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TQM: Total Quality Management

Total Quality Management

Total Quality Management

Notorious views on Quality

Quality, as generically defined, involves industry-specific standards for achieving product and/or service excellence. However, quality may encompass numerous dimensions with varying connotations depending on its sundry, industry-specific applications. Indeed, the linguistic ambiguity of “quality” with its assumed conflicting “multi-dimensional” definitions plausibly disrupts communication—articulating “a coherent strategic plan” for implementation. [i] Nevertheless, a non-exhaustive definition of differing quality perspectives might include, inter alia, the following descriptions:

Service Quality Dimensions

Generally, quality assumes even greater ambiguity for services than products given the greater diversity and subjective nature of attributes associated with them in various industries. Nonetheless, many service firms presumably use the following dimensions to measure quality service performance:

Differing Functional Perspectives on Quality

Differing quality perspectives tend to reflect functional differences in various organizations. These functions include supply chain management, engineering, operations, strategic management, marketing, finance/accounting, and human resources.

Three Spheres of Quality:


As aforementioned, quality connotatively assumes numerous definitions, not only within various industries but among different cultures manifest in the disparate geography, language, and/or economic/political conditions. In other words, quality may suggest industry differences from one to another, yet exhibit even further differences within even the same industry among different countries.

Moreover, quality presumably exudes greater globalized impact with technological proliferation, as international exposure perhaps increases such that nations may interdependently influence mutual trade relations exchanging information on quality standards.  For example, the U.S. may maintain stricter food guidelines to prevent spoliation than possibly other nations’ preservation regulations. Therefore, this globalizing influence to quality assumes a contingency theory—a concept which presupposes “no theory or method of business operation,” necessarily applies, “the same way in all instances.” [iv] If true, since no such universal quality standards exist to reasonably accommodate industry and/or cultural differences, variable quality definitions exist.

Assuming this conclusion, the various definitions of quality, whether industry-specific and/or culturally-influenced, may suggest a need for greater flexibility to accommodate differences. Hence, different quality standard definitions may enable greater flexibility in adapting to varying quality standards for mutually advantageous, sound, business practices. As an aspiring investment strategist/financial management professional, I may influence my organization to broaden its perspective from possibly perceiving functions in a controlled-vacuum. For instance, rather than isolating cost-savings “bottom-line,” my organization may consider a more cross-functional perspective that amalgamates all foregoing functions (supply chain management, engineering, operations, strategic management, marketing, finance/accounting, legal, human resources, etc.). Therefore, I may facilitate transparent correspondence—monitoring and participating in communications with all departments—investigating all options (domestically, internationally) such as to improve company operations on multiple fronts.

Additionally, with a flexible perspective, my organization may continually adapt to transitioning trends—differentiating from competitors with potentially profitable innovations in proprietary technology, listening always for continued improvements. By listening to all departments, I may readily mitigate unreasonable risks, with the collective information available from employees in each function. Moreover, this cross-functional integration may incentivize greater employee trust in the overall process, who might strive not merely to survive but thrive. Why? The discipline of considering various definitions assumes more listening, weighing perspectives proposed by all contributing members to improve operations. Consequently, this strategy gives voice to customers and employees alike in the common goal of seeking quality from multiple angles.

Furthermore, synchronizing cross functionality achieves competitive advantage by achieving economies of scale—extending operations to reduce costs. Ultimately, this utilitarian perspective—considering the totality of multi-cultural quality standard definitions within various industries—maximizes organizational performance from multiple vantage points. Thus, the organization plausibly ameliorates overall quality as elucidated from enhanced performance, generally synonymous with quality improvement.


The following luminaries remain responsible for influencing evolution in quality concepts over time:

Deming implies from the Law of Diminishing Returns that if improvement diminishes with continued investment past a certain threshold, than we may wish to reduce and/or re-prioritize investments for increased “continual improvement.” This particular view on quality impresses me because of its seeming universal application demonstrating how often after a certain threshold “less is more.” Why? Because Deming recognized that “quantity” may compromise “quality.” [viii]

