Jhulelal Institute of Technology, Nagpur
Prof. Rajesh Shende
Assistant Professor, Department of MBA,
Jhulelal Institute of Technology, Nagpur
Implementation of an effective quality assurance policy is the most important goal of pharmaceutical industry. The concept of quality assurance and quality control together develops towards assuring the quality, safety and efficacy of pharmaceutical products. Thus, quality is critically important ingredient to organizational success today, which can be achieved by total quality management (TQM), an organizational approach that focuses on quality as an overarching goal, aimed at the prevention of defects rather than detection of defects. It is a philosophy and practice of integrative quality management system adopted worldwide in pharmaceutical industries along with other regulatory requirements. The TQM perspective views quality as the pivotal purpose of the organization.
Keyword : Quality assurance, total quality control, total quality management (TQM), Pharmaceuticals.
Total Quality Management is approach that originated in the 1950’s has steadily become more popular since the early 1980’s. Total Quality is a descriptive of the culture attitude and organization of the company that strive to provide customer with product and service that satisfy their need. Total Quality Management is a Method by which management and employee which can become involved in the continues Improvement of the production of goods and services.
The pharmaceutical industry, as a vital segment of the health care system conducts research, manufacturing and marketing of pharmaceuticals and biological products and medicinal devices used for the diagnosis and treatment of diseases. The poor qualities of medicines are not only a health hazard, but also a waste of money for both government and individual consumers. Therefore, the maintenance of quality with continuous improvement in facilities is very important in pharmaceutical industries. The pursuit of quality being approached through the concept of total quality management (TQM) system which is aimed at prevention of defects rather than detection of defects.
The concept of total quality control refers to the process to produce a perfect product by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production. Although the responsibilities for assuring product quality belong primarily to quality assurance personnel, it involves many department and disciplines within a pharmaceutical company. To be effective, it must be supported by a team effort. Quality must be built into a pharmaceutical product during product and process design and it is influenced by the physical plant design, space, ventilation, cleanliness and sanitation during routine production. The assurance of quality of the product depends on more than just proper sampling and adequate testing of various components and finished dosage forms (products). Prime responsibility of maintaining the product quality during production rests with the manufacturing department. Quality assurance personnel must establish control or check points to monitor the quality of the product as it is processed and up to completion of manufacturing. This begins with raw materials and component testing and includes in-process packaging, labeling and finished product testing as well as batch auditing and stability monitoring.
A search was made of the following databases: WHO, FDA, ICH, EU to download their corresponding guidelines. Using the Google search engine; also a number of papers and articles were downloaded. Search words used were: pharmaceutical quality, quality and pharmaceutical industry
- To Study the Quality Management at Adroit Pharmaceuticals Private Limited.
- To Understand the Waste Management at Adroit Pharmaceuticals Private Limited.
- To Study the Reduction of Lead time.
- To Understand Mistake Prevention.
- To Study about the food and drugs administration (FDA).
II. RESEARCH METHODOLOGY
Data collection plays an important role in research work. Without proper data available for analysis you cannot do the research work accurately. This chapter describes the methodology of the study. This project is based on information collected from primary sources.
III.1 TYPES OF DATA COLLECTION There are two types of data collection methods available.
Primary data collection: The primary data is that data which is collected fresh or first hand, and for first time which is original in nature. Primary data can collect through personal interview, questionnaire etc. to support the secondary data.
Primary data used in this project is collected through three methods, namely, questionnaire method and direct personal interview method, observation method. All these methods proved to be great help in getting the required information.
Observation method- in this method a good report establishment of respondent with researcher plays a very important role. The researcher is present in the Factory from where he makes observation and from there he collects the relevant data according to the careful observation of respondents
Interview method- it is systematic method by which one person enters more or less imaginatively into the inner life of another who is generally a comparatively stranger for me.
Questionnaire- it is the method by which we can make a group of employees by dividing them in various subject or asking them question about their work, their problems and their product quality.
