Fluent Essays

5 pages due midnight or 1am   Evaluation of Agency's Human Resources Management   ASSIGNMENT OVERVIEW As a consultant, you need to develop an in-depth analysis and evaluation of the selected agency’s human resources management system and processes, and then provide recommendations for improvement. Therefore, you will conduct interviews with agency representatives and research related academic sources and websites. The analysis will be read by the VP of accounts and client support, as well as by the leaders of the agency for whom you are working. ASSIGNMENT INSTRUCTIONS Write a 5–6 page paper in which you: Analyze 3–4 of the major components of the agency’s human resource system, processes, and performance evaluation plan for hiring and retaining a diversified workforce. Title this section Human Resource Processes. Analyze and describe the implications impacting the agency’s current employment trend, growth, and delivery of its products and services. Title this section Implications of Human Resource Workforce. Recommend 2–3 managerial and professional skills and competencies required to improve the agency’s workforce. Explain each recommendation, providing reasons each recommendation would bring about improvement, and providing 2–3 ways the agency could implement programs in preparation for those skills not visible within the agency’s workforce as a method of promotion and advancement for current employees. Title this section Succession Planning for Human Resource Management. Describe the consultant position you are performing by a) giving it a title; b) explaining 2–3 major specifications required of the job and how each will be measured in a performance evaluation; and c) explaining 2–3 ways this position will be used within the various departments of the agency and for meeting the specific goals and objectives of the agency. (This job description will be provided to the agency director who has requested it. As a resource, use the Dictionary of Occupational Titles.) Title this section Job Analysis and Design. Provide the completed PAD599 Interview Template for 1–2 interviews, putting this information in the Appendix under Interviews. Go to Basic Search: Strayer University Online Library to locate and provide 4–5 relevant and credible outside resources that support the content of this assignment. Include no more than one non-government website. Note: Follow the Guidelines for Interview Assignments at Strayer University provided in the Assignment Preparation in Week 1. Your assignment must follow these formatting requirements: Be typed, double spaced, using Times New Roman font (size 12), with one-inch margins on all sides; citations and references must follow APA format. Check with your professor for any additional instructions. Include a cover page containing the title of the assignment, your name, the professor’s name, the course title, and the date. The sections must have appropriate titles. The cover page, reference page, and appendix pages are not included in the required assignment page length. The assignment must be submitted as a Microsoft Word document. The specific course learning outcome associated with this assignment is: Conduct an in-depth analysis and evaluation of an agency’s human resources management system and processes and provide recommendations for improvement. Running head: AGENCY EVALUATION 1 AGENCY EVALUATION 7 Evaluation of Agency’s Ethics, Cooperation, Leadership, and Legal Decisions Natashia Richmond PAD 599 Professor A. Smith May 17, 2020 Evaluation of Agency’s Ethics, Cooperation, Leadership, and Legal Decisions Administrative Ethics The Food and Drug Administration is an important Federal agency in the United States. The actions of this agency are capable of having tremendous impacts on society. There are current actions and events in which the organization is involved that are within its administrative responsibilities but present some ethical questions. The following is an examination of two of the organization’s current events and actions that fall within its responsibilities but present some ethical concerns F.D.A. Halts Coronavirus Testing Program Backed by Bill Gates There is no doubt that F.D.A. plays an important role in the fight against the novel coronavirus that has caused the current pandemic. The agency is tasked with the responsibility of approving drugs and test kits that are being used in the management of the disease. In the current event, as part of its administrative role, the organization decided to halt a testing program in Seattle that had been funded by Bill Gates. The ethical issue in this issue arises from the need to promote public safety by enhancing the testing of the public for the coronavirus, since it is only through testing that the country can effectively manage the spread of the virus (Al-Muharraqi, 2020). Thus, any course of action that decelerates testing is likely to have adverse effects on the management of the pandemic. In light of this reality, the actions of F.D.A. are of great concern to the public. Allowing many vaccine trials to be done on humans without critically ascertaining their possible negative impacts In recent weeks, many organizations have been racing towards the development of vaccines for coronavirus. Due to the massive impacts of this virus, many scientists who are involved in the development of the virus have had to skip some critical clinical steps that are followed