Additionally, this concept interestingly dovetails with perhaps an almost equally universal concept implemented in my daily routine to maximize prioritization management, specifically, Pareto’s 80/20 principle. Pareto’s 80/20 principle inherently assumes the Law of Diminishing Marginal Returns vis-à-vis  producing more with less—that perhaps +/-80% of results plausibly stem from our +/- 20% most productive efforts. [ix] Pareto’s principle applies to the Law of Diminishing Marginal Returns because, generally, maximizing efficient returns,  +/80% gains—whether building knowledge, a business, money, etc.—presumably stem from earlier +/- 20% investment efforts, before becoming counterproductive past a certain threshold.  Therefore, Deming, reputedly, “the preeminent authority on quality management,” impressively distinguishes himself as a guru because he inculcates quality improvement—progress measured in improving a process—through prioritization management. [x]

Juran applies this principle specifically to quality in facilitating evolution of time/prioritization quality management. As aforementioned the 80/20 Principle, helps narrow focus to pertinent issues in a disciplined manner, discriminating between relevant and extraneous for enhanced efficiency. Juran refashioned Pareto’s 80/20 Principle to become a practical resource for quality-management implementation because it facilitates prioritization—separating important from unimportant.

Hence, Pareto’s 80/20 principle, if logically applied in moderation, may plausibly help me harness +/- 80% of energy into +/- 20% most relevant responsibilities. If true, Juran’s view, much like Deming, helps achieve more with less by again demonstrating the presumably inverse relationship between quantity and quality. Thus, Juran innovatively expands Pareto’s 80/20 into a seemingly impressive quality-management formula for economical gains. Its near-universal application—focusing on the fewest perceived most important issues to maximize desired gains—may help clarify objectives amid confusion and/or ambivalence.  Therefore, Juran’s contributions to evolving quality concepts—mitigating wastefulness by re-prioritizing investment (energy, effort, time, money, etc.)—commands respect. For these foregoing reasons, Juran’s 80/20 Principle as applied to quality management impresses me.

As evidenced, Covey adapts Deming’s quality management principles to the context of achieving interpersonal effectiveness. For example, these seven habits seemingly centralize in the common theme of “continual improvement” as Deming advocated for productive returns. By integrating improvement standards with interpersonal emotional intelligence and/or soft skills, Covey demonstrates his impressive originality, expanding quality standards into previously unchartered domains.  Thus, Covey innovatively instantiates the inherent value of people skills to leadership in elevating organizational quality standards, a perspective perhaps overlooked by other empirical studies. Therefore, this self-improvement aspect to Covey writings perhaps most impresses me about him, inexorably inspiring me with insatiable desire as a rapacious reader for his literature.

Moreover, Camp’s Benchmarking: The Search for Industry Best Practices That Lead to Superior Performance, seems like a perspicuous primer sufficient to incentivize intrigue, educating myself on information-sharing and performance enhancement. Therefore, Camp’s ability to defy societal standards with an informative guideline for improving performance demonstrates his quality evolvement contribution, which impressively encapsulates my learning interest.

Additionally, Shewhart influenced the development of continuous improvement processes as Plan-Do-Check-Act (PDCA). PDCA—an analytical, problem-solving system that tests functionality—enable engineers to identify process issues and remediate them for quality improvement. [xvii] Shewhart’s two contributions—control charts and PDCA—“influence the daily work of quality.” [xviii] That control charts and PDCA still operate nearly a century later command respect, demonstrating Shewhart’s monumental significance in evolving quality standards.  Therefore, Shewhart’s contributions impress me because he produced a historically viable, problem-solving system which requires critical-thinking—inferring issues and applying logic to scrutinize potential flaws.


Given the ubiquitous application of quality as aforementioned, with technology propagating its omnipresence, all business and healthcare professionals everywhere study quality to avoid incurring risks. Since quality seems progressively pervasive, business and healthcare professionals who perhaps overlook its influence risk harming others with negligence.

Quality standards tend to evolve relative with technological expansion. Technological expansion tends to assume greater demand for continuing education—upgrading technical skills in executing fiduciary responsibilities with professional competence. Why? Clients entrust professionals as fiduciaries—relationship based on trust—with responsibility of providing reasonable care. This fiduciary relationship holds particularly true with patients to medical personnel and doctors, whom they entrust as guardians of their lives.  In other words, healthcare practitioners, maintain a requisite responsibility to diagnose and/or ensure the general health of patients.