Secondary data collection: Secondary data are those which have already been collected by others. When it is not possible to collect data in primary form, the researcher may take the help of secondary data. They are thus which have already been collected for serving the objectives other then what the researcher might have in his mind.
Books: A book is a collection of paper or other material with text, pictures, or both written on them, bound together along one edge, usually with covers. In library and information science, a book is calling a monograph to distinguish it from serial periodicals such as research books journals or newspapers.
Websites: A website may be the work of an individual, a business or other organization and is typically dedicated to some particular topic or purpose. Any website can content s hyperlink to any other website, so the distinction between individual sites, as perceived by the user, may sometimes to blur.
Journal: A journal may publication issued at stated intervals, such as research papers or the record of the transactions of a society, are often called journals. In academic use, a journals refers to a serious, scholarly publication, most often peer-reviewed. The purpose of a journal is to provide a place for the introduction a scrutiny of new research and often a forum for the critique of existing research.
Types of sampling: Types of sampling used in to check quality were simple random sampling. In this method, the sampling units have chosen randomly from the total batches.
Sample size determination: Sample size restricted as the sample is one organization. This sample size was determined as 10 as it is selected randomly from the Pharmaceutical factory.
I. DATA ANALYSIS
Management tools for process analysis planning and decision making:
After the development of the TQM, vision, mission, and value statements it is important to analyze the organization’s processes and provide the information needed to develop activity specific policies, procedures, and work instruction to carry out the TQM. The environmental aspects and impact must be characterized for each process, activity, product, or service is described. This requires a thorough analysis of all the processes. Objectives, targets will have to be linked to the quality policy. Popular decision making tools e. g. flowcharts, cause-and-effect diagram, brainstorming, histogram SWOT (Strength weakness- opportunities-threat) analysis, Pareto diagram etc may be applied planning, evaluation and continual improvement activities.
Flowcharts: A flowchart is a diagram that uses connecting lines and a set of symbols to show the
steps from beginning to end of an activity or procedure.
Cause-and-effect diagram: The cause and effective or CE diagram (also known as Fish- Bone Diagram) come of a brainstorming session, wherein various causes are identified for an effect. The resulting diagram shows pictorially the relationship between the identified causes and effect being looked into. For example, in any manufacturing process the various factors that can effect it can be grouped in so called 4 M’s, viz. materials, men, machines and methods. Therefore, a variation in materials, machines, personnel and methods can add up to great deal of final product quality variation. Thus in any TQM effort which uses this tool to analyze problems in a manufacturing process, normally starts with these primary causes. Example: cost reduction analysis.
Brainstorming: Putting the right group together and letting it brainstorm can have tremendous positive results, and there are many potential uses for this technique in the continual improvement program. Many quality programs use “quality circles” or “focus groups” to develop ideas for program development and improvement. These are similar in concept to brainstorming followed by analysis of data. Brainstorming can be used for selected problems or as part of the day-today activities. Participants should be those people who are affected by the problem.
FADE: Another technique that can be used to build on the ideas generated during brainstorming is the FADE (Focus, Analyze, Develop, and Execute) process, which was popularized by the total quality management (TQM) movement. In this process, the information developed during brainstorming is organized and analyzed. The participants focus on specific topics, analyze these topics, develop solutions, and execute those solutions.
Pareto diagram: An Italian economist, Velfredo Pareto, discovered a rule while studying distribution of income in 1897. He found that 80% of the wealth of the country was controlled by only 20% of the families. Later management experts also applied the rule to organizations. Juran observed that the majority portion of quality problems are on account of a very few types of defects arising out of a relatively small number of causes. Therefore, if these vital few causes are looked into and controlled, then the quality problems are solved to a great extent. It has been found that in organizational problem analysis that, 80% of the problems are caused by 20% of all causes. Therefore by solving 20% of all causes about 80% of the problems can be solved. This rule has come to be known as 80/20 rule or ‘vital few’ and ‘trivial many’ principle. Experience shows that this is indeed that this is indeed so in various spheres of life.
