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The TQM Journal

ISSN : 1754-2731

Article publication date: 7 September 2021

Issue publication date: 24 November 2022

The purpose of this paper is to analyze the evolution of total quality management (TQM) models, frameworks, and tools and techniques in higher education (HE) over the last thirty years from 1991 till 2020, based on a literature review

Design/methodology/approach

30 articles from 52 journals were used to perform this detailed literature review. For the detailed analysis, the focus was only on articles related to TQM in higher education and specifically related to models, frameworks and tools and techniques. The study has investigated the growth of research articles, research streams, research methodologies, models and frameworks in the higher education sector and tools and techniques related to those.

This review addresses the progress and gaps in the application of TQM in HE, including the shift in global research in this area from the USA and Europe to Asia in recent years. The articles have been classified into four research methodologies and two research streams which have been reviewed in detail. The findings include reasons for multiple models/frameworks in HE proposed by researchers over the years and the importance of tools and techniques used in TQM implementation.

Originality/value

This study, which tries to bring a perspective to the main trends in TQM application to higher education wrt models, frameworks, tools and techniques over the last thirty years, is expected to add to the body of knowledge in this area and help future researchers to focus on the relevant areas identified in this paper.

• Higher education
• Tools and techniques

Jasti, N.V.K. , Venkateswaran, V. , Kota, S. and Sangwan, K.S. (2022), "A literature review on total quality management (models, frameworks, and tools and techniques) in higher education", The TQM Journal , Vol. 34 No. 5, pp. 1298-1319. https://doi.org/10.1108/TQM-04-2021-0113

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• How to Write a Literature Review | Guide, Examples, & Templates

How to Write a Literature Review | Guide, Examples, & Templates

Published on January 2, 2023 by Shona McCombes . Revised on September 11, 2023.

What is a literature review? A literature review is a survey of scholarly sources on a specific topic. It provides an overview of current knowledge, allowing you to identify relevant theories, methods, and gaps in the existing research that you can later apply to your paper, thesis, or dissertation topic .

There are five key steps to writing a literature review:

• Search for relevant literature
• Evaluate sources
• Identify themes, debates, and gaps
• Outline the structure
• Write your literature review

A good literature review doesn’t just summarize sources—it analyzes, synthesizes , and critically evaluates to give a clear picture of the state of knowledge on the subject.

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Table of contents

What is the purpose of a literature review, examples of literature reviews, step 1 – search for relevant literature, step 2 – evaluate and select sources, step 3 – identify themes, debates, and gaps, step 4 – outline your literature review’s structure, step 5 – write your literature review, free lecture slides, other interesting articles, frequently asked questions, introduction.

• Quick Run-through
• Step 1 & 2

When you write a thesis , dissertation , or research paper , you will likely have to conduct a literature review to situate your research within existing knowledge. The literature review gives you a chance to:

• Demonstrate your familiarity with the topic and its scholarly context
• Develop a theoretical framework and methodology for your research
• Position your work in relation to other researchers and theorists
• Show how your research addresses a gap or contributes to a debate
• Evaluate the current state of research and demonstrate your knowledge of the scholarly debates around your topic.

Writing literature reviews is a particularly important skill if you want to apply for graduate school or pursue a career in research. We’ve written a step-by-step guide that you can follow below.

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See an example

Writing literature reviews can be quite challenging! A good starting point could be to look at some examples, depending on what kind of literature review you’d like to write.

• Example literature review #1: “Why Do People Migrate? A Review of the Theoretical Literature” ( Theoretical literature review about the development of economic migration theory from the 1950s to today.)
• Example literature review #2: “Literature review as a research methodology: An overview and guidelines” ( Methodological literature review about interdisciplinary knowledge acquisition and production.)
• Example literature review #3: “The Use of Technology in English Language Learning: A Literature Review” ( Thematic literature review about the effects of technology on language acquisition.)
• Example literature review #4: “Learners’ Listening Comprehension Difficulties in English Language Learning: A Literature Review” ( Chronological literature review about how the concept of listening skills has changed over time.)

You can also check out our templates with literature review examples and sample outlines at the links below.

Download Word doc Download Google doc

Before you begin searching for literature, you need a clearly defined topic .

If you are writing the literature review section of a dissertation or research paper, you will search for literature related to your research problem and questions .

Make a list of keywords

Start by creating a list of keywords related to your research question. Include each of the key concepts or variables you’re interested in, and list any synonyms and related terms. You can add to this list as you discover new keywords in the process of your literature search.

• Social media, Facebook, Instagram, Twitter, Snapchat, TikTok
• Body image, self-perception, self-esteem, mental health
• Generation Z, teenagers, adolescents, youth

Search for relevant sources

Use your keywords to begin searching for sources. Some useful databases to search for journals and articles include:

• Your university’s library catalogue
• Google Scholar
• Project Muse (humanities and social sciences)
• Medline (life sciences and biomedicine)
• EconLit (economics)
• Inspec (physics, engineering and computer science)

You can also use boolean operators to help narrow down your search.

Make sure to read the abstract to find out whether an article is relevant to your question. When you find a useful book or article, you can check the bibliography to find other relevant sources.

You likely won’t be able to read absolutely everything that has been written on your topic, so it will be necessary to evaluate which sources are most relevant to your research question.

For each publication, ask yourself:

• What question or problem is the author addressing?
• What are the key concepts and how are they defined?
• What are the key theories, models, and methods?
• Does the research use established frameworks or take an innovative approach?
• What are the results and conclusions of the study?
• How does the publication relate to other literature in the field? Does it confirm, add to, or challenge established knowledge?
• What are the strengths and weaknesses of the research?

Make sure the sources you use are credible , and make sure you read any landmark studies and major theories in your field of research.

You can use our template to summarize and evaluate sources you’re thinking about using. Click on either button below to download.

Take notes and cite your sources

As you read, you should also begin the writing process. Take notes that you can later incorporate into the text of your literature review.

It is important to keep track of your sources with citations to avoid plagiarism . It can be helpful to make an annotated bibliography , where you compile full citation information and write a paragraph of summary and analysis for each source. This helps you remember what you read and saves time later in the process.

Prevent plagiarism. Run a free check.

To begin organizing your literature review’s argument and structure, be sure you understand the connections and relationships between the sources you’ve read. Based on your reading and notes, you can look for:

• Trends and patterns (in theory, method or results): do certain approaches become more or less popular over time?
• Themes: what questions or concepts recur across the literature?
• Debates, conflicts and contradictions: where do sources disagree?
• Pivotal publications: are there any influential theories or studies that changed the direction of the field?
• Gaps: what is missing from the literature? Are there weaknesses that need to be addressed?

This step will help you work out the structure of your literature review and (if applicable) show how your own research will contribute to existing knowledge.

• Most research has focused on young women.
• There is an increasing interest in the visual aspects of social media.
• But there is still a lack of robust research on highly visual platforms like Instagram and Snapchat—this is a gap that you could address in your own research.

There are various approaches to organizing the body of a literature review. Depending on the length of your literature review, you can combine several of these strategies (for example, your overall structure might be thematic, but each theme is discussed chronologically).

Chronological

The simplest approach is to trace the development of the topic over time. However, if you choose this strategy, be careful to avoid simply listing and summarizing sources in order.

Try to analyze patterns, turning points and key debates that have shaped the direction of the field. Give your interpretation of how and why certain developments occurred.

If you have found some recurring central themes, you can organize your literature review into subsections that address different aspects of the topic.

For example, if you are reviewing literature about inequalities in migrant health outcomes, key themes might include healthcare policy, language barriers, cultural attitudes, legal status, and economic access.

Methodological

If you draw your sources from different disciplines or fields that use a variety of research methods , you might want to compare the results and conclusions that emerge from different approaches. For example:

• Look at what results have emerged in qualitative versus quantitative research
• Discuss how the topic has been approached by empirical versus theoretical scholarship
• Divide the literature into sociological, historical, and cultural sources

Theoretical

A literature review is often the foundation for a theoretical framework . You can use it to discuss various theories, models, and definitions of key concepts.

You might argue for the relevance of a specific theoretical approach, or combine various theoretical concepts to create a framework for your research.

Like any other academic text , your literature review should have an introduction , a main body, and a conclusion . What you include in each depends on the objective of your literature review.

The introduction should clearly establish the focus and purpose of the literature review.

Depending on the length of your literature review, you might want to divide the body into subsections. You can use a subheading for each theme, time period, or methodological approach.

As you write, you can follow these tips:

• Summarize and synthesize: give an overview of the main points of each source and combine them into a coherent whole
• Analyze and interpret: don’t just paraphrase other researchers — add your own interpretations where possible, discussing the significance of findings in relation to the literature as a whole
• Critically evaluate: mention the strengths and weaknesses of your sources
• Write in well-structured paragraphs: use transition words and topic sentences to draw connections, comparisons and contrasts

In the conclusion, you should summarize the key findings you have taken from the literature and emphasize their significance.

When you’ve finished writing and revising your literature review, don’t forget to proofread thoroughly before submitting. Not a language expert? Check out Scribbr’s professional proofreading services !

This article has been adapted into lecture slides that you can use to teach your students about writing a literature review.

Scribbr slides are free to use, customize, and distribute for educational purposes.

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If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A literature review is a survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question .

It is often written as part of a thesis, dissertation , or research paper , in order to situate your work in relation to existing knowledge.

There are several reasons to conduct a literature review at the beginning of a research project:

• To familiarize yourself with the current state of knowledge on your topic
• To ensure that you’re not just repeating what others have already done
• To identify gaps in knowledge and unresolved problems that your research can address
• To develop your theoretical framework and methodology
• To provide an overview of the key findings and debates on the topic

Writing the literature review shows your reader how your work relates to existing research and what new insights it will contribute.

The literature review usually comes near the beginning of your thesis or dissertation . After the introduction , it grounds your research in a scholarly field and leads directly to your theoretical framework or methodology .

A literature review is a survey of credible sources on a topic, often used in dissertations , theses, and research papers . Literature reviews give an overview of knowledge on a subject, helping you identify relevant theories and methods, as well as gaps in existing research. Literature reviews are set up similarly to other  academic texts , with an introduction , a main body, and a conclusion .

An  annotated bibliography is a list of  source references that has a short description (called an annotation ) for each of the sources. It is often assigned as part of the research process for a  paper .  

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The Literature Review: A Foundation for High-Quality Medical Education Research

a  These are subscription resources. Researchers should check with their librarian to determine their access rights.

