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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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Digital editions.

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.

Contributors

• Industry Outlook

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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Quality Management Software: A Case Study 

• Post author: Maryliya M J
• Post published: January 19, 2024
• Reading time: 11 mins read

Table of Contents

Quality management plays a critical role in ensuring organizations meet and exceed customer expectations while maintaining operational excellence. To achieve this, many businesses are turning to quality management software solutions. This article presents a case study that explores the implementation and impact of quality management software in an organization. It delves into the challenges faced in quality management, the process of selecting and integrating the software, as well as the benefits and lessons learned from its implementation.

Introduction to Quality Management Software

Quality management is an essential aspect of any organization, ensuring that products or services meet or exceed customer expectations. In today’s fast-paced and competitive business landscape, the need for effective quality management has become even more crucial. Enter quality management software, a powerful tool that can streamline and optimize quality management processes.

Understanding Quality Management

Quality management refers to the systematic processes, procedures, and activities an organization implements to achieve and maintain excellence in its products or services. It involves various aspects, such as quality planning, quality control, quality assurance, and continuous improvement. By focusing on quality management, organizations can enhance customer satisfaction, reduce costs, increase efficiency, and foster a culture of excellence.

Importance of Quality Management Software

Quality management software plays a vital role in enabling organizations to effectively manage and control their quality processes. It provides a centralized platform for capturing, analyzing, and monitoring quality-related data and activities. With quality management software, organizations can automate and streamline various tasks, such as document control, non-conformance management, corrective actions, audits, and supplier management. This software helps in standardizing processes, ensuring compliance with regulations and industry standards, and facilitating continuous improvement initiatives. By leveraging quality management software, organizations can enhance their overall quality management efforts and achieve desired business outcomes.

About the Client

Our client, a manufacturing company, encountered challenges in maintaining product quality standards and effectively tracking defects. Recognizing the critical importance of systematic quality control processes, they sought a Quality Management Software ( QMS ) to enhance their quality assurance procedures. The primary goal was to implement a comprehensive QMS that ensures adherence to quality standards, streamlines quality inspections, and enables efficient tracking of defects. 

Project Overview

The project aimed to develop a robust .NET-based QMS to address the client’s challenges. The primary objectives included implementing modules for quality inspections, defect tracking, and corrective action management. 

The Challenges

• Maintaining Quality Standards: Inconsistent adherence to quality standards was affecting the overall product quality. 
• Defect Tracking Difficulties: Difficulty in tracking defects and implementing timely corrective actions. 
• Lack of Systematic Processes: Absence of a systematic quality control process led to operational inefficiencies and increased defects. 

The Solution

Our team of experienced developers and project managers collaborated to design and implement a comprehensive .NET-based Quality Management Software. The solution included modules for quality inspections, defect tracking, and corrective action management to ensure systematic adherence to quality standards. 

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Key features of the qms.

• Quality Inspections: The QMS facilitated systematic quality inspections to ensure product quality standards were met. 
• Defect Tracking: Comprehensive tools for tracking defects and identifying root causes for timely corrective actions. 
• Corrective Action Management: The software provided a structured approach to corrective action management, addressing issues promptly. 
• Adherence to Quality Standards: Ensured consistent adherence to quality standards through standardized processes. 

The Outcome

The QMS was successfully deployed, resulting in significant improvements in product quality and defect tracking. Systematic quality inspections, defect tracking capabilities, and structured corrective action management contributed to a more streamlined and efficient quality control process. 

Our team’s expertise in developing a tailored Quality Management Software using .NET technologies effectively addressed the client’s challenges. The implementation of quality inspections, defect tracking modules, and corrective action management contributed to a more rigorous and effective quality assurance process. 

By leveraging the software’s capabilities across various departments, organizations can achieve greater operational efficiency, improved customer satisfaction, and enhanced overall performance. However, it is crucial to thoroughly assess the integration requirements and ensure proper training and support are provided to users.

In conclusion, the case study highlights the immense value of quality management software in organizations. By addressing the challenges faced in quality management and implementing an effective software solution, businesses can experience improved efficiency, enhanced quality control, and significant cost reductions.

Are you struggling with maintaining quality standards and defect tracking? Contact us today to explore how our expertise in QMS development can transform your quality control processes and enhance product quality. 

Frequently Asked Questions (FAQ)

1. what is quality management software.

Quality management software is a technological solution designed to assist organizations in effectively managing and improving their quality control processes. It typically includes features such as document control, corrective and preventive actions, audit management, risk assessment, and performance tracking, enabling companies to streamline their quality management practices.

2. How can qMS benefit my organization?

Implementing quality management software can bring numerous benefits to an organization. It enhances operational efficiency, facilitates compliance with industry standards and regulations, reduces the risk of product defects, and improves customer satisfaction by ensuring consistent quality. Additionally, it provides real-time visibility into quality metrics, enabling data-driven decision-making and fostering a culture of continuous improvement.

3. Are there specific industries or sectors that can benefit from quality management software?

QMS can benefit organizations across various industries and sectors. It is particularly valuable for industries with stringent quality requirements, such as manufacturing, healthcare, pharmaceuticals, aerospace, and automotive. However, any organization that values quality, consistency, and process optimization can reap the benefits of implementing quality management software.

4. What are some key considerations for successful implementation of quality management software?

Successful implementation of QMS requires careful planning and execution. Some key considerations include clearly defining quality objectives, involving stakeholders throughout the implementation process, choosing a software solution that aligns with the organization’s needs, providing adequate training to employees, and regularly evaluating and refining quality management processes to ensure ongoing improvement.

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Alternative Quality Management Systems for Highway Construction (2015)

Chapter: chapter 4 : case studies of alternative quality management.

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

CHAPTER 4 : CASE STUDIES OF ALTERNATIVE QUALITY MANAGEMENT 4.1 Introduction Previous chapters focused on the historic and current state of quality management practice and identified the most common quality management models in use in the highway industry. The focus of this chapter is on the ten case studies conducted by the research team and the relevant analyses and observations of those case studies. Case studies formed the bulk of the original research conducted in Phase I of this research project and offered examples of quality management practices delivered under a variety of project conditions, which may serve as models for the organization of quality management systems for future projects. This chapter begins with a discussion of the protocol and methodology used to conduct the case studies and secure the relevant information from each in a justifiable manner. Included in this section are a breakdown of the case study demographics and an explanation of how the case studies were chosen. Following the section on methodology are truncated versions of the case study summaries. The full case study summaries are presented in the appendices in full detail. A large amount of information is contained in the summaries. In order to assist with comparing among the various studies, tabular summaries of relevant details are presented at the end of the summaries section. The case study summaries include a description of the general trends observed when comparing the case studies. The cross-case analysis produced a list of potential alternative QM system tools. These tools are associated with applicable QAOs, which furnishes a mechanism by which agencies can determine which tools will be more valuable to a given project’s QM requirements. The tools are discussed in detail in in chapter 5. 4.2 Case Study Protocol While the survey conducted in Task 2 provided some useful insights into the overall state-of-the- practice, the case studies were the primary source of practical applications of innovative quality management techniques in Phase I and for the practices recommended by the guidebook in Phase II. As a result of the central role in the research project, the research team gave serious consideration to how best to conduct the case studies and capture their valuable information. While researchers may differ in their preference for which research techniques and strategies to use in various situations, case studies represent a valuable tool in the arsenal of any researcher. Case studies are particularly useful in answering questions about how things are done in detail, especially when examining a number of different cases (Yin 2003). In this project, the use of the case study method was essential in capturing not only the unique nature and methods of each project but also understanding questions of why projects were conducted a certain way and how successful those methods were. One of the traditional arguments against the use of case studies has been their perceived lack of 87

