ABSTRACT
The study is on impact of National Agency for Food, Drug, Administration and Control (NAFDAC) on quality management of Nigerian manufacturing sector, a study of Juhel Plc and Nigerian Bottling Company both in Enugu. The study has the following objectives: to determine the quality control methods in use by NAFDAC to ensure compliance with standard specifications, to identify to what extent manufacturing sector adopts quality management practice, to determine to what extent NAFDAC achieves its objectives on the Nigerian manufacturing sector. The research design adopted is survey. A Sample size of
315 was determined from the population of 1,500 using Taro Yamane’s sample size determination method. The instruments used for data collection was questionnaire structured in a Likert five point scale which was validated with content validity. Findings indicate that routine inspection and market surveillance are quality management methods used by NAFDAC to ensure compliance with standard specifications, the extent to which Nigerian manufacturing sector adopts quality management practice is high, the extent to which NAFDAC achieves its objectives on the Nigerian manufacturing sector is high. The researcher concludes that NAFDAC ensures that organizations develop a process that incorporates quality during production rather than a process that attempts quality through inspection after production. Qualitative personnel ensures quality of final products as they are customer driven with continuous improvement of process. Better raw materials, better machines, and better choice of manufacturing process ensures that quality is inherent in the product. The study recommends that all the regulatory agencies should ensure that consumers are protected and got redress when the need arises. National Agency for Food, Drug Administration and Control (NAFDAC) should be transparent and should not connive with scrupulous officers and manufacturers to lower standard. Government should collaborate with NAFDAC to ensure that the purpose for which it is set up was realized by ensuring that offenders are brought to book. There is need that manufacturers on their part should imbibe good organizational culture by not allowing themselves to be policed around by regulatory agencies. Consumers should ensure that products they are buying have NAFDAC registration number and expiring date.
CHAPTER ONE
INTRODUCTION
1.1 Background of the Study
According to Biech (1994:1) quality improvement or quality management is a customer focused, quality centered, fact-based, team driven, senior management-led process to achieve an organization’s strategic imperative through continuous process improvement. The success of any organization among a number of factors is traceable to quality of its products. Therefore the maintenance of such quality is dependent on the standard already in place which basically attracts different meanings to different scholars, entrepreneurs and agencies.
The National Agency for food, Drug Administration and control NAFDAC which was established as a parastatal of Federal Ministry of Health by Decree No. 15 of 1993 has the mandate to regulate and control, manufacture, importation, exportation, distribution, advertisements, sale and use of food, Drugs, cosmetics, medical devices, chemicals and packaged water and drinks. This was also necessitated by the death of 150 children as a result of formulation error in drug syrup ‘My Pikin’ NAFDAC (2001:9). The agency according to Keris (2004:4): is saddled with the task of ensuring that all its registered products continually meet the acceptable standard in terms of quality and efficacy.
Okwuraiwe, (2004:6): posits that the application of good manufacturing practice in industry backed up with effective enforcement of regulations are required to guarantee that quality assurance attributes are built into the product. She says that the scientific and management tools for achieving Good manufacturing practice (GMP) Good Hygiene practice (GHP), hazard Analysis and Critical control point (HACCP), lSO certification are now universally applicable in the manufacturing industry. She also says that through regular compliance monitoring, enforcement and application of sanctions, regulatory agency (NAFDAC) evaluates and determines manufacturer’s ability to
guarantee that the product as presented is safe for the intended purpose having met the quality standard.
Akhigbemidu (2007:10) posits that the agency to ensure quality standard and safety of products to consumers embark on product recalls following consumers response to NAFDAC on safety problems of products as a result of production defects, design flaws, new scientific information about the danger from materials previously thought safety, accidental combination and failure to meet safety standard.
1.2 Statement of the Problem
NAFDAC has been saddled with the onerous task of promoting and protecting public health by ensuring that quality products are manufactured and even imported into the country.
Despite the efforts of NAFDAC, the issue of quality and safety of products have not been fully realized, as the agency has almost on regular bases been destroying substandard and fake products. There were cases of children dying from ‘My Pikin’ a teething drug as a result of formulation error, also the issue of contaminated frozen chicken. There were reported cases of high mortality rate resulting from low quality drugs or fake drugs in some cases. The rate at which people travel aboard for medication because of lack of trust in the health sector because of low quality drugs, and subsequent depletion of foreign reserves was of great concern. The issue of particles in alcoholic and non- alcoholic beverages was assuming a dangerous dimension. This study was geared towards ascertaining the quality control method used by NAFDAC to ensure compliance with standard specification. Also to evaluate the quality management tools used by NAFDAC for effective control of manufacturing organization. The study went further to identify the extent to which
manufacturing sector adopts quality management practice. Finally, the study went into knowing the extent NAFDAC achieves its objective in the manufacturing sector, considering all these challenges being faced by the agency.
