An Overview on Quality Control as A Means of Enhancing Productivity in A Production Company

Abstract

Quality control is crucial for companies manufacturing products or services, as it improves customer satisfaction, reduces resource wastage, and increases efficiency and profits. In the pharmaceutical industry, productivity in production refers to the efficiency of transforming inputs into valuable outputs while maintaining strict quality and safety standards. High productivity can be achieved through automated processes, real-time data monitoring, and a well-trained workforce. Quality control is a foundation for productivity, reducing errors, rework, and waste. It also ensures regulatory compliance, preventing delays and legal issues. A balance between quality and productivity is essential, and implementing robust quality management systems is essential. Quality control processes include inspection, testing, and quality control methodologies. Effective QC identifies defects early, preventing costly rework and regulatory penalties.

Keywords

Introduction

Quality control is essential for any company that manufactures products or provides a service. It helps improve customer satisfaction by consistently delivering quality products or services, reduce wastage of resources and increase efficiency and profits for the company. Because certain industries rely on quality control to set product standards imagine a pharmacy makes a batch of pain relief tablets. Quality control would involve:

• Checking the ingredients: Making sure the correct amounts of each ingredient are used.
• Testing the tablets:

•  Checking if the tablets dissolve properly.
•  Measuring the amount of the active ingredient in the tablets.
•  Looking for any impurities or unwanted substances.

• Inspecting the packaging: Ensuring the labels are correct, the bottles are sealed properly, and the expiration dates are accurate.

In the pharmaceutical industry, "productivity in production" refers to the efficiency with which a company transforms inputs (like raw materials, labor, and equipment) into valuable outputs (finished drug products), while maintaining strict quality and safety standards. It's not just about producing more; it's about producing more effectively.

Low Productivity: If the company relies heavily on manual processes, experiences frequent equipment breakdowns, and has high rates of product defects, its productivity is low.

High Productivity: A company that implements automated tablet pressing and packaging equipment, utilizes real-time data monitoring to detect and correct process deviations, and has a well-trained workforce that adheres to strict GMP, will have high productivity.

For example, implementing a new system that reduces the time it takes to change over production lines between different medications. This would allow the company to produce more batches in a given time period, increasing productivity. Also, implementing a better-quality control system that reduces the amount of rejected batches, also increases productivity. pharmaceutical productivity is about achieving maximum output with minimal waste, while upholding the highest standards of quality and safety.

Relationship

Quality as a Foundation for Productivity:

• High-quality processes reduce errors, rework, and waste. This directly translates to increased efficiency and higher productivity.
• When quality is built into the manufacturing process (Quality by Design), it minimizes the need for costly and time-consuming end-product testing and corrections.
• Adherence to quality standards ensures regulatory compliance, preventing costly delays, recalls, and legal issues that would disrupt production.

Productivity's Impact on Quality:

• Excessive pressure to increase productivity without adequate quality control can lead to shortcuts and compromises, resulting in substandard products.
• However, optimized and efficient production processes, when done correctly, can enhance consistency and reduce variability, which are essential for maintaining quality.
• Technological advancements that improve productivity, such as automated systems and real-time monitoring, can also enhance quality by reducing human error.

The Importance of Balance:

• The pharmaceutical industry must strike a delicate balance between quality and productivity. Prioritizing one at the expense of the other can have severe consequences.
• A focus on continuous improvement, where both quality and efficiency are constantly evaluated and optimized, is crucial.
• Implementing robust quality management systems (QMS) is essential for ensuring that quality is maintained while maximizing productivity.

Impact of Quality Control on Productivity Reduces Waste:

• When QC is strong, problems are caught early in the production process. This prevents the waste of materials, time, and effort that would occur if faulty products were made.
• Fewer defective products mean less need for rework or disposal, which saves resources.

Prevents Delays:

• Effective QC helps ensure that products meet regulations and standards. This avoids costly delays caused by recalls or regulatory issues.
• Smooth production processes lead to more consistent output.

Builds Trust:

• A reputation for high-quality products increases customer trust and demand.
• This can lead to increased sales and production, boosting overall productivity.

Improves Efficiency:

• QC processes can identify areas where production can be improved, making the overall process more efficient.
• Using automated QC systems can speed up inspections, and reduce human error, therefore increasing productivity.