rigor. Recognizing this common criticism, the authors sought to generate a defensible, repeatable method to guide the case study process. This method was formalized and recorded in the case study protocol for the project, which Appendix C presents in detail. Yin (2003) provided guidance in creating the case study protocol. The case study protocol serves a number of purposes. Primarily it establishes the purpose of the case studies and the questions to be answered by them. While this information was later useful for the case study participants (albeit in a shortened form), clearly stating this information at the start of this crucial document ensured that all researchers who were conducting case study interviews understood the ultimate goals of the research. The background information for the protocol included key sections of the project proposal and work plan like the explicit research objectives and key questions and also included relevant readings which are fundamental to this research. The most important component of the protocol was the information relating to field procedures which are the heart of the case study protocol and form the bulk of the document. These procedures establish a standard method to conduct all of the case studies and seek to generate consistent and comparable results among the case studies. The key pieces of the field procedures are the case study questionnaire and the case study questions. The questionnaire was one of the first documents to be sent participants. While each case study is unique and the interview process sought to capture that uniqueness, the purpose of the questionnaire was generate a standard set of readily comparable information. To that end, the questionnaire was primarily populated with yes/no questions and matrices of checklists and was specified to be filled for every case study in its entirety. The section listing case study questions on the other hand was not expected to be answered in its entirety; instead, these questions were supplementary and to be used at the discretion of the researcher. Many of the questions represented in the questionnaire are open-ended questions crafted to generate in-depth discussion to help fill in the details the surveys cannot easily capture. The field procedures also include sample letters to send as well as a flowchart showing the order of key communications with participants. 4.3 Case Study Process The case study protocol included a minimum of two pilot case studies to evaluate the efficacy of the process before modifying the case study procedures and completing the rest. Rather than conducting the minimum of two, three pilot case studies were conducted to allow each of the three principal research teams an opportunity to become familiar with the case study protocol for this project and provide comments on it or recommendations for changes. One of the key changes, which came out of this, was firmly establishing the order to gather information, as discussed below. The case study protocol for this project included a particular order of communications and interactions with project participants that was to be followed on every project. First, direct contact was made with the project either over the telephone or in person. While initial inquiries occurred via email, personal contact was vital to every case study. The primary importance of personally contacting the key project participants lay in securing a champion for the research 88

effort. Because participants received no compensation for their time by the research team, it was essential to make contact with participants who expressed enthusiasm about assisting with the research effort and was in a position to coordinate with the rest of the participants on the project. After securing the support of a project champion, all of the key project participants (typically Owner/agency, designer, and builder quality or project managers) were sent a copy of the case study questionnaire and asked to complete and return it before the interview. This was the key change from the pilot case studies. Originally, the priority lay in simply completing the questionnaire before the end of the interview process. However, after the first round of case studies, it was discovered that the questionnaire was too time consuming to fill out in an interview setting and limited the amount of open-ended questions and discussion, which are vital to case studies, which could occur. Subsequent case study participants were given explicit instructions to return the questionnaires before the interview. While freeing up time for more expansive questions in the interviews, having multiple participants fill out the questionnaire independently exposed differing opinions, which led to further discussion for clarification in the interviews. After the questionnaires were completed, interviews were conducted with all of the key project staff. While these interviews typically took place with all the participants at once, in some instances, schedule conflicts were too great to overcome and individual interviews were used instead. While interviews were conducted in person as much as possible, due to limited budgets and geographic dispersion of project participants, in several cases interviews were conducted over the phone. When conducted in person, the authors recorded and showed the participants’ answers using an electronic projector in real time so they could verify the accuracy of the recorded statements. By combining standard questionnaires with personal interviews, the case studies generated the consistent, comparable data and the unique features of each project that were sought. The next step in the case study process was the collection of relevant project documents for later review. When possible, these documents were requested in electronic form for easier reproduction and use, though some materials were provided as hard copies. The documents requested included procurement and prequalification documents and project and quality management plans. The information in the documents was used to answer later questions that arose and to examine specific language used. Finally, once the interview were complete, the information gathered was combined and used to craft the case study reports found in the appendices. When necessary, project participants were contacted after the interview for further clarification, but these contacts were kept to a minimum by the comprehensive nature of the list of case study questions in the field procedures. 4.4 Case Study Selection and Demographics Given the limited number of case studies that were expected as part of this research, the selection of useful case studies was crucial. Guiding the selection process were a number of criteria that each narrowed the number of possible case studies. Table 4-1 contains a description of the selected case study projects. 89

Table 4-1 – List of Case Studies P – Pilot case study The primary criterion for case study selection was that the projects under consideration utilize some form of alternative quality management. While the range of possible alternative quality management procedures leads is long, this one requirement greatly limits the number of potential case studies as most projects still utilize the baseline delivery and quality management methods. Next, case studies were selected such that all the major alternative delivery methods, design- build (DB), construction manager/general contractor (CM/GC), and public-private partnership (PPP), were well represented. A concerted effort was made to seek out projects from agencies that were mature in their experience with alternative delivery methods. Related to this effort was the requirement that the list of case studies include at least two projects from non-STAs and one project that utilized the ISO 9000 certification. Projects from the U.S. Army Corps of Engineers (USACE) and TriMet, a regional transit provider in Oregon, were located and used as case studies. In spite of a reasonable search, an ISO 9000 certified project was not identified. However, the USACE project utilized ISO 9000 certified organizations and QM documents, and the concessionaire for FDOT project used ISO 9000 documentation to train its subcontractors on the project’s QM system. The next goal in case study selection was achieving at least a moderate level of geographic dispersion. Although the project was not funded to include significant travel to project sites, a conscious effort was made to ensure that no more than two projects came from the same state and that projects were not clustered in a particular portion of the country. Figure 4-1 shows this dispersion. Lastly, while there was no set dollar value requirement for projects, only those projects of at least moderate size and scope were considered as these were more likely to have sophisticated quality management procedures in use. # Agency State Size Delivery Method Project Mode 1 WSDOT Washington $18 million DBB w/eci George Sellar Bridge Bridge 2 ODOT, P Oregon $135 million CMGC Willamette River Bridge Bridge 3 TriMet Oregon $113 million CMGC Portland Transit Mall Transit 4 USACE Kansas $175 million CMGC Tuttle Creek Dam Dam 5 UDOT Utah $730 million CMGC Mountain View Corridor Highway 6 CDOT, P Colorado $29.5 million DB US 160 4th Lane Addition Highway 7 UDOT Utah $135 million DB I-15 Widening-Beck Street Highway 8 MnDOT, P Minnesota $120 million DB Hastings River Bridge Bridge 9 FDOT Florida $1.2 billion PPP I-595 Express Corridor Highway 10 TxDOT Texas $1.5 billion PPP SH130 Turnpike Extension Highway 90

Figure 4-1 – Geographic Dispersion of Case Studies After all the criteria were considered, 10 suitable projects were identified and used as case studies. As mentioned above, one of the most important aspects of all the projects was identification of a champion for the research effort. To that end, personal contacts of the primary investigators were leveraged to provide a more personal connection to each project when possible with the hope of increasing participant interest and involvement. Of the 10 projects identified there are/is:  One DBB project utilizing early contractor involvement in the design process  Two PPP projects  Three DB projects  Four CMGC projects (one of which uses the USACE ECI delivery method)  One dam project  One transit project  Three bridge projects  Five highway projects  Eight states represented  $3.8 billion represented 4.5 Case Study Summaries The following subsections contain brief summaries of each of the ten case studies conducted for this project. Each summary begins with key project data including project name; the name of the agency or owner responsible for the project; the location of the project; the project delivery and procurement methods used; the contract payment type; and a brief description of the nature of the project. The project quality profile provides a quick snapshot of the basic premise of the 91

