Quality Assurance (QA) is a framework used to ensure the quality of products and services through a systematic approach. Quality Control (QC) is a framework supported by systematic approaches to test and control quality in products and services.
It is essential to understand that there are differences between QA and QC, as they each play distinct roles in ensuring quality.
Although there are generally accepted differences between quality assurance and quality control, these distinctions can vary based on a company’s processes and size. As a result, the commonly accepted differences can be subject to analysis. This article will discuss these differences in detail and include our perspective on them.
QA and QC are closely related and work together as part of the Quality Management System (QMS).
QMS software supports QA and QC processes by providing features and capabilities that streamline quality assurance and quality control activities.
SimplerQMS provides a QMS software solution designed for life science companies. Book a personalized demo to learn how SimplerQMS streamlines the QA and QC processes.
Explore the specific topics covered in this article:
- What Is Quality Assurance (QA)?
- What Is Quality Control (QC)?
- What Are the Key Differences Between Quality Assurance (QA) and Quality Control (QC)?
- What Are the Relations Between Quality Assurance, Quality Control, and Quality Management Systems?
- What Is the Role of QMS Software in Supporting Quality Assurance and Quality Control?
What Is Quality Assurance (QA)?
Quality assurance is a framework that utilizes systematic approaches to ensure the quality of products and services.
QA helps companies ensure their products or services meet quality specifications and relevant requirements. QA involves processes and procedures that promote consistent quality throughout the product or service lifecycle.
QA aims to prevent quality issues in products or services by planning, monitoring, documenting, and reviewing processes.
What Is the History of Quality Assurance?
The history of quality assurance can be traced back to the early 20th century when industrialization began to reshape manufacturing processes. During this period, the focus shifted from individual craftsmanship to mass production, leading to the need for standardized quality.
The concept of QA, as we know it today, started with the introduction of process control methods by pioneers like Walter A. Shewhart, W. Edwards Deming, and Joseph M. Juran.
The evolution of QA led to the development of new tools, such as the Plan-Do-Check-Act (PDCA) cycle, also known as the Deming Cycle or Shewhart Cycle. The PDCA offers a structured approach with a systematic series of steps to continuously improve a product or process.
World War II played an important role in the development of QA practices. The high demand for military equipment required efficient and effective quality management systems. The United States military introduced sampling inspection techniques and sampling tables to manage production volumes and ensure reliability.
After World War II, QA practices saw significant advancements, particularly in Japan. Japan’s focus on rebuilding its economy led to adopting quality management principles. Japanese manufacturers prioritized product quality over cost, leading to the development of the Lean Management approach at Toyota. Lean Management aims to optimize production efficiency and minimize waste while maintaining high quality.
In response, the Total Quality Management (TQM) approach was developed in the late 20th century. TQM integrated statistical methods, employee involvement, and a focus on customer satisfaction to drive continuous improvement across all processes.
Further improvements in quality management followed, including the release of the ISO 9000 quality standard in 1987 and the establishment of the Baldrige National Quality Program in the USA during the same year.
Over the years, QA has evolved into a fundamental component of the quality management system, extending its influence across various industries, including healthcare, manufacturing, finance, and life sciences, among others.
Why Is Quality Assurance Important?
Quality assurance is important as it ensures that products and services are of uniform and high quality, safe, fit for intended use, and compliant with relevant requirements.
QA helps prevent issues and ensure the reliability and effectiveness of products or services through their lifecycle.
QA is essential from several perspectives, as outlined below.
- Company Perspective: QA helps companies maintain a competitive edge by ensuring the high quality of their products and services. QA reduces waste, helps ensure compliance, and minimizes costs associated with defects and rework.
- Employee Perspective: QA provides a clear framework and specifications for employees to follow, increasing job satisfaction by reducing task misunderstanding and potential errors.
- Customer Perspective: QA ensures that customers receive products and services that meet their expectations for quality and reliability, leading to increased trust and loyalty.
What Is the Quality Assurance Process?
The quality assurance process is a systematic approach used by companies to ensure the quality of products or services.
QA processes can vary significantly across different industries and companies because the definition of quality itself is not universal. Quality is defined based on specific needs, regulatory requirements, and customer expectations.
Each company tailors its QA processes to align with its specifications and relevant requirements, resulting in diverse approaches to maintaining and improving quality.
Companies can implement quality assurance systems to manage and execute QA processes and activities effectively. QA is an integral component of the Quality Management System (QMS), creating a cohesive system that encompasses all aspects of quality management.
What Is Quality Control (QC)?
Quality control is a framework for testing and controlling quality in products and services using systematic approaches.
QC is implemented by companies to support QA in ensuring that products or services comply with internal, customer, and regulatory requirements. QC involves the systematic testing and control of products and processes at various stages of the lifecycle.