in the development of vaccines. In spite of these glaring challenges and violations of procedures, F.D.A. has allowed these vaccines to go to the phases of clinical trials on Americans. It is the ethical and legal responsibility of the agency to make sure that it protects individuals and members of the public from harm that might arise from the potential harm that might arise during the trial. Leadership Influences The Food and Drug Administration is headed by a commissioner who is appointed by the president of the United States. The commissioner is ordinarily expected to be an individual who is from a medical background. Additionally, it is expected that the commissioner remains independent in all his actions and decisions. However, that is rarely the case. It is not uncommon to see the holders of the office being influenced by political players in their actions. Since the agency is a federal entity, it is difficult to see a situation where it can be linked totally from the control of the federal government. Reports indicate that for technology or medicine to be approved by the F.D.A., politics will, in most cases, emerge triumphant over science. In the United States, healthcare is run by private business organizations that are in competition with another. These business organizations have always found ways of manipulating the organization to approve their products rather than using science alone approve as the basis of the decisions. Secondly, there are cases where the agency has been accused of making decisions that are based on political lobbying (Milfred, 2012). For example, recently, F.D.A. approved the use of a device for the treatment of knee injuries despite the resistance from doctors. It emerged that there was a massive political lobbying and the leadership of the agency was forced to approve the device. That incident demonstrated the extent to which F.D.A. is susceptible to political pressure. Finally, in a study, it was presented that the policies and wishes of the government of the day have a bearing on the actions and policies of the agency. As a result of this fact, it is evident that many Americans are losing trust in F.D.A. (Adashi et al., 2019). Legal Decisions Organizations and individuals have various mechanisms, approaches, and tools that they can use to enforce their decisions. To enforce its mandate and decisions, the F.D.A. has the power to seize items that they feel do not meet the required standards. For example, when the agency realizes that there are certain drugs in the market that it has not approved, it has the powers to seize the drugs and institute legal proceedings against the culprits. However, one of the ways in which F.D.A. enforces its orders is by carrying out the inspection. The agency has the power to order for drug samples from manufacturers and their sellers to determine whether or not they are in line with the standards and regulations. Finally, the agency has the option of asking culprits to voluntarily destroy the drugs or materials that it finds to be unfit for purpose. There are several challenges that F.D.A. encounters as it seeks to enforce its orders and policies. One of the policies is litigation. It is not in doubt that Americans are very litigious and they will always resort to legal measures, some of which are very desperate, to stop government agencies from doing their work. Thus, when the F.D.A. wants to destroy some drugs that it feels are not fit for purpose, the affected persons will run to court to seek injunctions. These kinds of outcomes make it difficult for it to effectively execute its mandate. The second challenge that the organization faces is the inadequacy in human and financial resources that it requires to execute its mandate. For the agency to effectively inspect the drugs in the market, it must have adequate human capital at its disposal. The challenges in human and financial capital, thus, play an important role in preventing the organization from achieving its objectives. Strategies for Consideration to Administrative Processes Being aware of the challenges that it faces, the Food and Drug Administration has been looking for ways in which it can enhance its plans for administrative ethics, leadership, and legal frameworks so that it can effectively deliver services to its primary clients. One of the strategies that the company has been using is to reorganize its internal operational framework so that it may be in a position to address the needs of its clients. It is important that the organization knows the foundation of its problems to be within, and it has been making efforts to change internal operations. The second aspect of the organization's future changes is its approval processes. Today, the organization does not have robust approval, and that has made it possible for it to be bypassed by the players to bypass it. For example, it is out of this weakness that the various players have been making sure that their products are approved, yet they do not meet the standards. Finally, the organization has been making efforts to make sure that it effectively uses evidence-based practices in the execution of its responsibilities. The impact of this is that the organization intends to make use of evidence from objective, scientific findings in its decision-making. With this in mind, it is highly likely that the agency will start relying more on its scientists in decision-making; rather, those