Cost Reduction

Effective QC identifies defects early in the production process. This prevents the need for costly rework or the outright rejection of entire batches of products. Product recalls and regulatory penalties can be incredibly expensive, involving costs for product retrieval, disposal, legal fees, and damage to brand reputation. By preventing these issues, QC avoids substantial financial losses. Quality Control Processes and Methodologies Inspection:

• Think of inspection as a visual or physical check. It's about looking at things to see if they meet certain standards.
• Examples:

• Checking if medicine bottles are properly sealed.
• Looking for cracks or damage in packaging.
• Verifying that labels are accurate and legible.
• Visually checking the colour and appearance of tablets or capsules.
• Inspecting the cleanliness of manufacturing equipment.

Testing:

• Testing involves using scientific methods and equipment to measure and analyze the properties of a product or material. It's about getting objective data.
• Examples:

• Testing the purity of raw materials.
• Measuring the amount of active ingredient in a medicine.
• Checking if tablets dissolve at the correct rate.
• Testing for the presence of harmful bacteria or other contaminants.
• Testing the stability of a drug over time.

Statistical Process Control:

The method of quality control which employs statistical methods to monitor and control a process. This helps to ensure that thr process operates efficiently producing more specification conforming products with less waste. SPC, or Statistical Process Control, is like a tool that helps pharmaceutical companies keep a close eye on their manufacturing processes and make sure everything stays consistent. Think of it as a way to catch problems before they lead to bad medicine.

Measuring and Collecting Data:

• Throughout the production process, things like the weight of tablets, the temperature of a reaction, or the purity of a substance are measured regularly.
• This data is collected and recorded.

Creating Control Charts:

• The collected data is then plotted on charts called "control charts."
• These charts have lines that show the average (mean) and the acceptable range of variation.
• Think of the lines as boundaries that show what's "normal" for the process.

Monitoring Variation:

• As new data is collected, it's added to the control charts.
• If the data points stay within the control limits, the process is considered "in control," meaning it's working as expected.
• If a data point falls outside the limits, it signals that something might be wrong.

Identifying and Correcting Problems:

• When a data point goes outside the limits, it triggers an investigation.
• The company can then figure out what caused the variation and take steps to fix it.
• This might involve adjusting equipment, changing procedures, or retraining staff.

Importance

Consistency: SPC helps ensure that every batch of medicine is made the same way, so patients get consistent doses.

Quality: It helps catch problems early, preventing the production of defective or unsafe products.

Efficiency: By identifying and correcting problems quickly, SPC reduces waste and improves overall efficiency.

Regulatory Compliance: Regulatory bodies like the FDA expect pharmaceutical companies to use SPC to monitor and control their processes.

Quality Management System:

The Pharmaceutical Quality Management System (QMS) is a complete set of policies, processes, and procedures developed to ensure and maintain uniform and high quality in pharmaceutical product manufacturing. The pharmaceutical company's unique requirements as well as any applicable regulatory requirements must be included in the QMS. It is relevant to systems that facilitate the development and manufacturing of pharmaceutical drug substances at every stage in the product life cycle, as well as to pharmaceutical products, including biological and biotech products. The pharmaceutical quality management system includes several processes, such as:

• Document management
• Change control
• Training management
• Audit management
• CAPA management
• Deviation management

Quality is crucial for protecting public health and ensuring the integrity of pharmaceutical products and medical equipment. The value of an eQMS in this role cannot be overstated. Since the epidemic, paper-based processes have become nearly useless. Electronic accessibility and administration of quality records are not only conceivable, but also required for agile businesses. Unfortunately, many life sciences businesses employ different approaches to control quality processes. This strategy has some disadvantages. Data is frequently isolated, making it difficult to reconcile and validate information across systems. Employees that use multiple-point solutions must devote a significant amount of time to system management rather than value-add activities that promote strategic process improvement. With the evolution of system capabilities, many eQMS solutions now support and integrate the following processes:

• Document Control: Manage the lifecycle of specifications, policies, and other important documents through version control and a centralized repository.
• Quality Event Management: Report and resolve deviations to improve the quality of your organization's products and prevent reoccurrence of nonconformances. Other quality events that may be managed include findings, deviations and CAPAs.
• Training: Create, assign, and track completion of trainings so employees are educated on the latest procedures.
• Audits & Investigations: Conduct audit planning, execution, and follow-up to ensure compliance and identify opportunities for improvement (CAPAs).
• Supplier Management: Manage service providers and suppliers to enhance visibility into the supply chain. Often includes the generation of supplier corrective action requests (SCARs).

