IMPACT OF NAFDAC ON QUALITY MANAGEMENT OF NIGERIAN MANUFACTURING SECTOR

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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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