quality management system used on the project and any notable features of that system. The graphic included with each summary is the QAO diagram for that project. The diagram is a visual representation of who controls which key aspects of design and construction quality management. Further explanation of these diagrams can be found in the full case study reports in the appendices. The section devoted to QM plans describes whether these plans were required for design or construction and if so, what was required to be in them and when they were required to be submitted. The tables devoted to quality management roles list the primary quality management actions taken on most projects during design and construction and list (in greater detail than the QAO diagrams) who was responsible for what tasks. Following these tables is a list of notable and effective quality management procedures used on the project as determined by the authors. 4.5.1 George Sellar Bridge, Washington Project Name: George Sellar Bridge Additional Eastbound Lane Name of Agency: Washington State Department of Transportation (WSDOT) Location: MP 0.16 to MP 0.39 over the Columbia River between the towns of Wenatchee and East Wenatchee in the state of Washington Project Delivery Method/Procurement/Contract Type: DBB/A+B+C bidding/Lump sum Project Description: The primary focus of this project was to add an additional eastbound lane to the George Sellar Bridge in order to substantially increase its capacity. To do so, sidewalks on either side of the roadway were removed and the bridge deck was expanded from 54’ to 61’ wide using the new space. The new configuration accommodates five 11’ wide lanes and a narrow median and shoulders. A 10’ wide cantilevered pedestrian and bike pathway was added to the south side of the bridge and a tunnel was constructed through the East side approach to accommodate a new recreational trail. In order to accommodate the new load and increased traffic area the bridge required significant strengthening of 100 truss members and modification of the parabolic portals at either end of the bridge. Project Quality Profile: As a traditional design-bid-build project designed by WSDOT staff, the project quality profile exactly matches the baseline quality system. The constructor performed construction quality control and WSDOT performed all other quality functions. The notable feature of this project was its use of a joint WSDOT/AGC panel early in the design process to inform aspects of the design. QAO: Figure 4-2 shows that the QAO for this project was Deterministic. 92

Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Quality Assurance Constructor’s Responsibility Designer’s Responsibility Independent Assurance (if req’d) - functional audit -physical audit WSDOT’s Design Staff Responsiblity WSDOT’s Construction Staff Responsibility Independent Assurance (if req’d) - functional audit -physical audit Figure 4-2 – George Sellar Bridge QAO QA/QC Plans: While this project did use quality management plans on this project, they were more of a minor addition to the larger and more important project management plans (PMPs). WSDOT emphasizes the use of PMPs as the focus of the planning effort and references relevant documents related to quality as needed. For design, the PMP included references to WSDOT’s standard design quality management plan included in its Bridge Design Manual. As with design, the focus of the construction planning effort was a PMP, not a unique quality management plan. Instead, the primary quality management requirement was that the contractor conforms to the standard specifications of WSDOT and the special provisions for the project. Included in these documents were specific material and testing requirements or references to WSDOT’s materials manual, which lays out acceptable materials and certification tests. The contractor was never required to submit a formal quality control plan. 93

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-2. Table 4-2 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Pre-const. Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of design deliverables ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ Acceptance of design deliverables ✔ Review of specifications ✔ ✔ Approval of final construction plans & other design documents ✔ Approval of progress payments for design progress N/A N/A N/A N/A N/A N/A Approval of post-award design QM/QA/QC plans N/A N/A N/A N/A N/A N/A Responsibility allocation for construction management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Construction Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of construction shop drawings ✔ ✔ ✔ cursory Technical review of construction material submittals ✔ ✔ ✔ cursory Checking of pay quantities ✔ ✔ Routine construction inspection ✔ Quality control testing ✔ ✔ Verification testing ✔ ✔ Acceptance testing ✔ Approval of progress payments for construction progress ✔ ✔ Approval of construction post- award QM/QA/QC plans ✔ Report of nonconforming work or punchlist. ✔ Effective QM Practices:  Use of a joint AGC and WSDOT panel to inform the design process  Use of pre-bid meetings for clarification 94

4.5.2 Willamette River Bridge, Oregon Project Name: Willamette River Bridge Name of Agency: Oregon Department of Transportation (ODOT) Location: I-5 over the Willamette River in Lane County at the border of the cities of Eugene and Springfield, OR. Project Delivery Method/Procurement/Contract Type: CM/GC/Best-Value/Lump sum w/ GMP Project Description: The primary focus of the Willamette River Bridge project was the construction of two 1800’+ long arch bridges capable of carrying three lanes of traffic. Work included construction of the first bridge, demolition of an existing temporary bridge, and construction of the second bridge. In addition, the project included the repair or replacement of the nearby 100’ long Canoe Canal Bridge, realignment and grading work along I-5 to match the new bridges, and construction of sound walls, associated pedestrian trails, and extensive public artwork. The project was conducted above an active railroad corridor, Franklin Blvd, and an exit ramp for Franklin Blvd. Project Quality Profile: All four of the project parties collaborated on the design quality control function because of the contractor’s early involvement in the design process and the presence of Oregon Bridge Delivery Partners (OBDP) a program manager. ODOT provided primary quality assurance functions on the project and was supplemented by OBDP in that role. ODOT’s approach to construction quality control was rather restrictive limiting the contractor to only conduction quality control testing and nothing more. Acceptability, confidence, and verification testing were all performed by ODOT. 95

QAO: Figure 4-3 shows that the QAO for this project was Deterministic. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Quality Assurance Constructor’s Responsibility ODOT/OBDP’s CEI Staff Responsibility Designer’s Responsibility ODOT/OBDP’s Design Staff Responsibility Owner Verification (if req’d) Independent Assurance (if req’d) - functional audit -physical audit Figure 4-3 – Willamette River Bridge QAO QA/QC Plans: ODOT required the design team to submit a standard quality control plan to be used by the design team and all of its consultants. The plan was submitted for approval as a part of the design team’s proposal and was evaluated in determining which designer to award the contract to. Conversely, the construction quality control plan wasn’t a required submittal until after the CMGC contract was awarded. In addition, the construction quality control plan was significantly less detailed than that required of the design team as the project made use of a construction quality management system identical to that used on ODOT design-bid-build projects. The project team went out of its way to ensure that the project looked and felt like a design-bid-build project on the construction side of things. 96

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-3. Table 4-3 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Pre-const. Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of design deliverables ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ ✔ ✔ Acceptance of design deliverables ✔ Review of specifications ✔ ✔ ✔ Approval of final construction plans & other design documents ✔ ✔ ✔ Approval of progress payments for design progress ✔ Approval of post-award design QM/QA/QC plans ✔ Responsibility allocation for construction management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Construction Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of construction shop drawings ✔ ✔ Technical review of construction material submittals ✔ ✔ Checking of pay quantities ✔ ✔ Routine construction inspection ✔ OBDP+ ODOT ✔ Quality control testing ✔ Verification testing ✔ Acceptance testing ✔ Approval of progress payments for construction progress ✔ Approval of construction post- award QM/QA/QC plans ✔ Report of nonconforming work or punchlist. ✔ OBDP+ ODOT 97

Effective QM Practices:  Early contractor involvement in the design process  Flexibility afforded by CMGC method  Allowing contractor to use competitive bidding OR negotiated contracts for subcontractors 4.5.3 Portland Transit Mall Revitalization, Oregon Project Name: Portland Transit Mall (Greenline) Revitalization Name of Agency: Tri-County Metropolitan Transportation District or Oregon (TriMet) Location: The Portland Transit Mall is located along SW 5th and 6th Avenues in downtown Portland, OR and stretches 1.4 miles south from Union Station to I-405 Project Delivery Method/Procurement/Contract Type: CM/GC/Best-Value/Cost plus fee w/ GMP Project Description: The focus of this case study was the construction of a new light rail transit line along 5th and 6th Avenues, which was part of a larger revitalization of the whole Portland Transit Mall. The project included substantial utility relocation work both before and during construction of the rail bed, installation of 2.8 miles of light rail track, gantries, and supporting systems (signals, power substations, etc.), and the construction of a triple track turnout loop at the southern extent of the project. In addition, the contract included construction of 12 new light rail stations complete with shelters and signage. Project Quality Profile: All three of the project parties collaborated on the design quality control function as a result of the CMGC delivery method and the contractor’s early involvement in the design process. TriMet provided all primary quality assurance functions on the project and was supplemented with inspection staff from the city of Portland and local utilities. TriMet permitted the contractor to employ its own quality control inspectors and to perform its own materials testing if the staff were nationally certified for the work. Confidence testing was performed at the discretion of TriMet’s resident engineer by 3rd party testing labs kept on-call by TriMet. The project was marked by close collaboration between the contractor’s quality control manager and TriMet’s resident engineer. 98