Despite a surge in published scholarship in medical education 1 and rapid growth in journals that publish educational research, manuscript acceptance rates continue to fall. 2 Failure to conduct a thorough, accurate, and up-to-date literature review identifying an important problem and placing the study in context is consistently identified as one of the top reasons for rejection. 3 , 4 The purpose of this editorial is to provide a road map and practical recommendations for planning a literature review. By understanding the goals of a literature review and following a few basic processes, authors can enhance both the quality of their educational research and the likelihood of publication in the Journal of Graduate Medical Education ( JGME ) and in other journals.

The Literature Review Defined

In medical education, no organization has articulated a formal definition of a literature review for a research paper; thus, a literature review can take a number of forms. Depending on the type of article, target journal, and specific topic, these forms will vary in methodology, rigor, and depth. Several organizations have published guidelines for conducting an intensive literature search intended for formal systematic reviews, both broadly (eg, PRISMA) 5 and within medical education, 6 and there are excellent commentaries to guide authors of systematic reviews. 7 , 8

• A literature review forms the basis for high-quality medical education research and helps maximize relevance, originality, generalizability, and impact.
• A literature review provides context, informs methodology, maximizes innovation, avoids duplicative research, and ensures that professional standards are met.
• Literature reviews take time, are iterative, and should continue throughout the research process.
• Researchers should maximize the use of human resources (librarians, colleagues), search tools (databases/search engines), and existing literature (related articles).
• Keeping organized is critical.

Such work is outside the scope of this article, which focuses on literature reviews to inform reports of original medical education research. We define such a literature review as a synthetic review and summary of what is known and unknown regarding the topic of a scholarly body of work, including the current work's place within the existing knowledge . While this type of literature review may not require the intensive search processes mandated by systematic reviews, it merits a thoughtful and rigorous approach.

Purpose and Importance of the Literature Review

An understanding of the current literature is critical for all phases of a research study. Lingard 9 recently invoked the “journal-as-conversation” metaphor as a way of understanding how one's research fits into the larger medical education conversation. As she described it: “Imagine yourself joining a conversation at a social event. After you hang about eavesdropping to get the drift of what's being said (the conversational equivalent of the literature review), you join the conversation with a contribution that signals your shared interest in the topic, your knowledge of what's already been said, and your intention.” 9

The literature review helps any researcher “join the conversation” by providing context, informing methodology, identifying innovation, minimizing duplicative research, and ensuring that professional standards are met. Understanding the current literature also promotes scholarship, as proposed by Boyer, 10 by contributing to 5 of the 6 standards by which scholarly work should be evaluated. 11 Specifically, the review helps the researcher (1) articulate clear goals, (2) show evidence of adequate preparation, (3) select appropriate methods, (4) communicate relevant results, and (5) engage in reflective critique.

Failure to conduct a high-quality literature review is associated with several problems identified in the medical education literature, including studies that are repetitive, not grounded in theory, methodologically weak, and fail to expand knowledge beyond a single setting. 12 Indeed, medical education scholars complain that many studies repeat work already published and contribute little new knowledge—a likely cause of which is failure to conduct a proper literature review. 3 , 4

Likewise, studies that lack theoretical grounding or a conceptual framework make study design and interpretation difficult. 13 When theory is used in medical education studies, it is often invoked at a superficial level. As Norman 14 noted, when theory is used appropriately, it helps articulate variables that might be linked together and why, and it allows the researcher to make hypotheses and define a study's context and scope. Ultimately, a proper literature review is a first critical step toward identifying relevant conceptual frameworks.

Another problem is that many medical education studies are methodologically weak. 12 Good research requires trained investigators who can articulate relevant research questions, operationally define variables of interest, and choose the best method for specific research questions. Conducting a proper literature review helps both novice and experienced researchers select rigorous research methodologies.

Finally, many studies in medical education are “one-offs,” that is, single studies undertaken because the opportunity presented itself locally. Such studies frequently are not oriented toward progressive knowledge building and generalization to other settings. A firm grasp of the literature can encourage a programmatic approach to research.

Approaching the Literature Review

Considering these issues, journals have a responsibility to demand from authors a thoughtful synthesis of their study's position within the field, and it is the authors' responsibility to provide such a synthesis, based on a literature review. The aforementioned purposes of the literature review mandate that the review occurs throughout all phases of a study, from conception and design, to implementation and analysis, to manuscript preparation and submission.

Planning the literature review requires understanding of journal requirements, which vary greatly by journal ( table 1 ). Authors are advised to take note of common problems with reporting results of the literature review. Table 2 lists the most common problems that we have encountered as authors, reviewers, and editors.

Sample of Journals' Author Instructions for Literature Reviews Conducted as Part of Original Research Article a

Common Problem Areas for Reporting Literature Reviews in the Context of Scholarly Articles

Locating and Organizing the Literature

Three resources may facilitate identifying relevant literature: human resources, search tools, and related literature. As the process requires time, it is important to begin searching for literature early in the process (ie, the study design phase). Identifying and understanding relevant studies will increase the likelihood of designing a relevant, adaptable, generalizable, and novel study that is based on educational or learning theory and can maximize impact.

Human Resources

A medical librarian can help translate research interests into an effective search strategy, familiarize researchers with available information resources, provide information on organizing information, and introduce strategies for keeping current with emerging research. Often, librarians are also aware of research across their institutions and may be able to connect researchers with similar interests. Reaching out to colleagues for suggestions may help researchers quickly locate resources that would not otherwise be on their radar.

During this process, researchers will likely identify other researchers writing on aspects of their topic. Researchers should consider searching for the publications of these relevant researchers (see table 3 for search strategies). Additionally, institutional websites may include curriculum vitae of such relevant faculty with access to their entire publication record, including difficult to locate publications, such as book chapters, dissertations, and technical reports.

Strategies for Finding Related Researcher Publications in Databases and Search Engines

Search Tools and Related Literature

Researchers will locate the majority of needed information using databases and search engines. Excellent resources are available to guide researchers in the mechanics of literature searches. 15 , 16

Because medical education research draws on a variety of disciplines, researchers should include search tools with coverage beyond medicine (eg, psychology, nursing, education, and anthropology) and that cover several publication types, such as reports, standards, conference abstracts, and book chapters (see the box for several information resources). Many search tools include options for viewing citations of selected articles. Examining cited references provides additional articles for review and a sense of the influence of the selected article on its field.

Box Information Resources

• Web of Science a
• Education Resource Information Center (ERIC)
• Cumulative Index of Nursing & Allied Health (CINAHL) a
• Google Scholar

Once relevant articles are located, it is useful to mine those articles for additional citations. One strategy is to examine references of key articles, especially review articles, for relevant citations.

Getting Organized

As the aforementioned resources will likely provide a tremendous amount of information, organization is crucial. Researchers should determine which details are most important to their study (eg, participants, setting, methods, and outcomes) and generate a strategy for keeping those details organized and accessible. Increasingly, researchers utilize digital tools, such as Evernote, to capture such information, which enables accessibility across digital workspaces and search capabilities. Use of citation managers can also be helpful as they store citations and, in some cases, can generate bibliographies ( table 4 ).

Citation Managers

Knowing When to Say When

Researchers often ask how to know when they have located enough citations. Unfortunately, there is no magic or ideal number of citations to collect. One strategy for checking coverage of the literature is to inspect references of relevant articles. As researchers review references they will start noticing a repetition of the same articles with few new articles appearing. This can indicate that the researcher has covered the literature base on a particular topic.

Putting It All Together

In preparing to write a research paper, it is important to consider which citations to include and how they will inform the introduction and discussion sections. The “Instructions to Authors” for the targeted journal will often provide guidance on structuring the literature review (or introduction) and the number of total citations permitted for each article category. Reviewing articles of similar type published in the targeted journal can also provide guidance regarding structure and average lengths of the introduction and discussion sections.

When selecting references for the introduction consider those that illustrate core background theoretical and methodological concepts, as well as recent relevant studies. The introduction should be brief and present references not as a laundry list or narrative of available literature, but rather as a synthesized summary to provide context for the current study and to identify the gap in the literature that the study intends to fill. For the discussion, citations should be thoughtfully selected to compare and contrast the present study's findings with the current literature and to indicate how the present study moves the field forward.

To facilitate writing a literature review, journals are increasingly providing helpful features to guide authors. For example, the resources available through JGME include several articles on writing. 17 The journal Perspectives on Medical Education recently launched “The Writer's Craft,” which is intended to help medical educators improve their writing. Additionally, many institutions have writing centers that provide web-based materials on writing a literature review, and some even have writing coaches.

The literature review is a vital part of medical education research and should occur throughout the research process to help researchers design a strong study and effectively communicate study results and importance. To achieve these goals, researchers are advised to plan and execute the literature review carefully. The guidance in this editorial provides considerations and recommendations that may improve the quality of literature reviews.

Agency Use of Quality Control Plans for Administering Quality Assurance Specifications (2022)

Chapter: chapter 2 - literature review.

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.

10 Introduction This chapter documents the important findings from the literature review of agency use of QCPs for administering QA specifications. The purpose of this chapter is to establish the back- ground and context for the findings from the survey and case examples presented in Chapters 3 and 4, respectively. A discussion of QA programs and QA approaches to alternative-project- delivery methods, including DB, CM/GC, and P3, provides a framework for understanding the requirements of contractors regarding QCPs for various project-delivery methods. The chapter then provides a brief discussion on the use of a contractor’s quality data in the acceptance deci- sion. Construction quality and inspection are then presented to provide the background for DOT compliance monitoring and inspection of contractor implementation of QCPs (see FHWA 2004a). Next, the chapter discusses the overview of contractor QCPs, types of QCPs, requirements of QCPs, industry guidance of developing QCPs, and review and acceptance of QCPs. The chapter con- cludes with a detailed discussion on the various QC requirements used by state DOTs and how DOTs use QCPs for administering QA specification. Overview of Quality Assurance Programs QA programs are developed and implemented by state DOTs and federal transportation agencies across the country. All federal-aid projects on the NHS are required to comply with 23 CFR 637. For projects off the NHS, the established QA procedures that are approved by state DOTs and satisfy the federal requirements can be used for material acceptance (FHWA 2016). The development of QA programs is an evolutionary process, and the form and elements of QA programs vary among state DOTs. However, a good QA program often shares a similar feature that “seeks to balance the cost of testing and inspection for a project with the materials quality and performance risk to maximize the benefit to the traveling public” (Transportation Research E-Circular E-C249 2019). In the past two decades, the use of alternative-project-delivery methods (e.g., DB, CM/GC, and P3) challenged the traditional quality-management approach where the contractor per- formed QC while the state DOT conducted QA. The roles of state DOTs and contractors in quality-management systems are changing (Molenaar et al. 2015b). For example, under the tradi- tional DBB delivery method or a CM/GC agreement, the agency-dominated system is mainly responsible for quality management. Under DB or P3 agreements, the responsibility for quality management is shared to varying degrees between the contractor and the state DOT (Caltrans 2015; FHWA 2012). In today’s work environment, QA is viewed as an umbrella under which quality-management activities take place. Use of QA is now favored over the previously used abbreviation QA/QC or QC/QA (Caltrans 2015). C H A P T E R 2 Literature Review