Benefits of eQMS

1. Increase Efficiency: By streamlining deviation, audit, and CAPA processes, organizations can better address issues and proactively mitigate the occurrence of nonconformities. Many QMS are closed-loop systems, providing full control of processes from identification of deviations to effectiveness check completion. Not only can an eQMS ensure timely execution of quality processes, but it can also reduce manual work.
2. Make Data-Driven Decisions: Using customizable and insightful reports, quality teams can monitor key metrics such as severity of nonconformances, cycle times, and overdue trainings. By identifying trends via visualizations and dashboards, quality teams can develop actionable insights and inform higher-level decision makers.
3. Improve Compliance: In the medical device, pharmaceutical, and biotech industries, companies must adhere to strict regulations. Life sciences organizations produce a high volume of documents and records, many of which are subject to inspections. A unified QMS provides user-friendly interfaces, a centralized repository, and clear traceability, which reduces duplicative efforts and human error. Cloud-based QMS often permit role-based access, which improves data security. You can be confident that any information reviewed by regulators is accurate and up-to-date.
4. Enhance Collaboration: Today, document authoring and Supplier Corrective Action Requests (SCARs) may rely on back-and-forth emails in your organization. With the latest collaboration features, eQMS allows document editors to work in real time and suppliers to provide responses directly in the system. A centralized system reduces reliance on multiple communication methods; instead, instructions and comments provided within the QMS are considered the source of truth. These capabilities cut down on miscommunications and rework.

Data Analysis and Improvement

Data analytics in the pharmaceutical sector involves the use of advanced techniques and tools. to collect, process and analyze large volumes of data related to research, development, clinical trials, treatment effectiveness and pharmaceutical market data. These data can come from a variety of sources, including clinical studies, electronic medical records, preclinical trial data, and sales and prescription data. The main objective of data analytics in this sector is to obtain actionable information that helps pharmaceutical companies make strategic decisions and improve the efficiency and effectiveness of their operations. Quality control (QC) data collection and analysis in the pharmaceutical industry are crucial for ensuring product safety, efficacy, and consistency. Here's a breakdown of the methods involved:

1. Data Collection Methods:

• Sampling:

• This involves taking representative samples of raw materials, in-process materials, and finished products at various stages of production.
• Sampling plans are designed to ensure that the samples accurately reflect the quality of the entire batch.
• Strict adherence to standardized sampling procedures is essential to avoid bias and ensure data integrity.

• Analytical Testing:

• A wide range of analytical techniques are used to measure the physical, chemical, and microbiological properties of pharmaceutical products. These include:

• Chromatography:
• High-performance liquid chromatography (HPLC)
• Gas chromatography (GC)
• Thin-layer chromatography (TLC)
• Spectroscopy:
• Ultraviolet-visible (UV-Vis) spectroscopy
• Infrared (IR) spectroscopy
• Nuclear magnetic resonance (NMR) spectroscopy
• Mass spectrometry 1 (MS)
• Microbiological testing:
• Sterility testing
• Microbial limit testing
• Endotoxin testing
• Physical testing:
• Dissolution testing
• Particle size analysis
• Viscosity measurement
• Environmental Monitoring:

• Monitoring the environment in manufacturing and storage areas to ensure that it meets specified standards.
• This includes monitoring temperature, humidity, and microbial contamination.

• In-Process Controls:

• Monitoring critical process parameters during manufacturing to ensure that the process is operating within acceptable limits.
• This may involve continuous monitoring of temperature, pressure, and flow rates.

• Electronic Data Capture:

• Increasingly, electronic systems are used to capture and record QC data, reducing the risk of errors and improving data integrity.
• Laboratory information management systems (LIMS) are commonly used to manage QC data.

2. Data Analysis Methods:

• Statistical Analysis:

• Statistical methods are used to analyze QC data and identify trends, patterns, and outliers.
• Statistical process control (SPC) is used to monitor process variability and ensure that the process is in control.
• Descriptive statistics (e.g., mean, standard deviation) and inferential statistics (e.g., t-tests, ANOVA) are used to analyse data.

• Trend Analysis:

• Analysing QC data over time to identify trends and potential problems.
• This can help to identify process drift and predict future quality issues.

Root Cause Analysis

Root Cause Analysis is a useful process for understanding and solving a problem. As an analytical tool, Root Cause Analysis is an essential way to perform a comprehensive, system-wide review of significant problems as well as the events and factors leading to them.