If “knowledge transfers quickly throughout and across organizations,” as inferred from technology precipitating a global impact, then the learning curve presumably steepens. [xix]  In other words, exponential information dissemination through technology may surpass the rate of knowledge acquisition. If true, professionals, especially medical personnel, as fiduciaries, become more susceptible to malpractice by not seeking continual improvement because the risk of limited knowledge may jeopardize lives, overlooking pertinent health problems. Today, professionals compete in a constant race of obsolescence, as technological advances potentially lead to antiquated systems and anachronistic standards. For example, the failure to incorporate contractual assurances (force majeure provisions to assume impracticability events, unforeseen natural disasters, and/or non-performance/default-risk frustration of purpose events), may cost companies profligate expense, and without any remedy against customers suing for non-delivery/product defects. Express and Implied Warranty of Fitness assurance for products also present pertinent issues for professionals with increased exposure to advanced equipment, and its potentially pernicious implications if technology malfunctions. Hence, increased technological reliance warrants demand for quality-control specialists and/or engineers to inspect devices as a prophylactic precaution against complications/malfunctions arising. Therefore, if professionals refuse to continue learning, refining their reasoning, assimilating new knowledge consistent with transitioning trends, they risk ossifying.

Thus, understanding quality becomes virtually indispensable, particularly in healthcare, to safeguard “avoidable deaths, underuse, overuse, or misuse of medicines and processes.” [xx] Quality healthcare treatment assumes the following:


As an aspiring investment analyst, understanding that while quality “may not safeguard companies from bad management”—e.g., Merrill Lynch Credit Corporation—employees in non-managerial positions can assume leadership roles to remediate problems. [xxii]  In class we emphasized the need for proper assertiveness and humility to question superiors about operations, so we may analytically understand its underpinnings. By familiarizing ourselves with company operations we attempt to protect a company from performance defects which may threaten viability by potentially predisposing reasonably foreseeable harm. We may also politely and responsibly challenge unethical practices, or a tenuous system inherent to flaws at employee/customer detriment. In other words, a non-manager, as myself, need not capitulate to the complacency of common custom, business as usual “bottom-lines,” if one perceives potentially dubious management processes.

This course’s emphasis on professional leadership—positively influencing company improvement by considering multiple quality perspectives—proved particularly helpful in reaffirming that non-managers may assert leadership roles to improve company operations. Therefore, that non-managers, regardless of position, may exercise genuine leadership—“influencing team progression toward attaining superordinate goals,” proves helpful because it motivates me to more assertively help my organization optimize its organizational operations. [xxiii]


Taguchi further diversifies the definition of quality to include both product and service impairments in a system he characterized as ideal quality. According to Taguchi, the product achieves ideal quality, if delivered as intended “throughout its projected life under reasonable operating conditions without harmful side effects.” [xxiv] Taguchi’s perspective eloquently encapsulates my view in the following ways:

These three areas demonstrate potential major losses to society as a company or entire industry associated with some particular product/service risks becoming insolvent. For example, consider Merrill Lynch Credit Corp. If Merrill—a former Malcolm Baldrige recipient previously accredited with distinguished quality standards—loses billions of dollars from aiding fraudulent transactions, and selling subprime mortgages with reason to infer significant default-risk from its low-credit affiliations, it not only disgraces quality standards but potentially risks discrediting the entire financial industry. Interestingly, not a single financial institution thereafter receive Baldrige recognition. Merrill became attributed to what many people find wrong with the financial industry, resurrecting Wall-Street stereotypes of greedy Gordon Gekko types and virulent “Vampire Squids” exploiting for avaricious gain. If true, an entire industry may suffer, and the heightened psychological perception of risk may further exacerbate losses, tightened government regulations, e.g., Dodd-Frank Acts, which may further hinder growth for many securities firms. If true, inhibited growth for securities firms may translate into general restricted economic growth since the economy may rely significantly on securities firms to maintain market competitiveness.

Therefore, one quality issue leading to reputational degradation may undermine society with massive losses, especially if one company’s bankruptcy substantially influences the overall economy.


As a leader in finance, someone generally concerned about “returning value to shareholders,” Joseph Juran’s, “the language of management is money,” represents my quality concept mantra. [xxv] Therefore, I become entrusted with implementing quality from the context of ensuring economic viability, which entails investigating and analyzing:

From these responsibilities, I shall consistently apply Deming’s Law of Diminishing Marginal Returns to, among other things:

Deming’s philosophy here may enable me to not over-exhaust my research while simultaneously understand why some companies may uneconomically invest beyond efficient points—inconsistent with “the ethic of continual improvement”—in mitigating unnecessary risks. By diversifying these risks, in time, as a fledgling financial analyst, I shall facilitate ethically and logically sound investment practices, maximizing returns for the assumed risk.