Literature Review 11   In accordance with 23 CFR 637, a comprehensive construction QA program includes the following six core elements: (1) contractor QC; (2) agency acceptance; (3) IA; (4) dispute resolu- tion; (5) personnel qualification; and (6) laboratory accreditation/qualification. These six core elements of QA apply regardless of the project-delivery method (FHWA 2012). The following section briefly discusses these core elements related to QC. • Contractor QC: According to the Transportation Research E-Circular E-C249, agencies are encouraged to require contractors to perform QC sampling and testing that may result in reducing variability and increasing long-term performance (2019). If a con- tractor’s QC test results are part of the acceptance decision, they must be taken inde- pendently of the agency verification sampling. The verification test results are sampled with control by the state DOT, independently tested, and independently compared to the con- tractor’s independent QC test results (FHWA 2004b; Transportation Research E-Circular E-C249 2019). • Agency Acceptance: The purpose of acceptance is to evaluate the quality of the product (e.g., the degree of compliance with contract requirements) and establish payment when appro priate. There are several factors involved in the acceptance process, including agency responsibilities; quality measure; validation of QC data when contractor test results are used; inspection; and risks to the agency and the contractor (Hughes 2005; FHWA 2012). The Transportation Research E-Circular E-C249 highlighted that there is “a need for additional checks and balances within a QA program when contractor’s tests are included in the accep- tance decision since a small portion of contractors have taken advantage of weaknesses in state QA programs to increase their profit by reducing their costs and/or increasing pay adjust- ments using falsified test results” (2019). • IA: The purpose of IA is to ensure the reliability of all data used in the agency’s acceptance decision—including both the agency’s verification test results and the contractor’s QC testing (FHWA 2016). • Dispute Resolution: 23 CFR 637 requires agencies to have a dispute-resolution system in place to resolve possible discrepancies between the QC data and the agency’s acceptance data if QC testing data will be included in the agency acceptance. • Personnel Qualification: 23 CFR 637 requires that all personnel performing sampling and testing for QC used in the acceptance decision, verification, or IA are required to be quali- fied. FHWA also noted that agencies participate in state, regional, or national technician qualification or certification programs to ensure that technicians and inspectors are properly qualified (2012). • Laboratory Accreditation/Qualification: 23 CFR 637 requires that all contractor, vendor, and state DOT testing used in the acceptance decision must be performed by qualified laboratories. Historically, agencies used the term QC/QA with QC referring to the contractor’s role and QA to the agency’s role. This term implied that QC and QA are separate functions; in fact, QA refers to the overall system for assuring project quality, with QC being one element of a comprehensive QA program. Therefore, the transportation industry has moved away from the term QC/QA and now uses QA (FHWA 2012).

12 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications It is important to note that QA involves “continued evaluation of the activities of plan- ning, design, development of plans and specifications, advertising and awarding of contracts, construction, maintenance, and the interactions of these activities” (Transportation Research E-Circular E-C235 2018). The recent research found that “current material QA practices vary widely among DOTs, and what is acceptable for one DOT may not be for another” (Scott and Molenaar 2017). The study also highlighted that current “QA practices are also evolving, par- ticularly with regard to increased use of alternative project delivery methods that shift more responsibility to industry for managing quality, and with advances in general understanding of materials/product behavior and use of more performance-based quality measures and non- destructive testing technologies that provide for continuous sampling and data collection” (Scott and Molenaar 2017). Use of Contractor’s Quality Data in the Acceptance Decision In 1995, 23 CFR 637 was revised to expressly allow the use of contractor QC test results in a DOT’s acceptance decision and allows the use of consultants in the IA program and for verifi- cation sampling and testing. When quality is not being maintained, state DOTs can reallocate resources to increase the frequency of QA testing and verification to improve quality and lessen risk. FHWA T6120.3 noted that QC sampling and testing results may be used as part of the acceptance decision provided that: • The sampling and testing are performed by qualified laboratories using qualified sampling and testing personnel. • The QC sampling and testing is evaluated under an IA program. • The quality of the material is validated by the verification sampling and testing. The verifica- tion testing is performed on samples that are taken independently of the QC samples. The verification sampling and testing are performed by qualified testing personnel employed by the DOT or its designated agent (i.e., consultant under direct contract with the DOT). Use of a third-party testing-and-inspection firm hired by the contractor does not relieve the agency of its responsibility for verification. • The DOT has a dispute-resolution system in place to resolve possible discrepancies between the contractor’s QC and the agency’s verification data (FHWA 2004b). Additional guidance on the CFR requirements provided through Federal-Aid Policy Guide Non-Regulatory Supplement NS 23 CFR, Part 637B, issued in 2006, clarified the following key points: • A DOT’s acceptance program “should provide a reasonable level of inspection to adequately assess the specific attributes which reflect the quality of the finished product” (23 CFR 637B). Inspection should cover component materials at the time of placement or installation as well as the workmanship and quality of the finished product. The intended function of each part of QA is important because each function should supplement the other. The analogy has been used of QA being similar to a three-legged stool, with one leg being QC, one leg being acceptance, and the third leg being IA. With any leg missing, the whole is unbalanced. The present-day concept of QA is that QC is the responsibility of the contractor, acceptance is the responsibility of the agency (although this responsibility may involve contractor test results), and IA is conducted by an independent third party (Hughes 2005).

Literature Review 13   • Sampling and testing frequencies may vary across state DOTs because the quality and uni- formity of materials vary. State DOTs have some discretion to adjust testing frequencies for materials with a “history of accurate, uniform test results that consistently meet specifica- tion requirements. The rate of testing should be higher on newly developed material sources, sources with questionable quality, sources with a wide range of test results, and sources with failing test results” (23 CFR 637B). • If a contractor’s quality data is used in the acceptance decision and the DOT and contractor test results do not compare, the frequency of the DOT’s verification testing should be increased. • The DOT should obtain the contractor’s test data immediately, no later than 24 hours after sampling is completed. The DOT’s test results should not be given to the contractor until after the contractor results are received. • Test results should not be discarded unless the sampling or testing is flawed. Additional tests may need to be conducted when the quality of the material is in question. If addi- tional tests are performed, the acceptance and pay criteria need to be adjusted to account for the additional test results. • All test procedures used in the acceptance decision should be in the scope of accreditation for the DOT central laboratory. It is important to take the time to understand the strengths and weaknesses of specifications and test procedures when writing them. In addition, it is key to consider the quality assurance specifications and procedures from not just the agency’s perspective. Whenever possible, it is best practice to obtain all relevant data, including the originally measured weights. Doing so would afford an excellent opportunity to perform a data forensic investigation (Transportation Research E-Circular E-C249 2019). Quality Assurance for Alternative-Contracting Projects Alternative-delivery methods, including DB, CM/GC, and P3, are increasingly used among state DOTs. The growing use of these alternative-delivery methods has created a new environment for state DOTs to manage the quality of transportation projects. NCHRP Report 808: Guidebook on Alternative Quality Management Systems for Highway Construction pointed out that “when using project delivery methods in which the contractor is selected before the design is complete and is expected to contribute to the design, the agency should consider the impact of that shift on quality management planning and execution at every phase of project development” (Molenaar et al. 2015a). Figure 1 shows a generic QA framework that includes typical project quality activi- ties (e.g., construction QC, construction acceptance, and IA) associated with the roles and respon- sibilities of owners, constructors, and designers. A dashed line is used to separate responsibilities of the agency, contractor, and designer. For example, items above the dashed line are the respon- sibility of the agency. It is noted that design quality is typically not included in traditional DBB projects but plays an important role for alternative-contracting projects (Molenaar et al. 2015a). The following sections briefly discuss QA for DB, CM/GC, and P3 delivery methods. Overview of QA for DB Projects One of the main characteristics of DB project delivery is that the design and construction are performed under one contract by the same entity (i.e., the design-builder). This single source of responsibility for both design and construction in DB projects is the key difference to quality management between DB and DBB projects. NCHRP Synthesis 376: Quality Assurance in

14 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications Design-Build Projects highlighted that “with the changing quality roles found in the DB delivery method, it is imperative that quality responsibilities and the responsible parties are clearly stated in the contract documents” (Gransberg et al. 2008). FHWA also indicated that the “owner must define the responsibilities of the design-builder and the contracting agency” when preparing the request for proposal (RFP) (2012). Figure 1. Generic QA model (Source: Molenaar et al. 2015a). The management of quality in the DB project is of utmost importance and requires that a department of transportation (DOT) contemplating the use of a DB project delivery prepare a thorough and thoughtful approach to communicating the DB project’s quality requirements as well as the administrative and technical mechanisms that the DOT intends to use to manage both design and construction quality (Gransberg et al. 2008). Several state DOTs have developed QA guidance for their DB projects. For example, Texas DOT (TxDOT) has used its QA program to provide statewide consistency and a programmatic approach to QA for DB projects where the design-builder (i.e., DB contractor) test results are used in the acceptance decision regardless of how the project is funded (TxDOT 2017). Figure 2 illustrates the typical components and the relationships between the parties for the QA program in TxDOT. TxDOT noted that the design-builder in DB projects establishes a systematic QCP to define processes, methods, and documentation for delivery of QC. The plan clearly defines the authority and responsibility for the administration of QC to ensure that the work is delivered in accor- dance with the contract documents (TxDOT 2017).

Literature Review 15   Recently, Colorado DOT (CDOT) has developed a QA program for its DB projects. CDOT’s QA program consists of a QC program, an owner-acceptance program, and an IA program (CDOT 2020). Figure  3 presents the relationship among these three main components of CDOT’s QA program. CDOT noted that project management and quality management require some adjustment to address the shift in responsibility from the owner to the design-builder, but “it should be under- stood that the fundamental principles of quality assurance do not go away with the DB contract- ing method” (CDOT 2020). Figure 3 shows that CDOT’s QA program for DB projects allows for the use of the contractor’s performed test results, referred to as independent contractor quality control (ICQC), as part of an acceptance decision if those results are validated by the Owner Verification Testing (OVT) results performed by a representative for CDOT (CDOT 2020). Figure 2. TxDOT QA program for DB projects (Source: TxDOT 2017). The D-B project delivery system offers several documented benefits over the traditional D-B-B method on certain projects. While D-B offers the design-builder more control over design, materials, and construction methods than D-B-B, the agency still has an important role in assuring quality. As agencies develop DB procurement documents, it is important that roles and responsibilities for design- builder QC and agency acceptance be clearly defined. The responsibility for acceptance by the agency (or their designated agent) is applicable regardless of the project delivery method used (FHWA 2012). Figure 3. CDOT program for DB projects (Source: CDOT 2020).