QAO: Figure 4-4 shows that the QAO for this project was Deterministic. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Quality Assurance Constructor’s Responsibility ODOT/OBDP’s CEI Staff Responsibility Designer’s Responsibility ODOT/OBDP’s Design Staff Responsibility Owner Verification (if req’d) Independent Assurance (if req’d) - functional audit -physical audit Figure 4-4 – Portland Transit Mall QAO QA/QC Plans: The design QM plans used by TriMet are in some sense standardized across projects and delivery method types. TriMet has a formal quality assurance program approved by the Federal Transit Administration that design quality management plans (for both in-house staff and design consultants) must comply with. The contractor was required to develop a quality control plan and submit it for approval after it was awarded the project, it was not an evaluation criteria in the procurement process. 99

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-4. Table 4-4 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Pre-const. Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of design deliverables N/A ✔ ✔ ✔ Checking of design calculations N/A ✔ ✔ Checking of quantities N/A ✔ ✔ ✔ Acceptance of design deliverables N/A ✔ ✔ Review of specifications N/A ✔ ✔ ✔ Approval of final construction plans & other design documents N/A ✔ ✔ Approval of progress payments for design progress N/A ✔ Approval of post-award design QM/QA/QC plans N/A ✔ Responsibility allocation for construction management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Construction Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of construction shop drawings N/A S P Technical review of construction material submittals N/A P S Checking of pay quantities N/A P Routine construction inspection N/A S P Quality control testing N/A P S Verification testing – Note 1 N/A P P Acceptance testing N/A P Approval of progress payments for construction progress N/A P Approval of construction post- award QM/QA/QC plans N/A P Report of nonconforming work or punchlist. N/A S S P P – Primary responsibility; S – Secondary responsibility 100

Effective QM Practices:  Contractor involvement early in the design process  Electronic recording and submission of daily reports  Allowing contractor utilize own inspectors for QC and materials testing  Use of CMGC delivery method 4.5.4 Tuttle Creek Dam Safety Assurance Project, Kansas Project Name: Tuttle Creek Dam Safety Assurance Project Name of Agency: US Army Corps of Engineers (USACE) Location: Tuttle Creek, north of the City of Manhattan in Kansas, along the Big Blue River Project Delivery Method/Procurement/Contract Type: Corps Early Contractor Involvement (ECI)/Best-Value/Progressive GMP Note: ECI is the terminology used by USACE for a CMGC delivery method. It should not be confused with the ECI delivery method used in Europe and for the remainder of this report will be referred to as a CMGC delivery method. Project Description: The Tuttle Creek Dam Safety Ground Modification Project is the largest Dam Safety, ground modification project on an active Dam that has ever been performed. This project consisted of multiple contracts to make various repairs to the dam. The Ground Modification base contract was awarded in 2005 to Treviicos South for $49M (this was the ECI/CMGC Contract). A contract to provide structural reinforcement and bearing rehabilitation on the 18 Spillway Tainter Gates was awarded in 2007 and completed in 2010 for $10M. The wire ropes for the Tainter Gates will be replaced in 2011 and 2012. Project Quality Profile: The quality management system that was used on this project was not substantially different from that used by other agencies. USACE has documentation outlining the approach to quality assurance and quality procedures on projects. Also, an individual project specific quality management plan was written for the Tuttle Creek Dam project. The construction, design and project management organizations were all ISO certified. 101

QAO: Figure 4-5 shows that the QAO for this project was Deterministic. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Quality Assurance Constructor’s Responsibility Designer’s Responsibility Independent Assurance (if req’d) - functional audit -physical audit Owner’s Responsibility Owner’s Responsibility Independent Assurance (if req’d) - functional audit -physical audit Figure 4-5 – Tuttle Creek Dam Safety Assurance Project QAO Model QA/QC Plans: The design QM plans used on this project were different from design-bid-build (DBB) projects because this was a one of a kind design that involved both an advisory panel of experts as well as allowing for the construction contractor to participate in the design review process to help improve quality. The QM plan was not different as such, but it emphasized how heavily the government intended to rely on the construction contractors input. The construction QM plans used on this project were no different from the QM plans used on traditional DBB construction projects. 102

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-5. Table 4-5 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency personnel Consultant design staff Constructor’s preconstructi on staff Agency-hired QA/oversight consultant Technical review of design deliverables ✔ ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ ✔ Acceptance of design deliverables ✔ ✔ ✔ Review of specifications ✔ ✔ ✔ Approval of final construction plans & other design documents ✔ ✔ Approval of progress payments for design progress ✔ Approval of post-award design QM/QA/QC plans ✔ Responsibility allocation for construction management tasks Agency personnel Consultant design staff Constructor’s construction staff Agency-hired QA/oversight consultant Technical review of construction shop drawings ✔ ✔ Technical review of construction material submittals ✔ ✔ Checking of pay quantities ✔ Routine construction inspection ✔ Quality control testing ✔ Verification testing ✔ Acceptance testing ✔ Approval of progress payments for construction progress Approval of construction post-award QM/QA/QC plans Report of nonconforming work or punch list. ✔ Effective QM Practices: The following is a list of effective practices used on USACE projects.  Advisory Panel  Resident Management System (RMS) - An automated system for submittal and document control.  Design check - The designer must have his work checked by highly experienced technical person before each design submittal. This checking procedure is essential to the production of a quality product.  Quality control checklists - Checklists for designers and their checkers to ensure completeness. 103

 Interdisciplinary checks - Interdisciplinary coordination is a key element of the QCP. The checks are usually conducted by the design team members who check each other’s work to assure compatibility.  District Quality Control (DQC) Review - An internal peer review for quality control.  Agency Technical Review (ATR) - An ATR is an independent technical review, which is a critical examination by a qualified person or technical team outside the submitting district.  Independent External Peer Review (IEPR) - An IEPR is an independent review of the technical efficacy of a decision document by a review organization external to USACE.  Quality management review - Quality management reviews to assure that USACE Regulations are met. 4.5.5 Mountain View Corridor Project, Utah Project Name: Mountain View Corridor (MVC) Project Name of Agency: Utah Department of Transportation (UDOT) Location: The Mountain View Corridor encompasses Salt Lake County west of Bangerter Highway between I-80 and the Utah County border Project Delivery Method/Procurement/Contract Type: CM/GC/Best-Value/GMP Project Description: Initial construction includes building two outside lanes in each direction with signalized intersections where future interchanges will be located. This new roadway requires extensive grading and excavation, relocating utilities, acquiring property, constructing drainage systems, building bridges and structures, and laying new pavement. Trail sections will also be built. Future construction will build out the remainder of the corridor by adding interchanges and more lanes to achieve a fully functional freeway. Project Quality Profile: UDOT will provide some quality control and all quality assurance for the Project. The contractor is responsible for assuring the quality of the work of the subcontractors at all levels. UDOT or its designee will perform limited inspection and testing to audit and verify that all work and materials comply with the drawings, specifications, and all reference standards. Audits will be performed on a systematic basis and will be coordinated with the Quality Control Plan or as warranted by general quality trends. 104