1.3 Objectives of the Study
The main objective of the study is to identify the impact of NAFDAC on quality management of Nigerian manufacturing sector. The specific objectives are:
(1) To identify the quality control methods used by NAFDAC to ensure compliance with Standard specifications
(2) To identify to what extent manufacturing sector adopts quality management practice.
(3) To determine to what extent NAFDAC achieves its objectives on the
Nigerian manufacturing sector
1.4 Research Questions
The following research questions were formulated.
(1) What are the quality control methods used by NAFDAC to ensure compliance with standard specifications?
(2) To what extent does Nigerian manufacturing sector adopt quality management practice?
(3) To what extent does NAFDAC achieves its objectives on the Nigerian manufacturing sector?
1.5 Research Hypotheses
(1) Ho: Routine inspection and market surveillance are not quality management methods used by NAFDAC to ensure compliance with standard specification
Hi: Routine inspection and market surveillance are quality
| (2) | Ho: | management methods used by NAFDAC to ensure compliance with specifications. The extent to which the Nigerian manufacturing sector |
| adopts quality management practice is not high. | ||
| Hi: | The extent to which the Nigerian manufacturing sector adopts quality management practice is high. | |
| (3) | Ho: | The extent to which NAFDAC achieves its objectives on the |
| Hi: | Nigerian manufacturing sector is not high. The extent to which NAFDAC achieves its objectives on the | |
| Nigerian manufacturing sector is high. |
1.6 Significance of the Study
The study is significant to consumers, manufacturers, health care providers and students. The study will help in restoring the confidence of users of pharmaceuticals and other regulated products. It will help to boost the economy of Nigeria as those who travel abroad for medical treatment for conditions that could be handled locally for fear of fake and counterfeit drugs can now receive medication locally because of quality drug in use. The waste and depletion of our foreign exchange and reserves have to be channeled to the productive sectors to boost the economy. The loss of confidence by other African countries in Nigeria following explosion of fake and counterfeit and low quality pharmaceuticals and other products will be restored and they can start to import from Nigeria. The death of pharmaceutical companies in Nigeria will be revived as demands on their products following production of quality products. This will also serve as a reference material to research students in this area.
1.7 Scope of the Study
The study deals on impact of National Agency for Food, Drug, Administration and Control on quality management of Nigerian manufacturing sector: The study was carried out in Nigerian Bottling Company and Juhel Plc both in Enugu. The study focuses on the conceptual framework of quality management of NAFDAC, the theoretical framework of quality management, quality control methods in use by
NAFDAC to ensure compliance with standard specifications, quality management practice of the manufacturing sector, quality management tools used by NAFDAC for achievement of its objectives, and principles of quality management.
1.8 Limitations of the Study
The main constraints of the study are finance, attitude of the respondents and time. Finance: The researcher could not visit places where relevant information to the study would be obtained because of financial constraints.
Attitude of Respondents: Some of the respondents were reluctant to answer
the questionnaire as they felt it was of no financial benefit to them.
Time Constraints: Due to the limited time that was given for the study, the researcher could not get all the required information necessary for the study.
1.9 HISTORICAL BACKGROUNG OF THE COMPANIES UNDER STUDY
The profile of the Nigeria Bottling Company Plc (NBC)
Nigeria Bottling Company is a global organization that manufactures soft drinks bottled water and yoghurt for public consumption. The founding fathers with due regards for quality have the vision of what and how they want the company to be. In line with their vision are the land marks to work towards achieving their vision. One of the land marks is to establish standard adjudged to be the acceptable standard quality required by our consumers. These are among the key standards globally put in place by
the founding fathers at Atlanta Georgia for manufacturing of coca cola products (Coca Cola Quality Index 1996:2).
Profile of JUHEL Plc
Juhel Nigeria limited is located at Emene in Enugu state. It is 100% indigenous company which is into manufacturing of pharmaceutical products. The company maintains high quality standard in all its operations, with high production capacity, the policy thrust is to continue to provide cost effective,
affordable local alternatives of life saving drugs to the teaming population. The company at present service the needs of other countries of the west Africa Sub- region and is poised to reach out to more countries in Africa and beyond. Its production capacity for contract manufacturing for individual’s corporate bodies, government and non governmental agencies is available and the company looks forward to achieving its common goals (www.juhelnigeria.com) retrieved on 12th August, 2010.