To implement and manage quality policies I shall implement Deming’s 14 Points for Management, applied as follows:


Financial organizations, such as mine, create cost-savings initiatives. They not only expose people to prudent-risk taking, which may help generate revenue if properly implemented through logical inductive/deductive reasoning. The critical-thinking skills and competencies cultivated in finance also help people to mitigate risks—differentiating competitiveness through diversification. These assets, pun intended, represent the basis of business—profit-maximization.

However, my financial organization, as with any financial organization, may improve quality by incorporating greater cross-functionality—considering how other functions—legal, marketing, technology, supply-chain management, etc.—to further mitigate risks. For example, greater mindfulness about conflicts of interests arising, fiduciary violations from adversely affecting clients and/or the company may help insulate liability. Thus, counsel may invaluable liability-prevention insight.

Additionally, greater cohesiveness with marketing strategists who analyze plausible consumer trends among companies in a particular economic environment may also strengthen investment forecasting accuracy. Listening to potential market concerns, analyzing company life cycles/maturity, etc., financial management may improve accuracy inferring trends among customers in maximizing efficient returns on investment. If true, greater cross-functionality may help financial organizations as mine generate even more revenue, and differentiate in competitiveness with expanded diversification.

Furthermore, the synchronized efforts may fuel economies of scale, as collaborative efforts coalesce in a common, collective purpose to curtail costs and expand operations.


Therefore, controls, audits, accreditation, and certifications serve the role of distinguishing from ordinary processes by evidencing superior quality through objective, evidence-based processes. [xxviii]


Successful organizations evidencing high levels of customer service seemed to universally share the following traits:

An organization moving through change might suggest the following factors to employees concerning design for manufacture:

Change represents “the magnitude of differences between products measured at different times.” [xxxi] Assuming this definition, change in an organization becomes critical due to the risks generally associated with uncertainty. For example, a product at pinnacle performance stages generally witnesses declines later as it approaches maturity. However, predicting when a product peaks and falls generally depends on market trends in consumer behavior, which becomes susceptible to volatile fluctuations. Moreover, the generally “shorter product life cycles,” plausibly precipitated by technological advances, if true, might exacerbate unpredictability in determining when trends become fads. [xxxii]  Likewise, the truncated time risks significant losses if a product prematurely ossifies into obsolescence. Nonetheless, by spearheading cross-functionality within an organization, the organization may become more readily prepared to infer changes by extrapolating information from market researchers.  Those market researchers may then communicate how to perhaps remediate products in adapting toward plausible consumer preferences suggested from potential market trends. A change leader might implement the following steps in initiating change:

Both ERP and PDM may help regulate design phases for the product life cycle.

If true, these benefits may help prevent product deterioration by deploying analytical software to infer system sustainability. Likewise, FMEA may apply throughout the entire production phase. Thus, FMEA may help organizations target risk during production, and continually tailor products throughout life-cycle based on plausible projected risks.


Voice of the customer refers to implied customer preferences and/or perceptions. Since customer value proves integral to generating revenue, voice the customer exercises importance in preserving organizational performance. Why? Customers command sales. After all, “90% of business” presumably stems from repeat business. [xxxiv] If true, customer preferences drive economic viability, since the “voice of the customer” may positively or negatively impact organizations. If companies seek to satisfy customer preferences, they take strides in maintaining performance, as consistent with quality. If not, they risk brand damage, reputational loss perhaps from disparaging diatribes by disgruntled customers.


Customer-relationship management seeks to satisfy the voice of the customer by recognizing customers as valued assets requiring management for continued company success. Customer relationship management includes all the intangible, subjective qualities associated with providing customers a satisfying experience—e.g., professionalism, empathy. Customer relationship management generally assumes management reviews customer complaints, feedback, etc., as opportunities for remedial action and improvement.



