Proposed Improvement In The Quality Of Caplet Drug Products Using The Statistical Quality Control And Fault Tree Analysis Method At PT. Mutiara Mukti Farma
Introduction
PT. Mutiara Mukti Farma is a reputable company that specializes in the production of high-quality drug products, including caplet drugs. However, despite its efforts, the company has been facing significant challenges related to product quality, particularly in the production of caplet drugs. In 2014, a staggering 1,715,200 caplet units were detected, which accounted for 6.7% of the total production. This alarming rate of defective products far exceeds the company's standard defect limit of 5%. Therefore, it is imperative for PT. Mutiara Mukti Farma to identify and address the root causes of product disability to maintain the quality of its production and minimize the number of defective products.
Background of the Study
The production of caplet drugs is a complex process that involves multiple stages, from raw material procurement to final product packaging. Despite the company's best efforts, defects in the production process can occur due to various reasons, including human error, equipment malfunction, and inadequate quality control measures. In an effort to address these issues, a comprehensive study was conducted to identify the most dominant types of disability, observe the control limits of product quality, analyze the causes of disability, and formulate improvement actions using statistical quality control (SQC) methods with seven tools and fault trees analysis (FTA).
Methodology
The study employed a combination of statistical quality control (SQC) methods with seven tools and fault trees analysis (FTA) to analyze the causes of product disability. The SQC methods used included:
- Control Charts: To monitor and control the production process
- Pareto Analysis: To identify the most common causes of product disability
- Fishbone Diagram: To identify the root causes of product disability
- Scatter Diagram: To analyze the relationship between variables
- Histogram: To analyze the distribution of data
- Check Sheet: To collect and analyze data
- Flowchart: To analyze the production process
The FTA method was used to analyze the causes of product disability in depth. FTA is a systematic approach to analyzing complex problems by breaking them down into smaller, more manageable components. The FTA method involves identifying the causes of a problem, analyzing the relationships between these causes, and identifying the minimum set of causes that contribute to the problem.
Results
The results of the study revealed that the most common causes of product disability were related to the thickness and shape of the caplet. The FTA analysis revealed several causes of causes, including boredom, indiscipline, lack of skills, operator negligence, and communication errors among workers. The results of the analysis indicated that the main cause of product disability was employee indiscipline and communication errors between workers.
In-Depth Analysis
The results of the analysis highlighted the importance of human resource management in maintaining product quality. The company needs to focus on improving human resource management by providing training and development opportunities to employees to enhance their skills and knowledge. Additionally, the implementation of better communication procedures among workers can reduce miscommunication that has the potential to cause product disability.
Conclusion
The adoption of statistical quality control and fault tree analysis methods will not only help in reducing product disability but also build a better quality culture within the company. By emphasizing the importance of each individual in maintaining product quality, the company can achieve the expected quality standards and reduce the level of product disability. Continuing monitoring and performance evaluation are also essential to ensure that every improvement action taken has a significant impact.
Recommendations
Based on the findings of the study, the following recommendations are made:
- Improve Human Resource Management: Provide training and development opportunities to employees to enhance their skills and knowledge.
- Implement Better Communication Procedures: Reduce miscommunication that has the potential to cause product disability.
- Continuing Monitoring and Performance Evaluation: Ensure that every improvement action taken has a significant impact.
- Adopt Statistical Quality Control and Fault Tree Analysis Methods: Use these methods to analyze the causes of product disability and identify areas for improvement.
Future Research Directions
Future research should focus on:
- Developing a Comprehensive Quality Management System: A quality management system that incorporates statistical quality control and fault tree analysis methods.
- Implementing a Continuous Improvement Culture: A culture that emphasizes the importance of continuous improvement and encourages employees to identify and address areas for improvement.
- Developing a Performance Measurement System: A system that measures the performance of employees and the company as a whole.
Limitations of the Study
The study has several limitations, including:
- Limited Sample Size: The study was conducted on a limited sample size, which may not be representative of the entire population.
- Limited Data Collection: The study relied on secondary data, which may not be accurate or up-to-date.
- Limited Analysis: The study only analyzed the causes of product disability and did not explore other factors that may contribute to product quality.
Conclusion
In conclusion, the study highlights the importance of statistical quality control and fault tree analysis methods in improving product quality. The results of the study indicate that employee indiscipline and communication errors between workers are the main causes of product disability. The company needs to focus on improving human resource management and implementing better communication procedures to reduce miscommunication that has the potential to cause product disability. Continuing monitoring and performance evaluation are also essential to ensure that every improvement action taken has a significant impact.
Q: What is the main problem faced by PT. Mutiara Mukti Farma in terms of product quality?
A: The main problem faced by PT. Mutiara Mukti Farma is the high rate of defective products, particularly in the production of caplet drugs. In 2014, a staggering 1,715,200 caplet units were detected, which accounted for 6.7% of the total production.
Q: What are the causes of product disability in caplet drug production?
A: The causes of product disability in caplet drug production are related to the thickness and shape of the caplet. The FTA analysis revealed several causes of causes, including boredom, indiscipline, lack of skills, operator negligence, and communication errors among workers.
Q: What is the main cause of product disability in caplet drug production?
A: The main cause of product disability in caplet drug production is employee indiscipline and communication errors between workers.
Q: How can PT. Mutiara Mukti Farma improve product quality?
A: PT. Mutiara Mukti Farma can improve product quality by improving human resource management, providing training and development opportunities to employees to enhance their skills and knowledge, and implementing better communication procedures among workers.
Q: What is the role of statistical quality control and fault tree analysis methods in improving product quality?
A: Statistical quality control and fault tree analysis methods play a crucial role in improving product quality by analyzing the causes of product disability and identifying areas for improvement.
Q: What are the benefits of adopting statistical quality control and fault tree analysis methods?
A: The benefits of adopting statistical quality control and fault tree analysis methods include reducing product disability, building a better quality culture within the company, and improving employee skills and knowledge.
Q: How can PT. Mutiara Mukti Farma ensure that every improvement action taken has a significant impact?
A: PT. Mutiara Mukti Farma can ensure that every improvement action taken has a significant impact by continuing monitoring and performance evaluation.
Q: What are the limitations of the study?
A: The study has several limitations, including limited sample size, limited data collection, and limited analysis.
Q: What are the future research directions?
A: Future research should focus on developing a comprehensive quality management system, implementing a continuous improvement culture, and developing a performance measurement system.
Q: What is the conclusion of the study?
A: The study highlights the importance of statistical quality control and fault tree analysis methods in improving product quality. The results of the study indicate that employee indiscipline and communication errors between workers are the main causes of product disability. The company needs to focus on improving human resource management and implementing better communication procedures to reduce miscommunication that has the potential to cause product disability.
Q: What is the final recommendation of the study?
A: The final recommendation of the study is that PT. Mutiara Mukti Farma should adopt statistical quality control and fault tree analysis methods to improve product quality and reduce product disability.