PRINCIPLES:

• Focusing on corrective measures of root causes is more effective than simply treating the symptoms of a problem or event.
• RCA is performed most effectively when accomplished through a systematic process with conclusions backed up by evidence.
• There is usually more than one root cause for a problem or event.
• The focus of investigation and analysis through problem identification is WHY the event occurred, and not who made the error.

Types of Root Cause Analysis:

1. Brainstorming Technique
2. Fishbone/Ishikawa diagram
3. 5W and 1H Techniques
4. Corrective action and Preventive action (CAPA)
5. Affinity Diagrams
6. Pareto Diagram
7. Failure Mode and Effects Analysis (FMEA).

Fishbone/Ishikawa Diagram:

• The fishbone diagram identifies many possible causes for an effect or problem.
• The Fishbone diagram includes the potential cause of the problem and is used in order to find the real causes.
• This tool is mainly categorized in 6M i.e. Man, Materials, Machine Method, Measurement, Mother Nature. Below are the main 6M causes:

1. Man: Responsible persons who involved in the process or activity.
2. Materials: Raw materials, items, parts used or involved in the process or activity.
3. Method: It includes all procedures, rules, policy, regulation, and specific requirement for the activity or process
4. Measurements: Data generated during a process which measures the quality of products.
5. Machines: Any equipment, instrument involved in the activity or process.
6. Mother nature: This include environmental conditions like temperature, humidity, pressure differential etc. and culture in which process or activity performed.

Continuous Improvement:

The pharmaceutical industry is constantly evolving and faces a series of challenges that require continuous adaptation and innovation. The increasing complexity of regulations, the pressure to reduce costs and improve efficiency, and the need to develop new drugs more quickly are just a few of the obstacles that companies in this sector must overcome. Additionally, globalization and strong competition force these companies to seek ways to differentiate themselves in order to maintain their competitiveness in the global market.

Challenges in the Pharmaceutical Sector:

Increasing Service Level and Reducing Inventory Reducing Lead Time

Improving Quality

Promoting Digital Transformation

IMPORTANCE:

Continuous improvement is crucial for the pharmaceutical industry as it allows companies to optimize processes, reduce waste, and increase efficiency. By adopting continuous improvement practices, companies can respond quickly to market changes, improve the quality of their products and services, and remain competitive. This approach not only addresses immediate operational issues, but also establishes a culture of excellence and innovation that sustains long-term success.

CONCLUSION

Quality control is a vital component in the pharmaceutical industry, ensuring the safety, efficacy, and consistency of products. By implementing robust quality management systems, conducting thorough inspections and testing, and utilizing data analytics, companies can identify and address quality issues, reduce waste, and improve efficiency.

REFERENCES

1. D. Raheja, Assurance Technologies: Principles and Practices., McGraw Hill, Inc., 1991.
2. Farnum, N.R., Modern Statistical Quality Control and Improvement, Duxbury Press,
3. Belmont, California, p.500, 1994.
4. Freeman, J, G. Mintzas. 1999. Simulating c and you Control Schemes. The TQM Magazine. 11(4): 242-247.
5. Gronroos, C. (1983) ‘Strategic management and marketing in the service sector’, Report
6. No. 83-104, Marketing Science Institute, Cambridge, MA.
7. Hwang, C.L. and Lin, M.J. (1987) Group Decision Making Under Multiple Criteria:
8. Methods and Applications, Berlin: Springer-Verlag.
9. Ishikawa, K. 1985. What is Total Quality Control? Prentice Hall. Englewood Cliff, N.J.
10. Jayasuriya DC. Regulation of pharmaceuticals in developing countries: legal issues and approaches. World Health Organization; 1985.
11. Kumar A, Juluru K, Thimmaraju PK, Reddy J, Patil A. Pharmaceutical market access in emerging markets: concepts, components, and future. Journal of Market Access & Health Policy. 2014 Jan;2(1):25302.
12. Meijer A, Boon W, Moors E. Stakeholder engagement in pharmaceutical regulation: Connecting technical expertise and lay knowledge in risk monitoring. Public Administration. 2013 Sep;91(3):696- 711.
13. Adebayo VI, Paul PO, Eyo-Udo NL, Ogugua JO. Procurement in healthcare: Ensuring efficiency and compliance in medical supplies and equipment management. Magna Scientia Advanced Research and Reviews. 2024;11(2):060-9.
14. Reddy VV, Vishal Gupta N, Raghunandan HV, Nitin Kashyap U. Quality risk management in pharmaceutical industry: a review. International Journal of Pharm Tech Research. 2014;6(3):908-14.