QAO: Figure 4-6 shows that the QAO for this project was Assurance. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Owner Verification (if req’d) Quality Management Independent Assurance (if req’d) - functional audit -physical audit Designer’s Responsibility Owner’s Responsibility Constructor’s Responsibility Owner’s Responsibility Quality Assurance Figure 4-6 – Mountain View Corridor QAO QA/QC Plans: The design QM plans are no different from the QM plans used on traditional design projects. For UDOT the delivery method does not affect the quality methods. The quality methods are driven by the size of the project. The contractor was required to develop, implement, and maintain a Quality Control Plan. The Quality Control Plan had to include, at a minimum, provisions for continued education and training, toolbox meetings, various meetings with subcontractors and suppliers, and other activities. In addition, the Quality Control Plan had to include the Contractor assuring the quality of the work of the subcontractors at all levels. 105

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-6. Table 4-6 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency personnel Consultant design staff Constructor’s preconstruction staff Agency-hired QA/oversight consultant Technical review of design deliverables ✔ ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ ✔ Acceptance of design deliverables ✔ Review of specifications ✔ ✔ ✔ Approval of final construction plans & other design documents ✔ Approval of progress payments for design progress ✔ Approval of post-award design QM/QA/QC plans ✔ Responsibility allocation for construction management tasks Agency personnel Consultant design staff Constructor’s construction staff Agency-hired QA/oversight consultant Technical review of construction shop drawings ✔ ✔ Technical review of construction material submittals ✔ ✔ Checking of pay quantities ✔ ✔ Routine construction inspection ✔ ✔ Quality control testing ✔ Verification testing ✔ ✔ Acceptance testing ✔ Approval of progress payments for construction progress ✔ Approval of construction post-award QM/QA/QC plans ✔ ✔ Report of nonconforming work or punch list. ✔ ✔ Effective QM Practices: The following practices are used on the MVC project and lead to enhanced quality:  Project Records File and Distribution System  Regular Project Team Meetings  Reviews - The contractor is required to participate in formal constructability and material availability reviews that are conducted at up to four milestones throughout the Project.  Quality Personnel Education and Training - The extent of training is to correspond with the following: o Scope, complexity, and nature of the activity o Education, experience, and proficiency of the person o Specific requirements of the Contract Documents 106

 Goal-Setting Session - The Contractor was required to participate in an initial goal-setting session with UDOT 4.5.6 U.S. 160 4th Lane Addition, Colorado Project Name: U.S. 160 4th Lane Expansion Name of Agency: Colorado Department of Transportation (CDOT) Location: U.S. 160 at Farmington Hill Interchange/Wilson Gulch in Grandview Colorado just east of Durango, CO Project Delivery Method/Procurement/Contract Type: Modified Design-build (Low bid procurement) Note: Modified DB is a CDOT alteration on standard practice for DB. Modified DB contains a higher level of initial design and is awarded on a low-bid best value basis. For the remainder of this report, this case study will be listed simply as using a DB delivery method. Project Description: The project included the design and construction of four bridges in mountainous terrain and crossing U.S. 160 and the environmentally-sensitive Wilson Gulch. Highly-curved ramp geometries, high settlement soils and a limited construction season created design challenges which were overcome to deliver a successful design. Project Quality Profile: CDOT was responsible for all quality assurance and independent assurance on the project. The design builder was responsible for all quality control, both design and construction. Outside of the design builder having the responsibility for design QC, the project quality management was no different than a design-bid-build project. CDOT does use the same quality management system across all project, regardless of delivery method. CDOT performed testing on all materials; it appears that quality management system for the construction was heavily directed by the agency. The lack of a design builder created construction QC plan is further evidence that the construction quality management was directed by CDOT. 107

QAO: Figure 4-7 shows that the QAO for this project was Oversight. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Owner Verification (if req’d) Quality Assurance Design Builder’s Responsibility Owner’s Responsibility Figure 4-7 – U.S. 160 4th Lane Addition QAO QA/QC Plans: The primary quality management plan in place for this project was the design quality control plan (DQCP) which was created by the designer on the design-build team. This plan had to be submitted and approved by CDOT before any work could begin. CDOT required a quality control plan to be created by the design builder, but it appears that the DQCP was the document that was what all parties referred to when asked about QA/QC plans for the project. 108

Quality Management Responsibility Allocation: Table 4-7 shows a summary of design and construction QM roles. Table 4-7 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency personnel Consultant design staff Constructor’s preconstruction staff Agency-hired QA/oversight consultant Technical review of design deliverables ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ ✔ ✔ Acceptance of design deliverables ✔ Review of specifications ✔ Approval of final construction plans & other design documents ✔ Approval of progress payments for design progress ✔ Approval of post-award design QM/QA/QC plans ✔ Responsibility allocation for construction management tasks Agency personnel Consultant design staff Constructor’s construction staff Agency-hired QA/oversight consultant Technical review of construction shop drawings ✔ ✔ Technical review of construction material submittals ✔ ✔ Checking of pay quantities ✔ Routine construction inspection ✔ Quality control testing ✔ Verification testing ✔ ✔ Acceptance testing ✔ Approval of progress payments for construction progress ✔ Approval of construction post-award QM/QA/QC plans ✔ Report of nonconforming work or punchlist. ✔ Effective QM Practices: Design quality control forms that were included as parts of the appendix of the DQCP were very effective in tracking and organizing the various Design QC processes. 4.5.7 I-15 Widening, Beck Street Project, Utah Project Name: I-15; Widening, 500 North to I-215 Name of Agency: Utah Department of Transportation (UDOT) 109

Location: I-15, 500 North to I-215, Utah Project Delivery Method/Procurement/Contract Type: DB/Best-Value/Lump Sum Project Description: The project consists of the reconstruction of Interstate 15 from 500 North in Salt Lake City to the I-215 overpass in Davis County. The project includes the design, reconstruction, and widening of the mainline highway to include an Express Lane and three general purpose lanes in each direction. The work includes the total reconstruction of Mainline I- 15 between 500 North and the I-215 overpass. UDOT requires removal and replacement of the existing Beck Street Bridge with twin 600-feet, four-span bridges. Additionally, the 1100 North and U.S. 89 bridges will be replaced with two-span rapid bridges. The 800 North Bridge will be removed permanently. Project Quality Profile: The Quality Management plans used on this project were the same as those used on traditional UDOT projects, except the tracking and administration was handled differently. This was because the goals were the same with regards to testing requirements etc. except payment was not by quantity. Lump Sum payment was used; therefore quantities were recorded separately for verification testing. 110

QAO: Figure 4-8 shows that the QAO for this project was Oversight. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Owner Verification (if req’d) Quality Assurance Independent Assurance (if req’d) - functional audit -physical audit Design- Builder’s Responsibility Owner’s Responsibility Figure 4-8 – I-15 Widening QAO Model QA/QC Plans: UDOT specified that the Quality Management Plan (QMP) had to include procedures for design-builder construction quality control, design quality control and assurance, and Agency inspection and testing. The Design-Builder had the primary responsibility for the overall quality of the work including the quality of work produced by subcontractors, fabricators, suppliers, and vendors. An IQF was not required for this project. UDOT was to conduct oversight and inspection for the project. 111

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-8. Table 4-8 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency personnel Consultant design staff Constructor’s preconstruction staff Agency-hired QA/oversight consultant Technical review of design deliverables ✔ ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ Acceptance of design deliverables ✔ Review of specifications ✔ ✔ ✔ Approval of final construction plans & other design documents ✔ Approval of progress payments for design progress ✔ Approval of post-award design QM/QA/QC plans ✔ Responsibility allocation for construction management tasks Agency personnel Consultant design staff Constructor’s construction staff Agency-hired QA/oversight consultant Technical review of construction shop drawings ✔ Technical review of construction material submittals ✔ Checking of pay quantities ✔ Routine construction inspection ✔ Quality control testing ✔ Verification testing ✔ Acceptance testing ✔ Approval of progress payments for construction progress ✔ Approval of construction post-award QM/QA/QC plans ✔ Report of nonconforming work or punchlist. ✔ Effective QM Practices: The following procurement and project n practices helped the project achieve enhanced quality:  One-on-One Meetings - The Agency conducted one-on-one meetings with each Proposer to discuss issues and clarifications regarding the RFP and Proposer’s ATCs.  Alternative Technical Concept (ATCs) Process - A process for pre-Proposal review of ATCs that conflict with the requirements for design and construction of the Project, or otherwise require a modification of the technical requirements of the Project.  Competitive Range - The term “Competitive Range” means a list of the most highly rated Proposals, based on initial Technical Proposal ratings and evaluations of Price Proposals, which were judged by the Agency to have a reasonable chance of being selected for award. 112

