Quality assurance (QA) and quality control (QC) are essential components of modern quality management, especially in regulated industries such as life sciences. These processes are integral to ensuring compliance with standards like FDA 21 CFR 820 or ISO 9001.
While both QA and QC play vital roles, they serve distinct purposes within the broader framework of quality management. Understanding the differences between them is crucial for organisations aiming to maintain high-quality standards and meet regulatory requirements.
QA vs QC
Quality assurance (QA) and quality control (QC) are terms that are often used interchangeably, but they represent two distinct processes that occur at different stages within a quality management system. Each process plays a unique and critical role in ensuring an effective and comprehensive approach to quality.
A clear understanding and application of both QA and QC activities can significantly enhance your organisation’s operational quality. This article provides an in-depth breakdown of QA and QC, delves into their meanings, and offers practical examples to highlight the differences between these two essential processes.
What is Quality Assurance?
Quality assurance (QA) is a fundamental part of a quality management system, widely used across various regulated industries, including life sciences. It encompasses planned and systematic actions designed to ensure that products or services meet established quality requirements.
The US Code of Federal Regulations (23 CFR § 637.203) defines quality assurance as:
“…all those planned and systematic actions necessary to provide confidence that a product or service will satisfy given requirements for quality.”
This proactive approach aims to prevent defects and maintain consistent quality throughout processes and production.
Understanding Quality Assurance
Quality assurance (QA) involves implementing a formalised system of plans, policies, and processes to ensure products are manufactured accurately and meet relevant quality standards. This structured approach is essential for maintaining compliance with industry-specific regulations.
For instance, an FDA-regulated manufacturer must ensure their quality management system (QMS) aligns with current good manufacturing practice (cGMP) requirements. A quality assurance program would then be established to guarantee that all products adhere to these regulatory demands.
Beyond meeting baseline regulatory standards, companies often aim to exceed them as they grow and evolve. They may introduce stricter internal standards and quality objectives to enhance customer satisfaction and improve product quality and safety. QA plays a critical role in achieving and maintaining these benchmarks, such as ensuring a specific defect percentage or deviation rate is consistently met.
In essence, quality assurance ensures that products and services consistently fulfil their quality requirements, providing confidence to both the organisation and its customers.
What is QA?
QA stands for quality assurance, a fundamental aspect of quality management. The field of quality management is rife with acronyms—GxP, ISO, FDA, NCR, and more. QA (quality assurance) is often paired with QC (quality control) in discussions about maintaining standards, forming the QA vs QC distinction.
But what does applying QA actually mean in practice?
Understanding Quality Assurance
Quality assurance involves establishing a systematic, measurable, and proactive process within your manufacturing lifecycle. The goal is to prevent defects, errors, and deviations before they occur, rather than identifying and addressing them after the fact.
At its core, QA focuses on maintaining a consistent level of quality throughout the lifecycle of a product or service. This is achieved by defining applicable quality standards, implementing processes and procedures to meet those standards, and continually monitoring and evaluating results to ensure compliance.
One of the most widely recognised frameworks for QA is ISO 9001:2015, an international standard for quality assurance that serves as the foundation for many industry-specific standards, such as ISO 13485 for medical devices. These frameworks provide organisations with a roadmap for achieving and maintaining high-quality standards.
Another notable approach is Total Quality Management (TQM), a customer-focused methodology that involves training the entire organisation to improve processes, products, and services. TQM empowers all employees to contribute to continuous improvement, fostering a culture of excellence for the benefit of customers.
While there are numerous quality assurance methods, the ultimate goal remains the same: maximising customer satisfaction by producing products and services that meet or exceed required standards.
The Quality Assurance Process
Quality assurance involves a systematic approach with several essential activities to ensure products or services meet defined quality standards.
The process begins with planning, where quality objectives, requirements, and standards are clearly defined. During the design and development phase, quality controls are implemented to prevent errors and issues from arising. As the project progresses, process implementation ensures that consistent guidelines and procedures are followed to maintain quality throughout production or service delivery.