Occurrence of 20/80 rule in various situations:
- More than 80% of scrap in a manufacturing plant might be generated by less than 20% operators.
- More than 80% of the office errors in an office might be due to less than 20% of office staff.
- More than 80% of items in an inventory might cost less than 20% of total inventory cost.
- More than 80% of the turnover of a company might be generated by less than 20% of the products.
- More than 80% of the defective items might be produced on less than 20% of the machines.
Step-wise procedure to construct Pareto diagram:
- Decide on what defect data are to be collected (e.g. machine-wise defects).
- Decide on time period to be covered for the collection of above data. This is determined by the type of problem and frequency of data generated.
- Collect data on the defect area determined in step 1 for the time period established in step 2.
- Design a tally sheet and mark occurrence of classified defect by the tally mark. The total of tally marks for each cause will indicate frequency for that particular defect cause.
- Arrange the order of defects in descending order of frequency of occurrence and calculate individual percentage of occurrence of defects.
- Draw a horizontal axis and at the each end of it draw two vertical axis. We divide the horizontal axis into a number of intervals equal to number of classified defect sources. We mark the left vertical axis with a suitable scale denoting number of defectives and the right vertical axis with a suitable scale showing cumulative percentage defectives.
- Construct the column to represent the number of defectives classified by sources.
- Mark the cumulative percentage values by thick points and join these by straight lines.
- Put legends and marking on various axis to enable quick comprehension of the Pareto diagram.
- Use the Pareto diagram to help in reduction of a defect situation.
Bio-Chemical Oxygen Demand: The most common cause of high BOD was exceeding the plant’s capacity. The least frequent cause was power failure. Fig. 2 shows that the most common cause, exceeding plant capacity, accounted for 34% of the high BOD discharges. Concentrated wastes accounted for a total of 60% of the high BOD events. It should be noted that frequency of occurrence is not the only consideration when examining potential significance of the Pareto chart data. For example, there may be a problem or cause that does not occur The manufacturer should be in a position,
- to control the sources of product quality variation, namely materials, machines, methods and men.
- to ensure the correct and most appropriate manufacturing and packaging practices.
- to assure that the testing results are in compliance with the standards or specifications.
- to assure product stability and to perform other activities related to product quality through a well-organized total quality assurance system.
For the total quality management system to function effectively, certain basic operational rules should be established and should always prevail. First, control decisions must be based solely on considerations of product quality. Second, the operation must adhere rigidly to the established standards or specifications as determined by systemic inspection, sampling and testing, and should constantly strive for improving the levels of the current standards or specifications. Third, the facilities, funds for personnel and environment necessary for personnel to perform their responsibilities effectively should be adequately provided. Last but not the least, the control decisions should be independent administratively, and they must not yield to or be overruled by, production or marketing under any circumstances. Because the control decision can involve the health of the consumer and the reputation of the pharmaceutical manufacturer, the climate necessary for making judicious decisions is essential. In times of major disagreements, the control decision should be subjected to review only at the highest level of very often, but each occurrence is very costly. If so, this problem or cause may require correction first.
The professional, social and legal responsibility that rest with the pharmaceutical manufacturers for the assurance of product quality are tremendous. It is only through well organized, adequately staffed accurately performed process and dosage form control before, during and after production that adequate quality assurance of the product can be achieved. It should be realized that no amount of dosage form testing and control can maintain and assure product quality unless good manufacturing practices (GMP) are implemented systematically and process control is practiced rigorously. Product quality must be build into and not merely tested in the product. The pharmaceutical manufacturer assumes the major responsibility for the quality of his products.
Concept of quality management in pharmaceutical industry by Manohar A Potdar, Nirala prakashan.
Quality assurance of pharmaceuticals by world health organization, second edition.
Total quality management in pharmaceuticals, International Journal of Pharm Tech Research CODEN (USA): IJPRIF
Total Quality Management (TQM) in Pharmaceutical Industries, Faysal Ahamed Manarat International University