 Summary of Innovation and Enhanced Quality - The Proposers were to prepare a summary of no more than three pages that outlined the specific areas in which the Proposer had introduced innovation and provided enhanced quality in long-term performance, durability, or maintainability.  Document Control - The QMP had to specify procedures for meeting documentation requirements, for document control and for the specific responsibilities of personnel to satisfy these requirements.  Over-the-Shoulder Design Reviews - The DQM was to conduct design reviews.  Milestone (30% and 60%) Reviews - The DQM was to conduct formal milestone reviews.  Incentive/Disincentive Program 4.5.8 Hastings Bridge Project, Minnesota Project Name: TH61 Hastings Bridge Design-Build Project Name of Agency: Minnesota Department of Transportation (MnDOT) Location: T.H. 61 over the Mississippi River along the border of Washington and Dakota County, Minnesota within and near the City of Hastings. Project Delivery Method/Procurement/Contract Type: Design-Build/Best-Value/Lump Sum Project Description: The Project scope is to design and construct a new four-lane bridge over the Mississippi River, remove the existing 2-lane bridge, and construct the approaches on the north and south sides of the bridge. Project Quality Profile: The overall quality approach required the Contractor to develop, implement, and maintain a quality management system that encompassed the design and construction quality aspects, and documentation requirements for the Project. In addition, ATCs were used to permit the design-builder to literally negotiate the design quality criteria and the process for submitting and evaluating them was set forth in the Instructions to Proposers (ITP). 113

QAO: Figure 4-9 shows that the QAO for this project was Oversight. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Owner Verification (if req’d) Quality Assurance Independent Assurance (if req’d) - functional audit -physical audit Design- Builder’s Responsibility Owner’s Responsibility Figure 4-9 – Hastings Bridge QAO Model QA/QC Plans: The quality management process used on this project was a formal one that was project specific. The Contractor’s quality management system had to contain a Quality Manual (QM) that encompassed all Contract requirements with regard to design, construction, and documentation for all quality processes. The Quality Manual also included an Inspection and Testing Plan describing all of the proposed inspections and tests to be performed throughout the construction process. MnDOT had provided a Construction Quality Inspection and Testing Plan in the Quality Manual Template. The Contractor was to tailor the Inspection and Testing Plan to meet the Project requirements. 114

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-9. Table 4-9 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency personnel Consultant design staff Constructor’s preconstruction staff Agency-hired QA/oversight consultant Technical review of design deliverables ✔ ✔ Checking of design calculations ✔ Checking of quantities ✔ Acceptance of design deliverables ✔ Review of specifications ✔ Approval of final construction plans & other design documents ✔ Approval of progress payments for design progress ✔ Approval of post-award design QM/QA/QC plans ✔ Responsibility allocation for construction management tasks Agency personnel Consultant design staff Constructor’s construction staff Agency-hired QA/oversight consultant Technical review of construction shop drawings ✔ ✔ Technical review of construction material submittals ✔ Checking of pay quantities Routine construction inspection ✔ ✔ Quality control testing ✔ Verification testing ✔ Acceptance testing ✔ Approval of progress payments for construction progress ✔ Approval of construction post-award QM/QA/QC plans ✔ Report of nonconforming work or punchlist. ✔ ✔ Effective QM Practices: The following practices were implemented for the project and contributed to managing the quality of the project:  ATC/PAE Process - Approved ATCs were known as Pre-Approved Elements (PAEs). MnDOT then conducted one-on-one meetings with proposers to discuss ATCs and the Proposers were able to incorporate one or more acceptable ATCs in to their proposal.  Disciplinary Task Forces - Each task force will focus on a specific discipline of work.  Over-the-shoulder design reviews - Informal examinations by MnDOT of design documents during the project design process.  In-Progress Design Workshops - Throughout the design process, the Contractor or MnDOT could request in-progress design workshops to discuss and verify design progress and to assist the Contractor and/or its designer(s) in resolving design questions and issues. 115

 Quality Oversight Visits - During the design process, MnDOT could make oversight visits to discuss and verify design progress and ascertain the overall progress of the Project with respect to the Contractor’s Quality Manual.  Disincentive - Subject to MnDOT’s determination, MnDOT could assess the Contractor a $100-per-hour monetary deduction for failure to facilitate satisfactory progress or completion of the Work. 4.5.9 I-595 Express Corridor Improvements Project, Florida Project Name: I-595 Express Corridor Improvements Project Name of Agency: Florida Department of Transportation (FDOT) Location: Broward County, FL Project Delivery Method/Procurement/Contract Type: Public-Private-Partnership (P3), 2 step process for procurement, lump sum for design, construction, operate, and maintenance Project Description: The I-595 Express Corridor Improvements Project consists of the reconstruction of the I-595 mainline and all associated improvements to frontage roads and ramps from the I-75/Sawgrass Expressway interchange to the I-595/I-95 interchange, for a total length along I-595 of approximately 10.5 miles, and approximately 2.5 miles on Florida Turnpike from Peters Road to Griffin Road. The design and construction cost of the project is approximately $1.2 billion. Project Quality Profile: Because the project is PPP, and the concessionaire will be operating the project for 30 years, the concessionaire held the majority of the responsibility of the quality responsibilities, which equates to the acceptance quality assurance organizations, as shown in Figure 4-10. FDOT did hire several engineering consultants such as the design manager and the Oversight Construction Engineer Inspector (OCEI). Overall, the design manager’s responsibility was to make sure that the produced design met the requirements of the contract. FDOT and the design manager did have more involvement in the design when it came to elements of the project that were related to safety, such as bridges, and traffic control. The OCEI was responsible for conducting statistical sampling verification testing regarding the Concessionaire’s Construction Engineering Inspection. 116

QAO: Figure 4-10 shows that the QAO for this project was Acceptance. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Owner Verification Testing Quality Assurance Independent Assurance (if req’d) - functional audit -physical audit Owner’s Responsibility Concessionaires’s Responsibility Independent Engineering Consultant Figure 4-10 – I-595 Express Corridor Improvements Project QAO QA/QC Plans: The concessionaire holds most of the risk associated with gaining a quality product, in that they are responsible for operation and maintenance of the corridor for 30 years after construction. To ensure that quality was a priority, part of the contract required submission and approval of a QA and QC plan for both design and construction before work began. The concessionaire created an overall QM plan, while the designer created the design QM, QA, and QC plans and the design builder created the construction QM, QA, and QC plans. 117

Quality Management Responsibility Allocation Summary For this case study independent questionnaires were received from the design builder (D), the concessionaire (C), the agency (A) and the engineer (E). Not all four responded the same way to the questionnaire, thus table 4-10 shows how each party responded. Table 4-10 – Summary of design and construction QM roles Responsible Party (select all that apply) Responsibility allocation for design management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Pre-const. Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of design deliverables 1 Checking of design calculations 2 Checking of quantities 2 Acceptance of design deliverables Review of specifications 2 Approval of final construction plans & other design documents Approval of progress payments for design progress 2 Approval of post-award design QM/QA/QC plans 2 Other: 1 – Is FDOT design construction; 2 – Is the Concessionaire Responsibility allocation for construction management tasks Agency Design Staff Agency PM Staff Design Consultant Staff Constructor’s Construction Staff Agency-hired QA/oversight Consultant Other, specify below Technical review of construction shop drawings Technical review of construction material submittals Checking of pay quantities Routine construction inspection Quality control testing Verification testing Acceptance testing Approval of progress payments for construction progress Approval of construction post- award QM/QA/QC plans Report of nonconforming work or punchlist. Other: Concessionaire and Concessionaire CEI D – Design Builder; A – Agency; C – Concessionaire; E – Engineer 118