Inspections and testing play a crucial role in quality assurance. Products and services are carefully examined to verify they meet the established standards and requirements. This is followed by continuous improvement, where feedback, data analysis, and customer satisfaction metrics are used to identify areas for enhancement. Corrective and preventive actions are then implemented to maintain and elevate quality levels.
Documentation and reporting are also integral to the QA process. Detailed records of quality-related activities, such as test results, corrective measures, and audit findings, are maintained and shared with relevant stakeholders to guide decision-making and further improvements.
For regulated industries, regular QA inspections and tests are vital to ensure adherence to quality standards. When deviations or errors occur, corrective actions are taken to ensure the product remains safe and effective.
Quality assurance requires a balanced combination of planning, testing, and monitoring. Companies must develop robust strategies to meet quality standards before production begins. Testing activities should be conducted during the production process and validated upon completion. Long-term monitoring ensures quality standards are consistently upheld.
An effective QA process provides businesses with a competitive edge by ensuring products meet strict regulatory requirements. It helps companies avoid costly recalls, maintain a strong reputation, and deliver customer satisfaction. For these reasons, quality assurance should be an integral part of any quality management plan.
What is Quality Control?
Quality control (QC) is a critical phase within the broader quality assurance (QA) framework. It focuses on the inspection and testing of products to verify their safety and effectiveness after mass production. While QA encompasses the systems and processes designed to ensure quality throughout the production lifecycle, QC serves as the hands-on, detailed check to confirm that these systems are functioning as intended and that the final outputs meet established standards.
In essence, QC involves inspecting, measuring, and testing products and processes to identify and correct any deviations from the desired quality levels. For example, in the pharmaceutical industry, QC might include testing a completed batch of medication to ensure it meets critical quality attributes. If it falls short, the batch would be discarded and remanufactured.
Quality control plays a reactive role in the manufacturing process, contrasting with QA’s proactive approach. While QA involves implementing processes to prevent defects before they occur, QC is the final check to identify and address issues after production is complete, ensuring no defects or faults reach the customer.
A common misconception is that QA and QC are interchangeable terms for “quality.” However, while they are interrelated and fall under the same umbrella of quality management, they serve distinct purposes at different stages. QA focuses on establishing systems and processes to prevent issues, while QC is about inspecting and controlling the final product to ensure it meets required standards.
Both QA and QC are essential components of a comprehensive quality management system, and neither can function effectively in isolation. You cannot rely solely on QC to “test” quality into a product—it must work alongside QA to achieve a consistently high standard of output.
Various methodologies, such as Agile, Six Sigma, and other process improvement strategies, can be applied to both QA and QC to streamline operations and ensure effective quality management. These methods help save time and enhance the overall quality of the product or service.
A robust quality management system that integrates both QA and QC ensures your products meet stringent quality standards, providing value and reliability to your customers.
Quality Assurance vs. Quality Control: Examples
Understanding the distinctions between quality assurance (QA) and quality control (QC) is essential for integrating both processes effectively. These examples demonstrate how the two complement each other while serving distinct purposes.
Proactive QA vs Reactive QC
One of the key differences between QA and QC is their approach. QA is proactive, focusing on designing processes that prevent defects from occurring. By documenting and implementing standard operating procedures (SOPs) aligned with industry standards, QA ensures that following these processes will consistently produce safe and effective products.
QC, on the other hand, is reactive, identifying defects in products after they’ve been created. For example, QC testing might uncover an issue with a medical device exceeding its error tolerance levels. This non-conformance triggers a corrective and preventive action (CAPA) investigation under QA to find the root cause and update processes to prevent future occurrences.
Process-Oriented QA vs Product-Oriented QC
QA is process-oriented, aiming to prevent quality issues by designing and enforcing robust procedures throughout the production lifecycle. These processes extend from the manufacturing line to warehousing and beyond. In contrast, QC is product-focused, ensuring the final outputs meet the required standards and customer expectations.