Services comprise a mix of tangibles and intangibles delivered to the customer. [xxxv] The contingency of subjective intangibles, namely, service reliability factors—customer perceived “responsiveness, assurance, empathy, professionalism, timeliness, completeness, and/or pleasantness” create challenges. In other words, what may satisfy one customer, many not satisfy another depending as perceived by different people at any given time. For example, one person’s perception of “empathy,” the care/attention received from server may differ from another person. Likewise, services demand all of these factors simultaneously present—that customers receive “empathy,” assurance—courtesy shown with ability to inspire confidence and trust, etc. Indeed, responsiveness remains insufficient if the customer perceived no empathy, and vice versa. [xxxvi] Additionally, personality potentially factors into customer-service skills. The restaurant industry assumes this inference from its maxim, “if you are in it for the money, you generally won’t survive,” suggesting certain soft-skill people-pleasing predilections. [xxxvii] If true, these subjective factors support the probative inference of greater challenges providing services than products because services presumably possess “more diverse-quality attributes” compared to products. [xxxviii]


Six Sigma represents an advanced quality management system designed to target “90% of quality problems,” using its ostensibly “10%” most advanced “training and analytical techniques. [xxxix]  Like Pareto’s 80/20 Principle it provides an analytical prioritization framework, which reduces firms cost using fewer resources by, “planning, organization, training, and pay for knowledge.” [xl] Six Sigma utilizes DMAIC—Define, Measure, Analyze, Improve, Control, as an analytical framework adapted from Shewhart’s PDCA to spur organizational efficiency. The system enumerates as follows:

Six Sigma’s “3.4 errors per million opportunities,” demonstrates its efficacy as a control measure to reduce variation, eradicating defects for improved performance. [xli]

Given the perceived, compatibly complementary characteristic between Six Sigma and Lean concerning quality standards, firms undertook to merge them into Lean- Six Sigma. Ultimately, Lean-Six Sigma, an adaptation of Six Sigma—combines Lean and Sigma to expand the original Six Sigma system, which more closely emphasizes waste reduction than Six Sigma. By accentuating waste reduction, Lean-Six Sigma deploys statistical diagrams to target non-value activities, consequently lowering costs and defects while enhancing customer value. [xlii]



The FDA issues recalls with reports on defective devices, drugs, biological products, etc.


Statistics provides numerous correlative tools and methods to infer “root-cause” correlations for non-conformance defects. Those tools and methods typically manifest in the following charts:

Establishing root causes becomes a relevant, logical mechanism that attempts to more accurately infer outcomes. If evidence exists to suggest a root cause, we may mitigate non-conformance defect risks with some reasonable probability of certainty. Therefore, identifying a root cause becomes critical in potentially preventing foreseeable harm arising from products because tests may suggest non-conformance with some reasonably probable certainty—randomness occurring less than 1% of time.


Leadership, as per total quality management, involves the ability to positively influence organizational improvements. Assuming this definition, the following traits tend to associate with leadership:


Malcolm Baldrige Award—shows superior results-oriented in “financial performance, customer satisfaction, customer retention, product/service performance, and public citizenship.” [xlv] Organizations qualify for the award based 7 distinct principles:

The Baldrige Award proactively objectifies quality improvement standards since these traits typically attribute to successful organizations. After all, the basis for its model, “information and analysis,” confirms a core value factually associated with management. [xlvi] Therefore, the Baldrige Award defines quality by holding recipients accountable to global exemplary standards because anything less becomes an “embarrassment for other firms.” [xlvii] Organizations selected usually exhibit the highest measurable financial standards when awarded, e.g.—Merrill Credit Corp.

Benchmarking refers to improving organizational operations by emulating the superior quality perceived in another company’s operations. If an organization appears to differentiate itself from competitors, “setting the benchmark,” then exploring its innovative features may simplify the otherwise “daunting and discouraging process,” toward progress. [xlviii] In other words, the privilege to learn from “a truly outstanding competitor,” might demystify and distill secrets perhaps otherwise inaccessible but for benchmarking. [xlix]  My organization might benefit from the following benchmarking types:


Supply chain management involves managing goods moving down the chain of supply from supplier to consumer. Supply chain management constitutes an important business concept today because it encompasses numerous functions—operations, marketing, information systems, human resources, etc., especially as technological advances increasingly globalize operations. Therefore, supply chain management might support quality by “leveraging opportunities upstream and downstream,” to synchronize cross-functionality.

  • For example, supply chain management, given its access to multiple functions, could catalyze communications between the various functions (operations, marketing, finance/accounting, legal, IT, human resources, etc). The enhanced communication may facilitate transparency by ensuring a more seamless flow of materials from design to consumption.