government bureaucrats, business organizations, or the political class. Recommendations for Improvements to Administrative Processes There are several ways through which the organization can improve its administrative processes. One of the ways is by making efforts to delink its activities from politics as much as possible. While there may be no problem with the commissioner being appointed by the president, the problem arises, however, when it emerges that the president has some space that he may exploit to remove the commissioner from office. There is a need to insulate the commissioner from political machination by giving him the security of tenure. The second way of improving this agency's administrative processes is by making sure that it has an open and predictable communication system with the public. The members of the public are the organization's key stakeholders, and that means it needs to always make sure that it communicates with them. Open communication is essential because it makes sure that there are a few conflicts between the organization and its stakeholders (Men, 2014). References Adashi, E. Y., Rajan, R. S., & Cohen, I. G. (2019). When science and politics collide: Enhancing the F.D.A. Science, 364(6441), 628-631. Al-Muharraqi, M. A. (2020). Testing recommendation for COVID-19 (SARS-CoV-2) in patients planned for surgery-continuing the service and ‘suppressing' the pandemic. The British Journal of Oral & Maxillofacial Surgery. Men, L. R. (2014). Strategic internal communication: Transformational leadership, communication channels, and employee satisfaction. Management Communication Quarterly, 28(2), 264-284. Milfred, J. (2012). The Politics of F.D.A. Approval. Yale Scientific. Retrieved from http://www.yalescientific.org/2012/11/the-politics-of-fda-approval/ Running head: AGENCY SELECTION 1 AGENCY SELECTION 5 Agency Selection Natashia Richmond PAD 599 Dr. A. Smith April 19, 2020 Agency Selection Food and Drug Administration (FDA)  The rationale for Agency Selected Introduction The Federal Drug Administration is one of the federal agencies in the United States Department of Health and Human Services. The agency was founded in 1906 under the administration of President Theodore Roosevelt. The agency has its headquarters in White Oak Campus, New Hampshire Avenue. Silver Spring, Maryland. The primary responsibility of the agency is to promote the safety of “food, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.” Mission “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation” (FDA, 2020). Goals and objectives · Protect public health · Regulate tobacco use · Speed up innovations in health · Ensuring the security of food supply in the country Functions of the Agency The Federal Drug Administration is one of the most important agencies since it is at the heart of the country’s health systems. Firstly, this agency has the function of making sure that the drugs that are being manufactured by the country’s medicines are safe. Since most drugs are developed by private enterprises, it is necessary for the government to make sure the drugs that they manufacture will not hurt the public. Another important function of this organization is to regulate tobacco use. This organization is responsible for making sure that it regulates the production and marketing of tobacco in a manner that protects the public (Carpenter, 2014). It is also the responsibility of the organization to make sure that it encourages innovation in the field of healthcare. The agency also plays an important role in making sure that there is food security in the United States by making sure that there is a steady and consistent supply. Current Events One of the current events concerning the organization is the coronavirus pandemic. The pandemic is s global crisis that has brought the world to a stop. In the face of these challenges, many organizations are coming up with medications and vaccines to address the virus. It is the responsibility of the organization to make sure that these medications and vaccines that are being developed meet the desired quality standards (Prompetchara et al., 2020). The second event that concerns the agency is the surge in the number of counterfeit drugs in the market. There are reports that there are many medications that have sneaked into the market without going through the regulatory tests (Blackstone et al., 2014). There is a need to find the mechanisms through which the organization may prevent the entry of untested drugs into the market. Rationale The primary reason for settling on this organization is related to the purpose of the organization in the management of the present pandemic. The Federal Drug Administration is responsible for making sure that there are drugs that may be used to safely address the pandemic. At this time, the agency is required to put its best foot forward and make sure that there are adequate measures to test the safety of emerging COVID-19 drugs. The second reason for the selection of this agency is its role in protecting Americans from the drugs that are being brought into the market illegally. References Blackstone, E. A., Fuhr Jr, J. P., & Pociask, S. (2014). The health and economic effects of counterfeit drugs. American health & drug benefits, 7(4), 216. Carpenter, D. (2014). Reputation and power: organizational image and pharmaceutical regulation at the FDA (Vol. 137). Princeton University