QC aims to identify and address issues that could affect quality. QC encompasses inspections, testing, and verifications to maintain the uniform and high quality of products and services.
What Is the History of Quality Control?
The history of quality control dates back to early civilizations when craftsmanship ensured the quality of products. Civilizations like Egypt pioneered methods to control the quality of construction materials, such as meticulously verifying the shape of stones for the pyramids.
During the Industrial Revolution, mass production introduced standardized processes for creating interchangeable product parts. However, early processes were inconsistent, causing varying product quality. Eli Whitney’s introduction of interchangeable parts for musket production in the United States highlighted the advantages of standardized manufacturing processes and objective inspection.
In 1911, Fredrick W. Taylor’s influential monograph Principles of Scientific Management further developed QC by promoting systematic approaches to efficiency and quality in manufacturing. Taylor’s concepts, including the role of inspectors in ensuring shop floor quality, established a framework for modern QC practices.
Walter A. Shewhart’s pioneering work on Statistical Process Control (SPC) in the 1920s introduced the concept of “zero defects” in the production of telephone equipment. SPC emphasizes the use of statistical methods to monitor and improve production processes.
The SPC laid a solid foundation for future quality leaders like W. Edwards Deming and Joseph M. Juran, who expanded upon Shewhart’s principles and advanced QC globally.
The history of QC is marked by continuous improvement and refinement, from ancient craftsmanship to modern industrial practices. QC emphasizes systematic approaches, standardization, and the continuous pursuit of quality excellence.
Why Is Quality Control Important?
Quality control is important as it tests and controls the quality of products and services.
QC helps ensure that products or services meet quality specifications and comply with customer and regulatory requirements. QC identifies and addresses nonconformance and deviations from defined quality specifications during the product or service lifecycle.
QC is essential from several perspectives, as described below.
- Company Perspective: QC helps companies identify quality issues and ensure continuous improvements.
- Employee Perspective: QC provides clear guidelines for employees to follow, reducing errors and fostering satisfaction in delivering high-quality products and services.
- Customer Perspective: QC ensures that customers receive products or services of high and uniform quality.
What Is the Quality Control Process?
The quality control process is a systematic approach aimed at testing and controlling the quality of products or services.
QC processes can change across different industries and companies due to the subjective nature of quality. Quality is defined based on specific needs, regulatory requirements, and customer expectations. Each company customizes its QC processes to align with its specifications and applicable requirements, leading to diverse approaches to maintaining and improving quality.
Companies can implement QC systems to effectively manage and execute QC processes and activities. QC is integral to the Quality Management System (QMS), creating a system that covers all aspects of managing quality.
These systems include various features designed to assist companies in ensuring quality, such as audit management, nonconformance, and deviation management, CAPA management, supplier management, complaint management, and others.
What Are the Key Differences Between Quality Assurance (QA) and Quality Control (QC)?
There are generally accepted differences between quality assurance and quality control, which we will outline and clarify.
These QA and QC differences often vary and may not always be accurate depending on the specific processes a company adopts and the company size. These generally accepted differences will be further discussed in the following sections.
Listed below are commonly mentioned differences between QA and QC.
- Proactive (QA) vs. Reactive (QC)
- Process Oriented (QA) vs. Product Oriented (QC)
- System (QA) vs. Parts (QC)
- Cross-Functional (QA) vs. Dedicated Personnel (QC)
- Preventing (QA) vs. Verifying, Controlling, and Detecting (QC)
- Activities Across Full Lifecycle (QA) vs. Periodic Activities (QC)
- Managerial Tool (QA) vs. Operation Tool (QC)
The visual below illustrates the generally accepted differences between QA and QC.
1. Proactive (QA) vs. Reactive (QC)
The generally accepted difference is that QA is proactive, while QC is reactive.
QA is typically proactive, focusing on establishing processes and procedures to prevent issues before they occur. QC is more reactive, involving activities that detect and correct issues in the product or service lifecycle.
In quality management, QA emphasizes prevention through systematic procedure planning and implementation, while QC addresses issues through inspection, testing, and control actions.
From our perspective, both QA and QC can display proactive and reactive characteristics depending on how a company integrates them into its operations.
For instance, QA can be proactive when a company invests in robust employee training programs. QA can be reactive if it involves analyzing data from customer feedback or post-production inspections to identify areas for improvement.
Similarly, QC can be proactive when companies use predictive analytics to anticipate potential issues and adjust processes accordingly. QC can be reactive if it involves conducting inspections and tests on finished products to ensure they meet quality specifications after production.
Therefore, the nature of QA and QC often depends on how they are strategically implemented within the company’s overall quality management system.
2. Process Oriented (QA) vs. Product Oriented (QC)
The commonly mentioned difference is that QA is process-oriented, and QC is product-oriented.