While QA focuses on the actions that lead to product creation, QC verifies that the end results are satisfactory. For instance, QA activities might include documentation, audits, and supplier management, whereas QC involves tasks like batch inspection, product sampling, and laboratory testing.
System-Wide QA vs Component-Focused QC
QA operates at the system level, setting overarching methods and procedures to safeguard quality standards. For example, QA ensures raw materials from suppliers meet safety and efficacy standards through activities like supplier audits and batch sampling.
QC focuses on evaluating individual components or parts used in production, such as raw materials or specific product outputs. This ensures the quality of each element before it contributes to the final product.
Creation Through QA vs Verification Through QC
QA defines the roadmap for producing high-quality products. It involves setting standards for design, manufacturing, packaging, and distribution to guide the creation process. QC, by contrast, verifies the quality of products after manufacturing but before distribution, confirming they meet safety and efficacy requirements.
Entire Workforce in QA vs Dedicated Personnel in QC
QA activities involve the entire organisation. Everyone in the business plays a role in QA by adhering to SOPs, policies, and training standards established by the quality management system (QMS). Leadership and the quality unit oversee the QMS, ensuring it supports the organisation’s goals.
QC, as a subset of QA, is typically the responsibility of specialised personnel. These individuals follow SOPs to perform tasks such as product inspection, verification, and testing. The data collected through QC feeds back into the QA process, allowing for continuous improvement of the overall quality system.
By integrating both QA and QC effectively, organisations can ensure that quality is built into every stage of production and delivery, resulting in safer and more reliable products.
QA vs QC: The Role of an eQMS in Quality Assurance and Quality Control
Both quality assurance (QA) and quality control (QC) are essential components of a robust quality management system, and neither can be considered optional. QA establishes the standards and processes necessary for creating a safe and effective production environment, while QC validates the final product to ensure it meets those standards. A balanced approach to QA and QC is critical for maximising the effectiveness of your quality management system.
The Risks of Imbalance
When QC is neglected, businesses risk relying on lofty policies and procedures that don’t align with actual outputs. This can lead to undetected defects and weaknesses, resulting in dissatisfied customers, regulatory noncompliance, and even catastrophic outcomes such as recalls, fines, or shutdowns.
On the other hand, insufficient QA may result in steady but stagnant product quality. Without a proactive approach to refining processes, conducting audits, or upskilling employees, businesses may struggle to adapt and fail to reach their full potential.
The QA vs QC Challenge in Regulated Industries
Many modern quality professionals, particularly in regulated industries such as life sciences, face challenges in striking the right balance between QA and QC. According to a 2024 global survey, over half of life science quality professionals reported spending no more than 25% of their time on QA tasks, while 60% performed no QC activities at all.
This imbalance is often exacerbated by reliance on outdated quality management tools like paper and spreadsheets, which consume excessive amounts of time with manual administrative tasks. These inefficiencies force organisations to prioritise either QA or QC, resulting in compromised quality initiatives and hindering continuous improvement efforts.
The Role of eQMS in Balancing QA and QC
Electronic quality management systems (eQMS) provide a solution by digitising and automating quality systems, significantly reducing non-value-adding administrative tasks. This technology frees up time for professionals to focus on both QA and QC, ensuring a harmonious approach that supports operational excellence.
A cloud-based eQMS designed for life science companies enables businesses to both assure and control quality. Features such as document management, training, design control, quality event tracking, and supplier management are integrated into a single platform, streamlining operations and improving overall efficiency.
Why Choose EZtek Software?
EZtek Software is dedicated to providing tailored solutions for businesses of all sizes, from start-ups to scale-ups. Our expertise in software development ensures that we deliver scalable and user-friendly quality management systems designed to streamline your QA and QC processes. By integrating your operations into a single, state-of-the-art platform, EZtek empowers your organisation to uphold high-quality standards while fostering continuous improvement.
If your business needs a reliable and efficient solution to effectively balance QA and QC, EZtek Software is here to help. Get in touch with us today, and let’s work together to unlock your organisation’s full potential.