1.10 Definition of Relevant Terms
Regulated product is processed foods, medicines, for human and animal use, cosmetics, medical devices, detergents, packaged water and chemicals according to NAFDAC decree no 15 of 1993 as amended by no 20 of 1999. Quality management or total quality management is the way of life of an organization committed to customer satisfaction through continuous improvement according to Gryna, Tagushi (1982) .
Organizational culture is a “specific collection of values and norms that are shared by people and groups in an organization that control the way they interact with each other and with stakeholders outside the organization”http://en.wikiped.org./definition//orgnaization, retrieved on 12th August, 2010 .
Good manufacturing practice is part of quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods pharmaceutical products and medical devices.
Good Hygiene practice is how to maintain personal hygiene in manufacture of food and pharmaceutical products. retrieved on 12th August, 2010.
Manufacturing is defined by Australian and New Zealand standard industrial classification (ANZSLC), “the physical or chemical transformation of materials or components into new products, whether the work is performed by machine or by hand. manufacturing, retrieved on 12th August, 2010.
1.11 Historical Overview of National Agency for Food and Drug
Administration and Control
The formation of NAFDAC was inspired by a 1988 World Health Assembly resolution requesting countries’ help in combating the global health threat posed by counterfeit pharmaceuticals, and amidst growing concern about counterfeit and poorly regulated drugs in Nigeria (NAFDAC, 2008a: 1).
Prior to the establishment of NAFDAC, the Directorate of Food and Drug Administration and Control, in the Federal Ministry of Health was responsible for the control and regulation of food, drugs, cosmetics, and other regulated products in Nigeria.
There were drug laws (with deficiencies no doubt), quality control laboratories and provision for inspection, enforcement and even a fairly equipped drug- manufacturing laboratory. However product registration was not in place, and such, drug importation and manufacturing was a free for all affairs. Drug information and adverse drug reaction monitoring processes were not also in place, hence there were no effective drug recall procedures. (NAFDAC Consumer Safety Bulletin 2003: 10).
The paucity of enforcement of the existing drug laws, can be seen from the fact that in the twenty years between the enactment of Food and drug Decree no. 35 of 1974, and the establishment of NAFDAC in 1994, there are no records of prosecution of offenders despite the Ibadan and Jos incidents in 1989 when over 150 children were reported to have died due to a formulation error. Despite the fact that Nigeria had a relatively well developed regulatory process, civil service bureaucracy, corruption, political instability and a host of other
lapses thwarted this process. To remove these bottlenecks and ensure effectiveness, the Honourable Minister of Health Prof. Olukoye Ramsone Kuti, directed in September 1992 that a blueprint be prepared for the establishment of Food and Drug Regulatory Agency. In the words of the pioneer Director General of NAFDAC, Prof. G. E. Osuide, the excision of the functions of control and regulation of food, drugs and other regulated products from the main stream of civil service setting was a progressive decision in tune with what obtains in a number of countries. While inaugurating the pioneer governing council of NAFDAC in September 1992, the Hounourable Minister of Health Prof. Olukoye Ramsone Kuti said that the establishment of NAFDAC was to give a frontal attack to the health problems arising from food, chemicals, drugs, medicines and similar regulated products without the inhibitions of the civil service setting. (NAFDAC Consumer Safety Bulletin
2003: 10).
The National Agency for Food and Drug Administration and Control (NAFDAC), was therefore established by Decree No. 15 of 1993 (as amended), to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals/detergents, medical devise and all drinks including our popular “pure water”. (NAFDAC Consumer Safety Bulletin 2003: 10).
The scope of this mandate puts the responsibility of safeguarding public health on the Agency and these touches on the life of every Nigerian. The Agency was structured into the following six Directorates.
1. Registration and Regulatory Affairs,
2. Inspectorate,
3. Laboratory Services,
4. Narcotics,
5. Planning, Research and Statistics, 6. Finance and Administration (NAFDAC Consumer Safety Bulletin).
This material content is developed to serve as a GUIDE for students to conduct academic research
IMPACT OF NAFDAC ON QUALITY MANAGEMENT OF NIGERIAN MANUFACTURING SECTOR
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