belts who would reinvest in the system and train further White Belts.

CMO5: The context of early stages of implementation (C) failed to trigger sense-making processes necessary for staff to understand Lean and potentially engage with and begin to embed Lean into their practices (O). Shared values were evident between Lean principles and staff professional values as healthcare providers. However, value congruency without clear sense-making processes resulted in a lack of adoption of Lean behaviours as part of normalised frontline practices. Sense-making processes were hindered by a failure of initial Lean training efforts to translate the principles of Lean into the context of healthcare that would resonate with staff (M). Lean language and the lack of staff involvement in Lean changes also hindered sense-making processes and feelings of engagement. This resulted in negative perceptions of Lean, a lack of buy-in, and a lack of support for the continuation of Lean from frontline staff (O).

In this case study, it can be seen that there was a focus on sense-making from the outset. One learning from the LSS deployment to date is the need to explore and understand the pain/challenge from all perspectives from the outset.

Strengths and Limitations

The strengths of taking a case study approach are that it allows us to attempt to answer complex questions by triangulating different data from different sources [ 43 ]. Internal consistency was increased by collecting data from multiple sources and by using different types and sources of data. Reliability was aided by transparency in terms of outlining the questions and processes of synthesis [ 80 ].

A criticism, however, of this study could be that only one author (MEW) was outside of the process as it was happening. However, there is also a strength in combining insider insights on change and using the rigour of a STS analytic framework such as the CUBE combined with Oshry’s Organic Systems Framework to approach the case study.

A further point to be acknowledged is that this case study reports on the system that was one hospital. This is the strength of the case study approach and helps us give importance to and answer questions on topics in their own right. However, as noted above, whole system change is complex and there may be other factors at play when we consider a ‘systems-of-systems’ approach and acknowledge the wider impact of societal, legislative, political, and other factors on that system. As Flynn et al. note in this special issue [ 81 ], there is growing traction for the need to look at what has been termed ‘learning health systems, which are dynamic ecosystems where scientific, social, technological, policy, legal, and ethical dimensions are aligned to enable continuous learning and improvement to be embedded across the system [ 82 ]. COVID-19 has also taught us a great deal about the importance of taking a ‘systems-of-systems’ approach in healthcare and there are further lessons to be learned from this [ 83 ].

5. Conclusions

There are strengths and limits to the case study approach; however, we hope here, guided by an STS approach, to add to the body of literature on what would constitute whole system improvement in healthcare. Recognising the organisation’s culture , aligning complex system functionality requirements and the ability to activate these requirements to deliver concrete outcomes, and developing a shared understanding or sense-making of future goals aligned with embedding a person-centred approach to whole system improvement have synergised in a way that credibly addresses what it takes to change a whole system. Through the growing organisation-wide knowledge of the LSS approach and methods underpinned by person-centredness [ 27 ], the hospital is creating an increasing network of those who, in Oshry’s terms, “can”, “know”, and “want” to continuously strive for improvement in the quality and safety of patient care in the organisation [ 60 ]. This case study highlights achievements to date. The organisation will continue to grow and develop process improvement with a growing network of staff to support this important work. The STSA CUBE framework and Oshry’s OS framework were used here retrospectively to assess an intervention but could also be used prospectively to help healthcare organisations develop approaches to whole system improvement. Future areas of development for this organisation and to promote the sustainability of LSS and person-centred care include: (1) assessing the impact of LSS/person-centred process improvement through a stakeholder survey as well as the recording of formal project outputs; (2) disseminating and celebrating achievements internally and externally; and (3) continuing to reinvest in training and education to ensure leaders and process improvers remain equipped with skills and knowledge in this constantly evolving field.

Acknowledgments

The authors acknowledge the support of the hospital’s Executive Management Team, Board of Directors, and Education and Training Working Group in the scoping and implementation of this project. We also thank the UCD Mater Lean Academy for the support provided during this project.

Author Contributions

Conceptualisation, M.E.W., M.M., A.D., and S.P.T. methodology, M.E.W., M.M., and A.D.; formal analysis, M.E.W., M.M., and A.D., writing—original draft preparation, A.D., M.E.W., and M.M. writing—review and editing, A.D., M.E.W., M.M., S.G., and S.P.T.; visualisation, A.D. and M.E.W.; funding acquisition, A.D. and S.G. All authors have read and agreed to the published version of the manuscript.

The research received no external funding.

Institutional Review Board Statement

This work took place as part of ongoing organisational quality improvement. Institutional Review Board approval was not required.

Informed Consent Statement

Data availability statement, conflicts of interest.

The authors declare no conflict of interest.

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