Press. Prompetchara, E., Ketloy, C., & Palaga, T. (2020). Immune responses in COVID-19 and potential vaccines: Lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol, 38(1), 1-9. U.S Food and Drug Administration. (2020). What We Do. Retrieved from https://www.fda.gov/about-fda/what-we-do Running Head: AGENCY ANALYSIS 1 AGENCY ANALYSIS 10 Agency Analysis Natashia Richmond PAD 599 Dr. A. Smith May 2, 2020 Agency Analysis The selected agency for analysis in this report is the U.S. Food and Drug Administration (FDA). It is a government agency that has a mandate of protecting public health. The agency achieves this by guaranteeing efficacy, safety, and the security of medical products (GAO Reports, 2018). Other areas of focus for FDA are offering quality, efficient and science and health information to the public. FDA is an affiliate of the U.S. Department of Human Services (DHS) and with an obligation of managing human and animal drugs. History of FDA FDA was established in 1862 to address administrative issues in food products (U.S. Food & Drug, 2019). The primary focus was on meat and poultry. It also encompassed problems in animal and human drugs. Today, the agency operates a budget of about $4 and twenty district offices (U.S. Food & Drug, 2019). It has a hundred and fifty laboratories and field offices and more than 9,100 staff. Its existence is reinforced by the Federal Food and Drug Act. Goals and Objectives of the FDA Regulating the manufacture and distribution of substances like tobacco to promote public health Speeding the rate of innovation in medicine and foods science Offering scientific and accurate information to the public to improve health Safeguarding the supply chain of medical and food products Vision FDA is committed to achieving world-class competencies as a regulatory agency that is driven by science with a mission of public health. The organization aims to provide effective and innovative leadership, both internationally and locally. It aims to prevent illness, protect health, promote wellness, and extend life. Organizational Design FDA has changed its design as it adopts new responsibilities. Its design is hierarchical layers, with the topmost departments being the Office of the Commissioner of Food and Drugs that is headed by the commissioner (GAO Reports, 2018). This department reports directly to DHS. The commissioner is supported by two other executives of secretariat and counsel. Below this department is supporting organizations that report directly to the commissioner. This is the second administrative layer that is made up of Centers for Food Safety and Applied Nutrition, Tobacco Products, Regulatory Affairs, and Drugs Evaluation (U.S. Food & Drug, 2019). The third layer comprises the deputies that report directly to the commissioners. The offices include Food Policy, Clinical Policy, and Operations. The FDA’s Organizational Chart Deputy Commissioner Deputy Food Policy Deputy Commissioner Clinical Policy and Operations Center for Tobacco Products Center for Drugs Evaluation Centers for Food Safety and Applied Nutrition Center for Regulatory Affairs Office of the Executive Secretariat Office of the Commissioner Office of the Chief Counsel The organizational design of the FDA is vertical. All the heads of the department report directly to the office of the commissioner. It implies that power also emanates from the same office and trickle down to different centers and officers. This structure gives the agency a well-defined chain of command where the decisions from policies and decisions move from the top to various layers at the bottom. This implies that the FDA has a clear and quicker decision making process. Every staff has clear roles and responsibilities, which reduce the risks of ambiguity and redundancy (Haffer, 2012). This design can be attributed to the efficiency and success of this agency. A vertical organization structure promotes efficiency, and collaboration, and offer opportunities for further development and innovation that forms the foundation of organizational growth. The design has been effective in creating a culture where employees are included. This ensures that the workflow of the agency is not deterred by challenges such as poor communication between departments. Assessment of Organizational Design The proposed restructure of the FDA would be the incorporation of a Management Committee in the hierarchy of the agency. It should be the decision unit for the agency to support the Office of the Commissioner. This committee should comprise a technical team such as legal officers and H.R. executives among other experts. It should replace the offices of Executive Counsel and Executive Secretariat. However, it should be chaired by the commissioner of the agency. This restructuring is proposed to enable the FDA to meets its goals and objectives and in delivering quality services. Management Committee directs the activities of an organization by ensuring that it runs and deliver the outcomes that are embedded in the missions and visions of the organization (Haffer, 2012). It is an effective office that ensures the decisions and interests of individuals do not dominate the agency. The existing structure has the Office of the Commissioner with the sole responsibility of making decisions in the agency. The committee will assume the role of setting strategic direction to govern and direct the activities of the organization. Recommended FDA’s Organizational