    Technology exercises a progressively pervasive influence on quality. It accounts not only for globalizing operations but generally requires continuing education from business and healthcare professionals to stay abreast of current trends. See Supra, p. 12 & 13. This technological hypertrophy influences manufacturing/service delivery through the following three sources:

    * * *


    [i] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice Hall, Upper Saddle River, NJ (2007), p. 6.

    [ii] Garvin, D., What Does Product Quality Really Mean? Sloan Management Review (Fall 1984): 25-43.

    [iii] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice Hall, Upper Saddle River, NJ (2007), p. 7, 70.

    [iv] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice Hall, Upper Saddle River, NJ (2007), p. 6.

    [v] See Jones, Erick, “Quality Management for Organizations Using Lean Six Sigma Techniques,” Taylor & Francis Group, 2014, p. 8.

    [vi] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice Hall, Upper Saddle River, NJ (2007), p. 1, 14, 28, 65, 430.

    [vii] See SkyMark, “Dr. W. Edwards Deming,” SkyMark Corporation, 2016, p. 1,

    [viii] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice Hall, Upper Saddle River, NJ (2007), p. 28.

    [ix] See Richard Koch, “The 80/20 Principle: The Secret to Achieving More With Less”; See James T. McClave, P. George Benson, Terry Sincich, “Statistics for Business and Economics—12th Edition,” Library of Congress, 2014, p. 41; See Laura Stack, Time Management for Leaders: How to Get Everything Done and Still Leave the Office Early, Video.

    [x] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice Hall, Upper Saddle River, NJ (2007), p. 28.

    [xi] See Foster at 34.

    [xii] See Id. at 38-39.

    [xiii] See Id. at 131.

    [xiv] See Id. at 38-39.

    [xv] See Wilcox, Mark, Ph.D, The Philosophy of Shewhart’s Theory of Prediction, p. 1,

    [xvi] See Foster at 25.

    [xvii] See Heizer J., Render, Barry, Operations Management—Sustainability & Supply Chain Management, 11th Edition, Pearson, Inc., p. 222.

    [xviii] See Best, M., Neuhauser, D, Walter A. Shewhart, 1924, and the Hawthorne Factory, The National Center for Biotechnology Information (NCBI), PubMed Central (PMC) ©,, p. 2,

    [xix] See Gettinger, Marilyn, HCQB Chapter Summaries, p. 1.

    [xx] See Gettinger, Marilyn, HCQB Chapter Summaries, p. 1.

    [xxi] See Rescott, Lyle, The Failure of Obamacare, The Baltimore Sun, May 23, 2016, p. 1,

    [xxii] See Foster, S. Thomas, “Managing Quality Integrating the Supply Chain,” Sixth Edition, Prentice-Hall, Upper Saddle River, NJ (2007), p. 14.

    [xxiii] See Id. at 430.

    [xxiv] See Id. at 37.

    [xxv] See Id. at 14.

    [xxvi] See Id. at 30.

    [xxvii] See Id. at 417.

    [xxviii] See Id. at 414-15.

    [xxix] See Barrow, Keith, France Faces Tough Choices over Future of TGV, p.1,

    [xxx] See Eric’s Presentation.

    [xxxi] See Foster at 166.

    [xxxii] See Id. at 166.

    [xxxiii] See Id. at 166.

    [xxxiv] See Id. at 108.

    [xxxv] See Id. at 435.

    [xxxvi] See Id. at 6.

    [xxxvii] See Id. at 6.

    [xxxviii] See Id. at 5.

    [xxxix] See Id. at 338.

    [xl] See Id. at 339.

    [xli] See Gettinger, Marilyn, Foster Chapter Summaries, p. 3.

    [xlii] See Foster at 341.

    [xliii] See FDA, U.S. Food & Drug Administration, What We Do, p. 1,

    [xliv] See Foster at 283, 288.

    [xlv] See Id. at 54.

    [xlvi] See Id. at 55.

    [xlvii] See Id. at 54.

    [xlviii] See Id. at 131.

    [xlix] See Id. at 131.

    [l] See Id. at 132-34.

  • See Id. at 223.

    [lii] See NPD Solutions, p. 1,

    [liii] See Id. at 223.

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