16 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications NCHRP Report 808 indicated there are several QA models for DB projects, including assurance QA, variable QA, and oversight QA models (Molenaar et al. 2015a). Kraft and Molenaar found that the oversight QA model is the most feasible for DB projects (2015). In the oversight QA model, the agency’s role is to ensure that both the designer and contractor QA plans are effective at meet- ing the agency’s quality requirements and that the plans are being implemented (Kraft and Molenaar 2015). Figure 4 shows the oversight QA model for DB projects. Figure 4 also shows that the design-builder is responsible for all QC and acceptance for the project (Molenaar et al. 2015a). Overview of QA for CM/GC Projects Through an analysis of federal projects, Uhlik and Eller showed that CM/GC project delivery provides two main features that help enhance the project quality: (1) a system of checks and bal- ances exists between design and construction, and (2) input on quality is provided during design by a construction expert (1999). The FHWA Every Day Counts (EDC-2) indicated that one of the main benefits of CM/GC project delivery is improved design quality. Specifically, the FHWA EDC-2 highlighted that under the CM/GC delivery method “the contractor is able to review the designs and provide feedback, answer designer questions and provide changes. By including the contractor review, the designer can produce better designs that reduce issues in con- struction and prevent change orders that can lead to project overruns” (2014). The construction quality management of CM/GC projects does not differ greatly from tradi- tional DBB projects because the owner still occupies the same contractual position with respect to the designer and builder (Molenaar et al. 2015a). Several state DOTs have directly applied their Figure 4. Typical QA model for DB projects (Adapted from Molenaar et al. 2015a).

Literature Review 17   QA program for DBB projects to CM/GC projects with little alteration. For example, California DOT (Caltrans) developed its construction QA program manual that is applied to both DBB and CM/GC projects (Caltrans 2015). The Caltrans manual highlighted the following: The role of the Construction QA program is to provide confidence that the quality of the materials and workmanship incorporated into highway construction projects conforms to the requirements of the plans and specifications. The provisions of this manual apply to DBB projects and projects under a CM/GC agreement (Caltrans 2015). Similarly, CDOT’s Construction Manager/General Contractor Manual summarized the roles of the QA program as following: [A QA program] for CM/GC projects is performed as it would be for a DBB project. Construction Management, Testing and Inspection will be through CDOT or a Consultant Project Engineer and staff. The Contractor will have developed a Quality Control Plan during the Preconstruction Phase that should be referenced during the Construction Phase (CDOT 2015). Overview of QA for P3 Projects Public-Private Partnership (P3) Procurement: A Guide for Public Owners concluded that the traditional means of QA is not an option for P3 projects (FHWA 2019). Most transportation P3 projects in the United States have used a best-value procurement approach. QA and QC organization and approach and the quality of past performance are among the key technical evaluation factors for P3 best-value selection. FHWA highlighted that “the agency must focus on the quality of the proposer teams and their proposals, and rely on the P3 structure itself and the contract terms and conditions to give the P3 contractor incentives to provide a high-quality project and perform operations in a way that meets public needs” (2019). In P3 projects, the concessionaire often has a significant role in QA and QC. The Virginia DOT (VDOT) requires the QA plan to be separated and distinct from the QCP for both design and construction (VDOT 2018b). The concessionaire in P3 projects prepares the Quality Man- agement System Plan (QMSP) that includes an acceptable QA plan and an acceptable QCP. The QMSP defines a uniform process approach to design and construction quality management, quality procedures, records keeping, and document management/control that the concession- aire shall adhere to throughout the duration of the project (VDOT 2018b). The minimum requirement for the design QMSP includes the following: • Written documentation and definition of the project’s design criteria, standards, and processes; • Procedures for the performance of experienced senior engineers’ detailed checks of all design reports, calculations, drawings, and specifications; • Directions for interdisciplinary reviews by technical and management staff to provide coor- dination and uniformity among section designs; • Procedures for constructability reviews to facilitate the timely planning of construction activities; • Procedures for maintainability reviews to ensure feasibility of future maintenance and opera- tion; and • QA audit checklists (VDOT 2018b). The minimum requirements for the construction QMSP include the following: • Staffing plan; • Inspection plan; • Testing plan; and • Construction inspection checklists (VDOT 2018b). Kraft and Molenaar found that the acceptance QA model is the most feasible for P3 projects (2015). In the acceptance QA model, the agency is responsible only for verification testing and

18 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications final acceptance, and the concessionaire is responsible for all other quality roles and responsi- bilities. Figure 5 shows the acceptance QA model for P3 projects. The acceptance QA officer provides the agency with the least amount of direct control over QA of a project. The main agency’s focus in the acceptance QA model is to perform oversight of the design and construc- tion quality-management efforts to satisfy the legal responsibilities. As long as the QCPs meet the requirements of the contract, the agency approves them (Molenaar et al. 2015a). FHWA summarizes the difference in QA between P3 and traditional DBB projects as follows. Figure 5. Typical QA model for P3 projects (Source: Molenaar et al. 2015a). In P3 projects, the concessionaire is responsible for design and construction of the project as well as operations and maintenance over a long-term period. Furthermore, the concessionaire is obligated to hand the project back to the public owner at the end of the term, at a pre-defined level of service and quality. Consequently, the concessionaire has greater financial incentive to make investment decisions that are optimized over the life of the project rather than the incentives contractors have with traditional D-B-B delivery methods (FHWA 2019).

Literature Review 19   Overview of Construction Quality Control Plans A QCP is an essential component of managing quality. Because the QC function is the respon- sibility of the contractor, it is critical to the success of a highway-construction project that the contractor has a functional and responsive QCP. The Federal Lands Highway (FLH) Construction Manual emphasized that an effective QCP does not depend on the oversight and interaction of agency inspectors to control quality (FLH 2009). There is no one-size-fits-all approach to devel- oping a QCP. Each contractor has unique means, methods, and strategies to achieve quality that meets the agency’s needs and expectations. However, FLH highlighted that “a QC plan is not a vague feel-good commitment to quality and contract compliance. It is a detailed account of how the people and processes of an individual contractor will function to deliver quality” (2009). The main purpose of the QCP is to provide a framework or procedures that clearly describe how the contractor intends to address various quality requirements, given the project requirements and contractor resources, preferences, and risk tolerance. The QCP is developed to measure the quality characteristics and inspect construction activities when corrective actions can be taken to prevent nonconforming materials from being incorporated into the project (Burati et al. 2003). As a result, determining quality characteristics to measure for QC in a QC plan is an important step. Table 1 summarizes the typical quality characteristics for hot-mix asphalt (HMA) and portland cement concrete pavement (PCCP) as an example of good quality characteristics included in a QC plan. There are several approaches to implementing a QCP. For example, the QCP can be stipu- lated by the state DOT, chosen by the contractor, or a combination of both. As mentioned previ- ously, there is no one-size-fits-all QCP. Each approach has advantages and disadvantages. For example, if a DOT specifies the minimum requirements for a QCP, the contractor may view these requirements as all necessary for developing the QCP. On the other hand, if a DOT specifies all the requirements and properties for a QCP, the contractor may view the QCP as the agency’s plan rather than the contractor’s plan, which may result in less contractor innovation. FHWA noted that the approach selected to establish the QC plan will have a substantial impact on “the way that the QC plan is implemented and the decisions that must be made throughout the implementation of the plan” (2003). Further, it is important to reevaluate each quality characteristic selected for QCPs after QC data is collected, analyzed, and reviewed by the agency to determine whether to include the quality characteristic for QC purposes or for acceptance testing (Burati et al. 2003). HMA PCCP • Aggregate quality, including fractured faces, sand equivalency, cleanliness, etc.; • Nuclear density; • Gradation of critical sieve sizes; • Plant and discharge temperatures; • Degree of aggregate coating; and • Moisture content of fine aggregate and/or of finished mix. • Aggregate quality; • Gradation of critical sieve sizes; • Air content; • Water-to-cementitious-materials ratio; • Mix temperature; • Slump; and • Spread (for self-consolidating concrete). Table 1. Typical quality characteristics for QC testing (Burati et al. 2003). Quality and the processes that deliver quality are a somewhat open-ended concept. No matter how much detail is in the plan, it can always be argued that more could be, or should be, included (FLH 2009).

20 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications Types of Quality Control Plans Typically, there are two types of QC plans: (1) generic QCP and (2) contractor-specific QCP. NCHRP Synthesis 346: State Construction Quality Assurance Programs highlighted that the QC plan should be established based on a specific contractor or operation, but many state DOTs choose to develop a generic plan for all contractors (Hughes 2005). The following sections briefly discuss these two types of QCPs. Generic QCPs The purpose of using a generic QCP is to create a common approach for all contractors. State DOTs may use a generic QCP because of an inadequate contractor QC staff, contractor competition, and QC cost. Under a generic QC plan, state DOTs often stipulate minimum QC plan procedures (Burati et al. 2003). There are several potential drawbacks of using a generic QCP for both contractors and state DOTs. For example, the sampling and testing procedures and frequency stipulated in a generic QC plan are typically not operation-specific, and the con- tractor may face an out-of-control product (Burati et al. 2003). Likewise, state DOTs face chal- lenging issues when encountering a contractor that needs more frequent sampling and testing to maintain control. If state DOTs use a generic QCP, FHWA highlighted the following key items related to QC: • If state DOTs stipulate QC requirements, then these requirements will have to be generic in nature to apply to different contractors and different plant operations. • If state DOTs decide to establish initial statewide action or control limits, they must evaluate data from a number of typical operations. In addition, because the control limits are not devel- oped for each specific plan or operation, state DOTs should transfer the responsibility related to the control limits to the contractors quickly to establish specific limits for each operation. • To establish a generic QCP, state DOTs must collect data from a number of typical opera- tions based on their historical records, and data should be randomly sampled. If there is not sufficient data, the needed data must be obtained (Burati et al. 2003). Operation-Specific QCPs The operation-specific QCP is often considered as an ideal approach because of varying QC procedures for different construction operations. Typically, construction operations with a history of QC problems (e.g., high-risk items) will require more frequent sampling and testing than operations with few problems (e.g., low-risk items). FHWA emphasized that the contractor is in the best position to know the types of tests and the testing frequencies that are the most suitable indicators of QC (2003). Under the operation-specific QCP, the data used for estab- lishing the plan should come from prior production of similar products representative of that operation. The contractor will be responsible for gathering the data and establishing the operation-specific action or control limits. If state DOTs use an operation-specific QCP, FHWA highlighted the following key items related to QC: • To establish the action limits for control, a QC plan is developed based on the contractor’s specific plant operation and a measure of the average, and the variability must be examined over a period of time. • The data used to develop an operation-specific QCP should be collected in the same manner as that in the QCP that will be implemented. • To establish QC tests and frequencies, the selection of testing procedures and frequencies typically relies on each individual contractor. One of the keys to reaching a balance in testing