Effective QM Practices:  The dual Construction Engineer Inspection process where there is an oversight CEI (OCEI) hired by the agency and a CEI hired by the concessionaire (CCEI). The CCEI is responsible for the construction inspections on the project, while the oversight CEI audits the CCEI based on a statistical sampling process. This has been very successful, however because this was a new concept it took about a year to establish an understanding as to how the two CEI’s can best work together for the betterment of the project.  During the construction phase unique electronic inspection and testing request were implemented as part quality management system for all subcontractors to follow. This process included converting emails to text messages to be received by people in the field without email.  Two major procedures of the quality system, which affect all project work, are the witness and hold procedure and the testing and sampling (TSR) procedure, initiated by subcontractors, inspected by the design builder QC and verified by the CCEI. All work and materials used to advance the project are recorded and regulated by multiple parties (contractor’s QC staff, CCEI, OCEI).  This project had many subcontractors that had never worked on a FDOT project, much less one that was a P3 project and had requirements for both FDOT and the concessionaire. Every subcontractor had to be trained on FDOT requirements and the Concessionaire team requirements, which included the submittal of quality management plans by the subs and material suppliers. The training also included concepts of different quality management processes/philosophies such as ISO 90001 etc. ISO was also included as reference materials to the training and development of the subs quality management plans. 4.5.10 SH 130 Turnpike Project, Texas Project Name: SH 130 Turnpike Project Exclusive Development Agreement Name of Agency: Texas Department of Transportation (TxDOT) – Texas Turnpike Authority Location: SH 130 through Travis and Williamson Counties, Texas Project Delivery Method/Procurement/Contract Type: PPP/Best-Value/Guaranteed Lump Sum (Exclusive Development Agreement). Project Description: State Highway (SH) 130 is an approximately 49-mile new toll-way extending from IH-35 near SH 195, north of Georgetown, Texas Southward to US Highway 183 southeast of Austin. SH 130 is a four-lane controlled-access toll-way with discontinuous frontage roads and directional interchanges where warranted. Work for this project included the design, right-of-way acquisition, utility adjustment, construction, and fifteen years of capital maintenance (if elected by TxDOT). Project Quality Profile: The SH 130 project QC/QA program consisted of four inter-dependent 119

components: the Quality Control (QC) Program, the Owner Oversight Program, the Independent Assurance (IA) Program, and the independent Construction Quality Assurance (CQA) Program. TxDOT developed a project-specific quality assurance program (QAP) for the SH130 project. In addition to safeguards in the QAP, the EDA had several measures to ensure the quality of workmanship and materials in the project. The measures were broken into three basic categories including quality control, acceptance testing and inspection, and owner verification. QAO: Figure 4-11 shows that the QAO for this project was Acceptance. Project Acceptance Construction Quality Assurance Design Quality Assurance Design Quality Control Construction Quality Control Design Released for Construction Construction Released for Final Payment Independent Assurance (if req’d) - functional audit -physical audit Owner Verification Testing Quality Assurance Independent Assurance (if req’d) - functional audit -physical audit Owner’s Responsibility Concessionaires’s Responsibility Independent Engineering Consultant Figure 4-11 – SH 130 Turnpike QAO QA/QC Plans: The SH 130 was the first design-build highway infrastructure project in Texas where contractor QC testing was used in the acceptance decision for all project-produced materials. An enhancement to the previous owner verification process was the new three-tiered approach. In this approach Level 1 is applied to the tests which are strong indicators of performance and provides the highest level of confidence in the contractor’s QC testing. Level 2 is applied to tests that are secondary indicators of performance. Level 3 is applied to tests with extremely low test frequencies. 120

Quality Management Responsibility Allocation: A summary of design and construction QM roles is shown in table 4-11. Table 4-11 – Summary of design and construction QM roles Responsibility allocation for design management tasks Agency personnel Consultant design staff Constructor’s preconstruction staff Agency-hired QA/oversight consultant Technical review of design deliverables ✓ ✓ Checking of design calculations ✓ ✓ Checking of quantities ✓ ✓ Acceptance of design deliverables ✓ ✓ Review of specifications ✓ Approval of final construction plans & other design documents ✓ ✓ Approval of progress payments for design progress ✓ Approval of post-award design QM/QA/QC plans ✓ Responsibility allocation for construction management tasks Agency personnel Consultant design staff Constructor’s construction staff Agency-hired QA/oversight consultant Technical review of construction shop drawings ✓ Technical review of construction material submittals ✓ Checking of pay quantities ✓ Routine construction inspection ✓ ✓ Quality control testing ✓ Verification testing ✓ ✓ Acceptance testing ✓ Approval of progress payments for construction progress ✓ Approval of construction post-award QM/QA/QC plans ✓ ✓ Report of nonconforming work or punchlist. ✓ Effective QM Practices: Effective QM Practices that contributed to the success of the SH 130 Project are described below:  Co-location: Due to the magnitude of the project, it was critical for all parties to be co- located on the project.  Escalation Matrix: An escalation matrix was developed to provide a clear chain of command for escalating issues that could not be agreed upon, while promoting the resolution of issues at the lowest possible levels.  Clarification Requests and Reports: Field clarification requests were used to clarify plans that had disconnects or discrepancies. Construction Deficiency Reports and Non- Conformance Reports were used to track non-conforming materials and workmanship.  The Web-Based EDMS: The Electronic Laboratory Verification Information System (ELVIS) is a set of web-based data management and engineering analysis tools originally 121

developed to process material testing data and to transmit them electronically to TxDOT for statistical validation. To meet the project needs, ELVIS was further expanded to support CQAF construction inspection reporting and manage pavement surface ride quality.  Industry Review Process: The industry review process included the development of a risk allocation table as a trade-off with the proposers and includes a reiterative cycle of subtasks. 4.6 Case Study Synthesis This section includes a series of tables summarizing the key details of all the case studies. The purpose of these tables is to provide a visual manner in which to compare the various case studies and recognize key trends. While these tables certainly do not tell the full story of any of the case studies and cannot capture all of the unique features of and methods used on each project, they are nonetheless useful for distilling each project into its key quality constituents. 4.6.1 Relationship between Delivery Method and QAO Table 4-12 lists the case studies along with their delivery, procurement, and payment methods and their identified QAO type as well. While it is theoretically possible to use a number of different QAO models for a given project delivery method, the case studies analyzed suggest that certain QAOs may be well suited for particular delivery methods. For example, while a project using the PPP delivery method could theoretically structure its QAO to include the owner in design or construction quality management roles, such a system was not found in the case studies. Instead, of the two PPP projects studied, both utilized the Acceptance QAO in which the owner only performs project acceptance and delegates the remaining QM roles and responsibilities. Table 4-12 – Delivery, Procurement, and Payment Methods and QAO # Agency Name QAO Delivery Method Procurement Method Payment Provisions 1 WSDOT George Sellar Bridge Deterministic DBB w/eci Best value Lump sum 2 ODOT Willamette River Bridge Deterministic CMGC Best value GMP 3 TriMet Portland Transit Mall Deterministic CMGC Best value GMP 4 USACE Tuttle Creek Dam Deterministic CMGC QBS Prog. GMP 5 UDOT Mountain View Corridor Assurance CMGC Best value GMP 6 CDOT US 160 4th Lane Addition Oversight Mod. DB Low bid Lump sum 7 UDOT I-15 Widening-Beck Street Oversight DB Best value Lump sum 8 MnDOT Hastings River Bridge Oversight DB Best value Lump sum 9 FDOT I-595 Express Corridor Acceptance PPP Best value Lump sum 10 TxDOT SH130 Turnpike Extension Acceptance PPP Best value Lump sum GMP – Guaranteed Maximum Price; QBS – Quality Based Selection; Prog. GMP – Progressive GMP, multiple bid packages with separate GMPs for each package All three of the case studies using the DB delivery method used the Oversight QAO model. The Oversight QAO leaves all design and construction QA and QC functions in the hands of the designer, contractor, or design-builder. While an owner could retain a QA function if desired as 122