Chart Management Committee (Chaired by of the Commissioner) Deputy Commissioner Deputy Food Policy Deputy Commissioner Clinical Policy and Operations Center for Tobacco Products Center for Drugs Evaluation Centers for Food Safety and Applied Nutrition Center for Regulatory Affairs Evaluation of Planning and Implementation One of the driving factors for the success of the FDA is numerous streams of income. About 45% ($2.6b) of the revenue for the agency is generated internally (GAO Reports, 2018). The federal government support is about 55% of the budget. The regulatory activities of the organization in Human Drugs account for 33% of its budget. The user fees in the industry generate much of this income, amounting to 65%. Activities of food regulation contribute to 19% of the annual expenditure of the company. The biologic regulatory process amounts to 7% of the budget, and 40% of the income is paid for from the fees of users (GAO Reports, 2018). The regulation of animal feeds and drugs contribute to 4% of the budget each year. All the regulatory requirements for tobacco are catered for by the users in the industry. Another critical factor to the success of the FDA is faster approval of rates. This competency was facilitated by the users' fees that create a cycle of continuous efficiency. It has also increased the rates of approval. For example, 95% of all the products that were submitted for review in 2015 were approved in comparison to only 36% of what was approved a decade earlier (Hilzenrath, 2016). The agency achieves this without compromising the quality standards of biologics and new drugs. The result is efficacy, safety, and quality products that hit the market for the public. A major drawback that impends the agency in implementing its policy is regulatory requirements. The agency is governed by the Prescription User Fee Act (PDUFA). It requires the agency to lobby with players in the industry for funds. The requirement hinders some operations of the organization because it risks the infiltration of some large corporations in laying out the goals for the agency (David, 2009). It also translates to a lack of full independence that FDA needs to implementation of its decision. In situations where the agreement fails, it would be unclear if the agency can go on with its activities because the pharmaceutical industry has extraordinary influence over the company. This issue can risk the potential of the organization in protecting consumers. Another challenge that impends the achievement of the goals and objectives of the company is ethical concerns among the staff. This challenge has impacted the success of the agency and impacted its image in public. For example, the FDA approved a controversial drug eteplirsen to treat muscular dystrophy (Hilzenrath, 2016). The decision was made solely by Robert Califf, who was in charge of running and approving clinical trials for drugs. The officer established that the drug had no clinical significance but went ahead in approving its marketing. Recommendations for Planning and Implementation FDA should embark on training its staff on ethics. Communicating and enforcing ethical behaviors is an effective organizational strategy that improves its competency and reliability in public. Training programs on ethics are integral in ensuring that an organization does not compromise the quality of its product or services. It helps an organization build an impressive and acceptable image in public. The training should be reinforced by an independent evaluation committee that assesses the quality standards of the review process of the FDA before approving products. FDA can improve its planning and implementation of the policy by lobbying Congress to lift the requirement of user fee negotiation. The FDA is a government agency and has a unique position for engaging various stakeholders in the enactment of a policy that eliminates this policy (Cassanelli, 2019). The result can be an increase in the independence of this agency to implement its policies without being influenced by third parties. Being funded partly by drug manufacturers implies that the FDA can easily be influenced to their advantage. The engagement of Congress in amending the PDUFA means that the government has a mandate of increasing the funding for FDA from the current 55% to at least 90%. The agency will stop relying on the user fee and conduct its activities independently. It can be the most efficient effort of the company in achieving its goals and objectives. Cause and Effect Diagram Regulatory Requirement Prescription User Fee Act Lobbying for funds Compromised quality Lack of Efficiency Inaccurate approval Lack of external reviewEthical Issues References Cassanelli, N. A. (2019). Management of R & D projects, considerations for organization structure. Journal of Project Management 10(1), 143-153 David, E. (2009). Vision and will: The future of the FDA. Oncologist; Vol. 14 Issue 4, p317-319, 3p GAO Reports. (2018). FDA can build on existing efforts to measure progress and implement key activities. Haffer, J. (2012). Organizational structure of companies versus project management effectiveness. Torun Business Review, Vol 11, Iss 11, Pp 233-248 (2012) Hilzenrath, S. D. (2016). FDA depends on industry funding; Money comes with “strings attached. U.S. Food & Drug. (2019). Fact sheet: FDA at a glance. Retrieved from https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance