Organizational Culture and Employee Behavior 4

Central Michigan University

Master of Science in Administration (MSA) Program

Course Title: MSA 600 Administration Research and Report Methods

Submitted to: [Professor’s Name]

Submitted by: [Student’s Name]

[Street Address]

[City, State and Zip Code]

Work Phone: [703-555-1234]

Home/Cell Phone: [804-555-1111]

Email: [email protected]

Course Location: MSA600 Online

Submission Date: [Month, Day, Year]

Research Project Title: RESEARCH METHODOLOGY EXAMPLE

THE ECONOMIC IMPACT OF MELAMINE ADULTERATED FOOD ON FOOD AND DRUG ADMINISTRATION RESOURCES

CERTIFICATE OF AUTHORSHIP:

I certify that I am the author of this paper and that any assistance I receive in its preparation is fully acknowledged and disclosed in this paper. I have also cited any sources from which I used data, ideas, or works, either quoted directly or paraphrased. I also certify that this paper was prepared by me specifically for this course.

Student’s Signature:

Instructor’s Comments:

THE ECONOMIC IMPACT OF MELAMINE ADULTERATED FOOD ON FOOD AND DRUG ADMINISTRATION RESOURCES

MSA 600 Administrative Research and Report Methods

Submitted by:

Teresa Fox

Project Instructor:

Dr. Thomas Kessler

December 2008

Table of Contents

Page Number

List of Tables ii

List of Figures ii

Chapter 1 Problem Definition 1

Chapter 2 Literature Review 7

Chapter 3 Research Methodology 15

Chapter 4 Data Analysis [Future]

Chapter 5 Summary, Conclusions, and Recommendations [Future]

Terminology and Definitions Page 18

References Pages 19-22

Appendix A Permission to Conduct Study

Appendix B Transmittal Letter/Survey Instructions

Appendix C Survey/Interview Questions

Chapter 3

Methodology

Research Approach

The attempt to determine the financial impact of melamine on FDA resources is a question that will require the compilation of employee hours spent on investigations, import entry review, sample collections, development of lab methodologies, acquisition of equipment, lab analyses, analytical review of results, and appropriate policy review and implementation.

To that end, program evaluation will be the methodology of choice. Even though melamine adulteration is not a regular program per se, the FDA’s regulatory actions in response to unforeseen events can be seen as a program, since it involves multiple divisions that currently exist within the agency.

Data Collection Approach and Procedures

Data To Be Collected

Data will be collected from the FACTS computer database and existing data from FDA budget requests on resources devoted to melamine for fiscal years 2007and 2008, and the first two quarters of 2009. In addition, time spent on melamine assignments by employees who do not enter hours into FACTS will be determined by information obtained by personnel in supervisory roles in those divisions and a calculation will be made. Import entry review time on melamine products will be accomplished by running an ORA computer program tracking FDA product codes nationwide. A time estimate will be derived by assigning historical time increments needed by entry reviewers to determine if a sample collection is necessary. That, in turn, will be multiplied by the total number of import entry points where FDA entry review is taking place.

FACTS will specifically be able to show work hours associated with the Program Accomplishment Code (PAC) for melamine assignments. This is the most accurate means of determining financial impact on the ORA field employees.

The report on number of products with particular product codes will be used to determine number of extra hours spent by entry reviewers on the melamine sampling assignments. This is separate from FACTS and would be impossible to chronicle in an ongoing fashion, since the average entry reviewer is clearing hundreds of lines of products entering the country daily and quick turnaround is essential to not impeding commerce. The time estimate will include the time necessary to review products of interest using various databases, sampling and analytical history, as well as scheduling and coordinating examinations with field personnel, customs brokers, and importers.

Fact gathering from supervisors at the Centers and DIOP will consist of querying how much time was devoted to the melamine issue in which fiscal year. A calculation will determine the economic value. Laboratory supervisors will also be asked if their lab was required to purchase more equipment or hire more analysts or both, to accomplish melamine testing.

FDA regulates a vast array of products and provides oversight over industries related to the manufacture and distribution of regulated products. The complexity of the agency’s missions makes it extremely difficult to quantify individual assignments within the agency. These methods of data collection are the most reliable means available to answer the research question and determine what financial impact melamine has had on FDA resources. They represent the most accurate assessment available in an agency with many divisions, centers, and missions that are constantly evolving.

Data Collection Procedures

Existing data searches will be accomplished using FACTS and ORADSS databases. Reports will be compiled and hours determined from those reports. FDA personnel data will be used to determine the average salary of personnel performing melamine related activities in each FDA district, which are divided by geography. This is important because cost of living pay differs according to geographical area. Data reports in FACTS will be separated by districts as well; appropriate calculations will be made and a cumulative total will be determined accordingly. Personnel names and locations will not be used in this study. This information is available under the Freedom of Information Act (FOIA).

Information gathered should not be biased since it is merely an estimate on time spent on a particular event. That being said, because the first melamine contamination occurred in 2007, the data acquired on that event may not be accurate, as it may be dependent on a person’s record keeping. This information is available under FOIA.

Proposed Approach for Data Analysis and Synthesis

The parameter for this study will be FDA personnel involved with addressing the melamine adulteration problem on imported products. The data will be continuous and will vary according to geographical area. It is reasonable to assume that geographical areas where Asian imports are higher will show a greater number of hours spent in this program area. Once all available data has been collected, the dollar amount spent on melamine assignments will be calculated and expressed as a ratio of the total budget for ORA and CFSAN. This ratio will be used to determine the projected financial impact on FDA resources and the consequent effect on FDA food safety programs. This data can further be displayed as a dollar percentage for each operating division within FDA that has had to address melamine contamination in some way.

Since the data being acquired cannot be modified, this will be an observational study. The interview may yield variable results which may ultimately affect the accuracy of the final calculations, however, since most of the data will come from established databases, the ultimate conclusion should not be altered. The final data analysis will be displayed as pie charts to show the degree of influence the melamine issue has on a specific division’s budget.

Methodological Limitations

The limitations of this study are primarily related to calculations that will be made on employees who do not enter work hours into the FACTS database; therefore it will be harder to quantify their contribution to the melamine assignment. The data will not include hours spent on melamine by other government agencies. Ultimately, those hours could be shown as a ratio of their organization’s resources, not FDA’s. Another limitation will be the lack of similar studies from which to compare results for validity. The results of this study can be used in the future when budgeting dollars for specific responses, however, an in depth study would be required for true accuracy and precision.