found in the Assurance QAO, this was not found in the case studies examined. Similarly, while a project using DBB delivery could potentially allow the contractor to assume a quality assurance role as found in an Assurance QAO, the baseline QAO and the one used on the WSDOT project studied was the Deterministic QAO. The Deterministic arrangement of quality roles accurately reflects the baseline QM system and it would be expected to be found on most DBB projects. In contrast, the case studies, which used the CMGC delivery method, showed slightly more variation in their QAOs. While three of the case studies utilized a Deterministic QAO, the fourth, Mountain View Corridor, made use of an Assurance QAO. The Assurance QAO allows the designer to perform its own design QC without interference from the owner and its use on the Mountain View Corridor project may reflect UDOT’s long period of experience and comfort with the CMGC delivery method. Table 4-13 provides a succinct summary of the QM roles and responsibilities, which must be assigned under each QAO model. Only four of the five QAO models were found in the case studies as none of them made use of the Variable QAO. The QAOs show very little variation for the most part. However, case studies 2 and 3, which both used the CMGC delivery method, as shown in table 4-13 show some deviation from the other case studies using Deterministic QAOs. The primary difference is the sharing of the design QC function between the owner, designer, and builder. In fact, were it not for the sharing of this role, these case studies would have been listed as using an Assurance QAO. On each of these projects however, the owner wanted to maintain an active role in design QC despite outsourcing most of the projects’ design. 123

Table 4-13 – Summary of Varying Quality Roles Quality Management Roles and Responsibilities # QAO Project Acceptance Design QC Design QA Const. QC Const. QA Indep. Assurance OVT O D B O D B O D B O D B O D B O D B D B B 1 Deterministic ✔ ✔ ✔ ✔ ✔ ✔ 2 Deterministic ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ 3 Deterministic ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ 4 Deterministic ✔ ✔ ✔ ✔ ✔ ✔ 5 Assurance ✔ ✔ ✔ ✔ ✔ ✔ ✔ 6 Oversight ✔ ✔ ✔ ✔ ✔ ✔ 7 Oversight ✔ ✔ ✔ ✔ ✔ ✔ ✔ 8 Oversight ✔ ✔ ✔ ✔ ✔ ✔ ✔ 9 Acceptance ✔ Conc Conc Conc Conc Conc ✔ 10 Acceptance ✔ Conc Conc Conc Conc Conc ✔ O – Owner; D – Designer; B – Builder; Conc – Concessionaire 4.6.2 Documents Required Before Contract Award Quality management is not a static process but rather is affected by decisions made at all points along a project’s timeline from conception to ribbon cutting. One milestone where decisions must be made that will affect the overall quality of the project is just before the release of procurement documents like RFQs and RFPs. Table 4-14 lists the documents that were required to be submitted by interested designers, builders, or design-builders before the award of any contracts for design or construction. Those documents marked with a plus sign were specifically listed as being evaluated as part of the award decision. 124

Table 4-14 – Summary of Required pre-Award Submittals Required Proposal/Bid Package Submittals Case Study Number 1 2 3 4 5 6 7 8 9 10 Qualifications of Design Quality Manager ✔+ ✔+ ✔+ ✔+ ✔+ ✔+ Qualifications of Construction Quality Manager ✔ ✔+ ✔+ ✔+ ✔+ Qualifications of other QM personnel ✔+ ✔+ ✔+ ✔+ ✔+ ✔+ Design quality management plan ✔+ ✔+ ✔+ ✔+ ✔+ Design criteria checklists ✔+ ✔+ ✔+ ✔+ Construction quality management/control plan ✔+ ✔+ ✔+ Construction testing matrix ✔+ ✔ Quality-based incentive/disincentive features ✔+ ✔ Warranties ✔ ✔ ✔+ +: Evaluated to make award decision(s) Four case studies required submission of one of these documents or less before making award decisions. Of these four, three, with the exception of the sole DBB project, required several of these documents were after the award. For the remaining six case studies, the most common documents required were the qualifications of design quality managers (6 case studies), of other QM personnel (6), of the construction quality manager (5), and the design QMP (5). From this information, the owners of these six projects valued incorporating quality into their projects from the start. 4.6.3 Inventory of Emerging Tools Each of the case studies furnished a number of QM tools considered non-traditional that project participants indicated as beneficial to their project. Table 4-15 lists the primary tools identified and divides them into two groups: those used before the award of design or construction contracts and those used after. Use of the pre-award tools can help to ensure clarity in the procurement process, to modify project requirements, and to adjust quality requirements when it is prudent to do so. Owner, design-builders and concessionaires can use the post-award tools to improve aspects of QM along all the phases of a project after selecting a designer and contractor. One of the reasons for dividing the tools in this manner was to draw attention to the importance of when to incorporate quality in to a project. Traditional QM methods are reactive and emphasize QC testing to evaluate quality after completion of portions of a project. Most of the emerging tools discovered in the case studies are used not to measure if quality standards were met, as in QC testing, but rather to plan for and build quality into the project long before any designs are complete or any construction is started. Later research efforts will explore under what circumstances these tools might be used and with which QAOs they are compatible. 125

Table 4-15 – List of Emerging Alternative QM Tools Pre-award Tools Post-award Tools  Owner led o Pre-bid meeting with focus on quality o Industry review of draft RFP with focus on quality o ISO 9000 certification for organization, project, or team member o Alternative QM approaches in procurement o Quality based selection of contractors/subcontractors (project- specific prequalification) o Use of warranties (performance or materials)  Contractor led o One-on-one meetings during procurement with a focus on alternative quality o Contractor proposed alt. quality standards/specification deviations o “Red Flag” review of standard specs o Alternative Technical Concepts (ATCs) Design process  Design review: o External contractor panel input o Independent party review (agency, staff extension) o Over-the-shoulder agency reviews o In-progress design workshops o Discipline task force (parallel entire project) Construction process  Teaming: o Formal partnering with regulatory agencies o Formal team partnering/goal-setting process o Co-location of QM personnel o Discipline task force (parallel entire project) o No low bid requirement for subcontractors o Use of dual CEI/OCEI roles  Process control: o Innovation in witness and hold points o Continuous internal process audit o Real time electronic QM information management o Financial incentive/disincentives for quality o Contractor “controlled” QC testing o Innovation in clarification reports  Training: o ISO 9000 training of sub-contractors o Project-specific QM team training OCEI – Oversight CEI 4.7 Summary As seen in this chapter, great time and consideration was given to the identification and selection of the case studies used for this report and to ensuring that they were conducted using a rigorous and thorough methodology. After conducting the case studies, the information gathered was distilled into the full case studies found in the appendices and synthesized in the tables at the end of this chapter. Case studies were examined for their successes related to alternative QM as well as a breakdown of the primary design and construction QM roles and responsibilities. This information was then used to craft a QAO diagram for each case study which was then matched to one of the five primary QAOs identified in Chapter 3. Each of the ten case studies conducted for this project provided a wealth of information regarding the implementation of alternative QMSs and a number of innovative alternative QM tools. 126

TRB’s National Cooperative Highway Research Program (NCHRP) Web-Only Document 212: Alternative Quality Management Systems for Highway Construction documents the research process, data collection and analysis used to develop NCHRP Report 808: Guidebook on Alternative Quality Management Systems for Highway Construction .

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