QA is process-oriented and focuses on establishing and maintaining processes to ensure consistent quality in products or services. QA activities include developing and implementing Standard Operating Procedures (SOPs), conducting audits, and providing training to employees.
QC is product-oriented and involves activities that verify and evaluate the quality of products or services. QC includes inspections, testing, and sampling to detect issues and ensure products meet quality specifications and comply with relevant requirements.
3. System (QA) vs. Parts (QC)
The commonly mentioned difference is that QA focuses on the entire system, while QC focuses on individual system parts.
QA is often described as system-oriented, focusing on establishing and maintaining processes to ensure the overall quality of products or services. QC is typically viewed as part-oriented, concentrating on inspecting and testing individual products or components to detect and correct issues from established quality specifications.
From our perspective, QA and QC complement each other in ensuring and controlling quality throughout the product or service lifecycle. For example, in smaller companies or industries with specialized products, QA and QC may be more integrated and overlapping.
4. Cross-Functional (QA) vs. Dedicated Personnel (QC)
The generally accepted difference is that QA is cross-functional, and QC has dedicated personnel.
QA is often described as cross-functional, involving activities across all products, services, and processes within a company. QC is typically associated with dedicated personnel or teams responsible for inspecting, testing, and verifying the quality of specific products or components.
From our perspective, the distribution of QA and QC responsibilities can vary depending on the company’s size, organizational structure, and the complexity of the products or services offered.
For instance, larger companies typically have distinct QA and QC personnel, while smaller companies may integrate QA and QC roles more closely, with team members performing dual functions.
5. Preventing (QA) vs. Verifying, Controlling, and Detecting (QC)
The commonly accepted difference is that QA primarily focuses on preventing issues before they occur, while QC concentrates on verifying and controlling quality by detecting issues in products or services.
QA is primarily focused on preventing defects and issues before they occur by implementing systematic processes. QA activities include defining quality specifications, monitoring processes, and providing training to ensure adherence to procedures, among others.
QC is oriented toward verifying, controlling, and detecting issues through inspections and testing. QC ensures that products or services meet quality specifications and relevant requirements and are free from defects.
6. Activities Across Full Lifecycle (QA) vs. Periodic Activities (QC)
Another commonly mentioned difference is that QA activities encompass the full product or service lifecycle, while QC performs periodic activities in the lifecycle.
QA encompasses activities across the entire lifecycle of a product or service, from initial planning and development through to delivery and post-market.
QC activities are more periodic and focus on inspecting products or services at specific points in their lifecycle to verify the presence of quality.
The illustration below shows QA activities throughout the lifecycle with periodic QC activities.
7. Managerial Tool (QA) vs. Operation Tool (QC)
The generally accepted difference is that QA is a managerial tool, and QC is an operation tool.
QA is often described as a managerial tool due to its systematic approach to ensuring and improving the quality of products or services within a company. QA activities in managerial practices can encompass strategic planning, policy development, and the periodic review of quality across a company, among others.
QC is viewed as an operational tool that handles specific tasks related to testing and controlling the quality of products or services. QC activities include Statistical Process Control (SPC), sampling procedures, product evaluations, and others to ensure that products comply with quality specifications and relevant requirements.
From our perspective, QC is essential for supporting QA by identifying quality issues and necessary actions. While QC detects quality issues, QA takes responsibility for implementing necessary changes to ensure quality. Both QA and QC are essential components of a comprehensive quality management system.
What Are the Relations Between Quality Assurance, Quality Control, and Quality Management Systems?
Quality assurance, quality control, and the quality management system are interconnected components essential for ensuring and controlling quality within a company.
Both QA and QC operate simultaneously within the broader quality management system. The QMS integrates QA and QC activities into a unified approach for quality management.
QC is a subset of QA, which, in turn, is part of the overall QMS.
The image below shows the relation between QA, QC, and the QMS.
What Is the Role of QMS Software in Supporting Quality Assurance and Quality Control?
QMS software, often referred to as electronic QMS (eQMS), supports both QA and QC by streamlining and automating processes. The eQMS helps ensure companies meet quality specifications and comply with customer and regulatory requirements.
SimplerQMS provides a life science eQMS software solution designed for industries, such as pharmaceuticals, medical devices, biotechnology, and more.
SimplerQMS software facilitates QA and QC by supporting all quality processes, such as document management, change control, training management, CAPA management, audit management, supplier management, and others.
SimplerQMS system provides comprehensive process support that helps companies comply with various life science quality management requirements, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, ICH Q10, EudraLex Volume 4 GMP, and many more.
SimplerQMS software is fully validated according to ISPE GAMP 5. SimplerQMS manages all software validation processes, saving customers from needing extra resources, time, or expenses for validation.
Learn how SimplerQMS can streamline Quality Assurance and Quality Control processes. Book a demo and talk with our Quality Solution Consultants experts to better understand how SimplerQMS can support your company.