Literature Review 21   frequency is to compare the testing frequency to the rate and consistency of production. For example, if the production tends to be consistent, then less frequent testing is allowed. If there are many interruptions, then more frequent testing is required (Burati et al. 2003). Establishment of Quality Control Plans A contractor is responsible for developing a QCP. However, state DOTs need to understand the QCP development process to provide general guidance to the contractor on required plan elements. The development process of a QCP depends on several factors, including the project components required for a QCP; project-delivery methods used; and the relationships among the general contractor, subcontractors, and material suppliers. Typically, a QCP includes the following items: • Providing relationships among parties involved in the project or the work, including contact information for key personnel; • Listing personnel, along with their certifications and relevant experience to the project or the work; • Describing roles and responsibilities of each person involved in the QC process; • Providing required documentation for materials and manufactured products; • Providing references (e.g., test performed, test method, sampling plan, or frequency) for each material or component associated with specification provisions; • Describing monitoring activities along with frequency and other relevant information; • Providing a procedure for evaluating data, including analysis methods and tools; • Describing the means for maintaining control of the work, including the approach to adapt processes or stop work until it complies with expectations and re-equipments; • Describing corrective-action plans to address out-of-control processes and remedy deficient work; and • Describing the process of documentation of the work supporting the QCP (Cavalline et al. 2021). Appendix D provides a QCP outline for concrete-paving projects. For a given project, it is helpful if the state DOTs provide input on the content and level of detail required for an acceptable QCP, unless the contractor already has a documented company QCP. The Standard Specifications for the Construction of Roads and Bridges on Federal Highway Projects (FP-14) indicates that a QCP addresses all contract work categories that include related work items performed in a single operation. For example, a grading and drainage category of work may include the following work items: clearing, excavation, embankment, drainage, and slope protection. Depending on the nature of the project and the organization, the contract work categories may vary. According to FHWA, the typical construction categories are: • Grading and drainage; • Structures; • Masonry; • Pavement structures; • Safety appurtenances; • Seeding and landscaping; • Permanent traffic control; and • Temporary traffic control (2004a). Several state DOTs—California, Kansas, and Utah—indicated that the minimum requirements for a QCP include: • QCP certification by the QC manager (QCM); • QC organization;

22 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications • QCP distribution list; • QC inspection plans; • Sampling and testing plan; • Random sampling plan; • Laboratories and equipment; • Action limits and corrective-action plans; and • QC documents. FP-14 requires that a QC plan be submitted at least 14  days before the start of work. No work on a construction category will be performed until the QC for that category is accepted. In addition, FP-14 stated that approval of a QCP does not imply that the plan will result in contract compliance. When changes occur in the contract, work progress, or personnel, the QCP should be revised. For each construction category, FP-14 specified three main areas in a QCP: (1) QC personnel; (2) QC procedures; and (3) records and documentation. The following sections discuss briefly these three areas. QC Personnel QC personnel in a QCP may vary from agency to agency. Typically, the QC personnel include the QCM, inspectors, testers (e.g., laboratory technicians and QC sampler), and other personnel directly involved with inspection and testing. Figure 6 shows the relationship of the QCM, QC inspector, laboratory technician, and QC sampler. The main responsibilities of a QCM include: • Directing a program; • Providing and implementing a QCP; • Reviewing test results; • Reviewing inspection reports, material certificates, and construction-process records; • Coordinating QC activities; and • Other responsibilities (Hancher et al. 2002). For a full-time, on-site QCM, FP-14 requires that a QCM has no responsibilities for per- forming testing and inspection, managing the project, or performing operations other than managing QC. For a part-time, on-site QCM, FP-14 requires that a QCM has at least two years’ experience in highway construction, inspection, QC, and material testing. Additionally, FP-14 states that the required qualifications of a full-time, on-site QCM are: • One year experience managing QC on construction projects of similar type and scope; and • One of the following: – Two years’ experience as a construction project manager or superintendent on construc- tion projects of similar type and scope; – Three years’ experience as a project engineer, resident engineer, foreman, construction inspector, or equivalent on construction projects of similar type and scope; or – National Institute for Certification in Engineering Technologies (NICET) Level III certifi- cation or equivalent in highway construction or highway material. Figure 6. Contractor QC personnel (Source: Hancher et al. 2002).

Literature Review 23   The main responsibilities of a QC inspector include: • Inspecting source material; • Inspecting plant operation; • Inspecting on-site construction; and • Recording inspection results (Hancher et al. 2002). The main responsibilities of a laboratory technician include: • Calibrating testing equipment; • Performing QC testing; and • Reporting test results (Hancher et al. 2002). The main responsibilities of a QC sampler include: • Deciding QC sampling place; • Taking QC samples; • Taking acceptance samples; and • Recording sample places (Hancher et al. 2002). A QC inspector is required to have at least 2 years’ experience inspecting projects of similar complexity and with training related to the work to be inspected (FP-14). A tester is required to have at least one year’s experience in the type of sampling and testing required, with one of the following for the type of sampling and testing performed: • NICET Level II certification in highway material or equivalent state or industry certification; • Certification by a regional certification program, such as Western Alliance for Quality Trans- portation Construction (WAQTC), Northeast Transportation Technician Certification Program (NETTCP), Southeast Task Force for Technician Training and Qualification (STFTTQ), or Multi-Regional Training and Certification (M-TRAC); or • At least one year of employment by an AASHTO-accredited laboratory performing equiva- lent sampling and testing (FP-14). QC Procedures This portion of a QCP is challenging to develop because the process-control procedure evolves over time. For execution of work, the QC procedures describe the inspection, testing, and other activities to be performed for each phase of work, including preparatory, start-up, and production phases. Preparatory Phase FP-14 requires the contractor to hold a meeting before starting each work category. The meet- ing invitees will include the project superintendent, work foreman, contracting officer, QCM, and appropriate subcontractors, and will discuss the following topics: • Contract requirements for the work, including acceptance procedures, schedule, and con- trol strip; • Process and equipment for constructing the work; and • Plan for inspection, PC, testing, measuring, and reporting the work. Additionally, the contractor should complete the following items in the preparatory phase: • Reviewing and coordinating certifications, submittals, plans, drawings, and permits; • Verifying the capabilities of equipment, material, and personnel, and providing training as necessary; • Establishing a detailed testing schedule based on the production schedule; • Ensuring preparatory testing and inspection is accomplished; and • Reviewing accuracy of the surveying and staking.

24 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications Start-Up Phase The main purpose of this phase is to inspect, test, and report start-up work according to the QCP and ensure the work conforms to the contract. FP-14 indicates that a start-up meeting including the project superintendent, inspectors, testers, contracting officer, and QCM will be held to discuss the following topics: • Reviewing the contract, the construction processes, and the inspection, testing, and reporting requirements with the personnel performing the work; and • Explaining procedures that will be followed if defective work is identified. Production Phase This phase includes the following activities: • Inspect, test, and report according to the QCP and evaluate the acceptability of the work produced; • Identify and correct deficiencies; and • Request owner inspection and acceptance. For sampling and testing, the quality characteristics, test procedures, and inspection activities related to early indications of PC should be stipulated, and decisions will depend on the type of operation for which the QCP is being developed (Burati et al. 2003). It is noted that a testing fre- quency must be established to create a balance with the number of tests performed. The state DOT and contractor may use increased testing frequencies initially and then reduce the frequency as the operation is in control. FP-14 requires that the QC procedure in a QCP list the material to be tested by: • Pay item; • Applicable requirements of the sampling, testing, and acceptance requirements tables; • Persons responsible for performing the sampling and testing; • Laboratory-testing facilities to be used for PC and project testing; and • Proposed reporting formats. For each category and phase of the operation, FLH showed that the QC plan should address the following questions (2009): • Who will be responsible for QC during the operation? • What will that person do to ensure contract compliance? • Where will these activities be performed? • When will these activities be performed? • How will inspections be performed? Records and Documentation The purpose of this portion of a QCP is to describe the reporting format for inspection, testing, certification, and daily reports. The contractor is responsible for obtaining, reviewing, and verifying certifications for work and submitting certifications when required. FP-14 indicates that contractors submit written QC and construction-operation reports according to the QCP. The reports document meetings; work locations; labor and equipment used, including actual hours worked; testing and measurement activities; inspection results; defi- ciencies observed; corrective actions taken; and process changes. Additionally, control charts are used to (1) document variability of the process, (2) identify production and equipment problems, and (3) identify actions to improve processes or quality. However, it is important to note that documentation should be the minimum necessary to demonstrate that the contractor is pro- ducing work and using materials and equipment of acceptable quality.

Literature Review 25   Review of Quality Control Plans The QCP is typically reviewed by state DOTs before any construction work can begin. The QCP is found to conform to the contract requirements or returned for corrections. Specifi- cally, FLH indicated that when evaluating a QCP, the evaluator must consider the following questions (2009): • Does the plan address each category of work? • For each category, does it address the preparatory, start-up, and production phases? • For each category and phase, does it address the who, what, where, when, and how questions presented in the QC procedures? QCPs may be evaluated as conditional acceptance for partial plans. The conditional accep- tance of a QCP often involves the plan submitted with good faith but missing numerous amounts of key information. The conditionally accepted QCP may allow work to begin with the condition that the contractor will supplement the plan with the missing information within a specific time frame. The conditional acceptance is typically appropriate if the work deficiencies in the plan are not scheduled to commence for several weeks or months (FLH 2009). The partial QCP often involves subcontractors or suppliers at later phases of construction that have not been arranged at the time the contractor is ready to begin work on the initial phases. For this type of QCP, the acceptance letter should state that the contractor may only begin work that is covered by the partial plan, and the agency will not perform QA, accept, or pay for work not covered by the plan (FLH 2009). When contractors provide the QCP with little or no useful information related to the contrac- tor’s quality process, the QCP should not be accepted. To reject the QCP, state DOTs should specify the major reasons for the rejection in the rejection letter (FLH 2009). Additionally, the work related to the rejected QCP should not begin until an acceptable plan is submitted. Sample Industry Quality Control Plans The QC plan should minimize any parroting or paraphrasing of requirements in the contract and should avoid simply promising to comply with the contract. These kinds of statements and assurances add little value. The QC plan must go beyond the contract requirements and address the contractor’s organizational process for consistently delivering those requirements (FLH 2009). Chronic deficient work is evidence that the QC plan is not effective, and improvements to the plan should be required. Likewise, when the agency is compelled to increase its inspection levels to compensate for poor contractor quality control, that also is evidence that the QC plan is not effective (FLH 2009). Industry QCPs vary substantially among construction companies. Because specific company QCPs cannot be discussed in the synthesis report, this section briefly describes three sample templates/guidance for developing and implementing QCPs: (1) construction QCP templates

26 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications developed by the U.S. Army Corps of Engineers (USACE); (2) QC guidance from the National Ready Mixed Concrete Association (NRMCA); and (3) a model QCP prepared by NETTCP. USACE Construction QCP Guidance The contractor QCP, a foundation of quality work, is an outline of the planned QC proce- dures. As a result, the contractor must consider fully the specific contract requirements and special factors for a given project when establishing a QC plan. It is critical that the QCM is the author or coauthor of the QCP to ensure that all quality requirements contained in the contract are included and that the QCM is thoroughly familiar with the plan (USACE 2015). The USACE requires that a contractor QCP be developed and submitted. The USACE pro- vides two templates for a QCP: traditional DBB-construction and DB-construction QC templates. The QCP template for DB projects has additional components that are not required to be contained within a QCP for DBB projects. Both QCP templates describe the process for creating an effective, efficient, and auditable quality-management system that includes the process and procedure to perform QC tasks of activities in all phases of a project. Table 2 summarizes the outline of QCPs for both DBB and DB projects. The detailed instructions of each section can be found in the USACE templates (USACE 2021). NRMCA Guidelines for Quality Manual for Ready-Mixed Concrete Companies NRMCA is a leading industry advocate working to expand and improve the ready-mixed con- crete industry. In 2008, NRMCA approved the guidelines for a quality manual for ready-mixed concrete companies. The guideline provides the structured development of a quality manual that documents the process to ensure quality of the company’s products and services (NRMCA 2008). NRMCA noted that the term QC plan is used within the context of the quality manual as the overview document to describe the company quality-management system. QC plan template for DBB projects QC plan template for DB projects • Master Table of Contents • Acronyms and Abbreviations • Section A: Quality Control Organization • Section B: Project Staff Qualifications • Section C: Appointment Letters • Section D: Submittal Procedures • Section E: Testing Procedures • Section F: Procedures for Performing the Three Phases of Quality Control • Section G: Procedures for Tracking Construction Deficiencies • Section H: Reporting Procedures • Section I: Definable Features of Work • Master Table of Contents • Contract QC Plan Cross-Reference Table • Acronyms and Abbreviations • Section A: Quality Control Organization • Section B: Project Staff Qualifications • Section C: Duties and Responsibilities • Section D: Appointment Letter • Section E: Definable Features of Work • Section F: Submittal Procedures • Section G: Testing Procedures • Section H: Deficiencies • Section I: Three Phases of Quality Control • Section J: Documentation • Section K: Completion Inspection Procedures • Section L: Training and Certification Logs Table 2. Outline of USACE QCPs for DBB and DB projects (USACE 2021).

Literature Review 27   The NRMCA guideline was developed based on 15 sections in accordance with the primary outlines in ISO 9000 certification for quality systems, along with appendices. Table 3 summa- rizes the outline of the NRMCA guideline quality manual for ready-mixed concrete companies. The detailed instructions of each section, along with the sample quality manual, can be found at the NRMCA (2008). NRMCA noted that this guideline serves as a minimum standard to support the qualifications and credibility for ready-mixed concrete companies. In addition, the guideline can be used as “a good outline for all ready mixed concrete companies desiring to progress their individual quality initiatives and establish a written quality plan endorsed and supported by the executive management with defined responsibilities for those defined initiatives” (NRMCA 2008). NETTCP Model QCP The model QCP prepared by NETTCP provides a generic tool that includes a recommended format of 10 separate sections, plus appendices, to help contractors develop complete and useful QCPs. Each section addresses major QCP items. The 10 sections of the NETTCP model QCP include: • Terms and Definitions (optional); • Scope and Applicable Specifications; • Quality Control Organization; • Quality Control Laboratories; • Materials Control; • Quality Control Sampling and Testing; • Production Facilities; • Field Operations; • Acceptance of Work (optional); • Other Relevant Contractor QC Plans; and • Appendices. NETTCP noted that the level of detailed information in any QCP varies depending on the size and complexity of the project (NETTCP 2009). NETTCP provided an example of a completed earthwork QC plan for a fictitious construction project. A detailed discussion of this completed earthwork QC plan is available at https://www.nettcp.com/ or in Appendix B, “Quality Assurance Resource,” of FHWA (2004b). Based on the NETTCP model QCP, Cavalline et al. recently developed a model QCP for a fictitious concrete-paving project, which includes • Introduction • Quality Management System • Management Responsibility • Customer Focus • Human Resources • Facilities, Plant(s), and Equipment • Materials Management • Purchasing • Order Processing and Dispatching Procedures • Concrete Production • Concrete Testing • Concrete Delivery and Site Control • Concrete Troubleshooting • Measurement, Analysis, and Improvement • Concrete Mixture Development or Selection • Appendices Table 3. Outline of NRMCA guidelines for ready-mixed concrete companies.

28 Agency Use of Quality Control Plans for Administering Quality Assurance Specifications 3 divisions: Earthwork (Division 2), Concrete Pavements and Shoulders (Division 7) and Materials (Division 10) (2021). It is noted that the information presented in the model QCP needs to be modified to meet the needs of the project, the requirements of the agency, and the preferences of the contractor. A detailed discussion of the model QCP for a fictitious concrete- paving project can be found in Appendix D, “Model QC Plan,” from Cavalline et al. (2021). Summary The literature review results presented in this chapter document the most relevant topics of QCPs and QA programs. It provides key information for understanding the state of prac- tice of QCPs used by state DOTs for administering QA specifications. The key concepts of QA approaches to various project-delivery methods, requirements of contractors regarding QCPs, construction quality and inspection, the review and acceptance process of QCPs, and the use of contractor’s quality data in the acceptance decision are discussed in detail. The literature review results presented in this chapter set the basis for the survey and case example protocols applied in this synthesis. This chapter found that the agency-dominated system is mainly responsible for quality man- agement for traditional DBB or CM/GC projects. Under DB or P3 agreements, the responsibility for quality management is shared to varying degrees between the contractor and the state DOT. However, the six core elements of a QA program—contractor QC, agency acceptance, IA, dispute resolution, personnel qualification, and laboratory accreditation—apply regardless of project- delivery methods. The purpose of QCPs is to provide a framework or procedures to measure the quality characteristics and inspect construction activities when corrective actions can be taken to prevent nonconforming materials from being incorporated into the project. Although many components of QC can be included in the contract, there is no one-size-fits-all approach to developing QCPs. A QCP describes how the personnel and processes of an individual con- tractor will function to provide PC for delivering the required quality. An effective QCP does not depend on the oversight and interaction of agency inspectors to control quality. The QCP is typically reviewed by state DOTs before any construction work can begin. The review process often involves evaluating the contractor plan associated with each category of work, along with preparatory, start-up, and production phases. The QCP should avoid paraphrasing of require- ments or simply promising to comply with the contract. Finally, the use of contractor’s data in the agency acceptance decision requires a higher level of oversight of the QCPs related to QC sampling and testing.

For years, state departments of transportation (DOTs) were solely responsible for quality control (QC) and performed testing and inspection to verify construction quality. However, since the 1970s, many state DOTs have transferred the responsibility for QC processes of their highway-construction projects to contractors.

The TRB National Cooperative Highway Research Program's NCHRP Synthesis 590: Agency Use of Quality Control Plans for Administering Quality Assurance Specifications identifies and documents the various QC requirements used by state DOTs.

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A systematic literature review of imperfect quality items: challenges, opportunities, and insights with reference to SDGs

• S.I. : OR for Sustainability in Supply Chain Management
• Published: 20 June 2024

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• Prerna Gautam   ORCID: orcid.org/0000-0003-0482-3664 1 ,
• Sumit Maheshwari   ORCID: orcid.org/0000-0003-4771-6797 2 , 3 ,
• Ahmad Hasan   ORCID: orcid.org/0000-0001-6241-2287 4 &
• Chandra K. Jaggi   ORCID: orcid.org/0000-0001-6179-8376 4  

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Every business sector has inventory problems whether they are realized or not. The occurrence of imperfect quality items (IQI) in the inventory is obvious and cannot be overlooked. As mismanagement of these items may end up in waste emancipation and harmful environmental impacts. Copious work has been done in the area of inventory modeling for IQI with varying demand patterns which calls for a systematic review framework so as to assist the researchers and professionals with the direction of flow of the current and existing research. The present Systematic Literature Review (SLR) studies the inventory models with varying demand patterns under the presence of IQI. This study considered 107 peer-reviewed articles for the SLR obtained after a detailed study of 782 articles through the Web of Science database. VOSviewer has been used for the network analysis and visualization. The software provide the insights to identify and analyze the linkage between the considered problem for the bibliometric analysis and the relationship between the authors, keywords, countries etc. The insights are presented as to how the management of IQI can be a benchmark for an organization and contribute to several Sustainable Development Goals (SDGs). The time span for this study is from 2010 to 2024 * (up to 29 February).

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Systematic Literature Reviews in Sustainable Supply Chain—SSC: A Tertiary Study

A Systematic Literature Review on Sustainability and Disruptions in Supply Chains

Data science and big data analytics: a systematic review of methodologies used in the supply chain and logistics research

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The authors confirm that the data supporting the findings of this study are available within the article. Derived data supporting the findings of this study are available from the corresponding author [[email protected]] on request.

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Gautam, P., Maheshwari, S., Hasan, A. et al. A systematic literature review of imperfect quality items: challenges, opportunities, and insights with reference to SDGs. Ann Oper Res (2024). https://doi.org/10.1007/s10479-024-06084-4

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• Nyaga Fred , I. O. Temkin
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• Closing the gap on healthcare quality for equity-deserving groups: a scoping review of equity-focused quality improvement interventions in medicine
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• http://orcid.org/0000-0001-6066-9548 Jane Jomy 1 ,
• Ke Xin Lin 1 ,
• Ryan S Huang 1 ,
• Alisia Chen 1 ,
• Aleena Malik 1 ,
• Michelle Hwang 2 ,
• Tahara D Bhate 1 , 3 ,
• Nazia Sharfuddin 1 , 2
• 1 Temerty Faculty of Medicine , University of Toronto , Toronto , Ontario , Canada
• 2 Trillium Health Partners , Mississauga , Ontario , Canada
• 3 University Health Network , Toronto , Ontario , Canada
• Correspondence to Jane Jomy, University of Toronto Temerty Faculty of Medicine, Toronto, ON M5S 1A8, Canada; jane.jomy{at}mail.utoronto.ca

Introduction Quality improvement (QI) efforts are critical to promoting health equity and mitigating disparities in healthcare outcomes. Equity-focused QI (EF-QI) interventions address the unique needs of equity-deserving groups and the root causes of disparities. This scoping review aims to identify themes from EF-QI interventions that improve the health of equity-deserving groups, to serve as a resource for researchers embarking on QI.

Methods In adherence with Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines, several healthcare and medical databases were systematically searched from inception to December 2022. Primary studies that report results from EF-QI interventions in healthcare were included. Reviewers conducted screening and data extraction using Covidence. Inductive thematic analysis using NVivo identified key barriers to inform future EF-QI interventions.

Results Of 5,330 titles and abstracts screened, 36 articles were eligible for inclusion. They reported on EF-QI interventions across eight medical disciplines: primary care, obstetrics, psychiatry, paediatrics, oncology, cardiology, neurology and respirology. The most common focus was racialised communities (15/36; 42%). Barriers to EF-QI interventions included those at the provider level (training and supervision, time constraints) and institution level (funding and partnerships, infrastructure). The last theme critical to EF-QI interventions is sustainability. Only six (17%) interventions actively involved patient partners.

Discussion EF-QI interventions can be an effective tool for promoting health equity, but face numerous barriers to success. It is unclear whether the demonstrated barriers are intrinsic to the equity focus of the projects or can be generalised to all QI work. Researchers embarking on EF-QI work should engage patients, in addition to hospital and clinic leadership in the design process to secure funding and institutional support, improving sustainability. To the best of our knowledge, no review has synthesised the results of EF-QI interventions in healthcare. Further studies of EF-QI champions are required to better understand the barriers and how to overcome them.

• Healthcare quality improvement
• Outcome Assessment, Health Care
• Quality measurement

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Contributors JJ has full access to all study data and takes full responsibility for the integrity of the data and the accuracy of the data analysis. JJ is the guarantor of this work. Concept and design: JJ, KXL, NS. Acquisition of data: JJ, KXL, RSH, AC, AM. Analysis or interpretation of data: JJ, KXL. Critical review of the manuscript for important intellectual content: JJ, KXL, NS, TDB. Administrative, technical or material support: JJ, MH. Supervision: NS, TDB.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

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Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Examining the response to covid-19 in logistics and supply chain processes: insights from a state-of-the-art literature review and case study analysis.

1. Introduction

• RQ1 (scientific): How have researchers studied the impact of COVID-19 on logistics and supply chain processes? Which industrial sectors were mostly studied and why? Which additional topics can be related to COVID-19 and logistics/supply chain?
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• Industrial sector: aerospace, agri-food, apparel, automotive, construction, e-commerce, electronic, energy, fast-moving consumer goods, food, healthcare, logistics, manufacturing and service.
• Data collection method: questionnaire/interview, third-party sources or case study. This classification represents the method used by the authors to collect the data useful to their study.
• Research method: statistical, decision-making, simulation, empirical, literature review or economic. This category describes the tool used by the authors to conduct the study and reach the related goals.
• Specific method, e.g., descriptive statistics, structural equation modeling (SEM), multi-criteria decision making (MCDM), etc.; this feature describes more accurately the type of work carried out by the authors and the tools used.
• Country: it reflects the geographical area in which the study was carried out, in terms, for instance, of the country in which a sample of people has been interviewed or where empirical data were collected, or where the simulation was set. This method of classification, although more elaborated, was preferred over traditional approaches, in which the country of the study is defined based merely on the affiliation of the first author of the paper, because the exact knowledge of the country in which the study was carried out is, for sure, a more representative source of information about the research. This is true in general, but it is even more important for this subject matter, as the management of the COVID-19 pandemic was made on a country or regional basis, with significant differences from country to country; knowing the exact location of the study helps in better interpreting the research outcomes. Possible entries in this field also include “multiple countries” and “not specified”, with the obvious meanings of the terms.

2.1.4. Cross-Analyses

2.1.5. interrelated aspects, 2.2. case study, 2.2.1. data collection.

• Economic data: some key economic data were retrieved from the company’s balance sheet, from 2019 up to the latest available document, which refers to 2022.
• Organizational data: these data describe changes in the operational, decision-making and business structure of the company in terms, e.g., of number of employees hired, number of drivers, etc.
• The related data were collected and elaborated between July and September 2023.

2.2.2. Survey Phase

2.2.3. analysis and summary, 3. results—systematic literature review, 3.1. descriptive statistics, 3.2. common classification fields, 3.2.1. macro theme, 3.2.2. industrial sector, 3.2.3. data collection method, 3.2.4. research method, 3.2.5. country, 3.3. cross-analyses, 3.3.1. macro theme vs. industrial sector, 3.3.2. research method vs. macro theme, 3.4. interrelated aspects, 4. results—case study, 4.1. company overview, 4.2. pre-covid-19 period, 4.3. covid-19 period, 4.4. post-covid-19 period, 4.5. analysis and summary.

• Strengths : at present, Company A benefits from a robust network of relationships with customers and suppliers (e.g., drivers), which was leveraged during the pandemic period to provide a rapid response to the increased request by the consumers. The company has also leveraged the usage of digital technologies, which made logistics activities more efficient and, again, allowed the company to respond to consumer demand in the pandemic period.
• Weaknesses : Company A has suffered from low economic results, in particular in the post-COVID-19 period, mainly due to the high production costs. Efforts must be made by the company to reduce expenses. At the same time, however, the service level, in terms of delivery lead time or on-time delivery, should be safeguarded.
• Opportunities : the growth of e-commerce, experienced in the COVID-19 period but expected to last over time, creates opportunities for increasing the volume of items handled by Company A. Indeed, the survey phase demonstrated that the company’s consumers have shifted towards the usage of online sales; hence, the company could consider investing in this area to increase its market share. By leveraging the e-commerce logistics and diversifying service, expansions could also be possible at an international level. Even if the company has already embraced the implementation of digital technologies, some emerging technologies (e.g., drones or advanced traceability systems) could also be introduced for further improving the logistics efficiency. Finally, sustainability is another opportunity to be leveraged, because of the current push towards the adoption of environmental-friendly logistics solutions. Examples of those solutions include a reduction in CO 2 emissions, and the usage of electric vehicles or zero-impact materials.
• Threats : the growth of e-commerce can be seen as an opportunity, but because many logistics companies have already entered this field, the sector is characterized by very high competition, which could limit the market share of Company A; this could instead be seen as a threat needing to be properly managed. Another threat comes from the increased cost of fuel, which, for sure, for a logistics company plays an important role in determining the cost of the transport activities (also, having previously observed that the company suffered from a limited revenue in recent years). This factor could further push towards the adoption of environmentally friendly transport modes (e.g., electric vehicles), which have been previously mentioned as an opportunity for leveraging in the logistics sector.

5. Conclusions

5.1. answer to the research questions, 5.2. scientific and practical implications, 5.3. suggestions for future research directions, author contributions, institutional review board statement, informed consent statement, data availability statement, conflicts of interest.

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Monferdini, L.; Bottani, E. Examining the Response to COVID-19 in Logistics and Supply Chain Processes: Insights from a State-of-the-Art Literature Review and Case Study Analysis. Appl. Sci. 2024 , 14 , 5317. https://doi.org/10.3390/app14125317

Monferdini L, Bottani E. Examining the Response to COVID-19 in Logistics and Supply Chain Processes: Insights from a State-of-the-Art Literature Review and Case Study Analysis. Applied Sciences . 2024; 14(12):5317. https://doi.org/10.3390/app14125317

Monferdini, Laura, and Eleonora Bottani. 2024. "Examining the Response to COVID-19 in Logistics and Supply Chain Processes: Insights from a State-of-the-Art Literature Review and Case Study Analysis" Applied Sciences 14, no. 12: 5317. https://doi.org/10.3390/app14125317

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• Volume 14, Issue 6
• Eyelid sebaceous gland carcinoma: a protocol for a systematic review and meta-analysis of clinicopathological studies of prevalence
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• http://orcid.org/0000-0003-1181-1215 Mikkel Straarup Thagaard 1 , 2 , 3 , 4 ,
• http://orcid.org/0000-0002-9147-6930 Stine Dahl Vest 3 , 4 ,
• http://orcid.org/0000-0001-5906-7670 Steffen Heegaard 3 , 4 ,
• http://orcid.org/0000-0002-0516-9361 Niels Marcussen 1 , 2
• 1 Department of Pathology , Sygehus Sønderjylland , Aabenraa , Denmark
• 2 Institute of Regional Health Research , University of Southern Denmark , Odense , Denmark
• 3 Department of Ophthalmology , Copenhagen University Hospital - Rigshospitalet , Copenhagen , Denmark
• 4 Department of Pathology , Copenhagen University Hospital - Rigshospitalet , Copenhagen , Denmark
• Correspondence to Dr Mikkel Straarup Thagaard; mikkel.thagaard{at}rsyd.dk

Introduction Sebaceous gland carcinoma (SGC) of the eyelid is an aggressive tumour with the ability to metastasise and an increased morbidity. Controversies regarding the epidemiology of this malignant eyelid tumour is widespread in the scientific literature. Western reports repeatedly describes eyelid SGC as a rare occurring tumour in general, accounting for 1%–3% of all eyelid tumours, however studies from Asia have uncovered a higher frequency of eyelid SGC including 54% of all eyelid tumours in Japan, and 43%–56% in India. We wish to retrieve observational data of eyelid SGC prevalence in proportion to total eyelid tumours, from pathological studies published worldwide to resolve this controversy.

Methods and analysis We will search Ovid Medline, EMBASE, Cochrane Central Register of Controlled Trials, Scopus and Google Scholar to identify published reports on eyelid SGC prevalence proportions, aiming to clarify the incidence of the tumour. We will include observational clinicopathological studies reporting prevalence with confirmed histopathology. No limitations on publication date or language will be applied. Data from the individual studies and study quality will be extracted by two individual reviewers. Study quality will be assessed using the JBI Critical Appraisal Instrument for Studies Reporting Prevalence Data. Raw proportions will be transformed and pooled using a random effects model for meta-analysis. And subgroup analysis according to geography will be performed. If data are deemed unsuitable for a meta-analysis, a narrative synthesis will be presented. We will judge the certainty of evidence and present whether this has an overall effect on the results. The results may shed light on a long-standing academic disparity of the scientific literature.

Ethics and dissemination This systematic review does not require ethical approval. The results of this proposed review will be the subject to a publication in an international peer-reviewed journal within the ophthalmic or pathological specialty.

PROSPERO registration number CRD42023487141.

• ophthalmology
• oculoplastics
• observational study
• epidemiology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2024-086213

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STRENGTHS AND LIMITATIONS OF THIS STUDY

The quality of this study and protocol has been adjusted to align with studies based on observational data.

The retrieved data will be stratified according to geography to investigate on worldwide differences in reports.

A clear and reproducible electronic search strategy has been designed for each of the included databases including additional search strategies for existing grey literature.

Possible publications only indexed in Asia-specific databases may limit this study; however, due to a lack of search expertise within these, we chose to omit such.

We will assess the quality of the included studies using a recognised tool designed for use in prevalence studies.

Introduction

Malignant eyelid neoplasms are among the most common non-melanoma cancers of the skin. They are pathologically classified according to the histological tissue from which they derive. Sebaceous gland carcinomas (SGC) originate from the sebaceous glands in the skin, and on the eyelids, they stem from the Meibomian and Zeis glands associated with the eyelashes. In contrast to basal cell carcinoma of the eyelids, eyelid SGC displays an aggressive local behaviour, 1 with metastasis to the local lymph nodes reported in one study to be 21%. 2 The same study ultimately reported the need for orbital exenteration in 14% and a mortality of 6% due to the growth of the tumour.

Controversies regarding the epidemiology of this malignant eyelid tumour is widespread in the scientific literature. Pathological observational studies in Western countries report eyelid SGC to account for <1%–3% of all malignant eyelid neoplasms. 3–5 As a result, the scientific and academic literature repeatedly describes eyelid SGC as a rare occurring tumour. 2 6 However, recent observational studies from Asia on pathological specimens have uncovered a much higher frequency of eyelid SGC in this part of the world. These include 8% in Taiwan, 7 30% in the Phillipines 8 and 54% in Japan. 9 Recent studies from India also report observations of 43%–56% 10 11 and are among the highest in the world. Based on these findings and the large populations of these countries, we identified the need for a systematic review and analysis of the published literature worldwide on observations on eyelid SGC prevalence. We hypothesise that eyelid SGC is more prevalent on a worldwide scale than the previous academic consensus and common phrasing in the literature suggests. The aim of this proposed systematic review is to retrieve and asses reports from pathological studies on observational data of eyelid SGC prevalence in proportion to total eyelid tumours published worldwide. Additionally, we aim to report the geographical variances of these reports.

Methods and analysis

This protocol for a systematic review and meta-analysis has been approved and registered by PROSPERO with the registration number CRD42023487141.

This protocol was reported using the guidelines of the Meta-analysis of Observational Studies in Epidemiology 12 13 and in addition was elaborated using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Protocols 14 15 where applicable, as the PRISMA statements are focused on the reviewing of interventional studies and not observational studies. 13 14 Any methodological changes will be published in the final systematic review. We will follow the recommendations of the JBI Manual for Systematic Reviews of Prevalence and Incidence. 16

Eligibility criteria

We will consider the following study designs and Condition, Context and Population for observational studies criteria for inclusion.

Study designs

We will include observational studies on eyelid neoplasms, encompassing case-control studies, cohort studies and cross-sectional studies. Both prospective and retroperspective studies will be included. No language barriers will be applied.

Eyelid SGC with a confirmed histopathological diagnosis.

Eyelid neoplasms with a confirmed histopathological diagnosis after surgical removal. Studies on all ocular neoplasms will be included if eyelid SGC can be determined as a prevalence proportion of the estimated total cases.

Human patients. No age limits or specifications regarding gender, race or geographic region.

Reporting of outcomes

Relating to the existing literature in the above, we will include studies that report eyelid SGC as part of an observational cohort of total malignant eyelid neoplasms. Any measurement of sample size such as a prevalence proportion or percentage will be analysed. We will also analyse reported epidemiological estimates such as incidence or epidemiological prevalence.

Patients and public involvement

We have not involved patients or members of the public in planning this proposed systematic review.

Search methods for identification of studies

Electronic searches.

We have included an information specialist in the form of a health librarian to design a search query for each of the following database in order to retrieve any relevant studies on the subject. There will be no restrictions on language or year of publication.

The full search query for each database is listed in the online supplemental material .

Supplemental material

We will search Ovid Medline ( online supplemental material 1 ), Scopus ( online supplemental material 2 ), EMBASE ( online supplemental material 3 ), Cochrane Central Register of Controlled Trials ( online supplemental material 4 ) and Google Scholar to identify published reports on eyelid SGC prevalence proportions.

Other searches

We will perform manual forwards and backwards citation searches of the included studies as well as searches on the first and last author of the included studies. We will contact experts on ocular pathology in order to inquire on possible non-published reports.

Screening of the retrieved studies

The retrieved records of the search will be uploaded into Covidence. Following removal of duplicates, two authors with previous experience within medical research and systematic reviews (MST and SDV) will independently screen all retrieved titles and abstracts based on the listed eligibility criteria. The authors will secure a translation of the titles and abstract of non-English articles. The same authors will then independently assess full text of the remaining studies in order to determine potential eligible studies. Full-text translation of any possible non-English articles will also be secured. Any disagreements or conflicts will be resolved via discussion. A flow chart describing the inclusion of the final studies and including reasons for exclusion will be presented.

Data collection and analysis

Data extraction and management.

Two review authors (MST and SDV) will independently extract basic characteristics (article ID, article title, author name, publication year, study design, country(ies) where the study is based, sample size), exposure (surgery and description if any), outcome (histopathological diagnosis, diagnostic criteria, proportion, incidence, prevalence) and study quality assessment into standardised forms using Covidence.

Assessments of study quality and risk of bias in the included studies

Currently, no standardised tool for the assessment of risk of bias in observational prevalence studies in pathological observational studies exists. Despite this, two review authors (MST and SDV) will independently and thoroughly examine the available data to consider any potential risk of bias. The risk of bias of the included studies will be evaluated and presented using an adjusted version of the JBI Critical Appraisal Checklist for Studies Reporting Prevalence Data, 17 which accommodates the inclusion of pathological studies. We will investigate each for relevant information such as, but not limited to, whether trained or specialised pathologists, or artificial intelligence tools were involved in the diagnosis. Special attention will be given to whether pathological revisions of the samples have been performed and if inter-rater reliability statistic such as Cohen’s κ-coefficient has been applied. The quality of the included studies will be appraised accordingly.

Dealing with missing data

In the case of missing, insufficient or otherwise unclear data, we will contact the study authors. We will wait 2 weeks for the authors to reply. If no reply is received, we will consider the impact of the missing data on the overall quality of the study.

Statistical methods and assessment of study heterogeneity including possible publication bias

We will apply the generalised linear model and the Freeman-Tukey double arcsine transformation to raw proportions to present the eyelid SGC prevalence proportion with 95% CIs. 18 19 We will perform a sensitivity analysis between the two models to estimate any uncertainty of the transformation. Pooled prevalence proportions will also be computed.

We will evaluate heterogeneity, both clinical and statistical, by examining the patient characteristics and outcomes. By performing an I 2 statistic evaluation and evaluating forest plots, we will assess heterogeneity between study variance as opposed to sampling variance of the included studies. The weight of the individual studies will also be evaluated using the random effects model.

As our review focuses on observational prevalence data on all eyelid cancer subtypes, which includes the target condition eyelid SGC, a publication bias analysis (eg, funnel plot) has been deemed inappropriate. This is because the inclusion of the target condition will not directly affect publication of articles.

Data synthesis including subgroup analysis and certainty of evidence

We will provide a descriptive, qualitative synthesis of the included studies and their results. We will consider one subgroup analysis: geographical region, for example, Europe, Asia. If a significant difference in the appraisal of study quality is found, we will perform subgroup analysis according to these findings. If a meta-analysis based on the included studies proves impossible or irrelevant, we will present the results in the form of a narrative synthesis.

Rating of the evidence within systematic reviews of interventional studies is performed using the Grading of Recommendations, Assessment, Development and Evaluations standard. In our review, we will evaluate the certainty of evidence in a manner applicable to observational studies including, but not limited to, the domains such as risk of bias, inconsistency, imprecision and indirectness to observational studies. For instance, we will assess the extent to which the findings match the expectations based on the statistics from the included studies. Finally, we will judge whether these results may alter the overall level of certainty of the body of evidence.

Ethics and dissemination

Ethical approval is not required to conduct a systematic review of the literature or meta-analysis since it does not involve recruiting patients or handling patient data. We expect that the results from this systematic review will be published in a peer-reviewed scientific journal.

To our knowledge, this systematic review will be the first study to systematically retrieve and investigate on worldwide observational prevalences of eyelid SGC.

Eyelid SGC is a highly malignant skin cancer with the ability to metastasise, resulting in significant morbidity and potentially death. 1 2 6 20 Due to the malignancy of the tumour, an aggressive surgical approach is the preferred option. However, the diagnosis tends to be elusive due to the tumour’s ability to mimic benign neoplasms such as chalazion or benign eyelid cysts. 1 10 Furthermore, the final diagnosis of eyelid SGC often displays a significant diagnostic delay, 6 which may be exacerbated by the continuous description in the academic literature as being very rare as previously supported by Western studies. We intend on this systematic review to shed light on whether the worldwide occurrence of eyelid SGC may be much higher than previously described and with significant geographical variations. As opposed to systematic reviews of interventional studies, the current systematic review protocol accommodates the specific requirements of observational studies of prevalence. We will follow a rigorous methodology, including publication of this study protocol, to ensure the highest scientific standards, transparency and reproducibility.

The results of this review may assist ophthalmologists, oculoplastic surgeons and eye healthcare providers worldwide in their diagnostic considerations, potentially resolving a long-standing discrepancy in the description of eyelid SGC prevalence within the academic literature.

Ethics statements

Patient consent for publication.

Not applicable.

Acknowledgments

The authors would like to thank Caroline Moos, University Hospital of Southern Denmark and David Ruben Tendl, Center for Evidenced Based Medicine Odense, University of Southern Denmark for general advice on systematic reviews. The authors would also like to thank Mette Brandt Eriksen, University of Southern Denmark for guidance on search strategy and query design, and Sofie Ronja Petersen, University Hospital of Southern Denmark, for advice regarding statistical methods.

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1
• Data supplement 2
• Data supplement 3
• Data supplement 4

Contributors MST conceptualised the proposal for a systematic review and wrote the original draft. MST and SDV performed preliminary investigations, including methodology, with the assistance of an academic health librarian and a health statistician. SH and NM supervised the process including reviewing and editing of the final paper. All authors have read and approved the final manuscript.

Funding This work was supported by the University Hospital of Southern Denmark (grant number 23/19509) and University of Southern Denmark.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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